FrancophonIA/ELRC3.0 huggingface dataset:
English: Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Maltese: Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, ilma għall-injezzjonijiet, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH).
English: When treatment starts, Retacrit is usually injected by medical professional or a nurse.
Maltese: Meta jinbeda t-trattament, Retacrit normalment jiġi injettat minn professjonista mediku jew infermier.
English: OUTER LABEL (WITH BLUE BOX) MULTIPACK
Maltese: KARTUNA TA' BARRA (BIL-KAXXA BLU) TAL-PAKKETT MULTIPLU
English: Adults with myelodysplastic syndrome
Maltese: Adulti b'sindrome majelodisplastika
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Maltese: Sirdat, Mard bħal talInfluwenza, Reazzjoni fissit tal-injezzjoni, Edema periferika
English: Retacrit is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Maltese: Retacrit huwa indikat f'adulti li qegħdin jirċievu l-kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multiplu, u f'riskju ta' trasfużjoni kif assessjat mill-istatus ġenerali tal-pazjent (e.g. status kardjovaskulari, anemija pre-eżistenti fil-bidu tal-kimoterapija) għat-trattament ta' anemija u nuqqas fil-bżonnijiet ta' trasfużjoni.
English: Retacrit is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).
Maltese: Retacrit huwa indikat għat-trattament ta' anemija sintomatika (konċentrazzjoni tal-emoglobina ta' ≤10 g/dL) fl-adulti b'sindromi majelodisplastiċi (MDS) primarji b'riskju baxx jew intermedju-1 li għandhom eritropojetin baxx fis-serum (<200 mU/mL).
English: Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Maltese: Ilma għall-injezzjonijiet Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Usual maintenance dose
Maltese: Doża ta' manteniment tas-soltu
English: Adult peritoneal dialysis patients
Maltese: Pazjenti adulti fuq dijalisi peritonejali
English: Overdosage of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Maltese: Dosaġġ eċċessiv ta' eritropojetin jista' jipproduċi effetti li huma estensjonjiet tal-effetti farmakologiċi tal-ormon.
English: The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210).
Maltese: Iż-żmien għal progressjoni (TTP, time to progression) medjan ibbażat fuq marda progressiva (PD, progressive disease) iddeterminata mill-investigatur kien 7.5 xhur fil-grupp ta' epoetin alfa u SOC u 7.5 xhur fil-grupp ta' SOC (HR 1.099, 95% CI: 0.998, 1.210).
English: A major cardiovascular event (death, myocardial infarction, stroke or hospitalization for congestive heart failure) occurred among 125 (18%) of the 715 patients in the higher haemoglobin group compared to 97 (14%) among the 717 patients in the lower haemoglobin group (hazard ratio [HR] 1.3, 95% CI: 1.0, 1.7, p = 0.03).
Maltese: Seħħ avveniment kardjovaskulari maġġuri (mewt, infart mijokardijaku, puplesija jew dħul fl-isptar għal falliment tal-qalb konġestiv) fost 125 (18%) tas-715il pazjent fil-grupp ta' emoglobina ogħla meta mqabbel ma' 97 (14%) fost is-717-il pazjent fil-grupp ta' emoglobina aktar baxxa (proporzjon ta' periklu [HR] 1.3, 95% CI: 1.0, 1.7, p = 0.03).
English: No unexpected adverse events were reported (see section 4.2).
Maltese: Ma ġewx irrappurtati avvenimenti avversi mhux mistennija (ara sezzjoni 4.2).
English: The mean CL/F for the 150 IU/kg, 3-times-per-week and 40 000 IU, once-weekly regimens in the anaemic cancer subjects were 45.8 and 11.3 mL/h/kg, respectively.
Maltese: Is-CL/F medju għall-korsijiet ta' 150 IU/kg, 3 darbiet fil-ġimgħa u 40 000 IU, darba fil-ġimgħa f'individwi anemiċi bil-kanċer kienet 45.8 u 11.3 mL/h/kg, rispettivament.
English: The mean CL/F for the 150 IU/kg 3 times-per-week and 40 000 IU once-weekly regimens in healthy subjects were 31.2 and 12.6 mL/h/kg, respectively.
Maltese: Is-CL/F medju għall-korsijiet ta' 150 IU/kg 3 darbiet fil-ġimgħa u 40 000 IU darba fil-ġimgħa f'individwi b'saħħithom kienet 31.2 u 12.6 mL/h/kg, rispettivament.
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1,404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Maltese: Ma' dawn kien hemm 228 individwu b'CRF trattati b'epoetin alfa f'4 studji b'falliment kroniku talkliewi (2 studji ta' qabel il-dijalisi [N = 131 individwu espost b'CRF] u 2 fuq dijalisi [N = 97 individwu espost]; 1,404 individwi esposti għall-kanċer f'16-il studju ta' anemija minħabba kimoterapija; 147 individwu espost f'2 studji għal donazzjoni tad-demm awtologi; 213-il individwu espost fi studju 1 fil-perijodu perikirurġiku u 102 individwi esposti f'żewġ studji
English: Retacrit is a biosimilar medicinal product.
Maltese: Retacrit huwa prodott mediċinali bijosimili.
English: The pharmacokinetic profile of erythropoietins in children and adolescents appears to be similar to that of adults.
Maltese: Il-profil farmakokinetiku taleritropojetini fit-tfal u fl-adolexxenti jidher li huwa simili għal dak tal-adulti.
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 erythropoietin.
Maltese: Ġiet irrappurtata half-life ta' madwar 6.2 sa 8.7 sigħat f'individwi pedjatriċi b'falliment kroniku talkliewi wara għoti ta' dożi multipli ġol-vini ta' eritropojetina.
English: Chronic renal failure
Maltese: Falliment kroniku tal-kliewi
English: ANNEX III
Maltese: ANNEX
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 ir-riskju ta' trasfużjoni alloġeneika f'pazjenti b'emoglobina ta' qabel it-trattament ta' >10 sa ≤13 g/dL.
English: No evidence exists that indicates that treatment with epoetin zeta alters the metabolism of other medicinal products.
Maltese: Ma teżistix evidenza li tindika li t-trattament b'epoetin zeta jbiddel il-metaboliżmu ta' prodotti mediċinali oħra.
English: Tabulated list of adverse reactions
Maltese: Deskrizzjoni selettiva tar-reazzjonijiet avversi
English: A randomized prospective trial (CHOIR) evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Maltese: Prova prospettiva każwali (CHOIR) evalwat 1,432 pazjent anemiku b'falliment kroniku tal-kliewi li ma kinux għaddejjin fuq dijalisi.
English: Epoetin zeta is not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetin zeta mhuwiex approvat fil-ġestjoni ta' anemija assoċjata mal-epatite Ċ.
English: The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL; 8.1 mmol/L).
Maltese: L-akbar effetti huma osservati f'pazjenti b'emoglobina baxxa (≤ 13 g/dL; 8.1 mmol/L).
English: Autologous predonation programme
Maltese: Programm ta' predonazzjoni awtologa
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 fuq epoetin alfa kontra 69% tal-pazjenti fuq terapija standard).
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dL) was twice than that observed in the 300 IU/kg daily group (0.73 g/dL).
Maltese: IU/kg fil-ġimgħa (1.44 g/dL) kienet darbtejn dik li ġiet osservata fil-grupp ta' 300 IU/kg kuljum (0.73 g/dL).
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 biss (HR 1.07, 95% CI: 0.97, 1.18).
English: The desired haemoglobin concentration range was 9.6 to 11.2 g/dL.
Maltese: Il-medda tal-konċentrazzjoni tal-emoglobina mixtieqa kienet ta' 9.6 sa 11.2 g/dL.
English: Clinical data with subcutaneous administration in children are limited.
Maltese: Dejta farmakokinetika fi trabi tat-twelid hija limitata.
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 tal-konċentrazzjoni rakkomandata tal-emoglobina hija bejn 9.5 g/dL sa 11 g/dL (5.9 sa 6.8 mmol/L).
English: In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40 000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Maltese: F'pazjenti adulti nisa b'kanċer tas-sider metastatiku, l-għoti taħt il-ġilda ta' 40 000 IU/mL epoetin alfa ma' trastuzumab 6 mg/kg ma kellu l-ebda effett fuq il-farmakokinetika ta' trastuzumab.
English: Moreover, in patients with a baseline haemoglobin of >13 g/dL (>8.1 mmol/L), the possibility that epoetin zeta treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Maltese: Fuq kollox, f'pazjenti b'emoglobina fil-linja bażi ta' >13 g/dL (>8.1 mmol/L),, il-possibbiltà li t-trattament b'epoetin zeta jista' jkun assoċjat ma' żieda fir-riskju ta' episodji trombotiċi/vaskulari ma tistax tkun eskluża.
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: Epotein alfa ma jqanqalx mutazzjoni ġenetika batterika (Test Ames), aberrazzjonijiet kromożomiċi f'ċelluli tal-mammiferi, mikronuklei fil-ġrieden, jew mutazzjoni tal-ġene fil-lokus HGPRT.
English: Since cyclosporin is bound by RBCs there is potential for a drug interaction.
Maltese: Peress li ċ-ċiklosporin huwa marbut b'RBCs hemm potenzjal ta' interazzjoni mediċinali.
English: • anaemia from other causes
Maltese: • anemija minn kawżi oħra
English: In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer TherapyAnaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Maltese: Fi prova prospettiva, każwali, double-blind, ikkontrollata bil-plaċebo magħmula minn 375 pazjent anemiku b'tumuri malinni mhux majelojdi diversi li kienu qed jirċievu l-kimoterapija mhux talplatinu, kien hemm tnaqqis sinifikanti ta' konsegwenzi u kumplikazzjonijiet relatati mal-anemija (eż. għeja, nuqqas ta' enerġija, u nuqqas ta' attività), kif imkejla mill-istrumenti u skali li ġejjin:
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Maltese: Il-meta-analiżi tindika wkoll b'mod konsistenti żieda sinifikanti ta' riskju relattiv ta' avvenimenti tromboembolitiċi f'pazjenti bil-kanċer li qed jirċievu ertropoetina rikombinanti uman (ara sezzjoni 4.4).
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Maltese: Il-volum medju ta' distribuzzjoni kien 49.3 mL/kg wara dożi ġol-vini ta' 50 u 100 IU/kg f'individwi b'saħħithom.
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Maltese: Ġeneralment, tfal li jiżnu inqas minn 30 kg jeħtieġu dożi ta' manteniment ogħla minn tfal li jiżnu aktar minn 30 kg u adulti.
English: Other medicines and Retacrit
Maltese: Mediċini oħra u Retacrit
English: Paediatric patients with very low initial haemoglobin (<6.8 g/dL or <4.25 mmol/L) may require higher maintenance doses than patients whose initial haemoglobin is higher (>6.8 g/dL or >4.25 mmol/L).
Maltese: Pazjenti pedjatriċi b'emoglobina baxxa ħafna (<6.8 g/dL jew <4.25 mmol/L) jistgħu jeħtieġu dożi ta' manteniment ogħla minn pazjenti li l-emoglobina inizjali tagħhom hija ogħla (>6.8 g/dL jew >4.25 mmol/L).
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Maltese: Fl-istudju multiċentrali li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bilplaċebo, 4 (4.7%) individwi esperjenzaw TVEs (mewt għal għarrieda, puplesija iskemika, emboliżmu u flebite).
English: • after the expiry date on the label and outer carton
Maltese: • wara d-data ta' skadenza fuq it-tikketta jew il-kartuna ta' barra
English: The liquid needs to come to room temperature.
Maltese: Il-likwidu jkun jeħtieġ jiġi f'temperatura tal-kamra.
English: • Before use, leave the Retacrit syringe to stand until it reaches room temperature.
Maltese: • Qabel l-użu, ħalli s-siringa Retacrit toqgħod sakemm tilħaq temperatura ambjentali.
English: Retacrit should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤10 g/dL (6.2 mmol/L)).
Maltese: Retacrit għandu jingħata lil pazjenti b'anemija sintomatika (eż. konċentrazzjoni tal-emoglobina ≤10 g/dL (6.2 mmol/L)).
English: Pharmacokinetic data in neonates is limited.
Maltese: Dan jonqos matul it-terapija kontinwa.
English: Retacrit 5 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 5,000 IU epoetin zeta
English: Multipacks contain 4 (4 x 1) or 6 (6 x 1) pre-filled syringes.
Maltese: Pakketti multipli fihom 4 (4 pakketti ta' 1) jew 6 (6 pakketti ta' 1) siringi mimlijin lesti.
English: Treatment of adult patients with chemotherapy-induced anaemia
Maltese: Trattament ta' pazjenti adulti għal anemija sensitizzata bil-kimoterapija
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 inkluż sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN) ġew irrappurtati b'rabta ma' trattament b'epoetin.
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 PD iddeterminata minn IRC (Independent Review Committee- Kumitat Indipendenti talEvalwazzjoni) kien 8.0 xhur fil-grupp ta' epoetin alfa u SOC u 8.3 xhur fil-grupp ta' SOC (HR 1.033, 95% CI: 0.924, 1.156).
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 fil-provi kliniċi f'pazjenti adulti anemiċi b'CRF, li jinkludu pazjenti fuq emodijalisi u qabel dijalisi, biex jikkura anemija u jżomm l-ematokrit fi ħdan medda talkonċentrazzjoni fil-mira ta' 30 sa 36%.
English: The recommended starting dose is Retacrit 450 IU/kg (maximum total dose is 40 000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Maltese: Id-doża inizjali rakkomandata hija Retacrit 450 IU/kg (doża totali massima hija 40,000
English: These include venous and arterial thrombosis and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Maltese: Dawn jinkludu trombożi u emboliżmu venuż u arterjali (inkluż xi wħud b'riżultati fatali), bħal trombożi venuża fonda, emboli pulmonari, trombożi retinali u infart mijokardijaku.
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Maltese: Barra minn hekk, ġew irrappurtati inċidenti ċerebrovaskulari (inkluż infart ċerebrali, emorraġija ċerebrali u attakki iskemiċi temporanji).
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8).
Maltese: Ġiet osservata żieda fl-inċidenza ta' avvenimenti vaskulari trombotiċi (TVEs, thrombotic vascular events) f'pazjenti li jirċievu ESAs (ara sezzjoni 4.8).
English: Angioneurotic oedema
Maltese: Għoti taħt il-ġilda
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: Għal pazjenti b'falliment kroniku tal-kliewi, supplementazzjoni bil-ħadid (ħadid elementali 200 sa 300 mg/jum b'mod orali għall-adulti u 100 sa 200 mg/jum b'mod orali għall-pedjatriċi) hija rrakomandata jekk il-livelli tas-serum ferritin tagħhom huma taħt il-100 ng/mL.
English: • If you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Maltese: • Jekk dalwaqt se jkollok operazzjoni ortopedika elettiva maġġuri (bħalma hi operazzjoni talġenbejn jew tal-irkoppa), u jekk inti:
English: tiredness and dizziness.
Maltese: Dan jeħtieġ trattament urġenti.
English: Antibody-mediated pure red cell aplasia has been very rarely reported in <1/10 000 cases per patient year after months to years of treatment with epoetins (see section 4.4).
Maltese: Pure red cell aplasia medjata minn antikorp ġiet irrappurtata f'każijiet rari ħafna f'<1/10 000 għal kull sena ta' pazjent wara xhur sa snin ta' trattament b'epoetins (ara sezzjoni 4.4).
English: Administer over at least one to five minutes, depending on the total dose.
Maltese: Agħti fuq mill-inqas minuta sa ħames minuti, skont id-doża totali.
English: Chemotherapy-induced anaemia
Maltese: Anemija sensibilizzata bil-kimoterapija
English: Epoetin alfa has been shown to stimulate erythropoiesis in anaemic patients with CRF, including dialysis and pre-dialysis patients.
Maltese: Epoeti alfa ntwera li jistimula l-eritropoeżi f'pazjenti anemiċi b'CRF, inkluż pazjenti fuq dijalisi u qabel dijalisi.
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Maltese: Artralġja, Uġigħ fl-għadam, Mijalġja, Uġigħ flestremitajiet
English: In studies to explore extending the dosing interval (40 000 IU once weekly and 80 000, 100 000, and 120 000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
Maltese: Fi studji biex jesploraw l-estensjoni tal-intervall tad-dożaġġ (40 000 IU darba fil-ġimgħa u 80 000, 100 000, u 120 000 IU darbtejn fil-ġimgħa), ġiet osservata relazzjoni lineari iżda mhux proporzjonali għad-doża bejn is-Cmax medja u d-doża, u bejn l-AUC medja u d-doża fi stat fiss.
English: • in severely anaemic adults not yet undergoing dialysis.
Maltese: • f'adulti anemiċi b'mod sever li mhumiex digà fuq id-dijalisi.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Maltese: Fl-erba' studji ikkontrollati bil-plaċebo l-proporzjonijiet ta' ħsara għal sopravivenza globali kienu jvarjaw bejn 1.25 u 2.47 favur il-kontrolli.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata hija disponibbli fuq is-sit elettroniku tal-Aġenzija Ewropea tal-mediċini http://www.ema.europa.eu.
English: Yes ≤2 RBC Units ˃2 and ≤4 RBC Units ˃4 RBC Units No one subject did not have sEPO data in the ≥200 mU/ml stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Maltese: Le individwu wieħed ma kellux data dwar l-sEPO fl-istrat ≥200 mU/ml kien hemm 13-il individwu fil-grupp ta' epoetin alfa u 6 individwi fil-grupp talplaċebo
English: Retacrit should be administered to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dL [6.2 mmol/L]).
Maltese: Retacrit għandu jingħata lil pazjenti bl-anemija (eż. konċentrazzjoni tal-emoglobina ≤ 10 g/dL [6.2 mmol/L]).
English: Epoetin alfa was evaluated in an open-label, non-randomised, open dose-range, 52-week clinical study in paediatric CRF patients undergoing haemodialysis.
Maltese: Epoetin alfa ġie evalwat fi studju kliniku open-label, mhux randomizzat, b'medda ta' doża miftuħa, ta' 52 ġimgħa f'pazjenti pedjatriċi b'CRF li kienu fuq emodijalisi.
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: Meta sar il-cutoff tad-dejta klinika, is-sopravivenza mingħajr progressjoni (PFS) medjana skont il-valutazzjoni tal-investigatur talprogressjoni tal-marda kienet 7.4 xhur f'kull fergħa (HR 1.09, 95% CI: 0.99, 1.20), li tindika li lobjettiv tal-istudju ma ntlaħaqx.
English: Before use, leave the Retacrit syringe to stand until it reaches room temperature.
Maltese: Qabel l-użu, ħalli s-siringa ta' Retacrit toqgħod sakemm tilħaq temperatura ambjentali.
English: EU/1/07/431/018 EU/1/07/431/022 EU/1/07/431/023 EU/1/07/431/043 EU/1/07/431/047 EU/1/07/431/048 EU/1/07/431/073 EU/1/07/431/074 EU/1/07/431/075
Maltese: EU/1/07/431/018 EU/1/07/431/022 EU/1/07/431/023 EU/1/07/431/043 EU/1/07/431/047 EU/1/07/431/048 EU/1/07/431/073 EU/1/07/431/074
English: Retacrit 8 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 8,000 IU epoetin zeta
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 eritropojetiku osservat fiż-żewġ gruppi ta' trattament irriżulta f'rati ta' trasfużjoni simili (16% fil-grupp ta' 600
English: Common in dialysis Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms Addressed in the subsection below and/or in section 4.4
Maltese: Jinkludu każijiet arterjali u venużi, fatali u mhux fatali, bħal każijiet ta' trombożi tal-veni fondi, emboli pulmonari, trombożi retinali, trombożi arterjali (li jinkludi infart mijokardjali), inċidenti ċerebrovaskulari (li jinkludu infart ċerebrali u emorraġija ċerebrali), attakki iskemiċi għaddiena u trombożi tax-xant (li jinkludi tagħmir tad-dijalisi) u trombożi fi ħdan anewriżmi b'xant arterjovenuż.
English: No evidence exists that indicates an interaction between epoetin zeta and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Maltese: Ma teżistix evidenza li tindika interazzjoni bejn epoetin zeta u G-CSF jew GM-CSF fir-rigward ta' ddifferenzjar ematoloġiku jew il-proliferazzjoni ta' kampjuni ta' bijopsiji tat-tumuri in vitro.