Primovist 0.25 mmolml Solution for injection

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Gadoxetate, disodium

Διαθέσιμο από:

BAYER (SOUTH EAST ASIA) PTE LTD

Φαρμακολογική κατηγορία (ATC):

V08CA10

Δοσολογία:

181.430mg

Φαρμακοτεχνική μορφή:

INJECTION, SOLUTION

Σύνθεση:

Gadoxetate, disodium 181.430mg

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

BAYER AG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2007-06-25

Φύλλο οδηγιών χρήσης

 
Primovist PI_SG_CCDS7_17 Oct 2011 
1. NAME OF THE MEDICINAL PRODUCT 

Primovist 0.25 mmol/ml, solution for injection.  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

Each ml contains 0.25 mmol gadoxetate disodium (equivalent to 181.43mg gadoxetate 
disodium) as active ingredient. 

Excipient: Each ml contains 0.511 mmol (equivalent to
11.7mg) of sodium (see section 
“Special warnings and precautions of use”). 

For full list of excipients, see section “List of excipients”.  

3. PHARMACEUTICAL FORM 

Solution for injection.  

Clear, colourless to pale yellow solution. 

The physico-chemical properties of Primovist listed below are: 

Osmolality at 37 °C (mOsm/kg H
2
O) 
688 

Viscosity at 37 °C (mPa·s) 
1.19 

pH 
6.8 
– 8.0 

4. CLINICAL PARTICULARS 

4.1 INDICATION 

Primovist  is  indicated  for  use  in  adults  for  the  enhancement  of  magnetic  resonance 
imaging (MRI) of focal liver lesions. 

4.2 DOSAGE AND METHOD OF ADMINISTRATION  

4.2.1 METHOD OF ADMINISTRATION 

This medicinal product is for intravenous administration.  
The dose is administered undiluted as a
bolus injection. After the injection of the contrast 
medium the intravenous cannula/line should
be flushed using physiological saline 
solution. 
After bolus injection of Primovist, dynamic imaging
during arterial, portovenous, and 
equilibrium phases utilizes
the different temporal enhancement pattern of different liver 
lesion types to obtain
information about their classification (benign/malignant) and the 
specific characterization. It further improves visualization
of hypervascular liver lesions.  

Primovist PI_SG_CCDS7_17 Oct 2011 
The delayed (hepatocyte) phase starts at about 10 minutes post injection (in confirmatory 
studies most of t

Αρχείο Π.Χ.Π.

Primovist PI_CCDS7_ 13 Apr 2018
1. NAME OF THE MEDICINAL PRODUCT
Primovist 0.25 mmol/ml, solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.25 mmol gadoxetate disodium (equivalent to 181.43mg
gadoxetate
disodium) as active ingredient.
Excipient: Each ml contains 0.511 mmol (equivalent to 11.7mg) of
sodium (see section
“Special warnings and precautions of use”).
For full list of excipients, see section “List of excipients”.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
The physico-chemical properties of Primovist listed below are:
Osmolality at 37 °C (mOsm/kg H
2
O)
688
Viscosity at 37 °C (mPa·s)
1.19
pH
6.8 – 8.0
4. CLINICAL PARTICULARS
4.1 INDICATION
Primovist is indicated for use in adults for the enhancement of
magnetic resonance
imaging (MRI) of focal liver lesions.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
This medicinal product is for intravenous administration.
The dose is administered undiluted as a bolus injection. After the
injection of the contrast
medium the intravenous cannula/line should be flushed using
physiological saline
solution.
After bolus injection of Primovist, dynamic imaging during arterial,
portovenous, and
equilibrium phases utilizes the different temporal enhancement pattern
of different liver
lesion types to obtain information about their classification
(benign/malignant) and the
specific characterization. It further improves visualization of
hypervascular liver lesions.
Primovist PI_CCDS7_ 13 Apr 2018
The delayed (hepatocyte) phase starts at about 10 minutes post
injection (in confirmatory
studies most of the data were obtained at 20 minutes post injection)
with an imaging
window lasting at least 120 minutes. The imaging window is reduced to
60 minutes in
patients requiring hemodialysis and in patients with elevated
bilirubin values (> 3 mg/dl)
(see also section “Interaction with other medicinal products and
other forms of
interaction”).
The enhancement of liv