Visipaque 320mg iodine/ml solution for injection

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

iodixanol

Boleh didapati daripada:

GE Healthcare Ireland Limited

Kod ATC:

V08AB09

INN (Nama Antarabangsa):

iodixanol

Dos:

320mg iodine/ml

Borang farmaseutikal:

solution for injection

Unit dalam pakej:

(10) glass vials 50ml, (10) plastic vials 50ml

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2019-11-27

Ciri produk

V
ISIPAQUE 270 AND 320 MG I/ML SOLUTION FOR INJECTION
SPC IRELAND
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
VISIPAQUE 270 mg I/ml and 320 mg I/ml Solution for Injection, glass
container and
polypropylene container
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Strength
Content pr. ml.
Iodixanol (INN)
270 mg I/ml
550 mg equiv. 270 mg I
Iodixanol (INN)
320 mg I/ml
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
37°C
Viscosity (mPa
⋅
s)
20°C
37°C
270 mg I/ml
290
11.3
5.8
320 mg I/ml
290
25.4
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 on 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 270 AND 320 MG I/ML SOLUTION FOR INJECTION
SPC IRELAND
Page 2 of 17
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X-ray contrast medium for use in adults for cardioangiography,
cerebral angiography
(conventional), peripheral angiography, (conventional), abdominal
angiography (i.a.
DSA),urography, venography, CT-enhancement and studies of the
gastrointestinal tract ,
Lumbar, thoracic and cervical myelograp