Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
gadopentetic acid (gadopentetate dimeglumine)
Sanochemia Pharmazeutika AG
V08CA01
gadopentetic acid (gadopentetate dimeglumine)
469mg/ml (500micromol/ml)
solution for injection
(1) glass vial 20ml
Prescription
Registered
2015-02-20
1 FOR REGISTRATION AND TRANSLATION IN THE SCIENTIFIC CENTRE OF DRUG AND MEDICAL TECHNOLOGY EXPERTISE OF ARMENIA PACKAGE LEAFLET: INFORMATION FOR THE USER MAGNETOLUX 500 MICROMOL/ML, SOLUTION FOR INJECTION Gadopentetate dimeglumine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Magnetolux is and what it is used for 2. Before you are given Magnetolux 3. How to use Magnetolux 4. Possible side effects 5. How to store Magnetolux 6. Further information 1. WHAT MAGNETOLUX IS AND WHAT IT IS USED FOR Magnetolux contains gadopentetate dimeglumine, a product which enhances contrast. This medicine is for diagnostic use only. Magnetolux is used in examinations with Magnetic Resonance Imaging (MRI). Magnetolux is used during cranial (head), spinal and whole body MRI scans including head and neck region, the chest including heart and female breast, the belly including pancreas and liver, the kidneys, the pelvis including prostatic gland, bladder and womb, the muscles and the bones. It may be used to facilitate the visualization, detection and characterisation of_ _several different types of tumours (growths) or lesions in the head, spine and various sites of the body. In addition the visualisation of all blood vessels (MR-angiography) is possible (with exception of the arteries of the heart), especially for diagnosis of narrowing or obstructions of the vessels. The blood supply to the heart muscle under stress conditions, for example induced by drugs, can be measured and viability of the heart muscle can be diagnosed ("delayed enhancement"). 2. BEFORE YOU ARE Soma hati kamili
MAGNETOLUX ® SUMMARY OF PRODUCT CHARACTERISTICS the region to be investigated the maximum dose may be necessary in adults to visualize blood vessels (e.g. angiography). Maximum dose: 0.6 ml/kg body weight in adults or 0.4 ml/kg body weight in children. SPECIAL POPULATIONS RENAL IMPAIRMENT Magnetolux is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/ 1.73 m 2 ) and in patients in the perioperative liver transplantation period (see section 4.3). Magnetolux should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30 - 59 ml/min/1.73 m 2 ) at a dose not exceeding 0.2 ml/kg body weight (see section 4.4). More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Magnetolux injections should not be repeated unless the interval between injections is at least 7 days. NEONATES UP TO 4 WEEKS OF AGE AND INFANTS UP TO 1 YEAR OF AGE Magnetolux is contraindicated in neonates up to 4 weeks of age (see section 4.3). Due to immature renal function in infants up to 1 year of age, Magnetolux should only be used in these patients after careful consideration at a dose not exceeding 0.2 ml/kg body weight. More than one dose should not be used dur- ing a scan. Because of the lack of informa- tion on repeated administration, Magnetolux injections should not be repeated unless the interval between injections is at least 7 days. The required dose of Magnetolux should be administered by hand to avoid overdosage by mistake and must not be administered in combination with an autoinjector. Please refer also to section 4.4 for Special Warnings and Precautions (newborns and infants). ELDERLY (AGED 65 YEARS AND ABOVE) No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Magnetolux is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/ 1.73 m Soma hati kamili