Vitaminum B1

Thiamine hydrochloride – 25 mg
Solution for injections

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Description

25 mg/ml, solution for injection for cattle, sheep, horses, chickens, turkeys and dogs

 

Active substance and excipient content

1 ml contains:

 

Active substance:

thiamine hydrochloride – 25 mg

 

Excipient:

phenol – 2.25 mg

 

Therapeutic indications

Hypovitaminosis and avitaminosis B1:

  • in carnivorous animals that are on a diet rich in raw fish,
  • in animals artificially fed with glucose infusions,
  • in 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, osteoarthritis, nervous distemper, muscle weakness and digestive disorders leading to deficiency of vitamin B.
  • chickens, turkeys: ataxia, spasms, paralysis, muscle atrophy, polyneuritis.

 

Contraindications

Do not use in the case of hypersensitivity to the active substance or the excipient.

 

Adverse reactions

Acute pain resulting from the irritating effect of thiamine might occur during administration of the drug (particularly in dogs).

Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

 

Posology for each species, routes and methods of administration

Use intravenously 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.

 

Recommendations for proper administration

The product should not be administered intravenously as this might cause an anaphylactic shock.
In order to properly administer the product, instructions in this leaflet should be followed.

 

Withdrawal period

Edible tissues:

cattle, sheep, horses, chickens, turkeys – zero days

 

Eggs:
turkeys – zero days

 

Milk:
cattle – zero days

sheep – zero days

 

Dogs – not applicable.

 

Special precautions for storage

Keep out of the reach and sight of children.

Store below 25 °C. Protect from light. Do not freeze.

Store in the closed container.

 

Special warnings

Special warnings concerning each of the target animal species:

None

 

Special precautions for use in animals:

The product should not be administered intravenously as this might cause an anaphylactic shock.

 

Special precautions for persons administering the medicinal veterinary product to animals:

After accidental contact of the drug with the eye, the drug might have an irritating effect resulting in dacryorrhea. In this case, rinse the eye with plenty of lukewarm water or saline immediately.

Particular caution should be taken to avoid self-injection during administration.

In the case of self-injection, especially intravenously, an anaphylactic shock, impaired respiration and temporary hypotension might occur.

 

Pregnancy:
The product can be used in pregnancy.

Lactation:
The product can be used in lactation.

 

Laying period:

The product can be used in the laying period.

 

Interaction with other medicinal products and other forms of interaction

Administration of amprolium (particularly in turkeys) may cause thiamine deficiency.

The product should not be combined with iron solutions.

Avoid administering the drug in combination with plants with a large content of thiaminase as its excess causes decomposition of vitamin B.

 

Overdose (symptoms, procedures concerning immediate help and antidotes):

Acute poisonings occur in animals only when the recommended dose is exceeded many times. Convulsions, cyanosis, breathing difficulties and lower blood pressure occur. Symptoms of chronic poisoning do not occur as vitamin B1 is well soluble in water and is not accumulated in the body because its excess is excreted in urine.

Thiamine overdose effects are not observed in clinical practice. Even if the recommended doses are exceeded, no medical intervention is necessary.

 

Pharmaceutical incompatibilities:

Sulphites found in drinking water may cause decomposition of vitamin B1.

The product should not be administered with neutral or alkaline solutions as these might cause decomposition of thiamine.

Since no conformity studies of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary products.

 

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.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

 

Available containers

50 ml

 

Shelf life

18 months

 

For animal treatment only.

Subject to medical prescription – prescription drug.

To be administered under veterinary supervision.

 

Other information

For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.

Marketing Authorization Holder and manufacturer responsible for batch release:

Biowet  Puławy Sp. z o.o.

  1. H. Arciucha 2,  24-100 Puławy

Tel/fax: 81 886 33 53

 

2015-01-28 SmPC

31.08.2017 r.

Additional information

animal type

dogs, horses, cattle, other

type of medicine