ZERSEOS

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

IPRATROPIUM BROMIDE MONOHYDRATE ; SALBUTAMOL SULFATE

זמין מ:

Cipla (EU) Limited

קוד ATC:

R03AK04

INN (שם בינלאומי):

IPRATROPIUM BROMIDE MONOHYDRATE ; SALBUTAMOL SULFATE

כמות:

0.5mg/2.5 Milligram

טופס פרצבטיות:

Nebuliser Solution

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

salbutamol and sodium cromoglicate

מצב אישור:

Authorised

תאריך אישור:

2017-03-10

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZERSEOS 0.5 MG/2.5 MG 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 any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zerseos is and what it is used for
2.
What you need to know before you use Zerseos
3.
How to use Zerseos
4.
Possible side effects
5.
How to store Zerseos
6.
Contents of the pack and other information
1.
WHAT ZERSEOS IS AND WHAT IT IS USED FOR
Your medicine is called Zerseos. The active ingredients are
ipratropium bromide and salbutamol.
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 the beta
2
receptors in
the muscles.
Zerseos is used to treat breathing problems in patients over 12 years
of age with long-
standing breathing difficulties (chronic obstructive pulmonary disease
such as chronic
bronchitis, emphysema). Zerseos will relieve wheezing, shortness of
breath and chest
tightness.
You use it with a device called a ‘nebuliser’. This changes your
medicine into a mist for
you to breathe in.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZERSEOS
DO NOT USE ZERSEOS:

if you know that you have an enlarged heart or a condition k

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml single dose ampoule contains 0.5 mg ipratropium bromide
(as 525 micrograms ipratropium bromide
monohydrate) and 2.5 mg salbutamol (as sulphate).
Excipient with known effects
Each 2.5 ml single dose ampoule contains 8.8 mg sodium
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A polyethylene ampoule containing clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zerseos is indicated in the treatment of bronchospasm in patients
older than 12 years of age with chronic obstructive
pulmonary disease who require symptomatic treatment with both
ipratropium bromide and salbutamol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dose_
_Adults (including elderly patients and children over 12 years)_
The content of one ampoule three or four times daily.
Repeated administration should be done at the earliest after 6 hours.
The daily dosage should not exceed 4 ampoules.
_Paediatric population_
Zerseos is not recommended in children below 12 years of age due to
lack of data on safety and efficacy.
_Renal or hepatic impairment_
No data are available. Zerseos has not been studied in patients with
renal or hepatic impairment and should therefore
be administered with caution in these patients.
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