GADOVIST 1MMOLML PREFILLED SYRINGE 5.0 ML

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

GADOBUTROL

متاح من:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC رمز:

V08CA09

جرعة:

604.720 MG/ML(EQUIV. 1.0 MMOL)

الشكل الصيدلاني:

INJECTION

تركيب:

GADOBUTROL 604.720 MG/ML(EQUIV. 1.0 MMOL)

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

BAYER AG

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2010-05-21

نشرة المعلومات

1 
Gadovist 1.0 mmol/ml VIal & PFS PI_SG_CCDS 17 & 18.0_22 Sep 2014 

1.  NAME OF THE MEDICINAL PRODUCT 

GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION     

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION   

Each ml contains 1.0 mmol gadobutrol (equivalent to 604.72 mg gadobutrol) as active ingredient.   

For full list of excipients, see section ‘List of excipients’.   

3.  PHARMACEUTICAL FORM 

Solution for injection.   

Clear, colorless to pale yellow solution. 

The physico-chemical properties of the 1.0 mmol/ml solution for injection Gadovist listed below are:   

Osmolarity at 37 °C (mOsm/l solution)    1117   
Osmolality at 37 °C (mOsm/kg H
2
O)      1603   
pH of the solution 
6.6 – 8.0 
Viscosity at 37 °C (mPa·s)     
4.96   

4.  CLINICAL PARTICULARS 

4.1  INDICATIONS 

This medicinal product is for diagnostic use only. 

Gadovist is indicated in adults, adolescents, and children aged 2 years and older for: 

• 
Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). 
• 
Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal 
lesions to classify these lesions as benign or malignant. 
• 
Contrast enhancement in Magnetic Resonance Angiography (CE-MRA). 

Gadovist can also be used for MR Imaging of pathologies of the whole body. It facilitates visualisation of 
abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue. 

4.2 DOSAGE AND METHOD OF ADMINISTRATION   

4.2.1 METHOD OF ADMINISTRATION 

The dose required is administered intravenously as a bolus injection. 

For additional instructions see section ‘Instructions for use/handling’.   

Cont

خصائص المنتج

1
Gadovist 1.0 mmol/ml Vial & PFS PI_CCDS 20 _ 08 Mar 2019
RESTRICTED
1.
NAME OF THE MEDICINAL PRODUCT
GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1.0 mmol gadobutrol (equivalent to 604.72 mg
gadobutrol) as active ingredient.
For full list of excipients, see section ‘List of excipients’.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless to pale yellow solution.
The physico-chemical properties of the 1.0 mmol/ml solution for
injection Gadovist listed below are:
Osmolarity at 37 °C (mOsm/l solution) 1117
Osmolality at 37 °C (mOsm/kg H
2
O)
1603
pH of the solution
6.6 – 8.0
Viscosity at 37 °C (mPa·s)
4.96
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
This medicinal product is for diagnostic use only.
Gadovist is indicated in adults and children of all ages including
full-term newborns:
•
Contrast enhancement in cranial and spinal magnetic resonance imaging
(MRI).
•
Contrast enhanced MRI of liver or kidneys in patients with high
suspicion or evidence of having focal
lesions to classify these lesions as benign or malignant.
•
Contrast enhancement in Magnetic Resonance Angiography (CE-MRA).
Gadovist can also be used for MR Imaging of pathologies of the whole
body. It facilitates visualisation of
abnormal structures or lesions and helps in the differentiation
between healthy and pathological tissue.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
The dose required is administered intravenously as a bolus injection.
For additional instructions see section ‘Instructions for
use/handling’.
Contrast-enhanced MRI can commence immediately afterwards (shortly
after the injection depending on
the pulse sequences used and the protocol for the examination).
Optimal signal enhancement is
observed during arterial first pass for CE-MRA and within a period of
about 15 minutes after injection of
Gadovist for other indications (time depending on type of
lesion/tissue).
T
1
-weighted scanning sequences are particularly suitabl