Xenetix 250mg I/ml Solution for Injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Iobitridol

متاح من:

Guerbet

ATC رمز:

V08AB; V08AB11

INN (الاسم الدولي):

Iobitridol

جرعة:

250 millilitre(s)

الشكل الصيدلاني:

Solution for injection

نوع الوصفة الطبية :

Product subject to Restricted Prescription (C)

المجال العلاجي:

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

الوضع إذن:

Not marketed

تاريخ الترخيص:

1996-10-10

نشرة المعلومات

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

خصائص المنتج

Health Products Regulatory Authority
22 May 2023
CRN00D4L8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xenetix 250mg I/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per mL
50 mL
100 mL
200 mL
500 mL
Iobitridol
548.4 mg 27.42 g 54.84 g 109.68 g 274.2 g
corresponding
to Iodine
250 mg
12.5 g
25 g
50 g
125 g
Excipient with known effect : Sodium (up to 3.5mg 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:

venography

whole-body CT

intra-arterial digital subtraction angiography
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.
As a guideline, the dosages observed during the clinical trials were
as follows:
Indications
Recommended dosage
WHOLE-BODY CT
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 is preferable for slow scanners and injection (bolus)
for fast scanners. A dose of 3 mL/kg is usually considered as
a maximum dose.
Health Products Regulatory Authority
22 May 2023
CRN00D4L8
Page 2 of 9
Venography
mean dose: 2.6 mL/kg
min/max dose: 50-100 mLper leg
(maximum usual total dose: 250 mL)
Intra-arterial digital subtraction angiography
mean dose