Biemexol solution for injection

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

iohexol

Предлага се от:

IDOL ILAC DOLUM SAN.ve TIC.A.S. Davutpasa Cad.CebeAli Bey Sok.No:20 Zeytinburnu/ ISTANBUL / for Biem ilac San. Ve Tic.A.S. Anittepe Mah.Turgut Reis Cad. No:21

АТС код:

V08AB02

INN (Международно Name):

iohexol

дозиране:

350mg iodine/ml

Лекарствена форма:

solution for injection

Броя в опаковка:

glass vial100ml

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2019-01-18

Листовка

PATIENT INFORMATION LEAFLET
BIEMEXOL 350
MG
I /ML SOLUTION FOR INJECTIONS
IT
IS
ADMINISTERED INTO BODY CAVITIES AS
IA
AND IV
STERILE-APYROGEN
BY
SCDMTF
1~
_I _
0;1.C
'2
~
i,
_2 _
j
~
_(4 _
NT
'0
..
_AC_
_TIVE SUBSTLLNCE: _
Each vial contains 350 mg Iodine equivalent to 755 mg iohexol
_EXCIPIENTS: _
Trometamol, sodium calcium
EDT A, hydrochloric
acid
(for
pH
adjustment),
sodium hydroxide (for
pH
adjustment) and water.
BEFORE USING THIS
MEDICINE,
PLEASE
READ
THIS
PATIENT INFORMATION
LEAFLET
CAREFULLY,
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
_Keep this leaflet. _
_You _
_may need _
_to _
_read _
_it _
_again. _
•
_If _
_you have any further quest ions, consult your doctor or your
pharmacist. _
•
_This _
_medicine has been prescribed for you personally; you should not pass
it on _
_ro _
_others. _
•
_During use _
_of _
_this medicine please tell to your doctor that you use this medicine _
_when you go to the doctor or hospital. _
•
_Follow the information _
_in _
_the leaflet _
_ex_
_actly. Do not use lower or higher dosages _
_rather than recommended dosages regarding the medicine. _
IN THIS PATIENT INFORMATION LEAFLET:
1.
WHAT IS
BIEMEXOL
AND WHAT IT IS USED FOR?
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
BIEMEXOL?
3.
HOW TO USE
BIEMEXOL
4.
WHAT ARE THE POSSIBLE SIDE EFFECTS
OF
BIEMEXOL?
S.
HOW TO STORE
BIEMEXOL
1.
WHAT
IS
BIEMEXOL
AND WHAT
IT
IS
USED FOR?
BiEMEXOL 350
is
presented in 50
ml
, 100 ml and 200 ml, colorless, type
L
glass vial with
bromobutly closure and dark blue tear
off
cap.
BiEMEXOL contains the active substance
iohexol.
This medicine
is
for diagnostic use only.
It
is
used only to help identify an illness and not in connection with
treatment.
BiEMEXOL
is
a ·contrast medium' . It
is
given before an X-ray
to
make the picture that your
doctor takes clearer.
•
Once injected, it can help your doctor tell apart normal or abnormal
appearance and
shape
of
some organs in your body.
•
It
can be used for X-rays
of
your urinary system, spine or blood vessels, including
blood vessels
of

Данни за продукта

1.
SUMMARY
OF
PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
BiEMEXOL 350 mg
_Vm_
_l _
Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Iohexol 755 mg/ml equivalent to 350 mg/ml iodine
lohexol
is
a non-ionic, monomeric, triiodinated, water-soluble X-ray conrast
medium.
The osmolality and viscosity values
ofBfEMEXOL
350
mg
I/ml are as follows:
Concentration
Osmolality*
Viscosity(mPa.s)
Osm/kg
H20
20°c
37°c
350 mgl/ml
0.78
23.3
*
.
Method: Vapour - pressure osmometry.
EXCIPIENTS:
This medicinal product contains 0.012mg sodium per ml
For a full list
of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
37°c
10.6
BiEMEXOL
is
a clear colourless to pale yellow, sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
THIS MEDICINAL PRODUCT
IS
FOR DIAGNOSTIC USE ONLY.
...
_7 _
f
.U.
_/'8 _
_Pf' _
X-ray
contrast
medium
for
use
in
adults
and
children
for
angiography,
urography,
phlebography and CT-
enhancement. Lumbar, thoracic, cervical rnyelography and computed
tomography
of
the
basal
cisterns,
following
subarachnoid
injection.
Arthrography,
endoscopic
retrograde
pancreatography,
(ERP),
endoscopic
retrograde
cholangiopancreatography
(ERCP),
herniography,
hysterosalpingography,
sialography
and
studies
of
the
gastrointestinal tract.
4.2
POSOLOGY AND METHOD
OF
ADMINISTRATION
The dosage vary depending on
the type
of
examination, age, weight, cardiac output and
general condition
of
the
patient and the technique used. Usually the same iodine concentration
and volume
is
used as with other iodinated
X-ray contrast media
in
current use. Adequate
hydration should be assured before and after administration as for
other contrast media.
1/
16
J
For intravenous, intra-arterial and use
in
body cavities.
GUIDELINES FOR INTRAVENOUS USE
INDICATION
CONCENTRATION
VOLUME
_Urography _
300 mgl/ml
40-80 ml
Adults:
or
350
mgI/ml
40-80
ml
Children <7 kg:
240 mgI/rnl
4 ml/kg
or 300 mgl/ml
3 ml/kg
Children >7 kg:
240 mgl/ml
3 ml/kg
or 300 mgl/ml
2 ml/kg
_Ph