FrancophonIA/ELRC3.0 huggingface dataset:
English: The second study included a dose range of 2.0 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Maltese: It-tieni studju kien jinkludi firxa ta' dożi ta' bejn 2.0 sa 5.2 mg/m2 fi tfal (n = 8), adolexxenti (n = 3) u adulti żgħar (n = 3) b'lewkemija.
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 bażi jinkludu ILD fil-passat, , fibrożi pulmonari, kanċer tal-pulmun, espożizzjoni toraċika għal radjazzjoni u l-użu ta' sustanzi pnewmotossiċi u/jew fatturi li jistimulaw kolonji.
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95% CI: 0.45, 0.90).
Maltese: Il-proporzjon ta' periklu mhux aġġustat (hazard ratio) mhux aġġustat għall-grupp ta' topotecan mill-ħalq flimkien ma' BSC meta mqabbel mal-grupp ta' BSC waħdu kien ta' 0.64 (95 % CI: 0.45, 0.90).
English: − Breast-feeding (see section 4.6).
Maltese: Qed ireddgħu (ara sezzjoni 4.6);
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: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m 2 compared to 21.3 l/h/m 2 [n=9]) (see section 4.5).
Maltese: Meta ngħata flimkien ma' cisplatin (cisplatin jum 1, topotecan jiem 1 sa 5), ir-rata ta' tneħħija ta' topotecan tnaqqset f'jum 5 meta mqabbla ma' jum 1 (19.1 l/h/m2 meta mqabbel ma' 21.3 l/h/m
English: 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 % C.I. 18.3, 31.6) meta mqabbla ma' 13.9 ġimgħat (95 % C.I. 11.1, 18.6) għall-pazjenti li rċievew BSC waħdu (p=0.0104).
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: Studju wieħed kien jinkludi firxa ta' dożi bejn 1.4 sa 2.4 mg/m2 fi tfal (bejn l-etajiet ta' 2 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: 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, remettar, dijarea u mukosite (Skala 3 jew 4) kienet ta' 4, 3, 2 u 1 % rispettivament.
English: The mean metabolite: parent AUC ratio was < 10 % for both total topotecan and topotecan lactone.
Maltese: Il-metabolit medju: proporzjon tal-AUC ġenitur ˂ 10 % kemm għal topotecan totali u topotecan lactone.
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 trasfużjonijiet 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: Also contains: tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment).
Maltese: Fih ukoll: tartaric acid (E334), ilma għal injezzjonijiet, u hydrochloric acid (E507) jew sodium hydroxide (għal aġġustament ta' pH),.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Maltese: It-tipi ta' tumuri kienu jinkludu sarkoma ta' Ewing/tumur newroektodermali primittiv, newroblastoma, osteoblastoma, u rabdomajosarkoma.
English: Date(GMT)
Maltese: Sopravivenza (xhur)
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 30minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Maltese: Fi studju open-label, li kienet tinvolvi t-tfal (n = 108, varjazzjoni fl-età: trabi sa 16-il sena) b'tumuri li reġgħu feġġew jew kienu solidi progressivi, topotecan inbeda f'doża ta' 2.0 mg/m2 mogħtija bħala infużjoni ta' 30 minuta għal ħamest ijiem ripetuta kull tliet ġimgħat sa sena skont ir-rispons għatterapija.
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 days 1-3, every 21 days
Maltese: 0.75 mg/m2 fil-jiem 1-3, kull 21 jum
English: Approximately 51% was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Maltese: Madwar 51 % kien eliminat bħala topotecan totali u 3 % kien eliminat bħala N-desmethyl topotecan fl-awrina.
English: In those patients (n=102) with recurrence after 180 days, the 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 meta topotecan ingħata flimkien ma' cisplatin kienet ta' 9.9 xhur (95 % C.I.: 7, 12.6) versu 6.3 xhur (95 % C.I.: 4.9, 9.5) għal cisplatin bi proporzjon ta' periklu ta' 0.75 (0.49, 1.16).
English: Topotecan Hospira is used to treat:
Maltese: Topotecan Hospira jintuża biex jittratta:
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Maltese: Rarament dan jista' jwassal għal fsada aktar serja (emorraġija).
English: In another randomised Phase III trial 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: III oħra li qabblet topotecan ġol-vina ma' cyclophosphamide, doxorubicin u vincristine (CAV) f'pazjenti sensittivi għal SCLC li reġa' feġġ, ir-rata totali ta' rispons kienet ta' 24.3 % għal topotecan meta mqabbla ma' 18.3 % għall-grupp CAV.
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Maltese: Jekk, waqt it-terapija b'topotecan flimkien ma' cisplatin, il-kreatinina tas-serum taqbeż il-1.5 mg/dl huwa rakkomandat li tiġi konsultata l-informazzjoni kompleta ta' kif jiġi preskritt cisplatin għall-parir dwar tnaqqis jew tkomplija tad-doża.
English: • Feeling generally weak and tired (temporary anaemia).
Maltese: • Tħossok ġeneralment debboli u għajjien (anemija temporanja).
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 listudji ma kienx hemm differenzi apparenti fil-farmakokinetiċi ta' topotecan fost pazjenti tfal adolexxenti u adulti żgħar b'tumuri solidi jew lewkemija, imma t-tagħrif hu wisq limitat biex jinġibdu konklużjonijiet definittivi.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C under normal light conditions and at 2°C -8°C when protected from light.
Maltese: L-istabbilita kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f'temperatura ta' 25°C taħt kundizzjonijiet normali ta' dawl u f'temperatura ta' 2°C -8°C meta protett mid-dawl.
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 ta' topotecan li jingħata mill-ħalq flimkien ma' BSC kien hemm titjib statistikament sinifikanti bir-rata totali ta' sopravivenza meta kkomparat mal-grupp ta' BSC waħdu (Log-rank p=0.0104).
English: Metabolism accounts for <10% of the elimination of topotecan.
Maltese: Il-metaboliżmu jgħodd madwar <10 % tal-eliminazzjoni ta' topotecan.
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-terpaija ewlenija (żmien medjan għal progressjoni [TTP] mit-terapija ewlenija: 84 ġurnata b'topotecan flimkien ma' BSC, 90 jum għal BSC waħdu) u li għalihom trattament ieħor b'kimoterapija li tingħata fil-vina ma kienx ikkunsidrat xieraq.
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 t-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: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Maltese: Topotecan ġie assoċjat ma' rapporti ta' mard tal-interstizju tal-pulmun (ILD -interstitial lung disease), fejn ftit minnhom kienu fatali (ara sezzjoni 4.8).
English: Store in a refrigerator.
Maltese: Tagħmlux ġo friża.
English: This rare side effect may affect up to 1 in 1,000 people treated with Topotecan Hospira:
Maltese: Dan l-effett sekondarju rari jista' jaffettwa sa persuna 1 minn kull 1,000 ikkurati b'Topotecan Hospira:
English: The other ingredients are: tartaric acid (E334), water for injections and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH of the solution).
Maltese: Is-sustanzi l-oħra huma: tartaric acid (E334), ilma għall-injezzjonijiet u hydrochloric acid (E507) jew sodium hydroxide (E524) (għal aġġustament tal-pH tas-soluzzjoni).
English: 9/l, a platelet count of ≥ 100 x 10
Maltese: 9/l, għadd ta' plejtlits ta' ≥ 100 x 10
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: Fi studju kliniku randomisedi u kumparattiv tal-Fażi III mmexxija mill-Grupp Ġinekoloġiku talOnkoloġija (GOG 0179), topotecan flimkien ma' cisplatin (n = 147) ġie mqabbel ma' cisplatin waħdu (n = 146) għat-trattament ta' karċinoma taċ-ċerviċi persistenti, li reġgħat feġġet jew fl-Istat
English: • Allergic or hypersensitivity reactions (including rash).
Maltese: • Reazzjonijiet allerġiċi jew ta' sensittività eċċessiva (li jinkludu raxx).
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 % li damet ≥ sebat ijiem f'20 %, u b'kollox f'77 % tal-pazjenti (39 % 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: L-irkupru globali tal-materjal relatat mal-prodott mediċinali wara li topotecan ngħata għal ħamest ijiem kienet ta' bejn 71 sa 76 % tad-doża IV mogħtija.
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: Passaġġ ewlieni ta' eliminazzjoni ta' topotecan kien permezz tal-idroliżi tal-anell tal-lactone sabiex jifforma l-carboxylate bl-anell miftuħ.
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: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion requires dilution to a final concentration of 25-50 micrograms/ml, prior to administration to the patient.
Maltese: Topotecan Hospira 4 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni jeħtieġ li jiġi dilwit għal konċentrazzjoni finali ta' bejn 25 u 50 mikrogramm/ml kull ml qabel ma jingħata lill-pazjent.
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Maltese: 1.4 mg/m2/ġurnata mingħajr G-CSF fi studju farmakokinetiku f'pazjenti pedjatriċi b'tumuri solidi refrattarji (ara sezzjoni 5.2).
English: • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
Maltese: • Tħoss dardir (nawsja); rimettar; dijarea; uġigħ fl-istonku; stitikezza
English: 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Maltese: 1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fiha 1 mg topotecan (bħala hydrochloride).
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: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis) can be signs of bowel inflammation (colitis).
Maltese: Xi kultant uġigħ ta' żaqq qawwi, deni u possibilment dijarea (rarament bid-demm) jistgħu jkunu sinjali t'infjammazzjoni tal-musrana (kolite).
English: Each 4 ml vial contains 4 mg topotecan (as hydrochloride).
Maltese: Kull kunjett ta' 4 ml fih 4 mg topotecan (bħala hydrochloride).
English: Immune system disorders
Maltese: Disturbi fis-sistema immuni Komuni
English: • your body size (surface area measured in square metres)
Maltese: • id-daqs ta' ġismek (l-erja superfiċjali ta' ġismek imkejla f'metri kwadri)
English: • the disease being treated.
Maltese: • Sinjali ta' infezzjonijiet.
English: DDetailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: This pattern of treatment will normally be repeated every 3 weeks.
Maltese: Normalment dan il-mudell ta' kura se jkun ripetut kull 3 ġimgħat.
English: • Cervical cancer: 0.75 milligrams per m2 of body surface area per day.
Maltese: • Kanċer taċ-ċerviċi: 0.75 mg kull metru kwadru tal-erja tas-superfiċje tal-ġisem kuljum.
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 kkurati flistudji kliniċi (inklużi kemm dawk b'newtropenja qawwija kif ukoll dawk li ma żviluppawx newtropenja qawwia), 11 % (4 % tal-korsijiet) kellhom id-deni u 26 % (9 % ta' korsijiet) qabdithom infezzjoni.
English: • Swelling caused by fluid build up (angioedema).
Maltese: • Nefħa kkawżata minn akkumulazzjoni ta' fluwidu (anġjoedema).
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: 9/l and/or a platelet count of < 100 x 10
Maltese: 9/l u/jew b'għadd ta' plejtlets ta' ≤ 100 x 10
English: Thrombocytopenia: Severe (platelets <25 x 10
Maltese: Severa (inqas minn 25 x 10
English: Signed By:
Maltese: NN:
English: How to store Topotecan Hospira
Maltese: Mediċini oħra u Topotecan Hospira
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: 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 totali hija anqas f'pazjenti trattati b'topotecan flimkien ma' cisplatin meta mqabbla ma' monoterapija b'topotecan, iżda ogħla milli cisplatin waħdu.
English: • Staff should be adequately trained in the preparation, administration and disposal of cytotoxics
Maltese: • Il-personal għamdu jiġi mħarreġ fil-preparazzjoni, amministrazzjoni u rimi tac-citotossici.
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: Dożi eċċessivi ġew irrapportati f'pazjenti li kienu qegħdin jiġu kkurati b'topotecan ġol-vina (sa 10 darbiet id-doża rakkomandata) u bil-kapsuli ta' topetecan (sa 5 darbiet id-doża rakkomandata).
English: After first opening
Maltese: Doża inizjali
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: 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% C.I.
Maltese: F'pazjenti (n = 39) b'rikorenza fi żmien 180 jum wara l-kemoradjuterapija b'cisplatin, il-medjan ta' sopravivenza meta topotecan ingħata flimkien ma' cisplatin kien ta' 4.6 xhur (95 % C.I.: 2,6, 6.1) kontra 4.6 xhur (95 % C.I.: 2.9, 9.6) għal cisplatin bi proporzjon ta' periklu ta' 1.15 (0.59, 2.23).
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 benefiċċju fis-sopravivenza totali li kien statistikament sinifikanti meta mqabbel ma' monoterapija b'cisplatin, wara aġġustament għall-analiżi interim (Logrank p = 0.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Maltese: Flimkien ma' dan, 5 % tal-pazjenti kkurati (1 % tal-korsijiet) kellhom sepsis (ara sezzjoni
English: Metabolism and nutrition disorders Very common
Maltese: Disturbi tal-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: Each ml of concentrate contains 1 mg topotecan (as hydrochloride).
Maltese: Kull ml ta' konċentrat fih 1 mg topotecan (bħala hydrochloride)
English: Severe bleeding (associated with thrombocytopenia)
Maltese: Emorraġija qawwija (assoċjata ma' tromboċitopenija)
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: 9/l and a haemoglobin level of ≥ 9g/dl (after transfusion if necessary).
Maltese: 9/l u livell ta' emoglobina ta' ≥ 9g/dl (wara t-trasfużjoni jekk meħtieġ).
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 f'1.5 mg/m2/jum għal ħamest ijiem kull tliet ġimgħat.
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 kellhom effett sinifikanti fuq il-farmakokinetiċi ta topotecan totali (fil-forma attiva jew inattiva).
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) biex l-effikaċja ta' topotecan mill-ħalq kontra topotecan mogħti ġol-vina tiġi evalwata f'pazjenti li l-kanċer tagħhom reġa' feġġ ≥ 90 jum wara li spiċċaw kors wieħed ta' kimoterapija qabel (ara Tabella 1).
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: 9/l, the platelet count is ≥ 100 x 10
Maltese: 9/l għadd ta' plejtlits ta' 100 x 10
English: 9/l, a platelet count of ≥ 100 x 10 9/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Maltese: plejtlits ikun ≥ 100 x 10 9/l, u l-livell tal-emoglobina jkun ≥9 g/dl (wara trasfużjoni jekk ikun hemm bżonn).
English: The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Maltese: Id-doża ta' topotecan rakkomandata f'monoterapija f'pazjenti b'karċinoma tal-ovarji jew taċ-ċelluli ż-żgħar tal-pulmun u li għandhom tneħħija tal-kreatinina ta' bejn l-20 u d-39 ml/min hi ta' 0.75 mg/m2/ġurnata għal ħamest ijiem konsekuttivi.
English: • Itching sensation.
Maltese: • Sensazzjoni li trid tħokk
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: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Maltese: Il-profil tas-sigurtà ta' topotecan meta jingħata flimkien ma' cisplatin fi studji kliniċi għal kanċer taċċerviċi huwa konsistenti ma' dak li ntwerab'monoterapija ta' topotecan.