Serevent Inhaler (CFC-free)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salmeterol xinafoate 36.3ug equivalent to salmeterol 25 µg/dose;  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Salmeterol xinafoate 36.3 µg (equivalent to salmeterol 25 µg/dose)

Dosage:

25 mcg/dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Salmeterol xinafoate 36.3ug equivalent to salmeterol 25 µg/dose   Excipient: Norflurane

Units in package:

Inhaler, metered, 120 doses, sample pack, 120 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Glaxo Wellcome Manufacturing Pte Ltd

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, 120 doses, sample pack - 120 dose units - 24 months from date of manufacture stored at or below 30°C - Inhaler, metered, 120 doses - 120 dose units - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2004-05-27

Patient Information leaflet

1
SEREVENT INHALER (CFC-FREE)
Salmeterol xinafoate 25 microgram per actuation
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 Inhaler CFC-Free. 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 Inhaler CFC-
Free 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 Inhaler CFC-Free. You
may need to read it again.
WHAT SEREVENT
INHALER CFC-FREE IS
USED FOR
The medicine in Serevent
Inhaler CFC-Free 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
Inhaler CFC-Free 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 Inhaler CFC-Free
regularly every day, twice daily,
in the morning and in the
evening.
The medicine in Serevent
Inhaler CFC-Free does not start
working as quickly as a 'reliever
puffer' such as Ventolin

. YOU
SHOULD ALWAYS CARRY A 'RELIEVER
PUFFER' WITH YOU. IF YOU HAVE
AN ASTHMA ATTACK, USE YOUR
'RELIEVER PUFFER', NOT YOUR
SEREVENT INHALER CFC-FREE.
If you have asthma, your doc

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SEREVENT Inhaler (CFC-Free); 25 micrograms, aerosol inhaler, metered
dose _ _
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
SEREVENT Inhaler is a pressurised metered-dose inhaler delivering 25
micrograms
salmeterol as salmeterol xinafoate with each actuation.
For full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Aerosol inhaler, metered dose.
SEREVENT Inhaler (CFC-Free) consists of a white microfine suspension
of salmeterol
as salmeterol xinafoate (salmeterol hydroxynaphthoate) in a
chlorofluorohydrocarbon
(CFC)-free liquid propellant, norflurane, packed under its own vapour
pressure in an
aluminium can which is sealed with a metering valve.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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) bronchodilatation in
adults with
reversible airways obstruction due to (COPD)
2
4.2
DOSE AND METHOD OF ADMINISTRATION _ _
Dose
SEREVENT is administered by the inhaled route only.
Patients must be warned not to stop therapy or 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.