SYMBICORT TURBUHALER 804.5 mcgdose

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Saadav alates:

ASTRAZENECA SINGAPORE PTE LTD

ATC kood:

R03AK07

Annus:

80 mcg/dose

Ravimvorm:

POWDER, METERED

Koostis:

BUDESONIDE 80 mcg/dose; FORMOTEROL FUMARATE DIHYDRATE 4.5 mcg/dose

Manustamisviis:

RESPIRATORY (INHALATION)

Retsepti tüüp:

Prescription Only

Valmistatud:

ASTRAZENECA AB

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2001-09-24

Infovoldik

1(16)

PROPOSED PACKAGE INSERT - CLEAN 

SYMBICORT TURBUHALER 80/4.5 
μ
G/DOSE  
_budesonide/formoterol _
INHALATION POWDER 

COMPOSITION 
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 80 
micrograms/inhalation and formoterol fumarate dihydrate
4.5 micrograms/inhalation. 

Symbicort Turbuhaler 80/4.5 micrograms/inhalation delivers the
same amount of 
budesonide and formoterol as the corresponding Turbuhaler
monoproducts, i.e. 
budesonide 100 micrograms/inhalation (metered dose) and formoterol
6 
micrograms/inhalation (metered dose) alternatively labelled as 4.5 
micrograms/inhalation (delivered dose). 

Excipient: Lactose monohydrate 810 micrograms per dose. 
THERAPEUTIC INDICATION 

Symbicort is indicated in the regular treatment of asthma where use
of a combination 
(inhaled corticosteroid and long acting beta-agonist) is
appropriate: 

-  patients not adequately controlled with inhaled corticosteroids
and “as needed” 
inhaled short acting beta
2
-agonists 
or 
-  patients already adequately controlled on both inhaled
corticosteroids and long 
acting beta
2
-agonists. 

NOTE: Symbicort Turbuhaler 80/4.5 micrograms/inhalation is not
appropriate in 
patients with severe asthma. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Symbicort is not intended for the initial management of asthma. The
dosage of the 
components of Symbicort is individual and should be adjusted to the
severity of the 
disease. This should be considered not only when treatment with
combination 
products is initiated but also when the maintenance dose
is adjusted. If an individual 
patient should require a combination of doses other than those
available in the 
combination inhaler, appropriate doses of beta
2
-agonists and/or corticosteroids by 
individual inhalers should be prescribed. 

For Symbicort there are two alternative therapies: 

SYMBICORT MAINTENANCE AND RELIEVER THERAPY: Symbicort is taken as
both regular 

Toote omadused

1
SYMBICORT TURBUHALER
®
(BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE)
1.
NAME OF THE MEDICINAL PRODUCT
Symbicort Turbuhaler
80/4.5, 160/4.5 and 320/9 µg/dose
_budesonide/formoterol _
Inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 80 or 160 or
320 micrograms/inhalation and formoterol fumarate dihydrate 4.5 or 9
micrograms/inhalation.
Symbicort Turbuhaler 80/4.5 micrograms/inhalation delivers the same
amount of budesonide
and
formoterol
as
the
corresponding
Turbuhaler
monoproducts,
i.e.
budesonide
100
micrograms/inhalation (metered dose) and formoterol 6
micrograms/inhalation (metered dose)
alternatively
labelled
as
4.5
micrograms/inhalation
(delivered
dose).
Excipient:
Lactose
monohydrate 810 micrograms per dose.
Symbicort Turbuhaler 160/4.5 micrograms/inhalation delivers the same
amount of budesonide
and
formoterol
as
the
corresponding
Turbuhaler
monoproducts,
i.e.
budesonide
200
micrograms/inhalation (metered dose) and formoterol 6
micrograms/inhalation (metered dose)
alternatively
labelled
as
4.5
micrograms/inhalation
(delivered
dose).
Excipient:
Lactose
monohydrate 730 micrograms per dose.
Symbicort Turbuhaler 320/9 micrograms/inhalation delivers the same
amount of budesonide
and
formoterol
as
the
corresponding
Turbuhaler
monoproducts,
i.e.
budesonide
400
micrograms/inhalation (metered dose) and formoterol 12
micrograms/inhalation (metered dose)
alternatively
labelled
as
9
micrograms/inhalation
(delivered
dose).
Excipient:
Lactose
monohydrate 491 micrograms per dose.
Formoterol fumarate dihydrate is hereafter referred to as
“formoterol”.
3.
PHARMACEUTICAL FORM
Inhalation powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TABLE 1. THERAPEUTIC INDICATIONS
SYMBICORT TURBUHALER
80/4.5 ΜG/DOSE
SYMBICORT
TURBUHALER
160/4.5
ΜG/DOSE
SYMBICORT
TURBUHALER
320/9
ΜG/DOSE
Asthma
Symbicort is indicated in
the regular treatment of
Symbicort
Turbuhaler
is
indicated
in
the
Symbicort is indicated
in the regular treatmen