Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
ERLOTINIB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L01XX34
FILM COATED TABLETS
ERLOTINIB 150 MG
PER OS
Required
HOFFMANN LA ROCHE, SWITZERLAND
ERLOTINIB
Non-Small Cell Lung Cancer (NSCLC):Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.Tarceva 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.Tarceva 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:Tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
2020-09-30
. HOW SHOULD YOU USE THE MEDICINE? Always use according to the doctor’s instructions. Check with the doctor or pharmacist if you are uncertain. Usual dose The dose and treatment regimen will be determined by the doctor only. For treatment of lung cancer: The usual dose is generally one TARCEVA ® 150 MG tablet a day. For treatment of metastatic pancreatic cancer: The usual dose is generally one TARCEVA ® 100 MG tablet a day. TARCEVA ® will be given in combination with the standard medicinal treatment for this disease (gemcitabine). Your doctor may adjust your dose in 50 mg increments. For the different dose regimens, TARCEVA ® is available in strengths of 100 mg or 150 mg. DO NOT EXCEED THE RECOMMENDED DOSE. If you accidentally took a higher dose Contact your doctor or pharmacist immediately. You may have increased side effects and your doctor may stop your treatment. If you took an overdose, or if a child has accidentally swallowed the medicine, refer immediately to a doctor or proceed to a hospital emergency room, and bring the package of the medicine with you. If you forget to take the medicine If you forgot to take one or more doses of the medicine, contact your doctor or pharmacist as soon as possible. If you forgot to take the medicine at the scheduled time, do not take a double dose. Take the next dose at the usual time and consult the doctor. If you stop taking the medicine It is very important to keep taking TARCEVA ® every day, as long as your doctor prescribes it for you. Adhere to the treatment regimen as recommended by the doctor. Even if there is an improvement in your health, do not discontinue treatment with the medicine without consulting the doctor. How can you contribute to the success of the treatment? DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND THE DOSE EACH TIME YOU TAKE MEDICINE. WEAR GLASSES IF YOU NEED THEM. IF YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS MEDICINE, CONSULT THE DOCTOR OR PHARMACIST. 4. SIDE EFFECTS As with any medicine, use of TARCEVA ® may cause sid Přečtěte si celý dokument
1 TARCEVA_PI_VER 4.0 TARCEVA ® ERLOTINIB 100 mg and 150 mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg & 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tarceva 100 mg: One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 69.21 mg Lactose monohydrate. Tarceva 150 mg: One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each film-coated tablet contains 103.82 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablets. Tarceva 100 mg: White to yellowish, round, biconvex film-coated tablets with ‘T 100’ engraved on one side. Tarceva 150 mg: White to yellowish, round, biconvex film-coated tablets with ‘T 150’ engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. Tarceva 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. Tarceva 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: Tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies. Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed prior to initiation of Tarceva therapy in chemo-naïve patients with advanced or metastatic NSCLC. Tarceva ® Přečtěte si celý dokument