INFeD: Package Insert and Label Information (Page 2 of 2)

Administration:

The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula. (See Dosage).

1. Intravenous Injection — PRIOR TO THE FIRST INTRAVENOUS INFeD THERAPEUTIC DOSE, ADMINISTER AN INTRAVENOUS TEST DOSE OF 0.5 ML. ADMINISTER THE TEST DOSE AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

2. Intramuscular Injection — PRIOR TO THE FIRST INTRAMUSCULAR INFeD THERAPEUTIC DOSE, ADMINISTER AN INTRAMUSCULAR TEST DOSE OF 0.5 ML. (See BOXED WARNING and PRECAUTIONS.) The test dose should be administered in the buttock using the same technique as described in the last paragraph of this section. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given.

If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Each day’s dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients.

INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock — never into the arm or other exposed areas — and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.

NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

HOW SUPPLIED

INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (N DC 0023-6082-10).

Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].

R x O nly

REFERENCES

  1. Hatton RC, Portales IT, Finlay A, Ross EA. Removal of Iron Dextran by Hemodialysis: An In Vitro Study.
    Am J Kid D i s. 1995; 26(2):327-330.
  2. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. N ep h ron. 1972;9:94-98.

For all medical inquiries contact:
Allergan
Medical Communications
1-800-678-1605

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

Manufactured by:
Patheon Italia S.p.A.
Ferentino, Italy 03013

© 2020 Allergan. All rights reserved.
INFED® is a registered trademark of Allergan Sales, LLC.
Allergan® and its design are trademarks of Allergan, Inc.

Content Updated: June 2020

v.2.0USPI6082

PRINCIPAL DISPLAY PANEL

NDC 0023-6082-10

10 x 2 mL Single Dose Vials
INFeD
(IRON DEXTRAN Injection USP)
100 mg elemental iron/2 mL (50 mg/mL)
FOR INTRAMUSCULAR OR INTRAVENOUS USERx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6082-10
10 x 2 mL Single Dose Vials
INFeD
(IRON DEXTRAN Injection USP)
100 mg elemental iron/2 mL (50 mg/mL)
FOR INTRAMUSCULAR OR INTRAVENOUS USE
Rx Only
(click image for full-size original)

INFED iron dextran injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6082
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON DEXTRAN (FERRIC CATION) FERRIC CATION 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6082-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0023-6082-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017441 04/29/1974
Labeler — Allergan, Inc. (144796497)

Revised: 06/2020 Allergan, Inc.

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