Ipratropium Steri-Neb 250 micrograms/ml Nebuliser solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ipratropium bromide

Tilgjengelig fra:

Teva B.V.

ATC-kode:

R03BB; R03BB01

INN (International Name):

Ipratropium bromide

Dosering :

250 microgram(s)/millilitre

Legemiddelform:

Nebuliser solution

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Anticholinergics; ipratropium bromide

Autorisasjon status:

Marketed

Autorisasjon dato:

2002-11-14

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
IPRATROPIUM STERI-NEB 250 MICROGRAMS/ML NEBULISER SOLUTION
IPRATROPIUM BROMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Ipratropium Steri-Neb is and what it is used for
2. Before you use Ipratropium Steri-Neb
3. How to use Ipratropium Steri-Neb
4. Possible side effects
5. How to store Ipratropium Steri-Neb
6. Further information
1.
WHAT IPRATROPIUM STERI-NEB IS AND WHAT IT IS USED FOR
The name of your medicine is Ipratropium Steri-Neb 250 micrograms/ml
Nebuliser solution (called
‘Ipratropium Steri-Neb’ in the rest of this leaflet). You use it
with a device called a 'nebuliser'. This
changes your medicine into a mist for you to breathe in.
Ipratropium Steri-Neb contains a medicine called ipratropium bromide.
This belongs to a group of
medicines called bronchodilators. It is used to make breathing easier
for people who have breathing
difficulties, such as in chronic asthma or chronic obstructive
pulmonary disease (COPD). Ipratropium
Steri-Neb can be taken at the same time as medicines called 'beta
2
-agonist bronchodilators' such as
salbutamol.
Ipratropium Steri-Neb works by opening up your airways.
2.
BEFORE YOU USE IPRATROPIUM STERI-NEB
DO NOT USE IPRATROPIUM STERI-NEB:
•
You are allergic (hypersensitive) to ipratropium bromide or any of the
other ingredients listed in
section 6 of this leaflet
•
You are allergic (hypersensitive) to medicines that are similar to
Ipratropium Steri-Neb, such as
atropine.
Do not use this medicine if any of the above apply to you. If you are
not sure, talk to yo

Preparatomtale

Health Products Regulatory Authority
29 November 2021
CRN00CMY6
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ipratropium Steri-Neb 250 micrograms/ml Nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Steri-Neb containing 1ml of solution contains 250 micrograms of
Ipratropium Bromide (250 micrograms/1ml).
Each Steri-Neb containing 2ml of solution contains 500 micrograms of
Ipratropium Bromide (250 micrograms/1ml).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser Solution
Clear colourless to almost colourless sterile aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for maintenance treatment of bronchospasm associated with
chronic obstructive pulmonary disease and, when used
concomitantly with inhaled beta
2
-agonists, for treatment of acute and chronic asthma and acute
bronchospasm associated
with chronic obstructive pulmonary disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be adapted to the individual needs of the patient.
The following doses are recommended:
_Adults (including the elderly) and adolescents > 12 years of age_:
500 micrograms 3 to 4 times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable. The
time interval between the doses may be determined by the
physician.
It is advisable not to exceed the recommended daily dose during either
acute or maintenance treatment. Daily doses exceeding
2 mg in adults and adolescents > 12 years of age should only be given
under medical supervision.
PAEDIATRIC POPULATION
_Children 6-12 years of age: _
250 micrograms, up to a total daily dose of 1 mg. The time interval
between doses should be determined by a physician.
_Children 0-5 years of age (for treatment of acute asthma only):_
Since there is limited information for the use of this product in
children, the following dosage should be given under medical
supervision: 125 - 250 micrograms: (i.e. half to one ampoule of 2