Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
FLUORESCEIN SODIUM
TRADIS GAT LTD
S01JA01
SOLUTION FOR INJECTION
FLUORESCEIN SODIUM 10 G / 100 ML
I.V
Required
SERB SAS, FRANCE
FLUORESCEIN
FLUORESCEIN
For examination of the retina by Fluorescent Angiography.
2014-01-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluoresceine SERB 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluorescein sodium 10g/100 ml of solution for injection. One 5 mL ampoule contains 0.5g of fluorescein sodium. One 5 mL ampoule contains 65.5 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For examination of the retina by fluorescent angiography. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY One 5-ml ampoule (10%) injected intravenously. PATIENTS WITH RENAL IMPAIRMENT The limited experience with use of Fluorescein sodium in patients with renal impairment suggests that dose adjustment in these patients is not necessary required (see section 5.2). PATIENTS WITH HEPATIC IMPAIRMENT No studies have been performed in patients with hepatic Impairment. PAEDIATRIC POPULATION The safety and the efficacy of Fluorescein SERB in children and adolescents below 18 years have not been established. Therefore, Fluorescein SERB should not be used. GERIATRICS (65 YEARS OLD AND OVER) Experience in geriatric patients suggests that no dose adjustment is necessary. METHOD OF ADMINISTRATION Intravenous use. Fluorescein SERB should not be mixed with other medicinal products (see section 6.2 and section 6.6) and should preferably be injected into the antecubital vein after taking precautions to avoid extravasation (see section 4.4). 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use by intrathecal or arterial routes. 2 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE A detailed medical history of each patient must be carried out before examination including any history of allergy, history of cardiopulmonary disease, diabetes mellitus or concomitant treatments (in particular beta-blocking drugs, including eye drops solutions). Beta-blocking agents can reduce the vascular compensation reactions and reduce the effectiveness of a Đọc toàn bộ tài liệu