SYMBICORT RAPIHALER budesonide / formoterol fumarate dihydrate 100/6 pressurised metered dose inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 80 microgram; formoterol fumarate dihydrate, Quantity: 4.5 microgram

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Budesonide,formoterol (eformoterol)

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: povidone; macrogol 1000; apaflurane

Administration route:

Inhalation

Units in package:

120 doses, 2 x 120 doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma Symbicort Rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration). Chronic obstructive pulmonary disease (COPD) Symbicort 200/6 is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. Symbicort is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: Contents in metal can with plastic valve & actuation counter. After evaporation of the propellant the residue is free from visible contaminants. The external & internal can & valve surfaces are free from corrosion and significant defects.; Container Type: Inhaler - Metered Dose; Container Material: Other plastic laminate/Al; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-02-22

Summary of Product characteristics

1 of 21
AUSTRALIAN PRODUCT INFORMATION
SYMBICORT RAPIHALER
®
(BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE)
PRESSURISED INHALATION
1
NAME OF THE MEDICINE
Budesonide
Formoterol (eformoterol) fumarate dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symbicort Rapihaler is a pressurised metered dose inhaler (pMDI). For
ease of reference,
formoterol, formoterol fumarate or formoterol fumarate dihydrate have
been used throughout the
rest of this document.
The following strengths are registered:
•
_Symbicort Rapihaler 50/3: _
Each delivered dose (the dose that leaves the mouthpiece) contains
as active constituents: budesonide 40 μg/inhalation and formoterol
2.25 μg/inhalation.
•
_Symbicort Rapihaler 100/3: _
Each delivered dose (the dose that leaves the mouthpiece)
contains as active constituents: budesonide 80 μg/inhalation and
formoterol 2.25 μg/inhalation.
•
_Symbicort Rapihaler 100/6**: _
Each delivered dose (the dose that leaves the mouthpiece)
contains as active constituents: budesonide 80 μg/inhalation and
formoterol 4.5 μg/inhalation.
•
_Symbicort Rapihaler 200/6: _
Each delivered dose (the dose that leaves the mouthpiece) contains
as active constituents: budesonide 160 μg/inhalation and formoterol
4.5 μg/inhalation.
To avoid confusion, Symbicort Rapihaler is labelled as metered dose
like Symbicort Turbuhaler
®
.
The following table gives the corresponding dose delivered to the
patient.
TABLE 1
SYMBICORT RAPIHALER
METERED DOSE (

G)
CORRESPONDING DOSE DELIVERED TO PATIENT (

G)*
BUDESONIDE
FORMOTEROL
BUDESONIDE
FORMOTEROL
50/3
50
3
40
2.25
100/3
100
3
80
2.25
100/6**
100
6
80
4.5
200/6
200
6
160
4.5
_* doses referred to in Symbicort publications _
_** Not supplied in Australia _
For the full list of excipients, see Section 6.1 List of excipients.
2 of 21
3
PHARMACEUTICAL FORM
Inhalation, pressurised.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Rapihaler is indicated in adults and adolescents (12 years
and older), for the treatment of
asthma to achiev