Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Afatinib dimaleate 44.34mg equivalent to Afatinib 30 mg
Boehringer Ingelheim (NZ) Limited
Afatinib dimaleate 44.34 mg (= Afatinib 30 mg)
30 mg
Film coated tablet
Active: Afatinib dimaleate 44.34mg equivalent to Afatinib 30 mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Indigo carmine aluminium lake Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Purified talc Titanium dioxide
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
GIOTRIF is indicated as monotherapy for the treatment of 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 Epidermal Growth Factor Receptor (EGFR) mutations. Locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.
Package - Contents - Shelf Life: Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 14 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
2014-01-06
GIOTRIF NZ CMI v02 1 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.medsafe.govt.nz/ Consumers/cmi/CMIForm.asp 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 wi Đọc toàn bộ tài liệu
1 GIOTRIF NZ DS v06 NEW ZEALAND DATASHEET 1. PRODUCT NAME GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets 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 123.86 mg of lactose 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 185.79 mg of lactose 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 247.72 mg of lactose 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 309.65 mg of lactose monohydrate For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet GIOTRIF 20 mg film-coated tablets White to slightly yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 30 mg film-coated tablets Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 40 mg film-coated tablets Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 50 mg film-coated tablets Dark blue, oval and biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. Afatinib dimaleate is a white to brownish yellow powder. It is highly soluble in water and in aqueous buffer media up to pH 6 (> 50 mg/mL). Between pH 6 and 7, the solub Đọc toàn bộ tài liệu