Serevent Accuhaler

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Salmeterol xinafoate 72.5ug equivalent to 50 µg salmeterol;  

Tilgjengelig fra:

GlaxoSmithKline NZ Limited

INN (International Name):

Salmeterol xinafoate 72.5 µg (Equiv to 50 µg salmeterol)

Dosering :

50 mcg/dose

Legemiddelform:

Powder for inhalation

Sammensetning:

Active: Salmeterol xinafoate 72.5ug equivalent to 50 µg salmeterol   Excipient: Lactose monohydrate

Enheter i pakken:

Inhaler, metered, 60 dose units

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Glaxo Wellcome Manufacturing Pte Ltd

Indikasjoner:

SEREVENT is indicated for long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma) in adults and children who are receiving inhaled or oral corticosteroids. SEREVENT should be used only as an adjunct to corticosteroids in the management of asthma. SEREVENT should not be used in the treatment of acute asthmatic symptoms, or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.

Produkt oppsummering:

Package - Contents - Shelf Life: Inhaler, metered, - 60 dose units - 24 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1994-07-06

Informasjon til brukeren

1
SEREVENT ACCUHALER
Salmeterol xinafoate, 50microgram per inhalation
NEW ZEALAND CONSUMER MEDICINE INFORMATION
Please read all of this leaflet carefully before you take your
medicine
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about
Serevent Accuhaler. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist (also known as a
chemist).
All medicines have benefits and
risks. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the risks of
you using Serevent Accuhaler
against the expected benefits it
will have for you.
If you have any concerns about
taking this medicine, or
experience any difficulties
during or after using this
medicine, tell your doctor or
pharmacist.
This medicine is only one part of
a general plan to help you
manage your asthma. You
should discuss this plan with
your doctor. Your doctor should
check the treatment of your
asthma regularly.
KEEP THIS LEAFLET WITH YOUR
SEREVENT ACCUHALER.
You may
need to read it again.
WHAT SEREVENT
ACCUHALER IS USED
FOR
The medicine in Serevent
Accuhaler is known as a
bronchodilator. A
bronchodilator keeps the
breathing tubes in your lungs
open and relieves the symptoms
of asthma and other chest
conditions. When used as your
doctor has told you, Serevent
Accuhaler helps you to breathe
more easily. Serevent gives
relief, for up to twelve hours,
from chest tightness or wheeze
due to asthma, or other chest
conditions in adults namely
chronic obstructive pulmonary
disease (COPD). You should
use Serevent Accuhaler
regularly every day, twice daily,
in the morning and in the
evening.
The medicine in Serevent
Accuhaler does not start
working as quickly as a 'reliever'
medicine such as Ventolin

.
YOU SHOULD ALWAYS CARRY A
'RELIEVER' MEDICINE WITH YOU.
IF YOU HAVE AN ASTHMA ATTACK,
USE YOUR 'RELIEVER' MEDICINE,
NOT YOUR SEREVENT ACCUHALER.
If you have asthma, your doctor
will tell you to use a 'preventer'
medicine regularly every d

Preparatomtale

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SEREVENT Accuhaler, 50 micrograms, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose contains 50 micrograms of salmeterol as salmeterol
xinafoate.
Excipients with known effect:
SEREVENT Accuhaler also contains the excipient lactose (see Section
4.3
Contraindications).
For full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Inhalation powder.
SEREVENT Accuhaler is a moulded plastic device containing a foil strip
with regularly
placed blisters.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
Asthma
SEREVENT
is
indicated
for
long-term
regular
treatment
of
reversible
airways
obstruction in asthma (including nocturnal asthma and exercise-induced
asthma) in
adults and children aged 4 years and over who are receiving inhaled or
oral
corticosteroids.
SEREVENT should be used only as an adjunct to corticosteroids in the
management
of asthma.
SEREVENT should not be used in the treatment of acute asthmatic
symptoms, or in
patients whose asthma can be managed by occasional use of short-acting
beta-2
agonists.
Chronic Obstructive Pulmonary Disease (COPD)
SEREVENT is indicated for long-lasting (12 hour) bronchodilation in
adults with
reversible airways obstruction due to COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
SEREVENT Accuhaler is administered by the inhaled route only.
2
Patients must be warned not to stop steroid therapy and not to reduce
it without
medical advice even if they feel better on SEREVENT.
Asthma
In the management of reversible airways obstruction due to asthma,
SEREVENT (as
with other long-acting beta-2 agonists) MUST ONLY BE ADMINISTERED IN
COMBINATION
WITH ANTI-INFLAMMATORY THERAPY SUCH AS INHALED CORTICOSTEROIDS (ICS).
In asthma
patients not already receiving anti-inflammatory therapy, this must be
initiated at the
same time as SEREVENT.
_Adults: _
One inhalation (50 micrograms of salmeterol) twice daily.
In asthma patients with more severe airways obstruction up to 2
inhalations (2 x 50
micrograms of sal