Brodilaten 1.25 mg/2.5 ml Nebuliser solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

SALBUTAMOL SULFATE

Prieinama:

Noridem Enterprises Limited

ATC kodas:

R03AC02

INN (Tarptautinis Pavadinimas):

SALBUTAMOL SULFATE

Dozė:

1.25/2.5 milligram(s)/millilitre

Vaisto forma:

Nebuliser solution

Gydymo sritis:

salbutamol

Autorizacija statusas:

Not marketed

Leidimo data:

2019-09-13

Pakuotės lapelis

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

Prekės savybės

Health Products Regulatory Authority
23 June 2023
CRN00DHW7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brodilaten 1.25 mg/2.5 ml Nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mL of nebuliser solution contain 1.25 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
Symptomatic treatmentof acute severe asthma in children and infants.
NOTE: Acute severe asthma requires hospital treatment in the intensive
care unit.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric Population(under 12 years):_
This low-dose presentation is not suitable for treating adults, but is
suitable for children and infants.
_Infants: _
For infants and toddlers under 18 months: 50 to 150 microg of
salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in
nebulised form) without generally exceeding 2.5 mg of salbutamol (i.e.
two single doses of Brodilaten 1.25 mg or one single
dose of Brodilaten 2.5 mg in nebulised form).
For toddlers over 18 months up to 2 years old: 50 to 150 microg of
salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg
in nebulized form) without generally exceeding 5 mg (i.e. four single
doses of Brodilaten 1.25 mg or one single dose of
Brodilaten5 mg in nebulised form).
_Children:_
For children aged 2 – 4 years: 50 to 150 microg of salbutamol / kg
(i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in nebulized
form) without generally exceeding 5 mg (i.e. four single doses of
Brodilaten 1.25 mg or one single dose of Brodilaten 5 mg in
nebulised form).
For children aged 4 – 11 years: 2.5 mg to 5 mg salbutamol up to four
times a day.
The duration of action of the bronchiodilatory effect of inhaled
salbutamol is between four and six hours.
Under medical supervision, the nebulisation may be repeated every 20
to 30 minutes depending on the clinical result and
tolerance of the treatment, witho