SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vitamivet K1 50 mg Film-coated Tablets for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each divisible tablet contains:

Active substance:

Phytomenadione 50.0 mg

For the 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 halves and quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dog.

4.2 Indications for use, specifying the target species

Treatment of anticoagulant poisoning, following parenteral treatment.

4.3 Contraindications

Do not use in cases of 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 Vitamivet K1 with an oral formulation for 3 weeks. The coagulation status (via one stage prothrombin times) has to be evaluated 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, in these animals, careful monitoring of coagulation parameters after administration of the veterinary medicinal product is required.

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

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

Wash hands after use.

To avoid accidental ingestion, particularly by a child, unused part-tablets should be returned to the open blister space and inserted back into the carton.

Special precautions for the protection of the environment: Not applicable.

4.6 Adverse reactions (frequency and seriousness)

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Vomiting Skin disorders (e.g.erythema and dermatitis) Allergic edema

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 also the last section of the package leaflet for contact details.

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.

Pregnancy and lactation

Use only according to the benefit/risk assessment by the responsible veterinarian. Laboratories studies have shown not produced any evidence of teratogenic or foetotoxic effects. Vitamivet K1 crosses the placental barrier.

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 Vitamivet K1, by inhibition of the Vitamivet K1 recycling.

4.9 Amount(s) to be administered and administration route

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 Vitamivet K1 per kg bodyweight given 12 hours apart). See section 4.4.

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(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antihaemorrhagic

ATC Vet Code: QB02BA01

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic particulars

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

Some of the Vitamivet 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).

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 Major Incompatibilities

Not applicable

6.3 Shelf life

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

6.4 Special precautions for storage

Keep the blisters in the outer carton. 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. A remaining tablet portion should be given at the next administration.

6.5 Nature and composition of immediate packaging

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

Box of 1 thermosealed blisters 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

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Domes Pharma

3 Rue Andre Citroën

63430 Pont-Du-Chateau France

8. MARKETING AUTHORISATION NUMBER

Vm 54982/5004

9. DATE OF FIRST AUTHORISATION

26 March 2013

10. DATE OF REVISION OF THE TEXT

June 2023

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product not subject to prescription.

NFA-VPS

Approved: 07 May 2024