Finished product reference
Iron
Injection · Intravenous · 20 mg/1mL · 5 mL
- List code
- 4003
- Salt form
- Sucrose
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following 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.
What it is and how it works
Mechanism of Action The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores.
Indications
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, 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.
Dosage and administration (summary)
See Full Prescribing Information for weight-based dosing and administration information. Weight in Kg Weight in Kg INFeD dose volume Important Pre-Treatment Information Discontinue administration of any iron-containing products prior to administration of INFeD. Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. Administer a test dose of INFeD prior to administration of therapeutic dose . 2. 2 Recommended Dosage for Iron Deficiency Anemia Calculate the INFeD dose based upon Table 1 and formulas below.
Warnings and precautions
Delayed Reactions: May occur with large intravenous doses. Increased Risk of Toxicity in Patients with Underlying Conditions: Monitor for toxicity in these patients. Iron Overload: Excessive therapy can lead to iatrogenic hemosiderosis. Do not administer to patients with iron overload. Periodically monitor hematologic and iron parameters. Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including INFeD.
Pregnancy
Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant persons of the potential risk to the fetus.
Storage and supply
16. 2 Stability and Storage 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). .
Source: Iron Dextran (Infed) — US FDA prescribing information, 2024-08-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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