FrancophonIA/ELRC3.0 huggingface dataset:
English: Reticulocyte count increase ≥ 40,000/µL
Maltese: Żieda fl-għadd ta' retikuloċiti ≥ 40,000/µL
English: Surgery patients in autologous predonation programmes
Maltese: Pazjenti kirurġiċi fi programmi ta' predonazzjoni awtologa
English: Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL.
Maltese: Epoetin alfa 300 IU/kg naqqas b'mod sinifikanti r-riskju ta' trasfużjoni alloġeneika f'pazjenti b'emoglobina ta' qabel il-kura ta' > 10 sa ≥ 13 g/dL.
English: This is of uncertain significance in the clinical situation.
Maltese: Dan hu ta' importanza inċerta fis-sitwazzjoni klinika.
English: Moreover, epoetin alfa doses of 75 to 150 IU/kg per week have been shown to maintain haematocrits of 36 to 38% for up to six months.
Maltese: Barra minn hekk, intwera li dożi ta' epoetin alfa bejn 75 sa 150 IU/kg kull ġimgħa, iżommu ematokriti ta' 36 sa 38% għal sa sitt xhur.
English: In paediatric patients the recommended haemoglobin concentration range is between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Maltese: F'pazjenti pedjatriċi, il-medda rakkomandata tal-konċentrazzjoni tal-emoglobina hi bejn 9.5 g/dL sa 11 g/dL (5.9 sa 6.8 mmol/L).
English: Median time from baseline to first transfusion was statistically significantly longer in the epoetin alfa group compared to placebo (49 vs. 37 days; p = 0.046).
Maltese: Il-ħin medjan bejn il-linja bażi u l-ewwel trasfużjoni kien itwal b'mod statistikament sinifikanti fil grupp ta' epoetin alfa meta mqabbel mal-plaċebo (49 vs. 37 jum; p = 0.046).
English: Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p < 0.001).
Maltese: Ir-rispons tal-eritojde matul l-ewwel 24 ġimgħa tal-istudju ntwera minn 27/85 (31.8%) tal-individwi fil-grupp tal-epoetin alfa meta mqabbel ma' 2/45 (4.4%) tal-individwi fil-grupp tal-plaċebo (p < 0.001).
English: Adult peritoneal dialysis patients
Maltese: Pazjenti adulti fuq dijalisi peritonali
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Maltese: Distribuzzjoni Il-volum medju tad-distribuzzjoni kien ta' 49.3 mL/g wara dożi ġol-vini ta' 50 u 100 IU/kg f'individwi b'saħħithom.
English: Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Maltese: epoetin alfa 100 IU/kg, u 45% tal-pazjenti kkurati bi plaċebo kienu jeħtieġu trasfużjoni.
English: Clinical data with subcutaneous administration in children are limited.
Maltese: Data farmakokinetika fi trabi tat-twelid hija limitata.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 8,000 IU/0.8 mL 17.
Maltese: Epoetin alfa HEXAL 8,000 IU/0.8 mL
English: No a one subject did not have sEPO data b in the ≥ 200 mU/mL stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Maltese: b fl-istrat ta' ≥ 200 mU/mL kien hemm 13-il individwu fil-grupp ta' epoetin alfa u 6 individwi filgrupp tal-plaċebo
English: Epoetin alfa HEXAL is a biosimilar medicinal product.
Maltese: Epoetin alfa HEXAL hu prodott mediċinali bijosimili.
English: Recombinant human EPO (epoetin alfa), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays.
Maltese: EPO uman rikombinanti (epoetin alfa), espress fiċ-ċelluli tal-ovarji tal-ħamster Ċiniż, għandu sekwenza ta' 165 amino acids li hi identika għal dik ta' EPO uman urinarju; it-2 huma indistingwibbli fuq il-bażi ta' assaġġi funzjonali.
English: Administer over at least one to five minutes, depending on the total dose.
Maltese: Agħti fuq perjodu ta' mill-anqas minuta sa ħames minuti, skont id-doża totali.
English: Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18).
Maltese: 0-il xahar fil-grupp ta' SOC waħidha (HR 1.07, CI 95%: 0.97, 1.18).
English: The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
Maltese: Il-piż molekulari apparenti ta' eritropoetin hu minn 32,000 sa
English: • Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara “EXP”.
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 tindika wkoll b'mod konsistenti, żieda sinifikanti tar-riskju relattiv ta' avvenimenti tromboemboliċi f'pazjenti bil-kanċer li jkunu qed jirċievu erythropoietin uman rikombinanti (ara sezzjoni 4.4).
English: A half-life of approximately 6.2 to 8.7 hours has been reported in paediatric subjects with chronic renal failure following multiple dose intravenous administration of epoetin alfa.
Maltese: Half-life ta' madwar 6.2 sa 8.7 sigħat ġiet irrappurtata f'individwi pedjatriċi b'insuffiċjenza renali kronika wara l-għoti għal ġol-vini ta' dożi multipli ta' epoetin alfa.
English: The median TTP based on IRC-determined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI:
Maltese: It-TTP medjan ibbażat fuq il-PD iddeterminata mill-IRC kien ta' 8.0 xhur fil-grupp ta' epoetin alfa flimkien ma' SOC u ta' 8.3 xhur fil-grupp ta' SOC (HR 1.033, CI 95%: 0.924, 1.156).
English: • if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Maltese: • jekk tkun se tagħmel operazzjoni ortopedika maġġuri mhux obbligatorja (bħal operazzjoni tal-ġenbejn jew tal-irkoppa), u inti:
English: • Fits.
Maltese: • Urtikarja.
English: 1 pre-filled syringe of 0.6 mL contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.6 mL fiha 6,000 unità internazzjonali (IU) li jikkorrispondu għal 50.4 mikrogrammi ta' epoetin alfa.
English: Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Maltese: Reazzjonijiet avversi tal-mediċina rrappurtati minn ≤ 1% tal-individwi kkurati b'epoetin alfa f'dawn il-provi qed jintwerew fit-tabella hawn taħt.
English: In the 20-week study (n = 225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
Maltese: Jum 28 (62% tal-pazjenti b'epoetin alfa kontra 69% tal-pazjenti b'terapija standard).
English: Medicinal products that decrease erythropoiesis may decrease the response to epoetin alfa.
Maltese: Prodotti mediċinali li jnaqqsu l-erythropoiesis jistgħu jnaqqsu r-rispons għal epoetin alfa.
English: These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Maltese: Dawn jinkludu trombożi venużi u arterjali u emboliżmu (li jinkludu xi wħud b'riżultati fatali), bħal trombożi profonda tal-vini, emboli pulmonari, trombożi fir-retina u infart mijokardijaku.
English: In that stratum, 20/40 (50%) subjects without prior transfusions demonstrated erythroid response during the first 24 weeks, compared with 7/31 (22.6%) subjects with prior transfusions (two subjects with prior transfusion reached primary endpoint based on reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline).
Maltese: F'dak l-istrat 20/40 (50%) tal-individwi mingħajr trasfużjonijiet preċedenti wrew rispons tal-eritojde matul l-ewwel 24 ġimgħa, meta mqabbel ma' 7/31 (22.6%) tal-individwi bi trasfużjonijiet preċedenti (żewġ individwi bi trasfużjonijiet preċedenti laħqu l-punt ta' tmiem primarju abbażi ta' tnaqqis talunitajiet RBC trasfużi b'numru assolut ta' mill-inqas 4 unitajiet kull 8 ġimgħat meta mqabbel mat8 ġimgħat qabel il-linja bażi).
English: Treatment of symptomatic anaemia in adult chronic renal failure patients
Maltese: Kura ta' anemija sintomatika f'pazjenti adulti li għandhom insuffiċjenza renali kronika
English: Since cyclosporin is bound by red blood cells (RBCs) there is potential for a medicinal product interaction.
Maltese: Billi cyclosporin jeħel maċ-ċelluli l-ħomor tad-demm (RBCs, red blood cells), hemm il-potenzjal għal interazzjoni bejn il-prodotti mediċinali.
English: Epoetin alfa has been studied in clinical trials in adult anaemic CRF patients, including haemodialysis and pre-dialysis patients, to treat anaemia and maintain haematocrit within a target concentration range of 30 to 36%.
Maltese: Epoetin alfa ġie studjat fi provi kliniċi f'pazjenti adulti anemiċi b'CRF, li jinkludu pazjenti fuq id dijalisi u predijalisi, biex jikkura l-anemija u jżomm l-ematokrit f'medda ta' konċentrazzjoni fil-mira ta' 30 sa 36%.
English: At the time of clinical data cutoff, the median progression free survival (PFS) per investigator assessment of disease progression was 7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met.
Maltese: progression free survival) medjana għal kull evalwazzjoni tal-investigatur tal-progressjoni tal-marda kienet 7.4 xhur f'kull grupp (HR 1.09, CI 95%: 0.99, 1.20), li tindika li l-għan tal-istudju ma ntlaħaqx.
English: No unexpected adverse events were reported (see section 4.2).
Maltese: Ma kien irrappurtat l-ebda avveniment avvers mhux mistenni (ara sezzjoni 4.2).
English: or Hb increase ≥ 1 g/dL
Maltese: jew żieda fl-Hb ≥ 1 g/dL
English: A pre-filled syringe of 0.7 mL contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.7 mL fiha 7,000 unità internazzjonali (IU) li jikkorrispondu għal 58.8 mikrogrammi ta' epoetin alfa.
English: Treatment of adult patients scheduled for major elective orthopaedic surgery
Maltese: Kura ta' pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 3,000 IU/0.3 mL 17.
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL
English: A pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.75 mL fiha 30,000 unità internazzjonali (IU) li jikkorrispondu għal 252.0 mikrogrammi ta' epoetin alfa.
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8).
Maltese: Ġiet osservata inċidenza akbar ta' avvenimenti vaskulari trombotiċi (TVEs) f'pazjenti li kienu qed jirċievu ESAs (ara sezzjoni 4.8).
English: 1 pre-filled syringe of 0.75 mL 6 pre-filled syringes of 0.75 mL 1 pre-filled syringe of 0.75 mL with a needle safety guard 4 pre-filled syringes of 0.75 mL with a needle safety guard 6 pre-filled syringes of 0.75 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra 4 siringi mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra
English: No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Maltese: Ma teżisti l-ebda evidenza li tindika interazzjoni bejn epoetin alfa u fattur li jistimula kolonji ta' granuloċiti (G-CSF, granulocyte colony-stimulating factor) jew fattur li jistimula kolonji tal-makrofaġi tal-granuloċiti (GM-CSF, granulocyte macrophage colony-stimulating factor) fir-rigward taddifferenzjar ematoloġiku jew il-proliferazzjoni ta' kampjuni ta' bijopsiji tat-tumuri in vitro.
English: In 2 studies with extended interval dosing of epoetin alfa (3 times per week, once weekly, once every 2 weeks, and once every 4 weeks) some patients with longer dosing intervals did not maintain adequate haemoglobin levels and reached protocol-defined haemoglobin withdrawal criteria (0% in once weekly, 3.7% in once-every-2-weeks, and 3.3% in the once-every-4-weeks groups).
Maltese: F'2 studji b'intervall estiż ta' dożaġġ ta' epoetin alfa (3 darbiet fil-ġimgħa, darba fil-ġimgħa, darba kull ġimagħtejn, u darba kull 4 ġimgħat), xi pazjenti b'intervalli itwal ta' dożaġġ, ma żammewx livelli adegwati ta' emoglobina u laħqu l-kriterji ta' rtirar tal-emoglobina definiti mill-protokoll (0% fil grupp ta' darba fil-ġimgħa, 3.7% fil-grupp ta' darba kull ġimagħtejn, u 3.3% fil-grupp ta' darba kull 4 ġimgħat).
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Maltese: L-età medjana tal-pazjenti rreġistrati fl-istudju kienet ta' 11.6 snin (medda minn 0.5 sa 20.1 sena).
English: Reticulocyte count increase < 40,000/µL and Hb increase < 1 g/dL
Maltese: < 40,000/µL u żieda fl-Hb < 1 g/dL
English: A pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.5 mL fiha 20,000 unità internazzjonali (IU) li jikkorrispondu għal 168.0 mikrogrammi ta' epoetin alfa.
English: Epoetin alfa does not induce bacterial gene mutation (Ames Test), chromosomal aberrations in mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus.
Maltese: Epoetin alfa ma jinduċix mutazzjoni tal-ġeni tal-batterji (Test ta' Ames), aberrazzjonijiet kromożomoli f'ċelluli tal-mammali, mikronuklei fil-ġrieden, jew mutazzjoni tal-ġeni fl-HGPRT locus.
English: Pure Red Cell Aplasia (PRCA)
Maltese: Aplasija taċ-Ċelluli l-Ħomor tad-Demm Pura (PRCA, Pure Red Cell Aplasia)
English: - in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4).
Maltese: - f'adulti b'insuffiċjenza renali li jkunu għadhom mhux qegħdin fuq id-dijalisi għall-kura ta' anemija severa ta' oriġini renali akkumpanjata minn sintomi kliniċi f'pazjenti (ara sezzjoni 4.4).
English: Do not administer Epoetin alfa HEXAL by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Maltese: Tagħtix Epoetin alfa HEXAL permezz ta' infużjoni ġol-vini jew flimkien ma' soluzzjonijiet oħrajn ta' prodotti mediċinali (jekk jogħġbok irreferi għal sezzjoni 6.6 għal informazzjoni addizzjonali).
English: This regresses during the course of continued therapy.
Maltese: Din titreġġa' lura fil-kors ta' terapija kontinwa.
English: 1 pre-filled syringe of 0.9 mL contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.9 mL fiha 9,000 unità internazzjonali (IU) li jikkorrispondu għal 75.6 mikrogrammi ta' epoetin alfa.
English: A pre-filled syringe of 0.5 mL contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.5 mL fiha 5,000 unità internazzjonali (IU) li jikkorrispondu għal 42.0 mikrogrammi ta' epoetin alfa.
English: - If the haemoglobin concentration increase is < 1 g/dL (< 0.62 mmol/L) and the reticulocyte count has increased < 40,000 cells/µL above baseline, increase the dose to 300 IU/kg 3 times per week.
Maltese: - Jekk iż-żieda tal-konċentrazzjoni tal-emoglobina tkun < 1 g/dL (< 0.62 mmol/L) u l-għadd tar retikuloċiti jkun żdied < 40,000 ċellula/µL fuq il-linja bażi, żid id-doża għal 300 IU/kg 3 darbiet fil-ġimgħa.
English: Adult surgery patients in an autologous predonation programme
Maltese: Kura ta' pazjenti kirurġiċi adulti fi programm ta' predonazzjoni awtologa
English: Pharmacokinetic/pharmacodynamic relationships
Maltese: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi)
English: Other medicines and Epoetin alfa HEXAL
Maltese: Mediċini oħra u Epoetin alfa HEXAL
English: In patients with a poor haemoglobin response to Epoetin alfa HEXAL, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Maltese: F'pazjenti b'rispons batut tal-emoglobina għal Epoetin alfa HEXAL, għandhom jiġu kkunsidrati spegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.4 u 5.1).
English: A randomised prospective trial evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Maltese: Prova prospettiva li fiha l-parteċipanti ntgħażlu b'mod każwali, evalwat 1,432 pazjent anemiku b'insuffiċjenza renali kronika li ma kinux qed jirċievu dijalisi.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).
Maltese: Kien hemm rapporti ta' reazzjonijiet avversi serji tal-ġilda (SCARs, severe cutaneous adverse reactions) fosthom is-sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome) u nekrolisi epidermali tossika (TEN, toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' kura b'epoetin (ara s-sezzjoni 4.4).
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4).
Maltese: Ġiet osservata inċidenza akbar ta' avvenimenti vaskulari trombotiċi (TVEs, thrombotic vascular events) f'pazjenti li kienu qed jirċievu ESAs (ara sezzjoni 4.4).
English: The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Maltese: Ir-rispons eritropoietiku osservat fiż-żewġ gruppi ta' kura, irriżulta f'rati simili ta' trasfużjoni (16% fil grupp ta' 600
English: Epoetin alfa HEXAL is not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetin alfa mhuwiex approvat għall-immaniġġjar ta' anemija marbuta ma' epatite Ċ.
English: In healthy subjects, a dose-proportional increase in serum epoetin alfa concentrations was observed after intravenous administration of 150 and 300 IU/kg, 3 times per week.
Maltese: epoetin alfa fis-serum wara l-għoti għal ġol-vini ta' 150 u 300 IU/kg, 3 darbiet fil-ġimgħa.
English: The percentage of subjects who were transfused in the epoetin alfa group decreased from 51.8% in the 8 weeks prior to baseline to 24.7% between weeks 16 and 24, compared to the placebo group which had an increase in transfusion rate from 48.9% to 54.1% over the same time periods.
Maltese: 51.8% fit-8 ġimgħat ta' qabel il-linja bażi għal 24.7% bejn il-ġimgħat 16 u 24, meta mqabbel malgrupp tal-plaċebo li kellu żieda fir-rata ta' trasfużjoni minn 48.9% għal 54.1% matul l-istess perjodi ta' żmien.
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.8).
Maltese: Għandha tingħata attenzjoni partikulari għal uġigħ ta' ras qisu emigranja, li jiġi għall għarrieda, għax dan jista' jkun possibbilment sinjal ta' twissija (ara sezzjoni 4.8).
English: The recommended desired haemoglobin concentration range is between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Maltese: emoglobina bejn 10 g/dL u 12 g/dL (6.2 sa 7.5 mmol/L).
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Maltese: • Nefħa fil-wiċċ, xufftejn, ħalq, ilsien u ġerzuma,
English: Pre-filled syringes*
Maltese: TIKKETTA/SIRINGA
English: - For chronic renal failure patients, iron supplementation (elemental iron 200 to 300 mg/day orally for adults and 100 to 200 mg/day orally for paediatrics) is recommended if serum ferritin levels are below 100 ng/mL.
Maltese: 300 mg/jum b'mod orali għall-adulti u 100 sa 200 mg/jum b'mod orali għal pazjenti pedjatriċi) huwa rakkomandat jekk il-livelli ta' ferritin fis-serum tagħhom huma taħt il-100 ng/mL.
English: 1 pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.5 mL fiha 1,000 unità internazzjonali (IU) li jikkorrispondu għal 8.4 mikrogrammi ta' epoetin alfa.
English: This does not affect normal operation of the syringe.
Maltese: Dan ma jaffettwax l-operat normali tas-siringa.
English: EU/1/07/411/025 EU/1/07/411/026 EU/1/07/411/051 EU/1/07/411/055 EU/1/07/411/052
Maltese: EU/1/07/411/026 EU/1/07/411/051 EU/1/07/411/055 EU/1/07/411/052
English: In the three largest clinical trials conducted in adult patients on dialysis, the median maintenance dose necessary to maintain the haematocrit between 30 to 36% was approximately 75 IU/kg given 3 times per week.
Maltese: Fl-ikbar tliet provi kliniċi li twettqu f'pazjenti adulti fuq id-dijalisi, id-doża ta' manteniment medjana meħtieġa biex iżżomm l-ematokrit bejn 30 sa 36% kienet ta' madwar 75 IU/kg mogħtija 3 darbiet fil ġimgħa.
English: In clinical trials at starting doses of 50 to 150 IU/kg, three times per week, approximately 95% of all patients responded with a clinically significant increase in haematocrit.
Maltese: Fil-provi kliniċi, f'dożi tal-bidu ta' 50 sa 150 IU/kg, tliet darbiet fil-ġimgħa, madwar 95% tal-pazjenti kollha rrispondew permezz ta' żieda klinikament sinifikanti fl-ematokrit.
English: Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe EU/1/07/411/019
Maltese: IU/0.9 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/411/019
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Jekk inti pazjent b'insuffiċjenza renali kronika, u b'mod partikolari jekk ma tirrispondix kif suppost għal Epoetin alfa HEXAL, it-tabib tiegħek se jiċċekkja d-doża ta' Epoetin alfa HEXAL, għax jekk iżid ripetutament id-doża tiegħek ta' Epoetin alfa HEXAL jekk ma tkunx qed tirrispondi għall kura, jista' jiżdied ir-riskju li jkollok problema fil-qalb jew fil-vini/arterji, u jista' jiżdied ir-riskju ta' infart mijokardijaku, puplesija u mewt.
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa
Maltese: Epoetin alfa HEXAL 40,000 IU/1 mL injezzjoni Epoetin alfa
English: Comparable intensity of chemotherapy in the epoetin alfa and placebo groups in the chemotherapy trials was demonstrated by a similar area under the neutrophil time curve in patients treated with epoetin alfa and placebo-treated patients, as well as by a similar proportion of patients in groups treated with epoetin alfa and placebo-treated groups whose absolute neutrophil counts fell below 1,000 and 500 cells/µL.
Maltese: minn żona simili taħt il-kurva newtrofili-żmien f'pazjenti kkurati b'epoetin alfa u pazjenti kkurati bi plaċebo, kif ukoll minn proporzjon simili ta' pazjenti fil-gruppi kkurati b'epoetin alfa u plaċebo li lgħadd assolut tagħhom tan-newtrofili waqa' taħt 1,000 u 500 ċellula/µL.