iMedi.co.uk

Anivit 4bc Solution For Injection

Revised 22 October 2008

AN: 00396/2008


SUMMARY OF PRODUCT CHARACTERISTICS


1. Name of the veterinary medicinal product


Anivit 4BC Solution for Injection


2. Qualitative and quantitative composition


Active Substance: % w/v

Thiamine Hydrochloride 3.5

Riboflavin Sodium Phosphate 0.05

Pyridoxine Hydrochloride 0.70

Nicotinamide 2.30

Ascorbic Acid 7.00


Excipients:

Chlorocresol (as preservative) 0.1


For a full list of excipients, see section 6.1


3. Pharmaceutical form


Solution for injection.

A clear, pale yellow liquid

4. Clinical Particulars


4.1 Target species


Horses

Cattle

Sheep


4.2 Indications for use, specifying the target species


For the treatment of cerebrocortical necrosis in cattle and sheep, the treatment of bracken poisoning in horses and for the treatment of Vitamin B deficiencies in horses, cattle and sheep.


4.3 Contraindications


Anaphylactic reactions, particularly in the horse, may occur following intravenous administration. When this route is used, the product should be given slowly and may be diluted with sterile saline or dextrose saline solution.



4.4 Special Warnings for each target species


None


4.5 Special precautions for use


Special precautions for use in animals


None


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


Care should be taken to avoid accidental self-injection. Wash hands after use.


4.6 Adverse reactions (frequency and seriousness)


There may be slight irritation at the injection site when the product is given by the subcutaneous or intramuscular routes.


4.7 Use during pregnancy, lactation or lay


Anivit 4BC can be safely administered to pregnant and lactating animals.


4.8 Interaction with other medicinal products and other forms of interaction


None


4.9 Amounts to be administered and administration route


Administer by subcutaneous, deep intramuscular or slow intravenous injection. The dose should be repeated daily as required. Normal aseptic precautions should be observed.


Horses, Cattle 20 - 30 ml

Calves, Foals 5 - 10 ml

Sheep 5 - 10 ml


If dose volume exceeds 20 ml, it should be divided and injected into two sites.


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


Not applicable.


Withdrawal period


Meat : Zero days

Milk : Zero hours


5. pharmacological properties


Pharmacotherapeutic group: Vitamin B-complex, with vitamin C


ATC Vet Code: QA11EB


5.1 Pharmacodynamic properties


Thiamine Hydrochloride (Vitamin B1) acts as a co-enzyme in the breakdown of glucose and glycogen. Riboflavin Sodium Phosphate (Vitamin B2) is phosphorylated to form the co-enzymes Riboflavin-5-phosphate and Flavin Adenine Dinucleotide (FAD) which act as hydrogen recipients and donors.

Pyridoxine Hydrochloride (Vitamin B6) is converted to pyridoxal phosphate which functions as a co-enzyme with the transaminases and decarboxylases in the metabolism of proteins and amino acids. Nicotinamide is converted into the essential co-enzymes Nicotinamide Adenine Dinucleotide (NAD) and Nicotinamide Adenine Dinucleotide Phosphate (NADP).

Vitamin C (Ascorbic Acid) is involved in the conversion of folic acid to tetrahydrofolic acid and the conversion of proline to hydroxyproline which is essential to the formation of collagen.


6. Pharmaceutical particulars


6.1 List of excipients


Chlorocresol

Disodium Edetate Dihydrate

Propylene Glycol

Sodium Hydroxide

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 the immediate packaging: 28 days.


Special precautions for storage


Protect from light. Do not store above 25°C. Following withdrawal of first dose use the product within 28 days. Discard unused material.


Nature and composition of immediate packaging


50 ml and 100 ml amber Type II glass vials, sealed with bromobutyl bungs and aluminium caps.


Not all pack sizes may be marketed.


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

Northern Ireland


8. MARKETING AUTHORISATION NUMBER(S)


Vm 02000/4219


9. DATE OF FIRST AUTHORISATION


28th March 2002


10. DATE OF REVISION OF THE TEXT


October 2008