Medine.co.uk

Intravit 12 Solution For Injection, 0.05% W/V

Revised: 28th August 2008

AN: 02088/2007


SUMMARY OF PRODUCT CHARACTERISTICS


1. Name of the veterinary medicinal product


Intravit 12 Solution for Injection, 0.05% w/v


2. Qualitative and quantitative composition


Active Substance:


Qualitative Quantitative

Cyanocobalamin (Vitamin B12) 0.05% w/v


Excipients:

Phenol 0.5% w/v


For a full list of excipients, see section 6.1


3. Pharmaceutical form

Solution for injection.

A sterile, clear, red aqueous solution


4. Clinical Particulars


4.1 Target species


Cattle, horses, sheep, pigs.


4.2 Indications for use, specifying the target species


Maintenance of metabolic functions especially the synthesis of nucleic acid in cattle, horses, sheep and pigs.


4.3 Contraindications


None.


4.4 Special Warnings for each target species


None


4.5 Special precautions for use


Special precautions for use in animals


Normal aseptic precautions should be observed.

Ensure that suitable equipment is used when administering small dose volumes.

When administering the product to a large number of animals, a multiple dose injector must be used.


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.


4.6 Adverse reactions (frequency and seriousness)


None known


4.7 Use during pregnancy, lactation or lay


Intravit 12 can be safely administered to pregnant and 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


Administer by intramuscular or subcutaneous injection, once or twice a week:


Cattle, horses : 2 - 5 ml

Calves, foals : 1 - 3 ml

Sheep, pigs : 0.5 - 1.5 ml


Long term supplementation should be reviewed at least annually.


Overdose (symptoms, emergency procedures, antidotes), if necessary


Not applicable


Withdrawal period


Meat – Zero days

Milk – Zero hours


5. pharmacological properties


Pharmacotherapeutic group: Cyanocobalamin


ATC Vet Code: QB03BA01


5.1 Pharmacodynamic properties


Cyanocobalamin (Vitamin B12) is of importance in the utilisation of proteins and fats, in the production of red blood cells, in the synthesis of nucleic acid components (deoxynucleoside) and in the metabolism of propionic acid.


6. Pharmaceutical particulars


6.1 List of excipients

Phenol

Sodium Dihydrogen Phosphate dihydrate

Sodium Chloride

Water for Injections

6.2 Incompatibilities


None known


Shelf life


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

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


Special precautions for storage


Do not store above 25ºC. Protect from light.

Following withdrawal of the first dose, use the product within 28 days. Discard unused product.


Nature and composition of immediate packaging


100 ml amber, type II multidose glass vial, sealed with a bromobutyl rubber bung.


Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products


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



7. MARKETING AUTHORISATION HOLDER


Norbrook Laboratories Limited

Station Works

Newry

Co. Down

BT35 6JP


8. MARKETING AUTHORISATION NUMBER


Vm 02000/4116


9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


5thAugust 1993


10. DATE OF REVISION OF THE TEXT


August 2008