Veta-K1 (Canada)

Company: P.V.L.

Vitamin K1 Injection

(Phytonadione)

Aqueous Colloidal Solution of Vitamin K1

For Veterinary Use Only

DIN 00522155

WARNING - INTRAVENOUS USE:

Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of Phytonadione, even when precautions have been taken to dilute the Vitamin K1 and to avoid rapid infusion. Typically, these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some animals have exhibited these severe reactions on receiving VETA-K1 Injection for the first time. Therefore, the intravenous route should be restricted to those situations where other routes are not feasible and the serious risk involved is considered justified.

Description

VETA-K1 Injection is a yellow, sterile aqueous colloidal solution of vitamin K1 (phytonadione), available for injection by the intravenous, intramuscular and subcutaneous routes. Each ml contains:

Inactive Ingredients:

Added as a Preservative:

ACTIONS: VETA-K1 Injection, an aqueous colloidal solution of vitamin K1 for parenteral injection, possesses the same type and degree of activity as does naturally occurring vitamin K. The primary function of vitamin K is to stimulate the production, via the liver, of active prothrombin from a precursor protein. The mechanism by which vitamin K promotes formation of prothrombin at the molecular level has not been established.

The action of the aqueous colloidal solution, when administered intravenously, is generally detected within an hour or two and hemorrhage is usually controlled within three to six hours. A normal prothrombin level may often be obtained in 12 to 14 hours.

Veta-K1 Indications

VETA-K1 Injection is indicated in cattle, calves, horses, swine, sheep, goats, dogs, and cats to counter Hypoprothrombinemia induced by the ingestion of coumarin-based compounds, common ingredients in commercial rodenticides. VETA-K1 Injection is also indicated to counter hypoprothrombinemia caused by consumption of bishydroxycoumarin found in spoiled and moldy sweet clover.

NOTE: Regular determinations of prothrombin time response should be performed to guide in the initial and subsequent administration of VETA-K1 Injection. The dosage should be adjusted accordingly.

CONTRAINDICATION: Hypersensitivity to any component of this medication.

Warnings

An immediate coagulant effect should not be expected after the administration of phytonadione. A minimum of 1 to 2 hours is required for measurable improvement in the prothrombin time. Whole blood or component therapy may be necessary if the bleeding is severe.

Phytonadione will not counteract the anticoagulant action of heparin.

Repeated large doses of vitamin K are not warranted in hepatic disease if the response to the initial therapy is unsatisfactory. Failure to respond to vitamin K may indicate that the condition being treated is inherently unresponsive to vitamin K.

Precautions

Protect from light at all times. Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used.

ADVERSE REACTION: Deaths have occurred following intravenous injection. (See Warning at Beginning of Circular).

Pain, swelling, and tenderness at the injection site may occur. The possibility of allergic sensitivity, including an anaphylactic reaction, should be kept in mind.

Dosage and Administration

CATTLE, CALVES, HORSES, SWINE, SHEEP, AND GOATS:

Acute Hypoprothrombinemia (with Hemorrhage)

Intravenously, 0.5-2.5 mg/kg Body Weight, at a rate not to exceed 10 mg/minute in mature animals and 5 mg/minute in newborn and very young animals.

Non-Acute Hypoprothrombinemia

Intramuscularly or Sub-Cutaneously, 0.5-2.5 mg/kg Body Weight.

DOGS AND CATS:

Acute Hypoprothrombinemia (with Hemorrhage)

Intravenously, 0.25-2.5 mg/kg Body Weight, at a rate not to exceed 10 mg/minute.

Non-Acute Hypoprothrombinemia

Intramuscularly or Sub-Cutaneously, 0.25-2.5 mg/kg Body Weight.

Whenever possible, VETA-K1 Injection should be given by the intramuscular or subcutaneous routes. When intravenous injection is considered unavoidable, the drug should be given very slowly, at the rate indicated above. MONITOR PROTHROMBIN TIME AND ADJUST THE DOSAGE ACCORDINGLY.

Frequency and amount of subsequent doses should be guided by regular determination of prothrombin time response and clinical condition. If in six to eight hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.

THE SMALLEST EFFECTIVE DOSE SHOULD BE SOUGHT TO MINIMIZE THE RISK OF ADVERSE REACTION.

DIRECTIONS FOR DILUTION: VETA-K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose W/Sodium Chloride Injection. Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixing with the diluent, and unused portions of the solution should be discarded.

How Supplied

PVL VETA-K1 Injection is available in 30 mL and 100 mL multiple dose vials.

PROTECT FROM LIGHT - STORE IN A DARK PLACE

If outdated, not returnable

PROFESSIONAL VETERINARY LABORATORIES, Winnipeg, Man

12-81

CPN: 1203044.0