国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Iron (III) hydroxide dextran complex
Pharmacosmos A/S
B03AC
Iron (III) hydroxide dextran complex
50 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Iron, parenteral preparations
Marketed
2001-06-29
2 PACKAGE LEAFLET: INFORMATION FOR THE USER COSMOFER ® , 50 MG/ML SOLUTION FOR INJECTION AND FOR INFUSION IRON(III) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. WHAT IS IN THIS LEAFLET 1. What CosmoFer is and what it is used for 2. What you need to know before you receive CosmoFer 3. How to CosmoFer is given 4. Possible side effects 5. How to store CosmoFer 6. Contents of the pack and other information 1. WHAT COSMOFER IS AND WHAT IT IS USED FOR CosmoFer contains a combination of iron and dextran (a long chain of sugar molecules). The type of iron in CosmoFer is the same as that found naturally in the body called ‘ferritin’. This means that you can have CosmoFer by injection in high doses. CosmoFer is used for low levels of iron (sometimes called ‘iron deficiency’) if: • you cannot take iron by mouth, for example you cannot tolerate it • you have taken iron by mouth and it has not worked • your doctor decides you need iron very quickly to build up your iron stores. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE COSMOFER YOU MUST NOT RECEIVE COSMOFER: • if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6) • if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations • if you have anaemia that is not caused by low levels of iron (deficiency), such as ‘haemolytic’ anaemia • if you have too much iron (overload) or a problem in the way your body uses iron • if you have liver problems such as ‘cirrhosis’ or ‘hepatitis’ • if you have a bacterial or viral infection • if you have kidney problems, such as acute kidney failure. WARNINGS AND 完全なドキュメントを読む
Health Products Regulatory Authority 31 March 2023 CRN00DHKS Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CosmoFer 50mg/ml solution for infusion and injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2 ml ampoule containing 100 mg iron(III) as Iron(III)-hydroxide dextran complex 5 ml ampoule containing 250 mg iron(III) as Iron(III)-hydroxide dextran complex 10 ml ampoule containing 500 mg iron(III) as Iron(III)-hydroxide dextran complex Each ml contains 50 mg Iron (III). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion and injection A dark brown solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS · For adults only CosmoFer ® is indicated for the treatment of iron deficiency in the following indications: · 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. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Serum ferritin, serum iron, transferrin saturation and hypochromic red cells). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of CosmoFer. CosmoFer 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 CosmoFer injection (see section 4.4). ADMINISTRATION: CosmoFer solution for infusion and injection can be administered by an intravenous drip infusion or by a slow intravenous injection of which the intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes. However, CosmoFer may also be administered as undiluted solution intramuscular 完全なドキュメントを読む