Description
Vitaminum B1 Biowet Puławy, 25 mg/ml, solution for injection for cattle, sheep, horses, chickens, turkeys and dogs.
Composition:
1 ml contains:
Active substance:
Thiamine hydrochloride – 25 mg
Excipient:
Phenol 2,25 mg
Target species
Cattle, sheep, horse, chicken, turkey and dog
Indications for use
Vitamin B1 deficiency and avitaminosis:
– in carnivorous animals on raw fish diet
-in animals artificially nourished using glucose infusions,
– conditions of increased metabolism (fevers, pregnancy, lactation).
Treatment of the following conditions in target species:
– cattle, sheep, horses: reduced viability of newborns.
– dogs: inflammation and paralysis of peripheral nerves, rheumatoid arthritis, nervous form of canine distemper, muscle weakness and digestive disorders leading to vitamin B deficiency.
– chickens, turkeys: ataxia, spasms, paralysis, muscle atrophy, polyneuritis.
Contraindications
Do not use in the case of hypersensitivity to the active substance or any of the excipients.
Special warnings
Special precautions for safe use in the target species:
Do not administer the product intravenously as this might cause an anaphylactic shock.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
After accidental contact with eyes, irritation resulting in dacryorrhea might occur. In this case, flush the eye immediately with plenty of lukewarm water or saline solution.
Particular caution should be taken to avoid self-injection during administration of the product.
In the case of self-injection, especially intravenous self-injection, an anaphylactic shock, breathing disturbances and temporary hypotension might occur. After self-injection, seek medical help immediately and show the information leaflet or packaging to the doctor.
Special precautions for the protection of the environment:
Not applicable.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Laying birds:
The product can be used during the laying period.
Interaction with other medicinal products and other forms of interaction:
Administration of amprolium (particularly in turkeys) may cause thiamine deficiency.
Do not use the product together with iron solutions.
Avoid administering the drug in combination with plants with high thiaminase content as its excess causes decomposition of vitamin B1.
Overdose:
Acute poisonings in animals occur only when the recommended dose is exceeded many times. Overdose symptoms include convulsions, cyanosis, breathing difficulties and lower blood pressure. Symptoms of chronic poisoning do not occur as vitamin B1 is a water-soluble vitamin and it is not accumulated in the body as its excess is excreted in urine.
Thiamine overdose effects have not been observed in clinical practice. No medical intervention is necessary even if the recommended doses are exceeded.
Major incompatibilities:
Sulphates contained in the drinking water may cause decomposition of vitamin B1. Do not administer the product with neutral or alkaline solutions, as they may cause decomposition of thiamine.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Acute pain resulting from the irritating effect of thiamine might occur during administration of the drug (especially in dogs).
Reporting adverse events is important. It allows continuous safety monitoring of a product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system.
Dosage for each species, routes and method of administration
Use subcutaneously or intramuscularly once daily in the following doses until clinical symptoms subside:
cattle, sheep, horses: 0.5 ml of the product/10 kg b.w., which corresponds to 12.5 mg of vitamin B1/10 kg b.w.
chickens, turkeys, dogs: 0.1 ml of the product/1 kg b.w., which corresponds to 2.5 mg of vitamin B1/1 kg b.w.
Advice on correct administration
Do not administer the product intravenously as this might cause an anaphylactic shock.
In order to administer the product properly, follow the instructions contained in this leaflet.
Withdrawal periods
Meat and offal:
cattle, sheep, horses, chickens, turkeys – zero days
Eggs:
turkeys – zero days
Milk:
cattle – zero days
sheep – zero days
dogs – not applicable.
Special storage precautions
Keep out of the sight and reach of children.
Store below 25°C. Protect from light. Do not freeze.
Store in a closed container.
Do not use this veterinary medicinal product after its expiry date given on the label. The expiry date refers to the last day of that month.
Special precautions for disposal
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.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
Marketing authorisation numbers and pack sizes
969/00
Pack size: 50 ml
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel/fax: + 48 (81) 886 33 53, tel: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse reactions:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, tel: 509 750 .
e-mail: biowet@biowet.pl
Leaflet approval date: 17.11.2023
06.03.2025
