DEXAFER-200- iron dextran injection, solution
Vetoquinol N.-A. INC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
STERILE IRON DEXTRAN 20% W/V SOLUTION FOR INJECTION, Mfr. Std.
Veterinary Use Only
ACTIVE INGREDIENT: Each mL contains the equivalent of 200 mg of iron as ferric hydroxide dextran complex.
Preservative: Phenol 0.5% W/V
INDICATIONS: For the prevention and treatment of iron deficiency anaemia in new-born piglets.
DIRECTIONS FOR USE: For the prevention and treatment of iron deficiency anaemia in baby pigs, inject 1 mL (200 mg iron) intramuscularly, preferably in the neck region. Disinfect the site of injection with iodine or alcohol before injecting.
CAUTIONS: If symptoms of iron deficiency persist, consult a veterinarian.
STORAGE: Store at room temperature (between 15°C and 25°C). Avoid freezing.
Dexafer-200 is a sterile Iron Dextran for Injection (200 mg/mL) supplied in 100-mL bottles for veterinary use only. Dexafer-200 is not approved by the FDA.
FDA has agreed to allow Vetoquinol N.-A. Inc. to supply Dexafer-200 in order to help address the anticipated shortage of Iron Dextran Injection, 200 mg/mL for prevention and treatment of iron deficiency anemia in newborn piglets in the U.S.A.
Dexafer 200 is approved by Health Canada and exported to the U.S.A. by Vetoquinol N.-A. Inc. Dexafer 200 should be used in the US according to the directions provided on the back of this Client Information Sheet. You can use Dexafer 200 as you would use any FDA approved Iron Dextran injectable product for the prevention or treatment of iron deficiency in newborn piglets. For example, the site of injection should be in the hind leg as shown below.
ADVERSE DRUG EVENTS & PRODUCT DEFECTS
To report suspected adverse drug events and product defects, please contact Vetoquinol N.-A.’s toll-free number at 1-800-363-1700 and inform the representative that your call concerns the Canadian product, Dexafer-200. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Vetoquinol N.-.A. Inc.
2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5
STERILE IRON DEXTRAN
20% W/V SOLUTION
Net 100 mL
iron dextran injection, solution
|Labeler — Vetoquinol N.-A. INC (249335886)|
|Pharmacosmos A/S||309706968||API MANUFACTURE|
|Labiana Life Sciences||469734365||MANUFACTURE|
Revised: 12/2020 Vetoquinol N.-A. INC
VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.