Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iopamidol
Bracco UK Ltd
Iopamidol
340mg/1ml
Solution for injection
Intraventricular cardiac; Intraarterial; Intraarticular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5013837101531
OBJECT 1 NIOPAM 340 Summary of Product Characteristics Updated 26-Jul-2016 | Bracco UK Limited 1. Name of the medicinal product NIOPAM 340, solution for injection. 2. Qualitative and quantitative composition 69.4% w/v Iopamidol equivalent to 340mg iodine/ml. Each ml contains 694 mg Iopamidol. For the full list of excipients, see 6.1. 3. Pharmaceutical form Solution for injection. Clear aqueous solution filled into colourless glass bottles. 4. Clinical particulars 4.1 Therapeutic indications This medicinal product is for diagnostic use only X-ray contrast medium for use in peripheral arteriography, angiocardiography and left ventriculography, coronary arteriography, aortography-retrograde, selective renal arteriography, selective visceral angiography, digital subtraction angiography, computer tomography enhancement, urography and arthrography. 4.2 Posology and method of administration Route of administration Intra-ventricular Intra-arterial Intravenous Intra-articular Posology NIOPAM 340: DOSAGE SCHEDULE Procedure dosage Peripheral arteriography and venography Adults 10 - 50 ml Children: ** Angiocardiography and left ventriculography Adults 30 - 80 ml Children ** Coronary arteriography Adults: 4 - 8 ml * per artery Aortography - retrograde Adults: 30 - 80 ml * Selective renal arteriography Adults: 5 - 10ml Children: ** Selective visceral angiography Hepatic Coeliac Superior Mesenteric Inferior Mesenteric Adults: 30 - 70 ml Adults: 40 - 70ml Adults: 25 - 70ml Adults: 5 - 30ml Digital subtraction angiography (DSA) Intravenous injection Coronary arteriography - by intra-arterial DSA, Ventriculography Adults 30 - 50 ml Children: ** Adults: 2-5ml Adults: 25ml* Children: 1.0- 1.5ml/kg Computer tomography enhancement Adults: 50 - 100ml Intravenous urography Adults: up to 1.5ml/kg Children: 1- 2.5ml/kg or ** Arthrography Adults: 1 - 10ml according to the joint being examined * repeat as necessary; ** according to body size and age; Do not exceed 250 ml. Single injection volume depends on the vascular area to be examined. Læs hele dokumentet