Label: IRON HYDROGENATED DEXTRAN- iron injection

100 mg/mL

For Prevention and Treatment of Iron Deficiency Anemia in Nursing Piglets

Approved by FDA under NADA # 138-255

NOT FOR HUMAN USE

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.

For the prevention and treatment of anemia due to iron deficiency in nursing piglets. Iron deficiency anemia occurs commonly in the nursing piglets, 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.

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

Use a clean, sterile syringe and needle (20 gauge ½” needle); and ensure the injection site is clean and dry. Administer intramuscularly into the
back of the ham muscle to a depth of approximately ½ inch (see diagram below). Apply tension to the skin at the injection site by pulling skin and fat downward withpressure from the thumb or fingers.

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

WARNINGS WITHDRAWAL PERIODS: No withdrawal period is required when used according to labeling.

ANIMAL SAFETY WARNINGS: Clinical signs associated with iron toxicity in piglets include convulsion, respiratory distress (tachypnoea, dyspnea) injection site reactions (inflammation, infection or necrosis), muscle tremors or weakness, prostration, and death. There is increased risk for iron toxicity in piglets born to sows with vitamin E/ selenium deficiencies.

Occasionally nursing piglets 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.

100 mL and 250 mL multiple dose vials.

Each mL of sterile solution contains 100 mg of elemental iron stabilized with a low molecular weight hydrogenated dextran and 0.5% phenol as a preservative.

Store between 15º and 30ºC (59º - 86ºF).
Protect from freezing.
Use within 18 months of first puncture and
puncture a maximum of 200 times.

Contact Sparhawk Laboratories Inc. at 1-800-255-6388 or sparhawklabs.com. To report side effects, contact Sparhawk Laboratories Inc. at 1-800-255-6388. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.