Nicorette 16hr Invisipatch

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Nicotine 15.75mg (delivery 10 mg nicotine over 16 hrs)

Հասանելի է:

JNTL Consumer Health (New Zealand) Limited

INN (Միջազգային անվանումը):

Nicotine 15.75 mg (delivery 10 mg nicotine over 16 hrs)

Դոզան:

10mg/16 hours (Size 9sq.cms)

Դեղագործական ձեւ:

Transdermal patch

Կազմը:

Active: Nicotine 15.75mg (delivery 10 mg nicotine over 16 hrs) Excipient: Acrylic adhesive Aluminium acetylacetonate Butyl/isobutyl methacrylate copolymer Carmellose sodium Medium-chain triglycerides Potassium hydroxide

Միավորները փաթեթում:

Sachet, laminate, PET/polyacrylnitrile/Al sachet in card container, 7 patches

Դաս:

General sale

Ռեկվիզորի տեսակը:

General sale

Պատրաստված է:

Siegfried Ltd

Թերապեւտիկ ցուցումներ:

The treatment of nicotine dependence, and the relief of withdrawal symptoms associated with smoking cessation. In smokers who are not prepared to stop immediately the patch may also be used in a preparation phase to reduce the need to smoke prior to stopping smoking completely.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Sachet, laminate, . Patch contained within a paper/adhesive/PET/cyclo-olefin copolymer sachet in cardboard container - 7 patches - 36 months unopened stored at or below 25°C - Sachet, laminate, . Patch contained within a paper/adhesive/PET/cyclo-olefin copolymer sachet in cardboard container - 14 patches - 36 months unopened stored at or below 25°C - Sachet, laminate, . Patch contained within a paper/adhesive/PET/cyclo-olefin copolymer sachet in cardboard container - 28 patches - 36 months unopened stored at or below 25°C

Հաստատման ամսաթիվը:

2008-12-23

Ապրանքի հատկությունները

Page 1 of 19
NICORETTE
®
16hr INVISIPATCH
®
Patch Datasheet
Date of Preparation: 10 July 2023
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
NICORETTE
®
16hr INVISIPATCH
®
10mg/16hr, 15mg/16hr, 25mg/16hr
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NICORETTE
®
16hr INVISIPATCH
®
patch
is a transdermal delivery system
for topical application, available in sizes of 22.5, 13.5 and 9 cm
2
each
containing 1.75 mg/cm
2
of nicotine, releasing 25 mg, 15 mg and 10 mg
respectively over 16 hours.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Transdermal patch. NICORETTE
®
16hr INVISIPATCH
®
are semi-transparent,
beige, imprinted, 9.0cm2, rectangular Transdermal Therapeutic System
(TTS)
with rounded corners, centrally located on a rectangular, aluminised
and
siliconised release liner.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of nicotine dependence, and the relief of withdrawal
symptoms associated with smoking cessation. In smokers who are not
prepared to stop immediately the patch may also be used in a
preparation
phase to reduce the need to smoke prior to stopping smoking
completely.
Abrupt cessation of the use of tobacco-containing products following a
prolonged period of daily use results in a characteristic withdrawal
syndrome
that includes four or more of the following: dysphoria or depressed
mood;
insomnia; irritability, frustration or anger; anxiety; difficulty
concentrating,
restlessness or impatience; decreased heart rate; and increased
appetite or
weight gain. Nicotine craving, which is recognised as a clinically
relevant
symptom, is also an important element in nicotine withdrawal.
Clinical studies have shown that nicotine replacement products can
help
smokers abstain from smoking.
Page 2 of 19
NICORETTE
®
16hr INVISIPATCH
®
Patch Datasheet
Date of Preparation: 10 July 2023
4.2
DOSE AND METHOD OF ADMINISTRATION
Could be used as a single treatment or in combination with either
nicotine
chewing gum or nicotine inhaler.
CHILDREN AND ADOLESCENTS
N