NOVOLIZER SALBUTAMOL 100mcg Microgram Powder for Inhalation

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

SALBUTAMOL

Saadav alates:

Meda Health Sales Ireland Limited

ATC kood:

R03AC02

INN (Rahvusvaheline Nimetus):

SALBUTAMOL

Annus:

100mcg Microgram

Ravimvorm:

Powder for Inhalation

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Selective beta-2-adrenoreceptor agonists

Volitamisolek:

Authorised

Loa andmise kuupäev:

2006-07-14

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOLIZER SALBUTAMOL
100 micrograms / dose Inhalation Powder
Salbutamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
This medicine has been prescribed for you. 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Novolizer Salbutamol is and what it is used for
2.
What you need to know before you use Novolizer Salbutamol
3.
How to use Novolizer Salbutamol
4.
Possible side effects
5.
How to store Novolizer Salbutamol
6.
Contents of the pack and other Information
1.
WHAT NOVOLIZER SALBUTAMOL IS AND WHAT IT IS USED FOR
Novolizer Salbutamol is indicated in adults, adolescents and children
aged 6 to 12 years.
The active substance in Novolizer Salbutamol is an anti-asthmatic
agent for bronchodilation (beta
sympathomimetic agent).
Novolizer Salbutamol is used for
- Symptomatic treatment of conditions with associated reversible
airway obstruction, e.g. asthma or
chronic obstructive pulmonary disease (COPD) with a substantial
component of reversibility.
- Prevention of asthma attacks induced by exercise or exposure to
allergens.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOLIZER SALBUTAMOL
DO NOT USE NOVOLIZER SALBUTAMOL if you are allergic (hypersensitive)
to Salbutamol or to lactose
and/or to the milk protein contained therein.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Novolizer Salbutamol
TAKE SPECIAL CARE IN USING NOVOLIZER SALBUTAMOL ,
if you are suffering from one of the following conditions
-
Severe cardiac disease, in particular fresh myocardial infarction,
-
Disease of the coronary vessels (coronary heart disease), a cer

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Novolizer Salbutamol 100 micrograms/dose inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One delivered dose contains 100 micrograms of salbutamol equivalent to
120 micrograms of salbutamol sulphate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient:
11.42 milligrams of lactose monohydrate/delivered dose.
3 PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Novolizer Salbutamol is indicated in adults, adolescents and children
aged 6 to 12 years.
Symptomatic treatment of conditions with associated reversible airway
obstruction, e.g. asthma or chronic obstructive
pulmonary disease with a substantial component of reversibility.
Prevention of asthma attacks induced by exercise or exposure to
allergens.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the type, severity, and course of the disorder.
_Asthma_
Adults (including older and adolescents)
For the relief of acute symptoms including bronchospasm a starting
dose of one inhalation (100 micrograms) is
recommended for adults.
For prevention of exercise-induced or allergen induced symptoms two
inhalations (200 micrograms) should be taken
10-15 minutes prior to challenge.
The maximum on-demand use in any 24 hours should not exceed 8
inhalations (equivalent to 800 micrograms).
Children (aged 6 to 12 years)
For the relief of acute symptoms including bronchospasm a starting
dose of one inhalation (100 micrograms) is
recommended for children aged 6 years and above.
For prevention of exercise-induced or allergen induced symptoms one
inhalation (100 micrograms) should be taken 10-
15 minutes prior to challenge and a further inhalation (to a total of
200 micrograms), if necessary.
The maximum on-demand use in any 24 hours should not exceed 4
inhalations (equivalent to 400 micrograms).
Children below 6 years of age
Novolizer Salbutamol is not recommended for use in chi