UNIFERON 100- iron dextran injection 
Pharmacosmos, Inc
Reference Label Set Id: 69e7c883-2078-49c1-b8ea-c1d0ca7269bb

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Uniferon 100

Uniferon® 100 is a sterile solution containing a complex of ferric hydroxide with a low molecular weight dextran fraction equivalent to 100 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

Iron Dextran Complex Injection, 100 mg/mL
Iron Hydrogenated Dextran

NADA 106-772, Approved by FDA



Description: Uniferon® 100 is a sterile solution containing ferric hydroxide in complex with a low molecular weight dextran fraction equivalent to 100 mg elemental iron per mL with 0.5% phenol as a preservative.

Injectable Uniferon® 100 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® 100, the right dosage can be given to every animal with assurance that it will be utilized.

Treatment of baby pigs with Uniferon® 100 prevents anemia and reduces losses due to iron deficiency. Adequate iron is necessary for normal, healthy, vigorous growth.

Indications: Uniferon® 100 is intented for the prevention or treatment of iron deficiency anemia 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. 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. 

Dosage:
Intramuscular Injection
Prevention:
     1 mL (100 mg iron) at 2-4 days of age.
Treatment:
     1 mL (100 mg iron). May be repeated in approximately 10 days.

Directions For Use
:

100mL: Use product within 60 days of first puncture. Do not Puncture the stopper more than 20 times.

250mL: Use product within 60 days of first puncture. Do not puncture the stopper more than 50 times with a needle, or more than 10 times with the trocar of an automatic self-filling injector syringe.

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.

Uniferon® 100 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® 100 Injection, 100 mg/mL is available in 100 mL and 250 mL multidose vials.

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

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

Not a USP formulation.

TAKE TIME OBSERVE LABEL DIRECTIONS

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UNIFERON 100 
iron dextran injection
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:42552-077
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iron Dextran (UNII: 95HR524N2M) (Ferric Cation - UNII:91O4LML611) Ferric Cation100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Phenol (UNII: 339NCG44TV) 5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42552-077-25250 mL in 1 VIAL
2NDC:42552-077-10100 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA10677205/01/201709/09/2021
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: 9/2021
 
Pharmacosmos, Inc