GIONA EASYHALER 100 MCGDOSE INHALATION POWDER

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BUDESONIDE

Available from:

ORION PHARMA (MY) SDN. BHD.

INN (International Name):

BUDESONIDE

Units in package:

1Units Units; 1Units Units

Manufactured by:

ORION CORP

Patient Information leaflet

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GionaEH PIL_1004(3).pdf was not found on this server.

Summary of Product characteristics

159914-1
1. NAME OF THE MEDICINAL PRODUCT
GIONA EASYHALER 100 MCG
/
DOSE INHALATION POWDER.
GIONA EASYHALER 200 MCG
/
DOSE INHALATION POWDER.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
GIONA EASYHALER 100 microg/dose inhalation powder :
One metered dose contains 100 micrograms of budesonide.
GIONA EASYHALER 200 microg/dose inhalation powder :
One metered dose contains 200 micrograms of budesonide.
With the EASYHALER device the delivered dose (ex-actuator)
contains the same quantity of active substance as the metered
dose (ex-reservoir).
Excipient with known effect: Lactose monohydrate. For a full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder. White or almost white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild, moderate and severe asthma.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Method of administration: For inhalation use. For optimum
response, GIONA EASYHALER inhalation powder should be used
regularly.
The therapeutic effect begins after a few days’ treatment and
reaches its maximum after some weeks of treatment.
When transferring a patient to GIONA EASYHALER from other
inhalation devices, the treatment should be individualised. The
previous active substance, dose regimen, and method of delivery
should be considered. The patients should be prescribed a
starting dose of inhaled budesonide which is appropriate for the
severity or level of control of their disease.
THE STARTING DOSE for adults (including the elderly and children/
adolescents over 12 years of age) with mild asthma (Step 2) and
for children 6 to 12 years of age is 200-400 micrograms/day. If
needed, the dose can be increased up to 800 micrograms/day.
For adult patients with moderate (Step 3) and severe (Step 4)
asthma the starting dose can be up to 1600 micrograms/day. The
maintenance dose should be adjusted to meet the requirements
of an individual patient, taking into account the severity of the
disease and the clinical response of the patient. The dose should
be adjusted until contro