Shotaflor 300mg/mL Solution for Injection for Cattle

Introduction

Company name: Virbac Limited

Address: Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk

IP30 9UP

Telephone: 01359 243243

Fax: 01359 243200

Website: www.virbac.co.uk

Presentation

Non aqueous solution for injection containing 300mg/mL florfenicol

Uses

Diseases caused by florfenicol susceptible bacteria.

Therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica,

Pasteurella multocida and Haemophilus somnus.

Dosage and administration

IM route: 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart.

SC route: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only. The dose volume given at any one injection site should not exceed 10 ml.

The injection should only be given in the neck.

Contra-indications, warnings, etc

Do not use in adult bulls intended for breeding purposes.

Do not use the product in known cases of sensitivity to propylene glycol and polyethylene glycols.

A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.

Administration of the product by the intramuscular route may cause swelling at the injection site which may persist for 14 days. Inflammation at the injection site may persist for up to 32 days after administration.

Administration of the product by the subcutaneous route may cause swelling and inflammation at the injection site which may persist at least for 41 days.

The effect of Shotaflor on bovine reproductive performance and pregnancy has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Special precautions for use in animals

Swab septum before removing each dose. Use a dry sterile needle and syringe.

The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection.

Withdrawal periods:

Milk: Not to be used in lactating cattle producing milk for human consumption

Meat and offal:

By IM (at 20mg/kg bodyweight, twice): 30 days

By SC (at 40mg/kg bodyweight, once): 44 days

The withdrawl period is calculated from the last administration of the drug. It should be noted that whatever the the withdrawal period no food of animal origin can be given to humans during the period of treatment.

Pharmaceutical precautions

Keep out of the reach and sight of children.

No special precautions for storage.

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

Legal category

POM-V

Packaging Quantities

50, 100 and 250 ml Type I amber glass vials. Not all pack sizes may be marketed.

Further information

Nil

Marketing authorisation number

Vm 05653/4145.

Significant Changes