FrancophonIA/ELRC3.0 huggingface dataset:
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' jkollhom bżonn dożi ogħla ta' manteniment milli pazjenti li l-anemija inizjali tagħhom tkun anqas severa (> 8 g/dL jew
English: Epoetin alfa HEXAL 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: Epoetin alfa HEXAL hu indikat għall-użu f'adulti li jkunu qegħdin jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla, u li jkunu f'riskju ta' trasfużjoni kif evalwat mill-istat ġenerali tal-pazjent (eż. status kardjovaskulari, anemija diġà eżistenti fil-bidu tal-kimoterapija) għal kura ta' anemija u tnaqqis tal-ħtiġijiet ta' trasfużjoni.
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'epoetin alfa naqqset ir-riskju ta' esponiment għal demm alloġeneiku b'50% meta mqabbla ma' pazjenti li ma kinux qed jirċievu epoetin alfa.
English: > 13 g/dL (> 8.1 mmol/L), the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Maltese: f'pazjenti b'emoglobina fil-linja bażi ta' > 13 g/dL (> 8.1 mmol/L), il-possibbiltà li l-kura b'epoetin alfa tista' tiġi assoċjata ma' riskju miżjud ta' avvenimenti trombotiċi /avvenimenti vaskulari, ta' wara l-operazzjoni, ma tistax tiġi eskluża.
English: Haemoglobin levels should be monitored regularly.
Maltese: Il-livelli tal-emoglobina għandhom jiġu mmonitorjati regolarment.
English: A haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Maltese: emoglobina taqbeż 12 g/dL (7.5 mmoL/L).
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1).
Maltese: F'pazjenti b'rispons batut għal epoetins, għandhom jiġu kkunsidrati spegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.2 u 5.1).
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: ittitrat b'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 paediatric chronic renal failure patients on haemodialysis
Maltese: Anemija f'pazjenti b'insuffiċjenza renali kronika qabel il-bidu tad-dijalisi jew fuq dijalisi peritonali
English: • itchy rash (hives).
Maltese: • raxx bil-ħakk (urtikarja).
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Maltese: Jista' jkollok uġigħ fis-sider, qtugħ ta' nifs, u nefħa bl-uġigħ u ħmura normalment fir-riġel bħala sintomi.
English: Baseline Characteristics for Subjects with sEPO < 200 mU/mL at Screening
Maltese: Karatteristiċi fil-Linja Bażi għall-Pazjenti b'sEPO < 200 mU/mL fl-Eżami
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 ta' noninferjorità imfassal sabiex tiġi eskluża żieda ta' 15% fir-riskju ta' progressjoni tat-tumur jew mewt ta' epoetin alfa flimkien ma' kura standard (SOC - standard of care) meta mqabbel ma'
English: 1 pre-filled syringe of 0.7 mL 6 pre-filled syringes of 0.7 mL 1 pre-filled syringe of 0.7 mL with a needle safety guard 6 pre-filled syringes of 0.7 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.7 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.7 mL bi protezzjoni tas-sigurtà tal-labra
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 totali mqassra u żieda fl-imwiet attribwiti għall-progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer metastatiku tas-sider li jkunu qed jirċievu kimoterapija meta jingħata biex jinkiseb livell ta' konċentrazzjoni ta' emoglobina ta' 12 sa14 g/dL (7.5 sa 8.7 mmol/L),
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 alfa therapy.
Maltese: - Għal pazjenti skedati għal operazzjoni ortopedika mhux obbligatorja maġġuri, għandu jingħata suppliment ta' ħadid (ħadid elementali 200 mg/jum b'mod orali) matul il-kors tat-terapija b'epoetin alfa.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull siringa, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Adult haemodialysis patients
Maltese: EFFETIV TAL-PRODOTT MEDIĊINALI
English: Epoetin alfa HEXAL contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Mean Median Range 95% CI for mean Prior Transfusions N Yes
Maltese: 95% CI għall-medja
English: 1 pre-filled syringe of 0.8 mL 6 pre-filled syringes of 0.8 mL 1 pre-filled syringe of 0.8 mL with a needle safety guard 6 pre-filled syringes of 0.8 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.8 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.8 mL bi protezzjoni tas-sigurtà tal-labra
English: Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly.
Maltese: Kienu rrappurtati wkoll każijiet f'pazjenti b'epatite Ċ ikkurati b'interferon u ribavirin, meta ESAs jintużaw fl-istess ħin.
English: • after the expiry date on the label and outer carton
Maltese: • wara d-data ta' meta tiskadi fuq it-tikketta u l-kartuna ta' barra
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 mixtieq tal-konċentrazzjoni tal-emoglobina f'żewġ studji kienet ta' > 13 g/dL (8.1 mmol/L); fit-tliet studji l-oħrajn kienet ta' 12 sa 14 g/dL (7.5 sa 8.7 mmol/L).
English: The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Maltese: L-aktar reazzjonijiet avversi frekwenti tal-mediċina li seħħew fil-provi kliniċi ta' epoetin alfa huma dijarea, nawseja, rimettar, deni u wġigħ ta' ras.
English: • unusual tiredness,
Maltese: • għeja mhux tas-soltu,
English: Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Maltese: glycine, polysorbate 80, hydrochloric acid (għal aġġustament tal-pH), sodium hydroxide (għal aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: If Epoetin alfa HEXAL is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Maltese: Jekk Epoetin alfa HEXAL jiġi injettat taħt il-ġilda (b'mod subkutaneju), l-ammont injettat fi kwalunkwe post normalment ma jkunx iktar minn millilitru (1 mL) f'injezzjoni waħda.
English: Therefore, epoetin alfa should not be used in patients with baseline haemoglobin > 13 g/dL (> 8.1 mmol/L).
Maltese: Għalhekk, epoetin alfa m'għandux jintuża f'pazjenti b'emoglobina fil-linja bażi ta' > 13 g/dL (> 8.1 mmol/L).
English: Do not shake Epoetin alfa HEXAL syringes.
Maltese: Ħu doża waħda biss ta' Epoetin alfa HEXAL minn kull siringa.
English: Angioneurotic oedema3
Maltese: taħt il-ġilda
English: 1 pre-filled syringe of 1 mL 6 pre-filled syringes of 1 mL 1 pre-filled syringe of 1 mL with a needle safety guard 4 pre-filled syringes of 1 mL with a needle safety guard 6 pre-filled syringes of 1 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 1 mL bi protezzjoni tas-sigurtà tal-labra 4 siringi mimlija għal-lest ta' 1 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 1 mL bi protezzjoni tas-sigurtà tal-labra
English: 1 pre-filled syringe of 0.5 mL 6 pre-filled syringes of 0.5 mL 1 pre-filled syringe of 0.5 mL with a needle safety guard 6 pre-filled syringes of 0.5 mL with a needle safety guard
Maltese: 6 siringi mimlija għal-lest ta' 0.5 mL Siringa mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra
English: 1 pre-filled syringe of 0.9 mL 6 pre-filled syringes of 0.9 mL 1 pre-filled syringe of 0.9 mL with a needle safety guard 6 pre-filled syringes of 0.9 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.9 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.9 mL bi protezzjoni tas-sigurtà tal-labra
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage (see section 4.8).
Maltese: Dan hu kkaratterizzat minn tnaqqis sostnut ta' emoglobina minkejja żieda fid-dożaġġ ta' epoetin alfa (ara sezzjoni 4.8).
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 kura b'epoetin alfa li kellha fil-mira livell ta' manutenzjoni ta' emoglobina ta' 13.5 g/dL (ogħla mil-livell rakkomandat ta' konċentrazzjoni tal-emoglobina) jew 11.3 g/dL.
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 maġġuri mhux obbligatorja b'emoglobina qabel il-kura ta' > 10 sa ≥ 13 g/dL, intwera li epoetin alfa jnaqqas ir-riskju li jiġu riċevuti trasfużjonijiet alloġeniċi u jħaffef l-irkupru eritrojdi (żieda fil-livelli tal-emoglobina, livelli ta' ematokrit, u l-għadd ta'
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/009
Maltese: IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/411/001
English: • Store and transport refrigerated (2°C-8°C).
Maltese: • Żommu fi friġġ waqt il-ħażna u l-ġarr (2°C-8°C).
English: 1 pre-filled syringe of 0.4 mL 6 pre-filled syringes of 0.4 mL 1 pre-filled syringe of 0.4 mL with a needle safety guard 6 pre-filled syringes of 0.4 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.4 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.4 mL bi protezzjoni tas-sigurtà tal-labra
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: b'konsiderazzjoni għall-medda ta' konċentrazzjoni tal-emoglobina mixtieqa ta' 10 g/dL (6.2 mmol/L) sa 12 g/dL (7.5 mmol/L).
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Epoetin alfa HEXAL 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Maltese: Kura ta' pazjenti kirurġiċi adulti fi programm ta' predonazzjoni awtologa Pazjenti li għandhom anemija ħafifa (ematokrit ta' 33 sa 39%) li jeħtieġu predepożitu ta' ≥ 4 unitajiet ta' demm, għandhom jiġu kkurati b'Epoetin alfa HEXAL b'doża ta' 600
English: The pharmacokinetic profile of epoetin alfa in children and adolescents appears to be similar to that of adults.
Maltese: epoetin alfa fit-tfal u l-adolexxenti jidher li hu simili għal dak tal-adulti.
English: 1 pre-filled syringe of 0.5 mL 6 pre-filled syringes of 0.5 mL 1 pre-filled syringe of 0.5 mL with a needle safety guard 4 pre-filled syringes of 0.5 mL with a needle safety guard 6 pre-filled syringes of 0.5 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra 4 siringi mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra
English: Serum electrolytes should be monitored in chronic renal failure patients.
Maltese: L-elettroliti fisserum għandhom jiġu mmonitorjati f'pazjenti b'insuffiċjenza renali kronika.
English: A defined concentration-time profile with peak and return to baseline was observed for changes in percent reticulocytes.
Maltese: Ġie osservat profil definit ta' żmien-konċentrazzjoni b'massimu u ritorn għal-linja bażi għal bidliet fil-perċentwali ta' retikuloċiti.
English: A. LABELLING
Maltese: N Iva
English: Hypertensive crisis3
Maltese: Kriżi ipertensiva3
English: No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.
Maltese: Ma teżisti l-ebda evidenza li tindika li l-kura b'epoetin alfa tbiddel il-metaboliżmu ta' prodotti mediċinali oħra.
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe
Maltese: Epoetin alfa HEXAL 8,000 IU/0.8 mL injezzjoni Epoetin alfa
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Maltese: Kien hemm rapporti ta' reazzjonijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekrolisi epidermali tossika (TEN) b'rabta ma' kura b'epoetin.
English: A major cardiovascular event (death, myocardial infarction, stroke or hospitalisation 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: (14%) fost is-717-il pazjent fil-grupp ta' emoglobina iktar baxxa (proporzjon ta' periklu [HR] 1.3, 95% CI: 1.0, 1.7, p = 0.03).
English: Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Maltese: Epoetin alfa hu kopja tal-proteina umana erythropoietin u jaġixxi bl-istess mod.
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 inizjali baxxa ħafna (< 6.8 g/dL jew < 4.25 mmol/L) jistgħu jkunu jeħtieġu dożi ogħla ta' manteniment minn pazjenti li l-emoglobina inizjali tagħhom tkun ogħla
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 Epoetin alfa HEXAL therapy at a dose 25% below the previous dose.
Maltese: Jekk il-livell tal-konċentrazzjoni tal-emoglobina jaqbeż 13 g/dL (8.1 mmol/L), waqqaf it-terapija sakemm jinżel taħt 12 g/dL (7.5 mmol/L) u mbagħad erġa' ibda t-terapija b'Epoetin alfa HEXAL
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
Maltese: Epoetin alfa HEXAL 40,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull mL ta' soluzzjoni fih 40,000 IU ta' epoetin alfa* li jikkorrispondu għal 336.0 mikrogrammi f'kull mL
English: • Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness.
Maltese: • Sintomi jixbhu l-influwenza, bħal uġigħ ta' ras, u wġigħ fi-ġogi, sensazzjoni ta' dgħufija, tertir ta' bard, għeja u sturdament.
English: In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Maltese: Fi studji tossikoloġiċi dwar dożi ripetuti fil-klieb u l-firien, iżda mhux fix-xadini, it-terapija b'epoetin alfa kienet assoċjata ma' fibrożi subklinika tal-mudullun.
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) kien evalwat fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bil-plaċebo, ta' 16-il ġimgħa, u fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat, open-label, ta' 20 ġimgħa f'pazjenti pedjatriċi anemiċi li kienu qed jirċievu kimoterapija majelosoppressiva għat-trattament ta' diversi tumuri malinni mhux majelojdi tat-tfulija.
English: Following subcutaneous injection, serum levels of epoetin alfa reach a peak between 12 and 18 hours post-dose.
Maltese: Assorbiment Wara injezzjoni taħt il-ġilda, il-livelli ta' epoetin alfa fis-serum jilħqu l-massimu bejn 12 u 18-il siegħa wara d-doża.
English: If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin concentration has increased ≥ 1 g/dL (≥ 0.62 mmol/L) or the reticulocyte count has increased ≥ 40,000 cells/µL, the dose should remain at 300 IU/kg 3 times per week.
Maltese: IU/kg 3 darbiet fil-ġimgħa, ilkonċentrazzjoni tal-emoglobina tkun żdiedet għal ≥ 1 g/dL (≥ 0.62 mmol/L) jew l-għadd ta' retikuloċiti jkun żdied għal ≥ 40,000 ċellula/µL id-doża għandha tibqa' 300 IU/kg 3 darbiet filġimgħa.
English: Adult patients with low- or intermediate-1-risk MDS
Maltese: Kura tal-pazjenti adulti b'riskju baxx jew intermedju 1 ta' MDS
English: Available evidence suggests patients with haematological malignancies and solid tumours respond equivalently to epoetin alfa therapy, and that patients with or without tumour infiltration of the bone marrow respond equivalently to epoetin alfa therapy.
Maltese: Evidenza disponibbli tissuġġerixxi li pazjenti b'tumuri malinni ematoloġiċi u tumuri solidi, jirrispondu b'mod ekwivalenti għal terapija b'epoetin alfa, u li pazjenti bi jew mingħajr infiltrazzjoni tat-tumur tal-mudullun, jirrispondu b'mod ekwivalenti għal terapija b'epoetin alfa.
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each syringe contains 0.8 mL of solution for injection.
Maltese: Epoetin alfa HEXAL 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.8 mL ta' soluzzjoni għall-injezzjoni.
English: Side effects from an overdose of Epoetin alfa HEXAL are unlikely.
Maltese: Effetti sekondarji minn doża eċċessiva ta' Epoetin alfa HEXAL mhumiex mistennija.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL injezzjoni Epoetin alfa
English: Alternatively, Epoetin alfa HEXAL can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Maltese: Inkella, Epoetin alfa HEXAL jista' jingħata b'doża inizjali ta' 450 IU/kg taħt il-ġilda darba fil-ġimgħa.
English: The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL).
Maltese: L-ikbar effetti jiġu osservati f'pazjenti b'emoglobina baxxa (≥ 13 g/dL).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 1,000 IU/0.5 mL injection Epoetin alfa
Maltese: IL-PRODOTT MEDIĊINALI Epoetin alfa HEXAL 1,000 IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: The recommended dosing regimen is described in the following diagram: 150 IU/kg 3x/week or 450 IU/kg once weekly for 4 weeks
Maltese: id-doża għandha tibqa' 150 IU/kg 3 darbiet fil-ġimgħa jew 450 IU/kg kull ġimgħa.
English: The absolute bioavailability of subcutaneous injectable epoetin alfa is approximately 20% in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' epoetin alfa injettat minn taħt il-ġilda hija madwar 20% f'individwi b'saħħithom.
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: Kura ta' pazjenti b'anemija kkaġunata mill-kimoterapija Epoetin alfa ġie studjat fi provi kliniċi f'pazjenti adulti anemiċi bil-kanċer b'tumuri limfojde u solidi, u f'pazjenti fuq diversi korsijiet ta' kimoterapija, li jinkludu korsijiet li fihom il-platinum u bla platinum.
English: Anaphylactic reaction3
Maltese: Reazzjoni anafilattika3
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.4).
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 4.4).
English: General
Maltese: Deni
English: The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin alfa 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: Ir-riskju rrappurtat ta' dawn it-TVEs għandu jintiżen b'attenzjoni kontra l-benefiċċji li jistgħu jinkisbu minn kura b'epoetin alfa, b'mod partikolari f'pazjenti b'fatturi pre-eżistenti ta' riskju għal TVE, li jinkludu obeżità u storja medika fil-passat ta' TVEs (eż. trombożi profonda tal-vini, emboliżmu pulmonari, u inċident ċerebrovaskulari).
English: Haemoglobin variability should be addressed through dose management, with consideration for the desired haemoglobin concentration range between 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Maltese: Il-varjabilità tal-emoglobina għandha tiġi indirizzata permezz tal-immaniġġjar tad-doża, b'konsiderazzjoni għall-medda tal konċentrazzjoni tal-emoglobina ta' 10 g/dL (6.2 mmol/L) sa 12 g/dL (7.5 mmol/L).