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Clinical particulars
Target species
Cattle.
Indications for use, specifying the target species
Specifically formulated to provide initial anti-inflammatory for 24-36 hours and sustained anti-bacterial activity for 5-6 days following a single administration.
Indicated primarily for the treatment of bovine respiratory disease associated with Mannheimia haemolytica where an anti-inflammatory and anti-pyretic effect is required.
In addition, a wide range of organisms are known to be sensitive in vitro to oxytetracycline, including Pasteurella spp, Arcanobacterium pyogenes, Staphylococcus aureus and certain mycoplasmas. The product may therefore be of use in the treatment of disease in cattle caused by such organisms where an anti-inflammatory and antipyretic effect is required.
Contraindications
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding or where there is hypersensitivity to the product.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.
Do not administer other NSAIDs concurrently, or within 24 hours of each other.
Concurrent use of potentially nephrotoxic drugs should be avoided.
Do not exceed the stated dose or duration of treatment.
Special Warnings for Each Target Species
None known.
Special Precautions for Use
Special Precautions for use in animals:
Avoid intra-arterial injection.
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.
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.
Special precautions to be taken by the person administering the product to the animals:
Avoid eye contact and direct contact with skin.
To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during application.
Wash hands after use.
In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.
The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious.
Avoid accidental self-injection.
Adverse reactions (frequency and seriousness)
The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.
Although the product is well tolerated, occasionally a local reaction of a transient nature may be observed.
Hypersensitivity reactions (collapse) may occur very rarely. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
The frequency of adverse reactions is defined using the following convention:
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.
Safety studies have not been conducted in pregnant animals.
Interactions with other medicinal products and other forms of interaction
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Amount to be administered and administration route
Indicated for deep intramuscular administration to cattle. The recommended dosage is 1 ml per 10 kg bodyweight (equivalent to 2 mg/kg flunixin and 30 mg/kg oxytetracycline) on a single occasion.
Maximum volume per injection site: 15ml. If concurrent treatment is administered use a separate injection site.
Additional therapy with an NSAID may be administered after 24 hours if required.
Avoid the introduction of contamination.
Overdose (symptoms, emergency procedures, antidotes) (if necessary)
Symptomatic therapy as necessary. Maintain adequate hydration.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Cattle may be slaughtered for human consumption only after 35 days from the last treatment.
Not for use in cattle producing milk for human consumption.