UNIFERON 200- iron dextran injection

Uniferon 200 by

Drug Labeling and Warnings

Uniferon 200 by is a Animal medication manufactured, distributed, or labeled by Pharmacosmos, Inc, Med-Pharmex, Inc, Pharmacosmos A/S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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



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

NADA 134-708, Approved by FDA

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:

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

250 mL: Use product wihtin 60 days of first puncture. Do not puncture the stopper more than 50 times with a needle. or more than 10 times with 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. 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 and 250 mL multidose vials.

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

TAKE TIME OBSERVE LABEL DIRECTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIFERON 200  
iron dextran injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 42552-078
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Iron Dextran (UNII: 95HR524N2M) (Ferric Cation - UNII:91O4LML611)	Ferric Cation	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Phenol (UNII: 339NCG44TV)	5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42552-078-25	250 mL in 1 VIAL
2	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	10/01/2016

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