Nicorette Cooldrops

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Nicotine polacrilex 20mg equivalent to 4 mg nicotine (plus 5% overage);  

Հասանելի է:

JNTL Consumer Health (New Zealand) Limited

INN (Միջազգային անվանումը):

Nicotine polacrilex 20 mg (equiv to 4 mg nicotine (plus 5% overage))

Դոզան:

4 mg

Դեղագործական ձեւ:

Lozenge

Կազմը:

Active: Nicotine polacrilex 20mg equivalent to 4 mg nicotine (plus 5% overage)   Excipient: Acesulfame potassium   Hypromellose Magnesium stearate Mannitol Polysorbate 80 Purified water Sepifilm gloss Sodium carbonate Sucralose   Titanium dioxide Winterfresh flavour RDE4-149 0488110   Xanthan gum

Միավորները փաթեթում:

Bottle, plastic, Flip pack, 20 dose units

Դաս:

General sale

Ռեկվիզորի տեսակը:

General sale

Պատրաստված է:

Cambrex Charles City Inc

Թերապեւտիկ ցուցումներ:

For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Bottle, plastic, Flip pack - 20 dose units - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, Flip pack - 80 dose units - 36 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

2011-04-01

Ապրանքի հատկությունները

Page 1 of 13
NICORETTE
®
Cooldrops Lozenge Datasheet
Date of Preparation: 25 November 2022 NEW ZEALAND DATA SHEET
1 PRODUCT NAME
NICORETTE
®
Cooldrops Lozenge
2 mg, 4mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NICORETTE
®
Cooldrops Lozenge 2mg contains as active ingredient Nicotine-
resin complex 20% 10 mg equivalent to nicotine 2 mg.
NICORETTE
®
Cooldrops Lozenge 4mg contains as active ingredient Nicotine-
resin complex 20% 20 mg equivalent to nicotine 4 mg.
NICORETTE
®
Cooldrops Lozenge also contains sucralose and mannitol.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
NICORETTE
®
Cooldrops Lozenge is an oval, white to off-white film-coated
lozenge with a size of about 14 x 9 x 7 mm, imprinted with "n" on one
side and
“2” on the other side of the 2mg lozenge, and “4” on the other
side of the 4mg
lozenge.
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.
The initial dosage should be individualised on the basis of the
patient’s
nicotine dependence. NICORETTE
®
Cooldrops Lozenge should be used
when the urge to smoke is felt.
Page 2 of 13
NICORETTE
®
Cooldrops Lozenge Datasheet
Date of Preparation: 25 November 2022
NICORETTE
®
Cooldrops Lozenges 2 mg are suitable for smokers with a low
nicotine dependency e.g. those smoking their first cigarette of the
day more
than 30 minutes after waking up, or those who smoke fewer than 20
cigarettes per day.
NICORETTE
®
Cooldrops Lozenges 4 mg are suitable for smokers with a high
nicotine dependency e.g. those smoking their first cigarette of the
day within
30 minutes after waking up, or those who smoke more than 20 ciga