Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ERLOTINIBHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ERLOTINIB
Teva Nederland B.V.
L01XE03
ERLOTINIBHYDROCHLORIDE COMPOSITION corresponding to ; ERLOTINIB
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Erlotinib
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); PLANTAARDIGE OLIE, GEHYDREERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2017-04-06
1 PACKAGE LEAFLET 2 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER ERLOTINIB TEVA 25 MG, FILMOMHULDE TABLETTEN ERLOTINIB TEVA 100 MG, FILMOMHULDE TABLETTEN ERLOTINIG TEVA 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 any 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. Whatis and what it is used for 2. What you need to know before you take Prečítajte si celý dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains the active substance erlotinib. 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. 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 NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE : if you are allergic to erlotinib or any of the other ingre
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAAM VAN HET GENEESMIDDEL Erlotinib Teva 25 mg, filmomhulde tabletten Erlotinib Teva 100 mg, filmomhulde tabletten Erlotinib Teva 150 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride) One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride) One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride) Excipients with known effect: 25 mg: Each film-coated tablet contains 14.745 mg lactose monohydrate. 100 mg: Each film-coated tablet contains 58.98 mg lactose monohydrate. 150 mg: Each film-coated tablet contains 88.47 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets25 mg: White, round, biconvex tablets, with debossing 25 on one side and E on the other side with dimensions of about 6.1 x 3.3 mm. Prečítajte si celý dokument100 mg: White, round, biconvex tablets, with debossing 100E on one side with dimensions of about 10.1 x 4.1 mm. 150 mg: White, round, biconvex tablets, with debossing 150E on one side with dimensions of about 11.1 x 5.4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC): is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy. is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing , factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in pa