מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
ROCHE PHARMACEUTICALS (ISRAEL) LTD
B03XA03
SOLUTION FOR INJECTION
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 MCG / 0.3 ML
I.V, S.C
Required
ROCHE DIAGNOSTICS GmbH ,GERMANY
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Treatment of anemia associated with chronic kidney disease (CKD).
2013-04-30
Mircera_PL_Ver 3.0 THIS LEAFLET WAS CHECKED AND APPROVED BY THE MINISTRY OF HEALTH IN OCTOBER 2016 AND WAS UPDATED ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN MARCH 2018 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only MIRCERA ® 50 MCG/0.3 ML 75 MCG/0.3 ML 100 MCG/0.3 ML 150 MCG/0.3 ML 200 MCG/0.3 ML 360 MCG/0.6 ML Pre-filled syringe COMPOSITION: Each pre-filled syringe contains: Methoxy polyethylene glycol-epoetin beta *For information about inactive ingredients, see section 6 - “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. IMPORTANT INFORMATION FOR YOUR REVIEW ∙ The medicine MIRCERA is intended for subcutaneous (under the skin) or intravenous injection and comes in a pre-filled syringe. If you are self-injecting the medicine, follow the instructions for self-injection detailed at the end of the leaflet. ∙ Store the medicine in a refrigerator at a temperature of 2ºC-8ºC. Do not freeze. Keep the syringe in its original package in order to protect from light. 1) WHAT IS THE MEDICINE INTENDED FOR? MIRCERA is intended for the treatment of anaemia caused by chronic kidney disease, in adults aged 18 years or older, manifested by symptoms such as tiredness, weakness and shortness of breath. This means that you have too few red blood cells and your haemoglobin level is too low (your body’s tissues might not receive enough oxygen). The medicine is produced by gene technology and causes an increase in the number of red blood cells and the haemoglobin level in your blood, by a mechanism similar to that of the natural hormone secreted in the body called erythropoietin. קרא את המסמך השלם
EMEA/H/C/000739/II/0068_12 2019 Mircera_PI_Ver 4.0 Page 1 of 11 MIRCERA_PI_VERSION 4.0 _ _ MIRCERA ® _METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA _ Pre-filled syringe 50 mcg/0.3 ml, 75 mcg/0.3 ml, 100 mcg/0.3 ml, 150 mcg/0.3 ml, 200 mcg/0.3 ml, 360 mcg/0.6 ml 1. NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml. MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml. MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ml. MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml. MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micrograms/ml. MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 600 micrograms/ml. The s קרא את המסמך השלם