Vitamin K1 Laboratoire TVM, Solution for Injection for Dogs, 10 mg/ml 5ml (pack of 6)

Vitamin K1 Laboratoire TVM, Solution for Injection for Dogs, 10 mg/ml 5ml. Target species: Dogs.

Indications for use:
In dogs: Emergency treatment of anticoagulant rodenticide poisoning, before starting oral treatment.

Contraindications:
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 start Vitamin K1 supplementation with an oral formulation within 12 hours of the last injection for a duration of 3 weeks, and to evaluate the coagulation status (via one stage prothrombin times) 48 hours after the last administration. In the case of persistence of the anticoagulant in the body, the duration of treatment can be extended as long as the anticoagulant persists, to avoid relapse (the coagulation status has to be evaluated 48 hours after each attempt of treatment cessation).

Special precautions for use in animals:
The product should be administered only by a veterinarian. Administer by slow intravenous injection.

The formation of prothrombin may be inadequate when dealing with patients with severe liver dysfunction. Therefore, a 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 to animals

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

Avoid contact with eyes. In the event of accidental contact with the eyes, rinse immediately and thoroughly with tap water, then seek medical advice and show the label to the physician.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions:
Some cases of hypersensitivity reactions (anaphylactic-type reactions) have been described.

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:
Slow intravenous injection of 5 mg vitamin K1 per kg body weight (equivalent to 0.5 ml of the product per kg body weight) prior to commencing oral therapy (see Special warnings for each target species). Treatment by injection should be repeated once 12-18 hours later if oral treatment is not immediately possible.

Overdose:
Vomiting has been observed in the dog after the 1st and the 2nd injections, administered 12 hours apart at 3 times the recommended dose (15 mg of vitamin K1 per kg of body weight per injection).

Repeat dosing (10 days) at 7 times the recommended dose of a degraded solution (degradation of lecithin into lysolecithin is observed with time during the storage of the product) caused intravascular haemolysis, involving marked anaemia and vomiting.

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 hydrogenase enzyme that converts it to its active (hydroquinone) form.

Pharmacokinetic properties:
After intravenous administration at 5 mg/kg in the dog, the following pharmacokinetic parameters were obtained: Cmax=85.2 µg/ml, AUC=4246 µg/min/ml, T½=179.5 min, Cl=1.15 ml/min, a bioavailability of 100% and a distribution volume estimated at 4×10-4 ml.

One hour after intravenous administration, vitamin K1 is detected in the liver (90% unchanged) before being distributed throughout the body. 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:
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Use immediately after opening.

Special precautions for storage:
Protect from light. Do not store above 25°C. Any solution remaining in the ampoule following withdrawal of the required dose should be discarded. Keep out of the sight and reach of children.

Immediate packaging:
5 ml amber clear glass ampoules, type I.

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