GIONA EASYHALER INHALATION POWDER 200 mcgdose

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

BUDESONIDE

Saadav alates:

ORION PHARMA (SG) PTE. LTD.

ATC kood:

R03BA02

Annus:

200 mcg/dose

Ravimvorm:

POWDER, METERED

Koostis:

BUDESONIDE 200 mcg/dose

Manustamisviis:

RESPIRATORY (INHALATION)

Retsepti tüüp:

Prescription Only

Valmistatud:

ORION CORPORATION

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2004-12-06

Infovoldik

1. NAME OF THE MEDICINAL PRODUCT
Giona Easyhaler 100 micrograms/dose inhalation powder.
Giona Easyhaler
200 micrograms/dose inhalation powder.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Giona Easyhaler 100 micrograms/dose inhalation powder : One metered
dose contains 100 micrograms of budesonide.
Giona Easyhaler 200 micrograms/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
Bronchial asthma requiring maintenance treatment with glucocorticoids
for control of underlying airway inflammation.
(Note: Giona Easyhaler is not suitable for the treatment of acute
asthma attacks.)
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 with mild asthma (Step 2) 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 and the dose for
periods of severe asiluua can be up to 1600 micrograms/day.
For children
_5 _
—7 years old, the starting dose and the dose for periods of severe
asthma is 200 — 400 mcg daily. For

Toote omadused

REVISED PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
Giona Easyhaler™ 100 micrograms/dose inhalation powder.
Giona Easyhaler™
200 micrograms/dose inhalation powder.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Giona Easyhaler™ 100 micrograms/dose inhalation powder : One metered
dose contains 100 micrograms of budesonide.
Giona Easyhaler™ 200 micrograms/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
Bronchial asthma requiring maintenance treatment with glucocorticoids
for control of underlying airway inflammation.
(Note: Giona Easyhaler is not suitable for the treatment of acute
asthma attacks.)
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 with mild asthma (Step 2) 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 and the dose for
periods of severe asiluua can be up to 1600 micrograms/day.
For children
_5 _
—7 years old, the starting dose and the dose for periods of sev