TELEBRIX 12 SODIUM

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

SODIUM IOXITALAMATE

Disponible depuis:

PROMEDICO LTD

Code ATC:

V08AA05

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

SODIUM IOXITALAMATE 21 G / 100 ML

Mode d'administration:

INTRAVESICAL

Type d'ordonnance:

Required

Fabriqué par:

GUERBET, FRANCE

Groupe thérapeutique:

IOXITALAMIC ACID

Domaine thérapeutique:

IOXITALAMIC ACID

indications thérapeutiques:

contrast medium for retrograd cystography.

Date de l'autorisation:

2011-08-31

Notice patient

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה :ךיראת
28/07/2011 :תילגנאב רישכת םש
TELEBRIX 12 SODIUM : םושיר רפסמ
26111 : םושירה לעב םש
PROMEDICO LTD
.
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.3 CONTRAINDICATIONS

Hypersensitivity to ioxitalamic acid or to any of the excipients;

History of major immediate or delayed skin reaction (see
section 4.8) to Telebrix 12 Sodium
(120 mg iodine/mL),
solution for injection;

Decompensated heart failure, when used by systemic injection;

Endoscopic retrograde pancreatography (ERP) for acute
pancreatitis;

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 12 Sodium Intra-vascular administration.

Intra-vascular administration

Manifest thyrotoxicosis
.

Intrathecal or subarachnoid (or epidural) administration of TELEBRIX
12 Sodium 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
_4.4.1.2.1. Intolerance to iodinated contrast media:_
Prior to the examination:

Identify subjects at risk via
specific
questioning
concerning
history.
Corticosteroids
and
H1-antihistamines
were
suggested
as
4.4.1. SPECIAL WARNINGS
4.4.1.1 Hypersensitivity
Any All iodinated contrast medium can cause minor or major reactions
that
may be life-threatening. They may be immediate (less than 60 minutes)
or
delayed (up to 7 days). They are often unpredictable.
premedication in patients at the highest risk of intolerance reaction
(known to be intolerant to an iodinated contrast medium). However,
they do not prevent serious or fatal anaphylactic

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TELEBRIX 12 SODIUM , SOLUTION FOR INJECTION FOR INTRAVESICAL
ADMINISTRATION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 100 mL of solution:
Sodium ioxitalamate
................................................................................................
21.00 g
Equivalent to iodine
......................................................................................................
12 g
•
Iodine content per mL: 120 mg
•
Iodine mass per 250 mL bottle: 30g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for intravesical administration
•
Viscosity at 20°C: 1.7 mPa.s
•
Viscosity at 37 °C: 1.1 mPa.s
•
Osmolality: 640 mOsm / kg
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For diagnostic use only.
Contrast medium for:
•
Retrograde cystography;
4.2
POSOLOGY
INDICATIONS
AVERAGE DOSE
TOTAL VOLUME
ML/KG
(MIN.-MAX.) ML
Retrograde cystography
Dose to be adapted to the volume
of the organ to be injected
20 - 100
_U_
METHOD OF ADMINISTRATION
The product must be administered by intravesical administration only
4.3
CONTRAINDICATIONS
•
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 12
Sodium Intra-vascular administration.
•
Intra-vascular administration
•
Manifest thyrotoxicosis
•
Intrathecal or subarachnoid (or epidural) administration of TELEBRIX
12 Sodium 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
•
There is a risk of allergy, whatever the administration route or
dosage.
•
The risk of intolerance cannot be ruled out when medicinal products
are administered
locally to opacify body cavities:
a) administration via certain routes (e.g. articular, biliary,
intrathecal, intra-uterine) res