Vitbee® 1000, 0.100% w/v Solution for Injection

Introduction

Company name: Dechra Veterinary Products Limited

Address: (A business unit of Dechra Pharmaceuticals PLC)

Sansaw Business Park

Hadnall, Shrewsbury

Shropshire SY4 4AS

Telephone: 01939 211200

Fax: 01939 211201

Email: info.uk@dechra.com

Website: www.dechra.com

Presentation

Contains: Active substance:

Cyanocobalamin 0.100% w/v

Excipient: Phenol 0.500% w/v. Also contains sodium acid phosphate dihydrate, sodium chloride, water for injections.

A clear, red, sterile solution for injection.

Uses

As an aid in raising blood vitamin B12 levels in cattle and horses, calves and foals.

For use in the treatment of vitamin B12 deficiency, and for poor growth rates and general unthriftiness in young animals when associated with the above deficiency.

Dosage and administration

Cattle and horses: 1-3 ml

Calves and foals: 0.5-1 ml

By intramuscular or subcutaneous injection. Repeat in 7 days if required. Following treatment, the vitamin B12 status of herbivores should be maintained by dietary supplementation with cobalt.

Contraindications, warnings, etc

Do not give by the intravenous route.

Special precautions for use in animals: Observe normal aseptic precautions.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Care should be taken to avoid accidental self-injection or ingestion. In the case of accidental self-injection or ingestion, seek medical advice as a precautionary measure.

Following skin/eye contamination, wash/irrigate area thoroughly with cold water. Seek medical attention if irritation persists.

Wash hands after use.

Adverse reactions: None known.

Use during pregnancy and lactation: Not contraindicated in pregnant or lactating animals.

Interactions: None known.

Overdose: Overdosage is unlikely.

Withdrawal period: Meat: zero days; Milk: zero hours.

Incompatibilities: None known.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Keep the container in the outer carton.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

Disposal: 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-VPS

Packaging quantities

50 ml type I amber glass vial, fitted with a red type I bung and aluminium over-seal. Secondary packaging: cardboard carton.

Further information

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the reach and sight of children.

Date of last review: 08.07.2008

Marketing authorisation holder (if different from distributor)

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW.

Marketing authorisation number

Vm 10434/4039.

GTIN (Global Trade Item No)

Vitbee 1000, 0.100% w/v Solution for Injection

05055031419296