Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
gadofosveset trisodium
TMC Pharma Services Ltd.
V08CA
gadofosveset trisodium
Contrast media
Magnetic Resonance Angiography
This medicinal product is for diagnostic use only.Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.
Revision: 10
Withdrawn
2005-10-03
B. PACKAGE LEAFLET 21 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER ABLAVAR 0.25 MMOL/ML SOLUTION FOR INJECTION Gadofosveset READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask the doctor giving you Ablavar (the radiologist) or the hospital/MRI-centre personnel - 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 radiologist. IN THIS LEAFLET : 1. What Ablavar is and what it is used for 2. Before you are given Ablavar 3. How to use Ablavar 4. Possible side effects 5. How to store Ablavar 6. Further information 1. WHAT ABLAVAR IS AND WHAT IT IS USED FOR Ablavar is an injectable contrast medium for making a diagnostic image of the body's blood vessels in the abdomen or limb clearer. It is for use in adults only. Ablavar is for diagnostic use only. It is used to help detect changes in the blood vessels which are known or suspected to be abnormal. The diagnosis can be made with greater accuracy than without using this medicine. This medicine, a contrast agent with magnetic properties, helps to visualise the passage of blood through the vessels by brightening the blood for an extended period. This medicine is used together with an imaging technique called magnetic resonance imaging (MRI). If you have any questions or are not sure about something, ask the doctor or MRI-centre personnel. 2. BEFORE YOU ARE GIVEN ABLAVAR DO NOT USE ABLAVAR YOU MUST NOT BE GIVEN ABLAVAR IF YOU are allergic (hypersensitive) to gadofosveset or any of the other ingredients of this medicine (see section 6 of this leaflet). TAKE SPECIAL CARE WITH ABLAVAR YOU WILL NEED SPECIAL MEDICAL ATTENTION IF ALLERGY-LIKE REACTIONS OCCUR. TELL YOUR DOCTOR IMMEDIATELY if you notice itching, a feeling of mild swelling in your throat or tongue, which might be a first sign of some allergy-like reaction. Your doctor will be mindful of oth Izlasiet visu dokumentu
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Ablavar 0.25 mmol/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ 1 ml Ablavar solution for injection contains 244 mg (0.25 mmol) gadofosveset trisodium equivalent to 227 mg gadofosveset. Each vial of 10 ml solution contains a total of 2.44 g (2.50 mmol) of gadofosveset trisodium equivalent to 2.27 g of gadofosveset Each vial of 15 ml solution contains a total of 3.66 g (3.75 mmol) of gadofosveset trisodium equivalent to 3.41g of gadofosveset. Each vial of 20 ml solution contains a total of 4.88 g (5.00 mmol) of gadofosveset trisodium equivalent to 4.54g of gadofosveset. Excipient This medicinal product contains 6.3 mmol sodium (or 145 mg) per dose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be used by physicians experienced in the field of diagnostic imaging. Posology Adults: 0.12 ml/kg body weight (equivalent to 0.03 mmol/kg) Imaging time points Dynamic imaging begins immediately upon injection. Steady state imaging can begin after the dynamic scan has been completed. In clinical trials, imaging was completed up to approximately one hour following injection. No clinical information is available about repeated use of this medicinal product. Special populations Elderly (aged 65 years and above) 2 Medicinal product no longer authorised No dose adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4). Renal impairment Use of Ablavar should be avoided in patients with severe Izlasiet visu dokumentu