Company: Pharmacosmos UK Ltd.
Legal category: Prescription. Sport permitted.
Active ingredient: Iron (as iron(III) isomaltoside 1000) 50mg/ml.
Description: Solution for injection.
Presentation: 25 x 2ml, €735.29.
Indication: Treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used.
Pharmacology: Iron isomaltoside is a haematinic. The strongly bound complex comprising iron and isomaltoside 1000 enables a controlled and slow release of bioavailable iron to iron-binding proteins with little risk of free iron. Reticuloendothelial system cells rapidly take up iron isomaltoside 1000, remove circulating iron from the plasma and split the complex into its components. The released iron is immediately bound to the available protein moieties to form hemosiderin, ferritin or transferrin. This iron, which is subject to physiological control, replenishes haemoglobin and depleted iron stores.
Dosage: Adult: Up to 200mg (based on response, see SPC) by intravenous bolus injection or directly into venous limb of dialyser; maximum 1000mg weekly. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance, or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Non-iron deficiency anaemia (eg. haemolytic anaemia). Iron overload or disturbances in utilisation of iron (eg. haemochromatosis, haemosiderosis). Decompensated liver cirrhosis and hepatitis.
Special precautions: Risk of anaphylaxis; facilities for full resuscitation must be available; monitor patient during and for 30 minutes after each administration. Ongoing bacteraemia (do not use). Caution: Acute or chronic infection, known allergies, history of severe asthma or eczema, immune or inflammatory conditions (eg. systemic lupus erythematosus, rheumatoid arthritis). Hypotensive episodes may occur if IV injection too rapid. Pregnancy (2nd or 3rd trimester), lactation. Contains sodium.
Drug interactions: Caution: Oral iron, do not start earlier than 5 days after last injection.
Adverse drug reactions: None common.
Full prescribing information and references available from Pharmacosmos UK Ltd. Telephone: +44 1844 269007.
E-mail: support@pharmacosmos.ie
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