Ventolin Evohaler 100 micrograms pressurised inhalation, suspension

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Salbutamol

Pieejams no:

IMED Healthcare Ltd.

ATĶ kods:

R03AC; R03AC02

SNN (starptautisko nepatentēto nosaukumu):

Salbutamol

Deva:

100 microgram(s)/dose

Zāļu forma:

Pressurised inhalation, suspension

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Selective beta-2-adrenoreceptor agonists; salbutamol

Autorizācija statuss:

Authorised

Autorizācija datums:

2008-08-01

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN® EVOHALER® 100 MICROGRAMS
PRESSURISED INHALATION, SUSPENSION.
salbutamol (as sulphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to
others. It may harm them, even if their signs of illness are the same
as
yours.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1 What Ventolin Evohaler is and what it is used for
2 What you need to know before you use Ventolin Evohaler
3 How to use Ventolin Evohaler
4 Possible side effects
5 How to store Ventolin Evohaler
6 Contents of the pack and other information
1 WHAT VENTOLIN EVOHALER IS AND WHAT IT IS USED FOR
Ventolin Evohaler contains a medicine called salbutamol. This belongs
to a group of medicines called fast-acting bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This
makes it easier for air to get in and out.
• They help to relieve chest tightness, wheezing and cough.
Ventolin Evohaler is for use in adults, adolescents and children. For
babies and children under 4 years of age, see Section 3.
Ventolin Evohaler is used to help prevent and treat breathing problems
in
people with asthma and chronic obstructive airways disease. Ventolin
Evohaler contains a propellant called Norflurane. This is less harmful
to
the environment than older inhalers. Older inhalers may taste
differently
to Ventolin Evohaler. This will make no difference to how your
medicine
works.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN
EVOHALER
DO NOT USE VENTOLIN EVOHALER:
• If you are allergic to salbutamol sulphate or the other ingredient
of this
medicine, listed in section 6.
WARNINGS AND PRECAUTIONS

Produkta apraksts

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 a 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 two tone blue plastic
actuator and dustcap. There is an embossed letter “V” on the
plastic case and ridged touch pad.
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 (Hydroflouroalkane (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.
Do not refrigerate or freeze.
The canister contains a pressurized liquid.
Do not expose to temperatures higher than 50°C.
Do not puncture, break or burn the canister even when apparently
empty.
Protect from frost and sunlight.
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6.5 NATURE AND CONTENTS OF CONTA