Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
afatinib dimaleate, Quantity: 44.34 mg
Boehringer Ingelheim Pty Ltd
Afatinib dimaleate
Tablet, film coated
Excipient Ingredients: crospovidone; titanium dioxide; polysorbate 80; lactose monohydrate; macrogol 400; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; indigo carmine aluminium lake
Oral
14 film coated tablets, 28 film coated tablets, 7 film coated tablets
(S4) Prescription Only Medicine
GIOTRIF is indicated as monotherapy for the treatment of adult patients with:,? Locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. Tumours must have activating Epidermal Growth Factor Receptor (EGFR) mutations.,? Locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.
Visual Identification: Dark blue, round, biconvex, bevel-edged film coated tablet. One side debossed with T30, other side debossed with BI company symbol.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-11-07
GIOTRIF ® _FILM-COATED TABLETS_ _afatinib (as dimaleate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Giotrif. 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 taking this medicine against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS INFORMATION WITH THE MEDICINE. You may need to read it again. WHAT GIOTRIF IS USED FOR Giotrif contains the active substance afatinib (as afatinib dimaleate). Giotrif belongs to a group of medicines called antineoplastic (or anti-cancer) agents. It works by blocking the activity of a group of proteins from the ErbB family, which includes a protein called Epidermal Growth Factor Receptor (EGFR). These proteins are known to be involved in the growth and spread of cancer cells. By blocking the activity of these proteins Giotrif stops the cancer cells from growing and multiplying. Giotrif is used to treat adult patients with a type of lung cancer called non-small cell lung cancer (NSCLC): • of non-squamous type identified with a change (mutation) in the gene for EGFR. Giotrif can be prescribed to you as your first treatment or if your cancer has progressed after receiving chemotherapy • of squamous type if your cancer has progressed after receiving chemotherapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY GIOTRIF HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Giotrif for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE GIOTR Belgenin tamamını okuyun
GIOTRIF PI0143-08 1 AUSTRALIAN PRODUCT INFORMATION – GIOTRIF ® AFATINIB DIMALEATE FILM COATED TABLET 1 NAME OF THE MEDICINE afatinib (as afatinib dimaleate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate). Excipient with known effect: One film-coated tablet contains 118 mg lactose (as monohydrate). GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate). Excipient with known effect: One film-coated tablet contains 176 mg lactose (as monohydrate). GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate). Excipient with known effect: One film-coated tablet contains 235 mg lactose (as monohydrate). GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate). Excipient with known effect: One film-coated tablet contains 294 mg lactose (as monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM GIOTRIF 20 mg tablets are film-coated white to slightly yellowish, round, biconvex and bevel- edged. One side is debossed with the code “T20”, the other side is debossed with the Boehringer Ingelheim company symbol. GIOTRIF 30 mg tablets are film-coated dark blue, round, biconvex and bevel-edged. One side is debossed with the code “T30”, the other side is debossed with the Boehringer Ingelheim company symbol. GIOTRIF 40 mg tablets are film-coated light blue, round, biconvex and bevel-edged. One side is debossed with the code “T40”, the other side is debossed with the Boehringer Ingelheim company symbol. GIOTRIF 50 mg tablets are film-coated dark blue, oval and biconvex. One side is debossed with the code “T50”, the other side is debossed with the Boehringer Ingelheim company symbol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GIOTRIF is indicated as monotherapy for the treatment of patients with: • Locally advanced or metastatic non-squamous non-small Belgenin tamamını okuyun