FerroForte: Product Information

FERROFORTE- 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.

Bimeda-MTC

Sterile Iron Dextran for Injection

200 mg/mL

Veterinary Use Only

DIN 00857041

ACTIVE INGREDIENT: FerroForte® is a clear, free flowing dark brown solution containing a macromolecular dextran and iron complex containing 200 mg/mL elemental iron with 0.5% w/v phenol as a preservative.

INDICATIONS: For the prevention and treatment of iron deficiency anemia in newborn piglets.

DOSAGE AND ADMINISTRATION: Inject 1 mL (200 mg iron) intramuscularly at one (1) to three (3) days of age. Disinfect the site of injection.

STORAGE: Store at room temperature (15°-30°C).

Manufactured by:
Bimeda-MTC Animal Health Inc., Cambridge ON, N3C 2W4

Distributed by:
Vetoquinol N.-A. Inc.
2000, ch. Georges, Lavaltrie, QC, CANADA J5T 3S5
vetoquinol

Client Information Sheet
FerroForte®

FerroForte® is a sterile Iron Dextran for Injection (200 mg/mL) supplied in 100 mL bottles for veterinary use only. FerroForte® is not approved by the FDA.

FDA has agreed to allow Vetoquinol N.-A. Inc. to supply FerroForte® 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.

FerroForte® is approved by Health Canada and exported to the U.S.A. by Vetoquinol N.-A. Inc.

FerroForte® should be used according to the details of the Compendium text provided in the back of this Client Information Sheet. You can use FerroForte® as you would use any other Iron Dextran for Injection in the prevention and treatment of iron deficiency in newborn piglets in the U.S.A. For example, site of administration as illustrated below.

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(click image for full-size original)

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, FerroForte® . 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
vetoquinol

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label

FerroForte®

Sterile Iron Dextran
for Injection
200 mg/mL
Veterinary Use
Only

Net 100 mL

DIN 00857041
1FER005

vetoquinol

PRINCIPAL DISPLAY PANEL -- 100 mL Bottle Label
(click image for full-size original)
FERROFORTE
iron dextran injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59320-100
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:59320-100-12 12 BOTTLE in 1 BOX contains a BOTTLE
1 100 mL in 1 BOTTLE This package is contained within the BOX (59320-100-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/03/2020
Labeler — Vetoquinol N.-A. INC (249335886)
Registrant — Bimeda-MTC Animal Health (256232216)
Establishment
Name Address ID/FEI Operations
Serumwerk Bernburg AG 330105057 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Bimeda-MTC Animal Health 256232216 MANUFACTURE

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

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