SUMMARY OF PRODUCT CHARACTERISTICS

Vitamine K1 comprimés TVM (FR)

Vitamin K1 Laboratoire TVM 50 mg film-coated tablets for dogs (UK)

Vitamin K1 Laboratoire TVM 50 mg filmomhulde tablet voor honden (NL)

Vitamin K1 Laboratoire TVM 50 mg filmtabletten für Hunde (DE, AT)

Vitamina K1 Laboratoire TVM 50 mg comprimidos recubiertos con película para perros (ES)

Vitamina K1 Laboratoire TVM 50 mg compresse film-rivestite per cani (IT)

Each divisible tablet contains:

Active substance:

Phytomenadione 50.0 mg

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

Oblong tablet, slight yellow with 3 scored lines.

The tablet can be divided into equal halves and quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

In dogs:

Treatment of anticoagulant poisoning, following parenteral treatment.

4.3 Contraindications

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

4.4 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.

4.5 Special precautions for use

i. 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.

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

People with known hypersensitivity to phytomenadione should avoid contact with the veterinary medicinal product.

Wash hands after use.

iii. Other precautions

None.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

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 fœtotoxic effects. Vitamin K₁ crosses the placental barrier.

Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

For oral use.

5 mg phytomenadione per kg bodyweight per day, corresponding to 1 tablet per 10 kg bodyweight per day, once a day, for 21 days, in accordance with the following table:

Bodyweight (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 bodyweight given 12 hours apart).

See section 4.4.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

ATC vet code: QB02BA01

Pharmacotherapeutic classification: antihemorrhagic

5.1 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 K₁epoxide. It is then recycled back into vitamin K1. Antivitamin K rodenticides inhibit the recycling of vitamin K₁epoxide, 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.

5.2 Pharmacokinetics particulars

After oral administration, vitamin K1 is rapidly absorbed in the dog.

Some of the vitamin K1is 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).

6. PHARMACEUTICAL PARTICULARS

6.1 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

6.2 Incompatibilities

None known.

6.3 Shelf-life

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

Shelf-life of divided tablets: 3 days.

6.4 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.

6.5 Nature and composition of immediate packaging

Box containing white PVC/Aluminium thermosealed blister of 7 tablets each.

Box of 1 thermosealed blister of 7 tablets

Box of 2 thermosealed blisters of 7 tablets

Box of 3 thermosealed blisters of 7 tablets

Box of 4 thermosealed blisters of 7 tablets

Box of 5 thermosealed blisters of 7 tablets

Box of 12 thermosealed blisters of 7 tablets

Not all pack sizes may be marketed.

6.6 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.

Laboratoire TVM

57 rue des Bardines

63370 Lempdes

France

Vm 35079/4001

26 March 2013

January 2016

Approved: 26 January 2016