Evrenzo

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Roxadustat

Saadav alates:

Astellas Pharma Europe B.V.

ATC kood:

B03XA05

INN (Rahvusvaheline Nimetus):

roxadustat

Terapeutiline rühm:

Antianemic preparations

Terapeutiline ala:

Anemia; Kidney Failure, Chronic

Näidustused:

Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

Toote kokkuvõte:

Revision: 3

Volitamisolek:

Authorised

Loa andmise kuupäev:

2021-08-18

Infovoldik

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVRENZO 20 MG FILM-COATED TABLETS
EVRENZO 50 MG FILM-COATED TABLETS
EVRENZO 70 MG FILM-COATED TABLETS
EVRENZO 100 MG FILM-COATED TABLETS
EVRENZO 150 MG FILM-COATED TABLETS
roxadustat
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Evrenzo is and what it is used for
2.
What you need to know before you take Evrenzo
3.
How to take Evrenzo
4.
Possible side effects
5.
How to store Evrenzo
6.
Contents of the pack and other information
1.
WHAT EVRENZO IS AND WHAT IT IS USED FOR
WHAT EVRENZO IS
Evrenzo is a medicine that increases the number of red blood cells and
haemoglobin level in your
blood. It contains the active substance roxadustat.
WHAT EVRENZO IS USED FOR
Evrenzo is used to treat adults with symptomatic anaemia that occurs
in patients with chronic kidney
disease. Anaemia is when you have too few red blood cells and your
haemoglobin level is too low. As
a result, your body might not receive enough oxygen. Anaemia can cause
symptoms such as tiredness,
weakness, or shortness of breath.
HOW EVRENZO WORKS
Roxadustat, the active substance in Evrenzo, works by increasing the
level of HIF, a substance in the
body which increases the production of red blood cells when oxygen
levels are low. By raisin

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Evrenzo
20 mg film-coated tablets
Evrenzo
50 mg film-coated tablets
Evrenzo
70 mg film-coated tablets
Evrenzo
100 mg film-coated tablets
Evrenzo
150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Evrenzo 20 mg film-coated tablets
Each tablet contains 20 mg of roxadustat.
Evrenzo 50 mg film-coated tablets
Each tablet contains 50 mg of roxadustat.
Evrenzo 70 mg film-coated tablets
Each tablet contains 70 mg of roxadustat.
Evrenzo 100 mg film-coated tablets
Each tablet contains 100 mg of roxadustat.
Evrenzo 150 mg film-coated tablets
Each tablet contains 150 mg of roxadustat.
Excipient(s) with known effect
Each 20 mg film-coated tablet contains 40.5 mg of lactose, 0.9 mg of
Allura Red AC aluminium lake
and 0.21 mg soya lecithin.
Each 50 mg film-coated tablet contains 101.2 mg of lactose, 1.7 mg of
Allura Red AC aluminium lake
and 0.39 mg soya lecithin.
Each 70 mg film-coated tablet contains 141.6 mg of lactose, 2.1 mg of
Allura Red AC aluminium lake
and 0.47 mg soya lecithin.
Each 100 mg film-coated tablet contains 202.4 mg of lactose, 2.8 mg of
Allura Red AC aluminium
lake and 0.63 mg soya lecithin.
Each 150 mg film-coated tablet contains 303.5 mg of lactose, 3.7 mg of
Allura Red AC aluminium
lake and 0.84 mg soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablets).
Evrenzo 20 mg tablets
Red, oval tablets (approximately 8 mm × 4 mm) with ‘20’ debossed
on one side.
Evrenzo 50 mg tablets
Red, oval tablets (approximately 11 mm × 6 mm) with ‘50’ debossed
on one side.
Evrenzo 70 mg tablets
3
Red, round tablets (approximately 9 mm) with ‘70’ debossed on one
side.
Evrenzo 100 mg tablets
Red, oval tab