Budesonide 500micrograms2ml nebuliser liquid unit dose vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Budesonide

Commercializzato da:

Arrow Generics Ltd

Codice ATC:

R03BA02

INN (Nome Internazionale):

Budesonide

Dosaggio:

250microgram/1ml

Forma farmaceutica:

Nebuliser liquid

Via di somministrazione:

Inhalation

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 03020000; GTIN: 5060034833277

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BUDESONIDE 0.5MG & 1MG NEBULISER SUSPENSION AMPOULES PIL - UK
Black
Code Area
BBBA0475
S.Anson
26.01.17
06.12.17
S.Anson
120 x 315
8pts
Catalent
26.01.17
21.02.17
5
WHAT IS IN THIS LEAFLET:
1.
What Budesonide Nebuliser Suspension is and
what it is used for
2.
What you need to know before you use
Budesonide Nebuliser Suspension
3.
How to use Budesonide Nebuliser Suspension
4.
Possible side effects
5.
How to store Budesonide Nebuliser
Suspension
6.
Contents of the pack and other information
1.
WHAT BUDESONIDE NEBULISER SUSPENSION IS
AND WHAT IT IS USED FOR
Budesonide belongs to a group of steroids called
glucocorticoids which can be used to reduce or
prevent inflammatory reactions (inflammation) in the
lungs.
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.
This medicine may also be used for the treatment
in hospitals of very serious cases of pseudocroup
(a disease of the throat that may cause difficulty in
breathing).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
BUDESONIDE NEBULISER SUSPENSION
DO NOT USE BUDESONIDE NEBULISER SUSPENSION:
•
If you are allergic to budesonide or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before using
Budesonide Nebuliser Suspension if any of the
following apply to you:
•
If you have or have had tuberculosis
•
If you have or have had a liver disease or problems
with your liver
•

Scheda tecnica

OBJECT 1
BUDESONIDE 0.5MG NEBULISER SUSPENSION (BREATH
LTD)
Summary of Product Characteristics Updated 12-Jan-2018 | Accord-UK Ltd
1. Name of the medicinal product
Budesonide 0.5mg 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 the 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.
Very serious pseudocroup (laryngitis subglottica) in which
hospitalisation is indicated.
4.2 Posology and method of administration
POSOLOGY
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:
_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/adolescents over 12 years
of age: _
0.5 - 2.0mg daily. In very severe cases the dose