IPRATROPIUM STERI-NEB

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

ATC code:

R03BB01

INN (International Name):

IPRATROPIUM BROMIDE

Dosage:

250 Microgram/ML

Pharmaceutical form:

Nebuliser Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ipratropium bromide

Authorization status:

Not Marketed

Authorization date:

1997-11-14

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER 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 AND TALK TO
YOUR DOCTOR IF:
•
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 your doctor or
pharmacist before using Ipratropiu

Summary of Product characteristics

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.
Unless otherwise prescribed the following doses
are recommended:
_Adults (including the elderly) and children over 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 children over 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 250 micrograms in 1 ml) up to a total daily
dose