Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
dasatinib, Quantity: 100 mg
Sun Pharma ANZ Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; lactose monohydrate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; titanium dioxide; hypromellose; triacetin
Oral Application
30
(S4) Prescription Only Medicine
DASATINIB SUN 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 SUN 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, biconvex, oval, film-coated tablet debossed with "855" on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-07-20
Dasatinib SUN 1 DASATINIB SUN 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 DASATINIB SUN? DASATINIB SUN contains the active ingredient dasatinib. DASATINIB SUN is used to treat adults and children ages 12 months and older with chronic myeloid leukaemia (CML). It is also used to treat adults and children ages 12 months and older who have a particular form of acute lymphoblastic leukaemia (ALL) called Philadelphia chromosome positive or Ph+ ALL. For more information, see Section 1. Why am I using DASATINIB SUN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DASATINIB SUN? Do not use if you have ever had an allergic reaction to DASATINIB SUN 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 DASATINIB SUN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DASATINIB SUN 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 DASATINIB SUN? • The usual starting dose for adults is 100 mg once daily (either as one 100 mg tablet or two 50 mg tablets). • The doctor will prescribe the starting dose for children is determined by body weight. More instructions can be found in Section 4. How do I use DASATINIB SUN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DASATINIB SUN? THINGS YOU SHOULD DO • Tell all of the doctors, dentists and pharmacists who are treating you or your child that you are taking DASATINIB SUN. • Call your doctor straight away if you or your child develops a fever, shortness of breath and fatigue, experience bleeding or easy bruising, no matter how mild, become pregnant while taking DASATINIB SUN. TH Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION DASATINIB SUN (DASATINIB) TABLETS 1 NAME OF THE MEDICINE Dasatinib. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DASATINIB SUN film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Dasatinib is a white to off-white powder. Excipients of known effects: sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DASATINIB SUN film-coated tablets. Dasatinib 20 mg: White to off-white, biconvex, round, film-coated tablet debossed with "851" on one side and plain on other side. Dasatinib 50 mg: White to off-white, biconvex, oval, film-coated tablet debossed with "852" on one side and plain on other side. Dasatinib 70 mg: White to off-white, biconvex, round, film-coated tablet debossed with "853" on one side and plain on other side. Dasatinib 100 mg: White to off-white, biconvex, oval, film-coated tablet debossed with "855" on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS DASATINIB SUN 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 SUN 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, DASATINIB SUN 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. 2 ADULT DOSAGE CML The recommended starting dosage of DAS Preberite celoten dokument