FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Maltese: Meta-analiżi tat-tagħrif globali tas-sopravivenza pproduċiet stima tal-punt tal-proporzjon ta' periklu ta' 1.06 favur il-kontrolli (CI ta' 95%: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bil-kanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu globali tas-sopravivenza kien ta' 1.04 (CI ta' 95%: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: Subcutaneous route:
Maltese: Rotta fil-vini:
English: • The active substance is methoxy polyethylene glycol-epoetin beta.
Maltese: Is-sustanza attiva hi methoxy polyethylene glycol epoetin beta.
English: MIRCERA is available, for all strengths, in pack sizes of 1 and also packsize of 3 for the strengths 30, 50, 75 micrograms/0.3ml.
Maltese: MIRCERA huwa disponibbli f'daqsijiet tal-pakkett ta' 1 għall-qawwiet kollha, kif ukoll f'daqs tal-pakkett ta' 3 għallqawwiet ta' 30, 50, 75 mikrogramma/0.3 ml.
English: IMPORTANT INFORMATION · Only use MIRCERA pre-filled syringeif you have been prescribed with this · medication.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The frequency of possible side effects listed below:
Maltese: Il-frekwenza tal-effetti sekondarji possibli elenkati taħt:
English: The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Maltese: Il-biodisponibiltà assoluta ta' methoxy polyethylene glycol-epoetin beta wara amministrazzjoni taħt il-ġilda kienet ta' 54%.
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għall bnedmin mhux magħruf.
English: One pre-filled syringe contains: 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
Maltese: 30, 40, 50, 60, 75, 100, 120, 150, 200 jew 250 mikrogramma f'0.3 ml u 360 mikrogramma f'0.6 ml. ·
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 40 micrograms/0.3 ml solution for injection in pre-filled syringe 50 micrograms/0.3 ml solution for injection in pre-filled syringe 60 micrograms/0.3 ml solution for injection in pre-filled syringe 75 micrograms/0.3 ml solution for injection in pre-filled syringe 100 micrograms/0.3 ml solution for injection in pre-filled syringe 120 micrograms/0.3 ml solution for injection in pre-filled syringe 150 micrograms/0.3 ml solution for injection in pre-filled syringe 200 micrograms/0.3 ml solution for injection in pre-filled syringe 250 micrograms/0.3 ml solution for injection in pre-filled syringe 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 30 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 40 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 50 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 60 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 75 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 100 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 120 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 150 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 200 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 250 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 360 mikrogramma/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution.
Maltese: Siringi mimlija għal-lest ta' 30, 40, 50, 60, 75, 100, 120, 150, 200 u 250 mikrogramma fihom 0.3 ml ta' soluzzjoni.
English: For instructions on the administration of the medicinal product, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-għoti tal prodott mediċinali, ara sezzjoni 6.6.
English: Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, frequency unknown.
Maltese: Aplasija pura taċ-ċelluli l-ħomor (PRCA) medjata minn antikorpi newtralizzanti anti-eritropoetin ġiet irrappurtata, frekwenza mhux magħrufa.
English: In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8).
Maltese: Fi provi kliniċi, kienet osservata żjieda fir-riskju ta' mewt u ta' avvenimenti kardjovaskulari serji inkluż trombożi jew avvenimenti ċerebrovaskulari inkluż puplesija meta ESAs ingħataw biex tintlaħaq emoglobina ta' aktar minn 12 g/dl (7.5 mmol/l) (ara sezzjoni 4.8).
English: Not included in the pack:
Maltese: MATERJALI Inklużi fil-pakkett:
English: In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued (see section 4.2).
Maltese: F'każ ta' livelli ta' emoglobina għoljin ħafna, kura b'MIRCERA għandha titwaqqaf temporanjament (ara sezzjoni 4.2).
English: The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
Maltese: Il-half-life ta' eliminazzjoni terminali osservata kienet ta' 142 siegħa f'pazjenti b'CKD mhux fuq dijalisi.
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of stroke as common.
Maltese: Data minn prova klinika kkontrollata b'epoetin alfa jew darbepoetin alfa, irrappurtat inċidenza ta'
English: A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: 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.
Maltese: 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 ma'u dissoċjazzjoni aktar malajr minn mar-riċettur, attività speċifika in vitro mnaqqsa b'attività in vivo miżjuda, kif ukoll half-life mtawwla.
English: *Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
Maltese: *Proteina magħmula permezz ta' teknoloġija rikombinanti tad-DNA f'ċelluli tal-Ovarju ta' Ħamster Ċiniż (CHO) u kkonjugata b'mod kovalenti ma' methoxy-polyethylene glycol (PEG) lineari.
English: What is in this leaflet:
Maltese: Traċċabilità ta' MIRCERA:
English: The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
Maltese: Il-half-life ta' eliminazzjoni wara amministrazzjoni ta' methoxy polyethylene glycol-epoetin beta fil-vina hija ta' 134 siegħa.
English: Pre-filled syringe 360 micrograms contains 0.6 ml solution.
Maltese: Siringa mimlija għal-lest ta' 360 mikrogramma fiha 0.6 ml ta' soluzzjoni.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: MIRCERA is not approved for treatment of patients with chemotherapy induced anaemia (see section 4.1 and 4.4.
Maltese: MIRCERA mhux approvat għall-kura ta' pazjenti b'anemija kkaġunata minn kimoterapija (ara sezzjoni 4.1 u 4.4.).
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/l or with transferrin saturation below 20%.
Maltese: Terapija supplimentari ta' ħadid hija rrakkomandata għall-pazjenti kollha b'valuri ta' ferritin fis-serum taħt 100 mikrogramma/l jew b'saturazzjoni ta' transferrin taħt 20%.
English: In a randomised, double-blind, placebo-controlled study of 4,038 CRF patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dL, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dL or placebo (see section 4.4).
Maltese: Fi studju randomised, double-blind, ikkontrollat bil-plaċebo ta' 4,038 pazjent b'CRF li ma kienux fuq dijalisi, b'dijabete tat-tip 2 u b'livelli ta' emoglobina ≤ 11 g/dL, il-pazjenti rċevew kura b'darbepoetin alfa biex jintlaħqu livelli ta' emoglobina ta' 13 g/dL jew placebo (ara sezzjoni 4.4).
English: Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/h per kg.
Maltese: Wara amministrazzjoni ġol-vina lill-pazjenti b'CKD fuq id-dijalisi, it-tneħħija sistemika totali kienet ta' 0.494 ml/s kull kg.
English: Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 pre-filled syringe.
Maltese: Siringi mimlija għal-lest ta' 40, 60, 100, 120, 150, 200, 250 u 360 mikrogramma huma disponibbli f'daqs tal-pakkett ta' siringa waħda mimlija għal-lest.
English: Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis.
Maltese: Doża eċċessiva tista' tirriżulta f'manifestazzjonijiet ta' effett farmakodinamiku esaġerat, e.ż. eritropoesi eċċessiva.
English: INFORMATION IN BRAILLE mircera 120 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 120 mcg
English: During the study, platelet counts below 100 x 109/l were observed yearly in 1.5% to 3.0% of patients treated with MIRCERA and 1.6% to 2.5% of patients treated with other ESAs.'
Maltese: 109/l f'1.5% sa 3.0% tal-pazjenti ttrattati b'MIRCERA u f'1.6% sa 2.5% tal-pazjenti ttrattati b'ESAs oħra.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Maltese: Meta-analiżi ndikat ukoll b'mod konsistenti żjieda sinifikanti fir-riskju relattiv ta' avvenimenti tromboembolitiċi f'pazjenti bil-kanċer li kienu qed jirċievu eritropoetin rikombinanti uman (ara sezzjoni 4.4).
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Maltese: 10 g/dl (6.21 mmol/l) sa 12 g/dl (7.45 mmol/l).
English: An updated RMP should be submitted:
Maltese: RMP aġġornat għandu jiġi ppreżentat: ·
English: The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with MIRCERA and 1,103 with another ESA.
Maltese: Il-bażi ta' tagħrif ta' sigurtà minn provi kliniċi ikkonsistiet minn 3,042 pazjent b'CKD, inkluż 1,939
English: INFORMATION IN BRAILLE mircera 75 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 75 mcg
English: 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.
Maltese: 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.
English: INFORMATION IN BRAILLE mircera 360 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 360 mcg
English: The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Maltese: Il-qawwa tindika l-kwantità tal-parti minn proteina fil-molekula ta' methoxy polyethylene glycol epoetin beta mingħajr konsiderazzjoni tal-glikolsilazzjoni.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 360 mcg/0.6 ml
Maltese: 360 mcg/0.6 ml
English: INFORMATION IN BRAILLE mircera 200 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 200 mcg
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see section 4.2 and section 4.4).
Maltese: Kienet osservata tendenza lejn żieda fl-istimi ta' riskju ta' mortalità minn kull kawża, avvenimenti kardjovaskulari u ċerebrovaskulari assoċjati ma' dożi kumulattivi ta' ESA ogħla indipendenti mill-istat ta' dijabete jew ta' dijalisi (ara sezzjoni 4.2 u sezzjoni 4.4).
English: INFORMATION IN BRAILLE mircera 250 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 250 mcg
English: Hypertensive encephalopathy
Maltese: Enċefalopatija ipertensiva
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe
Maltese: MIRCERA 100 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest MIRCERA 120 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest MIRCERA 150 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis and patients not on dialysis.
Maltese: Analiżi f'126 pazjent b'CKD ma wriet l-ebda differenza fil-farmakokinetika bejn pazjenti fuq dijalisi u pazjenti mhux fuq dijalisi.
English: thrombocytopenia thrombosis
Maltese: Interruzzjoni tal-kura
English: Treatment of symptomatic anaemia in adult chronic kidney disease patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Maltese: Kura ta' anemija sintomatika f'pazjenti adulti b'mard kroniku tal-kliewi Is-sintomi u l-kumplikazzjonijiet tal-anemija jistgħu jvarjaw skont l-età, is-sess u l-effett globali talmarda; valutazzjoni mit-tabib tal-progressjoni u l-kundizzjoni klinika tal-pazjent individwali hija neċessarja.
English: In patients with a poor haemoglobin response to MIRCERA, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Maltese: F'pazjenti b'rispons ta' emoglobina batut għal MIRCERA, għandhom jiġu kkunsidrati spjegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.4 u 5.1).
English: 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.
Maltese: 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.
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided.
Maltese: Żjieda fl-emoglobina ta' aktar minn 2 g/dl (1.24 mmol/l) fuq perijodu ta' erba' ġimgħat għandha tiġi evitata.
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Maltese: Reazzjonijiet serji tal-ġilda li jinkludu s-sindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekroliżi epidermali tossika (TEN - toxic epidermal necrolysis) kienu rrappurtati b'rabta ma' trattament b'epoetin.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Maltese: ESAs mhumiex approvati fl-immaniġġar ta' anemija assoċjata ma' epatite Ċ.
English: Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association with epoetin treatement.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluż każijiet ta' reazzjoni anafilattika u raxxijiet serji tal ġilda li jinkludu s-sindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekroliżi epidermali tossika kienu rrappurtati b'rabta ma' trattament b'epoetin.
English: INFORMATION IN BRAILLE mircera 40 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 40 mcg
English: INFORMATION IN BRAILLE mircera 150 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 150 mcg
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Important information about some of the ingredients of MIRCERA This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free'.
Maltese: Tagħrif importanti dwar uħud mis-sustanzi ta' MIRCERA Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment ‘ħieles missodium'.
English: INFORMATION IN BRAILLE mircera 60 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 60 mcg
English: Uncommon side effects (may affect up to 1 in 100 pleople) are:
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) huma:
English: 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.
Maltese: Dawn l-istudji wrew mortalità eċċessiva statistikament sinifikanti u konsistenti mhux spjegata f'pazjenti li għandhom anemija assoċjata ma' diversi kanċers komuni li rċevew eritropoetin rikombinanti uman meta mqabbla mal-kontrolli.
English: 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.
Maltese: Infezzjonijiet fl-istess waqt, episodji ta' infjammazzjoni jew trawmatiċi, telf ta' demm okkult, emolisi, tossiċità tal-aluminju severa, preżenza ta' mard ematoloġiku fl-istess ħin, jew fibrożi tal-mudullun ukoll jistgħu jikkompromettu r-rispons eritropoetiku.
English: INFORMATION IN BRAILLE mircera 100 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 100 mcg
English: Treatment with MIRCERA is normally long-term.
Maltese: Kura b'MIRCERA normalment hija fit-tul.
English: INFORMATION IN BRAILLE mircera 30 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 30 mcg
English: PRCA in patients with Hepatitis C: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Maltese: PRCA f'pazjenti b'Epatite Ċ: Tnaqqis paradossali fl-emoglobina u żvilupp ta' anemija severa assoċjata ma' għadd baxx ta' retikuloċiti għandhom iwasslu għal waqfien tal-kura b'epoetin u għal testijiet għall-antikorpi kontra eritropoetin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentialy sodium free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment
English: 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).
Maltese: 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).
English: 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.
Maltese: Il-qawwa ta' methoxy polyethylene glycol-epoetin beta m'għandhiex titqabbel ma' dik ta' proteina oħra, pegylated jew mhux pegylated, tal-istess klassi terapewtika.
English: MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml.
Maltese: Siringa waħda mimlija għal-lest fiha 40 mikrogramma ta' methoxy polyethylene glycol-epoetin beta* f'konċentrazzjoni ta' 133 mikrogramma/ml.
English: After dose interruption a haemoglobin decrease of approximately 0.35 g/dl (0.22 mmol/l) per week is expected.
Maltese: Wara interruzzjoni tad-doża, huwa mistenni tnaqqis flemoglobina ta' madwar 0.35 g/dL (0.22 mmol/l) kull ġimgħa.
English: INFORMATION IN BRAILLE mircera 50 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE mircera 50 mcg
English: Cleansing alcohol swabs
Maltese: protezzjoni tal-labra
English: Studies in animals have shown no evidence of impaired fertility (see section 5.3).
Maltese: Studji fuq l-annimali ma wrew l-ebda evidenza ta' fertilità indebolita (ara sezzjoni 5.3).
English: 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.
Maltese: 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 ilfarmakokinetika ta' dan il-prodott mediċinali.
English: • maculo-papular rash (red skin reaction that can include pimples or spots)
Maltese: · raxx makulopapulari (reazzjoni fil-ġilda bi ħmura li tista' tinkludi ponot jew imsiemer) · fwawar
English: Uncontrolled hypertension.
Maltese: Ilma għall-injezzjonijiet
English: 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.
Maltese: 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.
English: MIRCERA has not shown evidence of impaired fertility in animals.
Maltese: MIRCERA ma weriex evidenza ta' indeboliment tal-fertilità fl-annimali.
English: Vascular access thrombosis
Maltese: Reazzjoni avversa