qanastek/EMEA-V3 huggingface dataset:
One pre-filled syringe contains 600 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 1000 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 600 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 1000 mikrogramma/ ml.
114 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
128 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) over a month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
129 Jekk ir- rata taż- żjieda fl- emoglobina hija ta ’ aktar minn 2 g/ dl (1. 24 mmol/ l) fuq medda ta ’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
115 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
Minħabba li l- esperjenza bil- kura hija limtata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
130 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
116 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
There is no evidence that MIRCERA alters the metabolism of other medicinal products.
Ma hemmx evidenza li MIRCERA tbiddel il- metaboliżmu ta ’ mediċini oħra.
Lactation:
131 Treddigħ:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
133 konċentrazzjonijiet ta ’ l- emoglobina inqas minn 13 g/ dl, mhux ċar minħabba li numru żgħir ta ’ pazjenti b’ dawn il- karatteristiċi kienu inklużi fl- analiżi tat- tagħrif.
119 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
120 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħieh mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
MIRCERA 800 micrograms/ 0.6 ml solution for injection in pre-filled syringe
MIRCERA 800 mikrogramm/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 800 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 1333 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 800 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 1333 mikrogramma/ ml.
122 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
137 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) over a month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Jekk ir- rata taż- żjieda fl- emoglobina hija ta ’ aktar minn 2 g/ dl (1. 24 mmol/ l) fuq medda ta ’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
123 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
138 Minħabba li l- esperjenza bil- kura hija limtata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
139 ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
124 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
4.8 Undesirable effects
140 4. 8 Effetti mhux mixtieqa
Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
Il- piż
The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
141 molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
Patients were randomized to stay on their treatment at thetime of enrollment or to be switched to MIRCERA in order to maintain stable haemoglobin levels.
Il- pazjenti kienu randomised biex jibqgħu fuq il - kura li kellhom meta daħlu fl- istudju jew biex jinqalbu għal MIRCERA biex b’ hekk iżommu livelli stabbli ta ’ emoglobina.
At the evaluation period (week 29-36), the mean and median level of haemoglobin in patients treated with MIRCERA was virtually identical to their baseline haemoglobin level.
Fil- perijodu ta ’ evalwazzjoni (ġimgħa 29- 36), il- livell medju u medjan ta ’ emoglobina f’ pazjenti kkurati b’ MIRCERA kien prattikament identiku għall- livell ta ’ emoglobina fil - linja bażi tagħhom.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
142 Wara amministrazzjoni taħt il- ġilda lill- pazjenti b’ CKD mhux fuq dijalisi, il- konċentrazzjonijiet massimi fis- serum ta ’ Mmethoxy polyethylene glycol- epoetin beta kienu osservati 95 siegħa (valur medjan) wara l- amministrazzjoni.
127 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Water for injections
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine
6.2 Incompatibilities
143 Poloxamer 188 Ilma għall- injezzjonijiet
128 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħieh mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
MIRCERA 30 micrograms/ 0.3 ml solution for injection in pre-filled syringe.
MIRCERA 30 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 30 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 100 mikrogramma/ ml.
130 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
146 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
Previous weekly Previous weekly darbepoetin alfa epoetin intravenous or intravenous or
(IU/ ġimgħa)
Monthly MIRCERA intravenous or subcutaneous dose
(mikrogramma/ darba
subcutaneous dose subcutaneous dose (microgram/ week) (IU/ week) < 40< 8000 40- 80 8000-16000 > 80 > 16000
8000- 16000 > 16000
131 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
147 Minħabba li l- esperjenza bil- kura hija limitata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
148 ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
132 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
4.8 Undesirable effects
149 150 4. 8 Effetti mhux mixtieqa
The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
151 molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
Four randomized controlled studies were performed in dialysis patients currently treated with darbepoetin alfa or epoetin at the time of enrollment.
Erba ’ studji randomised ikkontrollati, twettqu fuq pazjenti fuq dijalisi li kienu qed jiġu kkurati b’ darbepoetin alfa jew epoetin meta daħlu fl- istudju.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
152 Wara amministrazzjoni taħt il- ġilda lill- pazjenti b’ CKD mhux fuq dijalisi, il- konċentrazzjonijiet massimi fis- serum ta ’ methoxy polyethylene glycol- epoetin beta kienu osservati 95 siegħa (valur medjan) wara l- amministrazzjoni.
135 Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/ h per kg.
Wara amministrazzjoni ġol- vina lill- pazjenti b’ CKD fuq id- dijalisi, it- tneħħija sistemika totali kienet 0. 494 ml/ h kull kg.
A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
When MIRCERA was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Meta methoxy polyethylene glycol- epoetin beta ngħata taħt il- ġilda lill- firien irġiel u nisa qabel u waqt it- tgħammir, l- abbiltà riproduttiva, l- fertilità u parametri ta ’ stima ta ’ l- isperma ma kinux affettwati.
136 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħiih mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
137 1.
155 1.
MIRCERA 40 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 40 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 40 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 133 mikrogramma/ ml.
138 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
156 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
139 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
157 Minħabba li l- esperjenza bil- kura hija limitata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
158 ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
140 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
4.8 Undesirable effects
159 160 4. 8 Effetti mhux mixtieqa
The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
161 molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Wara amministrazzjoni taħt il- ġilda lill- pazjenti b’ CKD mhux fuq dijalisi, il- konċentrazzjonijiet massimi fis- serum ta ’ methoxy polyethylene glycol- epoetin beta kienu osservati 95 siegħa (valur
143 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
6.2 Incompatibilities
163 6. 2 Inkompatibilitajiet
144 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħiih mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
145 1.
165 1.
MIRCERA 60 micrograms/ 0.3 ml solution for injection in pre-filled syringe.
MIRCERA 60 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 200 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 60 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 200 mikrogramma/ ml.
146 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
166 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
147 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
167 Minħabba li l- esperjenza bil- kura hija limtata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
Elderly patients In clinical studies 24% of patients treated with MIRCERA were ageg 65 to 74 years, while 20% were ageg 75 years and over.
Pazjenti anzjani Fi istudji kliniċi 24% tal- pazjenti kkurati b’ MIRCERA kellhom età ta ’ 65 sa 74 sena, waqt li 20% kellhom età ta ’ 75 sena jew aktar.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
168 ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
148 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
There are no data from the use of MIRCERA in pregnant womn.
M’ hemmx tagħrif dwar l- użu ta ’ MIRCERA waqt it- tqala.
4.8 Undesirable effects
169 170 4. 8 Effetti mhux mixtieqa
In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily disconitnued (see section 4.2).
F’ każ ta ’ livelli ta ’ emoglobina għoljin ħafna, kura b’ MIRCERA għandha titwaqqaf temporanjament (ara sezzjoni 4. 2).
The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
171 molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
172 Wara amministrazzjoni taħt il- ġilda lill- pazjenti b’ CKD mhux fuq dijalisi, il- konċentrazzjonijiet massimi fis- serum ta ’ methoxy polyethylene glycol- epoetin beta kienu osservati 95 siegħa (valur medjan) wara l- amministrazzjoni.
151 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ MIRCERA mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il- farmakokinetika ta ’ dan il- prodott mediċinali.
6.
173 6.
152 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħiih mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
153 1.
175 1.
MIRCERA 120 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 120 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 400 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 120 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 400 mikrogramma/ ml.
154 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
176 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) over a month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
177 Jekk ir- rata taż- żjieda fl- emoglobina hija ta ’ aktar minn 2 g/ dl (1. 24 mmol/ l) fuq medda ta ’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
155 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
Minħabba li l- esperjenza bil- kura hija limtata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
178 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
156 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
179 Treddigħ:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
181 konċentrazzjonijiet ta ’ l- emoglobina inqas minn 13 g/ dl, mhux ċar minħabba li numru żgħir ta ’ pazjenti b’ dawn il- karatteristiċi kienu inklużi fl- analiżi tat- tagħrif.
5.2 Pharmacokinetic properties
182 5. 2 Tagħrif farmakokinetiku
159 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
160 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħiih mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
161 1.
185 1.
MIRCERA 360 micrograms/ 0.6 ml solution for injection in pre-filled syringe
MIRCERA 360 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta*at a concentration of 600 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 360 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 600 mikrogramma/ ml.
162 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
186 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
163 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
187 Minħabba li l- esperjenza bil- kura hija limitata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
188 ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
164 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
4.8 Undesirable effects
189 4. 8 Effetti mhux mixtieqa
The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
190 molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
167 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Paragun ta ’ konċentrazzjonijiet fis- serum ta ’ methoxy polyethylene glycol- epoetin beta mkejla qabel u wara l- emodijalisi f’ 41 pazjent b’ CKD wera li l- emodijalisi m’ għandu l- ebda effett fuq il - farmakokinetika ta ’ dan il- prodott mediċinali.
6.2 Incompatibilities
192 6. 2 Inkompatibilitajiet
168 Keep the pre-filled syringe in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl Minn se juża ’ l- prodott mediċinali jista ’ jneħħiih mill- friġġ u jaħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall- perijodu wieħed ta ’ xahar.
10.
193 10.
169 ANNEX II
194 ANNESS II
170 A.
195 A.
Roche Diagnostics GmbH Werk Penzberg Nonnenwald 2 D-82377 Penzberg Germany
Roche Diagnostics GmbH Werk Penzberg Nonnenwald 2 D- 82377 Penzberg Il- Ġermanja
Name and address of the manufacturer responsible for batch release for the vials
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għall- kunjetti
Roche Pharma AG Emil-Barrell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barrell- Strasse 1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
Name and address of the manufacturer responsible for batch release for the pre-filled syringes
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għas- siringi mimlija għal- lest
Medicinal product subject to restricted medical prescription (see Annex I:
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
Literature to provide information on loss of effect and its differential causes, the definition of AEAB-mediated PRCA, the diagnostic work-up of potential AEAB- mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of AEAB-mediated PRCA..
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiftiehem ma ’ l - Awtoritajiet Kompetenti Nazzjonali biex qabel it- tqegħid fis- suq jipprovdi lit- tobba materjal ta ’ edukazzjoni li jkun jinkludi informazzjoni fuq dawn il- punti li ġejjin: • Il- bżonn u l- importanza klinika ġenerali li jiġu rrappurtati reazzjonijiet avversi tal- mediċina (ADR). • Tagħrif ġenerali dwar aplasija pura taċ- ċelluli l- ħomor ikkawżata minn antikorpi għall - eritropoetin (PRCA ikkawżata minn AEAB) assoċjata ma ’ kura b’ sustanzi li jistimulaw l - eritropoesi (ESA). • Lista ta ’ terminoloġija ta ’ dijanjosi jew ta ’ avvenimenti avversi (AE) li jwasslu għal rapport ta ’ ADR għal MIRCERA. • Kwestjonarju biex tinġabar dokumentazzjoni dettaljata ta ’ rapport ta ’ ADR. • L- offerta tad- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq li jeżamina jew jeżamina mill- ġdid l- istat ta ’ l- antikorpi (AB) fl- laboratorju ta ’ referenza. • Letteratura biex tipprovdi informazzjoni dwar it- telf ta ’ effett u l- kawżi differenti ta ’ dan, definizzjoni ta ’ PRCA ikkawżata minn AEAB, attivitajiet li jwasslu għal dijanjosi ta ’ PRCA li tista ’ tkun ikkawżata minn AEAB, il- bżonn li titwaqqaf il- kura ta ’ ESA wara dijanjosi ta ’ PRCA ikkawżata minn AEAB minħabba reazzjoni marbuta ma ’ ESAs oħrajn.
2.
196 2.
The MAH shall provide physicians upon their request with free anti-erythropoietin antibody testing.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi lit- tobba li jitolbuh l- eżami għall- antikorpi kontra l- eritropoetin b’ xejn.
171 • OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1 of the Marketing Authorisation Application,is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmokoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li hemm aċċess sħiħ għas - sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 1. 0 ippreżentata f ’ Modulu 1. 8. 1 ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 4. 0 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għal - Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ RMP miftiehem mis - CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata wara li jintlaħaq għan ewlieni (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
172 ANNEX III
197 ANNESS III
173 A.
198 A.
174 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
199 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 50 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 50 mikrogramma
MIRCERA 50 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 50 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 50 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 u ilma għall- injezzjonijiet.
Solution for injection Each pack contains 1 vial of 1 ml
Soluzzjoni għall- injezzjoni Kull pakkett fih kunjett wieħed ta ’ 1 ml
For subcutaneous or intravenous use Read the package leaflet before use
Użu għal taħt il- ġilda jew għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu
Store in a refrigerator Do not freeze Keep the vial in the outer carton in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
175 10.
200 10.
176 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
201 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
50 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 50 mikrogramma
MIRCERA 50 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 50 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
177 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
202 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 100 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 100 mikrogramma
MIRCERA 100 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 100 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 100 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
178 10.
203 10.
179 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
204 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
100 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 100 mikrogramma
MIRCERA 100 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 100 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
180 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
205 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 200 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 200 mikrogramma
MIRCERA 200 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 200 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 200 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
Solutin for injection Each pack contains 1 vial of 1 ml
Soluzzjoni għall- injezzjoni Kull pakkett fih kunjett wieħed ta ’ 1 ml
181 10.
206 10.
182 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
207 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
200 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 200 mikrogramma
MIRCERA 200 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 200 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
183 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
208 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 300 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 300 mikrogramma
MIRCERA 300 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 300 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 300 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 300 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
184 10.
209 10.
185 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
210 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
300 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 300 mikrogramma
MIRCERA 300 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 300 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
186 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
211 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 400 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 400 mikrogramma
MIRCERA 400 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 400 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 400 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 400 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
187 10.
212 10.
188 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
213 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
400 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta '400 mikrogramma
MIRCERA 400 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 400 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
189 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
214 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 600 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT TA ’ 600 mikrogramma
MIRCERA 600 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 600 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 600 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 600 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
190 10.
215 10.
191 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
216 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
600 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 600 mikrogramma
MIRCERA 600 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 600 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
192 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
217 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 1000 micrograms VIAL
KARTUNA TA ’ BARRA – KUNJETT ta ’ 1000 mikrogramma
MIRCERA 1000 micrograms/ml solution for injection methoxy polyethylene glycol-epoetin beta
MIRCERA 1000 mikrogramma/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta
1 vial contains 1000 micrograms of methoxy polyethylene glycol-epoetin beta.
Kunjett wieħed fih 1000 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta
193 10.
218 10.
194 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
219 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
1000 micrograms VIAL LABEL
TIKKETTA TAL- KUNJETT ta ’ 1000 mikrogramma
MIRCERA 1000 µg/ml solution for injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 1000 µg/ ml soluzzjoni għall- injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
195 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
220 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 50 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 50 mikrogramma
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 50 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 50 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
Solution for injection Each pack contains a pre-filled syringe of 0.3 ml and a needle
Soluzzjoni għall- injezzjoni Kull pakkett fih siringa mimlija għal- lest ta ’ 0. 3ml u labra
Store in a refrigerator Do not freeze Keep the pre-filled syringe in the outer carton in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
196 10.
221 10.
197 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
222 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
50 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 50 mikrogramma
MIRCERA 50 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 50 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
198 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
223 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 75 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 75 mikrogramma
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 75 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 75 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
Solution for injection Each pack contains a pre-filled syringe of 0.3 ml and a needle
Soluzzjoni għall- injezzjoni Kull pakkett fih siringa mimlija għal- lest ta ’ 0. 3 ml u labra
199 10.
224 10.
200 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
225 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
75 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 75 mikrogramma
MIRCERA 75 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 75 µg/ 0. 3 injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
201 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
226 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 100 microgram PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 100 mikrogramma
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 100 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 100 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
202 10.
227 10.
203 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
228 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
100 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 100 mikrogramma
MIRCERA 100 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 100 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
204 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
229 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 150 microgram PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 150 mikrogramma
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 150 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 150 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
205 10.
230 10.
206 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
231 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
150 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 150 mikrogramma
MIRCERA 150 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 150 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
207 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
232 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 200 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 200 mikrogramma
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 200 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 200 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
208 10.
233 10.
209 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
234 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
200 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 200 mikrogramma
MIRCERA 200 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 200 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
210 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
235 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 250 microgram PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 250 mikrogramma
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 250 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 250 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
211 10.
236 10.
212 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
237 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
250 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 250 mikrogramma
MIRCERA 250 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 250 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
213 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
238 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 400 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 400 mikrogramma
MIRCERA 400 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 400 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 400 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 400 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
Solution for injection Each pack contains a pre-filled syringe of 0.6 ml and a needle
Soluzzjoni għall- injezzjoni Kull pakkett fih siringa mimlija għal- lest ta ’ 0. 6 ml u labra
214 10.
239 10.
215 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
240 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
400 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 400 mikrogramma
MIRCERA 400 µg/0.6 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 400 µg/ 0. 6 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
216 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
241 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 600 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 600 mikrogramma