Novem - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Novem 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

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Novem 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.

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.

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

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, including isolated reports treated).

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

Treatment of piglets with Novem 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 Novem 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 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.

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:

Novem 20 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

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Novem 20 mg/ml solution for injection for cattle and pigs Meloxicam

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

One ml contains:

Meloxicam 20 mg

Ethanol 150 mg

Clear yellow solution.

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.

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, 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 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/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.

• 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

• 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)

Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain. Novem 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 veterinary medicinal product 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.

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

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 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:

Novem 40 mg/ml solution for injection for cattle

• 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 realease:

Labiana Life Sciences S.A.

Venus, 26

Can Parellada Industrial

08228 Terrassa

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Novem 40 mg/ml solution for injection for cattle 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)

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.

• 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 1 week of age.

• 6. ADVERSE REACTIONS

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

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

Single subcutaneous 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.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 15 days; milk: 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 label after EXP.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

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

Can be used during pregnancy and lactation.

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

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 product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION