Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ERLOTINIBHYDROCHLORIDE 109,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 100 mg/stuk
Vipharm S.A. ul. A. i F. Radziwillow 9 05-850 OZARÓW MAZOWIECKI (POLEN)
L01XE03
ERLOTINIBHYDROCHLORIDE 109,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 100 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 Vipharm 25/100/150 mg (as hydrochloride) Film-coated tablets M1.3.1_PIL NL/H/4481/001-003/IB/004 v.nl Page 1 of 8 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER Erlotinib Vipharm 25 mg filmomhulde tabletten Erlotinib Vipharm 100 mg filmomhulde tabletten Erlotinib Vipharm 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1 WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance erlotinib. [Product name] 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. [Product name] 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. Erl Belgenin tamamını okuyun
Erlotinib Vipharm 25/100/150 mg (as hydrochloride) Film-coated tablets SmPC NL/H/4481/001-003/IB/004 v.nl plus renewal: update sections 9 and 10 Page 1 of 22 1.3.1 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Erlotinib Vipharm 25 mg filmomhulde tabletten Erlotinib Vipharm 100 mg filmomhulde tabletten Erlotinib Vipharm 150 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 25 mg film-coated tablets: One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). Excipient(s) with known effect Each film-coated tablet contains 17.7 mg lactose monohydrate. Each film-coated tablet contains less than 1 mmol sodium (23 mg). [Product name] 100 mg film-coated tablets: One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Excipient(s) with known effect Each film-coated tablet contains 70.7 mg lactose monohydrate. Each film-coated tablet contains less than 1 mmol sodium (23 mg). [Product name] 150 mg film-coated tablets: One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipient(s) with known effect Each film-coated tablet contains 106 mg lactose monohydrate. Each film-coated tablet contains less than 1 mmol sodium (23 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. [Product name] 25 mg film-coated tablets: White, round, biconvex tablets with “E9OB” debossed on one side and “25” on the other, with a diameter of approximately 6 mm. [ Product name] 100 mg film-coated tablets: White, round, biconvex tablets 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, with a diameter of approximately 10 mm. The tablet can be divided into equal doses. Product name] 150 mg film-coated tablets: White, round, biconvex tablets with “E9OB” debossed on one side and “150” on the other, with a diameter of approximately 10.4 mm. Erlotinib Vipharm 25/100/150 mg (as hydroch Belgenin tamamını okuyun