Hexabrix 320 Solution for Injection

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Iodine; Meglumine ioxaglate; Sodium ioxaglate

Tilgængelig fra:

Guerbet

ATC-kode:

V08AB; V08AB11

INN (International Name):

Iodine; Meglumine ioxaglate; Sodium ioxaglate

Dosering:

320 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

Product subject to Restricted Prescription (C)

Terapeutisk område:

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

Autorisation status:

Marketed

Autorisation dato:

1996-05-09

Indlægsseddel

_ _
1
HEXABRIX 320 (320 MG I/ML), SOLUTION FOR INJECTION
MEGLUMINE IOXAGLATE AND SODIUM IOXAGLATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What HEXABRIX 320, solution for injection is and what it is used
for
2. What you need to know before you use HEXABRIX 320, solution for
injection
3. How to use HEXABRIX 320, solution for injection
4. Possible side effects
5. How to store HEXABRIX 320, solution for injection
6. Contents of the pack and other information
1.
WHAT HEXABRIX 320 IS AND WHAT IT IS USED FOR
HEXABRIX 320 is a contrast agent. It belongs to the group of contrast
agents used for radiological
examinations.
HEXABRIX 320 is used to enhance the contrast of the images obtained
during these examinations, in
order to improve the visualisation and delineation of certain parts of
the body, such as:

Certain hollow organs (opacification of body cavities),

The uterus and fallopian tubes (ducts connecting the uterus to the
ovaries) in female patients
(hysterosalpingography),

Blood vessels (angiography),

Joints (arthrography),

Urinary system (urography).
This medicine is for diagnostic use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HEXABRIX 320
YOUR DOCTOR MUST NEVER GIVE YOU HEXABRIX 320 IN THE FOLLOWING CASES:

If you are allergic to the active substance (ioxaglic acid) or any of
the other ingredients of HEXABRIX
320. The list of these ingredients can be found in section 6. Contents
of the pack and other
information.

If you have already had an allergic reaction following the injection
of a medicinal product containing
the same active

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hexabrix 320 Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ioxaglic acid 53.33 % w/v
equivalent to 320 mg iodine per millilitre of solution.
Ioxaglic acid is present as meglumine ioxaglate and sodium ioxaglate.
(Sodium content:153 mEq/1)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to pale yellow solution with a pH of 6.5 to 7.6
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Low osmolar X-ray contrast medium for the opacification of the
vascular system, urinary tract and joints and
hysterosalpingography.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Procedure
Product
Dosage and Administration
Femoral and other peripheral
arteriographies
Hexabrix 320
15-20 ml. A similar or smaller dose is
indicated for smaller arteries
Cerebral angiography
(carotid and vertebral)
Hexabrix 320
Average adult dose: 6 - 8 ml for each
injection. Up to 10 injections may be
required.
Angiocardiography
Hexabrix 320
Multiple small test injections may be
used for positioning catheter tip.
_Adults_: 30-50 ml per injection
Children and infants: 1-1, 5 ml per kg
body weight.
Multiple injections may be required,
although total dosage should not
normally exceed 4 ml per kg body
weight.
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