SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vitamin B1 100 mg/ml Solution for Injection for Cattle and Sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substances:

Thiamine Hydrochloride 100.0 mg

Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Benzyl Alcohol (as preservative)	15.0 mg
Sodium Hydroxide
Disodium Edetate
Water for Injections

A clear, colourless to greenish-yellow liquid.

3. CLINICAL INFORMATION

3.1 Target species

Cattle and Sheep

3.2 Indications for use for each target species

For the treatment of cerebrocortical necrosis in cattle and sheep and as an adjunct in metabolic disorders of cattle.

3.3 Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Intravenous injections should be given slowly.

Observe aseptic techniques

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

Care should be taken to avoid accidental self-injection. In the event of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.

Special precautions for the protection of the environment Not applicable.

3.6 Adverse events

Adverse effects are not anticipated following administration of thiamine.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

It is not anticipated that the use of Vitamin B1 Injection will lead to any undesirable effects during Pregnancy and/or Lactation.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

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.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Meat and offal: Zero days Milk: Zero hours

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QA11DAO1

4.2 Pharmacodynamics

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.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2 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.

5.3 Special precautions for storage

Do not store above 25℃.

Protect from light.

Once broached, use vial within 28 days.

5.4 Nature and composition of immediate packaging

50 ml amber type I glass vial with a red bromobutyl rubber bung and plain aluminium cap.

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

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Bimeda Animal Health Limited

7. MARKETING AUTHORISATION NUMBER

Vm 50146/4029

8. DATE OF FIRST AUTHORISATION

27 May 1993

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 29 October 2026