SALBUTAMOL CFC - FREE INHALER 100 Microgram Pressurised Inhalation Suspension

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

SALBUTAMOL SULFATE

Dostopno od:

Norton Waterford

INN (mednarodno ime):

SALBUTAMOL SULFATE

Odmerek:

100 Microgram

Farmacevtska oblika:

Pressurised Inhalation Suspension

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2007-02-19

Lastnosti izdelka

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salbutamol CFC-Free 100 micrograms, pressurised inhalation,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation delivers Salbutamol Sulphate equivalent to
Salbutamol 100 micrograms per metered (ex valve) dose.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
A homogenous creamy white to greyish white suspension.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Salbutamol CFC-Free is indicated
for the treatment of acute attacks or exacerbations of bronchial asthma and
for the 
treatment of reversible airways obstruction.
Salbutamol CFC-Free may also be taken prophylactically
before exertion 
to prevent exercise-induced asthma.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
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.
ELDERLY: No special dosage recommendations are made for elderly
patients.
For all patients, the maximum recommended dose should not exceed
eight inhalations in 24 hours. With repetitive 
dosing, inhalations should not usually be repeated more often than
every 4 hours. For patients requiring a spacer 
device the Aerochamber has been shown to be compatible with
Salbutamol CFC-Free.
4.3 CONTRAINDICATIONS
Hypersensitivity to salbutamol or any
of the inactive ingredients in Salbutamol CFC-Free.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Salbutamol causes peripheral vasodilation which may result in
reflex tachycardia and increased cardiac output.
Caution should be used in patients suffering from angina,
severe tachycardia or thyrotoxicosis.
IRISH MEDICINES BO