Ferum Lek i/m solution for injection 100mg/2ml ampoule #50

International Nonproprietary Name - IRON (III) - HYDROXIDE DEXTRAN COMPLEX Composition: Each ampoule (2 ml) contains 100 mg of iron in the form of an iron (III) hydroxide-dextran complex. Excipients: Sodium hydroxide and hydrochloric acid (for pH adjustment), water for injection. Pharmacological group: Anti-anemic agents. Iron-based agents, parenteral iron-based agents. Indications: Treatment of all forms of iron deficiency states when oral iron preparations are ineffective and/or not tolerated by patients. Contraindications: • Hypersensitivity to the active substance, to this preparation or to any of its excipients; • Anemia not caused by iron deficiency; • Iron overload or disorders of iron utilization. Dosage and administration: During and after administration of this preparation, careful observation for signs and symptoms of hypersensitivity reactions is required. This preparation should only be administered in the presence of personnel with the knowledge to recognize and manage anaphylactic reactions and with resuscitation equipment available. Side effects should be assessed for at least 30 minutes after each administration of the preparation. This preparation can only be administered intramuscularly. It cannot be used for intravenous administration, neither by injection nor by infusion. Maximum daily doses: Children: 0.14 ml Ferum Lek/kg body weight/day (7 mg iron/kg/day). Adults: 4 ml (2 ampoules). Instructions for use/handling and administration: Improper storage of ampoules may lead to precipitation. Ampoules should be carefully inspected before use. Only ampoules containing a homogeneous solution without precipitate should be used. If precipitate forms in the ampoules or the expiry date has passed, they must be disposed of. An opened ampoule should be used immediately. Pregnancy and lactation: Adequate and well-controlled studies on the use of this parenteral iron preparation in pregnant women have not been conducted. Animal studies have revealed reproductive toxicity. Therefore, before use during pregnancy, the risk-benefit ratio must be carefully assessed. This preparation should only be used during pregnancy if absolutely necessary. Iron deficiency anemia in the first trimester of pregnancy can in most cases be treated with oral iron preparations. Treatment with this preparation should be limited to the second and third trimesters of pregnancy if its benefit outweighs the potential risk to both mother and fetus. It is unknown whether the preparation is excreted in breast milk, therefore its use during breastfeeding is not recommended. Effect on ability to drive and operate machinery: Effect is unlikely. If symptoms such as dizziness, confusion or pre-syncope occur after using this preparation, the patient should not drive or operate machinery until they have completely disappeared.