TELEBRIX GASTRO

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

MEGLUMINE IOXITALAMATE

Saadav alates:

PROMEDICO LTD

ATC kood:

P01CB01

Ravimvorm:

SOLUTION

Koostis:

MEGLUMINE IOXITALAMATE 66.03 G / 100 ML

Manustamisviis:

PER OS, RECTAL

Retsepti tüüp:

Required

Valmistatud:

GUERBET, FRANCE

Terapeutiline rühm:

MEGLUMINE ANTIMONATE

Terapeutiline ala:

MEGLUMINE ANTIMONATE

Näidustused:

Conventional x-ray and CT examinations of the gastrointestinal tract, gastroduodenal radiography, opaque enema examinations, especially in cases in which barium is contraindicated.

Loa andmise kuupäev:

2015-01-31

Infovoldik

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה :ךיראת
6.2013
( :םושירה רפסמו תילגנאב רישכת םש
117-64-25639-05 )
TELEBRIX GASTRO :םושירה לעב םש
PROMEDICO LTD ןולעב םייונישה
בוהצ עקר לע םינמוסמ
! דבלב תורמחהה טורפל דעוימ הז ספוט
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
2. QUALITATIVE
AND QUANTITATIVE
COMPOSITION
Excipient with known effect: ethanol (alcohol) (0.48 to 0.52 mL for
100 mL of solution)
4.2 POSOLOGY
AND METHOD OF
ADMINISTRATION
POSOLOGY
AND
METHOD
OF
ADMINISTRATION
ORAL OR RECTAL ROUTE
The
dose
administered
should
be
adjusted to the area examined, the
examination
technique
and
the
administration route.
ORAL ADMINISTRATION
- In adults : 200 ml of the contrast medium
diluted with 250 ml of water.
- In children : 40 ml of the contrast
medium diluted with 10 ml of water.
RECTAL ADMINISTRATION
- In adults : 400 ml of the contrast medium
diluted with 400 ml of water.
- In children : 30 to 150 ml of the undiluted
contrast medium.
Computed tomography : 50 ml of the
contrast medium added to 950 ml of
water.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The doses must be adapted to the examination and the regions to be
investigated, as well
as to the age and body weight of the subject, particularly in
children.
INDICATIONS
AVERAGE DOSE
TOTAL VOLUME
)MIN.-MAX.( ML
Conventional
Radiography
ORAL ROUTE
Adults
Children
RECTAL ROUTE
Adults
Children
200 mL of product diluted with 250 mL water
40 mL of product diluted with 10 mL water
400 mL of product diluted with 400 mL water
30 mL to 150 mL of undiluted product
< 500
< 100
< 1500
< 200
Computed tomography
50 mL diluted with 950 mL water
< 1300
Special
populations
_Elderly patients_
TELEBRIX GASTRO should be administered with caution (see section 4.4),
in well-
hydrated patients at the minimum effective dose.
_Paediatric population_
As with all other hyperosmolar contrast media

Toote omadused

_ _
SUMMARY OF PRODUCT CHARACTERISITCS
1.
NAME OF THE MEDICINAL PRODUCT
TELEBRIX GASTRO (300 MG I/ML),
SOLUTION FOR ORAL OR RECTAL ADMINISTRATION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 100 mL of solution:
Meglumine ioxitalamate
...........................................................................................................
66.03 g
Equivalent to iodine
.......................................................................................................................
30 g

Iodine content per mL: 300 mg

Iodine mass per 50 mL vial: 15 g

Iodine mass per 100 mL bottle: 30 g
Excipient with known effect: ethanol (alcohol) (0.48 to 0.52 mL for
100 mL of solution)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for oral or rectal administration
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Contrast medium for use in adults and children by oral or rectal
administration for:
Conventional
X-ray
and
computed
tomographic
(CT)
examinations
of
the
gastrointestinal
tract,
gastroduodenal radiography, opaque enema examinations, especially in
cases in which barium products
are contraindicated.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The doses must be adapted to the examination and the regions to be
investigated, as well as to the age and
body weight of the subject, particularly in children.
_ _
INDICATIONS
AVERAGE DOSE
TOTAL VOLUME
(MIN.-MAX.) ML
Conventional Radiography
ORAL ROUTE
Adults
Children
RECTAL ROUTE
Adults
Children
200 mL of product diluted with 250 mL water
40 mL of product diluted with 10 mL water
400 mL of product diluted with 400 mL water
30 mL to 150 mL of undiluted product
< 500
< 100
< 1500
< 200
Computed tomography
50 mL diluted with 950 mL water
< 1300
Special populations
_Elderly patients _
TELEBRIX GASTRO should be administered with caution (see section 4.4),
in well-hydrated patients at
the minimum effective dose.
_Paediatric population _
As with all other hyperosmolar contra