Melovem - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET FOR:

Melovem 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:

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer The Netherlands

Manufacturer responsible for batch release:

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

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

Each ml contains:

Active substance:

Meloxicam 5 mg

Excipient(s):

Benzyl alcohol 50 mg

A clear, greenish 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 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.

• 5. 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 case 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

Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle. Injection site swelling may be painful.

Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

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

• – very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals)

• – rare (more than 1 but less than 10 animals in 10,000 animals)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cattle (calves and young cattle) and pigs.

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

Cattle:

Single subcutaneous 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. It is recommended to administer the second injection at a different site since local tolerance has been assessed after single injection only.

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

Cattle: meat and offal: 15 days.

Not permitted for use in lactating animals producing milk for human consumption.

Pigs: meat and offal: 5 days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Keep injection vial in the outer carton in order to protect from light.

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

Shelf life after first opening the container: 28 days.

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

• 12. SPECIAL WARNINGS

Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain.

Melovem 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 Melovem 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 Melovem 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 Anti-Inflammatory 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.

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 anti-coagulant agents.

Overdose (symptoms, emergency procedures, antidotes) :

In the case of overdosage, symptomatic treatment should be initiated.

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

Waste materials should be disposed of in accordance with local requirements.

• 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 colourless type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

PACKAGE LEAFLET FOR

Melovem 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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Manufacturer responsible for the batch release

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

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

Each ml contains:

Active substance:

Meloxicam 20 mg

Excipient(s):

Ethanol 150 mg

A clear yellow solution.

• 4. INDICATIONS

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 case 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 and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; 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 can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

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

• – very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals)

• – rare (more than 1 but less than 10 animals in 10,000 animals)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports)

If you notice any serious effects or other effects not mentioned in this leaflet, 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).

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper.

The maximum number of broachings should be limited to 20.

• 10. WITHDRAWAL PERIOD

Cattle:

Meat and offal: 15 days

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.

Keep injection vial in the outer carton in order to protect from light.

Do not refrigerate or freeze. Protect from frost.

Shelf life after first opening the container: 28 days.

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

• 12. SPECIAL WARNINGS

Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain. Melovem 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.

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.

Special precautions to be taken by the person administering the product to animals

Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory 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.

Pregnancy and lactation

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

Horses: Do not use in pregnant or lactating mares.

Interactions with other medicinal products and other forms of interaction

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

Overdose (symptoms, emergency procedures, antidotes)

In the case of overdose, symptomatic treatment should be initiated.

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

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 colourless glass injection vial of 50 ml, 100 ml or 250 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET FOR

Melovem 30 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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Manufacturer responsible for the batch release

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam

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

each ml contains:

Active substance:

Meloxicam 30 mg

Excipient(s):

Benzyl alcohol 20 mg

A clear yellow solution.

• 4. INDICATIONS

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.

• 5. 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 case 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 and pigs, subcutaneous and intramuscular administration is well tolerated; 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 very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

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

• – very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals )

• – rare (more than 1 but less than 10 animals in 10,000 animals)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports)

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cattle and pigs

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

Cattle:

Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 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/150 kg body weight) in combination with antibiotic therapy, as appropriate.

If required, a second administration of meloxicam can be given after 24 hours.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper.

The maximum number of broachings should be limited to 20.

• 10. WITHDRAWAL PERIOD

Cattle:

Meat and offal: 15 days.

5 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 temperature storage conditions.

Shelf life after first opening the container: 28 days.

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

• 12. SPECIAL WARNINGS

Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain. Melovem 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.

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 product to animals

Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory 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.

Pregnancy and lactation

Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction

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

Overdose (symptoms, emergency procedures, antidotes)

In the case of overdose, symptomatic treatment should be initiated.

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

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