Niopam 370, 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:

370 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:

1983-03-10

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIOPAM 370 SOLUTION FOR INJECTION
(Iopamidol)
The name of your medicine is Niopam 370 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, urinary
tract or bladder 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)
ì
• Sickle ce

Vara einkenni

Health Products Regulatory Authority
13 March 2023
CRN00DGL8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niopam 370, Solution for Injection, glass bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 75.53% w/v Iopamidol, equivalent to 370 mg
Iodine/ml.
Each ml contains 755.3mg 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
X‑ray contrast medium for use in angiography, left ventriculography
and coronary arteriography and urography.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Intraventricular
Intra-arterial
Intravenous.
Posology
NIOPAM 370 : DOSAGE SCHEDULE
Procedure
Dosage
Peripheral arteriography
Venography
Adults 10 - 50ml*
Children * *
Adults 20 - 50ml
Children * *
Angiocardiography and left
ventriculography
Adults 30 - 80ml
Children * *
Coronary arteriography
Adults 4 - 8ml per artery
Aortography - retrograde
Adults 30 - 80ml
Children * *
Selective renal arteriography
Health Products Regulatory Authority
13 March 2023
CRN00DGL8
Page 2 of 9
Hepatic
Coeliac
Superior Mesenteric
Inferior Mesenteric
Adults 30 - 70ml
40 - 70ml
25 - 70ml
5 - 30ml
Children * *
Selective visceral angiography
Intravenous Injection
Left ventriculography
Selective Coronary
Arteriography by
Intra-Arterial DSA
Adults 30 - 70ml
Children 40 - 70ml
Adults 25 - 70ml
Children 5 - 30ml
Adults 2 - 5ml
Intravenous Urography
Adults 40 - 80ml
In severe renal failure the usual high dose methods should be employed
(up to 1.5ml/kg)
Children 1 - 2.5ml/kg or * *
* Repeat as necessary
* * According to body size and age
Elderly: Dosage as for adults.
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, th