Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Gefitinib 250mg
AstraZeneca Limited
Gefitinib 250 mg
250 mg
Coated tablet
Active: Gefitinib 250mg Excipient: Croscarmellose sodium Ethanol Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Macrogol 300 Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium laurilsulfate Titanium dioxide
Blister pack, 30 tablets
Prescription
Prescription
SA Ajinomoto OmniChem NV
Treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the EGFR tyrosine kinase.
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2002-07-26
Iressa CMI 061020 Copyright 1(5) IRESSA ® GEFITINIB 250 MG TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about IRESSA. It does not contain all the information that is known about IRESSA. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking IRESSA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IRESSA IS USED FOR IRESSA belongs to a group of medicines called antineoplastics. These medicines work by stopping cancer cells from growing and multiplying. IRESSA is used to treat non-small cell lung cancer, which is one type of lung cancer. Your doctor will have explained why you are being treated with IRESSA and told you what dose to take. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. This medicine is available only with a doctor's prescription. IRESSA is not addictive. HOW IRESSA WORKS IRESSA is a selective inhibitor of a growth factor that is found in non-small cell lung cancer. By blocking the action of the growth factor IRESSA may slow or stop the growth of non-small cell lung cancer. BEFORE YOU USE IRESSA _WHEN YOU MUST NOT USE IT _ DO NOT USE IRESSA IF: You are allergic to gefitinib or any of the other ingredients of Iressa; DO NOT USE IRESSA IF YOU ARE PREGNANT. It is not known if it is safe for you to take IRESSA while you are pregnant. It may affect your baby if you take it at any time during pregnancy. DO NOT BREASTFEED WHILE TAKING IRESSA . IRESSA passes into breast milk and therefore there is a possibility that the breast-fed baby may be affected. DO NOT GIVE IRESSA TO CHILDREN. There is no experience of its use in children. DO NOT TAKE IRESSA AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK. DO NOT Perskaitykite visą dokumentą
I RESSA Data Sheet 061020 Copyright NEW ZEALAND DATA SHEET 1. PRODUCT NAME I RESSA ® 250 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of gefitinib. Excipient with known effect: Each tablet contains 163.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet (tablets) Round, biconvex, brown, film-coated tablet intagliated with "IRESSA" and "250" on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the EGFR tyrosine kinase. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose of I RESSA is one 250 mg tablet once a day, taken with or without food. If a dose of I RESSA is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. Where dosing of whole tablets is not possible, such as patients who are only able to swallow liquids, tablets may be administered as a dispersion in water. The tablet should be dropped into half a glass of drinking water (non-carbonated), without crushing, and the glass stirred until the tablet has dispersed (approximately 15 minutes) and the contents subsequently drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The liquid can also be administered via a nasogastric tube. DOSAGE ADJUSTMENT No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity, renal function or in patients with moderate to severe hepatic impairment due to liver metastases. Gefitinib exposure is increased in patients with moderate to severe I RESSA Data Sheet 061020 Copyright 2 hepatic impairment due to cirrhosis or hepatitis (see Section 5.2). The Perskaitykite visą dokumentą