Xenetix 350mg I/ml Solution for injection, polypropylene bag

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iobitridol

Available from:

Guerbet

ATC code:

V08AB11

INN (International Name):

Iobitridol

Dosage:

350 millilitre(s)

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

iobitridol

Authorization status:

Not marketed

Authorization date:

2010-09-10

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
XENETIX 250 (250 MGI/ML), SOLUTION FOR INJECTION
XENETIX 300 (300 MGI/ML), SOLUTION FOR INJECTION
XENETIX 350 (350 MGI/ML), SOLUTION FOR INJECTION
lobitridol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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.
WHAT IS IN THIS LEAFLET:
1.
What Xenetix is and what it is used for
2.
What you need to know before you use Xenetix
3.
How to use Xenetix
4.
Possible side effects
5.
How to store Xenetix
6.
Contents of the pack and other information
1.
WHAT XENETIX IS AND WHAT IT IS USED FOR
Xenetix belongs to the class of iodinated contrast agents. These
medicinal products are used during
radiological examinations. Xenetix enhances the contrast of images
obtained during these examinations,
which improves the visualisation and delineation of the contours of
certain parts of the body.
This medicinal product is for diagnostic use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XENETIX
DO NOT USE XENETIX
•
if you have previously developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
taking Xenetix.
•
if you are allergic to the active substance (iobitridol) or any of the
other ingredients in Xenetix. See the
list of ingredients in Section 6. 'Further information'.
•
if you have had an allergic reaction to a medicinal product containing
the same active substance
(iobitridol) (also see Section 4. 'Possible side effects').
•
if you have excessive levels of thyroid hormones (thyrotoxicosis).
•
if you are pregnant, or if you think you are pregnant, and if you are
scheduled

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00D4L8
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xenetix 350mg I/ml Solution for injection, polypropylene bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml
100 ml
150 ml
200 ml
500 ml
Iobitridol corresponding to Iodine
767.8 mg
350 mg
76.78g
35g
115.17g
52.5g
153.56g
70g
383.9g
175g
Excipient with known effect : Sodium (up to 3.5 mg per 100 mL).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adults and children undergoing

Intravenous urography

Brain and whole body CT

Intravenous digital subtraction angiography

Arteriography of the aorta and lower limbs

Angiocardiography.
This medicinal product is for diagnostic use only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children:
The dosage may vary depending on the type of examination, the age,
weight, cardiac output and general condition of the
patient and the techniques used. As with all contrast media, the
lowest dose necessary to obtain visualisation should be used.
Adequate hydration should be assessed before and after administration.
The dosage guidelines are based on the dosages used in low molecular
weight contrast media in current use, and on the
dosages used during clinical trials with Xenetix.
Health Products Regulatory Authority
22 May 2023
CRN00D4L8
Page 2 of 10
As a guideline, the dosages observed during the clinical trials were
as follows:
Indications
Recommended dosage
Intravenous
urography
Minimum dose: 1 ml/kg. It may be necessary to increase the dose in
individual cases e.g. obesity or
impaired renal function.
Brain CT
Adults
1-1.5 ml/kg
Whole-body CT
Adults
The doses of contrast
medium and the rates of
administration depend on
the organs under
investigation, the
diagnostic problem and, in
particular, the different
scan and
image-reconstruction
times of the scanners in
use. Infusion i