Inofar IV Injection: Each 5 ml ampoule contains iron sucrose USP equivalent to 100 mg elemental iron.
Inofar (Iron Sucrose) is indicated for the treatment of iron deficiency in the following conditions:
Where there is a clinical need for a rapid iron supply in patients who cannot tolerate oral iron therapy or who are non-compliant and in active inflammatory bowel disease where oral preparations are ineffective.
Treatment of iron deficiency anemia in pregnancy, non-dialysis dependent-chronic kidney disease (CKD) patients either receiving or not receiving an erythropoietin and hemodialysis dependent-CKD patients receiving an erythropoietin, or peritoneal dialysis-CKD patients receiving an erythropoietin
Adults and the elderly: The total cumulative dose of Iron Sucrose, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose for Iron Sucrose must be individually determined for each patient according to the total iron deficit calculated with the following formula: Total iron deficit [mg]= body weight [kg] x (target Hb - actual Hb) [g/l] x 0.24* + depot iron [mg]
Below 35 kg body weight: target Hb = 130 g/l and depot iron = 15 mg/kg body weight
35 kg body weight and above: target Hb = 150 g/l and depot iron = 500 mg
*Factor 0.24 = 0.0034 x 0.07 x 1000 (Iron content of haemoglobin 0.34%; Blood volume 7% of body weight; Factor 1000 = conversion from g to mg)
The total single dose must not exceed 200 mg of iron given not more than three times per week. If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split.
Iron Sucrose must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Before administering the first dose to a new patient, a test dose of Iron Sucrose should be given. Iron Sucrose must not be used for intramuscular injection.
Intravenous drip infusion: Iron Sucrose must be diluted only in sterile 0.9% m/V sodium chloride solution:
5 ml Iron Sucrose (100 mg iron) in max. 100 ml sterile 0.9% m/V sodium chloride solution
10 ml Iron Sucrose (200 mg iron) in max. 200 ml sterile 0.9% m/V sodium chloride solution
For stability reasons, dilutions to lower Iron Sucrose concentrations are not permissible. Dilution must take place immediately prior to infusion and the solution should be administered as follows:
100 mg iron (5 ml Iron Sucrose) in at least 15 minutes
200 mg iron (10 ml Iron Sucrose) in at least 30 minutes
The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 50 ml in 15 minutes.
Intravenous injection: Iron Sucrose may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute (i.e. 5 minutes per ampoule) and not exceeding 2 ampoules Iron Sucrose (200 mg iron) per injection.
Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given.
Injection into dialyser: Iron Sucrose may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
The use of Iron Sucrose is contra-indicated in cases of known hypersensitivity to Iron Sucrose or any of its excipients, anaemias not attributable to iron deficiency, iron overload or disturbances in utilisation of iron, patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions, pregnancy first trimester.
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which may be potentially fatal. Therefore, treatment for serious allergic reactions and facilities with the established cardio-pulmonary resuscitation procedures should be available. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor. Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis. Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded. Paravenous leakage must be avoided because leakage of Iron Sucrose at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin. Do not save unused solution for future use. Do not administer if particular matter or discoloration noted.
Occasionally metallic taste, headache, nausea, vomiting, hypotension may occur. Parasthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactoid (pseudoallergic) reactions may occur rarely
Iron Sucrose should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Iron Sucrose.
Incompatibility: Do not mix with other medications or therapeutic agents, which may potential for precipitation and/or interaction.
Use in pregnancy: Pregnancy Category B.
Use in lactation: It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in breast milk, exercise caution when iron sucrose is administered to a breastfeeding woman.
Use in children: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Inofar IV Injection: Each box contains 1's ampoule in blister pack.
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