Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
erlotinib hydrochloride, Quantity: 109.29 mg
Roche Products Pty Ltd
Erlotinib hydrochloride
Tablet, film coated
Excipient Ingredients: sodium lauryl sulfate; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; hyprolose; macrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
Non-small cell lung cancer: TARCEVA is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. TARCEVA is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy. TARCEVA is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Pancreatic cancer: TARCEVA in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Visual Identification: Round, biconvex, white to yellowish film-coated tablet with "T 100" engraved on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2006-01-30
TARCEVA ® _FILM-COATED TABLETS_ pronounced "tar-see-va" _contains the active ingredient erlotinib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tarceva 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 taking Tarceva tablets 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 TARCEVA IS USED FOR Tarceva contains the active ingredient erlotinib. Tarceva is used for the treatment of non-small cell lung cancer (NSCLC). It can be given before or after initial chemotherapy if your cancer has specific mutations in a protein called epidermal growth factor receptor (EGFR). It can also be given later on when initial chemotherapy has not worked. Tarceva is also used in combination with gemcitabine for the treatment of pancreatic cancer. Tarceva belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used to treat cancer. Tarceva prevents the activity of the EGFR protein. This protein is known to be involved in the growth and spread of cancer cells. Your doctor may have prescribed Tarceva for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TARCEVA HAS BEEN PRESCRIBED FOR YOU. Tarceva is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE TARCEVA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE TARCEVA IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO ERLOTINIB OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin 2. THE PACKAGE IS TORN OR SHOWS SIGNS OF TAMPERING Lees het volledige document
Tarceva 190131 1 AUSTRALIAN PRODUCT INFORMATION TARCEVA ® (ERLOTINIB HYDROCHLORIDE) 1. NAME OF THE MEDICINE Erlotinib hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tarceva film coated tablets are available in 3 dosage strengths containing erlotinib hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib. Excipients with known effect Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate. Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate. Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Tarceva 25 mg film-coated tablets are white to yellowish, round, biconvex tablets engraved with ‘T 25’ on one side. Tarceva 100 mg film-coated tablets are white to yellowish, round, biconvex tablets engraved with ‘T 100’ on one side. Tarceva 150 mg film-coated tablets are white to yellowish, round, biconvex tablets engraved with ‘T 150’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER Tarceva is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. Tarceva is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy. PANCREATIC CANCER Tarceva in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. 4.2 DOSE AND METHOD OF ADMINISTRATION NON-SMALL CELL LUNG CANCER The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food. Treatment should be continued until disea Lees het volledige document