Rexxolide

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 Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin. The presence of the disease in the group must be established before the veterinary medicinal 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, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica susceptible to tulathromycin. The presence of the disease in the group must be established before the veterinary medicinal 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 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. The stopper may be safely punctured up to 25 times.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated):

Injection site pain^a, injection site swelling^a Injection site reactions (e.g. injection site congestion, injection site oedema, injection site fibrosis, injection site haemorrhage)^b

^aTransient, can persist for up to 30 days.

^bPathomorphological reversible changes, for approximately 30 days after injection.

Pigs:

Very common

(>1 animal / 10 animals treated):

Injection site reactions (e.g. injection site congestion, injection site oedema, injection site fibrosis, injection site haemorrhage)^a

^aPathomorphological reversible changes, for approximately 30 days after injection.

Sheep:

Very common

(>1 animal / 10 animals treated):

Discomfort^a

Head shake^a, backing away^a

Injection site scratching^a

^aThese 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 respective contact details.