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 reċenti ta ’ fsada li nħtieġ transfużjoni jew b’ livelli ta ’ plejtlets ogħla minn 500 x 109/ l.
Therefore, caution should be used in these patients.
Għalhekk, f’ dawn il- pazjenti għandha tintuża kawtela.
Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin.
Użu ħażin ta ’ MIRCERA minn persuni b’ saħħithom jista ’ jwassal għal żjieda eċċessiva ta ’ emoglobina.
This may be associated with life-threatening cardiovascular complications.
Dan jista ’ jkun assoċjat ma ’ komplikazzjonijiet kardjo- vaskulari b’ periklu għall- ħajja.
There is no evidence that MIRCERA alters the metabolism of other medicinal products.
M’ hemmx evidenza li MIRCERA tbiddel il- metaboliżmu ta ’ mediċini oħra.
There are no data from the use of MIRCERA in pregnant women.
M’ hemmx tagħrif dwar l- użu ta ’ MIRCERA waqt it- tqala.
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- klassi ta ’ din il- mediċina (ara sezzjoni 5. 3).
It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk.
Mhux magħruf jekk methoxy polyethylene glycol- epoetin beta jitneħħiex fil- ħalib tas- sider uman.
One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk.
Studju wieħed fuq l- annimali wera l- eskrezzjoni ta ’ methoxy polyethylene glycol- epoetin beta fil- ħalib ta ’ l- omm.
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.
Għandha tittieħed deċiżjoni b’ konsiderazzjoni tal- benefiċċju tat- treddigħ għat- tarbija u l - benefiċċju ta ’ terapija b’ MIRCERA għall- omm, dwar jekk jitkompliex jew jitwaqqafx it- treddigħ jew jekk titkompliex jew titwaqqafx it- terapija b’ MIRCERA.
MIRCERA has no or negligible influence on the ability to drive and use machines.
MIRCERA m’ għandu l- ebda effett jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
The safety data base from clinical trials comprised 2’ 737 CKD patients, including 1’ 789 patients treated with MIRCERA and 948 with another ESA.
Il- bażi ta ’ tagħrif ta ’ sigurtà minn studji kliniċi ikkonsistiet minn 2’ 737 pazjent b’ CKD, inkluż 1’ 789 pazjent ikkurati b’ MIRCERA u 948 b’ ESA ieħor.
Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions.
Madwar 6% tal- pazjenti kkurati b’ MIRCERA huma mistennija li jkollhom reazzjonijiet avversi.
The most frequent reported adverse reaction was hypertension (common).
Ir- reazzjoni avversa li kienet irrappurtata l- aktar kienet pressjoni għolja (komuni).
The frequencies are defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000)
Il- frekwenzi huma definiti kif ġej: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000)
Adverse reactions attributed to the treatment with MIRCERA in controlled clinical trials in CKD patients
Reazzjonijiet avversi attribwiti lil kura b’ MIRCERA fi studji kliniċi kkontrollati f’ pazjenti b’ CKD Sistema tal- klassifika ta ’ l - organi
Adverse reaction Headache
Reazzjoni avversa
Nervous system disorders
Disturbi fis- sistema nervuża Disturbi fis- sistema nervuża
Rare
Mhux komuni Rari
Hypertensive encephalopathy
Uġigħ ta ’ ras Enċefalopatija ipertensiva
Rash, maculo-papular
Raxx, makulo- papulari
Vascular access thrombosis
Trombożi ta ’ aċċess vaskulari
All other events attributed to MIRCERA were reported with rare frequency and the majority were mild to moderate in severity.
L- effetti l- oħra kollha attribwiti lil MIRCERA kienu rrappurtati bi frekwenza rari u l- biċċa l- kbira kienu ħfief għal moderati fis- severità.
These events were consistent with comorbidities known in the population.
Dawn l- effetti kienu konsistenti ma ’ ko- morbożità magħrufa fil - popolazzjoni.
During treatment with MIRCERA, a slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Fi studji kliniċi, waqt kura b’ MIRCERA, kien osservat tnaqqis żgħir ħafna fl- għadd tal- plejtlets li baqa ’ fil- firxa normali.
Platelet counts below 100 x 109/ l were observed in 7% of patients treated with MIRCERA and 4% of patients treated with other ESAs.
Kienu osservati għadd tal- plejtlets taħt 100 x 109/ l f’ 7% tal- pazjenti kkurati b’ MIRCERA u f’ 4% tal - pazjenti kkurati b’ ESAs oħra.
The therapeutic range of MIRCERA is wide.
Il- firxa terapewtika ta ’ MIRCERA hija wiesgħa.
Individual responsiveness must be considered when treatment is initiated.
Għandha tiġi kkunsidrata l- kapaċità ta ’ rispons individwali meta tinbeda l- kura.
Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e. g. excessive erythropoiesis.
Doża eċċessiva tista ’ tirriżulta f’ manifestazzjonijiet ta ’ effett farmakodinamiku esaġerat, eż. eritropoesi eċċessiva.
In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued (see section 4.2).
F’ każ ta ’ livelli ta ’ emoglobina għoljin ħafna, kura b’ MIRCERA għandha titwaqqaf temporanjament (ara sezzjoni 4. 2).
If clinically indicated, phlebotomy may be performed.
Jekk indikata klinikament, tista ’ ssir flebotomija.
Other antianemic preparations, ATC code:
Preparazzjonijiet oħra kontra l- anemija, Kodiċi ATC:
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.
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 average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
Il- piż molekulari medju huwa ta ’ madwar 60 kDa li minnu il- parti tal- proteina flimkien mal- parti tal - karboidrat jagħmlu madwar 30 kDa.
MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
MIRCERA tistimula l- eritropoesi b’ interazzjoni mar- riċettur ta ’ eritropoetin fuq ċelluli proġenituri fil - mudullun.
As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.
Bħala fattur tat- tkabbir primarju għall- iżvilupp eritroid, l- ormon naturali eritropoetin jiġi prodott fil- kliewi u jintreħa fiċ- ċirkulazzjoni tad- demm wara rispons għall- ipoxja.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
B’ rispons għall - ipoxja, l- ormon naturali eritropoetin jinteraġixxi ma ’ ċelluli proġenituri eritroidi biex tiżdied il - produzzjoni taċ- ċelluli ħomor.
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 ’ studji randomised ikkontrollati twettqu fuq pazjenti fuq dijalisi li kienu qed jiġu kkurati b’ darbepoetin alfa jew epoetin meta daħlu fl- istudju.
Patients were randomized to stay on their treatment at the time 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 għal- livell ta ’ emoglobina fil - linja bażi tagħhom.
Erythropoietin is a growth factor that primarily stimulates red cell production.
Eritropoetin huwa fattur tat- tkabbir li primarjament jistimola l- produzzjoni ta ’ ċelluli ħomor.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Riċetturi għall- eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ diversi ċelluli tat- tumur.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2’ 833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kkontrollati kbar li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
Two of the studies recruited patients who were being treated with chemotherapy.
Fi tnejn mill- istudji ħadu sehem pazjenti li kienu qed jiġu kkurati b’ kimoterapija.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
Il- konċentrazzjoni mmirata ta ’ l- emoglobina fi tnejn mill- istudji kienet > 13 g/ dl; fit - tliet studji l- oħra din kienet 12- 14 g/ dl.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Fl- istudju open- label ma kien hemm l- ebda differenza fis - sopravivenza globali bejn pazjenti kkurati b’ eritropoetin rikombinanti uman u l- kontrolli.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji kkontrollati bil- plaċebo il- proporzjon ta ’ periklu għas- sopravivenza globali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l- istudji wrew mortalità eċċessiva statistikament sinifikanti u konsistenti mhux spjegata f’ pazjenti li għandhom anemija assoċjata ma ’ deversi kanċers komuni li rċevew eritropoetin rikombinanti uman meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Ir- riżultat tas- sopravivenza globali fil - provi ma setgħax jiġi spjegat b’ mod sodisfaċenti mid- differenza fl- inċidenza ta ’ trombożi u mill - kumplikazzjonijiet relatati bejn dawk li ngħataw eritropoetin rikombinanti uman u dawk fil- grupp ta ’ kontroll.
A systematic review has also been performed involving more than 9’ 000 cancer patients participating in 57 clinical trials.
Saret ukoll analiżi sistematika li nvolviet aktar minn 9000 pazjent bil- kanċer li pparteċipaw f’ 57 prova klinika.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Meta- analiżi tat- tagħrif tas- sopravivenza globali pproduċiet estimu tal- punt ta ’ proporzjon ta ’ periklu ta ’ 1. 08 favur il- kontrolli (95% CI:
0.99, 1.18; 42 trials and 8’ 167 patients).
0. 99, 1. 18; 42 prova u 8167 pazjent).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Żjieda fir- riskju relattiv ta ’ episodji tromboembolitiċi (RR 1. 67, 95% CI:
1.35, 2.06, 35 trials and 6’ 769 patients) was observed in patients treated with recombinant human erythropoietin.
1. 35, 2. 06, 35 prova u 6769 pazjent) kienet osservata f’ pazjenti kkurati b’ eritropoetin rikombinanti uman.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Għalhekk hemm evidenza konsistenti biex tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lill- pazjenti b’ kanċer li huma kkurati b’ eritropoetin rikombinanti uman.
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.
7 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.
The pharmacokinetics of methoxy polyethylene glycol-epetin 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 f’ saħħithom u f’ pazjenti anemiċi b’ CKD, inkluż pazjenti fuq dijalisi u pazjenti mhux fuq dijalisi.
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 medjan) wara l- amministrazzjoni.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Il- biodisponibiltà assoluta ta ’ methoxy polyethylene glycol- epoetin beta wara amministrazzjoni taħt il- ġilda kienet ta ’ 54%.
The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
Il- half- life ta ’ eliminazzjoni terminali osservatakienet ta ’ 142 siegħa f’ pazjenti b’ CKD mhux fuq dijalisi.
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.
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.
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.
7 A comparison of serum concentrations of methoxy polyethylene glycol-epetin 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.
An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis and patients not on dialysis.
Analiżi f’ 126 pazjent b’ CKD ma wriet l- ebda differenza fil- farmakokinetika bejn pazjenti fuq dijalisi u pazjenti mhux fuq dijalisi.
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Fi studju b’ doża waħda, wara għoti fil- vini, il- farmakokinetika ta ’ methoxy polyethylene glycol - epoetin beta kienet simili f’ pazjenti b’ indeboliment sever tal- fwied meta mqabbla ma ’ individwi b’ saħħithom (ara sezzjoni 4. 2).
Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, repeat dose toxicity and reproductive toxicity.
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika kardjo - vaskulari, effett tossiku minn dożi ripetuti u effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
The carcinogenic potential of methoxy polyethylene glycol-epetin beta has not been evaluated in long- term animal studies.
Il- potenzjal karċinoġeniku ta ’ methoxy polyethylene glycol- epoetin beta ma ġiex evalwat fi studji fit - tul fuq l- annimali.
It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
Huwa ma kkawżax rispons proliferattiv f’ razez ta ’ ċelluli tat- tumur mhux ematoloġiċi in vitro.
In a six-month rat toxicity study no tumorigenic or unexpected mitogenic responses were observed in non-haematological tissues.
Fi studju ta ’ tossiċità ta ’ sitt xhur fil- firien ma kinux osservati reazzjonijiet mitoġeniċi mhux mistennija jew tumuroġeniċi f’ tessuti mhux ematoloġiċi.
In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epetin 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 ta ’ l- għadam).
No significant placental transfer of methoxy polyethylene glycol-epetin 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-epetin 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.
When methoxy polyethylene glycol-epetin 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 parametri ta ’ stima ta ’ l- isperma ma kinux affettwati.
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Water for injections
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Ilma għall- injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6. 2 Inkompatibilitajiet
6.3 Shelf life
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
6.4 Special precautions for storage
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Store in a refrigerator (2°C – 8°C) Do not freeze
6. 4 Prekawzjonijiet speċjali għall- ħażna
8 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.
Once removed from the refrigerator the medicinal product must be used within this period.
Ladarba jitneħħa mill- friġġ, il- prodott mediċinali għandu jintuża ’ f’ dan il- perijodu.
Vial (type I glass) with grey laminated stopper (bromobutyl rubber material) and flip-off cap (aluminium and polypropylene plastic material).
Kunjett (ħġieġ tip I) b’ tapp griż laminat (materjal tal- lastku bromobutyl) u għatu flip- off (materjal ta ’ aluminju u plastik polypropylene).
The sterile vial does not contain any preservative and is to be used for a single injection only.
Il- kunjett sterili ma fih l- ebda preservattivi u għandu jintuża għall- injezzjoni waħda biss.
Only one dose should be administered per vial.
Kull kunjett għandu jingħata bħala doża waħda biss.
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Għandhom jiġu njettati biss soluzzjonijiet li huma ċari, mingħajr kulur għal kemxejn safranin, u ħielsa minn frak viżibbli.
Allow the vial to reach room temperature before injecting.
Ħalli lill- kunjett jilħaq temperatura tal- kamra qabel tinjetta.
20 July 2007
20 ta ’ Lulju 2007
23 January 2009
23 ta ’ Jannar 2009
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /.
MIRCERA 100 micrograms/ ml solution for injection
MIRCERA 100 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 100 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 100 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 (CHO) u kkonjugata b’ mod kovalenti ma ’ methoxy- polyethylene glycol (PEG) lineari.
10 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.
11 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- 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%.
12 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%.
11 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.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairmented patients (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).
Uncontrolled hypertension.
Pressjoni għolja mhix ikkontrollata.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
Infezzjonijiet fl- istess waqt, episodji ta ’ infjammazzjoni jew trawmatiċi, telf ta ’ demm okkult, emolisi, tossiċità ta ’ l- aluminju severa, preżenza ta ’ mard ematoloġiku fl- istess ħin, jew fibrożi tal- mudullun tal- għadam ukoll jistgħu jikkompromettu r- rispons eritropoetiku.
If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered.
Jekk il- kundizzjonijiet imsemmija kollha huma esklużi u l- pazjent ikollu nuqqas f’ daqqa ta ’ emoglobina assoċjat ma ’ retikulocitopenija u antikorpi anti- eritropoetin, għandha tiġi kkunsidrata eżaminazzjoni tal- mudullun ta ’ l- għadam għad- dijanjosi ta ’ Aplasija Pura taċ- Ċelluli l- Ħomor (PRCA).
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
13 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
12 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk.
14 Mhux magħruf jekk methoxy polyethylene glycol- epoetin beta jitneħħiex fil- ħalib tas- sider uman.
All other events attributed to MIRCERA were reported with rare frequency and the majority were mild to moderate in severity.
L- effetti l- oħra kollha, attribwiti lil MIRCERA kienu rrappurtati bi frekwenza rari u l- biċċa l- kbira kienu ħfief għal moderati fis- severità.
Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e. g. excessive erythropoiesis.
Doża eċċessiva tista ’ tirriżulta f’ manifestazzjonijiet ta ’ effett farmakodinamiku esaġerat, e. ż. eritropoesi eċċessiva.
As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.
Bħala fattur tat- tkabbir primarju għal l- iżvilupp eritroid, l- ormon naturali eritropoetin jiġi prodott fil- kliewi u jintreħa fiċ- ċirkulazzjoni tad- demm wara rispons għall- ipoxja.
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetinat 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.
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.
16 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 f’ saħħithom u f’ pazjenti anemiċi b’ CKD, inkluż pazjenti fuq dijalisi u pazjenti mhux fuq dijalisi.
The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
Il- half- life ta ’ eliminazzjoni terminali osservata kienet ta ’ 142 siegħa f’ pazjenti b’ CKD mhux fuq dijalisi.
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.
15 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 a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Fi studju b’ doża waħda, wara għoti fil- vini, il- farmakokinetika ta ’ methoxy polyethylene glycol - epoetin beta kienet simili f’ pazjenti b’ indeboliment sever tal- fwied meta mqabbla ma ’ individwi b’ saħħithom (ara sezzjoni 4. 2).
The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Il- potenzjal karċinoġeniku ta ’ methoxy polyethylene glycol- epoetin beta ma ġiex evalwat fi studji fit - tul fuq l- annimali.
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 ta ’ għadam).
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.
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.
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 parametri ta ’ stima ta ’ l- isperma ma kinux affettwati.
16 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.
23 January 2009
23 ta’ Jannar 2009
MIRCERA 200 micrograms/ ml solution for injection
MIRCERA 200 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 200 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 200 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta *.
18 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.
20 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 level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Jekk il- livell ta ’ emoglobina jibqa ’ jiżdied, it- terapija għandha titwaqqaf sakemm il- livell ta ’ l - emoglobina jibda jonqos, imbagħad it- terapija għandha terġa ’ tinbeda b’ doża ta ’ madwar 25% inqas mid- doża li ngħatat qabel.
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%.
21 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%.
19 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.
22 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.
Dawn l- antikorpi ntwerew li jirreaġixxu ma ’ ESAs kollha, u pazjenti ssuspettati jew ikkonfermati li għandhom antikorpi għal eritropoetin m’ għandhomx jinqalbu fuq MIRCERA.
20 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
23 Treddigħ:
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 f’ 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.
25 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.
23 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 ta ’ l- għadam).
6.3 Shelf life
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
24 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 300 micrograms/ ml solution for injection
MIRCERA 300 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 300 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 300 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta *.
The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Il- qawwa ta ’ methoxy polyethylene glycol- epoetin beta m’ għandhiex titqabbel ma ’ dik ta ’ proteina oħra, pegylated jew mhux pegylated, ta ’ l- istess klassi terapewtika.
Treatment of symptomatic anaemia in adult chronic kidney disease patients Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Kura b’ MIRCERA għandha tinbeda taħt is- sorveljanza ta ’ tabib b’ esperjenza fl- immaniġġjar ta ’ pazjenti b’ indeboliment renali.
26 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.
29 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%.
30 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%.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
Jekk il- livell ta ’ emoglobina jibqa ’ jiżdied, it- terapija għandha titwaqqaf sakemm il- livell ta ’ l- emoglobina jibda jonqos, imbagħad it- terapija għandha terġa ’ tinbeda f’ doża ta ’ madwar 25% inqas mid- doża li ngħatat qabel. Wara interruzzjoni tad- doża, huwa mistenni tnaqqis fl - emoglobina ta ’ madwar 0. 35 g/ dL (0. 22 mmol/ l) kull ġimgħa.
27 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.
31 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
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).
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u 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).
28 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
Lactation:
32 Treddigħ:
Vascular disorders
Disturbi vaskulari Disturbi vaskulari
Hypertension
Komuni Rari
Vascular disorders
Pressjoni għolja Fwawar
Four randomized controlled studies were performed in dialysis patients 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.
Patients were randomized to stay on their treatment at the time of enrollmet 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.
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.
34 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.
31 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- abilità riproduttiva, l- fertilità u parametri ta ’ stima ta ’ l- isperma ma kinux effettwati.
32 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MIRCERA 400 micrograms/ ml solution for injection
MIRCERA 400 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 400 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 400 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.
34 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.
38 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%.
39 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%.
35 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.
40 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
36 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm: