Salmeterol/Fluticasonpropionaat Sandoz 25/250 microgram, aerosol, suspensie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FLUTICASONPROPIONAAT ; SALMETEROLXINAFOAAT SAMENSTELLING overeenkomend met ; SALMETEROL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

R03AK06

INN (Algemene Internationale Benaming):

Fluticasone propionate ; SALMETEROLXINAFOAAT COMPOSITION corresponding to ; SALMETEROL

farmaceutische vorm:

Aërosol, suspensie

Samenstelling:

NORFLURAAN,

Toedieningsweg:

Inhalatie

Therapeutisch gebied:

Salmeterol and fluticasone

Product samenvatting:

Hulpstoffen: NORFLURAAN;

Autorisatie datum:

2017-10-26

Bijsluiter

v2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/125 MICROGRAM, AEROSOL,
SUSPENSIE
SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/250 MICROGRAM, AEROSOL,
SUSPENSIE
Salmeterol (as salmeterol xinafoate)/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 [nationally completed name] is and what it is used for
2. What you need to know before you use [nationally completed name]
3. How to use [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains two medicines, salmeterol and
fluticasone propionate:

Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to
stay open. This makes it easier for air to get in and out. The effects
last for at least 12 hours.

Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
[Nationally completed name] is not recommended for use by children.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use [nationally completed name] every day as directed by your
doctor. This will make sure
that it works properly in controlling your asthma.
[Nationally completed name] helps to stop breathlessness and
wheeziness coming on. However
[Nationally completed name] should not be used to relieve a sudden
attack of br

Productkenmerken

Sandoz B.V.
Page 1/20
Salmeterol/Fluticasonpropionaat Sandoz 25/125 mcg, aerosol, suspensie
Salmeterol/Fluticasonpropionaat Sandoz 25/250 mcg, aerosol, suspensie
RVG 118844-5
1311-v4
1.3.1.1 Summary of Product Characteristics
Juli 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Salmeterol/Fluticasonpropionaat Sandoz 25/125 microgram, aerosol,
suspensie
Salmeterol/Fluticasonpropionaat Sandoz 25/250 microgram, aerosol,
suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
<{[NATIONALLY
COMPLETED
NAME]
25
MICROGRAMS/125
MICROGRAMS
PER
DOSE
-
PRESSURISED
INHALATION, SUSPENSION}>_ _
Each metered dose (ex valve) contains 25 micrograms of salmeterol (as
salmeterol xinafoate) and 125
micrograms of fluticasone propionate. This is equivalent to a
delivered dose (ex actuator) of 21
micrograms of salmeterol and 110 micrograms of fluticasone propionate.
<{[NATIONALLY
COMPLETED
NAME]
25
MICROGRAMS/250
MICROGRAMS
PER
DOSE
-
PRESSURISED
INHALATION, SUSPENSION}>_ _
Each metered dose (ex valve) contains 25 micrograms of salmeterol (as
salmeterol xinafoate) and 250
micrograms of fluticasone propionate. This is equivalent to a
delivered dose (ex actuator) of 21
micrograms of salmeterol and 220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The container contains a white homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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
Sandoz B.V.
Page 2/20
Salmeterol/Fluticasonpropionaat Sandoz 25/125 mcg, aerosol, suspensie
Salmeterol/Fluticasonpropionaat Sandoz 25/250 mcg, aerosol, suspensie
RVG 118844-5
1311-v4
1.3.1.1 Summary of Product Characteristics
Juli 2021
- patients already adequately controlled