Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Gadoxetate, disodium
BAYER (SOUTH EAST ASIA) PTE LTD
V08CA10
181.430mg
INJECTION, SOLUTION
Gadoxetate, disodium 181.430mg
INTRAVENOUS
Prescription Only
BAYER AG
ACTIVE
2007-06-25
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 Læs hele dokumentet
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 Læs hele dokumentet