Salbutamol CFC-Free Inhaler 100 micrograms per metered dose, pressurised inhalation, suspension

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Salbutamol

Saadav alates:

Valeas SPA Industria Chimica e Farmaceutica

ATC kood:

R03AC; R03AC02

INN (Rahvusvaheline Nimetus):

Salbutamol

Annus:

100 microgram(s)

Ravimvorm:

Pressurised inhalation, suspension

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Selective beta-2-adrenoreceptor agonists; salbutamol

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2011-07-27

Toote omadused

Health Products Regulatory Authority
12 November 2020
CRN00C14M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salbutamol CFC-Free Inhaler 100 micrograms per metered dose,
pressurised inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 100 micrograms of salbutamol (equivalent to
120 micrograms of salbutamol sulphate). This is
equivalent to a delivered dose of 90 micrograms of salbutamol
(equivalent to 108 micrograms of salbutamol sulphate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
Pressurised inhalation suspension supplied in an aluminium canister
with a metering valve and a plastic actuator and dust cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salbutamol CFC-Free Inhaler is indicated in adults, adolescents and
children. For babies and children under 4 years of age, see
sections 4.2 and 5.1.
Salbutamol CFC-Free Inhaler is indicated for the relief and prevention
of bronchial asthma and conditions associated with
reversible airways obstruction.
Salbutamol CFC-Free Inhaler can be used as relief medication in the
management of mild, moderate or severe asthma,
provided that its use does not delay the introduction and use of
regular inhaled corticosteroid therapy, where necessary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Salbutamol CFC-Free Inhaler is for oral inhalation use only.
Posology
ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS (CHILDREN 12 YEARS AND
OVER):
For the relief of acute bronchospasm, one inhalation (100 micrograms)
increasing to two inhalations (200 micrograms), if
necessary.
To prevent allergen- or exercise-induced symptoms, two inhalations
(200 micrograms) should be taken 10-15 minutes before
challenge.
Maximum daily dose: two inhalations (200 micrograms) up to four times
a day.
PAEDIATRIC POPULATION:
Babies and young children using Salbutamol CFC-Free Inhaler may
benefit from the use of a paediatric spacer device with a
face mask (for example the BABY