AEROLIN AUTOHALER CFC-FREE 100 MICROGRAMS PER METE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
SALBUTAMOL SULFATE
Available from:
Norton Waterford
Dosage:
100 Mcg/Acutuation
Pharmaceutical form:
Pressurised Inhalation Suspension
Authorization date:
2002-03-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aerolin Autohaler CFC-Free 100 micrograms per metered dose Pressurised Inhalation Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation of Aerolin Autohaler CFC-Free delivers Salbutamol Sulphate Ph. Eur. equivalent to Salbutamol 100
micrograms into the mouthpiece of the adapter.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Pressurised aluminium container fitted with a 25µl metering valve and supplied with a plastic breath-activated actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aerolin Autohaler CFC-Free is indicated for the treatment of acute attacks or exacerbations of bronchial asthma and for
the treatment of reversible airways obstruction. Aerolin Autohaler CFC-Free may also be taken prophylactically before
exertion to prevent exercise-induced asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral inhalation use.
ADULTS AND CHILDREN: For the relief of acute bronchospasm and for managing intermittent episodes of asthma,
one inhalation, increasing to two inhalations if necessary.
For prevention of exercise-induced bronchospasm, one inhalation before exertion, increasing to two inhalations if
necessary.
_Adults (including the Elderly)_
On demand use of Salbutamol inhalation aerosol or powder should not exceed eight inhalations in 24 hours.
_Children_
On demand use should not exceed 4 inhalations in 24 hours.
For all patients, inhalations should not usually be repeated more often than every 4 hours.
4.3 CONTRAINDICATIONS
Hypersensitivity to salbutamol or any of the inactive ingredients in Aerolin Autohaler CFC-Free.
IRISH MEDICINES BOARD
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