Mircera

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
07-12-2023
Tabia za bidhaa Tabia za bidhaa (SPC)
07-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
11-08-2023

Viambatanisho vya kazi:

Methoxy polyethylene glycol-epoetin beta

Inapatikana kutoka:

Roche Registration GmbH

ATC kanuni:

B03XA03

INN (Jina la Kimataifa):

methoxy polyethylene glycol-epoetin beta

Kundi la matibabu:

Antianemic preparations

Eneo la matibabu:

Anemia; Kidney Failure, Chronic

Matibabu dalili:

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).

Bidhaa muhtasari:

Revision: 29

Idhini hali ya:

Authorised

Idhini ya tarehe:

2007-07-20

Taarifa za kipeperushi

                                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
                                
                                Soma hati kamili

Tabia za bidhaa

                                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
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi Methoxy polyethylene glycol-epoetin beta

Methoxy polyethylene glycol-epoetin beta

ATC kanuni B03XA03

B03XA03

Mzalishaji au wazalishaji wadogowadogo Roche Registration GmbH

Roche Registration GmbH

INN (Jina la Kimataifa) methoxy polyethylene glycol-epoetin beta

methoxy polyethylene glycol-epoetin beta

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Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Mircera Methoxy polyethylene glycol-epoetin beta

Mircera Methoxy polyethylene glycol-epoetin beta

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