VENTOLIN EVOHALER 100 Microgram Pressurised Inhalation Suspension

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

SALBUTAMOL SULFATE

Διαθέσιμο από:

LTT Pharma Limited

Φαρμακολογική κατηγορία (ATC):

R03AC02

INN (Διεθνής Όνομα):

SALBUTAMOL SULFATE

Δοσολογία:

100 Microgram

Φαρμακοτεχνική μορφή:

Pressurised Inhalation Suspension

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Selective beta-2-adrenoreceptor agonists

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-05-08

Φύλλο οδηγιών χρήσης

CHILDREN
An adult should supervise use of the inhaler in 
children.
OTHER MEDICINES AND VENTOLIN EVOHALER
Please tell your doctor, nurse or pharmacist if 
you are taking or have recently taken any other 
medicines including medicines obtained without a
prescription. 
This includes herbal medicines. Remember to
take this medicine with you if you have to go to 
hospital.
In particular tell your doctor, nurse or pharmacist
if you are taking:
•
medicines for an irregular or fast heartbeat e.g.    
propranolol 
•
other medicines for your asthma
•
medicines used to treat high blood pressure e.g.  
guanethidine and methyldopa
•
reserpine (used to treat high blood pressure or 
severe agitation)
•
tricyclic antidepressants
•
diuretics, steroids and xanthine derivatives
•
anaesthetics such as chloroform, cyclopropane  
and halothane
Tell your doctor that you are taking Ventolin if you
are going to have an operation as it may interact
with some anaesthetics.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you
may be pregnant or are planning a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
DRIVING AND USING MACHINES
Ventolin is not likely to affect you being able to
drive or use any tools or machines.
3. HOW TO USE VENTOLIN EVOHALER
Always use your Ventolin Evohaler exactly as your
doctor has told you. Check with your doctor, nurse
or pharmacist if you are not sure.
_Adults and Adolescents (children 12 years and_
_over)_
TO RELIEVE ASTHMA
One or two puffs (100 or 200 micrograms)
TO PREVENT ASTHMA
Two puffs (200 micrograms) 10-15 
minutes before exercise or exposure to a
recognised allergen.  
LONG TERM TREATMENT
Up to two puffs (200 micrograms) 4 times a day.
Children under the age of 12 years
TO RELIEVE ASTHMA
One puff (100 micrograms). Your doctor may 
increase this to two puffs (200 micrograms) if 
required.
TO PREVENT ASTHMA
One puff (100 micrograms) 10-15 minutes before
exercise or exposure to a recognised allergen.
You

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin Evohaler 100 micrograms Pressurised Inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 100 micrograms of Salbutamol (as sulphate)
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension.
_Product imported from the UK._
Pressurised inhalation suspension supplied in an aluminium can with metering valve and a blue actuator.
4 CLINICAL PARTICULARS
As per PA1077/049/010
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/049/010
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (1, 1, 1, 2- Tetrafluoroethane, HFA 134a)
.
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC. Protect from direct sunlight. Do not refrigerate or freeze.
This canister contains a pressurised liquid. Do not expose to temperatures higher than 50ºC. Do not pierce the container
even when apparently empty.
6.5 NATURE AND CONTENTS OF CONTAINER
This suspension is contained in an aluminium alloy can, internally coated with fluoropolymer and sealed with a
metering valve. Each canister is fitted into a plastic actuator incorporating an atomising nozzle and fitted with a
dustcap, in an overlabelled carton, each canister contains at least 200 metered doses.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/04/2016_
_CRN 2175825_
_page number: 1_
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM