INFED- iron dextran injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Iron Dextran (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)

থেকে পাওয়া:

General Injectables & Vaccines, Inc

INN (আন্তর্জাতিক নাম):

Iron Dextran

রচনা:

FERRIC CATION 50 mg in 1 mL

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

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 52544-931-02). Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature]. Rx Only

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

INFED- IRON DEXTRAN INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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INFED (IRON DEXTRAN) 20 MG/ML INJECTION, USP 2 ML SINGLE DOSE VIAL
BOXED WARNING
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 INFED
ADMINISTRATION.
ADMINISTER A TEST INFED DOSE PRIOR TO THE FIRST THERAPEUTIC DOSE. IF
NO SIGNS OR
SYMPTOMS OF ANAPHYLACTIC-TYPE REACTIONS FOLLOW THE TEST DOSE,
ADMINISTER THE FULL
THERAPEUTIC INFED DOSE.
DURING ALL INFED 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 INFED 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 INFED.
DES CRIPTION
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 5.2 and 6.5.
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