Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg;
AstraZeneca Limited
Osimertinib mesilate 95.4 mg (equivalent to osimertinib 80 mg)
80 mg
Film coated tablet
Active: Osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg Excipient: Hyprolose Iron oxide black Iron oxide red Iron oxide yellow Macrogol 3350 Mannitol Microcrystalline cellulose Polyvinyl alcohol Purified talc Sodium stearyl fumarate Titanium dioxide
Prescription
Lonza AG
Tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. - the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. Tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR mutations
Package - Contents - Shelf Life: Blister pack, PVC/Al/PA laminate/Al foil blister - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2016-10-10
Tagrisso ® CMI 071223 Copyright 1(6) TAGRISSO ® OSIMERTINIB MESILATE 40 AND 80 MG TABLETS. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about TAGRISSO. It does not contain all the information that is known about TAGRISSO. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking TAGRISSO against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT TAGRISSO IS USED FOR This medicine is used to treat adults with a type of cancer called 'non-small cell lung cancer' when the tumour has a defect (mutation) in a gene called EGFR (epidermal growth factor receptor). It is used to help prevent your cancer from coming back after the tumour(s) have been removed by surgery or when your cancer is advanced and is worsening. TAGRISSO can be prescribed for you if you test positive for EGFR mutation. This medicine belongs to a class of medicines called Tyrosine Kinase Inhibitors (TKIs). It works by stopping cancer cells with the EGFR mutation from growing and multiplying. It may also help prevent the tumour from coming back after removal by surgery. Ask your doctor if you have any questions about why this medicine has been prescribed for you. TAGRISSO is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery, however, if symptoms occur that affect your ability to concentrate, do not drive or operate machinery until the effect subsides. BEFORE YOU USE TAGRISSO _WHEN YOU MUST NOT TAKE IT _ Do not take TAGRISSO if you have an allergy to: • any of the ingredients listed at the end of this leaflet • any other similar medicines, for example other Tyrosine Kinase Inhibitors. Some of the symptoms of an allergic reaction may include: • Lesen Sie das vollständige Dokument
T AGRISSO ® Data Sheet 071223 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME T AGRISSO ® 40 mg Film Coated Tablets T AGRISSO ® 80 mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION T AGRISSO 40 mg Tablets: Each tablet contains 40 mg osimertinib (as mesilate) T AGRISSO 80 mg Tablets: Each tablet contains 80 mg osimertinib (as mesilate) For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. T AGRISSO 40 mg Tablets: round, biconvex, beige, film-coated tablets with a diameter of approximately 9 mm. The tablets are debossed with ‘AZ’ over ‘40’ on 1 side and plain on the reverse. T AGRISSO 80 mg Tablets: oval, biconvex, beige, film-coated tablets measuring approximately 7.25 × 14.5 mm. The tablets are debossed with ‘AZ 80’ on 1 side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS T AGRISSO (osimertinib) is indicated for: • The adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. (see section 5.1 Pharmacodynamic Properties – Clinical Efficacy and Safety). • the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumours have EGFR mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with T AGRISSO should be initiated by a physician experienced in the use of anticancer therapies. T AGRISSO ® Data Sheet 071223 Copyright 2 When considering the use of T AGRISSO , EGFR mutation status in tumour or plasma specimens should be determined using a validated test method (see section 4.4 Special Warnings and Precautions for Use). DOSAGE IN ADULTS The recommended dose of T AGRISSO is 80 mg tablet once a day. T AGRISSO can be taken without regard to food at the same time each day. DURATION OF TREATMENT Patients in the adjuvant setting should receive treatment until Lesen Sie das vollständige Dokument