BUVENTOL EASYHALER 100 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:

100 mcg/dose

Pharmaceutical form:

POWDER, METERED

Composition:

SALBUTAMOL SULPHATE EQV SALBUTAMOL 100 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 metered dose inhaler properly and fo