B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Contacera 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:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 20 mg Ethanol (96%) 159.8 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 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

Common adverse reactions include slight transient swelling at the injection site following subcutaneous administration in cattle and pigs. This was observed in less than 10% of the cattle treated in clinical studies.

Uncommon adverse reactions include transient swelling at the injection site in horses, but resolves without intervention.

In very rare cases, anaphylactoid reactions, which may be serious (including fatal), when they occur, they 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 reaction(s))

• – 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 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 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam 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.

Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.

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

Pigs: meat and offal: 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 carton and vial after EXP. The expiry date refers to the last day of that month.

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

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.

Cardboard box containing one colourless glass vial of 20 ml, 50 ml, 100 ml or 250 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Contacera 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:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Meloxicam 20 mg Ethanol (96%) 159.8 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 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

Common adverse reactions include slight transient swelling at the injection site following subcutaneous administration in cattle and pigs. This was observed in less than 10% of the cattle treated in clinical studies.

Uncommon adverse reactions include transient swelling at the injection site in horses, but resolves without intervention.

In very rare cases, anaphylactoid reactions, which may be serious (including fatal), when they occur, they 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 reaction(s))

• – 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 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 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam 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.

Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.

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

Pigs: meat and offal: 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 carton and vial after EXP. The expiry date refers to the last day of that month.

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

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.

Cardboard box containing one colourless glass vial of 20 ml, 50 ml, 100 ml or 250 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Contacera 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:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Contacera 15 mg/ml oral suspension for horses meloxicam

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

One ml contains:

Meloxicam 15 mg

Sodium benzoate 5 mg

• 4. INDICATION(S)

Alleviation of inflammation and 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 case of hypersensitivity to the active substance or to any of the excipients.

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

• 6. ADVERSE REACTIONS

In very rare cases, adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur 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 reaction(s))

• – 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

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

This is equivalent to 1 ml of Contacera per 25 kg body weight of horse. For example, a horse weighing 400 kg will receive 16 ml of Contacera, a horse weighing 500 kg will receive 20 ml of Contacera, and a horse weighing 600 kg will receive 24 ml of Contacera.

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 2 ml scale.

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

Avoid introduction of contamination during use.

Meat and offal: 3 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.

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month.

Shelf- life after first opening the container: 3 months.

• 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 increased renal toxicity.

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.

Pregnancy and lactation:

Do not use in pregnant or lactating mares.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticoids, 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 PRODUCT OR WASTE MATERIAL, 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