FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Egranli, balugrastim, is made up of ‘granulocyte-colony-stimulating factor' (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow.
Maltese: Is-sustanza attiva f'Egranli, balugrastim, huwa magħmul minn ‘fattur stimulanti tal-kolonja talgranuloċiti' (G-CSF), proteina li tinstab b'mod naturali fil-ġisem li tippromwovi l-produzzjoni ta' ċelloli tad-demm bojod inklużi newtrofili fil-mudullun.
English: On 4 November 2014, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.
Maltese: Fl-4 ta' Novembru 2014, Teva Pharma B.V. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Egranli, għat-tnaqqis tat-tul ta' newtropenja u tal-okkorrenza ta' febrili f'pazjenti tal-kanċer adulti.
English: The evaluation had finished and the CHMP had given a positive opinion.
Maltese: L-evalwazzjoni kienet intemmet u s-CHMP kien ta opinjoni pożittiva.
English: The G-CSF in Egranli is attached to another natural blood protein called albumin, which decreases the rate at which G-CSF is removed from the body and allows the medicine to have a longer duration of action and to be given less often.
Maltese: Il-G-CSF f'Egranli huwa mwaħħal ma' proteina taddemm naturali oħra msejħa albumina, li tnaqqas ir-rata li biha, G-CSF jitneħħa mill-ġisem u jippermetti li l-mediċina jkollha tul ta' azzjoni itwal u tingħata inqas ta' spiss.
English: Egranli was to be used to reduce the duration of neutropenia (abnormally low level of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy (medicines that treat cancer by killing cells).
Maltese: Egranli kien mistenni li jintuża sabiex inaqqas it-tul ta' newtropenja (livell baxx b'mod anormali ta' newtrofili, tip ta' ċelloli tad-demm bojod li jiġġieldu l-infezzjonijiet) u l-okkorrenza ta' newtopenja febrili (newtropenja bid-deni) f'pazjenti adulti b'kanċer li jkunu qegħdin jirċievu kimoterapija ċitotossika (mediċini li jikkuraw il-kanċer billi joqtlu ċ-ċelloli).
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Egranli (balugrastim)
English: Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.
Maltese: Balugrastim jaħdem bl-istess mod bħal G-CSF prodott b'mod naturali, iżid il-produzzjoni ta' newtrofili u b'hekk jgħin biex inaqqas it-tul ta' newtropenja u biex jipprevjeni newtropenja febrili (sinjal ta' infezzjoni) f'pazjenti li jkunu qegħdin jirċievu kimoterapija.
English: How is Egranli expected to work?
Maltese: Kif huwa mistenni li jaħdem Egranli?
English: Arctic root EMA/HMPC/289537/2012
Maltese: Għerq tar-Rodjola EMA/HMPC/289537/2012
English: In its assessment, the HMPC also considered clinical studies of small size that have been carried out to investigate the effects of arctic root medicines in adults suffering from stress and fatigue as compared with placebo (a dummy treatment).
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra wkoll studji kliniċi ta' daqs żgħir li twettqu sabiex jiġu investigati l-effetti tal-mediċini tal-għerq artiku f'persuni adulti li jbatu minn stress u għeja meta mqabbel ma' plaċebo (kura finta).
English: Although a possible effect in the temporary relief of symptoms of stress was observed, several shortcomings have been identified in these studies.
Maltese: Għalkemm kien osservat effett possibbli fis-solliev temporanju tassintomi ta' stress, dawn l-istudji identifikaw diversi nuqqasijiet.
English: Arctic root preparations are obtained from the dried extracts prepared by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in ethanol).
Maltese: Il-preparazzjonijiet tal-għerq artiku jinkisbu mill-estratt imnixxef ippreparat permezz ta' estrazzjoni bletanol (teknika użata għall-estrazzjoni ta' komposti minn materjal tal-pjanti billi jiġu mdewba fl-etanol).
English: Further information on the HMPC assessment of arctic root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Arctic root is the common name for the underground stem (or rhizome) and root of the plant Rhodiola rosea L. The plant is cultivated or gathered to obtain the underground organs (root and rhizome) for medicinal use.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-għerq artiku.
English: Further information on the risks associated with arctic root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-għerq artiku, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: What are the risks associated with arctic root medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-għerq artiku?
English: Arctic root medicines should only be used in adults over the age of 18 years and should not be taken for longer than two weeks without seeking medical advice.
Maltese: Il-mediċini tal-għerq artiku għandhom jintużaw biss f'adulti ta' 'l fuq minn 18-il sena u m'għandhomx jittieħdu għal aktar minn ġimagħtejn mingħajr ma jitfittex parir mediku.
English: The HMPC conclusions on the use of arctic root medicines are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-għerq artiku huma bbażati fuq l-‘użi tradizzjonali' tagħhom.
English: Other information about arctic root medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-għerq artiku
English: SI-1234 Menges Slovenia
Maltese: SI-1234 Menges Is-Slovenja
English: MedDRA System Organ Classification (SOC)
Maltese: Sistema tal-Klassifika talOrgani MedDRA (SOC)
English: No data are available.
Maltese: M'hemm l ebda data disponibbli.
English: Linearity/Non-linearity
Maltese: Linearità/nuqqas ta' linearità
English: 8.4 micrograms 16.8 micrograms
Maltese: 8.4 mikrogrammi 16.8 mikrogrammi
English: D-83607 Holzkirchen Germany
Maltese: D-83607 Holzkirchen
English: Urticaria3
Maltese: Urtikarja3
English: ≤ 2 RBC Units >2 and ≤4 RBC Units >4 RBC Units
Maltese: ≤ 2 Unitajiet ta' RBC >2 u ≤4 Unitajiet ta' RBC >4 Unitajiet ta' RBC
English: Porphyria acute3
Maltese: Porfirija akuta3
English: 168.0 micrograms 252.0 micrograms 336.0 micrograms
Maltese: 168.0 mikrogramma 252.0 mikrogramma 336.0 mikrogramma
English: Pharmacotherapeutic group: other antianaemic preparations, erythropoietin, ATC code: B03XA01.
Maltese: Kategorija farmakoterapewtika: sustanzi anti-anemiċi oħrajn, eritropoetin, Kodiċi ATC: B03XA01.
English: Target Hb
Maltese: Hb intenzjonata
English: Hyperkalaemia1
Maltese: Iperkalemija1
English: Screening sEPO < 200 mU/mL (N) Haemoglobin (g/L) N
Maltese: Ezami tal-sEPO < 200 mU/mL (N) Emoglobina (g/l)
English: 25.2 micrograms 33.6 micrograms 42.0 micrograms 50.4 micrograms 58.8 micrograms 67.2 micrograms 75.6 micrograms 84.0 micrograms
Maltese: 25.2 mikrogrammi 33.6 mikrogrammi 42.0 mikrogramma 50.4 mikrogrammi 58.8 mikrogrammi 67.2 mikrogrammi 75.6 mikrogrammi 84.
English: Pack of 1, 4 or 6 syringes.
Maltese: Pakkett ta' 1, 4 jew 6 siringi.
English: Administer the dose as per standard protocol.
Maltese: Agħti d-doża skont il-protokoll standard.
English: Date of first authorisation: 28 August 2007 Date of latest renewal: 18 June 2012
Maltese: Data tal-aħħar tiġdid: 18 ta' Ġunju, 2012
English: Pack of 1 or 6 syringes.
Maltese: Pakkett ta' 1 jew 6 siringi.
English: Chronic renal failure
Maltese: Insuffiċjenza kronika renali
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Maltese: Meta-analiżi tad-dejta tas-sopravivenza totali pproduċiet stima ta' punt ta' proporzjon ta' periklu ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bil-kanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu ta' sopravivenza totali kien ta' 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjenti).
English: • porphyria (a rare blood disorder).
Maltese: • porfirija (disturb rari tad-demm).
English: Lek Pharmaceuticals d.d.
Maltese: Lek Pharmaceuticals d.d. Kolodvorska 27
English: Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Maltese: Epoetin alfa HEXAL huwa indikat għall-kura ta' anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (CRF):
English: Epoetin alfa HEXAL 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: Epoetin alfa HEXAL huwa indikat fit-trattament tal-anemija sintomatika (konċentrazzjoni ta' emoglobina ta' ≤ 10 g/dL) f'adulti b'riskju baxx jew intermedju 1 ta' sindromi majelodisplastiċi primarji (MDS, myelodysplastic syndromes) li għandhom eritropoetin baxx fis-serum (< 200 mU/mL).
English: At the final analysis, 1653 deaths were reported.
Maltese: Fl-analiżi finali, kienu rrappurtati 1,653 mewt.
English: 25, D-83607 Holzkirchen, Germany
Maltese: Hexal AG, Industriestr. 25, D-83607 Holzkirchen , Il-Ġermanja
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Further pharmacodynamic studies explored 40,000 IU once weekly versus 150 IU/kg 3 times per week.
Maltese: Studji addizzjonali farmakodinamiċi esploraw doża ta' 40,000 IU darba fil-ġimgħa kontra 150 IU/kg 3 darbiet fil-ġimgħa.
English: Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Maltese: Numru inqas b'mod sinifikanti ta' pazjenti rċivew trasfużjonijiet ta' RBC fil-grupp ta' epoetin alfa flimkien ma' SOC (5.8% kontra 11.4%); madankollu, numru akbar b'mod sinifikanti ta' pazjenti kellhom avvenimenti vaskulari trombotiċi fil-grupp ta' epoetin alfa flimkien ma' SOC (2.8% kontra 1.4%).
English: Anti-erythropoietin antibody positive
Maltese: Antikorpi kontra erythropoietin pożittiv
English: Overdosage of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Maltese: Dożaġġ eċċessiv ta' epoetin alfa tista' tipproduċi effetti li huma estensjonijiet ta' l-effetti farmakoloġiċi ta' l-ormon.
English: Very common side effects
Maltese: Effetti sekondarji rari
English: Epoetin alfa HEXAL contains sodium
Maltese: Epoetin alfa HEXAL fih sodium
English: Following intravenous administration of epoetin alfa in subjects with chronic renal failure, the volume of distribution ranged from 57-107 mL/kg after single dosing (12 IU/kg) to 4264 mL/kg after multiple dosing (48-192 IU/kg), respectively.
Maltese: Wara l-għoti għal ġol-vini ta' epoetin alfa f'individwi b'insuffiċjenza renali kronika, il volum ta' distribuzzjoni varja minn 57-107 mL/kg wara doża waħda (12 IU/kg) għal 42-64 mL/kg wara dożaġġ multiplu (48-192 IU/kg), rispettivament.
English: 20,000 IU/0.5 mL 30,000 IU/0.75 mL 40,000 IU/1 mL
Maltese: IU/0.75 mL 40,000 IU/1 mL
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in pre-dialysis [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: Inklużi kien hemm 228 individwu b'CRF ikkurati b'epoetin alfa f'4 studji dwar insuffiċjenza renali kronika (2 studji fi predijalisi [N = 131 individwu b'CRF esposti] u 2 f'dijalisi [N = 97 individwu b'CRF esposti]; 1,404 individwi b'kanċer esposti f'16-il studju dwar anemija minħabba kimoterapija; 147 f'2 studji għal donazzjoni ta' demm awtologu; 213-il individwu esposti fi studju wieħed fil-perjodu perikirurġiku, u 102 individwi esposti f'żewġ studji
English: - The active substance is: epoetin alfa (for quantity see the table below).
Maltese: - Is-sustanza attiva hi: epoetin alfa (għall-kwantità ara t-tabella hawn taħt).
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 Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Maltese: Fi studju prospettiv, ikkontrollat bil-plaċebo, tat-tip double-blind, u randomised fi 375 pazjent anemiku b'tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija mhux bil-platinu, kien hemm tnaqqis sinifikanti fis-sintomi relatati mal-anemija (eż. għeja, tnaqqis fl-enerġija, tnaqqis flattività), kif imkejla bl-istrumenti u l-iskali li ġejjin: l-iskala ġenerali tal-iStima Funzjonali ta' Anemija relatata mat-Terapija kontra l-Kanċer (FACT-An, Functional Assessment of Cancer TherapyAnaemia), l-iskala tal-għeja tal-FACT-An, u l-iSkala Lineari Analoga tal-Kanċer (CLAS, Cancer
English: - The other ingredients are: 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: - Is-sustanzi mhux attivi l-oħra huma: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (għal aġġustament tal-pH), sodium hydroxide (għal aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: 1 Common in dialysis 2 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 3 Addressed in the subsection below and/or in section 4.4
Maltese: 2 Jinkludi avvenimenti arterjali u venużi, fatali u mhux fatali, bħal trombożi tal-vini profondi, emboli pulmonari, trombożi retinali, trombożi arterjali (li tinkludi infart mijokardijaku), inċidenti ċerebrovaskulari (li jinkludu infart ċerebrali u emorraġija ċerebrali) attakki iskemiċi temporanji, u trombożi fix-shunt (li tinkludi tagħmir tad-dijalisi) u trombożi f'anewriżmi arterjovenużi tax-shunt 3 Indirizzati fis-sottosezzjoni hawn taħt u/jew f'sezzjoni 4.4
English: Pure red cell aplasia3, Thrombocythaemia
Maltese: Aplasija pura taċ-ċelluli ħomor3, Tromboċitemija
English: Take special care with Epoetin alfa HEXAL:
Maltese: Tużax Epoetin alfa HEXAL:
English: • epileptic seizures or fits;
Maltese: • puplesiji epilettiċi jew aċċessjonijiet;
English: A less defined profile was observed for RBCs and haemoglobin.
Maltese: Profil inqas definit ġie osservat għall-RBCs u l-emoglobina.
English: Adults with myelodysplastic syndrome
Maltese: Adulti bis-sindromu majelodisplastiku
English: • Allergic reaction.
Maltese: • Reazzjoni allerġika.
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 kkontrollati bil-plaċebo, il-proporzjonijiet tal-periklu għas-sopravivenza totali varjaw bejn 1.25 u 2.47 favur il-kontrolli.
English: Frequency estimate: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: - in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Maltese: - f'adulti u fi tfal li jkollhom minn sena sa 18-il sena fuq l-emodijalisi u f'pazjenti adulti fuq dijalisi peritonali (ara sezzjoni 4.4).
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: Il-medja ta' CL/F għall-korsijiet ta' 150 IU/kg 3 darbiet kull ġimgħa u 40,000 IU darba fil-ġimgħa f'individwi b'saħħithom, kienet ta' 31.2 u 12.6 mL/h/kg, rispettivament.
English: Presentation
Maltese: LISTA
English: Of a total 3,417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2,094 anaemic subjects.
Maltese: Minn total ta' 3,417 individwu fi 25 studju li fihom il-parteċipanti ntgħażlu b'mod każwali, double blinded, ikkontrollati bi plaċebo jew bi standard ta' kura, il-profil globali tas-sigurtà ta' epoetin alfa ġie evalwat f'2,094 individwu anemiku.
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Maltese: Id-doża totali rakkomandata fil-ġimgħa hija bejn 75 IU/kg u 300 IU/kg.
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dL, > 10 to ≤ 13 g/dL and > 13 g/dL).
Maltese: Il-pazjenti ġew stratifikati skont l-emoglobina tagħhom fil-linja bażi (≥ 10 g/dL, > 10 sa ≥ 13 g/dL u > 13 g/dL).
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 40,000 IU/1 mL
Maltese: Epoetin alfa HEXAL 40,000 IU/1 mL
English: Hypersensitivity3
Maltese: Sensittività eċċessiva3
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, tat-tip grupp parallel, li saret fuq individwi adulti li ma kellhomx defiċjenza ta' ħadid, b'emoglobina ta' qabel il-kura ta' ≤ 10 sa ≥ 13 g/dL, li kienu skedati għal operazzjoni ortopedika maġġuri tal-ġenbejn jew tal-irkoppa, qabbel epoetin alfa 300 IU/kg mogħti taħt il-ġilda kuljum għal 10 ijiem qabel l-operazzjoni, fil-jum tal-operazzjoni, u għal erbat ijiem wara loperazzjoni, ma' epoetin alfa 600
English: • Cough.
Maltese: • Sogħla.
English: When treatment starts, Epoetin alfa HEXAL is usually injected by a medical professional or a nurse.
Maltese: Meta tibda l-kura, Epoetin alfa HEXAL normalment jiġi injettat minn staff mediku jew mill infermiera.
English: Hypertension, Venous and arterial thromboses2
Maltese: Pressjoni għolja, trombożi venuża u arterjali2
English: 10,000 IU/mL: 3,000 IU/0.3 mL 4,000 IU/0.4 mL 5,000 IU/0.5 mL 6,000 IU/0.6 mL 7,000 IU/0.7 mL 8,000 IU/0.8 mL 9,000 IU/0.9 mL 10,000 IU/1 mL
Maltese: IU/0.6 mL 7,000 IU/0.7 mL 8,000 IU/0.8 mL 9,000
English: After single doses (20,000 to 160,000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.
Maltese: IU taħt il-ġilda) ta' epoetin alfa, ġie osservat rispons dipendenti mid-doża għall-markaturi farmakodinamiċi investigati, li jinkludu: retikuloċiti, RBCs, u emoglobina.
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: IU/kg 3 darbiet kull ġimgħa u 40,000 IU darba fil-ġimgħa f'individwi anemiċi bil kanċer, kienet ta' 45.8 u 11.3 mL/h/kg, rispettivament.
English: - Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Maltese: - Pazjenti li kellhom operazzjoni li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
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 il-ħin għall-ewwel trasfużjoni ġie mtawwal aktar fil-grupp tal-epoetin alfa (142 vs. 50 jum, p = 0.007).
English: - an observed 9% increase in risk for progress of disease (PD) or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
Maltese: - żieda ta' 9% osservata fir-riskju ta' progressjoni tal-marda (PD - progress of disease) jew mewt fil-grupp ta' epoetin alfa flimkien ma' kura standard (SOC - standard of care) minn analiżi primarja u żieda ta' 15% fir-riskju li ma tistax tiġi eskluża statistikament f'pazjenti b'kanċer metastatiku tas-sider li jkunu qed jirċievu kimoterapija meta jingħata biex jinkiseb livell ta' konċentrazzjoni ta' emoglobina ta' 10 sa 12 g/dL (6.2 sa 7.5 mmol/L).
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 medjan għall-progressjoni (TTP, time to progression) ibbażat fuq il-marda progressiva (PD, progressive disease) iddeterminata millinvestigatur kien ta' 7.5 xhur fil-grupp ta' epoetin alfa flimkien ma' SOC u ta' 7.5 xhur fil-grupp ta' SOC (HR 1.099, CI 95%: 0.998, 1.210).
English: In patients developing sudden lack of efficacy defined by a decrease in haemoglobin (1 to 2 g/dL or 0.62 to 1.25 mmol/L 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 bi tnaqqis fl-emoglobina (1 sa 2 g/dL jew 0.62 sa 1.25 mmol/L fix-xahar) bi ħtieġa akbar ta' trasfużjonijiet, għandu jinkiseb għadd tarretikuloċiti u jiġu investigati l-kawżi tipiċi tan-nuqqas ta' rispons (eż. defiċjenza ta' ħadid, folate, jew vitamina B12, avvelenament tal-aluminju, infezzjoni jew infjammazzjoni, telf ta' demm, emodijalisi u fibrożi tal-mudullun ta' kwalunkwe oriġini).
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Maltese: multiċentriku 4 (4.7%) individwi esperjenzaw TVEs (mewt għal għarrieda, puplesija iskemika, emboliżmu u flebite).