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  • 20ml Bottle £85.30
  • 50ml Bottle £194.14
  • 100ml Bottle £372.58

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Description

Draxxin Injection is given to cattle and pigs to control common respiratory diseases. A single injection is given at a dose rate of 1ml per 40kg bodyweight. The response to treatment should be evaluated after 48 hours and if this is poor, the diagnosis should be checked and an alternative treatment considered.

Presentation

A clear aqueous ready to use solution containing tulathromycin 100 mg/ml.

Uses

Cattle

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.

Pigs

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

Cattle

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.

Pigs

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.

Withdrawal periods

Cattle (meat and offal):

49 days

Pig (meat and offal):

33 days

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.

Pharmaceutical precautions

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.

Legal category

POM-V

Packaging Quantities

Clear glass vials containing 20ml, 50ml and 100ml.

Further information

Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product. It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.

Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.

Tulathromycin possesses in vitro activity against Mannheimia (Pasteurella) haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae, the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively. Increased MIC values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae.

Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux. MLSB resistance may be constitutive or inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.

In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg body weight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.5 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 L/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.

In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg body weight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.6 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg. The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.

Marketing authorisation number

EU/2/03/041/001-3.

GTIN (Global Trade Item No)

20 ml:

05013457079470

50 ml:

05013457079227

100 ml:

05013457079234

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