MIRCERA 360 MCG0.6 ML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Verfügbar ab:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC-Code:

B03XA01

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 360 MCG / 0.6 ML

Verabreichungsweg:

I.V, S.C

Verschreibungstyp:

Required

Hergestellt von:

ROCHE DIAGNOSTICS GmbH ,GERMANY

Therapiegruppe:

ERYTHROPOIETIN

Therapiebereich:

ERYTHROPOIETIN

Anwendungsgebiete:

Treatment of anemia associated with chronic kidney disease (CKD).

Berechtigungsdatum:

2013-04-30

Gebrauchsinformation

Mircera_PL_Ver 3.0
THIS LEAFLET WAS CHECKED AND APPROVED BY THE MINISTRY OF HEALTH IN
OCTOBER 2016 AND WAS UPDATED ACCORDING TO THE GUIDELINES OF THE
MINISTRY OF HEALTH IN MARCH 2018
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
MIRCERA
®
50 MCG/0.3 ML
75 MCG/0.3 ML
100 MCG/0.3 ML
150 MCG/0.3 ML
200 MCG/0.3 ML
360 MCG/0.6 ML
Pre-filled syringe
COMPOSITION:
Each pre-filled syringe contains:
Methoxy polyethylene glycol-epoetin beta
*For information about inactive ingredients, see section 6 -
“Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them even if it seems to you that their medical condition
is similar.
IMPORTANT INFORMATION FOR YOUR REVIEW
∙ The medicine MIRCERA is intended for subcutaneous (under the skin)
or intravenous injection and comes in a pre-filled syringe. If you are
self-injecting the medicine, follow the instructions for
self-injection
detailed at the end of the leaflet.
∙ Store the medicine in a refrigerator at a temperature of
2ºC-8ºC. Do
not freeze. Keep the syringe in its original package in order to
protect
from light.
1) WHAT IS THE MEDICINE INTENDED FOR?
MIRCERA is intended for the treatment of anaemia caused by chronic
kidney disease, in adults aged 18 years or older, manifested by
symptoms
such as tiredness, weakness and shortness of breath. This means that
you have too few red blood cells and your haemoglobin level is too low
(your body’s tissues might not receive enough oxygen).
The medicine is produced by gene technology and causes an increase in
the number of red blood cells and the haemoglobin level in your blood,
by a mechanism similar to that of the natural hormone secreted in the
body called erythropoietin.

Fachinformation

EMEA/H/C/000739/II/0068_12 2019
Mircera_PI_Ver 4.0
Page 1 of 11
MIRCERA_PI_VERSION 4.0
_ _
MIRCERA
®

_METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA _
Pre-filled syringe
50 mcg/0.3 ml, 75 mcg/0.3 ml, 100 mcg/0.3 ml, 150 mcg/0.3 ml, 200
mcg/0.3 ml, 360
mcg/0.6 ml
1.
NAME OF THE MEDICINAL PRODUCT
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled
syringe.
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled
syringe.
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled
syringe.
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled
syringe.
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled
syringe.
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled
syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 50 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 167 micrograms/ml.
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 75 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 250 micrograms/ml.
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 100 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 333 micrograms/ml.
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 150 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 500 micrograms/ml.
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 200 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 667 micrograms/ml.
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled
syringe:
One pre-filled syringe contains 360 micrograms of methoxy polyethylene
glycol-epoetin beta* at a concentration of 600 micrograms/ml.
The s