Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
nicotine polacrilex, Quantity: 10 mg (Equivalent: nicotine, Qty 2 mg)
Haleon Australia Pty Ltd
Lozenge
Excipient Ingredients: indigo carmine aluminium lake; sucralose; sodium bicarbonate; mannitol; magnesium stearate; hypromellose; acesulfame potassium; xanthan gum; sodium carbonate; microcrystalline cellulose; crospovidone; xylitol; calcium hydrogen phosphate; Flavour
Buccal
60, 20, 120
Not scheduled. Not considered by committee, Not Scheduled after consideration by Committee
For the relief of nicotine withdrawal symptoms including cravings associated with smoking cessation. It may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping smoking. It should be used as part of a behavioural support programme.
Visual Identification: A dual layer oval lozenge with convex surfaces. One side is white to off white, may contain bluish hue and the other side blue with a debossed ?2? logo; Container Type: Tube; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2022-07-11
1 AUSTRALIAN PRODUCT INFORMATION NICABATE MINI LOZENGES (NICOTINE) MINT FLAVOUR 1 NAME OF THE MEDICINE Nicotine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ _Nicotine polacrilex _ Nicotine 2 mg lozenge Nicotine 4 mg lozenge _Excipients: _For the full list of excipients, see section 6.1 List of Excipients._ _ 3 PHARMACEUTICAL FORM NICABATE MINI LOZENGES NICOTINE 2 MG MINT FLAVOUR A dual layer oval lozenge with convex surfaces. One side is white to off white, may contain bluish hue and the other side blue with a debossed “2” logo. NICABATE MINI LOZENGES NICOTINE 4 MG MINT FLAVOUR A dual layer oval lozenge with convex surfaces. One side is white to off white, may contain bluish hue and the other side blue with a debossed “4” logo. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the relief of nicotine withdrawal symptoms including cravings associated with smoking cessation. It may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping smoking. It should be used as part of a behavioural support programme. 4.2 D OSE AND METHOD OF ADMINISTRATION DIRECTIONS FOR USE One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other and repeated, until the lozenge is completely dissolved (approximately 10 – 13 minutes). The lozenge should not be chewed or swallowed whole. 2 Users should not eat or drink while a lozenge is in the mouth. ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY) ABRUPT CESSATION OF SMOKING Nicabate Mini Lozenges 2 mg are suitable for smokers who smoke less than 20 cigarettes a day. Nicabate Mini Lozenges 4 mg are suitable for smokers who smoke 20 or more cigarettes a day. Users should make every effort to stop smoking completely during treatment with Nicabate Mini Lozenges. Behavioural therapy, advice and support will normally improve the success rate. Users should follow the schedule of treatmen Olvassa el a teljes dokumentumot