Metacam - patient leaflet, side effects, dosage

Patient leaflet - Metacam

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Metacam 5 mg/ml solution for injection for cattle and pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

Manufacturer responsible for batch release

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa, Barcelona

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for cattle and pigs Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 5 mg

Ethanol 150 mg

Clear yellow solution.

INDICATION(S)

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For the relief of post operative pain associated with minor soft tissue surgery such as castration.

CONTRAINDICATIONS

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Do not use in pigs less than 2 days old.

6. ADVERSE REACTIONS

In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Cattle (calves and young cattle) and pigs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.

10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.

9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Cattle: meat and offal: 15 days

Pigs: meat and offal: 5 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle after EXP.

12. SPECIAL WARNING(S)

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.

To obtain the best possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical intervention.

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal antiinflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Cattle: Can be used during pregnancy.

Pigs: Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 1.5 mg/ml oral suspension for dogs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1.5 mg/ml oral suspension for dogs Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)

Yellowish viscous oral suspension with a green tinge.

4. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.

Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after > 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Method and route of administration

Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:

Initial dose: 4 drops/kg body weight

Maintenance dose: 2 drops/kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

Shake bottle well.

Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.

Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your dog's body weight in kilograms.

Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.

By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.

Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing.

Please carefully follow the instructions of the veterinarian.

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

10 ml, 32 ml, 100 ml or 180 ml bottle.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 5 mg/ml solution for injection for dogs and cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

Manufacturers responsible for batch release

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa, Barcelona

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for dogs and cats Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 5 mg

Ethanol 150 mg

Clear yellow solution.

4. INDICATION(S)

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rearely been reported from post-marketing safety experience.

Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Anaphylactoid reactions have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs and cats

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage for each species

Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).

Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).

Method and routes of administration

Dogs:

Musculo-skeletal disorders: single subcutaneous injection.

Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneaous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

10 ml or 20 ml injection vial.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

Manufacturers responsible for batch release

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa, Barcelona

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 20 mg

Ethanol 150 mg

Clear yellow solution.

4. INDICATION(S)

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses:

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

5. CONTRAINDICATIONS

Do not use in horses less than 6 weeks of age.

Do not use in pregnant or lactating mares.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

6. ADVERSE REACTIONS

In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site was observed in isolated cases in clinical studies, but resolved without intervention.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Cattle, pigs and horses

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.

2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Horses:

Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Cattle: meat and offal: 15 days; milk: 5 days

Pigs: meat and offal: 5 days

Horses: meat and offal: 5 days.

Not authorised to use in horses producing milk for human consumption.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Cattle and pigs: Can be used during pregnancy and lactation.

Horses: Do not use in pregnant or lactating mares.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose, symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

Cardboard box with either 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) of 250 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 15 mg/ml oral suspension for horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for horses Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains: Meloxicam 15 mg

Yellowish viscous oral suspension with a green tinge.

4. INDICATION(S)

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

5. CONTRAINDICATIONS

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in horses less than 6 weeks of age.

ADVERSE REACTIONS

Diarrhoea, typically associated with non-steroidal anti-inflammatory drugs (NSAIDs), was very rarely observed in clinical trials. The clinical sign was reversible.

Loss of appetite, lethargy, abdominal pain, colitis and urticaria have been reported very rarely from postmarketing safety experience.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Horses

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage

Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.

Method and route of administration

Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.

After administration of the drug, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Meat and offal: 3 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening of the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency

15. OTHER INFORMATION

100 ml or 250 ml bottle.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 0.5 mg/ml oral suspension for dogs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for dogs Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)

Yellowish viscous oral suspension with a green tinge.

4. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

6. ADVERSE REACTIONS

Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage

Method and route of administration

Dosing procedure using the drop dispenser of the bottle:

Initial dose: 10 drops/kg body weight

Maintenance dose: 5 drops/kg body weight.

Dosing procedure using the measuring syringe:

Shake bottle well.

Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.

Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your dog's body weight in kilograms.

Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.

By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.

Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

15 ml or 30 ml bottle.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 1 mg chewable tablets for dogs

Metacam 2.5 mg chewable tablets for dogs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1 mg chewable tablets for dogs

Metacam 2.5 mg chewable tablets for dogs

Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One tablet contains:

Meloxicam 1 mg

Meloxicam 2.5 mg

Round mottled beige biconvex tablet, scored on the upper side with embedded code either „M10“ or „M25“ on one side. The tablet can be divided into equal halves.

INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:

Body weight (kg)	Number of chewable tablets		mg/kg
Body weight (kg)	1 mg	2.5 mg	mg/kg
4.0–7.0	*/2		0.13–0.1
7.1–10.0	1		0.14–0.1
10.1– 15.0	1'/2		0.15–0.1
15.1–20.0	2		0.13–0.1
20.1–25.0		1	0.12–0.1
25.1–35.0		1'/2	0.15–0.1
35.1–50.0		2	0.14–0.1

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

Instructions for opening the child-resistant blisters: Push the tablet for release from the blister.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the blister after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the carton to the physician.

Pregnancy and lactation:

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

Package sizes:

Metacam 1 mg chewable tablets for dogs

Blisters: 7, 84 or 252 tablets.

Metacam 2.5 mg chewable tablets for dogs

Blisters: 7, 84 or 252 tablets.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 0.5 mg (equivalent to 0.017 mg per drop).

Yellowish viscous oral suspension with a green tinge.

INDICATION(S)

Cats:

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:

Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.

CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cats less than 6 weeks of age.

Do not use in guinea pigs less than 4 weeks of age.

ADVERSE REACTIONS

In cats, typical adverse reactions of non-steroidal anti-inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.

Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from postmarketing safety experience.

These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions during)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Cats and guinea pigs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cats:

Dosage

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to 4 days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight.

A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration

To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using the drop dispenser of the bottle for cats of any body weight.

Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the package can be used.

Particular care should be taken with regard to the accuracy of dosing.

The recommended dose should not be exceeded.

Dosing procedure using the drop dispenser of the bottle:

Dose of 0.2 mg meloxicam/kg body weight:

12 drops/kg body weight 6 drops/kg body weight 3 drops/kg body weight.

Dose of 0.1 mg meloxicam/kg body weight:

Dose of 0.05 mg meloxicam/kg body weight:

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the dose of 0.05 mg meloxicam/kg bodyweight. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required.

For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.

Shake bottle well.

Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.

Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your cat's body weight in kilograms.

Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.

By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.

Guinea pigs:

Dosage

Post-operative pain associated with soft tissue surgery:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).

Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration

The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight

Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs. advised to dispense a few drops corresponds to the body weight of more than required into the small the guinea pig.

Shake bottle well.

Push down and unscrew bottle top.

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is

Use the 1 ml standard syringe and draw up the required volume of Metacam oral suspension which

By pushing the plunger in empty the contents of the syringe directly into the mouth of the guinea pig.

container).

9. ADVICE ON CORRECT ADMINISTRATION

Please carefully follow the instructions of the veterinarian.

Shake well before use.

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S )

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container:

3 ml bottle: 14 days

10 ml, 15 ml and 30 ml bottles: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Post-operative use in cats and guinea pigs:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinany medicinal product to animals: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.

The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes):

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section „Adverse reactions“, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

3 ml, 10 ml, 15 ml or 30 ml bottle.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 2 mg/ml solution for injection for cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

Manufacturers responsible for batch release

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa, Barcelona

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 2 mg/ml solution for injection for cats Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 2 mg

Ethanol 150 mg

Clear yellow solution.

4. INDICATION(S)

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.

6. ADVERSE REACTIONS

Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from postmarketing safety-experience.

These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Anaphylactoid reactions have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Cats

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Single subcutaneous injection of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation. This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible e.g. feral cats. In this case do not use oral follow up treatment.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice. In case additional pain relief is required, multimodal pain therapy should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

See section „Contraindications“.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Overdose (symptoms, emergency procedures, antidotes):

In the case of overdose symptomatic treatment should be initiated.

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

10 ml or 20 ml injection vial.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 15 mg/ml oral suspension for pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for pigs Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

One ml contains:

Meloxicam 15 mg

Yellowish viscous oral suspension with a green tinge.

4. INDICATION(S)

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-Agalactia syndrome MMA) with appropriate antibiotic therapy.

5. CONTRAINDICATIONS

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

6. ADVERSE REACTIONS

None.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Pigs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam

20 mg/ml solution for injection is recommended.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

9. ADVICE ON CORRECT ADMINISTRATION

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.

10. WITHDRAWAL PERIOD(S)

Meat and offal: 5 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening of the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency

15. OTHER INFORMATION

100 ml or 250 ml bottle.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Metacam 40 mg/ml solution for injection for cattle and horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

Manufacturers responsible for batch release

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa, Barcelona

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 40 mg/ml solution for injection for cattle and horses Meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

One ml contains:

Active substance:

Meloxicam 40 mg

Excipient:

Ethanol 150 mg

Clear yellow solution.

4. INDICATION(S)

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Horses:

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

5. CONTRAINDICATIONS

Do not use in horses less than 6 weeks of age. Do not use in pregnant or lactating mares (see section “Pregnancy and lactation”).

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

6. ADVERSE REACTIONS

In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site was observed in isolated cases in clinical studies, but resolved without intervention.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Cattle and horses.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle:

Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.

1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Horses:

Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

Cattle: meat and offal: 15 days; milk: 5 days.

Horses: meat and offal: 5 days.

Not authorised for use in horses producing milk for human consumption.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the container: 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Cattle: Can be used during pregnancy and lactation.

Horses: Do not use in pregnant or lactating mares (see section “Contraindications”).

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose, symptomatic treatment should be initiated.

Major incompatibilities:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15. OTHER INFORMATION

Metacam - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Metacam

Metacam 5 mg/ml solution for injection for cattle and pigs

Metacam 1.5 mg/ml oral suspension for dogs

Metacam 5 mg/ml solution for injection for dogs and cats

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

Metacam 15 mg/ml oral suspension for horses

Metacam 0.5 mg/ml oral suspension for dogs

Metacam 1 mg chewable tablets for dogs

Metacam 2.5 mg chewable tablets for dogs

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

Metacam 2 mg/ml solution for injection for cats

Metacam 15 mg/ml oral suspension for pigs

Metacam 40 mg/ml solution for injection for cattle and horses