Cattle

For the treatment of bovine respiratory disease caused by Mannheimia (Pasteurella) haemolytica where an anti-inflammatory and anti-pyretic effect is required.

Do not use in in animals suffering from cardiac, hepatic, or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding.

Do no use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Do not use the veterinary medicinal product where there are signs of blood dyscrasias or haemostasis alteration.

Cross-resistance has been shown between oxytetracycline and other antimicrobials belonging to the tetracyclines class in Mannheimia (Pasteurella) haemolytica. When susceptibility testing has shown resistance to other tetracycline antimicrobials the use of oxytetracycline should be carefully considered because its effectiveness may be reduced.

Use in any animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.

It is preferable that prostaglandin inhibiting drugs are not administered to animals undergoing general anaesthesia until fully recovered.

Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.

Use of the veterinary medicinal product should be in accordance with official, national, and regional antimicrobial policies.

Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.

This veterinary medicinal product may be harmful after accidental self-injection. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.

This veterinary medicinal product may be irritating to the skin and/or eye. Avoid skin and/or eye contact. Latex or nitrile gloves should be worn during application. In case of accidental contact with skin or eyes, rinse with copious amounts of water. If irritation persists, seek medical advice.

This veterinary medicinal product may cause hypersensitivity reactions due to the presence of oxytetracycline, flunixin, polyethylene glycol or ethanolamine. People with known hypersensitivity to tetracyclines, NSAIDs or one of the excipients should avoid contact with the veterinary medicinal product. If allergic symptoms develop, such as a skin rash, swelling of the face, lips or eyes or difficulty in breathing, you should seek medical attention immediately and show the package leaflet or label to the doctor.

Daily exposure of laboratory animals (rats) to glycerol formal results in teratogenic and foetotoxic effects. Pregnant women and women of child-bearing age should take particular caution to avoid exposure when administering the veterinary medicinal product.

Cattle:

a May occur, which can be fatal.

b A usually mild reaction at the injection site may be observed following intramuscular administration and may persist for up to 30 days. Studies in cattle at the normal dose rate have shown transient and dose dependent reactions at the injection site.

c Any increase is transient and will be unlikely to occur in animals already suffering from pyrexia.

d The use of tetracyclines during the period of tooth and bone development may lead to discoloration.

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 national competent authority via the national reporting system or the marketing authorisation holder (or their local representative). See the package leaflet for contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Studies in laboratory animals have shown evidence of foetotoxicity after oral (rabbit and rat) and intramuscular (rat) administration of flunixin at maternotoxic doses, and a lengthening of the duration of gestation (rat).

Use is not recommended during pregnancy and lactation.

Concurrent use of potentially nephrotoxic drugs should be avoided (e.g. aminoglycosides). Flunixin may reduce the renal excretion of certain veterinary medicinal products and increase their toxicity, such as for aminoglycosides.

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

Do not administer other NSAIDs concurrently or within 24 hours of each other. Additional therapy with a NSAID may be administered after 24 hours if required.

Concurrent use of corticosteroids should be avoided.

Flunixin may reduce the effect of some anti-hypertensive medicinal products, such as diuretics and beta blockers, by inhibition of prostaglandin synthesis.

Indicated for deep intramuscular administration to cattle.

The recommended dosage is 1 ml per 10 kg body weight (equivalent to 2 mg/kg flunixin and 30 mg/kg oxytetracycline).

To ensure a correct dosage, body weight should be determined as accurately as possible. The veterinary medicinal product is recommended for administration on a single occasion only. Maximum volume per injection site: 15ml.

If concurrent treatment is administered use a separate injection site.

Following administration at twice the recommended treatment dose (4 mg/kg flunixin and 60 mg/kg oxytetracycline) the veterinary medicinal product is expected to be well tolerated. At this 2x dose level transient dysentery with or without apathy may occur; symptoms resolving without treatment within 48-72 hours. Studies in cattle at twice the normal dose rate have shown transient and dose dependent reactions at the injection site.

At higher dose levels, above 3x the recommended treatment dose, there is an increased risk of renal toxicity. This may manifest as elevated plasma urea and creatinine levels and pathological changes to the kidneys (cortical tubular necrosis).

Management of overdose should be symptomatic, ensuring adequate hydration is maintained.

Meat and offal: 35 days

Not authorised for use in cattle producing milk for human consumption.