Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
dasatinib propylene glycol, Quantity: 58 mg (Equivalent: dasatinib, Qty 50 mg)
Dr Reddys Laboratories Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; hydrogenated castor oil; magnesium stearate; hypromellose; titanium dioxide; lactose; triacetin; silicon dioxide
Oral
60
(S4) Prescription Only Medicine
DASATINIB DR.REDDY'S 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 DR.REDDY'S 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 shaped tablets debossed with '600' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-06-17
DASATINIB DR.REDDY’S CMI 1 DASATINIB DR.REDDY’S The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. Dasatinib Dr.Reddy’s contains the active ingredient dasatinib. Dasatinib Dr.Reddy’s is used for the treatment of chronic myeloid leukaemia (CML). It is also used to treat 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 Dr.Reddy’s? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DASATINIB DR.REDDY’S? Do not use if you have ever had an allergic reaction to 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 Dasatinib Dr.Reddy’s? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Dasatinib Dr.Reddy’s 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 DR.REDDY’S? • Your doctor will decide the dose that is most appropriate for you. Please follow your doctor's instructions about how and when to take Dasatinib Dr.Reddy’s. More instructions can be found in Section 4. How do I use Dasatinib Dr.Reddy’s? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DASATINIB DR.REDDY’S? THINGS YOU SHOULD DO • Tell all doctors, dentists and pharmacists who are treating you that you are taking Dasatinib Dr.Reddy’s. • Tell your doctor if you become pregnant while taking Dasatinib Dr.Reddy’s. • Tell your doctor immediately if you or your child experience bleeding or easy bruising, no matter how mild. • Have any tests recommended by your doctor done as soon as possible. THINGS YOU SHOULD NOT DO • Do not give Dasatinib Dr.Reddy’s to a Citiți documentul complet
AUSTRALIAN PRODUCT INFORMATION – DASATINIB DR.REDDY’S (DASATINIB) 1 NAME OF THE MEDICINE Dasatinib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DASATINIB DR.REDDY’S film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib. Dasatinib is a white to off-white powder. DASATINIB DR.REDDY’S film-coated tablets contain lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DASATINIB DR.REDDY’S film-coated tablets. The 20 mg tablets are white to off-white, round tablets with “599” debossed on one side and plain on the other side. The 50 mg tablets are white to off-white, oval shaped and debossed with “600” on one side and plain on the other side. The 70 mg tablets are white to off-white, round tablets with “601” debossed on one side and plain on the other side. The 100 mg tablets are white to off-white oval shaped and debossed “603” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS DASATINIB DR.REDDY’S 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 DR.REDDY’S 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 DR.REDDY’S 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. ADULT DOSAGE _CML_ The recommende Citiți documentul complet