Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
gadobutrol, Quantity: 604.72 mg/mL
Bayer Australia Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; water for injections; calcobutrol; trometamol
Intravenous
5 x 10mL syringes
Not scheduled. Not considered by committee
This medicinal product is for diagnostic use only. Gadovist 1.0 is indicated in adults and children including full-term newborns for: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) Contrast enhancement in whole body MRI including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system Use in first-pass MRI studies of cerebral perfusion (see PRECAUTIONS) Contrast enhancement in magnetic resonance angiography (CE MRA) (see CLINICAL TRIALS) Contrast enhancement in cardiac MRI including assessment of rest and pharmacological stress perfusion and delayed enhancement
Visual Identification: Clear, colourless to slightly yellow solution.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2000-01-17
GADOVIST® 1.0 1 GADOVIST® 1.0 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 GADOVIST 1.0? GADOVIST 1.0 contains the active ingredient gadobutrol. GADOVIST 1.0 is a contrast agent used during a magnetic resonance imaging (MRI) examination. For more information, see Section 1. Why am I given GADOVIST 1.0? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN GADOVIST 1.0? Do not use if you have ever had an allergic reaction to GADOVIST 1.0 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 OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I am given GADOVIST 1.0? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GADOVIST 1.0 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 GADOVIST 1.0? GADOVIST 1.0 is injected into your vein by a doctor, radiographer or nurse immediately before or during your MRI examination. It is recommended that you do not eat for 2 hours before you are given GADOVIST 1.0. More instructions can be found in Section 4. How am I given GADOVIST 1.0? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING GADOVIST 1.0? THINGS YOU SHOULD DO Tell your doctor, radiographer or nurse if you have: • 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, Read the complete document
210628 GADOVIST 1.0 PI Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION GADOVIST ® 1.0 (GADOBUTROL) 1. NAME OF THE MEDICINE Gadobutrol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gadovist 1.0 is available as a 1.0 mmol/mL solution for injection and each mL of Gadovist 1.0 contains 604.72 mg (1.0 mmol) gadobutrol. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Gadovist 1.0 solution for injection is a clear, colourless to pale yellow solution and contains no antimicrobial preservative. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Gadovist 1.0 is indicated in adults and children including full-term newborns for: • Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) • Contrast enhancement in whole body MRI including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system • Use in first–pass MRI studies of cerebral perfusion (see section 4.4 Special Warnings and Precautions for Use) • Contrast enhancement in magnetic resonance angiography (CE MRA) (see section 5.1 Clinical Trials) • Contrast enhancement in cardiac MRI including assessment of rest and pharmacological stress perfusion and delayed enhancement. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL INFORMATION This medicinal product is for intravenous administration only. The dose required is administered as a bolus dose. The lowest effective dose should be used. Contrast-enhanced MRI can usually commence 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 1.0 for other indications (depending on the type of lesion and tissue). Gadovist 1.0 should not be drawn into the syringe and the prefilled syringe Read the complete document