Draxxin 100 mg/ml solution for injection for cattle & pigs.
A clear aqueous ready to use solution containing tulathromycin 100 mg/ml.
Treatment and prevention of bovine respiratory disease associated with Mannheimia (Pasteurella) haemolytica, Pasteurella multocida, Mycoplasma bovis and Histophilus somni sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Treatment and prevention of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae and Haemophilus parasuis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment. Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.
Dosage and administration
A single subcutaneous injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.
A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.
To ensure correct dosage body weight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.
Contra-indications, warnings, etc
Do not use in case of hypersensitivity of the target animals to macrolide antibiotics.
Do not use the product simultaneously with other macrolides or lincosamides.
Do not use in lactating cattle producing milk for human consumption.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
In the absence of compatibility studies, do not mix with other veterinary medicinal products.
Cattle (meat and offal):
Pig (meat and offal):
Subcutaneous administration of DRAXXIN to cattle frequently causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs after intramuscular administration. Pathomorphological injection site reactions are present for approximately 30 days after injection in both species. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Cross resistance occurs with other macrolides.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs. Use only according to the benefit/risk assessment by the responsible veterinarian.
In cattle at dosages of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dose. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.
For the user
Wash hands after use.
Tulathromycin is irritating to eyes. If accidental eye exposure occurs, flush the eyes immediately with clean water.
Tulathromycin may cause sensitisation by skin contact. If accidental skin exposure occurs, wash the skin immediately with soap and water.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
No special precautions for storage.
Use within 28 days of first opening or broaching the vial.
Keep out of the reach and sight of children.
Any unused product or waste materials should be disposed of in accordance with local requirements.
Clear glass vials containing 20ml, 50ml and 100ml.
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