Bufomix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation powder

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Budesonide; Formoterol fumarate dihydrate

থেকে পাওয়া:

Orion Corporation

এটিসি কোড:

R03AK; R03AK07

INN (International Name):

Budesonide; Formoterol fumarate dihydrate

ডোজ:

320/9 microgram(s)

ফার্মাসিউটিকাল ফর্ম:

Inhalation powder

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2014-04-11

তথ্য লিফলেট

1
QR Code to URL: oeh.fi/bfie
Scan this code or visit www.oeh.fi/bfie to see instructions on how to
use Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFOMIX EASYHALER, 320 MICROGRAMS/9 MICROGRAMS/INHALATION, INHALATION
POWDER
Budesonide/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 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 Bufomix Easyhaler 320/9 is and what it is used for
2.
What you need to know before you use Bufomix Easyhaler 320/9
3.
How to use Bufomix Easyhaler 320/9
4.
Possible side effects
5.
How to store Bufomix Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT BUFOMIX EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Bufomix Easyhaler is an inhaler that is used to treat asthma in adults
and adolescents aged 12 – 17 years. It
is also used to treat the symptoms of Chronic Obstructive Pulmonary
Disease (COPD) in adults aged 18
years and older. It contains two different medicines: budesonide and
formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and
preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting beta
2
adrenoceptor
agonists’ or ‘bronchodilators’. It works by relaxing the muscles
in your airways. This helps you to
breathe more easily.
ASTHMA
For asthma, your doctor will prescribe two asthma inhalers: Bufomix
Easyhaler 320/9 and a separate
‘reliever inhaler’.

Use Bufomix Easyhaler every day. Thi

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
28 October 2022
CRN00D3F7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bufomix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation
powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
320 micrograms/inhalation and formoterol fumarate dihydrate 9
micrograms/inhalation.
With the Easyhaler device the delivered dose (ex-actuator) contains
similar quantity of active substance as the metered dose
(ex-reservoir).
Excipients with a known effect: Lactose monohydrate 7600 micrograms
per delivered dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powderin a device metered inhaler (Easyhaler).
White to yellowish powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Bufomix Easyhaler is indicated in adults and adolescents (12 years and
older) for the regular treatment of asthma where use of
a combination (inhaled corticosteroid and long-acting β
2
-adrenoceptor agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short‑acting β
2
-adrenoceptor
agonists.
or
- patients already adequately controlled on both inhaled
corticosteroids and long‑acting β
2
-adrenoceptor agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Bufomix Easyhaler is indicated in adults, aged 18 years and older, for
the symptomatic treatment of patients with COPD with
forced expiratory volume in 1 second (FEV
1
) < 70% predicted normal (post-bronchodilator) and an exacerbation
history despite
regular bronchodilator therapy (see also section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ASTHMA
Bufomix Easyhaler is not intended for the initial management of
asthma. The dosage of the components of Bufomix Easyhaler
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 bu