BUVENTOL EASYHALER 200 mcginhalation dose

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SALBUTAMOL SULPHATE EQV SALBUTAMOL

Available from:

ORION PHARMA (SG) PTE. LTD.

ATC code:

R03AC02

Dosage:

200 mcg/dose

Pharmaceutical form:

POWDER, METERED

Composition:

SALBUTAMOL SULPHATE EQV SALBUTAMOL 200 mcg/dose

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

ORION CORPORATION (ESPOO PLANT)

Authorization status:

ACTIVE

Authorization date:

1996-04-24

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
BUVENTOL EASYHALER
™ 100 MCG/ DOSE INHALATION POWDER
BUVENTOL EASYHALER
™ 200 MCG/ DOSE INHALATION POWDER
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Buventol Easyhaler
™
is an inhalation powder packed into a multiple dose powder inhaler
from which
the patient can accurately deliver the individual drug doses. It is
for oral inhalation.
_Buventol Easyhaler_
™
_ 100 mcg/ dose Inhalation Powder_
: The product contains salbutamol sulphate
equivalent to 100 mcg of salbutamol per metered dose. The dose, which
the patient gets through the
mouthpiece of the device is 90 mcg of salbutamol.
_Buventol Easyhaler_
™
_ 200 mcg/ dose Inhalation Powder_
: The product contains salbutamol sulphate
equivalent to 200 mcg of salbutamol per metered dose. The dose, which
the patient gets through the
mouthpiece of the device is 180 mcg of salbutamol.
The Buventol Easyhaler
™
multiple dose powder inhaler contains 200 doses of finely powdered
salbutamol sulphate mixed in a small quantity of lactose. The amount
of drug received by the patient (90
or 180 mcg/dose) corresponds to that from salbutamol inhalation
aerosol. The dose to be inhaled is
released from the container by pressing the device between the thumb
and forefinger. This is followed
by inhalation through the device. As a result, salbutamol particles
are transferred to their target, the
lungs. Use of the Buventol Easyhaler
™
does not require coordination of actuation of the dose and
inhalation.
3. PHARMACEUTICAL FORMS
Inhalation powder.
White or almost white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Symptomatic treatment of acute asthma attack.
•
Prevention of exercise-induced bronchospasm.
•
Symptomatic treatment of bronchial asthma and other conditions, such
as bronchitis and
emphysema, associated with reversible airways obstruction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The preparation is intended for oral inhalation only. This preparation
is particularly useful for patients
who are unable to use mete