BUDESITAN 0.5MG/2ML NEBULISER SUSPENSION 0.5mg/2ml Nebuliser Suspension
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
18-04-2024
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Ingredient activ:
BUDESONIDE
Disponibil de la:
Breath Limited
INN (nume internaţional):
BUDESONIDE
Dozare:
0.5mg/2ml
Forma farmaceutică:
Nebuliser Suspension
Statutul autorizaţiei:
Authorised
Data de autorizare:
0000-00-00
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budesitan 0.5mg/2ml Nebuliser Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains 0.25mg budesonide.
One ampoule of 2ml suspension contains 0.5mg budesonide.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nebuliser suspension
White to off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is
unsatisfactory or inappropriate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use only.
The dose should be given twice daily.
Administration once daily may be considered in cases of mild to moderate stable asthma.
INITIAL DOSAGE:
The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis.
The following doses are recommended but the minimum effective dose should always be sought:
Children aged 6 months and above:
0.25 – 1.0mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2.0 mg daily
should be considered.
Adults (including the elderly) and children/adolescents over 12 years of age:
0.5 - 2 mg daily. In very severe cases the dosage may be increased further.
MAINTENANCE DOSE:
The maintenance dose should be adjusted to meet the requirements of the individual patient taking account of the
severity of the disease and the clinical response of the patient. When the desired clinical effect has been obtained, the
maintenance dose should be reduced to the minimum required for control of the symptoms.
Children aged 6 months and above:
0.25 - 1.0mg daily.
Adults (including the elderly) and children/adole
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