Zactran

1 x 50 ml

Liquid for injection, solution

Active substance

Gamithromycin : 150 mg/ml

ATC code

QJ01FA95 Gamithromycin

QJ01FA Macrolides

QJ01F Macrolides, lincosamides and streptogramins

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle, sheep and pigs.

Indications

Cattle:

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

The presence of the disease in the group should be established before the product is used.

Pigs:

Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Glaesserella parasuis, and Pasteurella multocida.

Sheep:

Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.

Dose to be administered and administration route

A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep). To ensure correct dose, body weight should be determined as accurately as possible.

Cattle and sheep:

Subcutaneous injection. For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site.

Pigs:

Intramuscular injection. The injection volume should not exceed 5 ml per injection site.

This multi-usage presentation requires an automatic dosing device to be used to avoid excessive broaching of the stopper.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated)

Injection site swelling¹, injection site pain²

¹ Typically resolves within 3 to 14 days but may persist for up to 35 days

² Slight pain may develop for 1 day Sheep:

Common

(1 to 10 animals / 100 animals treated)

Injection site swelling³, injection site pain⁴

³ Mild to moderate and typically resolves within 4 days

⁴ Slight pain may develop for 1 day Pigs:

Common

(1 to 10 animals / 100 animals treated)

Injection site swelling⁵

⁵ Mild to moderate and typically resolves within 2 days

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.