Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
dasatinib, Quantity: 100 mg
Teva Pharma Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin
Oral
30
(S4) Prescription Only Medicine
Dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,Dasatinib is indicated for the treatment of paediatric patients with: ? Ph+ CML in the chronic phase. ? newly diagnosed Ph+ ALL in combination with chemotherapy.
Visual Identification: White to off-white, oval film-coated tablets with bevelled edges and debossed 100 on one side of the tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-03-18
TE-DASATINIB ® T E - D A S A T I N I B ® V e r s i o n 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. 1. WHY AM I USING TE-DASATINIB? TE-DASATINIB contains the active ingredient dasatinib. TE-DASATINIB is used to treat adults and children ages 12 months and older with chronic myeloid leukaemia (CML). For more information, see Section 1. Why am I using TE-DASATINIB? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TE-DASATINIB? Do not use if you have ever had an allergic reaction to TE-DASATINIB 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 use TE-DASATINIB? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TE-DASATINIB 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 TE-DASATINIB? • Follow all directions given to you by your doctor or pharmacist carefully. • The usual starting dose is 100 mg once daily (either as one 100 mg tablet or two 50 mg tablets). The entire dose of 100 mg is to be taken at one time either in the morning or the evening. • The starting dose for children is determined by body weight. The entire dose prescribed by your doctor should be taken at one time either in the morning or the evening. More instructions can be found in Section 4. How do I use TE-DASATINIB? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TE-DASATINIB? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are using TE-DASATINIB. • If you become pregnant while you are being treated with this medicine, tell your doctor immediately. • Keep all your doctor's appointments so that your progress can Izlasiet visu dokumentu
TE-DASATINIB V2.0 1 AUSTRALIAN PRODUCT INFORMATION – TE-DASATINIB (DASATINIB) 1 NAME OF THE MEDICINE Dasatinib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TE-DASATINIB film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Dasatinib is a white to off-white powder. TE-DASATINIB film-coated tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TE-DASATINIB film-coated tablets. The 20 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed “20” on one side of the tablet. The 50 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed ˝50˝ on one side of the tablet. The 70 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed ˝70˝ on one side of the tablet. The 100 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed ˝100˝ on one side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TE-DASATINIB is indicated for the treatment of adults aged 18 years or over with: • newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. • chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. • newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. • Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. TE-DASATINIB is indicated for the treatment of paediatric patients with: • Ph+ CML in the chronic phase. • newly diagnosed Ph+ ALL in combination with chemotherapy. 4.2 D OSE AND METHOD OF ADMINISTRATION To achieve the recommended dose, TE-DASATINIB is available as 20 mg, 50 mg, 70 mg and 100 mg film-coated tablets. Dose increase or reduction is recommended based on patient response and tolerability. TE-DASATINIB V Izlasiet visu dokumentu