FrancophonIA/ELRC3.0 huggingface dataset:
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 mukosite kienet ta' 4, 3, 2 u 1 %, rispettivament.
English: 9/l) occurred in 32% of patients in 13% of courses.
Maltese: 9/l) seħħet f'32 % tal-pazjenti f'13 % ta' korsijiet.
English: Intravenous use.
Maltese: Ġilda safra.
English: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
Maltese: • Xi kultant uġigħ ta' żaqq qawwi, deni u possibbilment dijarea (rarament bid-demm) jistgħu jkunu sinjali ta' infjammazzjoni tal-musrana (kolite).
English: Each capsule contains topotecan hydrochloride equivalent to 1 mg of topotecan.
Maltese: Kull kapsula fiha topotecan hydrochloride ekwivalenti għal 1 mg ta' topotecan.
English: Pruritus
Maltese: UŻU
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 ilpazjenti (n = 102) b'rikorrenza wara 180 ġurnata, is-sopravivenza 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: Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Maltese: Pazjenti bi tneħħija talkrejatinina > 60 ml/min ġew inklużi fl-istudji tal-effikaċja/sigurtà ta' topotecan.
English: Each capsule contains 0.25 mg of topotecan (as hydrochloride).
Maltese: Kull kapsula fiha 0.25 mg ta' topotecan (bħala hydrochloride).
English: 2, mucositis
Maltese: 2, mukosite
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: Sar studju tal-Fażi II (Studju 065) u studju tal-Fażi III (Studju 396) biex l-effikaċja ta' topotecan millħalq kontra topotecan mogħti ġol-vina tiġi evalwata f'pazjenti li l-kanċer tagħhom reġa' feġġ ≥ 90 jum wara li spiċċaw kors wieħed ta' kemoterapija qabel (ara Tabella 1).
English: This pattern of treatment will normally be repeated every 3 weeks.
Maltese: Normalment dan ilmudell ta' kura se jkun ripetut kull 3 ġimgħat.
English: • Cervical cancer: 0.75 mg per square metre of body surface area per day.
Maltese: • Kanċer taċ-ċerviċi: 0.75 mg kull metru kwadru tal-erja tas-superfiċje tal-ġisem kuljum.
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: The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Maltese: L-attività ta' topotecan kontra tumuri tikkonsisti fl-inibizzjoni ta' topoisomerase-I, li hija enżima partikolarment involuta fir-replikazzjoni ta' DNA waqt li jneħħi l-istrejn tat-tidwir ta' qabel il-moving replication fork.
English: Neutropenia Severe (neutrophil count <0.5 x 10
Maltese: Newtropenja Serja (numru ta' newtrofili < 0.5 x 10
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: (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 ġurnata għal-terapija b'topotecan flimkien ma' BSC, 90 ġurnata għal-BSC waħdu) u li għalihom trattament ieħor b'kimoterapija li tingħata fil-vina ma kienx ikkunsidrat xieraq.
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: HYCAMTIN 1 mg hard capsules topotecan
Maltese: HYCAMTIN 1 mg kapsuli ibsin topotecan
English: Median survival was 30.3 weeks (95% CI: 27.6, 33.4).
Maltese: Is-sopravivenza medjana kienet ta' 30.3 ġimgħat (95 % CI: 26.
English: Oral topotecan
Maltese: Topotecan ġol-vina
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Maltese: ILD, fibrożi pulmonari, kanċer tal-pulmun, espożizzjoni toraċika għal radjazzjoni u l-użu ta' sustanzi pnewmotossiċi u/jew fatturi li jistimulaw kolonji.
English: Red cell transfusions were given in 52% of patients (21% of courses).
Maltese: Trasfużjonijiet ta' ċelluli ħomor ingħataw lil 52 % tal-pazjenti (21 % tal-korsijiet).
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Maltese: HYCAMTIN 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull fjala fiha 4 mg topotecan (bħala hydrochloride).
English: Plasma concentrations of total topotecan (i.e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hours.
Maltese: Ilkonċentrazzjoni ta' topotecan totali fil-plażma (jiġifieri fil-forom lactone u carboxylate) u dik ta' topotecan lactone (l-parti attiva) jilħqu l-ogħla livell tagħhom wara bejn wieħed u ieħor sagħtejn u siegħa u nofs, rispettivament, u dawn jonqsu b'mod bi-exponential b'medja ta' half-life tal-aħħar ta' bejn wieħed u ieħor 3.0 sa 6.0 sigħat.
English: 5 x 4 mg vials
Maltese: 5 x 4 mg fjali
English: Neutropenia Severe neutropenia (Grade 4 - neutrophil count <0.5 x 10
Maltese: Newtropenja Newtropenja serja (Grad 4 - numru ta' newtrofili < 0.5 x 10
English: See section “Pregnancy and breast-feeding”
Maltese: Pazjenti b'indeboliment tal-fwied
English: Capsule shell Gelatin
Maltese: Meta toħroġ il-kapsula
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-metaboliżmu N-desmethyl ikkontribbwixxiet għal medja 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: Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).
Maltese: Kull fjala fiha 1 mg jew 4 mg ta' topotecan (bħala hydrochloride).
English: HYCAMTIN 0.25 mg hard capsules HYCAMTIN 1 mg hard capsules
Maltese: HYCAMTIN 0.25 mg kapsuli ibsin HYCAMTIN 1 mg kapsuli ibsin
English: Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
Maltese: Kull kapsula fiha 0.25 mg jew 1 mg ta' topotecan (bħala hydrochloride).
English: 5 x 1 mg vials
Maltese: 5 x 1 mg fjali
English: Haematological
Maltese: Ematoloġiċi
English: 9/l) during course 1 in 55% of patients, with duration  seven days in 20%, and overall in 77% of patients (39% of courses).
Maltese: 9/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: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without GCSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Maltese: CSF u 1.4 mg/m2/ġurnata mingħajr G-CSF fi studju farmakokinetiku f'pazjenti pedjatriċi b'tumuri solidi refrattarji (ara sezzjoni 5.2).
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 randomised li qabblet topotecan ġol-vina (IV) ma' cyclophosphamide, 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: 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 ġimgħa (95 % CI: 18.3, 31.6) meta mqabbla ma'13.9 ġimgħa (95 % CI: 11.1, 18.6) għall-pazjenti li rċievew BSC waħdu (p = 0.0104).
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 huma konsistenti mal-avvenimenti mhux mixtieqa magħrufa assoċjati ma' topotecan (ara sezzjoni 4.8).
English: Cervical carcinoma
Maltese: Karċinoma ċervikali
English: Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.
Maltese: Hycamtin kapsuli 0.25 mg u 1 mg jinsabu f'pakketti ta' 10 kapsuli.
English: Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Maltese: Dejta limitata f'pazjenti Koreani bi tneħħija tal-krejatinina ta' anqas minn 50 ml/min tissuġġerixxi li jista' jkun hemm il-ħtieġa ta' tnaqqis ulterjuri tad-doża (ara sezzjoni 5.2).
English: The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”.
Maltese: Il-kapsuli huma trasparenti, bojod għal bojod fl-isfar u mmarkati b' “HYCAMTIN” u “0.25 mg”.
English: 9/l) occurred in 6% of patients in 2% of courses.
Maltese: 9/l) seħħet f'6 % tal-pazjenti f'2 % tal-korsijiet.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Maltese: Il-ġbir 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: 2, constipation, mucositis, dyspepsia
Maltese: Uġigħ fl-istonku, stitikezza, indiġestjoni.
English: In clinical studies, rash was reported in 4% of patients and pruritus in 1.5% of patients.
Maltese: Fi studji kliniċi, ġie irrapurtat raxx f'4 % tal-pazjenti u ħakk f'1.5 % tal-pazjenti.
English: Hycamtin contains ethanol This medicine contains small amounts of ethanol (alcohol).
Maltese: Hycamtin fih etanol Din il-mediċina fiha xi traċċi żgħar ta' etanol (alkoħol).
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Maltese: Meta topotecan jintuża flimkien ma' cisplatin, l-informazzjoni kompleta ta' kif jiġi preskritt cisplatin għandha tiġi kkonsultata.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Maltese: U KWANTITATTIVA HYCAMTIN 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull fjala fiha 1 mg topotecan bħala (hydrochloride).
English: Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Maltese: L-interventi terapewtiċi assoċjati ma' effetti mhux ematoloġiċi kienu jinkludu mediċini kontra rrimettar, li ngħataw lil 47 % tal-pazjenti f'38 % tal-korsijiet u mediċini kontra d-dijarea, li ngħataw lil 15 % tal-pazjenti f'6 % tal-korsijiet. 30 % tal-pazjenti rċievew antagonist 5-HT3 f'24 % tal-korsijiet.
English: Monotherapy (ovarian and small cell lung carcinoma):
Maltese: Monoterapija (karċinoma tal-pulmun taċ-ċelluli ż-żgħar u tal-ovarji):
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Maltese: Bħal prodotti mediċinali ċitotossiċi oħra, topotecan jista' jikkawża suppressjoni serja tal-mudullun talgħadam.
English: Each capsule contains 1 mg of topotecan (as hydrochloride).
Maltese: Kull kapsula fiha 1 mg ta' topotecan (bħala hydrochloride).
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67% when compared with a control group of patients.
Maltese: It-tneħħija mill-plażma f'pazjenti li għandhom indeboliment tal-fwied (bilirubin fis-serum bejn 1.5 u 10 mg/dl) naqset għal bejn wieħed u ieħor 67 % meta ġiet imqabbla ma' dik f'pazjenti li kienu fi grupp ta' kontroll.
English: Severe neutropenia lasted beyond seven days in 11% of courses overall.
Maltese: Newtropenja qawwija damet iktar minn sebat ijiem fi 11 % tat-total talkorsijiet.
English: Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Maltese: Riżultati simili nkisbu jekk ir-rata tal-filtrazzjoni glomerulari (ml/min) kienet stmata permezz tal-formula MDRD ikkorreġuta għall-piż tal-ġisem.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Reports of significant sequelae associated with thrombocytopenia, including fatalities due to tumour bleeds, have been infrequent.
Maltese: Rapporti ta' konsegwenzi sinifikani assoċjati ma' tromboċitopenja, inkluż fatalitajiet minħabba fsada tat-tumuri, ma kienux frekwenti.
English: 1 x 4 mg 5 x 4 mg
Maltese: 5 x 4mg
English: Interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common Nausea, vomiting and diarrhoea (all of which may be severe), which may lead to dehydration (see sections 4.2 and 4.4)
Maltese: Disturbi gastro-intestinali Komuni ħafna Dardir, rimettar, u dijarrea (li kollha jistgħu jkunu serji), li jistgħu jwasslu għal deidratazzjoni (ara sezzjonijiet 4.2 u 4.4)
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, 87 pazjent irrispondew kompletament jew parzjalment, bi 13 minn dawn li ġraw waqt iċ-ċikli 5 u 6 u tlieta li ġraw wara.
English: Overall, the Ndesmethyl metabolite contributed a mean of less than 6% (range 4-8%) of the total topotecan-related material accounted for in the urine and faeces.
Maltese: Globalment is-sustanza mill-metaboliżmu Ndesmethyl ikkontribbwixxiet għal medja ta' anqas minn 6 % (bejn 4-8 %) tat-total tal-materjali li għandhom x'jaqsmu ma' topotecan li nstabu fl-awrina u fil-ħmieġ.
English: Growth factors were administered to 19% of patients in 8% of courses.
Maltese: 19 % tal-pazjenti ngħataw growth factors f'8 % tal-korsijiet.
English: Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolised to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Maltese: Barra l-idroliżi, topotecan jitneħħa l-iżjed mill-kliewi u parti żgħira titneħħa permezz tassustanza iffurmata mill-metaboliżmu N-desmethyl (SB-209780) li ġiet identifikata fl-awrina, filplasma u fil-ħmieġ.
English: Detailed information on this medicine product 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 tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl).
Maltese: M'hemmx biżżejjed esperjenza fl-użu ta' topotecan f'pazjenti b'indeboliment serju tal-fwied (bilirubin fis-serum  10 mg/dl).
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: Ir-rekwiżiti biex jiġu ppreżentati 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Maltese: Kien hemm tromboċitopenja moderata (Grad 3 - plejtlits bejn 10.0
English: • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Maltese: • kanċer taċ-ċerviċi avanzat jekk trattament kirurġiku jew radjuterapija mhumiex possibbli.
English: Severe hypersensitivity to the active substance or to any of the excipients.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata.
English: In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Maltese: Fi studju li sar fuq pazjenti permezz tal-għoti ġol-vina, l-għoti flimkien ta' granisetron, ondansetron, morfina jew kortikosterojdi ma jidhirx li kellha effett sinifikanti fuq il-farmakokinetika ta' topotecan totali (fil-forma attiva jew inattiva).
English: Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Maltese: u 24.7 ġimgħat, rispettivament.
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Maltese: L-informazzjoni ta' kif għandu jiġi preskritt cisplatin għandha tiġi kkonsultata għal-lista kompleta ta' reazzjonijiet avversi assoċjati mal-użu ta' cisplatin.
English: Hycamtin 0.25 mg hard capsules Hycamtin 1 mg hard capsules topotecan
Maltese: Informazzjoni għall-utent Hycamtin 0.25 mg kapsuli ibsin Hycamtin 1 mg kapsuli ibsin topotecan
English: Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Maltese: Il-farmakokinetika tal-kapsuli HYCAMTIN ma ġewx studjati speċifikament f'pazjenti b'indeboliment tal-fwied.
English: The appropriate volume of the reconstituted solution should be diluted with either 0.9 % w/v sodium chloride intravenous infusion or 5 % w/v glucose intravenous infusion, to a final concentration of between 25 and 50 microgram per ml.
Maltese: Il-volum addattat tas-soluzzjoni rikostitwita għandu jiġi dilwit jew b'0.9 % w/v sodium chloride li huwa wżat għal infużjoni ġol-vini jew b'5 % w/v glucose bħala infużjoni ġol-vini biex ikun hemm konċentrazzjoni finali ta' bejn 25 u 50 mikrogrammi kull ml.
English: EXP
Maltese: Telqa
English: HYCAMTIN 4 mg is available in packs containing 1 vial and 5 vials.
Maltese: HYCAMTIN 4 mg jiġi f'pakketti li fihom fjala waħda u pakketti ta' ħames fjali.
English: HYCAMTIN 0.25 mg hard capsules
Maltese: HYCAMTIN 0.25 mg kapsuli ibsin
English: Hepatic impairment
Maltese: Ġiet irrappurtata panċitopenja.
English: Sealing band Gelatin
Maltese: Ħażna tas-soluzzjoni lesta
English: A reduction in topotecan clearance was observed.
Maltese: Tnaqqis fittneħħija ta' topotecan ġiet osservata.
English: The carcinogenic potential of topotecan has not been studied.
Maltese: Il-potenzjal karċinoġenu ta' topotecan ma ġiex studjat.
English: No overall differences in effectiveness were observed between patients aged over 65 years and younger adult patients.
Maltese: Ma ġew osservati l-ebda differenzi fl-effikaċja bejn pazjenti li għandhom aktar minn 65 sena u pazjenti adulti iżgħar.
English: The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Maltese: Il-medja ta' sustanza millmetaboliżmu:proporżjon AUC tas-sustanza oriġinali kien < 10 % kemm għal topotecan kif ukoll għal topotecan lactone.
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 għal kura fl-istudju kollu tal-karċinoma fl-ovarji (n = 392, kollha preċedentement ikkurati b'cisplatin jew cisplatin u paclitaxel) kienet ta' 16 %.
English: HYCAMTIN 1 mg is available in packs containing 1 vial and 5 vials.
Maltese: HYCAMTIN 1 mg jiġi f'pakketti li fihom fjala waħda u pakketti ta' ħames fjali.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 49 to 72% (mean 57%) of the administered oral dose.
Maltese: Il-ġbir totali ta' materjali li għandhom x'jaqsmu ma' topotecan wara l-ħames dożi ta' topotecan li ngħataw darba kuljum kien ta' 49 sa 72% (medja ta' 57 %) tad-doża amministrata mill-ħalq.
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m 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/m 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: • Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
Maltese: • Kanċer tal-ovarji u taċ-ċelluli ż-żgħar tal-pulmun: 1.5 mg kull metru kwadru tal-erja tassuperfiċje tal-ġisem kuljum.
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 bl-użu ta' topotecan f'pazjenti b'indeboliment sever tal-funzjoni talfwied (bilirubin fis-serum  10 mg/dl) minħabba ċirrożi.
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Maltese: Topotecan ġie assoċċjat ma' rapporti ta' mard tal-interstizju tal-pulmun (ILD), fejn ftit minnhom kienu fatali (ara sezzjoni 4.8).
English: Renal impairment
Maltese: Tqala u treddigħ
English: What Hycamtin looks like and contents of the pack Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with “Hycamtin” and “0.25 mg”.
Maltese: Il-kapsuli Hycamtin 0.25 mg huma bojod għal bojod fl-isfar u mmarkati b'“Hycamtin” u “0.25mg”.
English: Hyperbilirubinaemia
Maltese: Kif jingħata Hycamtin
English: Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4)
Maltese: Kolite tan-newtropenja, inkluża l-kolite tan-newtropenja fatali, ġiet irrappurtata bħala kumplikazzjoni tan-newtropenja kkawżata minn topotecan (ara sezzjoni 4.4).
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m2/day for five days every three weeks.
Maltese: Numru żgħir ta' pazjenti b'indeboliment tal-fwied (bilirubin fis-serum bejn 1.5 u 10 mg/dl) ingħataw topotecan ġol-vina b'doża ta' 1.5 mg/m2/kuljum għal ħamest ijiem kull tlett ġimgħat.