BUDESONIDE TEVA 0.5 mg/2ml Nebuliser Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUDESONIDE

Available from:

Teva Pharma B.V.

INN (International Name):

BUDESONIDE

Dosage:

0.5 mg/2ml

Pharmaceutical form:

Nebuliser Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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PE2852
P2 1.5.14
Budesonide 0.5mg/2ml
CS108 Leaflet flat size 250x340mm, folded size 63x63mm
BlackU 
Pantone GreenU

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DM PE2852
EI
 PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
•   Keep this leaflet. You may need to read it again.
•   If you have any further questions, ask your 
doctor or pharmacist.
•   This medicine has been prescribed for you only. 
Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as 
yours.
•   If you get any side effects, talk to your doctor 
or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET: 
1.  WHAT BUDESONIDE TEVA NEBULISER SUSPENSION IS 
AND WHAT IT IS USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE YOU USE 
BUDESONIDE TEVA NEBULISER SUSPENSION
3.  HOW TO USE BUDESONIDE TEVA NEBULISER 
SUSPENSION
4. POSSIBLE SIDE E

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 the 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.
Budesonide Nebuliser Suspension is indicated for the 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.
Precautions to be taken before handling or administrating the medicinal product:
DO NOT USE A PARTIALLY USED, OPENED OR DAMAGED AMPOULE.
Budesonide Nebuliser Suspension should be administered via a suitable nebuliser. The dose delivered to the patient
varies depending on the nebulising equipment used. The nebulisation time and the dose delivered is dependent upon the
flow rate, the volume of the nebulisation chamber and the fill volume. An air-flow of 6 – 8 litres per minute through the
device should be employed. A suitable fill volume for most nebulisers is 2 – 4 ml.
BRONCHIAL ASTHMA
INITIATION OF THERAPY
When treatment is started, during periods of severe asthma and while reducing or discontinuing oral
IRISH MEDI