Niopam 340, Solution for Injection, glass bottles

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Iopamidol

Fáanlegur frá:

Bracco Imaging spa

ATC númer:

V08AB; V08AB04

INN (Alþjóðlegt nafn):

Iopamidol

Skammtar:

340 milligram(s)

Lyfjaform:

Solution for injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopamidol

Leyfisstaða:

Marketed

Leyfisdagur:

1989-11-06

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIOPAM 340 SOLUTION FOR INJECTION
(Iopamidol)
The name of your medicine is Niopam 340 solution for injection, which
will be called Niopam
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET
:
1. What Niopam is and what it is used for
2. What you need to know before you are given Niopam
3. How you are given Niopam
4. Possible side effects
5. How to store Niopam
6. Contents of the pack and other information
1. WHAT IS NIOPAM AND WHAT IT IS USED FOR
Niopam is a special dye (or contrast agent) which blocks X-rays
because it contains iodine. Niopam
works by helping your doctor to see the internal body structures on an
X-ray picture. Your doctor
has prescribed Niopam to help view the blood vessels, kidney, bladder
or joints using X-rays.
This medicine is for diagnostic use only.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIOPAM
YOU SHOULD NOT BE GIVEN NIOPAM IF YOU:
• Are allergic to Iopamidol, or any other ingredients of this
medicine (listed in Section 6)
TAKE SPECIAL CARE WITH NIOPAM AND TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING
CONDITIONS:
• A history of allergy or asthma
• Diabetes
• Heart problems
• High blood pressure in the lungs
• Kidney or liver problems
• Over-active thyroid gland (this is particularly important in
newborn babies)
• A history of epilepsy
• Myelomatosis (Cancer of the plasma cells in the blood)
• Severe systemic disease (a disease affecting more than one part or
organ of the body)
• Sickle cell disease

Vara einkenni

Health Products Regulatory Authority
06 January 2023
CRN00CSK5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niopam 340, Solution for Injection, glass bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 69.4% w/v Iopamidol equivalent to 340mg
iodine/ml.
Each ml contains 694 mg of Iopamidol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, aqueous solution.
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, selective renal arteriography, selective
visceral angiography, digital subtraction angiography,
computer tomography enhancement, urography and arthrography.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Intravenous
Intra-arterial
Intraventricular
or in Arthrography by injection.
POSOLOGY
NIOPAM 340 : DOSAGE SCHEDULE
Procedure
Dosage
Peripheral arteriography
Adults: 10-50ml*
Children: **
Angiocardiography and left ventriculography
Adults: 30-80ml
Children: **
Coronary arteriography
Adults: 4-8ml per artery
Aortography - retrograde
Adults: 30-80ml
Selective renal arteriography.
Adults: 5-10ml
Children: **
Selective visceral angiography
Hepatic
Coeliac
Superior Mesenteric
Inferior Mesenteric
Adults: 30-70ml
Adults: 40-70ml
Adults: 25-70ml
Adults: 5-30ml
Health Products Regulatory Authority
06 January 2023
CRN00CSK5
Page 2 of 9
Digital subtraction angiography (DSA)
Intravenous injection
Coronary arteriography - by intra-arterial DSA,
Ventriculography
Adults: 30-50ml
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-.5ml/kg or **
Arthrography
Adults 1-10ml according to the joint being examined.
* repeat as necessary;
** according to body size and age;
The dosage must be adapted