Salamol CFC-Free Inhaler 100 micrograms Pressurised Inhalation Suspension

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

SALBUTAMOL

Saadav alates:

Norton Waterford T/A IVAX Pharmaceuticals Ireland Unit 301, IDA Industrial Park, Waterford, Ireland

ATC kood:

R03AC02

INN (Rahvusvaheline Nimetus):

SALBUTAMOL 100 µg

Ravimvorm:

PRESSURISED INHALATION, SUSPENSION

Koostis:

SALBUTAMOL 100 µg

Retsepti tüüp:

POM

Terapeutiline ala:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2006-06-05

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Salamol CFC-Free Inhaler 100 micrograms Pressurised Inhalation,
Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains salbutamol sulphate equivalent to 100
micrograms salbutamol.
Excipients with known effect:
Each metered dose contains 3.93 mg ethanol anhydrous.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Pressurised container fitted with a metering valve.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Salamol is indicated for the treatment or prevention of bronchospasm.
It provides short acting (four
hours) bronchodilation in reversible airways obstruction due to asthma
and chronic obstructive
pulmonary disease (COPD) such as chronic bronchitis and emphysema. For
patients with asthma
salbutamol may be used to relieve symptoms when they occur and to
prevent them prior to a known
trigger.
Salamol is indicated in adults, adolescents and children. For babies
and children under
4
years
of
age, see sections 4.2 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Salamol is administered by the inhaled route only, to be breathed in
through the mouth.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-2 agonists may be a sign of worsening asthma.
Under these conditions a
reassessment of the patient's therapy plan may be required and
concomitant glucocorticosteroid
therapy should be considered.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer may be
used with Salamol.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of
administration should only be increased on medical advice.
Patients' inhaler technique should be checked to make sure that
aerosol actuation is synchronised with
inspiration of breath for optimum delivery of the drug to the lungs.
Adults and adolescents (children 12 years and over)
_ _
_Relief of acute bronchospasm_:
100 or