Tuloxxin

1 x 50 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, 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 bodyweight (equivalent to 1 ml/40 kg bodyweight). 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

Intramuscular use.

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) 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.

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/40 kg body weight) in the neck.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. The cap may be safely punctured up to 20 times. When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated):

Injection site reactions (congestion, oedema, fibrosis, haemorrhage, pain)¹

¹Reversible. May be observed or persist for approximately 30 days after injection.

Pigs:

Very common

(>1 animal / 10 animals treated):

Injection site reactions (congestion, oedema, fibrosis, haemorrhage)¹

¹Reversible, may be observed approximately for 30 days after injection.

Sheep:

Very common

(>1 animal / 10 animals treated):

Discomfort (head shaking, rubbing injection site, backing away)¹

¹The signs resolve within a few minutes.

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 also the package leaflet for contact details.