Vita-jec K1

Vita-jec K1

Vita-jec K1 Recall

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Questions & Answers

Side Effects & Adverse Reactions

WARNING:

WARNING - INTRAVENOUS USE: Severe reactions, including fatalities, have occurred during and immediately after the INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione 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 phytonadione for the first time. Therefore, the INTRAVENOUS route should be restricted to those situations where other routes are not feasible and the increased risk involved is considered justified.

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 also be necessary if bleeding is severe.

Phytonadione will not counteract the anticoagulant action of heparin.

When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS:

Vita-Jec® K1 is indicated in coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

Vita-Jec® K1 is indicated in cattle, calves, horses, swine, sheep, goats, dogs, and cats to counter hypoprothrombinemia induced by ingestion of anticoagulant rodenticides. Vita-Jec® K1 is also indicated to counter hypoprothrombinemia caused by consumption of bishydroxycoumarin found in a spoiled and moldy sweet clover.

History

There is currently no drug history available for this drug.

Other Information

Vita-Jec® K1

(Phytonadione) Aqueous Colloidal Solution

10 mg per mL

Vitamin K1 Injection

CAUTION: Federal law restricts this drug to use by or on the order of a lincensed veterinarian

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Net Contents: 100 mL

Multiple Dose Vial

For complete warnings and additional information see enclosed insert.

DESCRIPTION: Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2.

Vita-Jec® K1 is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular and subcutaneous routes.

EACH mL CONTAINS: Phytonadione 10 mg; Polyoxyethylated fatty acid derivative 65 mg; Dextrose monohydrate 37.5 mg; Butylated hydroxyanisole 1 mg; Butylated hydroxytoluene 1 mg; Citric acid 8.4 mg; Sodium phosphate 17.2 mg; with Benzyl Alcohol 0.9% w/v added as a preservative.

Vita-jec K1 Manufacturers


  • Aspen Veterinary Resources
    Vita-jec K1 (Phytonadione) Solution [Aspen Veterinary Resources]

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