Mircera
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
07-12-2023
Karatteristiċi tal-prodott
(SPC)
07-12-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
11-08-2023
Ingredjent attiv:
Methoxy polyethylene glycol-epoetin beta
Disponibbli minn:
Roche Registration GmbH
Kodiċi ATC:
B03XA03
INN (Isem Internazzjonali):
methoxy polyethylene glycol-epoetin beta
Grupp terapewtiku:
Antianemic preparations
Żona terapewtika:
Anemia; Kidney Failure, Chronic
Indikazzjonijiet terapewtiċi:
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).
Sommarju tal-prodott:
Revision: 29
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2007-07-20
Fuljett ta 'informazzjoni
53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRCERA
30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
50 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
60 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
75 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
100 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
120 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
150 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
200 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
250 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
360 MICROGRAMS/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
methoxy polyethylene glycol-epoetin beta
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What MIRCERA is and what it is used for
2.
What you need to know before you use MIRCERA
3.
How to use MIRCERA
4.
Possible side effects
5.
How to store MIRCERA
6.
Contents of the pack and other information
1.
WHAT MIRCERA IS AND WHAT IT IS USED FOR
This medicine is prescribed to you because you have anaemia caused by
your chronic kidney disease
and associated with typical 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).
MIRCERA is indicated to treat only the symptomatic an
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MIRCERA 30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
MIRCERA 40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
MIRCERA 50 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
MIRCERA 60 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 120 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 250 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 30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
One pre-filled syringe contains 30 micrograms of methoxy polyethylene
glycol-epoetin beta* at a
concentration of 100 micrograms/ml
MIRCERA 40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
One pre-filled syringe contains 40 micrograms of methoxy polyethylene
glycol-epoetin beta* at a
concentration of 133 micrograms/ml.
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 60 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
One pre-filled syringe contains 60 micrograms of methoxy polyethylene
glycol-epoetin beta* at a
concentration of 200 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
O
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