qanastek/EMEA-V3 huggingface dataset:
The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/ l.
Is- sigurtà u l- effikaċja ta ’ terapija b’ MIRCERA ma ġewx stabbiliti f’ pazjenti b’ emoglobinopatiji, eċċessjonijiet, fsada, jew passat riċenti ta ’ fsada li nħtieġ transfużjoni jew b’ livelli ta ’ plejtlets ogħla minn 500 x 109/ l.
Lactation:
41 Treddigħ:
Adverse reactions attributed to the treatment with MIRCERA in controlled clinical trials in CKD patients
Reazzjonijiet avversi attribwiti lill- kura b’ MIRCERA fi studji kliniċi kkontrollati f’ pazjenti b’ CKD Sistema tal- klassifika ta ’ l - organi
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.
43 eritropoetin rikombinanti uman lill- pazjenti bil- kanċer, ikkurati b’ kimoterapija biex jilħqu 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.
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Wara amministrazzjoni taħt il- ġilda lill- pazjenti b’ CKD fuq dijalisi, il- konċentrazzjonijiet massimi fis - serum ta ’ Methoxy polyethylene glycol- epoetin beta kienu osservati wara 72 siegħa (valur medjan).
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Il - biodisponibiltà assoluta ta ’ Methoxy polyethylene glycol- epoetin beta wara amministrazzjoni taħt il - ġilda kienet ta ’ 62% u l- half- life ta ’ eliminazzjoni terminali osservata kienet ta ’ 139 siegħa f’ pazjenti b’ CKD fuq dijalisi.
39 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.
In the absence of compatibility studies, this medicinalmproduct must not be mixed with other medicinal products.
6. 2 Inkompatibilitajiet
40 Keep the vial 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 il- kunjett 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 600 micrograms/ ml solution for injection
MIRCERA 600 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 600 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 600 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta *.
*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
* Proteina magħmula permezz ta ’ teknoloġija rikombinanti tad- DNA f’ ċelluli ta ’ l- Ovarju ta ’ Ħamster Ċiniż u kkonjugata b’ mod kovalenti ma ’ methoxy- polyethylene glycol (PEG) lineari.
42 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.
47 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%.
48 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%.
43 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.
49 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
44 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk.
50 Mhux magħruf jekk methoxy polyethylene glycol- epoetin beta jitneħħiex fil- ħalib tas- sider uman.
The therapeutic range of MIRCERA is wide.
Il- firxa terapewtika ta ’ MIRCERA hija wiegħsa.
Data from correction studies show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high (93.3% and 97.5% in the studies in patients on dialysis and not
Tagħrif minn studji ta ’ korrezzjoni juri li r- rati ta ’ rispons ta ’ l- emoglobina fil- grupp ta ’ MIRCERA fit - tmiem tal- perijodu ta ’ korrezzjoni kienu għolja (93. 3% u 97. 5% fl- istudji f’ pazjenti fuq dijalisi, u mhux fuq dijalisi rispettivament) u komparabbli mal- komparaturi (91. 3% u 96. 3%, rispettivament).
The median time to response was 43 days in the MIRCERA arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 0.2 g/ dl/ week and 0.3 g/ dl/ week, respectively.
Il - ħin medjan għal rispons kien ta ’ 43 ġurnata fil- grupp b’ MIRCERA, u 29 ġurnata fil- grupp ta ’ paragun, b’ żidiet ta ’ emoglobina fl- ewwel 6 ġimgħat ta ’ 0. 2 g/ dl/ ġimgħa u 0. 3 g/ dl/ ġimgħa, rispettivament.
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetin at the time of enrollment.
Erba ’ studju randomised ikkontrollati, twettqu fuq pazjenti fuq dijalisi li kienu qed jiġu kkurati b’ darbepoetin alfa jew epoetin meta daħlu fl- istudju.
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.
52 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.
47 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.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light
6. 4 Prekawzjonijiet speċjali għall- ħażna
48 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 il- kunjett 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 1000 micrograms/ ml solution for injection
MIRCERA 1000 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 1000 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 1000 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta *.
The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Il - qawwa tindika l- kwantità tal- parti minn proteina fil- molekula ta ’ methoxy polyethylene glycol- epoetin beta mingħajr konsiderazzjoni tal- glikolsilazzjoni.
*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
* Proteina magħmula permezz ta ’ teknoloġija rikombinanti tad- DNA f’ ċelluli ta ’ Ovarju ta ’ Ħamster Ċiniż (CHO) u kkonjugata b’ mod kovalenti ma ’ methoxy- polyethylene glycol (PEG) lineari.
50 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.
56 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.
It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically thereafter.
Huwa rrakkomandat li l- emoglobina tiġi sorveljata kull ġimagħtejn sakemm tistabilizza u minn hemm ’ l quddiem perjodikament.
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%.
57 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%.
51 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.
58 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
52 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
59 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.
61 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.
55 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 methoxy polyethylene glycol-epoetin beta 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 l- parametri ta ’ stima ta ’ l- isperma ma kinux affettwati.
56 Keep the vial 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 il- kunjett 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 50 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 50 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 50 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 167 mikrogramma/ ml.
The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Il- qawwa tindika l- kwantità tal- parti minn proteina fil - molekula ta ’ methoxy polyethylene glycol- epoetin beta mingħajr konsiderazzjoni tal- glikolsilazzjoni.
58 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.
65 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.
The recommended starting dose is 0.6 microgram/ kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase haemoglobin levelsto greater than 10 g/ dl (6.21 mmol/ l).
Id- doża tal- bidu rrakkomandata hija ta ’ 0. 6 mikrogramma/ kg piż tal- ġisem, mogħtija darba kull ġimagħtejn bħala injezzjoni waħda ġol- vina jew taħt il- ġilda biex b’ hekk iżżid il- livelli ta ’ l - emoglobina għal aktar minn 10 g/ dl (6. 21 mmol/ l).
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%.
66 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%.
59 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.
67 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
60 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
68 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.
70 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.
The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Il- farmakokinetika ta ’ methoxy polyethylene glycol- epoetin beta kienet studjata f’ voluntiera b’ saħħithom u f’ pazjenti anemiċi b’ CKD, inkluż pazjenti fuq dijalisi u pazjenti mhux fuq dijalisi.
63 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.
In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epoetin beta was only observed in target cells (bone marrow progenitor cells).
Barra minn hekk, b’ użu ta ’ numru ta ’ tessuti umani differenti, it- twaħħil in vitro ta ’ methoxy polyethylene glycol- epoetin beta kien osservat biss f’ ċelluli mmirati (ċelluli proġenituri tal- mudullun).
64 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.
Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber material) and tip cap (bromobutyl rubber material) and a needle 27G1/ 2.
Siringa mimlija għal- lest (ħġieġ tip I) b’ tapp tal- planġer laminat (materjal tal- lastku bromobutyl) u għatu tat- tarf (materjal tal- lastku bromobutyl) u labra 27G1/ 2.
Pack size of 1.
Daqs tal- pakkett ta ’ 1 u ta ’ 3.
The pre-filled syringe is ready for use.
Is- siringa mimlija għal- lest hija lesta għall- użu.
The sterile pre-filled syringe does not contain any preservative and is to be used for a single injection only.
Is- siringa sterili mimlija għal- lest ma fiha l- ebda preservattivi u għandha tintuża għall- injezzjoni waħda biss.
Only one dose should be administered per syringe.
Kull siringa għandha tingħata bħala doża waħda biss.
Allow the pre-filled syringe to reach room temperature before injecting.
Ħalli s- siringa mimlija għal- lest tilħaq temperatura tal- kamra qabel tinjetta.
MIRCERA 75 micrograms/ 0.3 ml solution for injection in pre-filled syringe.
MIRCERA 75 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 75 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 250 mikrogramma/ ml.
66 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.
74 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%.
75 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%.
67 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.
Paediatric use MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data.
Użu fit- tfal MIRCERA mhix irrrakkomandata għall- użu fit- tfal u adoloxxenti taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Pazjenti b’ indeboliment tal- fwied L- ebda aġġustament tad- doża tal- bidu jew tar- regoli tal - modifikazzjoni tad- doża ma huma meħtieġa f’ pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA.
76 ssuspettati jew ikkonfermati li għandhom antikorpi għal eritropoetin m’ għandhomx jinqalbu fuq MIRCERA.
68 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp ta ’ wara t- twelid, iżda jindikaw tnaqqis riversibbli fil- piż tal- fetu, relatat mal- klassita ’ din il- mediċina (ara sezzjoni 5. 3).
A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with MIRCERA should be made taking into account the benefit of breast-feeding to the child and the benefit of MIRCERA therapy to the woman.
77 benefiċċju ta ’ terapija b’ MIRCERA għall- omm, dwar jekk jitkompliex jew jitwaqqafx it- treddigħ jew jekk titkompliex jew titwaqqafx it- terapija b’ MIRCERA.
Pharmacotherapeutic group:
78 Kategorija farmakoterapewtika:
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.
Kemm dawn ir- riżultati jistgħu japplikaw għall- għoti ta ’ eritropoetin rikombinanti uman lill- pazjenti bil- kanċer, ikkurati b’ kimoterapija biex jilħqu 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.
71 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.
72 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.
MIRCERA 100 micrograms/ 0.3 ml solution for injection in pre-filled syringe.
MIRCERA 100 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 100 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 333 mikrogramma/ ml.
74 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.
83 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) in one 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 aktar minn 2 g/ dl (1. 24 mmol/ l) f’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), d- doża għandha titnaqqas b’ madwar 25%.
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%.
84 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%.
75 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 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.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Pazjenti b’ indeboliment tal- fwiedL- ebda aġġustament tad- doża tal- bidu jew tar- regoli tal - modifikazzjoni tad- doża ma huma meħtieġa f’ pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
85 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
76 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
86 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.
88 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.
79 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.
80 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.
MIRCERA 150 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 150 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 150 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 500 mikrogramma/ ml.
82 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.
92 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.
Dose adjustments should not be made more frequently than once a month.
Bidliet fid- doża m’ għandhomx isiru aktar spiss minn darba kull xahar.
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%.
93 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%.
83 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.
94 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
84 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
95 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.
97 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.
The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours
Il- half- life ta ’ eliminazzjoni wara amministrazzjoni ġol- vina ta ’ methoxy polyethylene glycol- epoetin beta hija 134 siegħa.
87 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.
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
6. 4 Prekawzjonijiet speċjali għall- ħażna
88 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 200 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 200 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micgrograms/ ml.
Siringa waħda mimlija għal- lest fiha 200 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 667 mikrogramma/ ml.
90 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.
101 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 haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every- two-weeks dose.
Jekk tintlaħaq il- mira ta ’ konċentrazzjoni ta ’ emoglobina ta ’ aktar minn 10 g/ dl (6. 21 mmol/ l) għall - pazjent individwali, MIRCERA tista ’ tingħata darba fix- xahar, bl- użu ta ’ doża ugwali għad- doppju tad- doża ta ’ qabel ta ’ darba kull ġimagħtejn.
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%.
102 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%.
91 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.
103 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
92 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
104 Treddigħ:
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetin at the time of enrollment.
Erba ’ studji randomised kkontrollati, twettqu fuq pazjenti fuq dijalisi li kienu qed jiġu kkurati b’ darbepoetin alfa jew epoetin meta daħlu fl- istudju.
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.
106 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.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Il - biodisponibiltà assoluta ta ’ polyethylene glycol- epoetin beta wara amministrazzjoni taħt il- ġilda kienet ta ’ 62% u l- half- life ta ’ eliminazzjoni terminali osservata kienet ta ’ 139 siegħa f’ pazjenti b’ CKD fuq dijalisi.
95 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.
Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
L- iżvilupp fiżiku, konoxxittiv u sesswali tal- wild ta ’ ommijiet li ngħataw methoxy polyethylene glycol- epoetin beta waqt it- tqala u t- treddigħ ma kinux effettwati.
96 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 250 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 250 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 833 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 250 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 833 mikrogramma/ ml.
98 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.
110 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%.
111 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%.
99 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.
112 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
100 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy.
Bħal b’ fatturi tat- tkabbir oħra, hemm il- biża ’ li ESAs jistgħu jistimolaw it - tkabbir ta ’ kull tip ta ’ tumur malinn.
Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Żewġ studji kliniċi kontrollati fejn epoetins ġew amministrati lill - pazjenti b’ diversi kanċers, inkluż kanċers fir- ras u fl - għonq, u kanċer tas- sider, urew żjieda mhux spjegata ta ’ mortalità.
It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk.
113 Mhux magħruf jekk methoxy polyethylene glycol- epoetin beta jitneħħiex fil- ħalib tas- sider uman.
5.1 Pharmacodynamic properties
114 5. 1 Tagħrif farmakodinamiku
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.
115 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.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Il - biodisponibiltà assoluta ta ’ Methoxy polyethylene glycol- epoetin beta wara amministrazzjoni taħt il - ġilda kienet ta ’ 62% u il- half- life ta ’ eliminazzjoni terminali osservata kienet ta ’ 139 siegħa f’ pazjenti b’ CKD fuq dijalisi.
103 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.
104 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 400 micrograms/ 0.6 ml solution for injection in pre-filled syringe
MIRCERA 400 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe contains 400 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micrograms/ ml.
Siringa waħda mimlija għal- lest fiha 400 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta * f’ konċentrazzjoni ta ’ 667 mikrogramma/ ml.
Solution for injection(injection).
Soluzzjoni għall- injezzjoni (injezzjoni).
106 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.
119 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%.
120 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%.
107 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 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.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
121 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
108 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
122 Treddigħ:
Methoxy polyethylene glycol-epoetin beta, the active sustance 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.
Methoxy polyethylene glycol- epoetin beta, s- sustanza attiva ta ’ MIRCERA, huwa attivatur kontinwu tar- riċetturi ta ’ eritropoetin li b’ kuntrast għal eritropoetin juri attività differenti fil- livell tar- riċettur ikkaratterizzata minn assoċjazzjoni aktar bil- mod u dissoċjazzjoni aktar malajr minn mar- riċettur, attività speċifika in vitro mnaqqsa b’ attività in vivo miżjuda, kif ukoll half- life mtawwla.
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.
124 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.
111 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.
No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Fil- firien ma kienx osservat trasferiment sinifikanti ta ’ methoxy polyethylene glycol- epoetin beta mill- plaċenta u studji fuq il- bhejjem ma wrewx effetti ħżiena fuq it- tqala, fuq l- iżvilupp ta ’ l - embriju/ fetu, ħlas jew żvilupp ta ’ wara t- twelid.
There was however a class-related reversible reduction in foetal weight and a decrease in postnatal body-weight gain of offspring at the doses causing exaggerated pharmacodynamic effects in mothers.
Madankollu, kien hemm tnaqqis riversibbli, fil- piż tal - fetu relatat mal- klassi u tnaqqis fiż- żjieda tal- piż tal- ġisem, ta ’ wara t- twelid tal- frieħ f’ dożi li jikkawżaw effetti farmakoloġiċi esaġerati fl- ommijiet.
Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
L- iżvilupp fiżiku, konoxxittiv u sesswali tal - wild ta ’ ommijiet li ngħataw methoxy polyethylene glycol- epoetin beta waqt it- tqala u t- treddigħ ma kinux affettwati.
112 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 600 micrograms/ 0.6 ml solution for injection in pre-filled syringe
MIRCERA 600 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest