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Date: Thursday, May 16, 2024 18:18

Description: Bimeda logo
Release 2.38
Vitamin B1 10% w/v Solution for Injection
 
Species: Cattle, Sheep
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Vitamin preparations - injectable
Active ingredient: Thiamine Hydrochloride
Product:Vitamin B1 10% w/v Solution for Injection
Product index: Vitamin B1 10% w/v Solution for Injection
Cattle - milk: Zero days
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active Substance(s)
%w/v
Thiamine Hydrochloride
10.0
Pharmaceutical form
A clear, colourless to greenish-yellow solution for injection.
Clinical particulars
Target species
Cattle and Sheep.
Indications for use
For the treatment of cerebrocortical necrosis in cattle and sheep and as an adjunct in metabolic disorders of cattle.
Contra-indications
Do not use in cases of known hypersensitivity to the active ingredient.
Special warnings for each target species
Not applicable.
Special precautions for use in animals
Intravenous injections should be given slowly.
Observe aseptic techniques.
Special precautions to be taken by the person administering the veterinary product to animals
Care should be taken to avoid accidental self-injection. In the event of accidental self-injection, consult medical advice immediately and show the doctor this label. Wash hands after use.
Adverse reactions
Adverse effects are not anticipated following administration of thiamine.
Use during pregnancy and lactation
It is not anticipated that the use of Vitamin B1 Injection will lead to any undesirable effects during pregnancy or lactation.
Interactions
None Known.
Amounts to be administered and administration route
By intramuscular or slow intravenous injections.
Dosage: 2.5 - 5ml per 50 kg bodyweight. Repeat every 3 hours for up to a total of 5 doses.
Overdose
Thiamine is very soluble in water and excess is excreted in the urine as a pyrimidine or as unchanged material. Tolerance studies have been carried out at twice the maximum recommended dose and the product was well tolerated.
Withdrawal periods
Meat - Zero days
Milk - Zero hours
Pharmacological particulars
Pharmacotherapeutic group: Vitamins, Vitamin B1, plain and in combination with vitamins B6 and B12, Vitamin B1, plain. ATC vet code: QA11DAO1.
Vitamin B1, also known as thiamine and as aneurine, is a water soluble vitamin. Aneurine is converted in the body to aneurine pyrophosphate (cocarboxylate) which acts as a coenzyme for several decarboxylating enzyme systems, the most important of which is decarboxylase. The enzyme is necessary for the decarboxylation of pyruvic acid, an intermediate stage in carbohydrate build-up or breakdown. When carbohydrates are a major source of energy the body requirements of aneurine increase. Deficiencies affect the nervous and gastrointestinal systems and skin.
Tissues dependent on glucose or lactate-pyruvate for energy such as the brain and heart are particularly compromised in thiamine deficiency. Thiamine deficiency may be primary, due to deficiency in the diet, or secondary, because of destruction of the vitamin in the diet by thiaminase. The principal cause of thiamine deficiency is the presence of thiamine-destroying agents which are widely distributed in nature, and produced by rumen microflora. Growing sheep are particularly susceptible, and outbreaks of cerebrocortical necrosis have been associated with sulphur in the diet.
Pharmaceutical particulars
Excipients
Benzyl Alcohol
Sodium Hydroxide
Disodium Edetate
Water for Injection
Major incompatibilities
None known.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25°C.
Protect from light.
Once broached, use vial within 28 days. Discard unused material.
Immediate packaging
50 ml amber type II glass vial with a red bromobutyl rubber bung and plain aluminium cap.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Number
Vm 50146/4029
Significant changes
Date of the first authorisation or date of renewal
27th May 1993
Date of revision of the text
October 2018
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Vitamin B1 50ml
GTIN:5391510231714