Salamol Easi-Breathe CFC-Free Inhaler 100mcg

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

SALBUTAMOL

Saadav alates:

Norton Waterford 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Withdrawn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 Easi-Breathe CFC-Free Inhaler 100 micrograms Pressurised
Inhalation, Suspension.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains salbutamol sulphate equivalent to 100
micrograms per actuation.
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 and a
breath-operated actuator.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Salamol Easi-Breathe 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 Easi-Breathe 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 Easi-Breathe 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.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of
administration should only be increased on medical advice.
Adults and adolescents (children 12 years and over)
_ _
_Relief of acute bronchospasm_:
100 or 200 micrograms.
On demand use of Salamol Easi-Breathe should not exceed four times
daily. Reliance on such
supplementary use or a sudden increase in dose indicates deteriorating
asthma (see Section 4.4_).