Salmeterol/Fluticasonpropionaat Sandoz 25/125 microgram, aerosol, suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FLUTICASONPROPIONAAT 125 µg/dosis ; SALMETEROLXINAFOAAT 36,3 µg/dosis SAMENSTELLING overeenkomend met ; SALMETEROL 25 µg/dosis

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

R03AK06

INN (Algemene Internationale Benaming):

FLUTICASONPROPIONAAT 125 µg/dosis ; SALMETEROLXINAFOAAT 36,3 µg/dosis SAMENSTELLING overeenkomend met ; SALMETEROL 25 µg/dosis

farmaceutische vorm:

Aërosol, suspensie

Samenstelling:

NORFLURAAN,

Toedieningsweg:

Inhalatie

Therapeutisch gebied:

Salmeterol and fluticasone

Product samenvatting:

Hulpstoffen: NORFLURAAN;

Autorisatie datum:

2017-10-26

Bijsluiter

V3
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/125 MICROGRAM, AEROSOL,
SUSPENSIE
SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/250 MICROGRAM, AEROSOL,
SUSPENSIE
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/Fluticasonpropionaat Sandoz is and what it is used
for
2. What you need to know before you use
Salmeterol/Fluticasonpropionaat Sandoz
3. How to use Salmeterol/Fluticasonpropionaat Sandoz
4. Possible side effects
5. How to store Salmeterol/Fluticasonpropionaat Sandoz
6. Contents of the pack and other information
1. WHAT SALMETEROL/FLUTICASONPROPIONAAT SANDOZ IS AND WHAT IT IS USED
FOR
Salmeterol/Fluticasonpropionaat
Sandoz
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.
Salmeterol/Fluticasonpropionaat Sandoz is not recommended for use by
children.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use Salmeterol/Fluticasonpropionaat Sandoz every day as
directed by your doctor. This will
make sure that it works properly in controlling your asthma.
Salmeterol/Fluticasonpropionaat Sandoz helps to stop breathlessness
and wheeziness coming on.
Howev

Productkenmerken

SANDOZ
Business use only
Page 1 of 22
1.3.1 spc-label-pl - common-spc - 9,346
(NL/H/3707/001-002_Change ID 167714, PAR Art. 46)
20181105
SALMETEROL XINAFOATE+FLUTICASONE PROPIONATE 25
MCG + 125 MCG / 1 DOS 25 MCG + 250 MCG / 1 DOS
PRESSURIZED INHALATION, SUSPENSION
722-2724.00 722-2725.00
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
SANDOZ
Business use only
Page 2 of 22
1.3.1 spc-label-pl - common-spc - 9,346
(NL/H/3707/001-002_Change ID 167714, PAR Art. 46)
20181105
SALMETEROL XINAFOATE+FLUTICASONE PROPIONATE 25
MCG + 125 MCG / 1 DOS 25 MCG + 250 MCG /