SALOMOL INHALER %v/v Pressurised Inhalation Suspension

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

SALBUTAMOL

Disponibil de la:

Norton Waterford

INN (nume internaţional):

SALBUTAMOL

Dozare:

%v/v

Forma farmaceutică:

Pressurised Inhalation Suspension

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2005-11-11

Caracteristicilor produsului

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salomol Inhaler-Salbutamol Aerosol Inhalation BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 100 micrograms of salbutamol.
3 PHARMACEUTICAL FORM
Pressurised Inhalation suspension.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
4.1.1
Treatment and prophylaxis of bronchial asthma.
4.1.2
Treatment of bronchitis and emphysema and conditions with
associated reversible airways obstruction.
4.1.3
Relief of acute dyspnoea.
4.1.4
Particularly
suitable for treatment of bronchospasm in patients with co-existing
heart disease or hypertension.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
_Adults:_
(i)
Acute bronchospasm and
intermittent episodes of asthma – one of two
inhalations as a single dose.
(ii)
Chronic maintenance or prophylactic therapy – two
inhalations three or four times daily.
(iii)
To prevent exercise induced bronchospasm – two
inhalations should be taken before exertion.
_Children:_
(i)
Acute bronchospasm and
intermittent episodes of asthma or before exercise – one inhalation.
(ii)
Routine maintenance or prophylactic therapy – one inhalation
three or four times daily.
_Elderly:_
The dosage is the same as for adults.
4.3 CONTRAINDICATIONS
In spite of the fact that salbutamol has been used
intravenously and orally in the management of uncomplicated 
premature labour, salbutamol inhalation preparations should
not be used for threatened abortion.
Salomol Inhaler is contra-indicated in patients with a history
of hypersensitivity to any of its components.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Asthmatic patients whose condition
deteriorates despite salbutamol therapy, or where a previously
effective dose fails 
to give relief for at least three hours, should seek
medical advice in order that any necessary additional steps m