IRON HYDROGENATED DEXTRAN- iron injection

IRON HYDROGENATED DEXTRAN by

Drug Labeling and Warnings

IRON HYDROGENATED DEXTRAN by is a Animal medication manufactured, distributed, or labeled by MWI Veterinary Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

DIRECTIONS FOR USE

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.

PRECAUTIONS

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

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IRON HYDROGENATED DEXTRAN 
iron injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-520
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	100  mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-520-02	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA138255	11/19/2011

Labeler - MWI Veterinary Supply, Inc. (019926120)