Target species
Cattle.
Indications for use for each target species
The veterinary medicinal product is indicated as an adjunct to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and acute mastitis in cattle.
Contraindications
Do not use in animals suffering from cardiac, hepatic or renal impairment.
Do not use in animals suffering from gastro-intestinal ulceration or bleeding.
Do not use where there is evidence of a blood dyscrasia.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.
Do not exceed the stated dose or the duration of treatment.
Do not administer other NSAID's concurrently or within 24 hours of each other.
As NSAID therapy can be accompanied by gastro-intestinal or renal impairment, adjunctive fluid therapy should be considered especially in the case of acute mastitis treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Carprofen, in common with other NSAIDs, has been shown to exhibit photosensitising potential in laboratory studies. Avoid skin contact with the veterinary medicinal product. Should this occur, wash the affected areas immediately.
Special precautions for the protection of the environment:
None.
Adverse events
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction1 |
1 Transient
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
The safety of the veterinary medicinal product has not been established during pregnancy.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
In common with other NSAIDs, carprofen should not be administered simultaneously with another veterinary medicinal product of the NSAID or glucocorticoid class.
NSAID's are highly bound to plasma proteins and may compete with other highly bound drugs, such that concomitant administration may result in toxic effects.
However, during clinical studies in cattle four different antibiotic classes were used, macrolides, tetracyclines, cephalosporins and potentiated penicillins without known interactions.
Administration routes and dosage
Subcutaneous or intravenous use.
Single subcutaneous or intravenous injection at a dosage of 1.4 mg carprofen/kg body weight (1 ml/35 kg) in combination with antibiotic therapy, as appropriate.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In clinical studies, no adverse signs were reported after intravenous and subcutaneous administration of up to 5 times the recommended dose.
There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAID's, should be applied.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Meat and offal: 21 days.
Milk: Zero days.