Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Ferumoxytol
Takeda Pharma A/S
B03
ferumoxytol
Other antianemic preparations
Anemia; Kidney Failure, Chronic
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Revision: 7
Withdrawn
2012-06-15
23 B. PACKAGE LEAFLET _ _ Medicinal product no longer authorised 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ RIENSO 30 MG/ML SOLUTION FOR INFUSION Iron as ferumoxytol 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, pharmacist or nurse. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rienso is and what it is used for 2. What you need to know before you receive Rienso 3. How Rienso is given 4. Possible side effects 5. How to store Rienso 6. Contents of the pack and other information 1. WHAT RIENSO IS AND WHAT IT IS USED FOR Rienso is an iron preparation, containing the active substance ferumoxytol, which is given by infusion into a vein. It is used to treat iron deficiency anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function. Iron is an essential element required to make haemoglobin, a molecule in red blood cells that enables oxygen to be carried around the body. When there is insufficient iron in the body, haemoglobin cannot be formed, resulting in anaemia (low levels of haemoglobin). The aim of Rienso therapy is to replenish the body’s iron stores. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIENSO Before you were prescribed Rienso, the doctor will have carried out a blood test to make sure that you have iron deficiency anaemia. YOU MUST NOT RECEIVE RIENSO: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6). - if you have a history of medicine allergy or h Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Medicinal product no longer authorised 2 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 Rienso 30 mg/ml solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 30 mg of iron as ferumoxytol. Each vial of 17 ml solution contains 510 mg of iron as ferumoxytol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Black to reddish brown solution Osmolality: 270-330 mosm/kg pH: 6.5 to 8.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rienso 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. Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso. In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter (see section 4.4). Posology _Treatment Course _ The recommended course of Rienso is based on the patient’s pre-treatment haemoglobin and body weight as provided in Table 1. Each 510 mg dose is administered as an intravenous infusion for at least 15 minutes. For patients receiving two doses, the second 510 mg infusion is to be administered 2 to 8 days later as per Table1. Med Прочетете целия документ