Tulaven

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 and sheep.

Indications

Cattle

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Histophilus somni ,Mannheimia haemolytica, Pasteurella multocida and Mycoplasma bovis susceptible to tulathromycin. 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 susceptible to tulathromycin.

Pigs

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with

Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Haemophilus parasuis Pasteurella multocida and Mycoplasma hyopneumoniae susceptible to tulathromycin. 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 of the veterinary medicinal product/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 of the veterinary medicinal product/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.

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 correct dosage, bodyweight 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. The stopper may be safely punctured up to 20 times.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated)

Injection site swelling¹, Injection site pain¹, Injection site oedema², Injection site fibrosis², Injection site haemorrhage²,

Injection site haematoma²

¹ These signs are observed after subcutaneous administration.

² These signs are reversible and can persist for approximately 30 days.

Pigs:

Very common

(>1 animal / 10 animals treated)

Injection site oedema, Injection site fibrosis, Injection site haemorrhage, Injection site

haematoma

These signs are reversible and can persist for approximately 30 days.

Sheep:

Very common

(>1 animal / 10 animals treated)

Discomfort¹

¹ Head shaking, rubbing injection site, backing away.

These signs appear after intramuscular injection and 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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.