País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
disodium gadoxetate, Quantity: 181.43 mg/mL
Bayer Australia Ltd
Disodium gadoxetate
Injection, solution
Excipient Ingredients: water for injections; trometamol; trisodium caloxetate; hydrochloric acid; sodium hydroxide
Intravenous
5 x 5mL vials, 10 x 5mL vials, 1 x 5mL vial
Not scheduled. Not considered by committee
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 lesion
Visual Identification: Clear solution in a colourless glass vial, fitted with black rubber stopper with bordered cup.; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2004-07-01
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 Leer el documento completo
2002 PRIMOVIST PI Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION PRIMOVIST ® (DISODIUM GADOXETATE) 1. NAME OF THE MEDICINE Disodium gadoxetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of the magnetic resonance imaging (MRI) contrast agent Primovist contains 0.25 mmol disodium gadoxetate (equivalent to 181.43 mg disodium gadoxetate as the active ingredient). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. 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. 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. DOSAGE 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 0.1 mL/kg body weight Primovist (equivalent to 25 µmol/kg body weight). Imaging After bolus injection of Primovist, dynamic imaging during arterial, portovenous, and equilibrium 2002 PRIMOVIST PI Page 2 of 16 phases utilises the different temporal enhancement pattern of different liver lesion types to obtain information about their classification (benign/malignant) and the specific characterisation. It further improves visualization of hypervascular liver lesions. 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 last Leer el documento completo