Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Granisetron hydrochloride
Mawdsley-Brooks & Company Ltd
A04AA02
Granisetron hydrochloride
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No . Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Myriad Pro 10 pt 10 pt Granisetron_Hydrochloride_1mg_10 Leaflet N/A N/A 1958859 PL 04569/0688 TBC TBC TBC N/A 102837246/0020 2 United Kingdom N/A 13 Sep 19 17:38 1 183 x 266 mm Black 1 / 2 3D Render ID N/A v3/Jul 2017 N/A PACKAGE LEAFLET: INFORMATION FOR THE USER GRANISETRON 1 MG FILM-COATED TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any • possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Granisetron is and what it is used for 2. What you need to know before you take Granisetron 3. How to take Granisetron 4. Possible side effects 5. How to store Granisetron 6. Contents of the pack and information 1. WHAT GRANISETRON IS AND WHAT IT IS USED FOR Granisetron belongs to a group of medicines known as ‘5-HT3 receptor antagonists’ or anti-emetics or anti-sickness medicines. These tablets are only for use in adults. It is used to prevent or treat nausea (feeling sick) and vomiting_ _(being sick) caused by other medical treatments, such as chemotherapy or radiation treatment for cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRANISETRON DO NOT TAKE GRANISETRON • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of this m Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Granisetron 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg granisetron (as hydrochloride). Excipient with known effect: Each tablet contains 55.78 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white tablet embossed "GS" on one side and plain on the reverse 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron tablets are indicated in adults_ _for the prevention and treatment_ _of acute nausea and vomiting associated with chemotherapy and radiotherapy. Granisetron tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy_. _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of granisetron should be administered within one hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally. Maximum Dose and Duration of Treatment Granisetron is also available as ampoules for intravenous administration. The maximum dose of granisetron administered orally and/or intravenously over 24 hours should not exceed 9 mg. Paediatric population The safety and efficacy of granisetron tablets in children have not yet been established. No data are available. Older people and renal impairment There are no special precautions required for its use in either elderly patients or those patients with renal impairment. Hepatic Impairment There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders. On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see section 5.2). Method of administration The tablets should be swallowed whole with water. 4.3 CONTRAINDICATIONS Gr Belgenin tamamını okuyun