Niopam 340 solution for injection 50ml bottles

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Iopamidol

MAH:

Bracco UK Ltd

INN:

Iopamidol

dosage:

340mg/1ml

pharmaceutical_form:

Solution for injection

administration_route:

Intraventricular cardiac; Intraarterial; Intraarticular; Intravenous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5013837101531

SPC

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.