UNIFERON 200  - iron dextran  injection 
Pharmacosmos, Inc

----------

Uniferon 200

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).

Image of Package Insert



image of vial label
Product Label
UNIFERON 200  
iron dextran injection
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:42552-078
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iron Dextran (Ferric Cation) Ferric Cation200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Phenol5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42552-078-10100 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA13470803/24/2011
Labeler - Pharmacosmos, Inc (878028943)
Registrant - Med-Pharmex, Inc (025353699)
Establishment
NameAddressID/FEIBusiness Operations
Med-Pharmex, Inc025353699manufacture
Establishment
NameAddressID/FEIBusiness Operations
Pharmacosmos A/S309706968api manufacture

Revised: 9/2012
Document Id: 531a9985-5f5d-470b-bf8c-ffcd639ee6fb
Set id: 4c5de520-17ee-449e-a658-ac357e6163ed
Version: 3
Effective Time: 20120913
 
Pharmacosmos, Inc