Страна: Израиль
Язык: английский
Источник: Ministry of Health
ERLOTINIB AS HYDROCHLORIDE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
L01XE03
FILM COATED TABLETS
ERLOTINIB AS HYDROCHLORIDE 150 MG
PER OS
Required
REMEDICA LTD., CYPRUS
ERLOTINIB
Non-Small Cell Lung Cancer (NSCLC): Erlotinib S.K. 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 S.K. 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 S.K. 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 S.K. is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
2022-06-26
Patient leaflet in accordance with the Pharmacists’ Regulations (Medicinal Products) - 1986 The medicine is dispensed with a doctor’s prescription only Erlotinib S.K. 25 mg film-coated tablets Erlotinib (erlotinib as hydrochloride) 25 mg Erlotinib S.K.100 mg film-coated tablets Erlotinib (erlotinib as hydrochloride) 100 mg Erlotinib S.K.150 mg film-coated tablets Erlotinib (erlotinib as hydrochloride) 150 mg For excipients and allergens, please see Section 2, subsection “Important information about some of the ingredients of this medicine”, and Section 6 – Further Information. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it appears to you that they have a similar illness. 1. What Erlotinib S.K. is and what it is used for Erlotinib S.K. contains the active substance erlotinib. Erlotinib S.K. 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 S.K. 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. Therapeutic group: antineoplastic agent protein kinase inhibitor 2. What you need to know before you take Erlotinib S.K. Do not take Erlotinib S.K. : if you are allergic to erlotinib or any of the ingredien Прочитать полный документ
https://www.medicines.org.uk/emc/product/8846/smpc/print 1/18 ERLOTINIB S.K. 25 MG film-coated tablets ERLOTINIB S.K. 100 MG film-coated tablets ERLOTINIB S.K. 150 MG film-coated tablets Summary of Product Characteristics Updated 24-Nov-2022 | Roche Products Limited 1. Name of the medicinal product ERLOTINIB S.K. 25 MG film-coated tablets ERLOTINIB S.K. 100 MG film-coated tablets ERLOTINIB S.K. 150 MG film- coated tablets 2. Qualitative and quantitative composition ERLOTINIB S.K. 25 mg film-coated tablets Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). ERLOTINIB S.K 100 mg film-coated tablets Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). ERLOTINIB S.K 150 mg film-coated tablets Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect _Tarceva 25 mg_ _film coated tablets _ Each 25 mg film-coated tablet contains 23.98 mg Lactose monohydrate. _Tarceva 100 mg_ _film-coated tablets _ Each 100 mg film-coated tablet contains 95.93 mg Lactose monohydrate. _Tarceva 150 mg_ _film-coated tablets _ Each 150 mg film-coated tablet contains 143.90 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. ERLOTINIB S.K 25 mg film coated tablets White to yellowish, round, biconvex tablets with '25' engraved on one side. ERLOTINIB S.K 100 mg film-coated tablets White to yellowish, round, biconvex tablets with '100' engraved on one side. ERLOTINIB S.K 150 mg film-coated tablets White to yellowish, round, biconvex tablets with ' 150' engraved on one side. 4. Clinical particulars 4.1 Therapeutic indications Non-Small Cell Lung Cancer (NSCLC) ERLOTINIB S.K 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 S.K is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and Прочитать полный документ