Label: UNIFERON 200 - iron dextran injection

  • 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 09/12

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  • DOSAGE & ADMINISTRATION

    Uniferon® 200 is a sterile solution containing a complex of ferric hydroxide with a low molecular weight dextran fraction equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative.

    Keep out of the reach of children.
    For use in animals only.

    Uniferon® is a Trademark of Pharmacosmos A/S.

    Manufactured for:
    Pharmacosmos, Inc.
    776 Mountain Boulevard
    Watchung, NJ 07069

    Issued 02-2011

    NADA 134-708, Approved by FDA


    Iron Dextran Complex Injection, 200 mg/mL
    Iron Hydrogenated Dextran

    Description: Uniferon® 200 is a sterile solution containing ferric hydroxide in complex with a low molecular weight dextran fraction equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative.

    Actions.  Injectable Uniferon® 200 is easy and economical to use. Injection into the ham is rapid, safe, effective, quickly absorbed by the blood and goes to work immediately. With injectable Uniferon® 200, the right dosage can be given to every animal with assurance that it will be utilized. 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. This natural deficiency lowers the resistance of the pig and scours, pneumonia or other infections may develop and lead to death of the animal. Pigs not hampered by iron deficiency anemia are more likely to experience normal growth and to maintain their normal level of resistance to disease. Adequate iron is necessary for normal, healthy, vigorous growth.

    Indications: Uniferon® 200 is intented for the prevention or treatment of anemia in baby pigs due to iron deficiency.

    Notice: Organic iron preparation injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the ham muscle.

    Dosage and Administration: For the prevention of anemia due to iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at 1 to 3 days of age. For the treatment of anemia due to  iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at the first signs of anemia.

    Directions For Use: Disinfect rubber stopper of vial as well as site of injection. Use small needle (20 gauge 5/8 inch) that has been sterilized (boiled in water for 20 minutes). Injection should be intramuscular into the back of the ham. Place tension on the skin over the rear of the ham and inject to a depth of 1/2” or slightly more.

    Uniferon® 200 cannot be considered a substitute for sound animal husbandry. If disease is present in the litter CONSULT A VETERINARIAN.

    Side Effects: Occasionally, pigs may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may result.
     
    How Supplied: Uniferon® 200 Injection, 200 mg/mL is available in 100 mL multidose vials.

    Store at controlled room temperature 59° - 86°F (15° - 30°C).

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    UNIFERON 200  
    iron dextran injection
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:42552-078
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Iron Dextran (Ferric Cation) Ferric Cation 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Phenol 5 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42552-078-10 100 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA134708 03/24/2011
    Labeler - Pharmacosmos, Inc (878028943)
    Registrant - Med-Pharmex, Inc (025353699)
    Establishment
    Name Address ID/FEI Business Operations
    Med-Pharmex, Inc 025353699 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Pharmacosmos A/S 309706968 api manufacture
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