ประเทศ: มอลตา
ภาษา: อังกฤษ
แหล่งที่มา: Malta Medicines Authority
IRON
Vifor France SA 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex, France
B03AC
IRON 50 mg
SOLUTION FOR INJECTION/INFUSION
IRON 50 mg
POM
ANTIANEMIC PREPARATIONS
Withdrawn
2010-04-09
161101_PIL-YV007/YV080/YV013/MR/E19 T UKMT01 1/6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FERINJECT 50 MG IRON/ML SOLUTION FOR INJECTION/INFUSION Ferric carboxymaltose This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ferinject is and what it is used for 2. What you need to know before you receive Ferinject 3. How Ferinject is given 4. Possible side effects 5. How to store Ferinject 6. Contents of the pack and other information 1. WHAT FERINJECT IS AND WHAT IT IS USED FOR Ferinject is an antianaemic preparation, a medicine that is used to treat anaemia. It contains iron in the form of an iron carbohydrate. Iron is an essential element required for the oxygen-carrying capacity of haemoglobin in red blood cells and of myoglobin in muscle tissue. Moreover, iron is involved in many other functions necessary for maintenance of life in the human body. Ferinject is used for the treatment of patients with iron deficiency, when oral iron preparations are ineffective or cannot be used. The aim of the therapy is to replenish body iron stores and to remedy anaemia, a lack of red blood cells due to iron deficiency. Before administration, your doctor will perform a blood test to determine the dose of Ferinject you require. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FERINJECT YOU MUST NOT RECEIVE FERINJECT - 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 seriou อ่านเอกสารฉบับเต็ม
170320_SPC-YV007/YV080/YV013/MR/E23 T UKMT01 1/10 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Ferinject 50 mg iron/mL solution for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of solution contains 50 mg of iron as ferric carboxymaltose. Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Each 20 mL vial contains 1,000 mg of iron as ferric carboxymaltose. One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Dark brown, non-transparent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis of iron deficiency must be based on laboratory tests. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject. Ferinject 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 Ferinject administration (see section 4.4). Posology The posology of Ferinject follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments. These steps are outlined below: _Step 1: Determination of the iron need_ The individual iron need for repletion using Ferinject is determined based on the อ่านเอกสารฉบับเต็ม