SERETIDE MDI 250/25 inhalation

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 250 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane

Administration route:

Inhalation

Units in package:

120 doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include: *Patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids. *Patients who are symptomatic on current inhaled corticosteroid therapy. For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Seretide is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: Actuator & metal can with concave base fitted with a metering valve. The canister contains a white to off-white suspension. The internal surfaces of the can & the valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SERETIDE (FLUTICASONE PROPIONATE/ SALMETEROL XINAFOATE)
ACCUHALER AND MDI
1
NAME OF THE MEDICINE
Fluticasone propionate/ salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SERETIDE ACCUHALER:
Each a foil strip contains regularly placed blisters each containing
100, 250 or 500
micrograms of fluticasone propionate and 50 micrograms of salmeterol
(as xinafoate).
SERETIDE metered dose inhaler (MDI):
Each single actuation provides 50, 125 or 250 micrograms of
fluticasone propionate and 25
micrograms of salmeterol (as xinafoate).
LIST OF EXCIPIENTS WITH KNOWN EFFECT
SERETIDE ACCUHALER also contains the excipient lactose monohydrate
(which contains
milk protein) (see Section 4.3 CONTRAINDICATIONS).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SERETIDE ACCUHALER: Powder for inhalation
SERETIDE MDI: Pressurised inhalation
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the regular treatment of asthma, where the use of a combination
product is appropriate.
This may include:
•
Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled
corticosteroids
•
Patients who are symptomatic on current inhaled corticosteroid therapy
•
Initiation of maintenance therapy in those patients with moderate
persistent asthma
not adequately controlled on ‘as needed’ reliever medication, and
who have
moderate/severe airway limitation and daily symptoms requiring
reliever medication
every day (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical
trials).
For the symptomatic treatment of patients with severe COPD (FEV1<50%
predicted normal)
and a history of repeated exacerbations who have significant symptoms
despite regular
2
beta-2 agonist bronchodilator therapy. SERETIDE is not indicated for
the initiation of
bronchodilator therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
SERETIDE ACCUHALER and MDI are for inhalation only.
SERETIDE ACCUHALER and MDI must be used regularly for optimum benefit,
even when
asym