TELEBRIX 30 MEGLUMINE

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

MEGLUMINE IOXITALAMATE

Saadav alates:

PROMEDICO LTD

ATC kood:

P01CB01

Ravimvorm:

SOLUTION FOR INJECTION

Koostis:

MEGLUMINE IOXITALAMATE 66.03 G / 100 ML

Manustamisviis:

I.V, INTRAVASCULAR

Retsepti tüüp:

Required

Valmistatud:

GUERBET, FRANCE

Terapeutiline rühm:

MEGLUMINE ANTIMONATE

Terapeutiline ala:

MEGLUMINE ANTIMONATE

Näidustused:

For urograph, selective angiography, peripheral angiography, arthrography, hysterosalpingography and digestive exploration.

Loa andmise kuupäev:

2012-11-30

Infovoldik

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
ל
אפור :ךיראת
5.2013
םש
רישכת
תילגנאב
רפסמו
( :םושירה
027-67-21780-00 )
TELEBRIX 30 MEGLUMINE
םש
לעב
םושירה :
PROMEDICO LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.8.
UNDE
SIRABL
E
EFFECT
S
TABULATED LIST OF ADVERSE REACTIONS WITH TELEBRIX 30 MEGLUMINE
OR ANOTHER FORM OF TELEBRIX FOLLOWING NON-ENTERAL
ADMINISTRATION:
SYSTEM ORGAN CLASS
FREQUENCY: ADVERSE REACTION
Immune system
disorder
Frequency not known: Anaphylactic shock,
anaphylactic reaction, anaphylactoid reaction,
hypersensetivity
Endocrine disorders
Frequency not known: Thyrotoxic crisis*,
hyperthyroidism*, thyroid disorder**
Psychiatric disorders
Frequency not known: Conusional state,
List summarising the undesirable effects reported with TELEBRIX 30
Meglumine or another form of TELEBRIX after intravascular
administration or instillation:
SYSTEM ORGAN CLASS
FREQUENCY:
UNDESIRABLE EFFECT
Immune system disorders
Unknown frequency: anaphylactic shock,
anaphylactic reaction, anaphylactoid reaction,
hypersensitivity
Endocrine disorders
agitation
Nervous system
disorders
Frequency not known: Coma,
loss of consciousness, syncope, convulsion,
paresis/paralysis, paresthesia, tremor,
dizziness, headache
Eye disorders
Frequency not known: Eyelid oedema
Ear and labyrinth
disorders
Frequency not known: Vertigo
Cardiac disorders
Frequency not known: Cardiac arrest,
myocardial infarction, angina pectoris,
arrhythmia, tachycardia, cyanosis
Vascular disorders
Frequency not known: Shock, hypertension,
hypotension, thrombophlebitis
1
, flushing,
pallor
Respiratory, thoracic
and mediastinal
disorders
Frequency not known: Respiratory arrest,
respiratory failure, laryngeal oedema,
laryngospasm, pulmonary oedema, dyspnoea,
bronchospasm, throat tightness, cough,
sneezing
Gastrointestinal
disorders
Frequency not known: Diarrhoea, nausea,
vomit

Toote omadused

_ _
_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TELEBRIX 30 MEGLUMINE (300 MG IODINE/ML), SOLUTION FOR INJECTION
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 30 mL vial: 9 g

Iodine mass per 50 mL vial: 15 g

Iodine mass per 100 mL bottle: 30 g
Excipient with known effect: Sodium (8.4 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: 10.2 mPa.s

Viscosity at 37° C: 5.3 mPa.s

Osmolality: 1710 mOsm/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Contrast medium for use in adults and children
via intra
-arterial and intravenous administration and by
instillation for:
Urograph, selective angiography, peripheral angiography, arthrography,
hysterosalpingography and
digestive exploration.
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.
_ _
_ _
2
INDICATIONS
AVERAGE DOSE
ML/KG
TOTAL VOLUME
(MIN.-MAX.) ML
Intravenous urography
The standard dose is 1 to 2
ml/kg. In children under 20
kg, the dose is 2 to 3 ml/kg.
50 – 100 mL
Retrograde
urethrocystography
Dosage to be adapted to the
volume
of
the
organ
to
be
injected.
20 – 100 mL
Suprapubic cystography
Dosage to be adapted to the
volume
of
the
organ
to
be
injected.
100 – 250 mL
SPECIAL POPULATIONS
_Elderly patients _
TELEBRIX 30 Meglumine 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 contr