DEXFERRUM iron dextran injection solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)

Dostupno od:

American Regent, Inc.

INN (International ime):

IRON DEXTRAN

Sastav:

FERRIC CATION 50 mg in 1 mL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

DEXFERRUM- IRON DEXTRAN INJECTION, SOLUTION
AMERICAN REGENT, INC.
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DEXFERRUM (IRON DEXTRAN INJECTION, USP)
RX ONLY
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
ANAPHYLACTIC-TYPE REACTIONS, INCLUDING FATALITIES, HAVE FOLLOWED THE
PARENTERAL ADMINISTRATION
OF IRON DEXTRAN INJECTION.
HAVE RESUSCITATION EQUIPMENT AND PERSONNEL TRAINED IN THE DETECTION
AND TREATMENT OF
ANAPHYLACTIC-TYPE REACTIONS READILY AVAILABLE DURING DEXFERRUM
ADMINISTRATION.
ADMINISTER A TEST DEXFERRUM DOSE PRIOR TO THE FIRST THERAPEUTIC DOSE.
IF NO SIGNS OR
SYMPTOMS OF ANAPHYLACTIC-TYPE REACTIONS FOLLOW THE TEST DOSE,
ADMINISTER THE FULL
THERAPEUTIC DEXFERRUM DOSE.
DURING ALL DEXFERRUM ADMINISTRATIONS, OBSERVE FOR SIGNS OR SYMPTOMS OF
ANAPHYLACTIC-
TYPE REACTIONS. FATAL REACTIONS HAVE FOLLOWED THE TEST DOSE OF IRON
DEXTRAN INJECTION. FATAL
REACTIONS HAVE ALSO OCCURRED IN SITUATIONS WHERE THE TEST DOSE WAS
TOLERATED.
USE DEXFERRUM ONLY IN PATIENTS IN WHOM CLINICAL AND LABORATORY
INVESTIGATIONS HAVE
ESTABLISHED AN IRON DEFICIENT STATE NOT AMENABLE TO ORAL IRON THERAPY.
PATIENTS WITH A HISTORY OF DRUG ALLERGY OR MULTIPLE DRUG ALLERGIES MAY
BE AT INCREASED RISK
OF ANAPHYLACTIC-TYPE REACTIONS TO DEXFERRUM.
DESCRIPTION
DEXFERRUM (IRON DEXTRAN INJECTION, USP) is a dark brown, slightly
viscous sterile liquid
complex of ferric oxyhydroxide for intravenous use. Each mL contains:
50 mg elemental iron as an iron
dextran complex. Sodium chloride may have been added for tonicity.
Water for injection q.s. pH (range
4.5-7.0) adjusted with hydrochloric acid and, if necessary, sodium
hydroxide. Sterile, nonpyrogenic.
Therapeutic Class: Hematinic
CLINICAL PHARMACOLOGY
GENERAL: Circulating iron dextran is removed from the plasma by cells
of the reticuloendothelial
system, which split the complex into its components of iron and
dextran. The iron is immediately bound
to the available protein moieties to form hemosiderin or ferritin, the
physiological forms of iron, or to a
lesser extent to transferrin. This iron which is subject to
physiological control re