QVAR AUTOHALER 50 Mcg/Acutuation Pressurised Inhalation Soln

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

BECLOMETASONE DIPROPIONATE

제공처:

Norton Waterford

ATC 코드:

R03BA01

INN (국제 이름):

BECLOMETASONE DIPROPIONATE

복용량:

50 Mcg/Acutuation

약제 형태:

Pressurised Inhalation Soln

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Glucocorticoids

승인 상태:

Authorised

승인 날짜:

1999-07-26

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
QVAR AUTOHALER 50 & 100 MICROGRAMS PRESSURISED INHALATION, SOLUTION
Beclometasone dipropionate
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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT QVAR AUTOHALER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR AUTOHALER
3.
HOW TO USE QVAR AUTOHALER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE QVAR AUTOHALER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT QVAR AUTOHALER IS AND WHAT IT IS USED FOR
Qvar Autohaler contains the active substance beclometasone
dipropionate, which is one of a group of
medicines known as corticosteroids.
Qvar Autohaler is used to prevent the symptoms of mild, moderate, or
severe asthma in patients who require
regular treatment.
This medicine is indicated in adults and children aged 5 years and
older (see section 3, “How to use Qvar
Autohaler”).
HOW YOUR MEDICINE WORKS

Qvar Autohaler works deep in your lungs to make breathing easier by
reducing the inflammation,
swelling and irritation in the airways. This type of medicine is known
as a ‘preventer’. It needs to be
taken regularly every day, even if you have no symptoms.

This inhaler will not give immediate relief of wheezing or
breathlessness during a sudden asthma attack.
You will need to use a ‘reliever’ inhaler, which contains a
different medicine. You should still continue
to use this inhaler.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR AUTOHALER
DO NOT USE QVAR AUTOHALER IF YOU:

are allergic (hypersensitive) to beclometasone dip

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Qvar Autohaler 50 micrograms pressurised inhalation, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers Beclometasone Dipropionate 50 micrograms
ex-valve into the mouthpiece of the actuator.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution.
Pressurised aluminium container closed with a metering valve
containing a pressurised inhalation solution, inserted into a
breath actuated beige (cap) and grey (mouthpiece) plastic actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylactic anti-inflammatory treatment of reversible obstructive
airway disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
NOTE: THE RECOMMENDED TOTAL DAILY DOSE OF BECLOMETASONE DIPROPIONATE
EXTRAFINE AEROSOL FROM QVAR IS LOWER
THAN THAT FOR CURRENT BECLOMETASONE DIPROPIONATE CFC PRODUCT AND
SHOULD BE ADJUSTED TO THE INDIVIDUAL
PATIENT.
Qvar is for inhalation use only.
The patient should read the instruction leaflet before use.
As the canister is pressurised, no attempt should be made to puncture
or dispose of it by burning.
For normal hygiene, the mouth piece of your autohaler device should be
cleaned weekly with a clean dry tissue or
cloth. Do not wash or put any part of the inhaler in water.
ADULTS STARTING AND MAINTENANCE DOSE:
For mild to moderate asthma: 50 µg to 200 µg twice daily.
In more severe cases: doses up to 400 µg twice daily.
The maximum recommended daily dose in adults is 800 µg.
When patients’ symptoms remain under satisfactory control, the dose
can be gradually reduced to the minimum
effective dose to maintain control.
CHILDREN AGES FIVE YEARS AND OVER
The recommended dose for Qvar in children is 50 µg twice daily.
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