BUDESONIDE TEVA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
BUDESONIDE
Available from:
Teva Pharma B.V.
Dosage:
0.5 mg/2ml
Pharmaceutical form:
Nebuliser Suspension
Authorization date:
2011-03-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budesonide Teva 0.5 mg/2 ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains 0.5 mg budesonide (0.25 mg/ml).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nebuliser Suspension.
A white to off white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Budesonide Nebuliser Suspension is indicated in adults, adolescents and in infants and children aged six months to 12
years.
BRONCHIAL ASTHMA
Budesonide Nebuliser Suspension is indicated for use in bronchial asthma, in patients where use of a pressurised
metered dose inhaler or dry powder device is unsatisfactory or inappropriate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The safety and efficacy of Budesonide Nebuliser Suspension in infants aged less than six months has not yet been
established.
There is no relevant use of Budesonide Nebuliser Suspension in children aged less than six months in the indication.
_Method of administration_
For inhalation use only.
Precautions to be taken before handling or administrating the medicinal product.
BUDESONIDE NEBULISER SUSPENSION IS FOR INHALATION USE. DO NOT USE A PARTIALLY USED, OPENED OR DAMAGED AMPOULE.
Budesonide Nebuliser Suspension should be administered via a suitable nebuliser, which should be designed to provide
nebulised particles of an appropriate size to permit passage of droplets into the lungs. Typically these will have a DV
(50) < 3µm and a DV (90) < 6µm.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/03/2012_
_CRN 2113955_
_page number: 1_
INITIATION OF THERAPY
When treatment is started, during periods of severe
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