Ventolin 5mg Nebules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Salbutamol sulfate

제공처:

Mawdsley-Brooks & Company Ltd

ATC 코드:

R03AC02

INN (국제 이름):

Salbutamol sulfate

복용량:

2mg/1ml

약제 형태:

Nebuliser liquid

관리 경로:

Inhalation

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 03010101

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBULES
2.5 MG AND 5 MG
SALBUTAMOL SULFATE
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, nurse 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, nurse or
pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Ventolin Nebules are and what they are used for
2 What you need to know before you use Ventolin Nebules
3 How to use Ventolin Nebules
4 Possible side effects
5 How to store Ventolin Nebules
6 Contents of the pack and other information
1 WHAT VENTOLIN NEBULES ARE AND WHAT THEY ARE USED FOR
Ventolin Nebules contain a medicine called salbutamol. This belongs to
a group of
medicines called fast-acting bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This
makes it easier
for air to get in and out.
• They help to relieve chest tightness, wheezing and cough.
Ventolin Nebules are used to treat breathing problems in people with
asthma and
other chest illnesses. They are usually given to people who suffer
quite badly from
these conditions when other forms of treatment do not help enough.
Ventolin
Nebules are also given to treat severe attacks of asthma.
A Nebule is a small plastic container that contains a liquid. The
liquid is put into a
machine called a nebuliser. This machine makes a fine mist for you to
breathe in
through a face mask.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN NEBULES
DO NOT USE VENTOLIN NEBULES IF:
• you are allergic to salbutamol sulfate or any of the other
ingredients of this
medicine (listed in Section 6).
• you unexpectedly go into early labour (premature labour) or
threatened abortion

제품 특성 요약

1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plastic ampoule containing 2.5 ml of a sterile 0.2% w/v solution of
salbutamol (as Salbutamol
Sulfate BP) in normal saline.
3.
PHARMACEUTICAL FORM
Solution for inhalation via a nebuliser.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Nebules are indicated in adults, adolescents and children,
see Section
4.2.
Salbutamol
is
a
selective
β
2-agonist
providing
short-acting
(4-6
hour)
bronchodilation
with
a
fast
onset
(within
5
minutes)
in
reversible
airways
obstruction.
Ventolin Nebules are indicated for use in the routine management of
chronic
bronchospasm unresponsive to conventional therapy, and in the
treatment of acute
severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Nebules are for inhalation use only, to be breathed in
through the mouth, under the
direction of a physician, using a suitable nebuliser.
The solution should not be injected or swallowed.
_Adults (including the elderly):_ 2.5 mg to 5 mg salbutamol up to four
times a day. Up to 40 mg per
day can be given under strict medical supervision in hospital.
_Paediatric Population _
Children aged 12 years and over: Dose as per adult population.
Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration
in children under 4 years
old.
Infants under 18 months old: Clinical efficacy of nebulised salbutamol
in infants under 18 months
is uncertain. As transient hypoxia may occur supplemental oxygen
therapy should be considered.
Ventolin Nebules are intended to be used undiluted. However, if
prolonged delivery time (more
than 10 minutes) is required, the solution may be diluted with sterile
normal saline.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
Non-IV formulations of salbutamol must not be used to arrest
uncomplicated premature labour or
threatened abortion.
4.4
SPECIAL WARNINGS AND PRECAUTIONS