IRON DEXTRAN injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

HF Acquisition Co LLC, DBA HealthFirst

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. Hypersensitivity to the product. All anemias not associated with iron deficiency.

Tuoteyhteenveto:

INFED(R) (IRON DEXTRAN INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1441-1 INFED(R) (IRON DEXTRAN INJECTION, USP) 100mg elemental iron/2mL (50mg/mL) 2mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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 (NDC 0023-6082-10). Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature]. Rx Only

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

IRON DEXTRAN- IRON DEXTRAN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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INFED(R) (IRON DEXTRAN INJECTION, USP) 100MG ELEMENTAL IRON/2ML
(50MG/ML) 2ML
VIAL
BOXED WARNING
DESCRIPTION
INFeD (Iron Dextran Injection USP) is a dark brown, slightly viscous
sterile liquid complex of ferric
hydroxide and dextran for intravenous or intramuscular use.
Each mL contains the equivalent of 50 mg of elemental iron (as an iron
dextran complex), approximately
0.9% sodium chloride, in water for injection. Sodium hydroxide and/or
hydrochloric acid may have
been used to adjust pH. The pH of the solution is between 4.5 to 7.0.
Therapeutic Class: Hematinic
CLINICAL PHARMACOLOGY
General: After intramuscular injection, iron dextran is absorbed from
the injection site into the
capillaries and the lymphatic system. 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
replenishes hemoglobin and depleted iron stores.
Dextran, a polyglucose, is either metabolized or excreted. Negligible
amounts of iron are lost via the
urinary or alimentary pathways after administration of iron dextran.
The major portion of intramuscular injections of iron dextran is
absorbed within 72 hours; most of the
remaining iron is absorbed over the ensuing 3 to 4 weeks.
Various studies involving intravenously administered 59Fe iron dextran
to iron deficient subjects, some
of whom had coexisting diseases, have yielded half-life values ranging
from 5 hours to more than 20
hours. The 5-hour value was determined for 59Fe iron dextran from a
study that used laboratory
methods to separate the circulating 59Fe iron dextran from the
transferrin-bound 59Fe. The 20-hour
value reflects a half-life determined by measuring total 59Fe, both
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