Nicotinell (Liquorice flavoured)

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Nicotine 2mg

Tilgængelig fra:

Novartis Consumer Health Australasia Pty Ltd (NZ)

INN (International Name):

Nicotine 2 mg

Dosering:

2 mg

Lægemiddelform:

Chewing gum

Sammensætning:

Active: Nicotine 2mg Excipient: Acesulfame potassium Amberlite Anise oil   Calcium carbonate Carnauba wax Eucalyptus oil   Gelatin Glycerol gum base DAN Med 1 (Med BHT) Pharma Liquorice powder Mannitol Menthol   Purified water Saccharin Saccharin sodium Sodium bicarbonate Sodium carbonate Sorbitol Titanium dioxide Xylitol

Enheder i pakken:

Blister pack, PVC,PE,PVdC/Al, 12 pieces

Klasse:

General sale

Recept type:

General sale

Fremstillet af:

Siegfried Ltd

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC,PE,PVdC/Al - 12 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 24 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 36 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 48 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 60 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 72 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 96 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 120 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 144 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 168 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 192 pieces - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC,PE,PVdC/Al - 204 pieces - 24 months from date of manufacture stored at or below 25°C

Autorisation dato:

2003-11-03

Produktets egenskaber

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