Omnipaque solution for injection

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

iohexol

Dostopno od:

GE Healthcare Ireland Limited

Koda artikla:

V08AB02

INN (mednarodno ime):

iohexol

Odmerek:

350mg iodine/ml

Farmacevtska oblika:

solution for injection

Enote v paketu:

(10) plastic vial 50ml

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2017-12-08

Lastnosti izdelka

OMNIPAQUE 140 MG I/ML, 180 MG I/ML, 240 MG I/ML, 300 MG I/ML, 350 MG
I/ML
SOLUTION FOR INJECTION
SPC IRELAND
Page 1 of
21
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omnipaque 140 mg I/ml, 180 mg I/ml, 240 mg I/ml, 300 mg I/ml, 350 mg
I/ml Solution
for Injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iohexol 302 mg/ml equivalent to 140 mg/ml Iodine
Iohexol 388 mg/ml equivalent to 180 mg/ml Iodine
Iohexol 518 mg/ml equivalent to 240 mg/ml Iodine
Iohexol 647 mg/ml equivalent to 300 mg/ml Iodine
Iohexol 755 mg/ml equivalent to 350 mg/ml Iodine
Iohexol is a non-ionic, monomeric, tri-iodinated, water-soluble X-ray
contrast medium.
The osmolality and viscosity values of Omnipaque 140, 180, 240, 300,
350 mg I/ml are as
follows:
Concentration
Osmolality *
Osm/kg H
2
O
37°C
Viscosity (mPa
s)
20°C
37°C
140 mg I/ml
0.29
2.3
1.5
180 mg I/ml
0.36
3.2
2.0
240 mg I/ml
0.51
5.6
3.3
300 mg I/ml
0.64
11.6
6.1
350 mg I/ml
0.78
23.3
10.6
* Method: Vapour - pressure osmometry.
This medicinal product contains 0.012 mg sodium per ml, i.e.
essentially sodium free.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Omnipaque injection is supplied ready to use as clear, colourless to
pale yellow, sterile
aqueous solution.
OMNIPAQUE 140 MG I/ML, 180 MG I/ML, 240 MG I/ML, 300 MG I/ML, 350 MG
I/ML
SOLUTION FOR INJECTION
SPC IRELAND
Page 2 of
21
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X-ray contrast medium for use in adults and children for angiography,
urography,,myelography, CT-enhancement and studies of the
gastrointestinal tract
. In adults only, phlebography, lumbar, thoracic, cervical myelography
and computed
tomography of the basal cisterns, following subarachnoid injection.
Arthrography,
endoscopic retrograde pancreatography (ERP), endoscopic retrograde
cholangiopancreatography (ERCP), herniography, hysterosalpingography,
sialography.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage varies dependi