Medine.co.uk

Anivit B12 Solution For Injection 1000 Μg/Ml

Revised: November 2016

AN: 01006/2016


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

Cyanocobalamin 0.100


Other ingredients

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.


4.3 Contra-indications


Do not give by the intravenous route.


Special warnings for each target species


None known.


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)


None known.


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


None known.


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


Phenol

Sodium acid phosphate dihydrate

Sodium chloride

Water for injections


6.2 Incompatibilities


None.


Shelf life


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


Dechra Limited

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire

BD23 2RW

8. MARKETING AUTHORISATION NUMBER


Vm 10434/4064


DATE OF FIRST AUTHORISATION

27 October 1999


10. DATE OF ANY REVISION OF THE TEXT


N ovember 2016



Approved: 03 November 2016