Nicotinell Classic

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Nicotine 4mg

Saatavilla:

Novartis Consumer Health Australasia Pty Ltd (NZ)

INN (Kansainvälinen yleisnimi):

Nicotine 4 mg

Annos:

4 mg

Lääkemuoto:

Chewing gum

Koostumus:

Active: Nicotine 4mg Excipient: Amberlite Calcium carbonate Carnauba wax Gelatin Glycerol Gum base Tutti flavouring Maltitol As liquid Mannitol Menthol Purified water Sodium bicarbonate Sodium carbonate Sorbitol As powder Titanium dioxide Xylitol

Kpl paketissa:

Blister pack, PVC/PVdC/Al blister sheet packed in lots of 1, 2, 3, 4, 5, 6 and 8 sheets in card carton, 12 pieces

luokka:

General sale

Prescription tyyppi:

General sale

Valmistaja:

Siegfried Ltd

Tuoteyhteenveto:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al blister sheet packed in lots of 1, 2, 3, 4, 5, 6 and 8 sheets in card carton - 12 pieces - 24 months unopened stored at or below 25°C

Valtuutus päivämäärä:

2009-07-06

Valmisteyhteenveto

NAME OF MEDICINE  
NICOTINELL®  
Nicotine Chewing Gum 2 mg, 4 mg  
PRESENTATION  
NICOTINELL chewing gum contains 2mg or 4mg of nicotine as a nicotine
resin in 
a chewing gum formulation. Gum pieces are rectangular in shape and
available 
in, fruit, mint, liquorice and classic flavours 
USES  
ACTIONS  
Nicotine gum mimics the pharmacological effects of nicotine from
smoking and 
may therefore be used to help provide relief from nicotine withdrawal
symptoms. 
In addition to effects on the central nervous system, nicotine
produces 
haemodynamic effects such as increased heart rate and systolic blood
pressure.  
PHARMACOKINETICS  
When the gum is chewed, nicotine is steadily released into the mouth
and is 
rapidly absorbed through the buccal mucosa. A proportion, by the
swallowing of 
nicotine containing saliva, reaches the stomach and intestine where it
is 
inactivated.  

The peak plasma concentration after a single dose of the 2 mg gum
is 
approximately 6.4 nanograms per ml. For the 4 mg chewing gum, it has
been 
calculated that the nicotine peak plasma concentration after a single
dose is 
approximately 9.3 nanograms per mL (after approximately 60 minutes).
 After 45 
minutes average plasma concentration of nicotine when smoking a
cigarette is 
15-30 nanograms per mL. 

Nicotine crosses the blood-brain barrier the placenta, and
is detectable in breast 
milk.  

Nicotine is eliminated mainly via hepatic metabolism, small amounts
being 
eliminated in unchanged form via the kidneys. The plasma half-life
is 
approximately three hours. 
INDICATIONS  
NICOTINELL chewing gum treatment is indicated for the relief of
nicotine 
withdrawal symptoms, in nicotine dependency as an aid to smoking
cessation. It 
may 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
completely. 
May be used by smokers who are unable or not ready to quit on
occasions when 
they want to temporari