Rolenium powder inhalation, pre-dispensed

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

fluticasone (fluticasone propionate), salmeterol (salmeterol xinafoate)

Saadav alates:

ELPEN Pharmaceutical CO.

ATC kood:

R03AK06

INN (Rahvusvaheline Nimetus):

fluticasone (fluticasone propionate), salmeterol (salmeterol xinafoate)

Annus:

100mcg/dose+ 50mcg/dose

Ravimvorm:

powder inhalation, pre-dispensed

Ühikuid pakis:

(1) inhalation device (60 doses)

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2020-04-15

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROLENIUM (100+50) MICROGRAM/DOSE INHALATION POWDER, PRE- DISPENSED
ROLENIUM (250+50) MICROGRAM/DOSE INHALATION POWDER, PRE- DISPENSED
ROLENIUM (500+50) MICROGRAM/DOSE INHALATION POWDER, PRE- DISPENSED
(FLUTICASONE PROPIONATE/SALMETEROL)
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 Rolenium is and what it is used for
2.
What you need to know before you use Rolenium
3.
How to use Rolenium
4.
Possible side effects
5.
How to store Rolenium
6.
Contents of the pack and other information
1.
WHAT ROLENIUM IS AND WHAT IT IS USED FOR
Rolenium contains two medicines, fluticasone propionate and
salmeterol:
•
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation
in the lungs.
•
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.
The doctor has prescribed this medicine to help prevent breathing
problems such as:
•
Asthma
•
Chronic Obstuctive Pulmonary Disease (COPD)
Rolenium at a dose of 500/50 micrograms, reduces the number of flare
ups of
COPD.
You must use Rolenium every day as directed by your doctor. This will
make sure
that it works properly in controlling your asthma or COPD.
2
ROLENIUM HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER
ROLENIUM SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OR
WHEEZING. IF THIS HAPPENS YOU NEED TO USE A FAST-ACTING ‘RELI

Toote omadused

1
1. NAME OF THE MEDICINAL PRODUCT
Rolenium (100+50) mcg/dose inhalation powder, pre-dispensed.
Rolenium (250+50) mcg/dose inhalation powder, pre-dispensed.
Rolenium (500+50) mcg/dose inhalation powder, pre-dispensed.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose of Rolenium contains:
100 micrograms of fluticasone propionate and 50 micrograms salmeterol
(as salmeterol
xinafoate).
250 micrograms of fluticasone propionate and 50 micrograms salmeterol
(as salmeterol
xinafoate).
500 micrograms of fluticasone propionate and 50 micrograms salmeterol
(as salmeterol
xinafoate).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asthma
Rolenium 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.
Rolenium (100+50) mcg is not appropriate in adults and children with
severe asthma.
Chronic Obstructive Pulmonary Disease (COPD)
Rolenium is indicated for the symptomatic treatment of patients with
COPD, with a FEV
1
<60% predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who
have significant symptoms despite regular bronchodilator therapy.
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: Inhalation use.
Patients should be made aware that Rolenium must be used daily for
optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Rolenium they are
receiving remains optimal and is only changed on medical advice.
THE DOSE SHOULD BE
TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS
MAINTAINED. WHERE
THE CONTROL OF SYMPTOMS IS MAINTAINED WITH THE LOWEST STRENGTH OF THE