Niopam 150 solution for injection 50ml bottles

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Iopamidol

Boleh didapati daripada:

Bracco UK Ltd

INN (Nama Antarabangsa):

Iopamidol

Dos:

150mg/1ml

Borang farmaseutikal:

Solution for injection

Laluan pentadbiran:

Intraventricular cardiac; Intraarterial; Intravenous; Intraarticular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: ; GTIN: 5013837000001

Ciri produk

OBJECT 1
NIOPAM 150
Summary of Product Characteristics Updated 26-Jul-2016 | Bracco UK
Limited
1. Name of the medicinal product
NIOPAM 150, solution for injection.
2. Qualitative and quantitative composition
30.62 w/v Iopamidol equivalent to 150mg iodine/ml.
Each ml contains 306.2 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 injection, particularly in digital
subtraction angiography.
4.2 Posology and method of administration
Route of administration
In digital subtraction angiography:
- Intra-ventricular
- Intra-arterial
Posology
NIOPAM 150: DOSAGE SCHEDULE
Procedure Dosage
Intra arterial procedures
Adults: 1-40 ml
Children: 0.5 - 0.75 ml/kg
Ventricular angiography
Children: 1-1.5 ml/kg
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.
Method of administration
As with all contrast media, the lowest dose necessary to obtain
adequate visualisation should be used.
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
angiographic techniques are recommended including close attention to
guide wir