País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
gadoteric acid, Quantity: 279.32 mg/mL
Bayer Australia Ltd
Injection, solution
Excipient Ingredients: meglumine; tetraxetan; water for injections
Intravenous
10 x 60 mL
Not Scheduled after consideration by Committee
DOTAGRAF is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see Section 5.1 Pharmacodynamic properties ? Clinical trials).
Visual Identification: Clear, colourless to yellow solution for injection supplied in glass bottle; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-10-19
DOTAGRAF® 1 DOTAGRAF® 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 DOTAGRAF? DOTAGRAF contains the active ingredient gadoteric acid. DOTAGRAF is a contrast agent used during a magnetic resonance imaging (MRI) examination. For more information, see Section 1. Why am I given DOTAGRAF? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN DOTAGRAF? Do not use if you have ever had an allergic reaction to DOTAGRAF 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 DOTAGRAF? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DOTAGRAF and affect how it works. TELL YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU ARE TAKING A BETA-BLOCKER ORE ANOTHER MEDICINE USED TO TREAT HIGH BLOOD PRESSURE OR A HEART CONDITION. 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 DOTAGRAF? DOTAGRAF is injected into your vein by a doctor, radiographer or nurse immediately before or during your MRI examination. More instructions can be found in Section 4. How am I given DOTAGRAF? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING DOTAGRAF? THINGS YOU SHOULD DO Tell your doctor, radiographer or nurse if you: • experience any of the severe symptoms such as 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 Leia o documento completo
221019 DOTAGRAF PI Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION DOTAGRAF ® (GADOTERIC ACID) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Gadoteric acid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DOTAGRAF solution for injection contains gadoteric acid 0.5 mM/mL. Each vial or bottle contains the active ingredient gadoteric acid 279.32 mg/mL (0.5 M). Gadoteric acid is a complex of the paramagnetic ion gadolinium oxide 90.62 mg/mL with tetraxetan (DOTA; 1,4,7,10-tetraazacyclododecane-N,N’,N’’,N’’’-tetraacetic acid) 202.46 mg/mL. DOTAGRAF has the following chemical physical properties: osmolality 1350 mOsmol/kg viscosity at 20°C: 3.2 mPa.s viscosity at 37°C: 2.0 mPa.s pH: 6.5 to 8.0. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DOTAGRAF is a sterile, preservative-free, clear, colourless to yellow solution for injection free of visible particles and packaged in glass vials or bottles for intravenous injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DOTAGRAF is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see Section 5.1 Pharmacodynamic properties – Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The lowest effective dose should be used. The dose should be calculated based on the patient’s body weight and should not exceed the recommended dose per kilogram of body weight detailed in this section. ADULTS (≥ 18 YEARS) The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for adults. 221019 DOTAGRAF PI Page 2 of 12 PAEDIATRICS (0 TO 18 YEARS) The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for children and infants. METHOD OF ADMINISTRATION DOTAGRAF is intended for intravenous administration only. Volumes required for doses of 0.1 mmol/kg are shown below. WEIGHT (KG) VOLUME (ML) REQUIRED FOR A DOSE OF 0. Leia o documento completo