Audited Supplier
Human Iron Dextran Injection 100mg/2ml
Iron Dextran injection 100mg/2ml
Composition:
Each 2 ml contains:
Iron Dextran...….100 mg
Water for Injection BP...…q.s.
| Product Name: | Iron Dextran injection 100mg/2ml |
| Strength: | 100mg/2ml |
| Dosage Form: | I.M. Ampoule |
| Packing: | 2mL Ampoule, 5 ampoule per box |
| Route of Administration: | For I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Storage: | Store below 25°C. Protect from Light. Do not freeze. |
Indication:
1. What Iron Dextran injection is and what it is used for
Iron Dextran injection contains s iron as an iron dextran complex (a molecule acting as a sugar chain), which is the same as the form of iron found naturally in the body called ferritin.
Iron Dextran injection is indicated in the treatment of iron deficiency in the following situations:
•When oral iron preparations cannot be used, e.g. due to intolerance, or in case of demonstrated lack-of effect of oral iron therapy.
•Where there is a clinical need to deliver iron rapidly to iron stores.
2.What you need to know before you take Iron Dextran injection
Contraindications
Contraindicated in patients with hypersensitivity to the product, and all anemias not associated with iron deficiency.
Warnings and precautions
Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy. There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
The intramuscular and subcutaneous injection of iron-carbohydrate complexes in very large doses under experimental conditions in animals produced sarcoma in rats, mice, rabbits, possibly hamsters but not in guinea pigs. Cumulative information and independent assessment indicate that the risk of sarcoma formation in man is minimal.
Hypotensive episodes may occur if intravenous injection is administered too rapidly.
Other medicines and Iron Dextran injection
Iron Dextran injection should not be administered concomitantly with oral iron medicines as the absorption of oral iron will be reduced. Oral iron therapy should not be started earlier than 5 days after the last injection of Iron Dextran injection.
Large doses of iron dextran (5ml or more) have been reported to give a brown colour to serum from a blood sample drawn four hours after administration. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, herbal preparations, vitamins or minerals.
Pregnancy
Pregnancy Category C: Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Iron Dextran injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding
Caution should be exercised when Iron Dextran injection is administered to a breast-feeding woman as traces of unmetabolized iron dextran are excreted in human milk.
Children (under 14 years)
Iron Dextran injection should not be used for children.
