FrancophonIA/ELRC3.0 huggingface dataset:
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, ikkontrollat bi plaċebo, multiċentriku, dwar il-kwalità tal-ħajja f'pazjenti b'CRF fuq l-emodijalisi, intwera titjib klinikament u statistikament sinifikanti fil-pazjenti kkurati b'epoetin alfa meta mqabbla mal-grupp tal-plaċebo meta tkejlu l-għeja, sintomi fiżiċi, relazzjonijiet u depressjoni (Kwestjonarju dwar Mard tal-Kliewi) wara sitt xhur ta' terapija.
English: 1 pre-filled syringe of 0.6 mL 6 pre-filled syringes of 0.6 mL 1 pre-filled syringe of 0.6 mL with a needle safety guard 6 pre-filled syringes of 0.6 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.6 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.6 mL bi protezzjoni tas-sigurtà tal-labra
English: How to store Epoetin alfa HEXAL Contents of the pack and other information
Maltese: Kif jidher Epoetin alfa HEXAL u l-kontenut tal-pakkett
English: Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Maltese: [Hb] bejn 10 u 13 g/dL [6.2 u 8.1 mmol/L], li m'għandhomx defiċjenza ta' ħadid), jekk il proċeduri li jiffrankaw id-demm ma jkunux disponibbli jew ikunu insuffiċjenti meta operazzjoni skedata maġġuri tkun teħtieġ volum kbir ta' demm (4 jew iktar unitajiet ta' demm għan-nisa jew 5 jew iktar unitajiet għall-irġiel).
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 Epoetin alfa HEXAL dose by 25%.
Maltese: Jekk lemoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell sostnut ta' emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Epoetin alfa HEXAL b'25%.
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 l-ebda differenza fis-sopravivenza totali bejn pazjenti kkurati b'eritropoetin uman rikombinanti u l-kontrolli.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each syringe contains 0.3 mL of solution for injection.
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.3 mL ta' soluzzjoni għall-injezzjoni.
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: Il-pazjenti għandhom ikunu mmonitorjati mill-qrib biex ikun żgurat li tintuża l-inqas doża approvata ta' Epoetin alfa HEXAL biex tipprovdi kontroll adegwat tal-anemija u tas-sintomi tal-anemija.
English: The pre-filled syringes are ready to use (see section 4.2).
Maltese: Prodott, sezzjoni 4.2).
English: The initial dose is 150 IU/kg subcutaneously, 3 times per week.
Maltese: Id-doża inizjali hi 150 IU/kg taħt il-ġilda, 3 darbiet fil-ġimgħa.
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Maltese: Ġeneralment, tfal li jiżnu anqas minn 30 kg ikunu jeħtieġu dożi ta' manteniment ogħla minn tfal li jiżnu aktar minn 30 kg u l-adulti.
English: Instructions on how to inject yourself (for patients with symptomatic anaemia caused by kidney disease, for adult patients receiving chemotherapy, adult patients scheduled for orthopaedic surgery, or adult patients with myelodysplastic syndromes only)
Maltese: Istruzzjonijiet dwar kif tinjetta lilek innifsek (għal pazjenti adulti b'anemija sintomatika kkawżata minn mard tal-kliewi, għal pazjenti li jkunu qed jirċievu kimoterapija, pazjenti adulti skedati biex ikollhom operazzjoni kirurġika, jew pazjenti adulti b'sindromi majelodisplastiċi biss)
English: Graduation rings
Maltese: Edema periferali
English: • Hives.
Maltese: HEXAL.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Maltese: Dawn l-istudji wrew mortalità eċċessiva konsistenti li kienet statistikament sinifikanti, u li ma kinitx spjegabbli, f'pazjenti li kellhom anemija assoċjata ma' diversi kanċers komuni, li rċivew eritropoetin uman rikombinanti, meta mqabbla mal-kontrolli.
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 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 6 siringi mimlija għal-lest ta' 1 mL bi protezzjoni tas-sigurtà tal-labra
English: EU/1/07/411/015 EU/1/07/411/016 EU/1/07/411/045 EU/1/07/411/046
Maltese: EU/1/07/411/016 EU/1/07/411/045
English: If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Epoetin alfa HEXAL should be stopped and further dosages should not be administered.
Maltese: Jekk il-livell tal-emoglobina jilħaq il-15 g/dL (9.38 mmol/L), jew ogħla, matul il-perjodu ta' qabel l operazzjoni, l-għoti ta' Epoetin alfa HEXAL għandu jitwaqqaf u ma għandhomx jingħataw aktar dożaġġi.
English: If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Epoetin alfa HEXAL dose by about 25 to 50%.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell tal-konċentrazzjoni tal-emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Epoetin alfa HEXAL b'madwar 25 sa 50%.
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: (≥ 39% u l-ebda anemija sottostanti minħabba defiċjenza ta' ħadid), skedati għal operazzjoni ortopedika maġġuri, ġie evalwat fi studju double-blind, ikkontrollat bi plaċebo, li twettaq fuq
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 għall-kura b'sintomi “bħal tal influwenza” (ara sezzjoni 4.8).
English: Extending dose intervals may require an increase in dose.
Maltese: jkollhom rwol bħala proliferaturi tat-tumuri.
English: Epoetin alfa HEXAL is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
Maltese: Epoetin alfa HEXAL jintuża f'persuni adulti li huma moderatament anemiċi li jkun se jkollhom operazzjoni ortopedika maġġuri (pereżempju operazzjonijiet tas-sostituzzjoni tal-ġenbejn jew tal irkoppa), biex titnaqqas il-ħtieġa potenzjali għal trasfużjonijiet tad-demm.
English: All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Maltese: Il-kawżi l-oħrajn kollha ta' anemija (defiċjenza ta' ħadid, folate jew ta' vitamina B12, avvelenament blaluminju, infezzjoni jew infjammazzjoni, telf ta' demm, emolisi u fibrożi tal-mudullun ta' kwalunkwe oriġini) għandhom jiġu kkunsidrati u kkurati qabel ma tinbeda t-terapija b'epoetin alfa, u meta tiddeċiedi biex iżżid id-doża.
English: Epoetin alfa exhibits a dose-related effect on haematological parameters which is independent of route of administration.
Maltese: Epoetin alfa juri effett relatat mad-doża fuq il-parametri ematoloġiċi li hu indipendenti mir-rotta tal għoti.
English: 1 pre-filled syringe of 0.3 mL 6 pre-filled syringes of 0.3 mL 1 pre-filled syringe of 0.3 mL with a needle safety guard 6 pre-filled syringes of 0.3 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.3 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.3 mL bi protezzjoni tas-sigurtà tal-labra
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Maltese: Barra minn hekk, inċidenti ċerebrovaskulari (li jinkludu infart ċerebrali, emorraġija ċerebrali u attakki iskemiċi temporanji) kienu rrappurtati.
English: In the double-blind study, patients were treated with epoetin alfa 600 IU/kg or placebo intravenously once daily every 3 to 4 days over 3 weeks (total 6 doses).
Maltese: IU/kg jew plaċebo ġol-vini darba kuljum kull 3 sa 4 ijiem, fuq perjodu ta' 3 ġimgħat (total ta' 6 dożi).
English: Chemotherapy-induced anaemia
Maltese: Anemija kkawżata mill-kimoterapija
English: Epoetin alfa HEXAL is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Maltese: Epoetin alfa HEXAL jintuża biex tiġi kkurata anemija f'adulti li jkunu qed jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla (kanċer tal-mudullun) li jista' jkollhom bżonn ta' trasfużjoni tad-demm.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull mL ta' soluzzjoni fih 10,000
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 9,000 IU/0.9 mL injection Epoetin alfa
Maltese: IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 9,000
English: • You may take Epoetin alfa HEXAL out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Maltese: • Tista' toħroġ Epoetin alfa HEXAL mill-friġġ u żżommu f'temperatura tal-kamra (sa 25°C) għal mhux aktar minn 3 ijiem.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 6,000 IU/0.6 mL injection Epoetin alfa
Maltese: IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 6,000
English: Adverse Reaction (Preferred Term Level)
Maltese: Reazzjoni avversa (Livell ta' Terminu Ppreferut)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 8,000 IU/0.8 mL injection Epoetin alfa
Maltese: IL-PRODOTT MEDIĊINALI Epoetin alfa HEXAL 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 4,000 IU/0.4 mL injection Epoetin alfa
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 4,000
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Maltese: Minkejja d-differenzi fil-profili ta' konċentrazzjoni-żmien, ir-rispons farmakodinamiku (kif imkejjel mit-tibdil fil-perċentwali ta' retikuloċiti, emoglobina, u RBCs totali) kien simili bejn dawn il-korsijiet.
English: In 5 small, open label, uncontrolled studies (number of patients ranged from 9-22, total N = 72), Epoetin alfa has been administered subcutaneously in children at starting doses of 100 IU/kg/week to 150 IU/kg/week with the possibility to increase up to 300 IU/kg/week.
Maltese: F'5 studji żgħar, open label, mhux ikkontrollati (numru ta' pazjenti varja minn 9-22, N totali = 72), Epoetin alfa ingħata taħt il-ġilda fit-tfal b'dożi talbidu ta' 100
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Epoetin alfa HEXAL 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 7,000 IU/0.7 mL injection Epoetin alfa
Maltese: IU/0.6 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 7,000
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 5,000 IU/0.5 mL injection Epoetin alfa
Maltese: IU/0.4 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 5,000
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), f'pazjenti ttrattati b'epoetin alfa, ma kien hemm l-ebda effett statistikament sinifikanti fuq l-Inventarju tal-Kwalità tal-Ħajja Pedjatrika jew fuq il-punteġġi talModulu tal-Kanċer irrappurtati mill-pazjenti jew irrappurtati mill-ġenituri mqabbla mal-plaċebo (punt aħħari primarju tal-effikaċja).
English: How to store Epoetin alfa HEXAL
Maltese: X'fih Epoetin alfa HEXAL
English: In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
Maltese: Il-livell tal-emoglobina fit-tfal għandu jinżamm bejn 9.5 u 11 g/dL.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 30,000 IU/0.75 mL injection Epoetin alfa
Maltese: IU/0.75 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin alfa HEXAL 40,000
English: Treatment of paediatric patients scheduled for major elective orthopaedic surgery
Maltese: Kura ta' pazjenti pedjatriċi skedati għal operazzjoni ortopedika elettiva maġġuri
English: Pregnancy
Maltese: Preżentazzjoni
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe Each syringe contains 1 mL of solution for injection.
Maltese: Epoetin alfa HEXAL 40,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 1 mL ta' soluzzjoni għall-injezzjoni.
English: - increased risk of death when administered to achieve a haemoglobin concentration level of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Maltese: - żieda fir-riskju ta' mewt meta jingħata biex jinkiseb livell ta' konċentrazzjoni ta' emoglobina ta' 12 g/dL (7.5 mmol/L) f'pazjenti b'mard malinn attiv li ma jkunux qed jirċievu la kimoterapija u lanqas terapija bir-radjazzjoni.
English: Epoetin alfa HEXAL is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Maltese: Jekk jitfaċċaw sinjali u sintomi li jissuġġerixxu dawn ir-reazzjonijiet, Epoetin alfa HEXAL għandu jitwaqqaf minnufih u jiġi kkunsidrat trattament alternattiv.
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per mL
Maltese: Kull mL ta' soluzzjoni fih 2,000 IU ta' epoetin alfa* li jikkorrispondu għal 16.8 mikrogrammi f'kull mL
English: In cancer patients receiving chemotherapy, the 2 to 3 week delay between ESA administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).
Maltese: F'pazjenti bil-kanċer li jkunu qed jirċievu kimoterapija, id-dewmien ta' minn 2 sa 3 ġimgħat bejn lgħoti ta' ESA u d-dehra ta' ċelluli ħomor ikkaġunati minn erythropoietin, għandu jiġi kkunsidrat meta ssir evalwazzjoni ta' jekk it-terapija b'epoetin alfa hix adattata (pazjenti f'riskju li jkollhom trasfużjoni).
English: • feeling dizzy,
Maltese: Flimkien ma' dan,
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, li fih il-parteċipanti ma ntgħażlux b'mod każwali, b'medda ta' doża miftuħa, li dam 52 ġimgħa, li sar fuq pazjenti pedjatriċi b'CRF li kienu qegħdin fuq l-emodijalisi.
English: CLINICAL PARTICULARS
Maltese: IL-PRODOTT MEDIĊINALI
English: Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa
Maltese: Epoetin alfa HEXAL 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
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: Kura ta' pazjenti adulti b'anemija kkawżata mill-kimoterapija Sintomi ta' anemija u l-konsegwenzi tagħha jistgħu jvarjaw skont l-età, is-sess, u l-gravità totali talmarda; hemm bżonn ta' evalwazzjoni ta' tabib tal-kors kliniku u tal-kundizzjoni tal-pazjent individwali.
English: On average, patients treated with epoetin alfa were able to predeposit significantly more units of blood (4.5 units) than placebo-treated patients (3.0 units).
Maltese: minn pazjenti kkurati bi plaċebo (3.0 unitajiet).
English: FeLV recombinant Canarypox virus (vCP97) ≥ 10 7.2 CCID50 (cell culture infective dose)
Maltese: FeLV vajrus rikombinant talCanarypox (vCP97) ≥ 10 7.2 CCID50 (doża infettiva tas-cell culture)
English: Invented name
Maltese: Isem Inventat
English: EU Number
Maltese: Numru ta' lUnjoni Europea
English: Target Species
Maltese: 10 dożi
English: Tumour size ≤2 cm >2 cm
Maltese: Daqs tat-tumur 2 cm >2 cm
English: • oral candidiasis
Maltese: • candidiasis orali
English: Subgroups
Maltese: Sottogruppi
English: Statistical analysis
Maltese: Analiżi statistika
English: Second episode: discontinue treatment.
Maltese: It-tieni episodju: waqqaf it-trattament.
English: FAC Hazard ratio (TAC/FAC)
Maltese: Proporzjon ta' riskju (TAC/FAC)
English: Cisplatin and 5-fluorouracil
Maltese: Cisplatin u 5-fluorouracil
English: • loss of appetite (anorexia)
Maltese: • nuqqas t'aptit (anoreskja)
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Maltese: Minoranza ta' pazjenti kienu ittestjati blużu ta' fluorescence in-situ hybridization (FISH).
English: Prednisone and dexamethasone
Maltese: Prednisone u dexamethasone
English: • insomnia
Maltese: • Insonnja
English: Alopecia;
Maltese: Alopeċja;
English: Cardiac toxicity
Maltese: Tossiċità kardijaka
English: Usual dose
Maltese: Doża normali
English: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Maltese: Lion Court, Farnham Road Bordon, Hampshire, GU35 0NF
English: Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Maltese: Farnham Road, Bordon Hampshire, GU35 0NF
English: Hazard Ratio: 1.032 [95% CI: 0.876; 1.216]
Maltese: Riskju Proporzjonali: 1.032 [95% CI: 0.876; 1.216]
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Maltese: Din kienet ukoll statistikament sinifikanti bi HR ta' 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
English: Age category 2 <35 years ≥35 years
Maltese: Kategorija ta' età 2 <35 sena ≥35 sena
English: Overall
Maltese: Total
English: • pneumonia (infection of the lungs)
Maltese: • pnewmonja (infezzjoni fil-pulmuni)
English: Dermatitis;
Maltese: Dermatite;
English: Oral candidiasis (G3/4: < 1%)
Maltese: Candidiasis orali(G3/4: < 1%)
English: Age category 1 <50 years ≥50 years
Maltese: Kategorija ta' età 1 <50 sena ≥50 sena
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Maltese: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Il-Ġermanja
English: Docetaxel plus trastuzumab1 n = 92
Maltese: Docetaxel flimkien ma' trastuzumab1 n = 92
English: Anhydrous citric acid (pH adjustment)
Maltese: Citric acid anidru (aġġustament tal-pH)
English: A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS  60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Maltese: Mingħajr prevenzjoni primarja G-CSF (n = 111) n (%)
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Maltese: Newtropenja (Grad 4) Newtropenja bid-deni Infezzjoni newtropenika Infezzjoni newtropenika (Grad 3-4)
English: Amenorrhoea (G3/4: NA)
Maltese: Amenorreja (G3/4: NA)
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Maltese: Docetaxel huwa metaboliżżat minn CYP3A4 u l-prednisone huwa magħruf li jinduċi CYP3A4.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3.
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size > 5 cm
Maltese: RP = riċettur tal-proġesteron a RE/RP-negattiv jew Grad 3 jew daqs tat-tumur >5 cm
English: Docetaxel is more than 95% bound to plasma proteins.
Maltese: Docetaxel huwa iktar minn 95% marbut mal-proteini tal-plażma.
English: Date of latest renewal: 23 February 2017
Maltese: Mejju 22, 2012 Data tal-aħħar tiġdid: 23 ta 'Frar 2017
English: Dehydration and pulmonary oedema have rarely been reported.
Maltese: Id-deidrazzjoni u l-edima pulmonari kienu rarament irrapportati.
English: Tumor response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA:
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Maltese: Is-sopravivenza medjana kienet ta' 442 jum (docetaxel + capecitabine) kontra 352 jum (docetaxel waħdu).
English: Myalgia (severe: 1.4%)
Maltese: Majalġja (severa: 1.4%)
English: Gastrointestinal reactions
Maltese: Disturbi gastrointestinali
English: With primary G-CSF prophylaxis (n = 421) n (%)
Maltese: Flimkien ma' prevenzjoni primarja G-CSF (n = 421) n (%)
English: Contents of the pack and other information
Maltese: Kontenut tal-pakett u informazzjoni oħra
English: Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Maltese: Il-pazjenti għandhom jiġu mħarsa mill-viċin għal manifestazzjonijiet bikrija ta' tossiċità gastro-intestinali serja (ara sezzjonijiet 4.2, 4.4 Ematoloġija u 4.8).