FrancophonIA/ELRC3.0 huggingface dataset:
English: • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 12 to 14 g/dL (7.5 to 8.7 mmol/L),
Maltese: • sopravivenza globali iqsar u żieda fl-imwiet attribwita għall-progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer tas-sider metastatiku li qegħdin jirċievu kimoterapija meta tingħata biex tinkiseb medda tal-konċentrazzjoni tal-emoglobina ta' 12 sa 14 g/dL (7.5 sa 8.7 mmol/L),
English: B. PACKAGE LEAFLET
Maltese: TAL-PAKKETT MULTIPLU
English: This medicine contains phenylalanine and may be harmful for people with phenylketonuria (genetic enzyme deficiency that increases excretion of a chemical (phenylketone) in urine and may cause nervous system disorders).
Maltese: Din il-mediċina fiha l-fenilalanina u tista' tkun ta' ħsara għal persuni b'fenilketonurja (defiċjenza ġenetika ta' enżima li żżid l-eliminazzjoni ta' kimika (phenylketone) fl-awrina u tista' tikkaġuna disturbi tas-sistema nervuża).
English: Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Maltese: Il-pazjenti ta' operazzjoni li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
English: In healthy subjects, a dose-proportional increase in serum erythropoietin concentrations was observed after intravenous administration of 150 and 300 IU/kg, 3 times per week.
Maltese: F'individwi b'saħħithom, ġiet osservata żieda proporzjonali għad-doża f'konċentrazzjonijiet ta' eritropojetina fis-serum wara għoti ġol-vini ta' 150 u 300 IU/kg, 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 b'dożi tal-bidu ta' 50 sa 150 IU/kg, tliet darbiet fil-ġimgħa, madwar 95% tal-pazjenti kollha rrispondew b'żieda klinikament sinifikanti fl-ematokrit.
English: Patients with very low initial haemoglobin (<6 g/dL or <3.75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (>8 g/dL or >5 mmol/L).
Maltese: Pazjenti b'emoglobina inizjali baxxa ħafna (<6 g/dL jew <3.75 mmol/L) jista' jkun li jkollhom bżonn dożi ta' manteniment ogħla minn pazjenti li l-anemija inizjali tagħhom hija anqas severa (>8 g/dL jew >5 mmol/L).
English: An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dL who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
Maltese: Prova open-label ta' grupp parallel f'individwi adulti li m'għandhomx defiċjenza tal-ħadid b'emoglobina ta' qabel it-trattament ta' ≥ 10 sa ≤ 13 g/dL li kienu skedati għal operazzjoni tal-ġenbejn jew tal-irkoppa ortopedika maġġuri qabblet epoetin alfa 300 IU/kg taħt il-ġilda kuljum għal 10 ijiem qabel l-operazzjoni, fil-jum tal-operazzjoni, u għal erbat ijiem wara l-operazzjoni ma' epoetin alfa 600
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin zeta.
Maltese: Jista' jkun hemm żieda moderata, li tiddependi mid-doża, fl-għadd tal-plejtlits fil-limiti normali matul it-trattament b'epoetin zeta.
English: How to store Retacrit
Maltese: X'fih Retacrit
English: Adults scheduled for major orthopaedic surgery
Maltese: Adulti skedati għal operazzjoni ortopedika maġġuri
English: If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Retacrit therapy at a dose 25% below the previous dose.
Maltese: Jekk l-emoglobina taqbeż it-13 g/dL (8.1 mmol/L), it-terapija għandha titwaqqaf sakemm tinżel għal 12 g/dL (7.5 mmol/L) u mbagħad erġa' agħti t-terapija ta' Retacrit f'doża ta' 25% anqas mid-doża ta' qabel.
English: A randomised, open-label, multicentre study was conducted in 2 098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Maltese: Sar studju każwali, open-label multiċentriku f'2 098 mara anemika b'kanċer tas-sider metastatiku, li rċivew kimoterapija tal-ewwel linja jew tat-tieni linja.
English: Dose (IU/kg given 3 times per week)
Maltese: Doża (IU/kg mogħtija 3 darbiet fil-ġimgħa)
English: Retacrit 20 000 IU
Maltese: Retacrit 20,000
English: Retacrit 6 000 IU
Maltese: Retacrit 6,000
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: Intweriet intensità komparabbli ta' kimoterapija fil-gruppi ta' epoetin alfa u plaċebo fil-provi tal-kimoterapija permezz ta' erja simili taħt il-kurva ta' żmien ta' newtrofili f'pazjenti kkurati b'epoetin alfa u pazjenti kkurati bil-plaċebo, kif ukoll permezz ta' proporzjon simili ta' pazjenti fil-gruppi kkurati b'epoetin alfa u gruppi kkurati bilplaċebo li l-għadd ta' newtrofili assolut tagħhom waqa' taħt 1 000 u 500 ċellula/μL.
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Retacrit 8,000 IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'0.8 ml soluzzjoni għall-injezzjoni għandha 8,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of >10 to ≤ 13 g/dL, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Maltese: F'pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri b'emoglobina ta' qabel it-trattament ta' >10 sa ≤ 13 g/dL, epoetin alfa ntwera li jnaqqas ir-riskju li jiġu riċevuti trasfużjonijiet alloġeneiċi u jaċċellera l-irkupru tal-eritojde (żieda fil-livelli tal-emoglobina, livelli tal-ematokrit, u l-għadd tarretikuloċiti).
English: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2C-8C).
English: A slower administration is preferable in patients who react to the treatment with “flu-like” symptoms (see section 4.8).
Maltese: Għoti aktar bil-mod huwa preferibbli f'pazjenti li jirreaġixxu għat-trattament b'sintomi “bħal talinfluwenza” (ara sezzjoni 4.8).
English: The desired haemoglobin concentration level in two studies was >13 g/dL (8.1 mmol/L); in the remaining three studies it was 12 to 14 g/dL (7.5 to 8.7 mmol/L).
Maltese: Il-livell ta' konċentrazzjoni tal-emoglobina mixtieq f'żewġ studji kien ta' > 13 g/dL (8.1 mmol/L); fit-tliet studji li jifdal kien ta' 12 sa 14 g/dL (7.5 sa 8.7 mmol/L).
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4).
Maltese: Ġiet osservata żieda fl-inċidenza ta' episodji trombotiċi vaskulari (TVEs) f'pazjenti li jirċievu ESAs (ara sezzjoni 4.4).
English: The effect of epoetin alfa in facilitating autologous blood donation in patients with low haematocrits (≤ 39% and no underlying anaemia due to iron deficiency) scheduled for major orthopaedic surgery was evaluated in a double-blind, placebo-controlled study conducted in 204 patients, and a single-blind placebo controlled study in 55 patients.
Maltese: L-effett ta' epoetin alfa fl-iffaċilitar ta' donazzjoni tad-demm awtologa f'pazjenti b'ematokriti baxxi (≤ 39% u l-ebda anemija sottostanti minħabba defiċjenza tal-ħadid) skedati għal operazzjoni ortopedika maġġuri ġie evalwat fi studju double-blind bil-plaċebo bħala kontroll li sar f'204 pazjenti, u studju single-blind bil-plaċebo bħala kontroll f'55 pazjent.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Patients were assigned to epoetin alfa treatment targeting a maintenance haemoglobin level of 13.5 g/dL (higher than the recommended haemoglobin concentration level) or 11.3 g/dL.
Maltese: Il-pazjenti ġew assenjati għal trattament b'epoetin alfa li jimmira livell ta' manteniment tal-emoglobina ta' 13.5 g/dL (ogħla mil-livell ta' konċentrazzjoni talemoglobina rakkomandat) jew 11.3 g/dL.
English: Epoetin alfa has been studied in clinical trials in adult anaemic cancer patients with lymphoid and solid tumors, and patients on various chemotherapy regimens, including platinum and non-platinum-containing regimens.
Maltese: Epoetin alfa ġie studjat fil-provi kliniċi f'pazjenti adulti anemiċi bil-kanċer b'limfojdi u tumuri solidi, u f'pazjenti fuq diversi korsijiet ta' kimoterapija, li jinkludu korsijiet li fihom il-platinu u li ma fihomx il-platinu.
English: - The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese
Maltese: - Is-sustanza attiva hi epoetin zeta (magħmul permezz tat-teknoloġija rikombinanti tad-DNA
English: EU/1/07/431/011 EU/1/07/431/012 EU/1/07/431/036 EU/1/07/431/037 EU/1/07/431/064 EU/1/07/431/065
Maltese: EU/1/07/431/011 EU/1/07/431/012 EU/1/07/431/036 EU/1/07/431/037 EU/1/07/431/064
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2C sa 8C).
English: Epoetin alfa therapy reduced the risk of exposure to allogeneic blood by 50% compared to patients not receiving epoetin alfa.
Maltese: It-terapija b'epotein alfa naqqset ir-riskju ta' esponiment għal demm alloeġeniku b'50% meta mqabbel ma' pazjenti li ma rċivewx epoetin alfa.
English: Retacrit may be given by injection:
Maltese: Retacrit jista' jingħata permezz ta' injezzjoni:
English: In controlled clinical studies, use of epoetin zeta and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Maltese: Fi studji kliniċi kkontrollati, l-użu ta' epoetin zeta u ESAs oħra ġie assoċjat ma' kontroll imnaqqas tat-tumur lokoreġjonali jew sopravivenza globali mnaqqsa:
English: Retacrit 30 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 30,000 IU epoetin zeta
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Maltese: Id-doża rakkomandata fil-ġimgħa hija ta' bejn il-75 IU/kg u t-300 IU/kg.
English: Multipack: 6 (6 x 1) pre-filled syringes.
Maltese: Pakkett multiplu: 6 (6 pakketti ta' 1) siringi mimlija għal-lest
English: Retacrit is not approved in the management of anaemia associated with hepatitis C.
Maltese: Retacrit mhuwiex approvat fil-ġestjoni ta' anemija assoċjata mal-epatite Ċ.
English: Surgery patients in autologous predonation programmes
Maltese: Trattament ta' pazjenti kirurġiċi fi programmi ta' predonazzjoni awtologi
English: Dose should not be increased over the maximum of 1 050 IU/kg (total dose 80 000 IU) per week.
Maltese: Id-doża ma għandhiex tiżdied aktar mill-massimu ta' 1,050 IU/kg (doża totali 80,000
English: Multipack: 4 (4 x 1) pre-filled syringes.
Maltese: Pakkett multiplu: 4 (4 x 1) siringi mimlija għal-lest
English: Retacrit 6 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 6,000 IU epoetin zeta
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: Retacrit 8,000 IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel epoetin zeta
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, dożi ta' epoetin alfa ta' 75 sa 150 IU/kg fil-ġimgħa wrew li jżommu l-ematokrit ta' 36 sa 38% sa sitt xhur.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Maltese: IU/kg) fuq l-esponiment għal trasfużjoni ta' demm alloġeneika ġie evalwat fi prova klinika bil-plaċebo bħala kontroll, double-blind f'pazjenti adulti li m'għandhomx defiċjenza tal-ħadid skedat għal operazzjoni tal-ġenbejn jew tal-irkoppa ortopedika elettiva maġġuri.
English: EU/1/07/431/001 EU/1/07/431/002 EU/1/07/431/026 EU/1/07/431/027 EU/1/07/431/054 EU/1/07/431/055
Maltese: EU/1/07/431/001 EU/1/07/431/002 EU/1/07/431/026 EU/1/07/431/027 EU/1/07/431/054
English: Retacrit 40 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 40,000 IU epoetin zeta
English: Adult surgery patients in an autologous predonation programme
Maltese: Pazjenti adulti operati fi programm ta' predonazzjoni awtologa
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Maltese: Fl-istudju open-label ma kien hemm ebda differenza fis-sopravivenza globali fost pazjenti kkurati b'eritropoetina rikombinanti uman u l-kontrolli.
English: Epoetin zeta should be withheld when the haemoglobin concentration exceeds 12 g/dL (7.5 mmol/L).
Maltese: Epoetin zeta għandu jitrażżan meta l-konċentrazzjoni tal-emoglobina taqbeż 12 g/dL (7.5 mmol/L).
English: 18.UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Retacrit 8,000 IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Retacrit 10,000UI/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Retacrit 20,000
English: In patients developing sudden lack of efficacy defined by a decrease in haemoglobin (1 to 2 g/dL per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be investigated.
Maltese: F'pazjenti li jiżviluppaw nuqqas f'daqqa ta' effikaċja definit minn tnaqqis fl-emoglobina (1 sa 2 g/dL fix-xahar) bi ħtieġa miżjuda ta' trasfużjonijiet, għandu jinkiseb l-għadd tar-retikuloċiti u għandhom jiġu investigati l-kawżi tipiċi ta' nuqqas ta' rispons (eż. defiċjenza tal-ħadid, folate jew Vitamina B12, intossikazzjoni bl-aluminju, infezzjoni jew infjammazzjoni, telf ta' demm, emolisi u fibrożi talmudullun ta' kwalunkwe oriġini).
English: In the 16-week study (n=222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
Maltese: Fl-istudju ta' 16-il ġimgħa (n=222), fil-pazjenti kkurati b'epoetin-alfa ma kien hemm l-ebda effett statistikament sinifikanti fuq il-punteġġi rrappurtati mill-pazjent jew mill-ġenituri tal-Inventarju talKwalità tal-Ħajja Pedjatrika jew tal-Modulu tal-Kanċer meta mqabbel mal-plaċebo (punt ta' tmiem tal-effikaċja primarja).
English: • decreased locoregional control in patients with advanced head and neck cancer receiving radiation therapy when administered to achieve a haemoglobin concentration level of greater than 14 g/dL (8.7 mmol/L),
Maltese: • kontroll lokoreġjonali mnaqqas f'pazjenti b'kanċer tar-ras u tal-għonq avvanzat li qed jirċievu terapija bir-radjazzjoni meta tingħata biex jinkiseb livell tal-konċentrazzjoni tal-emoglobina ta' ikbar minn 14 g/dL (8.7 mmol/L),
English: This medicinal product contains phenylalanine which may be harmful for people with phenylketonuria.
Maltese: Dan il-prodott mediċinali fih phenylalanine li jista' jkun ta' ħsara għal persuni li għandhom phenylketonuria.
English: Additional studies compared the 40 000 IU once-weekly regimen of epoetin alfa with biweekly doses ranging from 80 000 to 120 000 IU subcutaneously.
Maltese: Studji addizzjonali qabblu l-kors ta' 40 000 IU darba fil-ġimgħa ta' epoetin alfa ma' dożi darba kull ġimagħtejn li varjaw minn 80 000 sa 120 000
English: Retacrit 4 000 IU injection epoetin zeta
Maltese: Injezzjoni għal Retacrit 4,000 IU epoetin zeta
English: Dose adjustment to maintain haemoglobin concentrations between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L)
Maltese: Il-medda tal-konċentrazzjoni tal-emoglobina mixtieqa rakkomandata hija bejn 10 g/dL sa 12 g/dL (6.2 sa 7.5 mmol/L).
English: Epoetin alfa 600 IU/kg (administered intravenously or subcutaneously once weekly) has been evaluated in a randomised, double-blind, placebo-controlled, 16-week study and in a randomised, controlled, open-label, 20-week study in anaemic paediatric patients receiving myelosuppressive chemotherapy for the treatment of various childhood non-myeloid malignancies.
Maltese: IU/kg (mogħti ġol-vini jew taħt il-ġilda darba fil-ġimgħa) ġie evalwat fi studju randomizzat, double-blind, bil-plaċebo bħala kontroll, ta' 16-il ġimgħa u fi studju każwali, ikkontrollat, open-label, ta' 20 ġimgħa f'pazjenti pedjatriċi anemiċi li rċivew kimoterapija majelosoppressiva għat-trattament ta' diversi tumuri malinni mhux majelojdi tat-tfulija.
English: You should discuss this with your doctor because a combination of epoetin zeta with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases.
Maltese: Għandek tiddiskuti dan mat-tabib tiegħek minħabba li kombinazzjoni ta' epoetin zeta ma' interferon u ribavirin wasslet għal telf tal effett u żvilupp ta' kundizzjoni msejħa pure red cell aplasia (PRCA), forma severa ta' anemija, f'każijiet rari.
English: 1 pre-filled syringe without needle guard containing 0.75 ml solution for injection 4 pre-filled syringes without needle guard containing 0.75 ml solution for injection 6 pre-filled syringes without needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle guard containing 0.75 ml solution for injection 4 pre-filled syringes with needle guard containing 0.75 ml solution for injection 6 pre-filled syringes with needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.75 ml solution for injection 4 pre-filled syringes with needle-trap containing 0.75 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.75 ml solution for injection
Maltese: 4 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.75 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.75 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.75 ml ta' soluzzjoni għall-injezzjoni 4 siringi mimlija għal-lest b'nassa għal-labra b'0.75 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.75 ml ta' soluzzjoni għall-injezzjoni
English: In a double-blind, placebo-controlled, multicentre, quality of life study in CRF patients on haemodialysis, clinically and statistically significant improvement was shown in the patients treated with epoetin alfa compared to the placebo group when measuring fatigue, physical symptoms, relationships and depression (Kidney Disease Questionnaire) after six months of therapy.
Maltese: Fi studju double-blind, multiċentriku tal-kwalità tal-ħajja bil-plaċebo bħala kontroll, f'pazjenti b'CRF fuq emodijalisi, intwera titjib klinikament u statistikament sinifikanti fil-pazjenti kkurati b'epoetin alfa meta mqabbel mal-grupp tal-plaċebo meta tkejlu għeja mhux tas-soltu, sintomi fiżiċi, relazzjonijiet u dipressjoni (Kwestjonarju ta' Mard tal-Kliewi) wara sitt xhur ta' terapija.
English: Treatment of symptomatic anaemia in adult chronic renal failure patients
Maltese: Trattament għal anemija sintomatika f'pazjenti adulti b'falliment renali kroniku.
English: Excipients with known effect Each pre-filled syringe contains 0.38 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.38 mg phenylalanine.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Maltese: L-esponiment ta' pazjenti pedjatriċi b'falliment kroniku tal-kliewi fuq emodijalisi fil-provi kliniċi u esperjenza wara t-tqegħid fis-suq hija limitata.
English: Side effects from an overdose of Retacrit are unlikely.
Maltese: Effetti sekondarji minn doża eċċesiva ta' Retacrit mhumiex probabbli.
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 fil-konċentrazzjoni tal-emoglobina hija <1 g/dL (<0.62 mmol/L) u l-għadd tarretikoloċiti żdied <40,000 ċelluli/µl 'il fuq mil-inja bażi, żid id-doża għal 300 IU/kg 3 darbiet fil-ġimgħa.
English: Chronic renal failure patients treated with epoetin zeta by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin zeta treatment in patients who previously responded to such therapy.
Maltese: Pazjenti b'falliment kroniku tal-kliewi kkurati b'epoetin zeta permezz tar-rotta taħt il-ġilda għandhom jiġu mmonitorjati regolarment għal nuqqas ta' effikaċja, definit bħala nuqqas ta' rispons jew wieħed imnaqqas għal trattament b'epoetin zeta f'pazjenti li preċedentement irrispondew għal tali terapija.
English: If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the Retracrit dose by 25%.
Maltese: Jekk lemoglobina taqbeż b'aktar minn 2 g/dL (1.25 mmol/L) fix-xahar, jew jekk l-emoglobina sostnuta taqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Retacrit b'25%.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin zeta dosage (see section 4.8).
Maltese: Dan huwa kkaratterizzat minn tnaqqis sostnut fl-emoglobina minkejja żieda fid-dożaġġ ta' epoetin zeta (ara sezzjoni 4.8).
English: The use of Retacrit in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Maltese: L-użu ta' Retacrit f'pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri u li mhumiex qegħdin jipparteċipaw fi programmi ta' pre-donazzjoni awtologa huwa kontraindikat f'pazjenti b'mard gravi karotidu koronarju, periferali arterjali jew vaskulari ċelebrali, inkluż pazjenti b'infart mijokardijaku riċenti jew inċident vaskulari ċelebrali.