Respimix Easyhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

Страна: Швеция

Язык: шведский

Источник: Läkemedelsverket (Medical Products Agency)

Активный ингредиент:

budesonid; formoterolfumaratdihydrat

Доступна с:

Orion Corporation

код АТС:

R03AK07

ИНН (Международная Имя):

budesonide; formoterol

дозировка:

320 mikrogram/9 mikrogram/inhalation

Фармацевтическая форма:

Inhalationspulver

состав:

formoterolfumaratdihydrat 9 mikrog Aktiv substans; budesonid 320 mikrog Aktiv substans; laktosmonohydrat Hjälpämne

Тип рецепта:

Receptbelagt

Обзор продуктов:

Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 180 (3 x 60) doser

Статус Авторизация:

Godkänd

Дата Авторизация:

2017-08-25

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RESPIMIX 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 Respimix Easyhaler 320/9 is and what it is used for
2.
What you need to know before you use Respimix Easyhaler 320/9
3.
How to use Respimix Easyhaler 320/9
4.
Possible side effects
5.
How to store Respimix Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT RESPIMIX EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Respimix 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RESPIMIX EASYHALER 320/9
DO NOT USE RESPIMIX EASYHALER 320/9:
-
if you are allergic to budesonide, formoterol or the other ingredient
of this medicine (listed in
section 6), which is lactose (which contains small amounts of milk
protein)

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
Respimix 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 known effect: Lactose monohydrate 7600 micrograms per
delivered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder in a device metered inhaler (Easyhaler).
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Respimix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated
in adults and adolescents
aged 12-17 years, 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)
Respimix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated
in adults, aged 18 years
and older, for the symptomatic treatment of patients with COPD with
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
Respimix Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Respimix 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 but also
when the maintenance dose is adjusted. If an individual patient