VITAMIN K1 INJECTABLE (PHYTONADIONE) INJECTION [NEOGEN CORPORATION - NANDINO]

VITAMIN K1 INJECTABLE (PHYTONADIONE) INJECTION [NEOGEN CORPORATION - NANDINO]
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NDC 59051-9089-5
Set ID 7a32a988-05f1-4b63-8175-5a744c65fa63
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Neogen Corporation - Nandino
Generic Name
Product Class
Product Number
Application Number
  • USE IN SPECIFIC POPULATIONS

    ​FOR ANIMAL USE ONLY

  • ​Each mL contains:

    ​Phytonadione..................................10 mg

    Emulphor EL-719.............................70 mg

    Dextrose H​2​O...............................41.2 mg

    Benzyl Alcohol (preservative)............1.5%

    Water for Injection..............................q.s.

  • STORAGE AND HANDLING

    Protect from light - store in a dark place. Store at controlled room temperature between 15°-30°C (59°-86°F).

  • SPL UNCLASSIFIED SECTION

    Rev. 7-09

    V-0681-04

    Item No. 09089

  • ​Principal Display Panel Vitamin K​1​ Injection 100 mL

    NDC: 59051-9089-5

    Vitamin K​1 ​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

    Vitamin K1 Injection

  • WARNINGS

    ​KEEP OUT OF REACH OF CHILDREN

  • ​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.

  • SPL UNCLASSIFIED SECTION

    Manufactured by Sparhawk laboratories, Lenexa, KS 66215

    for Neogen®Corporation, Lexington, KY 40511 859-254-1221

  • ​Package Insert

    ​VITAMIN K​1

    ​(Phytonadione)

    ​Injection

    Vitamin K Injection

    (Phytonadione)

    Aqueous Colloidal Solution of Vitamin K​1

    ___________________________________________________________________________________________________________

    ​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 K​1 ​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 K​1​ 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.

    _____________________________________________________________________________________________________________

    ​DESCRIPTION: ​Vitamin K​1 ​Injection is a yellow, sterile acqueous colloidal solution of Vitamin K​1 ​(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 H​2​O...............................41.2 mg

    Water...................................................q.s.

    Added as a preservative

    Benzyl Alcohol....................................1.5%

    ​ACTIONS: ​Vitamin K​1​ Injection, an aqueous colloidal solution of Vitamin K​1 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 K​1​ 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 K​1​ 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 K​1​ 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.

  • INGREDIENTS AND APPEARANCE
    VITAMIN K1 INJECTABLE 
    phytonadione injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59051-9089
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59051-9089-5100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/27/2012
    Labeler - Neogen Corporation - Nandino (042125879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk147979082manufacture, analysis, sterilize

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