Vitamin k1 50mg 14 tablets

Treatment of poisoning with anticoagulants, after parenteral treatment.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
VITAMIN K1 LABORATOIRE TVM 50 MG FILM-COATED TABLETS
FOR DOGS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each divisible tablet contains:
Active substance:
Phytomenadione 50mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, slightly yellow tablet with 3 scored lines.
The tablet can be divided into equal halves and quarters.
4. CLINICAL DATA
4.1 – Target species(s)
Dogs.
4.2 – Indications for use, specifying the target species
In dogs:
Treatment of poisoning with anticoagulants, after parenteral treatment.
4.3 – Contraindications
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
4.4 – Special warnings for each target species
Since the anticoagulant effects of rodenticides are long lasting, it is recommended
administer vitamin K1 in an oral formulation for 3 weeks, and assess the status of
clotting (via one-stage prothrombin times) 48 hours after injection
last administration. If it is prolonged, the treatment is maintained until the time of
coagulation is normal 48 hours after discontinuation of treatment to avoid
relapse. The duration of treatment can be prolonged as long as the
anticoagulant in the body.
4.5 – Special precautions for use
Special precautions for use in animals
Prothrombin formation may be inadequate if treating patients with a disorder
severe hepatic. Therefore, careful monitoring of the parameters of
coagulation after administration of vitamin K1.

Special precautions to be taken by the person administering the medicinal product to
animals
People with known hypersensitivity to phytomenadione should avoid all contact with
the veterinary drug.
Wash hands after use.
4.6 – Adverse reactions (frequency and seriousness)
None known.
4.7 – Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product in bitches has not been established during
pregnancy and lactation.
Laboratory studies in animals have not shown teratogenic or
toxic to the fetus. Vitamin K1 crosses the placental barrier.
Use only in accordance with the benefit/risk assessment performed by the veterinarian
responsible.
4.8 – Interaction with other medicinal products and other forms of interaction
Salicylates (NSAIDs) and cephalosporins that have N-methyl-thiotetrazole groups can
reduce the effect of vitamin K1, by inhibiting the recycling of vitamin K1.
4.9 – Dosage and route of administration
For oral route.
5 mg phytomenadione per kg body weight per day, corresponding to 1 tablet per
every 10 kg of body weight per day, once a day, for 21 days, according to the
following table

* Dog > 10 kg: ¼ tablet every 2,5 kg
It is preferable that the dog is not fasting.
Oral treatment should be carried out within 12 hours after the end of the
emergency intravenous treatment (2 intravenous injections of 5 mg of
vitamin K1 per kg of body weight given 12 hours apart).
See section 4.4.
Return any divided tablets to the blister and use them within 3 days. He
blister must be placed back in the cardboard box.
4.10 -Overdose (symptoms, emergency procedures, antidotes), if necessary
There were no signs of intolerance to doses 3 times the therapeutic dose, administered
for 3 weeks.

4.11 -Waiting time
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
ATCvet code: QB02BA01
Pharmacotherapeutic group: antihaemorrhagic. Phytomenadione
5.1 – Pharmacodynamic properties
Vitamin K1 is a necessary cofactor for the synthesis of the K-dependent coagulation factors (factors II, VII, IX and X). During this synthesis, vitamin K1 is converted to
vitamin K1 hydroquinone (active form of vitamin K1) and subsequently into vitamin K1
epoxy. It is then recycled as vitamin K1. Anti-vitamin K rodenticides inhibit the
recycling of vitamin K1 epoxide, increasing the risk of uncontrolled bleeding due to
the absence of functional factors II, VII, IX and X. The supply of vitamin K1 must be
important enough to activate the alternative pathway of the enzyme hydrogenase that
converts to its active form (hydroquinone).
5.2 – Pharmacokinetic data
After oral administration, vitamin K1 is rapidly absorbed in the dog.
Part of the vitamin K1 is eliminated by the bile into the intestinal tract after being
metabolized in the liver, and part is eliminated through the urine (in the form of metabolites
glucuronoconjugates).
6. PHARMACEUTICAL DATA
6.1 – List of excipients
Tablet core:
colloidal anhydrous silica
Calcium hydrogen phosphate dihydrate
glycerol dibehenate
Magnesium stearate
Lactose monohydrate
croscarmellose sodium
Movie:
hypromellose
Polydextrose
Talc
maltodextrin
medium chain triglycerides
6.2 – Incompatibilities
None known.

6.3 – Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after split tablets: 3 days.
6.4 – Special conservation precautions
Store in the original package, protect from light.
After opening a blister pocket, replace the remaining portion of the blister pack.
compressed in the cavity, and place the blister in the carton.
6.5 – Nature and composition of the primary packaging
Box with a heat-sealed white PVC / aluminum blister of 7 tablets each.
Box with 1 heat-sealed blister of 7 tablets.
Box with 2 heat-sealed blisters of 7 tablets.
Box with 3 heat-sealed blisters of 7 tablets.
Box with 4 heat-sealed blisters of 7 tablets.
Box with 5 heat-sealed blisters of 7 tablets.
Box with 12 heat-sealed blisters of 7 tablets.
Not all formats may be marketed
6.6 – Special precautions for disposal of the veterinary medicinal product
used or, where appropriate, the residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
TVM Laboratory
57 rue des Bardines
63370 Lempdes
France
8. MARKETING AUTHORIZATION NUMBER(S)
2732 ESP
9. DATE OF THE FIRST MARKETING AUTHORIZATION
February 15th 2013
10. DATE OF REVISION OF THE TEXT
February 15th 2013
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use-medicine subject to veterinary prescription

Administration under control or supervision of the veterinarian

See technical sheet