देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
granisetron
Kyowa Kirin Holdings B.V.
A04AA02
granisetron
Antiemetics and antinauseants, , Serotonin (5HT3) antagonists
Vomiting; Cancer
Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.
Revision: 14
Authorised
2012-04-20
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SANCUSO 3.1 MG/24 HOURS TRANSDERMAL PATCH granisetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. - 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SANCUSO is and what it is used for 2. What you need to know before you use SANCUSO 3. How to use SANCUSO 4. Possible side effects 5. How to store SANCUSO 6. Contents of the pack and other information 1. WHAT SANCUSO IS AND WHAT IT IS USED FOR The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants. SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the mouth or throat). You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SANCUSO DO NOT USE SANCUSO: - if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other anti-sickness medicines whose name ends in “setron” e.g. ondansetron. WARNINGS AND PRECAUTIONS Tell your doctor or nurse before using this treatment if any of the following applies to you: - if you have been told you have a heart disorder or disease - if you have pain in your stomach or your stomach is swollen - if you have problems with your kidney पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT SANCUSO 3.1 mg/24 hours transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 52 cm 2 transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 24 hours. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch. Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate. Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy. The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy. The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron. _Use of concomitant corticosteroids_ The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT 3 antagonist prior to chemotherapy. In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen. Any increa पूरा दस्तावेज़ पढ़ें