XENETIX 250

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

IOBITRIDOL

Boleh didapati daripada:

PROMEDICO LTD

Kod ATC:

V08AB11

Borang farmaseutikal:

SOLUTION FOR INJECTION

Komposisi:

IOBITRIDOL 250 MG/ML

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

GUERBET, FRANCE

Kumpulan terapeutik:

IOBITRIDOL

Kawasan terapeutik:

IOBITRIDOL

Tanda-tanda terapeutik:

For adults and children undergoing: phlebography, chest CT scan, intra - arterial digital subtraction angiography.

Tarikh kebenaran:

2022-03-31

Risalah maklumat

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה :ךיראת
7.2013
:םושירה רפסמו תילגנאב רישכת םש
XENETIX 250 )105-07-28746-00(, XENETIX 300 )105-08-28747-00(, XENETIX
350 )105-09-28748-00( :םושירה לעב םש
PROMEDICO LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
2. QUALITATIVE AND
QUANTITATIVE
COMPOSITION
Excipient with known effect: sodium (up to 3.5 mg per 100 mL).
4.3. CONTRAINDICATIONS
CONTRA-INDICATIONS
Xenetix is contraindicated in patients hypersensitive to the
product.
A history of sensitivity to iodine contraindicates the use of
Xenetix (see Warnings).
In the absence of specific studies, iobitridol is not indicated
for myelography.
4.3.
CONTRAINDICATIONS

Hypersensitivity to iobitridol or any of the excipients.

History of a major immediate reaction or delayed skin reaction (see
Section 4.8) to a Xenetix injection.

Manifest thyrotoxicosis
4.4.
SPECIAL
WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS
As in the case of all iodinated contrast agents, non-ionic
water soluble tri-iodinated products
may induce mild, severe or fatal intolerance reactions, often
of early onset but sometimes
delayed.
These reactions cannot be predicted but are more frequent
in patients with a history of allergy
(hives, asthma, hay-fever, eczema, various food and drug
allergies) or who have shown
particular sensitivity during a previous examination with an
iodinated contrast medium.
2
Risk-benefit should be considered when dehydration
exists, especially when associated with
pre-existing renal or hepatic disease, advanced vascular
disease, and diabetes mellitus, in
infants, young children and elderly patients.
Screening for these reactions by means of iodine reaction
tests or any other tests currently
available is not possible.
Precautions for use
During the examination, the following are required:

surveillance by

Ciri produk

1
N
AME OF THE
M
EDICINAL
P
RODUCT
XENETIX 250, 300, 350
solution for injection
(250, 300, 350 mg iodine/mL)
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
PER
100
M
L
Xenetix 250 Xenetix 300 Xenetix 350
Iobitridol ................................ 54.8400 g ................
65.8100 g ................ 76.7800 g
Equivalent to iodine ................. 25.0000 g ............. 30.0000
g ................ 35.0000 g
Excipients: Edetate calcium disodium; Tromethamine hydrochloride
Tromethamine; Hydrochloric acid or sodium hydroxide; Water for
injection
3
PHARMACEUTICAL
FORM
Solution for injection
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xenetix 250
For adults and children undergoing:
•
phlebography
•
chest CT-scan
•
intra-arterial digital subtraction angiography
Xenetix 300, 350
For adults and children undergoing:
•
intravenous urography
•
brain or whole-body CT scan
•
intravenous digital subtraction angiography
•
arteriography
•
angiocardiography
4.2
Dosage and method of administration
Doses will be adjusted as a function of the examination and the
regions of interest as well as to body weight, and the renal function
of the
subject, particularly in children.
The recommended mean doses are as follows:
XENETIX 250
Indications
Mean dose
(mL/kg)
Total volume
(min.-max.) mL
Phlebography
2.6
150-220
Chest CT-scan
2.0
95-170
Intra-arterial digital
subtraction angiography
3.1
75-360
XENETIX 300
Indications
Mean dose (mL/kg)
Total volume
(min.-max.) mL
Intravenous urography:
•
fast injection:
•
slow injection:
1.2
1.6
50-100
100
CT-scan
•
Brain
•
whole-body
1.4
1.9
20-100
20-150
Intravenous digital
subtraction angiography
1.7
40-270
Arteriography
•
Brain
•
lower limbs
1.8
2.8
42-210
85-300
Angiocardiography
1.1
70-125
XENETIX 350
Indications
Mean dose (mL/kg)
Total volume
(min.-max.) mL
Intravenous urography
1
50-100
CT-scan
•
brain
•
whole-body
1
1. 8
40-100
90-180
Intravenous digital
subtraction angiography
2.1
95-250
Arteriography
•
peripheral
•
lower limbs
•
abdominal
2.2
1.8
3.6
10