देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
TOPOTECAN AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L01XX17
HARD GELATIN CAPSULES
TOPOTECAN AS HYDROCHLORIDE 1 MG
PER OS
Required
GLAXO SMITH KLINE MANUFACTURING S.P.A., ITALY
TOPOTECAN
TOPOTECAN
Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
2014-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only HYCAMTIN ® 0.25 MG HYCAMTIN ® 1 MG Hard gelatin capsules THE ACTIVE INGREDIENT AND ITS QUANTITY: Each Hycamtin 0.25 mg capsule contains 0.25 mg Topotecan (as Hydrochloride). Each Hycamtin 1 mg capsule contains 1 mg Topotecan (as Hydrochloride). List of the additional ingredients detailed in section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? HYCAMTIN IS USED TO TREAT: patients with relapsed small cell lung cancer (SCLC) for whom retreatment with the first-line regimen is not considered appropriate. Your physician will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy. THERAPEUTIC GROUP Antineoplastic agent 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: ∙ IF YOU ARE SENSITIVE (ALLERGIC) to topotecan or to any of the additional ingredients contained in the medicine (listed in Section 6). ∙ Do not use the medicine if you are BREAST- FEEDING. ∙ IF YOUR BLOOD CELL COUNTS ARE TOO LOW. Your physician will tell you whether this is the case, based on the results of your last blood test. TELL YOUR PHYSICIAN if any of these applies to you. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE THE TREATMENT WITH HYCAMTIN, TELL THE PHYSICIAN IF: ∙ YOU HAVE ANY KIDNEY OR LIVER PROBLEMS. Your dose of Hycamtin may need to be adjusted. ∙ YOU ARE PREGNANT OR ARE PLANNING TO BECOME PREGNANT (see "Pregnancy and breast-feeding" section). ∙ YOU PLAN TO FATHER A CHILD (see "Pregnancy and breast-feeding" section). TELL YOUR PHYSICIAN if any of these applie पूरा दस्तावेज़ पढ़ें
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