Novem
meloxicam
Novem 5 mg/ml solution for injection for cattle and pigs
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
Novem 5 mg/ml solution for injection for cattle and pigs Meloxicam
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.
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.
Cattle (calves and young cattle) and pigs
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.
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.
Avoid introduction of contamination during use.
Cattle: meat and offal: 15 days Pigs: meat and offal: 5 days
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.
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.
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.
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.
Novem 20 mg/ml solution for injection for cattle and pigs
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
Novem 20 mg/ml solution for injection for cattle and pigs Meloxicam
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.
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.
Cattle and pigs
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.
Avoid introduction of contamination during use.
Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
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.
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.
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.
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.
Novem 40 mg/ml solution for injection for cattle
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
Novem 40 mg/ml solution for injection for cattle Meloxicam
One ml contains:
Meloxicam 40 mg
Ethanol 150 mg
Clear yellow solution.
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.
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.
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.
Cattle
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.
Avoid introduction of contamination during use.
Meat and offal: 15 days; milk: 5 days.
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.
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.
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.
Detailed information on this product is available on the website of the European Medicines Agency .
Pack sizes of 1 or 12 colourless glass injection vial(s) of 50 ml or 100 ml. Not all pack sizes may be marketed.