Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
ibrutinib, Quantity: 420 mg
Janssen-Cilag Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
30
(S4) Prescription Only Medicine
IMBRUVICA is indicated for the treatment of patients with MCL who have received at least one prior therapy.,IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenstr?m?s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with Waldenstrom?s macroglobulinaemia (WM).,IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).,IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior therapy.
Visual Identification: Yellow-green to green oblong film-coated tablet debossed with "ibr" on one side and "420" on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2020-08-04
IMBRUVICA® (220601) CMI 1 IMBRUVICA ® CAPSULES AND TABLETS _ibrutinib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about IMBRUVICA capsules and tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given IMBRUVICA against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN IMBRUVICA ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL. KEEP THIS LEAFLET WHILE YOU ARE TAKING IMBRUVICA. You may need to read it again. WHAT IMBRUVICA IS USED FOR IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. IMBRUVICA is used to treat the following blood cancers in adults: • Mantle Cell Lymphoma (MCL), a type of cancer affecting the lymph nodes; • Chronic Lymphocytic Leukaemia (CLL), including Small Lymphocytic Lymphoma (SLL), a type of cancer affecting a type of white blood cell called lymphocytes that also involve the lymph nodes. • Waldenström's macroglobulinemia (WM), a very rare cancer affecting the lymphocytes IMBRUVICA works by blocking a protein in the body that helps cancer cells live and grow. This protein is called Bruton's tyrosine kinase. By blocking this protein, IMBRUVICA may help kill and reduce the number of cancer cells and may also slow the spread of the cancer. ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS ABOUT WHY IMBRUVICA HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE IMBRUVICA _WHEN YOU MUST NOT USE IT: _ DO NOT TAKE IMBRUVICA: • if you are allergic (hypersensitive) to ibrutinib, or other ingredients of IMBRUVICA. See Product Description at the end of this leaflet for a list of ingredients. DO NOT TAKE IMBRUVICA: • if the packaging is torn or shows signs of tampering. • if the expiry date (month and year) printed on the pack has pas Lestu allt skjalið
32.211106 1 IMBRUVICA (220531) API A USTRALIAN P RODUCT I NFORMATION IMBRUVICA ® IBRUTINIB CAPSULES AND TABLETS 1. NAME OF THE MEDICINE Ibrutinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CAPSULES _140 MG CAPSULES _ IMBRUVICA capsules contain 140 mg ibrutinib as the active ingredient. FILM- COATED TABLETS IMBRUVICA tablets contain 140 mg, 280 mg, 420 mg or 560 mg of ibrutinib. Excipients with known effect: sugars as lactose The characterization data demonstrate that ibrutinib at pH 1.2 is considered slightly soluble and at pH 3 to 8 ibrutinib is considered practically insoluble as defined by USP and European Pharmacopoeia nomenclature. Ibrutinib is non-hygroscopic and the melting onset temperature is 149-158 ˚C. The drug substance has one ionizable group, the protonated pyrimidine moiety, with a pKa of 3.74 in an aqueous solution with methanol as a co-solvent. For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM CAPSULES _140 MG CAPSULES_ White opaque, size 0, hard gelatin capsule is marked with “ibr 140 mg” in black ink. FILM-COATED TABLETS _140 MG TABLETS _ Yellow-green to green round film-coated tablet debossed with “ibr” on one side and “140” on the other. _280 MG TABLETS _ Purple oblong film-coated tablet debossed with “ibr” on one side and “280” on the other. _420 MG TABLETS _ Yellow-green to green oblong film-coated tablet debossed with “ibr” on one side and “420” on the other. _560 MG TABLETS _ Yellow to orange oblong film-coated tablet debossed with “ibr” on one side and “560” on the other. Product Information - Australia 32.211106 2 IMBRUVICA (220531) API 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IMBRUVICA is indicated for the treatment of patients with MCL who have received at least one prior therapy. IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable Lestu allt skjalið