국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
FLUORESCEIN
Alcon Laboratories (UK) Ltd
10 %v/v
Solution for Injection
2007-10-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anatera 100mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium) One 5 ml vial contains 500 mg fluorescein (as 566 mg fluorescein sodium) Contains sodium (from fluorescein sodium and sodium hydroxide) at amounts up to 1.45% (approximately 3.15 mmol) per dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, red-orange solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. For fluorescein angiography of the ocular fundus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Use in adults, including the elderly: 5 ml of Anatera 100 mg/ml solution for injection rapidly into the antecubital vein after taking precautions to avoid extravasation. In cases when highly sensitive imaging systems e.g., scanning laser ophthalmoscope are used, the dose of this product should be reduced to 2 ml of Anatera 100 mg/ml solution for injection. Use in paediatric patients: Anatera 100 mg/ml solution for injection has not been studied in children and dose-adaptation data are not available. Therefore, Anatera 100 mg/ml solution for injection should not be used in patients below 18 years as efficacy and safety in this group have not been established. Use in patients with renal insufficiency (glomerular filtration rate below 20 ml/min): Limited experience in renally impaired subjects (glomerular filtration rate below 20 ml/min) suggests that, in general, no dose adjustment is required although a longer excretion rate in patients with renal impairment is possible (see section 5.2). Dialysed patients: Reduce dose to 2.5 ml (half a vial) METH 전체 문서 읽기