Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Budesonide

थमां उपलब्ध:

Teva Pharma B.V.

ए.टी.सी कोड:

R03BA; R03BA02

INN (इंटरनेशनल नाम):

Budesonide

डोज़:

0.5 mg/2ml

फार्मास्यूटिकल फॉर्म:

Nebuliser suspension

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Glucocorticoids; budesonide

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2014-03-07

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUDESONIDE TEVA PHARMA 0.5 MG/2 ML NEBULISER SUSPENSION
BUDESONIDE TEVA PHARMA 1 MG/2 ML NEBULISER SUSPENSION
budesonide
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 Pharma Nebuliser Suspension is and what it is
used for
2.
What you need to know before you use Budesonide Teva Pharma Nebuliser
Suspension
3.
How to use Budesonide Teva Pharma Nebuliser Suspension
4.
Possible side effects
5.
How to store Budesonide Teva Pharma Nebuliser Suspension
6.
Contents of the pack and other information
1.
WHAT BUDESONIDE TEVA PHARMA NEBULISER SUSPENSION IS AND WHAT IT IS
USED FOR
Budesonide belongs to a group of steroids called glucocorticosteroids
which can be used to reduce or prevent
inflammatory reactions (swelling) in the lungs.
This medicine can be used in adults, adolescents, children and infants
aged 6 months and older.
Your medicine is used for the treatment of asthma. It is used in
patients where other types of inhaler, such as
a pressurised inhaler or an inhaler containing a dry powder are
unsatisfactory or inappropriate.
Budesonide Nebuliser suspension can also be used to treat very serious
pseudocroup (laryngitis subglottica)
in infants and children who are in hospital.
Budesonide Nebuliser suspension can also be given for the treatment of
lung attacks in chronic obstructive
pulmonary disease (COPD) as an alternative to systemic (oral and/or
injection) anti-inflammatories, only
after suitable training in the use of this nebulised medic

उत्पाद विशेषताएं

Health Products Regulatory Authority
10 October 2022
CRN00D0ZX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension:
Each ampoule of 2 ml suspension contains 0.5 mg budesonide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser suspension.
A white to off white suspension in a single dose ampoule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Budesonide Nebuliser Suspension is indicated in adults, adolescents,
children and infants aged six months and older.
_Asthma_
Budesonide Nebuliser Suspension is indicated for the use in persistent
bronchial asthma, in patients where use of a pressurised
inhaler or dry powder formulation is unsatisfactory or inappropriate.
_Pseudocroup_
Very serious pseudocroup (laryngitis subglottica), in which
hospitalisation is indicated.
_Chronic obstructive pulmonary disease (COPD)_
Exacerbations of chronic obstructive pulmonary disease (COPD) as an
alternative to systemic corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_General_
Budesonide Nebuliser Suspension are nebulised using a suitable
nebuliser (jet nebuliser with mouthpiece and face mask). The
amount of budesonide that reaches the patient when administered via a
nebuliser varies and depends on the following factors,
among others:
• nebulisation time
• the volume used;
• the properties of the nebuliser;
• the ratio of inspiratory and expiratory volume of the patient and
the dead space;
• the use of face mask or mouthpiece.
_ASTHMA_
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.
Healt