FerroForte by Vetoquinol N.-A. INC / Bimeda-MTC Animal Health / Serumwerk Bernburg AG FerroForte®

FerroForte by

Drug Labeling and Warnings

FerroForte by is a Animal medication manufactured, distributed, or labeled by Vetoquinol N.-A. INC, Bimeda-MTC Animal Health, Serumwerk Bernburg AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

----------

FerroForte®

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.

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

FERROFORTE 
iron dextran injection, solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 59320-100
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59320-100-12	12 in 1 BOX
1		100 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		11/03/2020	12/04/2023

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

Registrant - Bimeda-MTC Animal Health (256232216)

Establishment
Name	Address	ID/FEI	Business Operations
Serumwerk Bernburg AG		330105057	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC Animal Health		256232216	MANUFACTURE

Revised: 12/2023

Document Id: b6a3ae03-6b81-4ec3-9180-efe8527a8c0a

50577-6

Set id: 4b594e2b-8d17-44c7-a9ee-fd449144c148

Version: 3

Effective Time: 20231205