Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
mangafodipir trisodium
GE Healthcare AS
V08CA05
mangafodipir
Contrast media
Magnetic Resonance Imaging
This medicinal product is for diagnostic use only.Contrast medium for diagnostic magnetic resonance imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Revision: 9
Withdrawn
1997-05-22
Medicinal product no longer authorised 16 B. PACKAGE LEAFLET Medicinal product no longer authorised 17 PACKAGE LEAFLET: INFORMATION FOR THE USER TESLASCAN 0.01 MMOL/ML SOLUTION FOR INFUSION. Mangafodipir trisodium 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. - 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 pharmacist. IN THIS LEAFLET: 1. What TESLASCAN is and what it is used for. 2. Before you use TESLASCAN. 3. How to use TESLASCAN. 4. Possible side effects. 5. How to store TESLASCAN. 6. Further information. 1. WHAT TESLASCAN IS AND WHAT IT IS USED FOR TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information. THIS MEDICINE IS FOR DIAGNOSTIC USE ONLY. TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and pancreas. 2. BEFORE YOU USE TESLASCAN DO NOT USE TESLASCAN IF ONE OF THE FOLLOWING CONDITIONS EXISTS: - Pregnancy - Allergy (hypersensitivity) to the active substance or any of the other ingredients of TESLASCAN - Pheochromocytoma - Breast-feeding _ _ - Severe kidney disease _ _ - Severe liver disease TAKE SPECIAL CARE WITH TESLASCAN IF ONE OF THE FOLLOWING CONDITIONS EXISTS: - Severe heart disease - in particular heart failure or when there is a risk of disorders of heart rhythm - in patients with injuries of the blood brain barrier and severe cerebral disease Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) may occur. USING OTHER MEDICINES: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Medicinal product no longer authorised 18 PREGNANCY AND BREAST-FEEDING TESLASCAN must not be used if you are pregnant. The amount of TESLASCAN in breast milk is not k Aqra d-dokument sħiħ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT TESLASCAN 0.01 mmol/ml solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μmol), equivalent to 6.91 mg of mangafodipir. 50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 μmol), equivalent to 345.5 mg of mangafodipir. Excipient: Sodium 0.16 mmol (3.6 mg)/ml equivalent to 126 mg per normal dose of 35 ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion A clear bright to dark yellow solution, TESLASCAN has the following physicochemical properties: pH: 7.0-8.0. Osmolality (mosmol/kg H 2 O) at 37 °C 290 Viscosity (mPa.s) at 20 °C 1.0 Viscosity (mPa.s) at 37 °C 0.7 Density (g/ml) at 20 °C 1.01 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The medicinal product is for single intravenous use only as repeated dosing has not been studied. It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas. Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately _ _ 4 hours. At the clinical dose the contrast agent has no T 2 -effect, and pre- and post- T 2 -weighted images are equivalent. The clinical use of TESLASCAN has been investigated at field strengths from 0.5 to 2.0 Tesla. Medicinal product no longer authorised 3 DOSAGE FOR ADULTS The recommended dose is 0. Aqra d-dokument sħiħ