SALAMOL STERI-NEB

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

SALBUTAMOL SULFATE

Disponibil de la:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

Codul ATC:

R03AC02

INN (nume internaţional):

SALBUTAMOL SULFATE

Dozare:

2.5/2.5 Mg/Ml

Forma farmaceutică:

Nebuliser Solution

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

salbutamol

Statutul autorizaţiei:

Marketed

Data de autorizare:

1992-11-16

Prospect

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, pharmacist or nurse.
•
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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT SALAMOL STERI-NEB IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SALAMOL STERI-NEB
3. HOW TO USE SALAMOL STERI-NEB
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SALAMOL STERI-NEB
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT SALAMOL STERI-NEB IS AND WHAT IT
IS USED FOR
Your medicine is called Salamol Steri-Neb
2.5 mg/2.5 ml Nebuliser Solution (referred to
as Salamol Steri-Neb throughout this leaflet).
It contains a substance called salbutamol,
which belongs to a class of medicines called
bronchodilators.
Bronchodilators help manage BRONCHOSPASM
(sudden narrowing of the tubes to the lungs
caused by muscle spasm), by opening up the air
passages in the lungs for up to 4 – 6 hours after
administration.
Salamol Steri-Neb is used to treat:
•
ASTHMA
•
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
(COPD), such as chronic bronchitis and
emphysema.
If you suffer from asthma, Salamol Steri-Neb can
be used to both manage the symptoms before
they occur and to relieve symptoms once they
occur.
Salamol Steri-Neb is for use in adults,
adolescents and children aged 4 to 11 years (see
section 3, “How to use Salamol Steri-Neb”).
2
WHAT YOU NEED TO KNOW BEFORE YOU
USE SALAMOL STERI-NEB
DO NOT USE SALAMOL STERI-NEB:
•
if you are allergic to salbutamol or any of the
other ingredients of this medicine (listed in
section 6)
•
for the general management of premature
labour or threat

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salamol Steri-Neb 2.5 mg/2.5 ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Steri-Neb nebuliser solution (2.5ml) contains Salbutamol Sulphate
equivalent to 2.5 mg salbutamol
(1mg/ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
Clear, colourless to pale yellow, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salamol Steri-Nebs are indicated for the treatment or routine
management of bronchospasm. They provide short-acting
(four hours) bronchodilation in reversible airways obstruction due to
asthma and chronic obstructive pulmonary disease
(COPD)
such as chronic bronchitis and emphysema.
For
patients with asthma salbutamol
may be used to relieve
symptoms when they occur and to manage them prior to a known trigger.
Salamol
Steri-Nebs are indicated in adults,
adolescents and children 4 to 11 years.
For babies and children under 4
years of age, see section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 years and over:_
A suitable starting dose of salbutamol by wet inhalation is 2.5
milligrams.
This may be increased to 5 milligrams. Treatment may be repeated up to
four times daily.
The maximum daily dose in adults is normally 20 mg/day. In adult
dosing, up to 40 milligrams per day, can be given
under strict medical supervision in hospital for the treatment of
severe airways obstruction.
_Paediatric population:_
For children aged 4 to 11 years: A suitable starting dose of
salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated up to
four times daily.
Other pharmaceutical forms may be more appropriate for administration
in children under 4 years old.
Clinical efficacy of nebulised salbutamol in infants under 18 months
is uncertain.
As transient hypoxaemia may occur, supplemental oxygen therapy should
be considered.
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