Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
ERLOTINIB AS HYDROCHLORIDE
TARO INTERNATIONAL LTD, ISRAEL
L01XE03
FILM COATED TABLETS
ERLOTINIB AS HYDROCHLORIDE 150 MG
PER OS
Required
SYNTHON CHILE LTDA, CHILE
ERLOTINIB
Non-Small Cell Lung Cancer (NSCLC): Erlotinib Taro is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. Erlotinib Taro is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations and stable disease after first-line chemotherapy. Erlotinib Taro is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.Pancreatic cancer: Erlotinib Taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
2021-12-30
Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ERLOTINIB TARO 25 MG ERLOTINIB TARO 100 MG ERLOTINIB TARO 150 MG FILM-COATED TABLETS NAME AND QUANTITY OF ACTIVE INGREDIENT: Each film-coated tablet contains: erlotinib 25 mg (as erlotinib hydrochloride) erlotinib 100 mg (as erlotinib hydrochloride) erlotinib 150 mg (as erlotinib hydrochloride) Inactive ingredients and allergens: see section 2 under “Important information regarding some of the ingredients of the medicine” and section 6, “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others; it may harm them even if it seems to you that their ailment is similar to yours. Erlotinib Taro is not intended for use in children and adolescents below the age of 18. IMPORTANT INFORMATION FOR YOUR REVIEW • Avoid pregnancy during the course of treatment with Erlotinib Taro, and do not breastfeed during the course of treatment with the medicine. • It is advisable to stop smoking during the course of treatment with Erlotinib Taro. • Take the medicine on an empty stomach - at least one hour before or two hours after the end of a meal. Do not take the medicine with grapefruit or with grapefruit juice. • Erlotinib Taro contains a type of sugar called lactose. 1. WHAT IS THE MEDICINE INTENDED FOR? Erlotinib Taro is intended for treatment of adults and can be prescribed for you in the following situations: • Treatment of patients with advanced non-small cell lung cancer (NSCLC) if previous chemotherapy treatment was unsuccessful in stopping your disease. • First line treatment in patients with advanced non-small cell lung cancer (NSCLC) if the cancer cells express mutations in EGFR. • Maintenance treatm Citiți documentul complet
1 1. NAME OF THE MEDICINAL PRODUCT ERLOTINIB TARO 25 mg, 100 mg, and 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ERLOTINIB TARO 25 mg: One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 17.66 mg Lactose monohydrate. ERLOTINIB TARO 100 mg: One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 70.65 mg Lactose monohydrate. ERLOTINIB TARO 150 mg: One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 105.98 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablets. ERLOTINIB TARO 25 mg: White, round, biconvex tablets with “E9OB” debossed on one side and “25” on the other. The tablets have a diameter of approximately 6 mm. ERLOTINIB TARO 100 mg: White, round, biconvex with a score line on both sides, on one side the tablet is debossed with “E9OB” above the score line and “100” below the score line. The tablets have a diameter of approximately 10 mm. E RLOTINIB TARO 150 mg: White, round, biconvex tablets with “E9OB” debossed in one side and “150” on the other”. The tablets have a diameter of approximately 10.4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) ERLOTINIB TARO is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. ERLOTINIB TARO is indicated for switch maintenance treatment in patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations and stable disease after first-line chemotherapy. ERLOTINIB TARO is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of at least one prior che Citiți documentul complet