Draxxin

1 x 20 ml

Liquid for injection, solution

Active substance

Tulathromycin : 100 mg/ml

ATC code

QJ01FA94 Tulathromycin

QJ01FA Macrolides

QJ01F Macrolides, lincosamides and streptogramins

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle, pigs and sheep

Indications

Cattle:

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis . The presence of the disease in the group must be established before the product is used.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Pigs:

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica . The presence of the disease in the group must be established before the product is used. The veterinary medicinal product should only be used if pigs are expected to develop the disease within 2–3 days.

Sheep:

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Dose to be administered and administration route

Cattle:

Subcutaneous use.

A single subcutaneous injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml of the veterinary medicinal product/40 kg bodyweight). For treatment of cattle over 300 kg body weight, divide the dose so that no more than 7.5 ml are injected at one site.

Pigs:

Intramuscular use.

A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml of the veterinary medicinal product/40 kg body weight) in the neck.

For treatment of pigs over 80 kg body weight, divide the dose so that no more than 2 ml are injected at one site.

For any respiratory disease, 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.

Sheep:

Intramuscular use.

A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml of the veterinary medicinal product/40 kg body weight) in the neck.

To ensure a correct dosage body weight should be determined as accurately as possible. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.

Adverse reactions

Cattle:

Very common (>1 animal / 10 animals treated):

Injection site swelling^{^[1]}, Injection site fibrosis^{^[2]}, Injection site haemorrhage¹, Injection site oedema¹, Injection site reaction², Injection site pain³

¹ Can persist for approximately 30 days after injection.

² Reversible changes of congestion

³ Transient

Pigs:

Very common (>1 animal / 10 animals treated):

Injection site reaction^1,2, Injection site fibrosis¹,

Injection site haemorrhage¹, Injection site oedema¹

¹Can persist for approximately 30 days after injection.

² Reversible changes of congestion

Sheep:

Very common (>1 animal / 10 animals treated):

Discomfort¹

¹Transient, resolving within a few minutes: head shaking, rubbing injection site, backing away.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.