FrancophonIA/ELRC3.0 huggingface dataset:
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 imtawwal bejn dożaġġi ta' epoetin alfa (3 darbiet fil-ġimgħa, darba fil-ġimgħa, darba kull ġimagħtejn, u darba kull 4 ġimgħat) xi pazjenti b'intervalli ta' dożaġġ itwal ma żammewx livelli xierqa ta' emoglobina u laħqu kriterji mfissra minn qabel bil-protokoll għall-waqfien talemoglobina (0% fil-gruppi ta' darba fil-ġimgħa, 3.7% f'ta' darba kull ġimagħtejn, u 3.3% f'ta' darba kull 4 ġimgħat).
English: Treatment of paediatric patients scheduled for major elective orthopaedic surgery
Maltese: Trattament ta' pazjenti pedjatriċi skedati għal operazzjoni ortopedika elettiva maġġuri
English: The prefilled syringes contain between 0.3 and 1 ml solution, depending on the content of epoetin zeta (see “What Retacrit contains”).
Maltese: Is-siringi mimlija minn qabel fihom bejn 0.3 u 1 ml ta' soluzzjoni, skont il-kontenut tal-epoetin zeta (ara “X'fih Retacrit”).
English: Anaemia in chronic renal failure patients before initiation of dialysis or on peritoneal dialysis
Maltese: Anemija f'pazjenti b'falliment kroniku tal-kliewi qabel il-bidu ta' dijalisi jew fuq dijalisi peritoneali
English: For patients scheduled for major elective orthopaedic surgery, iron supplementation (elemental iron 200 mg/day orally) should be administered throughout the course of epoetin zeta therapy.
Maltese: Għal pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri, supplimentazzjoni bil-ħadid (ħadid elementali 200 mg/jum b'mod orali) għandha tingħata matul il-kors ta' terapija b'epotein zeta.
English: If you are a patient with hepatitis C and you receive interferon and ribavirin
Maltese: Jekk inti pazjent bl-epatite Ċ u tirċievi interferon u ribavirin
English: Recombinant human EPO (epoetin zeta), 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: għandha sekwenza ta' 165 aċidu amminiku identiku għal dik tal-EPO urinarja tal-bniedem; it-2 li huma ma jintgħarfux minn xulxin abbażi tal-assaġġi funzjonali.
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Retacrit 3,000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'0.9 ml soluzzjoni għall-injezzjoni għandha 3,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.8 ml soluzzjoni għall-injezzjoni li fiha 8,000 unit internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Maltese: Minkejja differenzi fil-profili ta' konċentrazzjoni-żmien, ir-rispons farmakodinamiku (kif imkejjel minn bidliet fil-perċentwal ta' retikuloċiti, emoglobina, u RBCs totali) kien simili bejn dawn il-korsijiet.
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.
Maltese: Ġew irrappurtati reazzjonijiet avversi tal-ġilda severi (SCARs, severe cutaneous adverse reactions) li jinkludu sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN, toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' trattament b'epoetin.
English: Retacrit 1 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 1,000 IU epoetin zeta
English: Major elective orthopaedic surgery
Maltese: • attakki epilettiċi jew aċċessjonijiet
English: Retacrit 3 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 3,000 IU epoetin zeta
English: Retacrit 2 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 2,000 IU epoetin zeta
English: EU/1/07/431/013 EU/1/07/431/014 EU/1/07/431/038 EU/1/07/431/039 EU/1/07/431/066 EU/1/07/431/067
Maltese: EU/1/07/431/038 EU/1/07/431/039 EU/1/07/431/066 EU/1/07/431/067
English: The absolute bioavailability of subcutaneous injectable erythropoietin is approximately 20% in healthy subjects.
Maltese: Il-bijodisponibilità assoluta tal-eritropojetin injettat taħt il-ġilda hija bejn wieħed u ieħor 20%
English: Therefore, epoetin zeta should not be used in patients with baseline haemoglobin >13 g/dL (>8.1 mmol/L).
Maltese: Għaldaqstant, epoetin zeta m'għandux jintuża f'pazjenti bl-emoglobina fil-linja bażi ta' >13 g/dL (>8.1 mmol/L).
English: Do not shake Retacrit syringes.
Maltese: Ħu doża waħda biss ta' Retacrit minn kull siringa.
English: After 4 weeks of treatment the time to first transfusion was further increased in the epoetin alfa group (142 vs. 50 days, p=0.007).
Maltese: Wara 4 ġimgħat ta' trattament iż-żmien sal-ewwel trasfużjoni kompla jiżdied fil-grupp tal-epoetin alfa (142 vs. 50 jum,
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: Ġew irrappurtati reazzjonijiet avversi tal-ġilda severi (SCARs) li jinkludu sindrome ta' StevensJohnson (SJS) u nekroliżi epidermali tossika (TEN, toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' trattament b'epoetin (ara sezzjoni 4.4).
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/431/013 1 pre-filled syringe EU/1/07/431/014 6 pre-filled syringes EU/1/07/431/038 1 pre-filled syringe with needle guard EU/1/07/431/039 6 pre-filled syringes with needle guard EU/1/07/431/066 1 pre-filled syringe with needle-trap EU/1/07/431/067 6 pre-filled syringes with needle-trap
Maltese: Retacrit 8,000 IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/013 siringa 1 mimlija għal-lest EU/1/07/431/014 6 siringi mimlija għal-lest EU/1/07/431/038 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/039 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/066 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/067 6 siringi mimlija għal-lest b'tarka għal-labra
English: Retacrit should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Maltese: Retacrit għandu jingħata sabiex l-emoglobina tiżdied mhux aktar minn 11 g/dL (6.8 mmol/L).
English: Retacrit 4 000 IU
Maltese: Retacrit 4,000
English: Excipients with known effect Each pre-filled syringe contains 0.20 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.20 mg phenylalanine.
English: Hyperkalaemia has been observed in isolated cases though causality has not been established.
Maltese: L-iperkalemija ġiet osservata f'kazijiet iżolati għalkemm il-kawżalità ma ġietx determinata.
English: The safety and efficacy of epoetin alfa in paediatric patients receiving chemotherapy have not been established (see section 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' epoetin alfa f'pazjenti pedjatriċi li qed jirċievu l-kimoterapija ma ġewx determinati s'issa (ara sezzjoni 5.1).
English: For cancer patients, iron supplementation (elemental iron 200 to 300 mg/day orally) is recommended if transferrin saturation is below 20%.
Maltese: Għal pazjenti tal-kanċer, supplimentazzjoni bil-ħadid (ħadid elementali 200 sa 300 mg/jum b'mod orali) hija rrakomandata jekk is-saturazzjoni tat-transferrin hija taħt l-20%.
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 konsistenti statistikament sinifikanti u bla spjegazzjoni f'pazjenti li għandhom anemija assoċjata ma' diversi kanċers komuni li rċevew eritropoetina rikombinanti umana meta mqabblin ma' kontrolli.
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 sections 4.2 and 4.4).
Maltese: Ġiet osservata tendenza ta' żieda fl-estimi ta' riskju għal kwalunkwe kawża ta' mewt, episodju kardjovaskulari u ċerebrovaskulari assoċjati ma' dożi aktar għoljin ta' ESA kumulattivi indipendenti mid-dijabete jew il-qagħda tad-dijalisi (ara sezzjonijiet 4.2 u 4.4).
English: Retacrit is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): o in adults and paediatrics aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Maltese: Retacrit huwa indikat għat-trattament għal anemija sintomatika assoċjata ma' falliment renali kroniku (CRF, chronic renal failure): o f'adulti u pazjenti pedjatriċi minn età ta' sena sa 18-il sena fuq emodijalisi u pazjenti adulti fuq dijalisi peritoneali (ara sezzjoni 4.4). o f'adulti b'insuffiċjenza tal-kliewi li għad mhux ikollhom dijalisi għat-trattament ta' anemija severa li ġejja mill-kliewi akkumpanjata minn sintomi kliniċi fil-pazjenti (ara sezzjoni 4.4).
English: Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe EU/1/07/431/018 1 pre-filled syringe EU/1/07/431/022 4 pre-filled syringes EU/1/07/431/023 6 pre-filled syringes EU/1/07/431/043 1 pre-filled syringe with needle guard EU/1/07/431/047 4 pre-filled syringes with needle guard EU/1/07/431/048 6 pre-filled syringes with needle guard EU/1/07/431/052 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/073 1 pre-filled syringe with needle-trap EU/1/07/431/074 4 pre-filled syringes with needle-trap EU/1/07/431/075 6 pre-filled syringes with needle-trap
Maltese: IU/0.75 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/018 siringa 1 mimlija għal-lest EU/1/07/431/022 4 siringi mimlija għal-lest EU/1/07/431/023 6 siringi mimlija għal-lest EU/1/07/431/043 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/047 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/048 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/052 4 siringi mimlija għal-lest (pakkett multiplu ta' 4 x 1) EU/1/07/431/073 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/074 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/075 6 siringi mimlija għal-lest b'tarka għal-labra
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe EU/1/07/431/005 1 pre-filled syringe EU/1/07/431/006 6 pre-filled syringes EU/1/07/431/030 1 pre-filled syringe with needle guard EU/1/07/431/031 6 pre-filled syringes with needle guard EU/1/07/431/058 1 pre-filled syringe with needle-trap EU/1/07/431/059 6 pre-filled syringes with needle-trap
Maltese: Retacrit 3,000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/005 siringa 1 mimlija għal-lest EU/1/07/431/006 6 siringi mimlija għal-lest EU/1/07/431/030 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/031 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/058 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/059 6 siringi mimlija għal-lest b'tarka għal-labra
English: In general, all pharmacodynamic markers increased in a linear manner with dose reaching a maximum response at the highest dose levels.
Maltese: B'mod ġenerali, il-markaturi farmakodinamiċi kollha żdiedu b'mod lineari bid-doża tilħaq rispons massimu fl-ogħla livelli tad-doża.
English: This was a non inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin alfa plus standard of care (SOC) as compared with SOC alone.
Maltese: Dan kien studju mhux ta' inferjorità mfassal biex jeskludi żieda ta' 15% fir-riskju fil-progressjoni tat-tumur jew mewt ta' epoetin alfa u kura ta' standard (SOC, standard of care) kif imqabbel ma' SOC waħidha.
English: Excipients with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.15 mg phenylalanine.
English: Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.75 ml soluzzjoni għall-injezzjoni li fiha 30,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: Retacrit 3,000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel epoetin zeta
English: Multipacks contain 4 (4 x 1) pre-filled syringes.
Maltese: Il-pakketti multipli fihom 4 (4 x 1) siringi mimlija għal-lest.
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/431/019 1 pre-filled syringe EU/1/07/431/024 4 pre-filled syringes EU/1/07/431/025 6 pre-filled syringes EU/1/07/431/044 1 pre-filled syringe with needle guard EU/1/07/431/049 4 pre-filled syringes with needle guard EU/1/07/431/050 6 pre-filled syringes with needle guard EU/1/07/431/053 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/076 1 pre-filled syringe with needle-trap
Maltese: Retacrit 40,000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa 1 mimlija għal-lest EU/1/07/431/019 siringa 1 mimlija għal-lest EU/1/07/431/024 4 siringi mimlija għal-lest EU/1/07/431/025 6 siringi mimlija għal-lest EU/1/07/431/044 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/049 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/050 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/053 4 siringi mimlija għal-lest (pakkett multiplu ta' 4 x 1) EU/1/07/431/076 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/077 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/078 6 siringi mimlija għal-lest b'tarka għal-labra
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Retacrit 40,000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'1 ml soluzzjoni għall-injezzjoni għandha 40,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: Excipients with known effect Each pre-filled syringe contains 0.25 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.25 mg phenylalanine.
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/431/017 1 pre-filled syringe EU/1/07/431/020 4 pre-filled syringes EU/1/07/431/021 6 pre-filled syringes EU/1/07/431/042 1 pre-filled syringe with needle guard EU/1/07/431/045 4 pre-filled syringes with needle guard EU/1/07/431/046 6 pre-filled syringes with needle guard EU/1/07/431/051 6 (6 x 1) pre-filled syringes (multipack) EU/1/07/431/070 1 pre-filled syringe with needle-trap EU/1/07/431/071 4 pre-filled syringes with needle-trap EU/1/07/431/072 6 pre-filled syringes with needle-trap
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/017 siringa 1 mimlija għal-lest EU/1/07/431/020 4 siringi mimlija għal-lest EU/1/07/431/021 6 siringi mimlija għal-lest EU/1/07/431/042 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/045 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/046 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/051 6 siringi mimlija għal-lest (pakkett multiplu ta' 6 x 1) EU/1/07/431/070 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/071 4 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/072 6 siringi mimlija għal-lest b'tarka għal-labra
English: Excipients with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.45 mg phenylalanine.
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 mL).
Maltese: L-użu għandu jkun ristrett għal pazjenti b'anemija moderata (eż. medda tal-konċentrazzjoni tal-emoglobina 10 sa 13 g/dL jew 6.2 sa 8.1 mmol/L) li m'għandhomx programm ta' predonazzjoni awtologu disponibbli u b'telf moderat mistenni ta' demm (900 sa 1,800 mL).
English: The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin zeta particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g., deep venous thrombosis, pulmonary embolism, and cerebral vascular accident).
Maltese: TVE, inkluż obeżità u storja preċedenti ta' TVEs (eż., trombożi venuża fonda, emboliżmu pulmonari, u inċident vaskulari ċerebrali).
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni fiha li 20,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'0.6 ml soluzzjoni għall-injezzjoni għandha 6,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: Epoetin alfa was administered at 75 IU/kg/week intravenously in 2 or 3 divided doses post-dialysis, titrated by 75 IU/kg/week at intervals of 4 weeks (up to a maximum of 300 IU/kg/week), to achieve a 1 g/dL/month increase in haemoglobin.
Maltese: Epoetin alfa ngħata f'75 IU/kg/ġimgħa ġol-vini f'2 jew 3 dożi maqsumin wara d-dijalisi, titrati minn 75 IU/kg/ġimgħa f'intervalli ta' 4 ġimgħat (sa massimu ta' 300 IU/kg/ġimgħa), biex tinkiseb żieda ta' 1 g/dL/xahar fl-emoglobina.
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Maltese: Trattament ta' anemija sintomatika f'pazjenti adulti u pedjatriċi b'falliment kroniku tal-kliewi
English: Antibody-mediated pure red cell aplasia (PRCA) has been reported after months to years of treatment with epoetins.
Maltese: Ġiet irrappurtata pure red cell aplasia (PRCA) medjata minn antikorp wara xhur sa snin ta' trattament b'epoetins.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin concentration range of 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Maltese: Il-differenza tal-emoglobina għandha tiġi indirizzata permezz tal-ġestjoni tad-doża, b'konsidrazzjoni għal medda tal-konċentrazzjoni mixtieqa għall-emoglobina bejn 10 g/dL (6.2 mmol/L) sa 12 g/dL (7.5 mmol/L).
English: • The starting dose is 450 IU per kilogram bodyweight once a week.
Maltese: • Id-doża inizjali hija ta' 450 IU għal kull kilogramma ta' piż tal-ġisem darba fil-ġimgħa.
English: Take special care with Retacrit
Maltese: Jekk tinsa tuża Retacrit
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin zetaand perform anti-erythropoietin antibody testing.
Maltese: Tnaqqis paradossali fl-emoglobina u fl-iżvilupp ta' anemija severa assoċjata ma' għadd baxx tarretikuloċiti għandu jwassal biex jitwaqqaf it-trattament b'epoetin zeta u jsir ittestjar tal-antikorp kontra l-eritropoetina.
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: Retacrit 40,000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel epoetin zeta
English: 1 pre-filled syringe without needle guard containing 0.5 ml solution for injection 4 pre-filled syringes without needle guard containing 0.5 ml solution for injection 6 pre-filled syringes without needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle guard containing 0.5 ml solution for injection 4 pre-filled syringes with needle guard containing 0.5 ml solution for injection 6 pre-filled syringes with needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.5 ml solution for injection 4 pre-filled syringes with needle-trap containing 0.5 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.5 ml solution for injection
Maltese: 4 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.5 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.5 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.5 ml ta' soluzzjoni għall-injezzjoni 4 siringi mimlija għal-lest b'nassa għal-labra b'0.5 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.5 ml ta' soluzzjoni għall-injezzjoni
English: 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni li fiha 40,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Treatment of symptomatic anaemia in chronic renal failure patients on haemodialysis
Maltese: Trattament ta' anemija sintomatika f'pazjenti b'falliment kroniku tal-kliewi fuq emodijalisi
English: Each pre-filled syringe contains 0.6 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.6 ml soluzzjoni.
English: EU/1/07/431/019 EU/1/07/431/024 EU/1/07/431/025 EU/1/07/431/044 EU/1/07/431/049 EU/1/07/431/050 EU/1/07/431/076 EU/1/07/431/077 EU/1/07/431/078
Maltese: EU/1/07/431/049 EU/1/07/431/050 EU/1/07/431/076 EU/1/07/431/077 EU/1/07/431/078
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: Fit-tliet l-akbar provi kliniċi li saru f'pazjenti adulti fuq dijalisi, id-doża ta' manteniment medjana meħtieġa biex l-ematokrit jinżamm bejn 30 sa 36% kienet madwar 75 IU/kg mogħtija 3 darbiet filġimgħa.
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: Retacrit 1,000 IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel
English: Hyperkalaemia
Maltese: Kriżi ipertensiva
English: Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'0.4 ml soluzzjoni għall-injezzjoni għandha 4,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).