Држава: Израел
Језик: Енглески
Извор: Ministry of Health
NICOTINE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
N07BA01
PATCHES
NICOTINE 17.5 MG
TRANSDERMAL
Not required
GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND
NICOTINE
NICOTINE
Aid to smoking cessation.
2012-05-31
_ _ _ _ _ _ _ _ _The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in Februdary 2017 _ _ _ 1. NAME OF THE MEDICINAL PRODUCT NICOTINELL 7mg/24h patch NICOTINELL 14mg/24h patch NICOTINELL 21mg/24h patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Nicotinell 7MG/24H PATCH patch contains 17.5 mg S(-)-nicotine which provides an average absorption rate of 7 mg nicotine in 24 hours. Each Nicotinell 14MG/24H PATCH patch contains 35.0 mg S(-)-nicotine which provides an average absorption rate of 14 mg nicotine in 24 hours. Each Nicotinell 21MG/24H PATCH patch contains 52.5 mg S(-)-nicotine which provides an average absorption rate of 21 mg nicotine in 24 hours. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patches The Nicotinell patch is a transdermal therapeutic system, consisting of a round, flat, matrix-type self- adhesive, yellowish-ochre coloured patch. It is protected by a rectangular metallic release liner backing to be discarded before application. Nicotinell 7MG/24H PATCH patch 7mg/24 hour has a drug releasing area of 10 cm 2 and is printed CG CWC on the patch surface. Nicotinell 14MG/24H PATCH patch 14mg/24 hour has a drug releasing area of 20 cm 2 and is printed CG FEF on the patch surface. Nicotinell 21MG/24H PATCH patch 21mg/24 Hour has a drug releasing area of 30 cm 2 and is printed CG EME on the patch surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aid to smoking cessation 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: For individuals smoking 20 cigarettes or more a day, it is recommended that treatment be started with Nicotinell 21MG/24H PATCH (Step 1) once daily, applied to a dry non-hairy area of the skin on the trunk or upper arm. Those smoking less than this are recommended to start with Nicotinell 14MG/24H PATCH (Step 2). Sizes of 30cm 2 , 20cm 2 and 10cm 2 are available to permit gradual withdrawal of nicotine replacement, using treatment periods of 3-4 weeks (for each size). The siz Прочитајте комплетан документ