Vitamin K1 Laboratoire TVM 50 Mg Film-coated Tablets For Dogs (pack Of 14)

Target species: Dogs.

Indications for use:
In dogs: Treatment of anticoagulant poisoning, following parenteral treatment.

Contra-indications:
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species:
As the anticoagulant effects of rodenticides are known to be long lasting, it is recommended to administer vitamin K1 with an oral formulation for 3 weeks, and to evaluate the coagulation status (via one stage prothrombin times) 48 hours after the last administration. If it is prolonged, the treatment is maintained until the clotting time is normal 48 hours after cessation of treatment to avoid relapse. The duration of treatment can be extended as long as the anticoagulant persists in the body.

Special precautions for use in animals:
The formation of prothrombin may be inadequate when dealing with patients with severe liver dysfunction. Therefore, careful monitoring of coagulation parameters after administration of vitamin K1 is required.

Special precautions to be taken by the person administering the veterinary medicinal product:
People with known hypersensitivity to phytomenadione should avoid contact with the veterinary medicinal product.

Wash hands after use.

Use during pregnancy and lactation:
The safety of the veterinary medicinal product has not been established in bitches during pregnancy and lactation. Studies conducted in laboratory animals have shown no teratogenic or foetotoxic effects. Vitamin K1 crosses the placental barrier. Use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions:
Salicylates (NSAIDs) and cephalosporins presenting the N-methyl-thiotetrazole moiety may reduce the effect of vitamin K1, by inhibition of the vitamin K1 recycling.

Amounts to be administered and administration route:
For oral use.
5 mg phytomenadione per kg body weight per day, corresponding to 1 tablet per 10 kg body weight per day, once a day, for 21 days, in accordance with the following table:

Body weight (kg)

Number of tablets

< 2.5

¼ tablet

from 2.5 to 5

½ tablet

from 5 to 7.5

¾ tablet

from 7.5 to 10*

1 tablet

* Dog > 10 kg: ¼ tablet per 2.5 kg

Preferably use in non-fasted animals.

Oral treatment should be undertaken within 12 hours after the end of the emergency treatment by the intravenous route (2 intravenous injections of 5 mg vitamin K1 per kg body weight given 12 hours apart). See ‘Special warnings for each target species’.

Return any divided tablet to the blister pack and use within 3 days. The blister pack should be inserted back into the cardboard carton.

Overdose:
No signs of intolerance were displayed at 3 times the therapeutic dose, administered for 3 weeks.

Pharmacological particulars:
Pharmacotherapeutic group: Antihaemorrhagic

ATC Vet code: QB02BA01

Pharmacodynamic properties:
Vitamin K1 is a cofactor necessary for the synthesis of K-dependent coagulation factors (factors II, VII, IX and X). During this synthesis, vitamin K1 is converted into vitamin K1 hydroquinone (active form of vitamin K1) and then into vitamin K1 epoxide. It is then recycled back into vitamin K1. Antivitamin K rodenticides inhibit the recycling of vitamin K1 epoxide, causing a risk of uncontrolled bleeding through the absence of functional factors II, VII, IX and X synthesis. The supply of vitamin K1 must be sufficiently large to activate the alternative hydrogenase enzyme pathway that converts it to its active (hydroquinone) form.

Pharmacokinetic properties:
After oral administration, vitamin K1 is rapidly absorbed in the dog.Some of the vitamin K1 is eliminated with the bile in the intestinal tract after metabolism in the liver, and some is eliminated in urine (in the form of glucuronoconjugated metabolites).

PHARMACEUTICAL PARTICULARS
List of excipients
Tablet core:
Silica, colloidal anhydrous
Calcium hydrogen phosphate dihydrate
Glycerol dibehenate
Magnesium stearate
Lactose monohydrate
Croscarmellose sodium

Coating:
Hypromellose
Polydextrose
Talc
Maltodextrine
Medium Chain Triglycerides

Incompatibilities:
None known.

Shelf-life:
Shelf-life of the veterinary medicinal product as packaged for sales: 4 years.
Shelf-life of divided tablets: 3 days.

Special precautions for storage:
Store in the original packaging, protect from light.
After opening the blister pocket, replace the remaining portion(s) of tablet in the blister pocket and return the blister strip to the cardboard carton.

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.