Vitamin K1 Injection

Company: Neogen

Vitamin K Injection

(Phytonadione) 10 mg/mL

Aqueous Colloidal Solution of Vitamin K₁

STERILE SOLUTION

Description

Vitamin 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: Vitamin 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 detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. A normal prothrombin level may often be obtained in 12 to 14 hours.

Vitamin K1 Injection Indications

Vitamin K₁ Injection is indicated in cattle, calves, horses, swine, sheep, goats, dogs and cats to counter Hypoprothrombinemia induced by ingestion of coumarin-based compounds, common ingredients in commercial rodenticides. Vitamin 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 Vitamin K₁ Injection. The dosage should be adjusted accordingly.

Contraindications

Hypersensitivity to any component of this medication.

Warnings

An immediate coagulant effect should not be expected after 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 Box Warning at Beginning of Circular).

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

Certain allergic manifestations, although rare, may occur following Intramuscular or Subcutaneous administration. These may include hives, urticaria, shortness of breath and edema.

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 Subcutaneously, 0.5-2.5 mg/kg Body Weight.

DOGS AND CATS

Acute Hypoprothrombinemia (with Hemorrhage) -

Intravenously, 0.25-5 mg/kg Body Weight, at a rate not to exceed 5 mg/minute.

Non-Acute Hypoprothrombinemia -

Intramuscularly or Subcutaneously, 0.25-5 mg/kg Body Weight.

Whenever possible, Vitamin 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 DOSAGE ACCORDINGLY.

Frequency and amount of subsequent doses should be guided by regular determination of prothrombin time response and clinical condition. If in 6 to 8 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: Vitamin 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 mixture with the diluent, and unused portions of the dilution should be discarded.

Vitamin K1 Injection Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

How Supplied

Vitamin K₁ Injection is available in 100mL multiple dose vials.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Protect from light - store in a dark place.

Store at a temperature between 15° and 30°C (59° - 86°F).

NEOGEN^® Vet

Manufactured by: Sparhawk Laboratories, Lenexa, KS 66215

Manufactured for: Neogen Corporation, Lexington, KY 40511

859-254-1221

animalsafety.neogen.com

Made in the USA

Rev: 06-09

CPN: 1491018.6