Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
erlotinib hydrochloride, Quantity: 163.9 mg (Equivalent: erlotinib, Qty 150 mg)
Accelagen Pty Ltd
Tablet, film coated
Excipient Ingredients: titanium dioxide; sodium starch glycollate; lactose monohydrate; magnesium stearate; hyprolose; propylene glycol; microcrystalline cellulose; hypromellose; sodium lauryl sulfate
Oral
30
(S4) Prescription Only Medicine
Non-Small cell lung cancer,ERLOTINIB ARX 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.,ERLOTINIB ARX 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.,ERLOTINIB ARX 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,ERLOTINIB ARX in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Visual Identification: White coloured, round shaped, biconvex film-coated tablets debossed with E 150 on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-08-13
Erlotinib APOTEX CMI Ver 0.2 1 ERLOTINIB APOTEX _FILM-COATED TABLETS _ _contains the active ingredient erlotinib hydrochloride _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Erlotinib APOTEX 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 Erlotinib APOTEX 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 ERLOTINIB APOTEX IS USED FOR Erlotinib APOTEX contains the active ingredient erlotinib hydrochloride. Erlotinib APOTEX 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. Erlotinib APOTEX is also used in combination with gemcitabine for the treatment of pancreatic cancer. Erlotinib APOTEX belongs to a group of medicines called anti- neoplastic (or anti-cancer) agents which are used to treat cancer. Erlotinib APOTEX 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 Erlotinib APOTEX for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ERLOTINIB APOTEX HAS BEEN PRESCRIBED FOR YOU. Erlotinib APOTEX is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE ERLOTINIB APOTEX _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ERLOTINIB APOTEX 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 bre Διαβάστε το πλήρες έγγραφο
ERLOTINIB PI Ver 0.3 1 AUSTRALIAN PRODUCT INFORMATION – ERLOTINIB APOTEX (ERLOTINIB HYDROCHLORIDE) 1. NAME OF THE MEDICINE Erlotinib hydrochloride 2. QUALITIATIVE AND QUANTITATIVE COMPOSITION Erlotinib APOTEX 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 17.47 mg Lactose monohydrate. Each 100 mg film-coated tablet contains 69.86 mg Lactose monohydrate. Each 150 mg film-coated tablet contains 104.80 mg Lactose monohydrate. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Erlotinib APOTEX 25 mg film-coated tablets are white-coloured, round shaped, biconvex film-coated tablets, debossed with ‘E 25’ on one side and plain on the other side. Erlotinib APOTEX 100 mg film-coated tablets are white coloured, round shaped, biconvex film- coated tablets debossed with ‘E 100’ on one side and plain on the other side. Erlotinib APOTEX 150 mg film-coated tablets are white coloured, round shaped, biconvex film- coated tablets engraved with ‘E 150’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER Erlotinib APOTEX 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. Erlotinib APOTEX 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. Erlotinib APOTEX 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 Erlotinib APOTEX in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. 4.2 DO Διαβάστε το πλήρες έγγραφο