Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

제공처:

Chiesi Limited

ATC 코드:

R03AK; R03AK08

INN (국제 이름):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

복용량:

100/6 Mcg/Dose

약제 형태:

Inhalation powder

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone

승인 상태:

Not marketed

승인 날짜:

2018-01-19

환자 정보 전단

C
ONFIDENTIAL
CTD 1.3.1
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSTAIR NEXTHALER 100 MICROGRAMS/6 MICROGRAMS PER METERED DOSE
INHALATION POWDER
FOR USE IN ADULTS
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate
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.
WHAT IS IN THIS LEAFLET
1.
What Fostair Nexthaler is and what it is used for
2.
What you need to know before you use Fostair Nexthaler
3.
How to use Fostair Nexthaler
4.
Possible side effects
5.
How to store Fostair Nexthaler
6.
Contents of the pack and other information
1.
WHAT FOSTAIR NEXTHALER IS AND WHAT IT IS USED FOR
Fostair Nexthaler is a powder that is inhaled through your mouth and
delivered deeply into
your lungs. It contains two active ingredients: beclometasone
dipropionate anhydrous and
formoterol fumarate dihydrate.
-
Beclometasone dipropionate belongs to a group of medicines called
corticosteroids
which
have an anti-inflammatory action reducing the swelling and irritation
in your lungs.
-
Formoterol fumarate dihydrate belongs to a group of medicines called
long-acting
bronchodilators. These relax the muscles in your airways, widening the
airways so that it
is easier for you to breathe air in and out of your lungs.
These two active substances make breathing easier by providing relief
from symptoms such as
shortness of breath, wheezing and coughing in patients with asthma or
COPD and also help to
prevent asthma symptoms.
ASTHMA
Fostair Nexthaler is used to treat asthma in adults.
If you are prescribed Fostair Nexthaler it is likely tha

제품 특성 요약

Health Products Regulatory Authority
21 January 2019
CRN008JNW
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair Nexthaler 100 micrograms/6 micrograms per metered dose
inhalation
powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of 10 mg inhalation powder contains:
100 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (the dose leaving the
mouthpiece) of 81.9
micrograms
of
beclometasone
dipropionate
anhydrous
and
5.0
micrograms
of
formoterol fumarate dihydrate.
Excipients with known effect:
Each inhalation contains 9.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Fostair Nexthaler is indicated in the regular treatment of asthma
where use of a
combination
product
(inhaled
corticosteroid
and
long-acting
beta
2
-agonist)
is
appropriate:
- patients not adequately controlled with inhaled corticosteroids and
'as needed'
inhaled short-acting beta
2
-agonist or
-
patients
already
adequately
controlled
on
both
inhaled
corticosteroids
and
long-acting beta
2
-agonists.
Fostair Nexthaler is indicated for adult patients.
COPD
Health Products Regulatory Authority
21 January 2019
CRN008JNW
Page 2 of 24
Symptomatic treatment of patients with severe COPD (FEV
1
< 50% predicted normal)
and a history of repeated exacerbations, who have significant symptoms
despite
regular therapy with long-acting bronchodilators.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fostair Nexthaler is for inhalation use.
ASTHMA
Fostair Nexthaler is not intended for the initial management of
asthma. The dosage
of Fostair Nexthaler is individual and should be adjusted to the
severity of the
disease. This should be considered not only when treatment with
combination
products is initiated but also when the dose is adjusted. If an