FrancophonIA/ELRC3.0 huggingface dataset:
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Maltese: darbiet id-doża rakkomandata) u bil-kapsuli ta' topetecan (sa 5 darbiet id-doża rakkomandata).
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Maltese: Imwiet dovuti għal kolite newtropenika ġew rapportati fi studji kliniċi b'topotecan.
English: Metabolism accounts for <10 % of the elimination of topotecan.
Maltese: Il-metaboliżmu jgħodd madwar <10 % tal-eliminazzjoni ta' topotecan.
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Maltese: Trasfużjonijiet ta' ċelluli ħomor ingħataw f'52 % ta' pazjenti (21 % ta' korsijiet).
English: Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Maltese: Topotecan flimkien ma' cisplatin kellu siwi statistikament sinifikanti fis-sopravivenza globali meta mqabbel mal-monoterapija ta' cisplatin, wara li sar aġġustament għal analiżi interim (Log-rank p = 0.
English: One study included a dose range of 1.4 to 2.4 mg/m2 in children (aged 2 up to 12 years, 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: sa 12-il sena, n = 18), adolexxenti (bejn l-etajiet ta' 12 sa 16-il sena, n = 9) u adulti żgħar (bejn l-etajiet ta' 16-il sena sa 21 sena, n = 9) b'tumuri solidi refrattorji.
English: However, when combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Maltese: Madankollu, meta jiġi kkombinat ma' sustanzi tal-platinu, hemm interazzjoni distinta dipendenti minn sekwenza li tiddependi minn jekk is-sustanza ta' platinu tingħatax f'jum 1 jew 5 tad-doża tat-topotecan.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Maltese: Fi studji kliniċi, raxx ġie rapportat f'4 % ta' pazjenti u ħakk f'1.5 % ta'
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Maltese: Il-medjan għal sopravivenza globali kienet ta' 62 ġimgħa għal topotecan kontra 53 ġimgħa għal paclitaxel (proporzjon ta' periklu 0.9 [0.6, 1.3]).
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 tal-popolazzjoni permezz tal-għoti ġol-vina, l-għoti flimkien ta' granisetron, ondansetron, morfina jew kortikosterojdi ma dehrx li kellhom effett sinifikanti fuq il-farmakokinetiċi ta topotecan totali (l-għamla attiva u mhux attiva).
English: 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: tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections.
Maltese: tartaric acid (E334), hydrochloric acid (E507) (għal aġġustament ta' pH), sodium hydroxide (E524)
English: Topotecan Teva is used to treat:
Maltese: Tużax Topotecan Teva:
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Maltese: L-għeja kienet osservata f'madwar 25 % u astenja f'16 % ta' pazjenti li kienu qed jirċievu topotecan.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA) http://www.ema.europa.eu/
English: Thrombocytopenia
Maltese: OĦRAJN Ċitotossiku
English: Mild abdominal pain was reported in 4 % of patients.
Maltese: Uġigħ addominali ħafif ġie rapportat f'4 % ta' pazjenti.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Maltese: Il-volum tad-distribuzzjoni kienet kemmxejn imnaqqsa u għalhekk il-half-life żdied b'14 %.
English: Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Maltese: Il-half-life ta' topotecan żdiedet b'madwar 30 % imma ma ġiet osservata ebda bidla ċara fil-volum ta' distribuzzjoni.
English: 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: Qawwija (< 25 x 109/l plejtlets) f'25 % tal-pazjenti (8 % ta' korsijiet); moderata (bejn 25.0
English: One vial of 4 ml of concentrate contains 4 mg topotecan (as hydrochloride).
Maltese: Kull kunjett ta' 4 ml ta' konċentrat fih 4 mg of topotecan (bħala hydrochloride).
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Maltese: Eliminazzjoni L-irkupru globali tal-materjal relatat ma' topotecan wara li topotecan ngħata għal ħamest ijiem kienet ta' bejn 71 sa 76 % tad-doża IV mogħtija.
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 l-għoti ġol-vina ta' topotecan f'dożi ta' bejn 0.5 sa 1.5 mg/m2 bħala infużjoni ta' 30 minuta kuljum għal ħamest ijiem, topotecan wera rata għolja ta' tneħħija mill-plażma ta' 62 l/h (SD 22), li tikkorispondi għal madwar 2/3 tal-influss tad-demm fil-fwied.
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: Fatturi ta' riskju li jikkontribwixxu għal dan jinkludu storja ta' mard interstizzjali tal-pulmun, fibrosi pulmonari, kanċer tal-pulmun, espożizzjoni toraċika għar-radjazzjoni u l-użu ta' sustanzi pnewmotossiċi u/jew fatturi ta' kolonja li tistimula.
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Maltese: F'dawn l istudji ma kienx hemm differenzi apparenti fil-farmakokinetiċi ta' topotecan fost pazjenti tfal adoloxxenti u adulti żgħar b'tumuri solidi jew lewkemija, imma t-tagħrif hu wisq limitat biex jinġibdu konklużjonijiet definittivi.
English: Staff handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
Maltese: Il-personel li jimmanipula dan il-prodott mediċinali waqt id-dilwazzjoni għandu jilbes ilbies protettiv li jinkludi maskra, gogils u ingwanti.
English: Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
Maltese: - Selħiet fil-ħalq, diffikultà biex tibla', uġigħ addominali, dardir, rimettar, dijarea, ippurgar bid demm (sinjali u sintomi possibbli ta' infjammazzjoni tal-inforra ta' ġewwa tal-ħalq, fl-istonku u/jew fil-musrana [infjammazzjoni tal-mukuża]).
English: Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Maltese: It-tossiċitajiet ta' topotecan f'pazjenti pedjatriċi b'tumuri solidi rikorrenti u refrattorji kienu simili għal dawk li storikament dehru f'pazjenti adulti.
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 kontra t-tumuri ta' topotecan tinvolvi l-impediment ta' topoisomerase-I, enżima marbuta b'mod intimu fir-replikazzjoni tad-DNA peress li sserraħ l-istrain torsjonali li ġiet introdotta qabel il furketta miexja li tirreplika.
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jinkludu raxx, urtikarja, anġjodema u reazzjonijiet anafilattiċi ġew rapportati b'mod rari.
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Maltese: Topotecan Teva 4 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni 1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 1 mg topotecan (bħala hydrochloride).
English: If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Maltese: Jekk sija cisplatin jew inkella carboplatin jingħatawx f'jum 1 tad-doża ta' topotecan, doża anqas baxxa ta' kull sustanza għandha tingħata biex titjib it-tollerabilità meta mqabbla mad-doża ta' kull sustanza li tista' tingħata jekk is-sustanza tal-platinu tingħata f'jum 5 tad-doża ta' topotecan.
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Maltese: Kif inhu mistenni, pazjenti bi stat ta' prestazzjoni baxxa (PS>1) li għandhom rata ta' rispons inqas baxxa u inċidenza ogħla ta' kumplikazzjonijiet bħal deni, infezzjoni u sepsis (ara sezzjoni 4.8).
English: Study results Study GOG-0179 ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Maltese: Popolazzjoni ITT Cisplatin f'jum 1, kull 21 jum
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Maltese: eliminazzjoni ta' topotecan kien permezz tal-idroliżi tal-anell tal-lactone sabiex jifforma l-carboxylate bl-anell miftuħ.
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-sopravivenza medjana fid-driegħ ta' topotecan flimkien ma' cisplatin kienet ta' 9.9 xhur (95 % CI: 7, 12.6) kontra 6.3 xhur (95 % CI: 4.9,
English: The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Maltese: It-tossiċità ematoloġika globali hija inqas f'pazjenti trattati b'topotecan f'kombinazzjoni ma' cisplatin meta mqabbla mal monoterapija b'topotecan, imma ogħla minn cisplatin waħdu.
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 mqabbla ma' 13.9 ġimgħat (95 % CI 11.1, 18.6)
English: The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
Maltese: - Is-sustanzi l-oħra huma: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) u ilma għall-injezzjonijiet.
English: Itching (pruritus).
Maltese: Sopravivenza (xhur)
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Maltese: Topotecan Teva 1 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni 1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fiha 1 mg topotecan (bħala hydrochloride).
English: One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride).
Maltese: Kull kunjett ta' 1 ml ta' konċentrat fih 1 mg of topotecan (bħala hydrochloride).
English: • Infections (very common (may affect more than 1 in 10 people)), with signs such as: fever serious decline of your general condition local symptoms such as sore throat or burning sensation when urinating severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis).
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) - Ġeneralment tħossok dgħajjef u għajjien, li jistgħu jkunu sintomi ta' tnaqqis fl-għadd ta' ċelluli ħomor tad-demm (anemija).
English: The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy.
Maltese: Il-frekwenzi assoċjati mar-reazzjonijiet ematoloġiċi u mhux ematoloġiċi avversi elenkati hawn isfel jirrapreżentaw ir-rapporti ta' każijiet avversi kkunsidrati li għandhom x'jaqsmu/possibilment relatati mat-terapija topotecan.
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Maltese: u 24.7 ġimgħat, rispettivament.
English: EU/1/09/552/003 - 1 vial EU/1/09/552/004 - 5 vials
Maltese: EU/1/09/552/003 - kunjett 1 EU/1/09/552/004 - 5 kunjetti
English: EU/1/09/552/001 - 1 vial EU/1/09/552/002 - 5 vials
Maltese: EU/1/09/552/001 - kunjett 1 EU/1/09/552/002 - 5 kunjetti
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn isfel, skont il-klassi tas-sistema tal-organi u l-frekwenza assoluta (każijiet kollha rapportati).
English: Ovarian and small cell lung carcinoma Initial dose
Maltese: Karċinoma ovarjana u mikroċitoma pulmonari
English: Weight loss and loss of appetite (anorexia), tiredness, weakness.
Maltese: Telf tal-piż u nuqqas t'aptit (anoreksja), għeja, debolezza, tħossok ma tiflaħx
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Maltese: riferiment ta' ≥ 1.5 x 109/l fl-għadd ta' newtrofili, ≥ għadd ta' plejtlets ta' 100 x 109/l, u livell ta' emoglobina ta' > 9 g/dl (wara trasfużjoni jekk meħtieġ).
English: Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Maltese: Minħabba l-mekkaniżmu tal-azzjoni tiegħu, topotecan hu ġenotossiku għal ċelluli mammiferi (ċelluli tal-limfoma tal-ġurdien u limfoċiti umani) in vitro u ċelluli tal-mudullun tal-ġurdien in vivo.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Maltese: Jekk jiġi ttolerat sew, it-trattament jista' jissokta sakemm il-marda tipprogressa (ara sezzjonijiet 4.8 u 5.1).
English: Each vial contains 4 mg topotecan (as hydrochloride) in 4 ml concentrate.
Maltese: Kull kunjett fih 4 mg topotecan (bħala hydrochloride) f'konċentrat ta' 4 ml.
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/jum għal ħamest ijiem kull tliet ġimgħat.
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan
Maltese: TAL-PRODOTT MEDIĊINALI Topotecan Teva 4 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni topotecan
English: Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Maltese: Il-pazjenti għandhom jiġu monitorati għal sintomi pulmonari indikattivi għal mard interstizzjali tal-pulmun (eż. sogħla, deni, dispnea u/jew ipoksja), u topotecan għandu jitwaqqaf jekk tiġi kkonfermata dijanjosi ġdida għal mard interstizzjali tal-pulmun.
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan
Maltese: TAL-PRODOTT MEDIĊINALI Topotecan Teva 1 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni topotecan
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: III (Studju 396) saru biex jevalwaw l-effikaċja ta' topotecan orali mqabbel ma' topotecan li jingħata ġol-vina f'pazjenti li kienu rkadew ≥ 90 jum wara li kien ingħata kors sħiħ ta' kimoterapija (ara Tabella 1).
English: Each vial contains 1 mg topotecan (as hydrochloride) in 1 ml concentrate.
Maltese: Kull kunjett fih 1 mg topotecan (bħala hydrochloride) f'konċentrat ta' 1 ml.
English: The recommended dose of topotecan is 1.5 mg/m2 body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Maltese: Doża inizjali Id-doża rakkomandata ta' topotecan hi ta' 1.5 mg/m2 tal-erja superfiċjali korporali kuljum li tingħata b'infużjoni ġol-vina fuq 30 minuta kuljum għal ħames t'ijiem konsekuttivi b'intervall ta' tliet ġimgħat bejn il-bidu ta' kull kors.
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: plejtlets jilħaq ≥ 100 x 109/l, u l-livell ta' emoglobina hu ≥ 9 g/dl (wara t-trasfużjoni jekk meħtieġ).
English: Topotecan must be further diluted before use (see section 6.6).
Maltese: Topotecan għandu jiġi dilwit aktar wara l-użu (ara sezzjoni 6.6).
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Maltese: Il-monoterapija b'topotecan u topotecan f'kombinazzjoni ma' cisplatin huma komunament assoċjati b'tromboċitopenija klinikament rilevanti.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Maltese: Pazjenti b'espożizzjoni minn qabel għal cisplatin jinħtieġu intervall ħieles minn kull trattament sostnut sabiex jiġġustifika it trattament bil-kombinazzjoni (ara section 5.1).
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/kuljum għal 5 ijiem konsekuttivi) u cisplatin (60 mg/m2/jum f'jum 1)
English: Package leaflet: Information for the user Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan
Maltese: Informazzjoni għall-utent Topotecan Teva 4 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni topotecan
English: fever serious decline of your general condition local symptoms such as sore throat or burning sensation when urinating severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis).
Maltese: ħruq meta tgħaddi l-urina, li jista' jkun infezzjoni urinarja) uġigħ fl-istonku sever okkażjonalment, deni u possibilment dijarea (b'mod rari bid demm) jistgħu jkunu sinjali t'infjammazzjoni fl-imsaren (kolite newtropenika).
English: Neutropenia
Maltese: Iperbilirubinimja
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Maltese: Analiżi retrospettiva supplimentari saret fuq it-tagħrif minn 523 pazjent li kellhom kanċer ovarjan li rkada.
English: How to store Topotecan Teva
Maltese: Kif taħżen Topotecan Teva
English: Hyperbilirubinaemia
Maltese: Sopravivenza medjana
English: There is insufficient experience with the use of topotecan in patients with 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: 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 b'indeboliment fil-fwied (bilirubin fis-serum ta' bejn 1.5 u 10 mg/dl) tnaqqset għal madwar 67 % meta mqabbla ma' grupp ta' pazjenti li ntużaw bħala kontroll.
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: plejtlets 'l fuq minn 139 u 159 kors (30.5 % u 34.9 %), rispettivament.
English: Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Maltese: Topotecan kien evalwat fil-popolazzjoni pedjatrika; madankollu, hemm biss tagħrif limitat disponibbli dwar l-effikaċja u s-sigurtà.
English: This increase is considered unlikely to be of clinical relevance.
Maltese: Din iż-żjieda hi kkonsidra li x'aktarx mhix ta' rilevanza klinika.
English: In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
Maltese: Fi studji kliniċi, topotecan ġie mwaqqaf meta d-doża tnaqqset għal 1.0 mg/m2/jum u aktar tnaqqis għad-doża kien meħtieġ sabiex jiġu ġestiti l-effetti avversi.
English: CYTOTOXIC, special handling instructions (see package leaflet).
Maltese: OĦRA, JEKK MEĦTIEĠA ĊITOTOSSIKU, struzzjonijiet ta' manipulazzjoni speċjali (ara l-fuljett tal-pakkett).
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 fl-istudji kliniċi (li jinkludu kemm dawk b'newtropenija severa u dawk li ma żviluppawx newtropenja severa), 11 % (4 % ta' korsijiet) żviluppaw id-deni u
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 talkliewi (tneħħija tal-krejatinina ta' < 20 ml/min).
English: In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan, was administered at a starting dose of 2.0 mg/m2 given as a 30- minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Maltese: Fi studju bit-tikketta murija, li kienet tinvolvi t-tfal (n = 108, fuq firxa t'etajiet: tarbija sa 16-il sena) b'tumuri solidi rikorrenti jew progressivi, topotecan, kien amministrat b'doża inizjali ta' 2.0 mg/m2