Salmeterol/Fluticasone 1A Farma 50 mikrogram/500 mikrogram/dos Inhalationspulver, avdelad dos

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

flutikasonpropionat; salmeterolxinafoat

Prieinama:

1A Farma A/S

ATC kodas:

R03AK06

INN (Tarptautinis Pavadinimas):

fluticasone propionate; salmeterol

Dozė:

50 mikrogram/500 mikrogram/dos

Vaisto forma:

Inhalationspulver, avdelad dos

Sudėtis:

flutikasonpropionat 0,5 mg Aktiv substans; salmeterolxinafoat 0,073 mg Aktiv substans; laktosmonohydrat Hjälpämne

Recepto tipas:

Receptbelagt

Produkto santrauka:

Förpacknings: Inhalator, 2 x 60 doser; Inhalator, 1 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 10 x 60 doser

Autorizacija statusas:

Avregistrerad

Leidimo data:

2017-02-17

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
[Salmeterol/Fluticasone 1A Farma, 50 microgram/500 microgram/dose,
inhalation powder,
predispensed]
SALMETEROL/FLUTICASONE PROPIONATE
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 [Salmeterol/Fluticasone 1A Farma] is and what it is used for
2. What you need to know before you use [Salmeterol/Fluticasone 1A
Farma]
3. How to use [Salmeterol/Fluticasone 1A Farma]
4. Possible side effects
5. How to store [Salmeterol/Fluticasone 1A Farma]
6. Contents of the pack and other information
1.
WHAT [SALMETEROL/FLUTICASONE 1A FARMA] IS AND WHAT IT IS USED FOR
[Salmeterol/Fluticasone 1A Farma] is used to treat:

asthma

chronic obstructive pulmonary disease (COPD)
This disease is characterized by continuous breathing difficulties
caused by narrowed
airways, often accompanied with coughing and phlegm. This medicine
reduces the
number of flare ups of COPD symptoms.
This medicine contains two active substances.

Salmeterol: a long-acting substance that widens the airways

Fluticasone: a corticosteroid which reduces swelling and inflammation
in the lungs
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [SALMETEROL/FLUTICASONE 1A FARMA]
DO NOT USE [SALMETEROL/FLUTICASONE 1A FARMA]

if you are
ALLERGIC
to salmeterol, fluticasone or to the other ingredient of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using [Salmeterol/Fluticasone
1A Farma] if you
have:

heart disease, including an irregular or fas

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
{Salmeterol/Fluticasone 1A Farma, 50 microgram/250 microgram/dose,
inhalation powder, pre-
dispensed}
{Salmeterol/Fluticasone 1A Farma, 50 microgram/500 microgram/dose,
inhalation powder, pre-
dispensed}
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of {Salmeterol/Fluticasone 1A Farma} provides:
For 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of salmeterol (as salmeterol xinafoate) and 233
micrograms of fluticasone propionate
Excipient with known effect
Lactose monohydrate: 12.20 mg per metered dose
Each metered dose of {Salmeterol/Fluticasone 1A Farma} provides:
For 50 microgram/500 microgram/dose, inhalation powder, pre-dispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of salmeterol (as salmeterol xinafoate) and 465
micrograms of fluticasone propionate
Excipient with known effect
Lactose monohydrate: 11.95 mg per metered dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White, homogenous powder.
The pre-dispensed powder, contained in blister, is delivered by a
purple plastic dry-powder inhalation
device.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
{Salmeterol/Fluticasone 1A Farma} is indicated in the regular
treatment of asthma where use of a
combination product (long-acting β
2
agonist and inhaled corticosteroid) is appropriate:

patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-acting
β
2
agonist
or

patients already adequately controlled on both inhaled corticosteroid
and long-acting β
2
agonist.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
{Salmeterol/Fluticasone 1A Farma} is indicated for the symptomatic
t