Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
ertugliflozin pyroglutamic acid, Quantity: 19.43 mg (Equivalent: ertugliflozin, Qty 15 mg)
Merck Sharp & Dohme (Australia) Pty Ltd
Tablet, film coated
Excipient Ingredients: sodium starch glycollate type A; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350
Oral
7, 28
(S4) Prescription Only Medicine
STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE for available data on different add-on combination therapies].
Visual Identification: Red, triangular-shaped, film-coated tablets debossed with '702' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2018-05-17
STEGLATRO ® S T E G L A T R O ® CONSUMER MEDICINE INFORMATION (CMI) The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being taken differently. Please report side effects. See the full CMI for further details. 1. WHY AM I TAKING STEGLATRO? STEGLATRO contains the active ingredient ertugliflozin. STEGLATRO can be used to lower your blood sugar (glucose) alone or in combination with certain other medicines, along with a recommended diet and exercise program. For more information, see Section 1. Why am I taking STEGLATRO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE STEGLATRO? Do not use if you have ever had an allergic reaction to ertugliflozin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR 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 take STEGLATRO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with STEGLATRO 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 DO I TAKE STEGLATRO? • Take one tablet once a day. More instructions can be found in Section 4. How do I take STEGLATRO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING STEGLATRO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking STEGLATRO. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly unless your doctor tells you. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how STEGLATRO affects you. LOOKING AFTER YOUR MEDICINE • Keep STEGLATRO in its original packaging in a cool dry place where the temperature stays below 30°C. For more information, see Section 5. What should I know while taking STEGLATRO? in the full CMI. 6. ARE Διαβάστε το πλήρες έγγραφο
Page 1 of 35 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION - STEGLATRO ® (ERTUGLIFLOZIN) 1 NAME OF THE MEDICINE Ertugliflozin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ertugliflozin tablets contain ertugliflozin pyroglutamic acid, the isolated form of the active ingredient ertugliflozin. Ertugliflozin tablets contain 6.48 or 19.43 mg of ertugliflozin pyroglutamic acid, which is equivalent to 5 and 15 mg of the active ingredient ertugliflozin. Excipients with known effect: Lactose monohydrate. For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM STEGLATRO 5 mg are pink, triangular-shaped, film-coated tablets debossed with “701” on one side and plain on the other side. STEGLATRO 15 mg are red, triangular-shaped, film-coated tablets debossed with “702” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: • monotherapy when metformin is considered inappropriate due to intolerance; or • in combination with other anti-hyperglycaemic agents [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE for available data on different add-on combination therapies]. Page 2 of 35 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL The recommended starting dose of STEGLATRO is 5 mg once daily, taken in the morning, with or without food. In patients tolerating STEGLATRO 5 mg once daily the dose may be increased to 15 mg once daily if additional glycaemic control is needed. RENAL IMPAIRMENT Assessment of renal function is recommended prior to initiation of STEGLATRO and periodically thereafter [see 4.4 SPECIAL WARNINGS A Διαβάστε το πλήρες έγγραφο