Nicorette Freshfruit Gum

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Nicotine polacrilex 10mg equivalent to 2 mg nicotine;  ;  

Հասանելի է:

JNTL Consumer Health (New Zealand) Limited

INN (Միջազգային անվանումը):

Nicotine polacrilex 10 mg (equiv to 2 mg nicotine)

Դոզան:

2 mg

Դեղագործական ձեւ:

Chewing gum

Կազմը:

Active: Nicotine polacrilex 10mg equivalent to 2 mg nicotine     Excipient: Acacia Acesulfame potassium Cafosa 258 soft Carnauba wax Hypromellose Levomenthol Light magnesium oxide Nitrogen Peppermint oil Polysorbate 80 Purified talc Purified water Sodium bicarbonate Sodium carbonate Sucralose Titanium dioxide Tutti fruitti flavour QL84441 Xylitol  

Միավորները փաթեթում:

Blister pack, PVC/PVDC/AL/Vinylacryl, 15 pieces, 15 pieces

Դաս:

General sale

Ռեկվիզորի տեսակը:

General sale

Պատրաստված է:

Siegfried Ltd

Թերապեւտիկ ցուցումներ:

For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms thus: Facilitating smoking cessation in smokers motivated to quit. Helping smokers to temporarily abstain from smoking. Facilitating smoking reduction in smokers unable or unwilling to quit.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/AL/Vinylacryl - 15 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 30 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 60 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 75 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 105 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 150 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 200 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 210 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 300 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 310 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 315 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 325 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 340 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 355 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 370 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 385 pieces - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL/Vinylacryl - 400 pieces - 36 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

2006-07-14

Ապրանքի հատկությունները

Page 1 of 16
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Nicorette
®
Gum, Nicorette
®
Freshmint Gum, Nicorette
®
Freshfruit Gum, Nicorette
®
Spearmint Gum and Nicorette
®
Icy Mint Gum
Chewing Gum containing 2mg or 4mg nicotine.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NICORETTE® chewing gum contains nicotine, added as nicotine
polacrilex. They are
available in 2mg and 4mg strengths and are available in five flavours:
classic, icy mint,
freshmint, spearmint and freshfruit.
NICORETTE® classic chewing gum also contains: sodium and sorbitol.
NICORETTE® freshfruit, icymint and spearmint chewing gum also
contains: sucralose,
sodium and xylitol.
NICORETTE® freshmint chewing gum also contains: sodium and xylitol.
For the full list
of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
NICORETTE® chewing gums are square, coated pieces of gum. NICORETTE®
2mg
classic chewing gums are beige in colour.
NICORETTE® 2mg icy mint, freshfruit, spearmint and freshmint chewing
gums are white
in colour.
NICORETTE® 4mg classic chewing gums are yellow in colour.
NICORETTE® 4mg icy mint, freshfruit, spearmint and freshmint chewing
gums are
cream in colour.
Page 2 of 16
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of tobacco dependence by relieving nicotine craving
and withdrawal
symptoms thus:
Facilitating smoking cessation in smokers motivated to quit.
Helping smokers to temporarily abstain from smoking.
Facilitating smoking reduction in smokers unable or unwilling to quit.
4.2
DOSE AND METHOD OF ADMINISTRATION
Could be used as a single treatment or in combination with nicotine
patch.
Each piece of Nicorette gum should be chewed intermittently for about
30 minutes.
Nicorette gum should be chewed until a strong taste or a slight
tingling sensation is felt, then
stop chewing, place the gum between the cheek and gums until the taste
or tingling has
disappeared, then chew slowly again and repeat.
CHILDREN AND ADOLESCENTS
Nicorette chewing gum should not be administered to persons under 18