TELEBRIX 35

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

MEGLUMINE IOXITALAMATE; SODIUM IOXITALAMATE

Доступно од:

PROMEDICO LTD

АТЦ код:

V08AA05

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

SODIUM IOXITALAMATE 9.66 %; MEGLUMINE IOXITALAMATE 65.09 %

Пут администрације:

INTRAVASCULAR

Тип рецептора:

Required

Произведен од:

GUERBET, FRANCE

Терапеутска група:

IOXITALAMIC ACID

Терапеутска област:

IOXITALAMIC ACID

Терапеутске индикације:

Angiocardiography (ventriculography - coronary angiography) - digital substraction angiography - computerized tomography- intravenous urography.

Датум одобрења:

2011-08-31

Информативни летак

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
ל
אפור :ךיראת
6.2013
םש
רישכת
תילגנאב
רפסמו
( :םושירה
054-38-26112-00 )
TELEBRIX 35 MEGLUMINE
םש
לעב
םושירה :
PROMEDICO LTD
םייונישה
ןולעב
םינמוסמ
לע
עקר
בוהצ
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
2. QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Excipient with known effect: Sodium (341.8 mg sodium per 100 mL).
4.2 POSOLOGY
AND METHOD OF
ADMINISTRATION
_Special populations_
_Elderly patients_
TELEBRIX 35 should be administered with caution (see section 4.4), in
well-hydrated patients at
the minimum effective dose.
_Patients with renal impairment_
In patients with renal failure, the dose is reduced and sufficient
hydration must be ensured (see also
section 4.4.2.2. Precautions for use – Renal failure).
METHOD OF ADMINISTRATION
The product must be administered via intra-arterial or intravenous
route.
4.3 CONTRA-
INDICATIONS

Hypersensitivity to ioxitalamic acid or to
any of the excipients;

History of major immediate or delayed
skin
reaction
(see
section
4.8)
to
TELEBRIX 35 ;

Decompensated heart failure by systemic
injection;

Overt thyrotoxicosis;

Myelography.

Hypersensitivity to ioxitalamic acid or to any of the excipients
listed in section 6.1.

History of major immediate or delayed skin reaction (see section 4.8)
to TELEBRIX 35
injection

Decompensated heart failure

Manifest thyrotoxicosis

Intrathecal or subarachnoid (or epidural) administration of TELEBRIX
35 for myelography,
cerebral ventriculography or cisternography is contraindicated as
severe and potentially life-
threatening neurotoxic reactions (e.g. myoclonus or epilepsy) can
occur.
4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR
USE
_4.4.1._
_ _
_ 3. _
_ _
_ Extravasation_
_ _
_ _
Extravasation is not an uncommon complication (0.04% to 0.9%) of
intravenous injectio

Карактеристике производа

_ _
_ _
1
SUMMARY OF PRODUCT CHARACTERISITCS
1.
NAME OF THE MEDICINAL PRODUCT
TELEBRIX 35 (350 MG I/ML),
SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 100 mL of solution:
Meglumine ioxitalamate
............................................................................................................
65.09g
Sodium ioxitalamate
...................................................................................................................
9.66 g
Equivalent to iodine
........................................................................................................................
35 g

Iodine content per mL: 350 mg

Iodine mass per 50 mL vial: 17.5 g

Iodine mass per 100 mL bottle: 35 g

Iodine mass per 200 mL bottle: 70 g
Excipient with known effect: Sodium (341.8 mg sodium per 100 mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection

Viscosity at 20° C: 15.1 mPa.s

Viscosity at 37° C: 7.5 mPa.s

Osmolality: 2130 mOsm / kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Contrast medium for use via intra-arterial and intravenous
administration for:
- Angiocardiography (ventriculography- coronary angiography)
- digital substraction angiography
- computerized tomography
- intravenous urography.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose must be adapted according to the patient’s age, weight,
renal function, the type of examination and
the volume of the organ to be examined.
INDICATIONS
AVERAGE DOSE
ML/KG
TOTAL VOLUME
(MIN. - MAX.) ML
Intravenous urography:
1.0
50 - 100
Computed tomography:

head

full body
1.0
1.8
40 - 100
90 - 180
Digital angiography
2.1
95 - 250
Angiocardiography:

ventriculography

coronarography
40 mL per injection
4 to 8 mL per injection
30 - 60
270
_ _
_ _
2
_Special populations _
_Elderly patients _
TELEBRIX 35 should be administered with caution (see section 4.4), in
well-hydrated patients at the minimu