Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ERLOTINIBHYDROCHLORIDE 27,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 25 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
L01XE03
ERLOTINIBHYDROCHLORIDE 27,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 25 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Erlotinib
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated tablet_NL_en_NL-H-4011-001-003_ EPAR 05/2023 + DL 10/2023 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ERLOTINIB ZENTIVA 25 MG FILMOMHULDE TABLETTEN ERLOTINIB ZENTIVA 100 MG FILMOMHULDE TABLETTEN ERLOTINIB ZENTIVA 150 MG FILMOMHULDE TABLETTEN erlotinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Erlotinib Zentiva is and what it is used for 2. What you need to know before you take Erlotinib Zentiva 3. How to take Erlotinib Zentiva 4. Possible side effects 5. How to store Erlotinib Zentiva 6. Contents of the pack and other information 1. WHAT ERLOTINIB ZENTIVA IS AND WHAT IT IS USED FOR Erlotinib Zentiva contains the active substance erlotinib. Erlotinib Zentiva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells. Erlotinib Zentiva is indicated for adults. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It can also be prescribed if previous chemotherapy has not helped to stop your disease. This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage. 2. WHAT YOU NEE Belgenin tamamını okuyun
ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated tablet_NL_en_NL-H-4011-001-003_ EPAR 05/2023 + DL 10/2023 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL ERLOTINIB ZENTIVA 25 MG FILMOMHULDE TABLETTEN ERLOTINIB ZENTIVA 100 MG FILMOMHULDE TABLETTEN ERLOTINIB ZENTIVA 150 MG FILMOMHULDE TABLETTEN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erlotinib Zentiva 25 mg film-coated tablets: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 17.7 mg lactose monohydrate, 0.29 mg sodium. Erlotinib Zentiva 100 mg film-coated tablets: Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 70.7 mg lactose monohydrate, 1.17 mg sodium. Erlotinib Zentiva 150 mg film-coated tablets: Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 106 mg lactose monohydrate, 1.75 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Erlotinib Zentiva 25 mg film-coated tablets: White, round, biconvex tablets with “E9OB” embossed in one side and “25” in the other, with a diameter of approximately 6 mm. Erlotinib Zentiva 100 mg film-coated tablets: White, round, biconvex tablets with a score line on both sides, on one side the tablet is embossed with “E9OB” above the score line and “100” below the score line, with a diameter of approximately 10 mm. The tablet can be divided into equal doses. Erlotinib Zentiva 150 mg film-coated tablets: White, round, biconvex tablets with “E9OB” embossed in one side and “150” in the other, with a diameter of approximately 10.4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-small cell lung cancer (NSCLC) Erlotinib Zentiva is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSC Belgenin tamamını okuyun