Brodilaten 2.5 mg/2.5 ml nebuliser solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

SALBUTAMOL SULFATE

Dostupno od:

Noridem Enterprises Limited

ATC koda:

R03AC; R03AC03

INN (International ime):

SALBUTAMOL SULFATE

Doziranje:

2.5/2.5 milligram(s)/millilitre

Farmaceutski oblik:

Nebuliser solution

Područje terapije:

Selective beta-2-adrenoreceptor agonists; terbutaline

Status autorizacije:

Not marketed

Datum autorizacije:

2019-09-13

Uputa o lijeku

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Brodilaten 1.25 mg / 2.5 mL Nebuliser solution
Brodilaten 2.5 mg / 2.5 mL Nebuliser solution
Brodilaten 5.0 mg / 2.5 mL Nebuliser solution
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, nurse 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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS THE FOLLOWING:
- Brodilaten 1.25 mg / 2.5 mL Nebuliser solution
- Brodilaten 2.5 mg / 2.5 mL Nebuliser solution
- Brodilaten 5.0 mg / 2.5 mL Nebuliser solution
In the rest of this leaflet your medicine is called Brodilaten.
WHAT IS IN THIS LEAFLET
1.
What Brodilaten is and what it is used for
2.
What you need to know before you use Brodilaten
3.
How to use Brodilaten
4.
Possible side effects
5.
How to store Brodilaten
6.
Contents of the pack and other information
1.
WHAT BRODILATEN
IS AND WHAT IT IS USED FOR
Brodilaten contains a medicine called salbutamol. This belongs to a
group of medicines called fast-
acting bronchodilators.
•
Bronchodilators help the airways in your lungs to stay open. This
makes it easier for air to get in
and out.
•
They help to relieve chest tightness, wheezing and cough.
BRODILATEN 1.25 MG/2.5 ML:
This low dose is adapted for use in children and infants only to treat
severe asthma attacks, where inhalation of high doses of salbutamol is
required.
Brodilaten is used to treat breathing problems in people with asthma
and other chest illnesses. It is
usually given to people who suffer quite badly from these conditions.
Brodilaten is also given to treat
severe attacks of asthma.
Brodilaten is a liquid contain

Svojstava lijeka

Health Products Regulatory Authority
23 June 2023
CRN00DHW7
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brodilaten 2.5 mg/2.5 ml Nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mL of nebuliser solution contain 2.50 mg salbutamol (as salbutamol
sulfate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brodilaten is indicated in adults, adolescents and children aged 4 to
11 years. Brodilaten 2.5 mg / 2.5 mL Nebuliser solution is
not indicated for babies and children under 4 years of age, see
section 4.2.
Brodilaten is indicated for treatment of severe acute exacerbations of
chronic obstructive pulmonary disease (COPD), and in the
treatment of acute severe asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly):_ 2.5 mg to 5 mg salbutamol up to four
times a day. Up to 40 mg per day can be given under strict
medical supervision in hospital.
_Paediatric Population_
Children aged 12 years and over: Dose as per adult population.
Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day.
The clinical efficacy of nebulised salbutamol in infants under 18
months is uncertain. As transient hypoxaemia may occur,
supplemental oxygen therapy should be considered.
Brodilaten is intended to be used undiluted. However, if prolonged
delivery time (more than 10 minutes) is required, the
solution may be diluted with sterile normal saline to a 1:1 dilution.
Method of administration
Brodilaten is for inhalation use only, to be breathed in through the
mouth, under the direction of a physician, using a suitable
nebuliser.
The solution should not be injected or swallowed.
For single use only. Use immediately after first opening the
single-dose container. Any solution remaining in the nebuliser
after nebulisation should be discarded.
Brodilaten may be administered from a suitable nebuliser, e.g. PARI LC
SPRINT nebuliser, af