VITAMIN K1 INJECTABLE- phytonadione injection
Vitamin K1 Injectable by
Drug Labeling and Warnings
Vitamin K1 Injectable by is a Animal medication manufactured, distributed, or labeled by Neogen Corporation - Nandino, Sparhawk. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- USE IN SPECIFIC POPULATIONS
- Each mL contains:
- STORAGE AND HANDLING
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Principal Display Panel Vitamin K1 Injection 100 mL
NDC: 59051-9089-5
Vitamin K1 Injections
(Phytonadione) 10 mg/mL
Aqueous Colloidal
STERILE SOLUTION
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
NEOGEN.Vet
Net Contents: 100 mL
MULTIPLE DOSE VIAL
- WARNINGS
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Dosage and Administration:
Cattle, Calves, Horses, Swine, Sheep, and Goats: Acute hypotrothrombinemia (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 per body weight.
Dogs and Cats: Acute hypoprothrombinemia (with hemorrhage) and non-acute hypoprothrombinemia-- 0.25-5 mg/kg subcutaneously OR intramuscularly. Use higher end dose for second generation rodenticides.
ADVERSE REACTIONS: See insert for additional information.
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Package Insert
VITAMIN K1
(Phytonadione)
Injection
Vitamin K Injection
(Phytonadione)
Aqueous Colloidal Solution of Vitamin K1
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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 Vitamin 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.
See ADVERSE REACTION section for possible Intramuscular and Subcutaneous reactions.
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DESCRIPTION: Vitamin K1 Injection is a yellow, sterile acqueous colloidal solution of Vitamin K1 (phytonadione), available for injection by the intravenous, intramuscular and subcutaneous routes. Each mL contains:
Phytonadione...................................10 mg
Inactive Ingredients
Emulphor EL-719..............................70 mg
Dextrose H2O...............................41.2 mg
Water...................................................q.s.
Added as a preservative
Benzyl Alcohol....................................1.5%
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.
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: Regualr 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.
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INGREDIENTS AND APPEARANCE
VITAMIN K1 INJECTABLE
phytonadione injectionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 59051-9089 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength PEG-40 CASTOR OIL (UNII: 4ERD2076EF) DEXTROSE (UNII: IY9XDZ35W2) BENZYL ALCOHOL (UNII: LKG8494WBH) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59051-9089-5 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/27/2012 Labeler - Neogen Corporation - Nandino (042125879) Establishment Name Address ID/FEI Business Operations Sparhawk 147979082 manufacture, analysis, sterilize
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