Seretide

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Fluticasone propionate 40mg equivalent to 250 µg/dose;  ; Salmeterol xinafoate 5.8mg equivalent to 25 µg/dose salmeterol;  

Διαθέσιμο από:

GlaxoSmithKline NZ Limited

INN (Διεθνής Όνομα):

Fluticasone propionate 40 mg (equivalent to 250 µg/dose)

Δοσολογία:

250µg/25µg

Φαρμακοτεχνική μορφή:

Aerosol inhaler, metered dose

Σύνθεση:

Active: Fluticasone propionate 40mg equivalent to 250 µg/dose   Salmeterol xinafoate 5.8mg equivalent to 25 µg/dose salmeterol   Excipient: Norflurane

Μονάδες σε πακέτο:

Inhaler, metered, Sample pack, with actuation counter, 28 dose units

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Glaxo Wellcome Manufacturing Pte Ltd

Θεραπευτικές ενδείξεις:

SERETIDE is indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. This may include: Patients on effective maintenance doses of long-acting ?-agonists and inhaled corticosteroids. Patients who are symptomatic on current inhaled corticosteroid therapy. Patients who are symptomatic on "as needed" short-acting betaagonists, as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroid alone.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Inhaler, metered, Sample pack, with actuation counter - 28 dose units - 24 months from date of manufacture stored at or below 30°C - Inhaler, metered, with actuation counter - 120 dose units - 24 months from date of manufacture stored at or below 30°C

Ημερομηνία της άδειας:

2000-02-23

Φύλλο οδηγιών χρήσης

SERETIDE
®
1
SERETIDE
_Fluticasone propionate/Salmeterol xinafoate _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using SERETIDE.
This leaflet answers some common
questions about SERETIDE. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SERETIDE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SERETIDE IS
USED FOR
SERETIDE is available as a dry
powder device called an
ACCUHALER and a Metered Dose
Inhaler (MDI) also known as an"
inhaler".
•
SERETIDE ACCUHALER:
100/50, 250/50
•
SERETIDE MDI: 50/25, 125/25,
250/25
SERETIDE is used to help with
asthma and chronic obstructive
pulmonary disease (COPD) in people
who need regular treatment.
Asthma is a condition affecting the
lungs. Symptoms of asthma include
shortness of breath, wheezing, chest
tightness and cough. Two main
causes of asthma symptoms are
bronchoconstriction (tightening of
the muscle surrounding the airways)
and inflammation (swelling and
irritation of the airways).
Chronic obstructive pulmonary
disease (COPD) is a long-term
condition affecting the lungs,
resulting from chronic bronchitis or
emphysema. Symptoms of COPD
include shortness of breath, cough,
chest discomfort and coughing up
phlegm. The COPD symptoms are
mainly due to bronchoconstriction
(tightening of the muscle
surrounding the airways) and
inflammation (swelling and irritation
of the airways).
SERETIDE contains two medicines,
fluticasone propionate and salmeterol
xinafoate.
Fluticasone propionate belongs to a
group of medicines known as
corticosteroids, frequently called
'steroids'. They are not 'anabolic
steroids' which are the steroids
sometimes misused by athletes.
Corticosteroids have an
anti-inf

Αρχείο Π.Χ.Π.

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SERETIDE Inhaler (with counter), 25 mcg/50 mcg, aerosol inhaler,
metered dose
SERETIDE Inhaler (with counter), 25 mcg/125 mcg, aerosol inhaler,
metered dose
SERETIDE Inhaler (with counter), 25 mcg/250 mcg, aerosol inhaler,
metered dose
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SERETIDE Inhaler 25 mcg/50 mcg:
Each single actuation provides salmeterol xinafoate equivalent to 25
micrograms of
salmeterol and 50 micrograms of fluticasone propionate.
SERETIDE Inhaler 25 mcg/125 mcg:
Each single actuation provides salmeterol xinafoate equivalent to 25
micrograms of
salmeterol and 125 micrograms of fluticasone propionate.
SERETIDE Inhaler 25 mcg/250 mcg:
Each single actuation provides salmeterol xinafoate equivalent to 25
micrograms of
salmeterol and 250 micrograms of fluticasone propionate.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Aerosol inhaler, metered dose.
The canisters are fitted into plastic actuators incorporating an
atomising orifice and
fitted with dustcaps.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asthma:
SERETIDE is indicated for the regular treatment of asthma (Reversible
Obstructive
Airways Disease) in adults, adolescents and children aged 4 years and
over, where
use of a combination product (bronchodilator and inhaled
corticosteroid) is
appropriate.
This may include:
•
Patients on effective maintenance doses of both long-acting
beta-agonists and
inhaled corticosteroids using separate products._ _
•
Patients who are not adequately controlled on current inhaled
corticosteroid
therapy.
2
•
Patients who are not adequately controlled on “as needed”
short-acting beta-
agonists, as an alternative to initiation of maintenance therapy with
moderate or
high doses of inhaled corticosteroid alone.
SERETIDE should not typically be used for the initial management of
asthma, unless
symptoms are severely uncontrolled, nor in patients whose asthma can
be managed
by occasional use of short-acting beta-2 agonist