MULTIHANCE

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

GADOBENIC ACID AS DIMEGLUMINE SALT

Verfügbar ab:

DEXCEL LTD, ISRAEL

ATC-Code:

V08CA08

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

GADOBENIC ACID AS DIMEGLUMINE SALT 334 MG/ML

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

BRACCO IMAGING S.P.A., ITALY

Therapiegruppe:

GADOBENIC ACID

Therapiebereich:

GADOBENIC ACID

Anwendungsgebiete:

MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: • MRI of the liver for the detection of focal liver lesions in patients with known or suspected primary liver cancer (eg. hepatocellular carcinoma) or metastatic disease.• MRI of the brain and spine where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI.• Contrast-enhanced MR- angiography where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries.• MRI of the breast, for the detection of malignant lesions in patients where breast cancer is known or suspected on the basis of previous mammography or ultrasound results

Berechtigungsdatum:

2020-09-30

Gebrauchsinformation

לירפא
2018
MULTIHANCE, SOLUTION FOR INJECTION
,דבכנ יאופר תווצ
ןוכדע לע םכעידוהל תשקבמ מ"עב לסקד תרבח
ןולעה
אפורל
ה לש
רישכת
סנהיטלמ
.
העדוהב
וז
.דבלב םייתוהמה םינוכדעה םיטרופמ
עדימל
.ןולעב ןייעל שי ,אלמ
ולעה
ן
אפורל
חלשנ
לבקל ןתינו תואירבה דרשמ רתאבש תופורתה
רגאמב םוסרפל
ו
פדומ
ס
היינפ י"ע
לסקד 'חר ,מ"עב לסקד :םושירה לעבל
1
אביקע רוא ,
3060000
:'לט ,לארשי ,
04-6364000
.
:רישכתה בכרה
1 ml of solution for injection contains: gadobenic acid 334 mg (0.5M)
as the
dimeglumine salt.
:תורשואמה תויוותהה
MultiHance is a paramagnetic contrast agent for use in diagnostic
magnetic resonance
imaging (MRI) indicated for:
• MRI of the liver for the detection of focal liver lesions in
patients with known or
suspected primary liver cancer (eg. hepatocellular carcinoma) or
metastatic disease.
• MRI of the brain and spine where it improves the detection of
lesions and provides
diagnostic information additional to that obtained with unenhanced
MRI.
• Contrast-enhanced MR- angiography where it improves the diagnostic
accuracy for
detecting clinically significant steno-occlusive vascular disease in
patients with suspected
or known vascular disease of the abdominal or peripheral arteries.
• MRI of the breast, for the detection of malignant lesions in
patients where breast cancer
is known or suspected on the basis of previous mammography or
ultrasound results ןולעה
אפורל
ב ןכדוע
-
03/2018 . םייתוהמה םינוכדעה ןלהל
ב םינמוסמ(
םודא
)
:
...
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest dose that provides sufficient enhancement for diagnostic
purposes should be used.
MRI of the liver: the recommended dose of MultiHance injection in
adult patients is 0.05
mmol/kg body weight. This corresponds to 0.1 mL/kg of the 0.5 M
solu

Fachinformation

MULTIHANCE - SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MultiHance, 0.5 M solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains: gadobenic acid 334 mg (0.5M)
as the dimeglumine salt.
[Gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195
mg].
5 ml of solution for injection contain: gadobenic acid 1670 mg (2.5
mmol) as dimeglumine salt.
[gadobenate dimeglumine 2645 mg = gadobenic acid 1670 mg + meglumine
975 mg].
10 ml of solution for injection contain: gadobenic acid 3340 mg (5
mmol) as dimeglumine salt.
[gadobenate dimeglumine 5290 mg = gadobenic acid 3340 mg + meglumine
1950 mg]
15 ml of solution for injection contain: gadobenic acid 5010 mg (7.5
mmol) as dimeglumine salt.
[gadobenate dimeglumine 7935 mg = gadobenic acid 5010 mg + meglumine
2925 mg].
20 ml of solution for injection contain: gadobenic acid 6680 mg (10
mmol) as dimeglumine salt.
[gadobenate dimeglumine 10580 mg = gadobenic acid 6680 mg + meglumine
3900 mg].
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Clear aqueous solution filled into colourless glass vials.
Osmolality at 37°C: 1.97 osmol/kg
Viscosity at 37°C: 5.3 mPa.s
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
MultiHance is a paramagnetic contrast agent for use in diagnostic
magnetic resonance imaging
(MRI) indicated for:

MRI of the liver for the detection of focal liver lesions in patients
with known or suspected
primary liver cancer (eg. hepatocellular carcinoma) or metastatic
disease.

MRI of the brain and spine where it improves the detection of lesions
and provides diagnostic
information additional to that obtained with unenhanced MRI.

Contrast-enhanced MR- angiography where it improves the diagnostic
accuracy for detecting
clinically significant steno-occlusive vascular disease in patients
with suspected or known
vascular disease of the abdominal or peripheral arteries.
