Nicorette

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
17-12-2010

Aktiivinen ainesosa:

Nicotine 16.6mg (20cm² patch delivers 10mg/16hours.);  

Saatavilla:

Johnson & Johnson (New Zealand) Limited

INN (Kansainvälinen yleisnimi):

Nicotine 16.6 mg (20cm² patch delivers 10mg/16hours.)

Annos:

10mg/16hours

Lääkemuoto:

Transdermal patch

Koostumus:

Active: Nicotine 16.6mg (20cm² patch delivers 10mg/16hours.)  

Kpl paketissa:

Individual wrap, 7x20cm� patches, 7 patches

luokka:

General sale

Prescription tyyppi:

General sale

Valmistaja:

Siegfried Ltd

Tuoteyhteenveto:

Package - Contents - Shelf Life: Individual wrap, 7x20cm? patches - 7 patches - 36 months from date of manufacture stored at or below 25°C

Valtuutus päivämäärä:

1991-06-28

Valmisteyhteenveto

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DATA SHEET 
NICORETTE
®
 PATCH 
5MG/16H, 10MG/16H, 15MG/16H 
PRESENTATION 
Nicorette Patch is a transdermal delivery system for topical
application, 
available in sizes of 30, 20 and 10 cm
2
 each containing 0.83 mg/cm
2
 of 
nicotine, releasing 15 mg, 10 mg and 5 mg respectively over 16 hours.
Each 
patch is rectangular in shape and comprises 3 distinct layers; an
outer beige 
matt finish backing layer, a patterned silvery middle layer and an
inner clear 
release liner, which is removed prior to use. Each patch is packaged
in a heat 
sealed multilaminate sachet. 
USES 
ACTIONS 
Pharmacotherapeutic group: Drug for treatment of addiction. 
 
ATC code: N07B A01 
 
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. 
PHARMACOKINETICS 
GENERAL PHARMACOKINETIC PROPERTIES OF NICOTINE 
The volume of distribution following i.v. administration of nicotine
is about 2 to 
3 L/kg. Plasma protein binding of nicotine is <5%. Therefore, changes
in 
nicotine binding from use of concomitant drugs or alterations of
plasma 
proteins by disease states would not be expected to have significant
effects 
on nicotine kinetics. 
 
The average plasma clearance following intravenous administration
of 
nicotine is about 70 L/hour and the terminal half-life approximately
2 hours. 
The major eliminat
                                
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