Label: IRON HYDROGENATED DEXTRAN - iron injection

  • NDC Code(s): 58005-040-04
  • Packager: Sparhawk Laboratories, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

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  • DESCRIPTION

    HEMATINIC

    For Prevention and Treatment of Iron Deficiency Anemia in Baby Pigs

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN


    DESCRIPTION

    IRON HYDROGENATED DEXTRAN INJECTION is a sterile solution containing 100 mg of elemental iron per mL, stabilized with a low molecular weight hydrogenated dextran and 0.5% phenol as a preservative.

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  • INDICATIONS

    For the prevention and treatment of anemia due to iron deficiency in baby pigs.

    Iron deficiency anemia occurs commonly in the suckling pig, often within the first few days following birth. As body size and blood volume increase rapidly from the first few days following birth, hemoglobin levels in the blood fall due to diminishing iron reserves which cannot be replaced adequately from iron in the sow's milk. Thus, the need  for a readily available outside source of iron is apparent. Without this additional iron many newborn pigs may develop anemia within the first few days of life. Anemia retards growth and lowers the body defenses against disease; scours, pneumonia, and other conditions may develop. Death from anemia or infections may occur, sometimes destroying entire litters.

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  • DOSAGE

    For intramuscular injection only.

    For Prevention of iron deficiency anemia, administer 1 mL (100 mg iron) at 2 to 4 days of age.

    For Treatment of iron deficiency anemia, administer 1 mL (100 mg iron). Treatment may be repeated in 10 days.

    Disinfect rubber stopper of vial and injection site with a cotton ball moistened with rubbing alcohol or other suitable disinfectant. Use a small needle (20 gauge, 5/8 inch) and syringe that have been sterilized by boiling in water for 20 minutes. Injection should be made intramuscularly into the back of the ham (see diagram below). Apply tension to the skin at the injection site by pulling skin and fat downward with pressure from the thumb or fingers. Inject into the muscle to a depth of approximately 1/2 inch. Use a clean, sterile needle and syringe for each pig to avoid spreading infection.

    Injection Site

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  • PRECAUTIONS

    If disease or abnormal condition is suspected, consult veterinarian before administration.

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  • SIDE EFFECTS

    Occasionally pigs may exhibit a reaction to iron injection, clinically characterized by prostration and muscular weakness. In extreme cases, death may result.

    NOTICE: The intramuscular injection of organic iron preparations into pigs beyond 4 weeks of age may cause staining of muscle tissue.

    HOW SUPPLIED

    100 mL multiple dose vials.

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  • STORAGE AND HANDLING

    Store at controlled room temperature between 15o and 30oC (59o - 86oF).

    Protect from freezing.

    TAKE TIME OBSERVE LABEL DIRECTIONS

    See accompanying leaflet for additional information.

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  • INGREDIENTS AND APPEARANCE
    IRON HYDROGENATED DEXTRAN 
    iron injection
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:58005-040
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IRON (IRON) IRON 100  mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58005-040-04 100 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138255 08/11/1995
    Labeler - Sparhawk Laboratories, Inc. (147979082)
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