Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ipratropium bromide; SALBUTAMOL SULFATE

Available from:

Teva B.V.

ATC code:

R03AL; R03AL02

INN (International Name):

Ipratropium bromide; SALBUTAMOL SULFATE

Dosage:

0.5/2.5 mg/mg

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergics in combination with anticholinergics; salbutamol and ipratropium bromide

Authorization status:

Marketed

Authorization date:

2005-04-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IPRAMOL STERI-NEB 0.5 MG/2.5 MG PER 2.5 ML NEBULISER SOLUTION
IPRATROPIUM BROMIDE AND SALBUTAMOL
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 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.
WHAT IS IN THIS LEAFLET
1.
What Ipramol Steri-Neb is and what it is used for
2.
What you need to know before you use Ipramol Steri-Neb
3.
How to use Ipramol Steri-Neb
4.
Possible side effects
5.
How to store Ipramol Steri-Neb
6.
Contents of the pack and other information
1.
WHAT IPRAMOL STERI-NEB IS AND WHAT IT IS USED FOR
Your medicine is called Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml
Nebuliser Solution. The active
ingredients are ipratropium bromide and salbutamol sulfate.
Ipratropium bromide and salbutamol both
belong to a group of medicines called bronchodilators, which help to
improve your breathing by
opening up your airways. This is achieved by preventing the
contraction of the smooth muscles
surrounding the airways, therefore allowing the airways to remain
open. Ipratropium bromide acts by
blocking the nerve signals that go to the muscles surrounding the
airways, and salbutamol acts by
stimulating specific receptors in the muscles.
Ipramol
Steri-Neb
is
used
to
treat
breathing
problems
in
people
with
long-standing
breathing
difficulties in an illness called ‘chronic obstructive pulmonary
disease’ or ‘COPD’. Ipramol Steri-Neb
will relieve wheezing, shortness of breath and chest tightness by
opening up your airways.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IPRAMOL STERI-NEB
DO NOT USE IPRAMOL STERI-NEB:

if you are allergic to ipr

Summary of Product characteristics

Health Products Regulatory Authority
03 June 2022
CRN00CG0V
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ipramol Steri-Neb 0.5mg / 2.5mg per 2.5ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml ampoule contains 0.5 mg ipratropium bromide (as the
monohydrate) and 2.5 mg salbutamol (as the sulfate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A low density polyethylene ampoule containing a colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ipramol Steri-Neb is indicated in adults, adolescents and children
aged 12 years and above.
Ipramol Steri-Neb is indicated for the management of bronchospasm in
patients suffering from chronic obstructive pulmonary
disease (COPD) who require regular treatment with both ipratropium
bromide and salbutamol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In situations of acute dyspnea (difficulty breathing) or rapid
worsening of dyspnea, patients should be advised to immediately
consult a doctor or the nearest hospital if additional inhalations of
Ipramol Steri-Neb do not produce adequate improvement.
Posology
_Adults (including elderly patients and children over 12 years):_ The
content of one ampoule three or four times daily.
Ipramol Steri-Neb has not been studied in patients with liver or
kidney failure and should be used with caution in these patient
populations.
_Paediatric population_
The safety and efficacy of Ipramol Steri-Neb in children aged below 12
years have not been established.
Method of administration
Inhalation use.
Ipramol Steri-Neb may be administered from a suitable nebuliser or an
intermittent positive pressure ventilator after the single
dose ampoule has been opened and its contents transferred to the
nebuliser chamber. Administration should be in accordance
with the manufacturer's instructions for the devices. The solution in
the single dose ampoules is intended for inhalation use
only and should not be taken orally or administered paren