Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Dostępny od:

Azure Pharmaceuticals Ltd

Kod ATC:

R03AK; R03AK04

INN (International Nazwa):

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Dawkowanie:

0.5mg/2.5 milligram(s)

Forma farmaceutyczna:

Nebuliser solution

Dziedzina terapeutyczna:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salbutamol and sodium cromoglicate

Status autoryzacji:

Not marketed

Data autoryzacji:

2017-03-10

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZERSEOS 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 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 are allergic to salbutamol, ipratropium bromide, a

Charakterystyka produktu

Health Products Regulatory Authority
13 February 2024
CRN00F33F
Page 1 of 10
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.
Apolyethylene 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
Treatment should be initiated and administered under medical
supervision, e.g. in the hospital setting. Home based treatment
can be recommended in exceptional cases (severe symptoms or
experienced patients requiring higher doses) when a low dose
rapid acting beta‐agonist bronchodilator has been insufficient in
providing relief after consultation with an experienced
physician.
The treatment with Zerseos nebuliser solution should always be started
with the recommended dose. (1 Unit Dose Ampoules).
In very severe cases, two unit dose ampules may be required for
symptom relief. The patient should be instructed to consult a
doctor immediately in the event of acute, rapidly worsening dyspnoea.
In addition, the patient should be warned to seek
medical advice should a reduced response become apparent.
Administration should be stopped when sufficient symptom relief
is achieved.
_The recommended dose is_
_Adults (including elderly patients and children over 12 years)_
The contents of one ampoule three or four times daily.
Repeated administration should be done at the earliest after 6 hours