Salamol Steri-Neb 2.5 mg/2.5 ml nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALBUTAMOL SULFATE

Available from:

Teva B.V.

ATC code:

R03AC; R03AC02

INN (International Name):

SALBUTAMOL SULFATE

Dosage:

2.5/2.5 milligram(s)/millilitre

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; salbutamol

Authorization status:

Marketed

Authorization date:

2002-11-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALAMOL STERI-NEB 2.5 MG/2.5 ML NEBULISER SOLUTION
salbutamol (as 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. 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). Salamol Steri-Neb contains a
medicine called salbutamol, which
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.
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.
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.
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�

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2022
CRN00CN84
Page 1 of 8
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 in adults, adolescents and children 4
to 11 years. For babies and children under 4 years of age,
see section 4.2.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 years and over:_
A suitable starting dose of salbutamol by wet inhalationis 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