Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA)
Bayer New Zealand Limited
Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA)
181.43 mg/mL
Solution for injection
Active: Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA) Excipient: Hydrochloric acid As 3.6% w/w aqueous solution Caloxetate complexing agent Sodium hydroxide Trometamol Water for injection
Syringe, Pre-filled, unit dose 10 ml syringe, 1 dose unit
General sale
General sale
Bayer AG
For use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions
Package - Contents - Shelf Life: Syringe, glass, Pre-filled, 10 ml syringe - 1 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 10 dose units - 36 months from date of manufacture stored at or below 30°C
2011-06-07
PRIMOVIST® 1 PRIMOVIST® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I GIVEN PRIMOVIST? PRIMOVIST contains the active ingredient disodium gadoxetate. PRIMOVIST is a contrast agent used during a magnetic resonance imaging (MRI) examination of the liver in adults. For more information, see Section 1. Why am I given PRIMOVIST? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN PRIMOVIST? Do not use if you have ever had an allergic reaction to PRIMOVIST or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT. It is recommended that you do not eat for 2 hours before you are given PRIMOVIST. For more information, see Section 2. What should I know before I am given PRIMOVIST? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PRIMOVIST and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW AM I GIVEN PRIMOVIST? PRIMOVIST is injected into your vein by a doctor, radiographer or nurse during your MRI examination. More instructions can be found in Section 4. How am I given PRIMOVIST? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING PRIMOVIST? THINGS YOU SHOULD DO Tell your doctor, radiographer or nurse if you: • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock • have very poor kidney function or severe kidney problems • had a liver transplant, impaired liver function or liver cirrhosis • have severe he Olvassa el a teljes dokumentumot
180916 PRIMOVIST DS 1 DATA SHEET PRIMOVIST Gadoxetate disodium 181.43 mg/mL 1 PRODUCT NAME PRIMOVIST (181.43 mg/mL solution for injection) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PRIMOVIST contains gadoxetate disodium 181.43 mgl/mL as the active ingredient. Each 1 mL of the MRI contrast agent PRIMOVIST contains 0.25 mmol disodium gadoxetate (equivalent to 181.43 mg disodium gadoxetate as the active ingredient). Each mL contains 0.511 mmol (equivalent to 11.755 mg) of sodium (See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). PRIMOVIST contains no antimicrobial preservative. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM PRIMOVIST is a clear, colourless to pale yellow solution for injection The physico-chemical properties of PRIMOVIST are listed below: Osmolality at 37°C (mOsm/kg H 2 O) 688 Density at 37°C (g/mL) 1.0881 Viscosity at 37°C (mPa·s) 1.19 pH 6.8 – 8.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. PRIMOVIST is indicated for use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions. 180916 PRIMOVIST DS 2 4.2 DOSE AND METHOD OF ADMINISTRATION General information The usual safety rules for magnetic resonance imaging must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants. PRIMOVIST is for use as a single dose in one patient only. Discard any remaining content. Dose The lowest effective dose should be used. PRIMOVIST is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 mL/sec through a large-bore needle or indwelling catheter (18-20 gauge is recommended). After the injection of the contrast medium the intravenous cannula should be flushed using physiological saline solution. The recommended dose of PRIMOVIST is: Adults mL/kg body weight PRIMOVIST (equivalent to 25 µmol/kg body weight). Imaging After bolus injection of PRIMOVIST, dynamic imaging during arterial, portovenous, and eq Olvassa el a teljes dokumentumot