SALINE STERI-NEB 0.9 % W/V NEBULISER SOLUTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

ATC code:

B05XA03

INN (International Name):

SODIUM CHLORIDE

Dosage:

0.9 %w/v

Pharmaceutical form:

Nebuliser Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

sodium chloride

Authorization status:

Marketed

Authorization date:

1994-02-18

Patient Information leaflet

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 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.
IN THIS LEAFLET
1. WHAT SALINE STERI-NEB IS AND WHAT IT
IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SALINE STERI-NEB
3. HOW TO USE SALINE STERI-NEB
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SALINE STERI-NEB
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT SALINE STERI-NEB IS AND WHAT
IT IS USED FOR
Saline Steri-Neb is used to dilute
nebuliser solutions. The nebuliser turns
the solution into a fine mist which you
can breathe in.
You should carefully read the leaflet
supplied with the nebuliser solutions
before using them with Saline Steri-Neb.
2
WHAT YOU NEED TO KNOW BEFORE
YOU USE SALINE STERI-NEB
DO NOT USE SALINE STERI-NEB IF YOU:
•
are allergic (hypersensitive) to
sodium chloride or any of the other
ingredients of this medicine.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, planning to become
pregnant or breast-feeding, ask your
doctor for advice before taking any
medicine.
DRIVING AND USING MACHINES
Saline Steri-Neb is not expected to
affect your ability to drive or operate
machinery.
3
HOW TO USE SALINE STERI-NEB
Always use Saline Steri-Neb exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
You must only use Saline Steri-Neb in a
nebuliser. Do not swallow the solution or
use it in in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saline Steri-Neb 0.9% w/v Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Steri-Neb unit containing 2.5ml of solution contains 0.9%w/v
sodium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser Solution
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the dilution of solutions for nebulisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and elderly:
Use as directed by the physician.
Route of Administration
The solution to be diluted should be emptied into nebuliser following
the manufacturer’s instructions. The prescribed
amount of sodium chloride solution is added to the nebuliser. The
whole solution is then administered from a power-
operated nebuliser at an adequate flow rate, via a face mask or
mouthpiece.
4.3 CONTRAINDICATIONS
Not applicable.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable.
4.6 FERTILITY, PREGNANCY AND LACTATION
Not applicable.
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4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRABLE EFFECTS
Not applicable.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse re