Xenetix 300mg I/ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-05-2023
Summary of Product characteristics
(SPC)
22-05-2023
Active ingredient:
Iobitridol
Available from:
Guerbet
ATC code:
V08AB; V08AB11
INN (International Name):
Iobitridol
Dosage:
300 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to Restricted Prescription (C)
Therapeutic area:
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iobitridol
Authorization status:
Not marketed
Authorization date:
1996-10-10
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
Read the complete document
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 300mg I/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml
20 ml
50 ml
60 ml
75 ml
100 ml
150 ml
200 ml
500 ml
Iobitridol corresponding to Iodine
658.1 mg
300 mg
13.16 g
6 g
32.90 g
15 g
39.49 g
18 g
49.36 g
22.5 g
65.81 g
30 g
98.71 g
45 g
131.6 g
60 g
329 g
150 g
Excipient with known effect: Sodium (up to 3.5mg per 100mL).
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
Angiocardiography.
Arthrography
Hysterosalpingography
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
Urography
Adults
Minimum dose: 1 ml/kg. It may
be necessary to increase the
dose in individual cases e.g.
obesity or impaired renal
function.
Children
The poor concentrating ability
of immature nephron of
infantile kidneys necessitates
the use of relatively high doses
of contrast medium, i.e.:
Neonates: 4.0 ml/kg
Babies: 3.0 ml/kg
Small children: 1.5 m
Read the complete document
