FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Maltese: Irriżulta illi kumplessivament, ġew osservati 87 rispons komplet u parzjali, bi 13 minnhom iseħħu matul iċ-ċikli 5 u 6, u 3 iseħħu wara.
English: In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Maltese: Fi studju komparattiv ta' topotecan u paclitaxel f'pazjenti li kienu ġew ittrattati qabel għal karċinoma tal-ovarji b'kemoterapija bbażata fuq il-platinum (n = 112 u 114, rispettivament), ir-rata ta' rispons (95 % CI) kienet 20.5 % (13 %, 28 %) kontra 14 % (8 %, 20 %) u ż-żmien medju għal progressjoni kien 19-il ġimgħa kontra 15-il ġimgħa (proporzjon ta' riskju 0.7 [0.6, 1.0]), għal topotecan u paclitaxel, rispettivament.
English: pancytopenia
Maltese: panċitopenija
English: In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
Maltese: III, imwettaq mill-Grupp tal-Onkoloġija Ġinekoloġika (GOG 0179), topotecan flimkien ma' cisplatin (n = 147) tqabbel ma' cisplatin waħdu (n = 146) għat trattament ta' karċinoma ċervikali persistenti, li reġgħet feġġet jew fl-Istadju IVB, ikkonfermata b'mod istoloġiku, fejn it-trattament kurattiv b'kirurġija u/jew radjazzjoni ma kienx ikkunsidrat bħala xieraq.
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5.
Maltese: Meta topotecan (0.75 mg/m2/jum għal 5 ijiem konsekuttivi) u cisplatin (60 mg/m2/jum fil-Jum 1) ġew amministrati lil 13-il pazjent b'kanċer tal-ovarji, żieda żgħira fl-AUC (12 %, n=9) u Cmax (23%, n=11)
English: Response rate (%)
Maltese: Rata ta' reazzjoni (%)
English: Each pack contains one vial.
Maltese: Kull pakkett fih fjala.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, aġenti antineoplastiċi oħra, Kodiċi
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Maltese: Topotecan kellu wkoll volum ta' distribuzzjoni għoli, ta' madwar 132 l, (SD 57), u half-life pjuttost qasira ta' 2-3 sigħat.
English: A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
Maltese: Studju kliniku tal-Fażi III (Studju 478) qabbel topotecan orali flimkien ma' l-aħjar kura ta' appoġġ (Best Supportive Care) (BSC) (n = 71) ma' BSC waħdu (n = 70) f'pazjenti li l-kanċer tagħhom reġa' feġġ wara t-terapija ewlenija (żmien medjan għall-progressjoni [TTP] mit-terapija ewlenija: 84 jum għal-terapija b'topotecan orali flimkien ma' BSC, 90 jum għall-BSC waħdu) u li għalihom trattament ieħor b'kimoterapija li tingħata fil-vina ma kienx ikkunsidrat xieraq.
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Maltese: L-inċidenza ta' dardir qawwi (Skala 3 jew 4), rimettar, dijarrea u mukożite kienet ta' 4, 3, 2 u 1 %, rispettivament.
English: Median (95 % CI) Hazard ratio (95 % CI)
Maltese: Medjana (95% CI) Proporzjon ta' periklu (95% CI)
English: Vials 4 years.
Maltese: Fjali 4 snin.
English: Thrombocytopenia: Severe (platelets < 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Maltese: Severa (plejtlits < 25 x 109/l) f'25 % tal-pazjenti (8 % tal-korsijiet); moderata (plejtlits bejn 25.0
English: Potactasol 1 mg powder for concentrate for solution for infusion EU/1/10/660/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/660/001
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Maltese: Saret analiżi retrospettiva supplimentari fuq dejta minn 523 pazjent b'kanċer tal-ovarji li reġa' feġġ.
English: Potactasol 4 mg powder for concentrate for solution for infusion EU/1/10/660/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/660/002
English: Adequate protective disposable gloves, goggles, gown and mask should be worn.
Maltese: Għandhom jintlibsu ingwanti disponibbli, goggles, gown u maskra protettivi u adegwati.
English: OTHER
Maltese: Fjala
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Maltese: Globalment is-sustanza mill-metabolit N-desmethyl ikkontribbwixxiet għal medja (mean) ta' anqas minn 7 % (bejn 4-9 %) tat-total tal-materjali li għandhom x'jaqsmu ma' topotecan li nstabu fl-awrina u fil-ħmieġ.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Maltese: Pazjenti li qabel kienu ħadu kimoradjuterapija b'cisplatin Cisplatin
English: Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Maltese: Rekjavíkurvegi 76-78
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn 1,000)
English: In those patients (n = 102) with recurrence after 180 days, median survival in the topotecan plus cisplatin arm was 9.9 months (95 % CI: 7, 12.6) versus 6.3 months (95 % CI: 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16).
Maltese: F'dawk il-pazjenti (n = 102) b'rikorrenza wara 180 jum, is-soppravivenza medjana meta topotecan ingħata flimkien ma' cisplatin kienet ta' 9.9 xhur (95 % CI: 7, 12.6) versu 6.3 xhur (95 % CI: 4.9, 9.5) għal cisplatin bi proporzjoni ta' periklu ta' 0.75 (0.49, 1.16).
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 %, CI 0.78 -1.40).
Maltese: periklu għas-soppravivenza b'topotecan li jingħata fil-vina meta mqabbel ma' CAV kien 1.04 (95 % CI 0.78, 1.40).
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Maltese: Rapporti ta' konsegwenzi sinifikanti assoċjati ma' tromboċitopenja inkluż fatalitajiet minħabba fsada tat-tumuri, ma kienux frekwenti.
English: - If you get any side effects, talk to your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew infermiera tiegħek.
English: n = 18), adolescents (aged 12 up to 16 years, n = 9) and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Maltese: Studju wieħed inkluda limiti tad-doza bejn 1.4 u 2.4 mg/m2 fi tfal (età minn 2 sa 12-il sena, n = 18), adoloxxenti (età minn 12 sa 16-il sena, n = 9) u adulti żgħażagħ (età minn 16-il sena sa 21 sena, n = 9) b'tumuri solidi refrattarji.
English: One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Maltese: Prova waħda tal-Fażi II (studju 065) u studju wieħed tal-Fażi III (studju 396) tmexxew sabiex tiġi evalwata l-effikaċja ta' topotecan orali kontra topotecan li jittiehed ġol-vina f'pazjenti li kienu rkadew ≥ 90 jum wara li lestew kors ta' kimoterapija (ara Tabella 1).
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Maltese: Is-soppravivenza medjana kienet ta' 30.3 ġimgħat (95 % CI: 26.
English: Median survival in patients treated with oral topotecan plus BSC was 25.9 weeks (95 % CI 18.3, 31.6) compared to 13.9 weeks (95 % CI 11.1, 18.6) for patients receiving BSC alone (p = 0.0104).
Maltese: 9 ġimgħat (95 % CI 18.3, 31.6) meta mqabbel ma'13.9 ġimgħat (95 % CI 11.1, 18.6) għall-pazjenti li rċevew BSC waħdu (p = 0.0104).
English: How to store Potactasol
Maltese: X'fih Potactasol
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Maltese: Metabolit N-desmethyl, li wera attività tixtiebah jew anqas minn dik tas-sustanza oriġinali fi prova bbażata fiċ-ċellula, instabet flawrina, fil-plasma, u fil-ħmieġ.
English: Relapsed SCLC
Maltese: SCLC li reġa' tfaċċa
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Maltese: Fil-grupp li ħa topotecan orali ma' BSC kien hemm titjib statistiku sinifikanti fis-soppravivenza kumplessiva meta mqabbel mal grupp BSC waħdu (Log-rank p = 0.0104).
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Maltese: L-irkupru totali ta' materjali li għandhom x'jaqsmu ma' topotecan wara l-ħames dożi ta' topotecan li ngħataw darba kuljum kien ta' 71-76 % tad-doża amministrata fil-vina.
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Maltese: Fi studju ieħor tal-Fażi III randomized li qabbel topotecan li jingħata fil-vina (IV) ma' ċiklofosfamid, doxorubicin u vincristine (CAV) f'pazjenti b'SCLC sensittiv li reġa' feġġ, ir-rata totali ta' rispons kienet ta' 24.3 % għal topotecan meta mqabbla ma'18.3 % għall-grupp CAV.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Maltese: Fost il-pazjenti kollha li kienu ttrattati fi studji kliniċi (inklużi kemm dawk b'newtropenija severa kif ukoll dawk li ma żviluppawx newtropenija severa), 11 % (4 % tal korsijiet) kellhom d-deni u 26 % (9 % tal-korsijiet) qabdithom infezzjoni.
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of packed red blood cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %), respectively.
Maltese: F'dan l-istudju, sitta u erbgħin (43 %) pazjent irċevew G-CSF fuq medda ta' 192 (42.1 %) kors; ħamsa u sittin (60 %) rċievew transfużjonijiet ta' ċelluli ħomor tad-demm ippakkjati u ħamsin (46 %) irċevew plejtlits fuq medda ta' 139 u 159 kors (30.5 % u 34.9 %), rispettivament.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/.
English: Difference in response rate (95 % CI)
Maltese: Differenza fir-rata ta' reazzjoni (95 % CI)
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Maltese: Ir-rata ta' rispons għall-programm sħiħ tal-karċinoma tal-ovarji (n = 392, kollha ttrattati qabel b'cisplatin jew cisplatin u paclitaxel) kienet 16 %.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Maltese: lestew l-istudju kif ippjanat jew ġew ittrattati sal-progressjoni tal-marda, filwaqt li 3 % biss twaqqfu minħabba episodji avversi.
English: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Iceland
Maltese: Rekjavíkurvegi 76-78 220
English: Potactasol INSTRUCTIONS ON USE
Maltese: Potactasol huwa disponibbli f'kartun li fihom fjala waħda.
English: mucosal inflammation
Maltese: Disturbi gastro-intestinali
English: The mean metabolite:parent AUC ratio was < 10 % for both total topotecan and topotecan lactone.
Maltese: Il-proporzjoni AUC metabolit medjan: sustanza oriġinali kien < 10 % kemm għal topotecan kif ukoll għal topotecan lactone.
English: Each vial contains 4 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 4 mg topotecan (bħala hydrochloride).
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita jeħtieġ li jerġa' jiġi dilwit ma' 9 mg/ml (0.9%) sodium chloride jew inkella ma' 5 % w/v glucose, sabiex jagħti konċentrazzjoni finali ta' bejn 25 u 50 mikrogramma/ml.
English: A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Maltese: Tabib jew infermier itik id-doża rikostitwita u dilwita tas-soluzzjoni ta' Potactasol bħala infużjoni (dripp), isoltu ġod-driegħ, fuq medda ta' madwar 30 minuta.
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Maltese: L-istabilità kimika u fiżika tas-soluzzjoni miksuba wara d-dilwizzjoni tal-konċentrat f' soluzzjoni ta' klorur tas-sodju 9 mg/ml (0.9 %) għall-injezzjoni jew 50 mg/ml (5 %) soluzzjoni ta' glukożju għall infużjoni ntweriet għal 4 sigħat b'temperatura ta' 25 ± 2°C, f'kundizzjonijiet ta' dawl normali.
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Maltese: (n = 480) għall-pazjenti fejn reġgħet feġġet il-marda li kienet sensittiva għat-terapija ewlenija kien ta' 20.2 %.
English: pyrexia asthenia fatigue
Maltese: Kif jiġi ppreparat Potactasol
English: The physico-chemical stability of the medicinal product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25oC ± 2oC and then diluted.
Maltese: L-istabbiltà fiżiko-kimika tas-soluzzjoni tal-prodott mediċinali miksuba wara d-dilwizzjoni fis soluzzjonijiet għall-infużjoni (NaCl 0.9% u Glukosju 5%) ġiet demonstrata għal 4 sigħat f'temperatura tal-kamra, f'kondizzjonijiet normali tad-dawl, fuq kampjuni rikostitwiti u maħżuna għal 12-il siegħa u rispettivament 24 siegħa f'temperatura 25oC ± 2oC u mbagħad dilwit.
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2).
Maltese: - L-ingredjenti l-oħra huma: mannitol (E421), aċdu tartariku (E334), aċdu idrokloriku (E507) u idrossidu tas-sodju (ara sezzjoni 2).
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leucopenia
Maltese: Pazjenti b'indeboliment tal-kliewi Monoterapija (karċinoma tal-pulmun taċ-ċelluli ż-żgħar u tal-ovarji)
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull fjala, jiġifieri essenzjalment 'ħieles mis-sodju'.
English: The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Maltese: Issinjali u s-sintomi osservati wara doża eċċessiva kienu konsistenti mal-avvenimenti mhux mixtieqa magħrufa assoċjati ma' topotecan (ara sezzjoni 4.8).
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna tal-prodott mediċinali rikostitwit u dilwit, ara s-sezzjoni 6.3. 6.5
English: Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Maltese: Potactasol 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull fjala fiha 1 mg topotecan (bħala idrokloridu).
English: Each vial contains 1 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 1 mg topotecan (bħala idrokloridu).
English: ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Maltese: Riżultati tal-Istudju Studju GOG-0179 Popolazzjoni ITT Cisplatin 50 mg/m2 fil-jum 1, kull 21 jum
English: Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Maltese: Severa (għadd ta' newtrofili <0.5 x 109/l) wara l-ewwel kors f'55 % tal-pazjenti li damet ≥ sebat ijiem f'20 % u b'kollox f'77 % tal-pazjenti (39 % tal-korsijiet).
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Maltese: Tqabbil ta' parametri farmakokinetiċi ma ssuġġerew l-ebda tibdil fil-farmakokinetika f'perjodu ta' 5 ijiem ta'
English: Blood and lymphatic system disorders Very common:
Maltese: Disturbi fis-sistema immuni Komuni:
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Maltese: newtropenija bid-deni newtropenija (ara Disturbi gastro-intestinali taħt)
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Maltese: Wara li topotecan ingħata ġol-vina f'dożi ta' 0.5 sa 1.5 mg/m2 bħala infużjoni ta' 30 minuta kuljum għal ħamest ijiem, topotecan wera tneħħija għolja fil-plażma ta' 62 l/h (SD 22), li tikkorrispondi għal bejn wieħed u ieħor 2/3 taċ-ċirkolazjoni tad-demm fil-fwied.
English: Potactasol contains sodium
Maltese: Id-Dehra ta' Potactasol u l-kontenuti tal-pakkett
English: Serious side effects
Maltese: Effetti sekondarji serji:
English: Each vial contains 1 mg or 4 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 1 mg jew 4 mg ta' topotecan (bħala hydrochloride).
English: You must not breast-feed while on treatment with Potactasol.
Maltese: M'għandekx tredda' waqt it-trattament b'Potactasol.
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Maltese: plejtlits ikun ≥ 100 x 109/l, u l-livell tal-emoglobina jkun ≥ 9 g/dl (wara trasfużjoni, jekk ikun hemm bżonn).
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Maltese: M'hemmx biżżejjed esperjenza dwar l-użu ta' topotecan f'pazjenti li għandhom indeboliment serju tal kliewi (tneħħija tal-krejatinina < 20 ml/min) jew li jbatu minn indeboliment serju tal-fwied (bilirubin fis-serum ≥ 10 mg/dl) minħabba ċirrożi.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Maltese: 2.6, 6.1) versu 4.5 xhur (95 % CI: 2.9, 9.6) għal cisplatin, bi proporzjon ta' periklu ta' 1.15 (0.59, 2.23).
English: - Weight loss and loss of appetite (anorexia); tiredness; weakness.
Maltese: • Tnaqqis fil-piż u nuqqas t'aptit (anoressija); għeja; debbulizza • Tħoss dardir (nawsja); rimettar; dijarea; uġigħ fl-istonku; stitikezza
English: These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Maltese: Din id-dejta għandha tiġi evalwata fil-kuntest tal-profil globali tas-sigurtà tal-prodott mediċinali, b'mod partikolari għat-tossiċità ematoloġika sinifikanti (ara sezzjoni 4.8).
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Maltese: kif għandu jiġi preskritt cisplatin għandha tiġi kkonsultata għal-lista kompleta ta' reazzjonijiet avversi assoċjati mal-użu ta' cisplatin.
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Maltese: Newtropenija severa damet iktar minn sebat ijiem fi 11% tat-total tal-korsijiet.
English: Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Maltese: Fjal tal-ħġieġ Tip 1 bla kulur (8 ml), b'tapp brombutiliku griż u siġill tal-aluminju b'għatu tal-plastik li jitneħħa b'daqqa ta' saba' li jkun fih 4 mg topotecan.
English: Monotherapy (ovarian and small cell lung carcinoma) There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Maltese: M'hemmx biżżejjed esperjenza bl-użu ta' topotecan f'pazjenti b'indeboliment sever tal-funzjoni tal kliewi (tneħħija tal-krejatinina ta' < 20 ml/min).
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Maltese: f'kondizzjonijiet tad-dawl normali, u għal 24 siegħa f'2°C sa 8°C meta protett mid-dawl.
English: - Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Maltese: - Sensittività eċċessiva qawwija għas-sustanza attiva jew kwalunkwe sustanza mhux attiva elenkata f'sezzjoni 6.1 - Qed ireddgħu (ara sezzjoni 4.6)
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Maltese: 2 Kolite tan-newtropenija, inkluża l-kolite tan-newtropenja fatali, ġiet irrappurtata bħala kumplikazzjoni tan-newtropenija kkawżata minn topotecan (ara sezzjoni 4.4).
English: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Maltese: Barra minn hekk, ġew irrapportati enzimi epatiċi elevati b'doża eċċessiva ta' topotecon ġol-vina.
English: (95 % CI) Hazard ratio (95 % CI)
Maltese: .I) Proporzjon ta' periklu (95% CI)
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Maltese: fsada severa (assoċjata ma' tromboċitopenija)
English: Potactasol is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Maltese: - jekk għandek infjammazzjoni tal-pulmuni b'sinjali ta' sogħla, deni u diffikultajiet biex tieħu n nifs, ara wkoll is-sezzjoni 4 “Effetti sekondarji possibbli”.