VISIPAQUE 320

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

IODIXANOL

Διαθέσιμο από:

ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

V08AB09

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

IODIXANOL 652 equivalent to 320 mg/ml I MG/ML

Οδός χορήγησης:

INTRA-ARTERIAL, I.V, INTRATHECAL

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

GE HEALTHCARE AS, NORWAY

Θεραπευτική ομάδα:

IODIXANOL

Θεραπευτική περιοχή:

IODIXANOL

Θεραπευτικές ενδείξεις:

X- ray contrast medium for use in adults for cardioangiography peripheral arteriography (conventional and i.a. DSA) abdominal angiography (i.a. DSA) urography venography and CT- enhancement. Pediatric use: cardioangiography urography and CT-enhancement. Myelography - Lumbar thoracic and cervical myelography.

Ημερομηνία της άδειας:

2014-05-31

Αρχείο Π.Χ.Π.

V
ISIPAQUE
 INJECTION X-RAY CONTRAST MEDIUM
Page 1 of 14
GE HEALTHCARE
VISIPAQUE
TM
1
NAME OF THE MEDICINAL PRODUCT
VISIPAQUE 270 MG I/ML, 320 MG I/ML
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Strength
Content pr. ml.
Iodixanol (INN)
Iodixanol (INN)
270 mg I/ml
320 mg I/ml
550 mg equiv. 270 mg I
652 mg equiv. 320 mg I
Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble X-ray
contrast medium.
Pure aqueous solutions of iodixanol in all clinical relevant
concentrations have a lower osmolality
than whole blood and the corresponding strengths of the non-ionic
monomeric contrast media.
VISIPAQUE is made isotonic with normal body fluids by addition of
electrolytes. The osmolality
and viscosity values of VISIPAQUE are as follows:
Concentration
Osmolality *
mOsm/kg H
2
O
Viscosity (mPa•s)
37

C
20

C
37

C
270 mg I/ml
320 mg I/ml
290
290
11.3
25.4
5.8
11.4
* Method: Vapour - pressure osmometry.
270
mg
I/ml:
This
medicinal
product
contains
0.76
mg
(0.03
mmol)
sodium
per
ml.
To
be
taken
into consideration
by
patient
on a
controlled
sodium
diet.
320
mg
I/ml:
This
medicinal
product
contains
0.45
mg
(0.02
mmol)
sodium
per
ml.
To
be
taken
into
consideration
by
patient
o
n a
controlled
sodium
diet
(see section 4.4).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
VISIPAQUE is supplied ready to use as clear, colourless to pale yellow
aqueous solutions.
The
pH
of
the
product
is
6.8
‐
7.6.
V
ISIPAQUE
 INJECTION X-RAY CONTRAST MEDIUM
Page 2 of 14
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
X-ray
contrast
medium
for
use
in
adults
for
cardioangiography,
peripheral
arteriography
(conventional and i.a.DSA), abdominal angiography (i.a.DSA),
urography, venography and CT-
enhancement. Pediatric use: cardioangiography, urography and
CT-enhancement. Myelography -
Lumbar, thoracic and cervical myelography.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage may vary depending on the type of examination, the age,
weight, cardiac output and
g