Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iopamidol
Bracco UK Ltd
Iopamidol
200mg/1ml
Solution for injection
Intraventricular cardiac; Intraarterial; Intraarticular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5013837312111
OBJECT 1 NIOPAM 200 Summary of Product Characteristics Updated 26-Jul-2016 | Bracco UK Limited 1. Name of the medicinal product NIOPAM 200, solution for injection. 2. Qualitative and quantitative composition 40.8 % w/v Iopamidol equivalent to 200mg iodine/ml. Each ml contains 408.2 mg Iopamidol. For the full list of excipients, see 6.1. 3. Pharmaceutical form Solution for injection. Clear aqueous solution filled into colourless glass ampoules or bottles. 4. Clinical particulars 4.1 Therapeutic indications This medicinal product is for diagnostic use only. X-ray contrast medium for use in lumbar and thoraco-cervical myelography, computer tomography enhancement. 4.2 Posology and method of administration Route of administration Intra-ventricular Intra-venous Intra-thecal Intra-cisternal PosologyNIOPAM 200: DOSAGE SCHEDULE Procedure Dosage Lumbar Myelography Adults 10 - 15 ml Thoracc-Cervical Myelography Adults 5 - 15 ml Computer Tomography Enhancement Adults: Brain scanning Whole body scanning 50 - 100ml 40-100ml The dosage must be adapted to the examination, the age, body weight, cardiac output, renal function, general condition of the patient and the technique used. Usually the same iodine concentration and volume are used with other iodinated x-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Method of administration Non-ionic contrast media have less anti-coagulant activity _in-vitro _than ionic media. Meticulous attention should therefore be paid to angiographic technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently, to minimise the risk of clotting, which rarely has led to serious thromboembolic complications after procedures. Factors such as length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. Therefore, meticulous angio Olvassa el a teljes dokumentumot