Iron Sucrose Injection USP is indicated for the treatment of iron deficiency in the following indications: • where there is a clinical need to deliver iron rapidly to iron stores, • in patients who cannot tolerate oral iron therapy or who are non-compliant, • in active inflammatory bowel disease where oral iron preparations are ineffective. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, serum iron, etc.).

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of iron sucrose. Iron sucrose should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each iron sucrose injection. Iron sucrose must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Iron sucrose must not be used for intramuscular injection. 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 amount of iron sucrose required in mg is determined from above calculation. Alternatively, total amount of iron sucrose required in ml can be calculated from the below equation: Total amount of iron sucrose required (ml) = [Total iron deficit (mg)] / 20 mg per ml Total dosage 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. Children: The use of iron sucrose has not been adequately studied in children and, therefore, iron sucrose is not recommended for use in children. Slow intravenous injection Iron sucrose may be administered undiluted by slow intravenous injection at a rate of 1 ml (20 mg iron) solution per minute not exceeding 10 ml iron sucrose (200 mg) per injection. Intravenous drip infusion Infusion must be administered as every 5 ml iron sucrose injection diluted exclusively in a maximum of 100 ml of 0.9% NaCl, immediately prior to infusion. The solution must be infused at a rate of 100 mg of iron over a period of at least 15 minutes and 200 mg of iron over a period of at least 30 minutes. Unused diluted solution must be discarded.   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. NOTE: Do not mix iron sucrose with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

"• Known hypersensitivity to iron sucrose or any of its excipients • Known serious hypersensitivity to other parenteral iron products • Anaemias not attributable to iron deficiency • Iron overload or disturbances in utilisation of iron • Pregnancy first trimester "

Hypersensitivity reactions 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). Iron sucrose should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each iron sucrose injection. If hypersensitivity reactions or signs of   intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. Liver dysfunction 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, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload. Hypotension 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. Acute or chronic infection 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. Paravenous leakage 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.

Drug interactions involving iron sucrose have not been studied. However, iron sucrose may reduce the absorption of concomitantly administered oral iron preparations. Therefore, oral iron therapy should be started at least 5 days after the last injection of iron sucrose.

Pregnancy Category B: Iron sucrose should be used in pregnant women during second and third trimester only if clearly indicated. Iron sucrose should not be used during the first trimester of pregnancy. Nursing mothers Non-metabolised iron sucrose is unlikely to pass into the mother's milk. No well- controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.

In the case of symptoms of dizziness, confusion or light headedness following the administration of iron sucrose, patients should not drive or use machinery until the symptoms have ceased.

Most frequently reported adverse drug reactions (0.5–1.5% incidence) - transient taste perversion (metallic taste), hypotension, fever and shivering, injection site reactions and nausea. Non-serious anaphylactoid reactions occurred rarely. In general anaphylactoid reactions are potentially the most serious adverse events. Adverse events reported in clinical trials on iron sucrose and their frequencies of occurrence are given below: Nervous system disorders Common (≥ 1/100, < 1/10): transient taste perversions (in particular metallic taste). Uncommon (≥ 1/1000, < 1/100): headache, dizziness. Rare (≥ 1/10000, < 1/1000): paraesthesia, syncope, loss of consciousness, burning sensation. Cardio-vascular disorders Uncommon (≥ 1/1000, < 1/100): hypotension and collapse, tachycardia and palpitations. Rare (≥ 1/10000, < 1/1000): hypertension.   Respiratory, thoracic and mediastinal disorders Uncommon (≥ 1/1000, < 1/100): bronchospasm, dyspnoea. Gastrointestinal disorders Uncommon (≥ 1/1000, < 1/100): nausea; vomiting, abdominal pain, diarrhoea. Skin and subcutaneous tissue disorders Uncommon (≥ 1/1000, < 1/100): pruritus, urticaria, rash, exanthema, erythema. Musculoskeletal, connective tissue and bone disorders Uncommon (≥ 1/1000, < 1/100): muscle cramps, myalgia. General disorders and administration site disorders Uncommon (≥ 1/1000, < 1/100): fever, shivering, flushing, chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling Rare (≥ 1/10000, < 1/1000): arthralgia, peripheral oedema, fatigue, asthenia, malaise, feeling hot, oedema Immune system disorders Rare (≥ 1/10000, < 1/1000): anaphylactoid reactions. Moreover, in spontaneous reports the following adverse reactions have been reported: Isolated cases: reduced level of consciousness, light-headed feeling, confusion, angio- oedema, swelling of joints, hyperhidrosis, back pain, bradycardia, chromaturia.

Overdosage can cause acute iron overloading which may manifest itself as haemosiderosis. Overdosage should be treated, if required, with an iron chelating agent.

Iron sucrose is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

Following intravenous injection of a single dose of iron sucrose containing 100 mg iron, maximum iron levels, averaging 538 µmol/l, are obtained 10 minutes after injection. Iron sucrose exhibits first order kinetics with an elimination half-life of 6 h. The volume of distribution at steady state was about 8 litres, indicating a low iron distribution in the body fluid. Since iron disappearance from serum depends on the need for iron in the iron stores and iron utilizing tissues of the body, serum clearance of iron is expected to be more rapid in iron deficient patients treated with iron sucrose as compared to healthy individuals. The effects of age and gender on the pharmacokinetics of iron sucrose have not been studied. Following intravenous administration of iron sucrose, the iron component appears to distribute mainly in blood and to some extent in extravascular fluid. Significant amount of administered iron is distributed in the liver, spleen and bone marrow. Following intravenous administration, iron sucrose dissociates into iron and sucrose by the reticuloendothelial system. The sucrose component is eliminated mainly by urinary excretion. Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than 5% of the total body clearance. After 24 h the plasma levels of iron reduce to the pre-dose iron level and about 75% of the dosage of sucrose is excreted.

There are no preclinical data of relevance to the prescriber that are additional to information already in other sections of the SPC.

List of excipients: Sodium hydroxide & Water for Injection

Incompatibilities Iron Sucrose Injection must only be mixed with sterile 0.9% m/V sodium chloride solution. No other solutions and therapeutic agents should be used as there is the potential for precipitation and/or interaction.

"Shelf life of the product as packaged for sale: 24 months Shelf life after first opening of the container: From a microbiological point of view, the product should be used immediately. Shelf life after dilution with sterile 0.9% m/V sodium chloride solution: From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution. "

Store in a dark place, below 30°C. Do not freeze. Keep away from the reach of children.

5 ml solution in one glass vial.

Vials should be visually inspected for sediment and damage before use. Only those with sediment free and homogenous solution must be used.