INFED- iron dextran injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Actavis Pharma, Inc.

INN (Jina la Kimataifa):

IRON DEXTRAN

Tungo:

FERRIC CATION 50 mg in 1 mL

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions ( 5.1 ) ] . Risk Summary   Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant persons of the potential risk to the fetus. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbi

Bidhaa muhtasari:

INFeD (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 52544-931-02). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Idhini hali ya:

New Drug Application

Tabia za bidhaa

INFED- IRON DEXTRAN INJECTION
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFED SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFED.
INFED (IRON DEXTRAN INJECTION), FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1974
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANAPHYLACTIC-TYPE REACTIONS, INCLUDING FATALITIES, HAVE BEEN REPORTED
FOLLOWING THE
PARENTERAL ADMINISTRATION OF IRON DEXTRAN INJECTION. (5.1)
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 BEEN REPORTED FOLLOWING 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. (5.3)
INDICATIONS AND USAGE
INFeD, an iron replacement product, is indicated for treatment of
adult and pediatric patients of age 4
months and older with documented iron deficiency who have intolerance
to oral iron or an unsatisfactory
response to oral iron. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for weight-based dosing and
administration information. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/2 mL (50 mg/mL) in single-dose vials (3)
CONTRAINDICATIONS
Known hypersensitivity to INFeD (4)
WARNINGS AND PRECAUTIONS
Delayed Reactio