ZACTRAN 150MG

Zactran 150mg use For use in cattle for therapeutic and preventative treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before preventative treatment

Zactran 150mg/ml solution for injection for cattle.

Presentation

Solution for injection containing gamithromycin 150mg/ml. Also contains monothioglycerol 1mg/ml.

Uses

For use in cattle for therapeutic and preventative treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

The presence of the disease in the herd should be established before preventative treatment.

Dosage and administration

A single subcutaneous injection of 6 mg gamithromycin/kg bodyweight (equivalent to 1 ml/25 kg bodyweight) in the neck.

For treatment of cattle over 250 kg bodyweight, divide the dose so that no more than 10 ml are injected at one site.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing.

Contra-indications, warnings, etc

Keep out of the reach and sight of children.

For animal treatment only.Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg Zactran 150mg

Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.

Cross-resistance may occur with other macrolides. Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.

Use of the product should be based on susceptibility testing and take into account official and local policies on the use of antimicrobials in farm animals.

During clinical trials transient injection site swellings were observed. Visible injection site swellings may develop in up to 45% of treated animals associated with occasional, slight pain evident for one day. The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment.

Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in cattle. In a young adult cattle study, gamithromycin was administered by subcutaneous injection at 6, 18 and 30 mg/kg (1, 3 and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use). Injection site reactions were noted in a dose-related manner.

Based on laboratory animal data, gamithromycin has not produced any evidence of selective developmental or reproductive effects. The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle. Use only according to the risk/benefit assessment by the responsible veterinarian.

Operator safety

People with known hypersensitivity to the macrolide class of antibiotics should avoid contact with the product.

Gamithromycin may cause irritation to eyes and/or skin.

Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If skin exposure occurs, wash the affected area immediately with clean water.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.

Wash hands after use.

Withdrawal periods

Meat and offal: 64 days.

Not authorised for use in lactating animals producing milk for human consumption.

Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Do not mix with any other veterinary medicinal product.

This product does not require any special storage conditions.

Once opened, used within 28 days.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

50ml glass and 100ml and 250ml polypropylene bottles