Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
avatrombopag maleate, Quantity: 23.6 mg
Swedish Orphan Biovitrum Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
10, 30, 15
(S4) Prescription Only Medicine
DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.,DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Visual Identification: Pale yellow, round biconvex, film-coated tablet, debossed with 'AVA' on one side and '20' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2023-01-16
DOPTELET 1 DOPTELET 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. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING DOPTELET? DOPTELET contains the active ingredient avatrombopag maleate. DOPTELET is used to treat low platelet count (called thrombocytopenia) in adults with chronic liver disease before having an invasive medical procedure where there is a risk of bleeding and adults with low platelet counts due to primary chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. For more information, see Section 1. Why am I using DOPTELET? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DOPTELET? Do not use if you have ever had an allergic reaction to avatrombopag or to 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 use DOPTELET? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DOPTELET 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 USE DOPTELET? • Take DOPTELET exactly as your doctor has told you. Your dose will depend on your platelet counts. • If you have chronic liver disease and are scheduled for an invasive medical procedure, the usual dose is either 40 mg (2 tablets) or 60 mg (3 tablets) every day for 5 days in a row. • If you have chronic immune thrombocytopenia, the usual starting dose is 20 mg (1 tablet) a day. • DOPTELET tablets should be swallowed whole and taken with food. More instructions can be found in Section 4. How do I use DOPTELET? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DOPTELET? Διαβάστε το πλήρες έγγραφο
Product Information - Australia CCDSv3 Page 1 of 14 a 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 – DOPTELET (AVATROMBOPAG) FILM COATED TABLETS 1. NAME OF THE MEDICINE avatrombopag maleate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each DOPTELET tablet contains 23.6 mg avatrombopag maleate (equivalent to 20 mg of avatrombopag). Excipients with known effect: sugars as lactose. For the full list of excipients, see _section 6.1 List of excipients_. 3. PHARMACEUTICAL FORM Film coated tablet. Pale yellow, round biconvex, film-coated tablet, debossed with “AVA” on one side and “20” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE FOR PATIENTS WITH CHRONIC LIVER DISEASE Obtain a platelet count prior to administration of DOPTELET therapy and on the day of a procedure to ensure an adequate increase in platelet count. DOPTELET should only be used for procedures for which an adequate platelet count is required to reduce the risk of bleeding. Begin DOPTELET dosing 10 to 13 days prior to the scheduled procedure. The recommended daily dose of DOPTELET is based on the patient’s platelet count prior to the scheduled procedure (see Table 1). Patients should undergo their procedure 5 to 8 days after the last dose of DOPTELET. DOPTELET should be taken orally once daily for 5 consecutive days with food. In the case of a missed dose, patients should take the next dose of DOPTEL Διαβάστε το πλήρες έγγραφο