Anivit B12 Solution For Injection 1000 Μg/Ml
Revised: November 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of Veterinary Medicinal Product
Anivit B12 Solution for Injection 1000 mg/ml
2. Qualitative and Quantitative Composition
Active ingredient % w/v
Phenol (Preservative) 0.500
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
A clear, red, sterile solution for injection.
4. Clinical Particulars
4.1 Target species
Horses and foals, cattle and calves.
4.2 Indications for use, specifying the target species
As an aid in raising Vitamin B12 levels in horses and cattle.
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.
Do not give by the intravenous route.
Special warnings for each target species
Special precautions for use
i. Special precautions for use in animals
Take adequate measures to maintain sterility.
Observe normal aseptic precautions.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical advice immediately.
In case of accidental ingestion, seek medical advice immediately.
In case of spillage onto the skin or eyes, wash the affected area immediately with clean running water. Seek medical attention if irritation persists.
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Not contra-indicated in pregnant or lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Foals and calves 0.5-1 ml
Horses and cattle 1-3 ml
By intra-muscular 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage is unlikely.
4.11 Withdrawal periods
Cattle – Meat: Zero days
Milk: Zero hours
Horses – Meat: Zero days
5. Pharmacological Particulars
Pharmacotherapeutic group: Cyanocobalamin
ATC Vet Code: QB03BA01
5.1 Pharmacodynamic properties
B vitamins are not stored in the body to any great extent.
5.2 Pharmacokinetic properties
The metabolism of cyanocobalamin is complex and is associated closely with that of folic acid and of ascorbic acid. It is important for maintenance of normal haemopoiesis, protection of the liver, maintenance of muscle tissue, healthy skin, brain and pancreatic metabolism.
6. Pharmaceutical Particulars
6.1 List of excipients
Sodium acid phosphate dihydrate
Water for injections
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Do not store above 25°C.
Protect from light.
6.5 Nature and contents of immediate packaging
Amber glass vial fitted with a red pharmaceutical grade rubber multidose plug and an aluminium seal, containing 50 ml sterile injection for parenteral administration.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Snaygill Industrial Estate
8. MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION
27 October 1999
10. DATE OF ANY REVISION OF THE TEXT
N ovember 2016
Approved: 03 November 2016