IPRAMOL STERI-NEB

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

IPRATROPIUM BROMIDE MONOHYDRATE ; SALBUTAMOL SULFATE

Prieinama:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

ATC kodas:

R03AL02

INN (Tarptautinis Pavadinimas):

IPRATROPIUM BROMIDE MONOHYDRATE ; SALBUTAMOL SULFATE

Dozė:

0.5/2.5 mg/mg

Vaisto forma:

Nebuliser Solution

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

salbutamol and ipratropium bromide

Autorizacija statusas:

Marketed

Leidimo data:

2005-04-15

Pakuotės lapelis

Ipratropium/Salbutamol-IE/H/01603/001
Ipramol Steri-Neb 0.5mg / 2.5mg Nebuliser Solution
Var. PSUSA
Proposed PIL-clean-06.11.2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
IPRAMOL STERI-NEB 0.5MG / 2.5MG PER 2.5ML 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-Nebis 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 0.5mg / 2.5mg per 2.5ml
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-
Nebwill relieve wheezing, shortness of breath and chest tightness by
opening up your

Prekės savybės

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
Inhalation use.
Posology
_Adults (including elderly patients and children over 12 years):_
The content of one ampoule three or four times daily.
_Paediatric population_
The safety and efficacy of Ipramol Steri-Neb in children aged below 12
years have not been established.
Method of administration
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
parenterally.
i. Prepare the nebuliser by following the manufacturer’s
instructions and the advice of your doctor.
ii. Carefully separate a new ampoule from the strip. Never use an
ampoule that has been opened already.
iii. Open the ampoule by simply twisting off the top always taking
care to hold it in an upright position.
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