Salamol CFC-Free Inhaler

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Salbutamol sulfate 29.64mg equivalent to salbutamol 100 µg/actuation (200 doses);  

Prieinama:

Teva Pharma (New Zealand) Limited

INN (Tarptautinis Pavadinimas):

Salbutamol sulfate 29.64 mg (equivalent to salbutamol 100 µg/actuation (200 doses))

Dozė:

100 mcg/dose

Vaisto forma:

Aerosol inhaler, metered dose

Sudėtis:

Active: Salbutamol sulfate 29.64mg equivalent to salbutamol 100 µg/actuation (200 doses)   Excipient: Ethanol Norflurane

Vienetai pakuotėje:

Inhaler, metered, MDIs, actuator, 200 dose units

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Sicor (Societa Italiana Corticosteroidi) Srl

Terapinės indikacijos:

Salbutamol provides short-acting (4 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. It is suitable for long-term use in the relief and prevention of asthmatic symptoms. Salamol CFC-Free Inhaler should be used to relieve symptoms when they occur and to prevent them in those circumstances recognised by the patient to precipitate an asthmatic attack (e.g. before exercise or unavoidable allergen exposure).

Produkto santrauka:

Package - Contents - Shelf Life: Inhaler, metered, MDIs, actuator - 200 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze, puncture, break, or burn

Leidimo data:

2003-11-04

Pakuotės lapelis

NEW ZEALAND CONSUMER MEDICINE INFORMATION
SALAMOL® CFC-FREE INHALER
SALBUTAMOL (AS SULPHATE) 100 MICROGRAMS PER METERED DOSE (“PUFF”)
Please read this leaflet carefully before you start using Salamol.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Salamol CFC-Free
Inhaler. It does not
contain all the available information. It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using Salamol,
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
WHAT SALAMOL CFC-FREE INHALER IS USED FOR
Salamol works by widening the airways in your lungs to allow air in
and out. This helps you to
feel less breathless, wheezy or tight-chested. This kind of medicine
is known as a ‘Reliever’,
or a bronchodilator. Your doctor may have given you a Salamol inhaler
to treat asthma,
bronchitis, emphysema, or other breathing problems. Salamol provides
fast relief
of symptoms
(within 5 minutes), and relief for around 4-6 hours.
Salamol may also be used to prevent asthma caused by exercise or
asthma caused by a
substance that you are allergic to (e.g. house dust, pollen, dogs,
cats, cigarette smoke, etc.)
or to treat breathing difficulties which are caused by other chest
diseases.
Your doctor may have prescribed Salamol Inhaler for another reason.
Ask your doctor if you
have any questions about why Salamol has been prescribed for you.
Your doctor may have prescribed another kind of inhaler medicine to
prevent you from having
an asthma attack. This kind is known as a 'Preventer’. Your doctor
may have told you to use
the 'Preventer' inhaler in addition to your Salamol inhaler.
There is no evidence that Salamol is addictive.
Salamol is only available on a doctor's prescription.
BEFORE YOU USE SALAMOL CFC-FREE INHALER
DO NOT USE SALAMOL IF:
•
you have an allergy to Salamol, salbutamo

Prekės savybės

NEW ZEALAND DATA SHEET
SALAMOL
™
CFC-FREE INHALER
SALBUTAMOL
SULPHATE
PH.EUR.,
EQUIVALENT
TO
SALBUTAMOL
100
MICROGRAMS
PER ACTUATION, METERED DOSE INHALER
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salamol CFC-Free Inhaler is a metered dose aerosol inhaler which
delivers 100 micrograms of
salbutamol (as sulphate) per actuation (or metered dose, or "puff").
The inhaler also contains the
non-CFC propellant norflurane (or HFA134a), and Ethanol anhydrous.
Each canister contains 200
metered actuations.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Salamol CFC-Free Inhaler is a metered dose aerosol inhaler consisting
of a pressurised aluminium
canister
fitted
with
a
metered
dispensing
valve,
and
fitted
into
a
blue
colour
plastic
actuator/mouthpiece with a dark blue colour cap.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Salbutamol is a selective ß-2 adrenoceptor agonist.
At therapeutic doses it acts on the ß-2
adrenoceptors of bronchial muscle, with little or no action on the
ß-1 adrenoceptors of the heart.
With its fast onset of action, it is particularly suitable for the
management and prevention of
attack in mild asthma and for the treatment of acute exacerbations in
moderate and severe asthma.
Bronchodilators should not be the only or main treatment in patients
with severe or unstable
asthma. Severe asthma requires regular medical assessment as death may
occur. Patients with
severe asthma have constant symptoms and frequent exacerbations, with
limited physical capacity,
and PEF values below 60% predicted at baseline with greater than 30%
variability, usually not
returning entirely to normal after a bronchodilator. These patients
will require high dose inhaled
(e.g. >1mg/day beclomethason
e dipropionate) or oral corticosteroid therapy.
With this primary background corticosteroid treatment, Salamol
CFC-Free Inhaler provides essential
rescue medication
for
a severe asthmatic in
treating acute exacerbations. Failure to respond
promptly
or
fully
to
such
rescue
medication
signals
a
need
for
urgent
medical
a