Dexafer-200: Product Information

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.

Vetoquinol

STERILE IRON DEXTRAN 20% W/V SOLUTION FOR INJECTION, Mfr. Std.

Veterinary Use Only

DIN 02252724

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.

Client Information Sheet Dexafer-200

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

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label

DIN 02252724

Code 992052

Dexafer-200

STERILE IRON DEXTRAN
20% W/V SOLUTION
FOR INJECTION,
Mfr. Std.

Veterinary Use
Only

Net 100 mL

52060071-001

vetoquinol

DEXAFER-200 iron dextran injection, solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59320-010 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRON DEXTRAN (FERRIC CATION) FERRIC CATION 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL

Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59320-010-12 4 BOX in 1 CARTON contains a BOX 1 12 BOTTLE, GLASS in 1 BOX This package is contained within the CARTON (59320-010-12) and contains a BOTTLE, GLASS 1 100 mL in 1 BOTTLE, GLASS This package is contained within a BOX and a CARTON (59320-010-12)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/30/2020

Labeler — Vetoquinol N.-A. INC (249335886)

Establishment
Name	Address	ID/FEI	Operations
Pharmacosmos A/S		309706968	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Labiana Life Sciences		469734365	MANUFACTURE

Revised: 12/2020 Vetoquinol N.-A. INC