FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Maltese: In vitro, topotecan ma wriex inibizzjoni tal-enżemi P450 umani CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A jew CYP4A, u l-anqas inibizzjoni tal-enżemi ċitosoliċi umani dihydropyrimidine jew xanthine oxidase.
English: Toxicity was predictable and reversible.
Maltese: It-tossiċità kienet prevedibbli u wkoll riversibbli.
English: You should use an effective method of contraception.
Maltese: Għandek tuża metodu effettiv ta' kontraċezzjoni.
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Maltese: Topotecan ma jinibixxix l-enżimi umani P450 (ara sezzjoni 5.2).
English: Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Maltese: Topotecan huwa substrate kemm għal ABCB1 (P-glycoprotein) kif ukoll għal ABCG2 (BCRP).
English: Total exposure (AUC) increases approximately proportionally with dose.
Maltese: L-esponiment totali (AUC) jiżdied bejn wieħed u ieħor proporzjonalment skont id-doża.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Maltese: Il-half-life medja żdiedet minn 1.9 sigħat għal 4.9 sigħat.
English: Black iron oxide (E172)
Maltese: Iron oxide iswed (E172)
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2C - 8C).
English: Median (95% CI) Hazard ratio (95% CI)
Maltese: Medjan (95 % CI) Proporzjon ta' periklu (95 % CI)
English: IV use
Maltese: Użu IV
English: 9/l) in 25% of patients (15% of courses).
Maltese: 9/l) f'25 % tal-pazjenti (15 % tal-korsijiet).
English: Metabolism accounts for <10% of the elimination of topotecan.
Maltese: Il-metaboliżmu jispjega < 10 % tal-eliminazzjoni ta' topotecan.
English: The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%).
Maltese: Effetti mhux ematoloġiċi li ġew irrappurtati l-aktar frekwenti kienu dardir (37 %), dijarea (29 %), għeja (26 %), rimettar (24 %), alopeċja (21 %) u anoreksja (18 %).
English: Anaemia
Maltese: Anemija
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: Breast-feeding (see section 4.6).
Maltese: - Qed ireddgħu (ara sezzjoni 4.6).
English: ITT population Cisplatin 50 mg/m on day 1, every 21 days
Maltese: Popolazzjoni ITT Cisplatin 50 mg/m filjum 1, kull 21 jum
English: White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Maltese: Blister abjad magħmul minn polyvinyl chloride / polychlorotrifluoroethylene siġillat b'għatu ta' aluminium foil/Polyethylenterephtalate (PET).
English: The capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
Maltese: Ilkapsuli huma mmarkati b'inka sewda li fiha iron oxide iswed (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, soluzzjoni konċentrata ta' ammonia u potassium hydroxide.
English: GlaxoSmithKline Manufacturing S.p.A. Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma
Maltese: Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma
English: Pancytopenia
Maltese: Panċitopenija
English: Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Maltese: Sopravivenza medjan (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) Rata ta' rispons (%) (95 % CI) Differenza fir-rata ta' rispons (95 % CI) Żmien medjan għallprogressjoni (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) N = numru totali ta' pazjenti li rċievew trattament. CI = confidence interval.
English: For severe cases (CTC Grade 3/4) reported as related/possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
Maltese: Grad 3/4) li ġew irrappurtati bħala relatati / possibbilment relatati mal-għoti ta' topotecan kienet ta' 5 % għad-dijarea (ara sezzjoni 4.4), għeja 4 %, rimettar 3 %, dardir 3 % u anoreksja 2 %.
English: • High body temperature (fever).
Maltese: Temperatura tal-ġisem għolja (deni).
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, aġenti antineoplastiċi oħra: Kodiċi ATC:
English: • The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
Maltese: • Is-sustanzi mhux attivi l-oħra huma: hydrogenated vegetable oil, glyceryl monostearate, ġelatina,titanium dioxide (E171), u għall-kapsuli ta' 1 mg biss, iron oxide aħmar (E172).
English: One study included a dose range of 1.4 to 2.4 mg/m 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 inkluda limiti tad-doza bejn 1.4 u 2.4 mg/m fi tfal (età minn sentejn sa 12-il sena, n = 18), adoloxxenti (età minn 12 sa 16-il sena, n = 9),u adulti ż-żgħar (età minn 16-il sena sa 21 sena, n = 9) b'tumuri solidi refrattarji.
English: The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Maltese: L-inċidenza totali tad-dijarea kkawżata mit-trattament kienet ta' 22 %, inkluż 4 % b'Grad 3 u 0.4 % b'Grad 4.
English: Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Maltese: Anemija moderata sa qawwija (Grad 3 u 4 - Hb  8.0 g/dl) seħħet f'25 % tal-pazjenti (12 % talkorsijiet).
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Maltese: Reazzjoni anafilattika, anġoedima, urtikarja Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Anoreksja (li tista' tkun serja) Disturbi respiratorji, toraċiċi u medjastinali Rari
English: Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Maltese: Eliminazzjoni mal-ħmieġ ta' topotecan totali kienet ta' 33 % filwaqt li eliminazzjoni malħmieġ ta' N-desmethyl topotecan kienet ta' 1.5 %.
English: The second study included a dose range of 2.0 to 5.2 mg/m in children (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Maltese: It-tieni studju inkluda limiti tad-doża bejn 2.0 u 5.2 mg/m fi tfal (n = 18), adoloxxenti (n = 3), u adulti ż-żgħar (n = 3) b'lewkimja.
English: Thrombocytopenia Severe (platelets <25 x 10
Maltese: Tromboċitopenja Serja (plejtlits <25 x 10
English: Sepsis Blood and lymphatic system disorders Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Maltese: Sepsis Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Newtropenja bid-deni, newtropenja (ara “Disturbi gastro-intestinali”), tromboċitopenja, anemija, lewkopenja
English: Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7%.
Maltese: Eliminazzjoni malħmieġ ta' topotecan totali kienet ta' 18 % filwaqt li eliminazzjoni mal-ħmieġ ta' N-desmethyl topotecan kienet ta' 1.7 %.
English: Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Maltese: Alopeċja kompleta jew serja ġiet osservata f'30 % tal-pazjenti u alopeċja parzjali f'15 % tal-pazjenti.
English: Loperamide was administered to 13% of patients in 5% of courses.
Maltese: Loperamide ngħata lil 13 % tal-pazjenti f'5 % tal-korsijiet.
English: Moderate to severe (Hb 8.0 g/dl) in 37% of patients (14% of courses).
Maltese: Moderata sa qawwija (Hb  8.0 g/dl) f'37 % tal-pazjenti (14 % tal-korsijiet).
English: Infections and infestations Very common Infection Common
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna Infezzjoni Komuni
English: No in vivo human pharmacokinetic interaction studies have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni farmakokinetika umana in vivo.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Maltese: Pazjenti li qabel kienu ħadu kimoradjuterapija b'cisplatin Cisplatin Topotecan/Cisplatin
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 4.4).
English: Complete alopecia related/possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/possibly related to topotecan administration in 11% of patients.
Maltese: Alopeċja kompleta relatata / possibbilment relatata mal-għoti ta' topotecan ġiet osservata f'9 % talpazjenti u alopeċja parzjali relatata / possibbilment relatata mal-għoti ta' topotecan f'11 % tal-pazjenti.
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52%), vomiting (32%), diarrhoea (18%), constipation (9%) and mucositis (14%).
Maltese: Effetti mhux ematoloġiċi li ġew irrappuratati b'mod frekwenti kienu dawk gastro-intestinali, bħal dardir (52 %), rimettar (32 %), dijarrea (18 %), stitikezza (9 %) u mukosite (14 %).
English: Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Maltese: Tromboċitopenja Tromboċitopenja serja (Grad 4 - plejtlits < 10 x 10
English: Anhydrous ethanol - see leaflet for further information Propylene glycol
Maltese: Anhydrous ethanol - ara l-fuljett għal aktar tagħrif Propylene glycol
English: 9/l, the platelet count is 100 x 10
Maltese: 9/l, għadd ta' plejtlits ta'  100 x 10
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Maltese: It-tipi ta' tumuri kienu jinkludu sarkoma ta' Erwing/ tumur newroektodermali primittiv, newroblastoma, osteoblastoma, u rabdomijosarkoma.
English: Manufacturer
Maltese: MANIFATTURI
English: The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
Maltese: Ilbioavailability fil-bnedmin ta' topotecan mill-ħalq (total u lactone) hija bejn wieħed u ieħor 40 %.
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Maltese: Topotecan huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: The median time to response in clinical studies was 7.6-11.6 weeks.
Maltese: Iż-żmien medjan ta' rispons ta' dawk li rrispondew għall-kura fi studji kliniċi kienet ta' bejn 7.6 u 11.6 ġimgħat.
English: Separate one capsule: tear along the perforated lines to separate one capsule “pocket” from the strip.
Maltese: Issepara kapsula waħda: aqta' mal-linji ta' perforazzjoni biex tissepara “borża" ta' kapsula waħda mill-istrixxa.
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/ġurnata għal ħamest ijiem konsekuttivi) u cisplatin (60 mg/m2/ġurnata fil-ġurnata 1) ġew amministrati lil 13-il pazjent b'kanċer tal-ovarji, żjieda żgħira fl-AUC (12 %, n = 9) u Cmax (23 %, n = 11) kienet innutata fil-ġurnata 5.
English: Also contains: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
Maltese: Fih ukoll: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Maltese: Is-sustanza mill-metaboliżmu ta' O-glucuronidation ta' topotecan u N-desmethyl topotecan ġew identifikati fl-awrina.
English: 9/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
Maltese: 9/l u livell ta' emoglobina ta' ≥ 9g/dl (jekk hemm bżonn wara trasfużjoni).
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 kumparattiv bejn topotecan u paclitaxel f'pazjenti li diġà ġew ikkurati għal karċinoma flovarji permezz ta' kimoterapija ibbażata fuq il-platinum (n = 112 u 114, rispettivament,) ir-rata ta' rispons (95 % CI) kienet ta' 20.5 % (13 %, 28 %) kontra 14 % (8 %, 20 %) u ż-żmien medjan għal kontinwazzjoni kienet ta' 19-il ġimgħa versu 15-il ġimgħa (proporzjon ta periklu 0.7 [0.6, 1.0]), għal topotecan u paclitaxel rispettivament.
English: Other medicines and Hycamtin
Maltese: Mediċini oħra u Hycamtin
English: Geometric mean topotecan lactone dose-normalised AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively (see section 4.2 and 4.4).
Maltese: Ilvaluri ġeometriċi medji tal-AUC(0-) normalizzati skont id-doża ta' topotecan lactone għal pazjenti Koreani kienu ta' 7.9, 12.9 u 19.7 ng*h/ml f'individwi b'valuri tat-tneħħija tal-krejatinina ta' aktar minn 80 ml/min, 50 sa 80 ml/min u 30 sa 49 ml/min, rispettivament (ara sezzjoni 4.2 u 4.4).
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Maltese: L- O-glucuronide ta' topotecan u l- O-glucuronide ta' Ndesmethyl topotecan fl-awrina kienu anqas minn 2.0 %.
English: Each capsule contains topotecan hydrochloride equivalent to 0.25 mg of topotecan.
Maltese: Kull kapsula fiha topotecan hydrochloride ekwivalenti għal 0.25 mg ta' topotecan.
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 compared to 21.3 l/h/m
Maltese: Meta mogħti flimkien ma' cisplatin (cisplatin fil-ġurnata 1, topotecan fil-ġranet 1-5), it-tneħħija ta' topotecan kienet imnaqqsa fil-ġurnata 5 meta mqabbla mal-ġurnata 1 (19.1 l/s/m meta mqabbel ma'
English: Topotecan 0.75 mg/m on days 1-3, every 21 days
Maltese: Cisplatin 50 mg/m fil-jum 1+ Topotecan 0.75 mg/m fil-jiem 13, kull 21 jum
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Maltese: Il-farmakokinetika ta' topotecan mogħti bħala infużjoni ta' 30 minuta għal ħamest ijiem kienet evalwata f'żewġ studji.
English: In 46% of courses with moderate to severe anaemia, the duration was >7 days.
Maltese: F'46 % tal-korsijiet b'anemija moderata sa qawwija, din damet > 7 ijiem.
English: 9/l and/or a platelet count of 100 x 10
Maltese: 9/l u/jew għadd ta' plejtlits ta' < 100 x 10
English: below.
Maltese: AVVIŻ:
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Maltese: Reazzjonijiet ta' sensittivita' eċċessiva, inkluż raxx, urtikarja, anġjoedima u reazjonijiet anafilattiċi ġew irrappurtati f'każijiet rari.
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Maltese: Rarament, dan jista' jwassal għal fsada aktar serja (emorraġija).
English: Administration of oral cyclosporine A (15 mg/kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0and 2.5-fold, respectively (see section 4.5).
Maltese: Meta cyclosporine A (15 mg/kg), inibitur tal-ġarriera ABCB1 (P-gp) u ABCC1 (MRP-1) kif ukoll inibitur tal-enżema tal-metaboliżmu CYP3A4, jingħata mill-ħalq fi żmien erba' sigħat wara topotecan mill-ħalq, l-AUC0-24h, normalizzat skont id-doża, ta' topotecan lactone u topotecan totali żdiedet għal bejn wieħed u ieħor 2.0 u 2.5-darba, rispettivament (ara sezzjoni 4.5).
English: Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2,536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Maltese: It-tagħrif ta' sigurtà ppreżentat huwa bbażat fuq tagħrif integrat minn 682 pazjent b'kanċer tal-pulmun li reġa' tfaċċa li ħadu 2,536 kors ta' topotecan mill-ħalq bħala monoterapija (275 pazjent b'SCLC li reġa' tfaċċa u 407 b'non-SCLC li reġa' tfaċċa).
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/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-krejatinina tas-serum taqbeż il-1.5 mg/dl, huwa rakkommandat li tiġi kkonsultata l-informazzjoni kompleta ta' kif jiġi preskritt cisplatin għall-parir dwar tnaqqis jew tkomplija tad-doża.
English: • your body size (surface area measured in square metres)
Maltese: • id-daqs ta' ġismek (erja tas-superfiċje imkejla f'metri kwadri)
English: In 18% of courses with severe thrombocytopenia the duration was >7 days.
Maltese: F'18 % tal-korsijiet b'tromboċitopenja qawwija, din damet > 7 ijiem.
English: Relapsed SCLC
Maltese: SCLC li reġa' feġġ
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: Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Maltese: Topotecan ġol-vina għandu jiġi kkunsidrat f'dawn il-każijiet kliniċi li ġejjin: rimettar mhux kontrollat, problemi biex tibla', dijarea mhux kontrollata, kundizzjonijiet kliniċi u mediċini li jistgħu jbidlu lmotilità gastro-intestinali u l-assorbiment ta' mediċini.
English: Geometric mean topotecan lactone dose-normalised AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively.
Maltese: Il-valuri ġeometriċi medji tal-AUC(0-) normalizzati skont id-doża ta' topotecan lactone kienu ta' 9.4, 11.1 u 12.0 ng*h/ml f'individwi b'valuri tat-tneħħija tal-krejatinina ta' aktar minn 80 mL/min, 50 sa 80 ml/min u 30 sa 49 ml/min, rispettivament.
English: Lot
Maltese: Lott
English: Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Maltese: Kien hemm infezzjoni, sepsis, u newtropenja bid-deni f'17 %, 2 % u 4 % tal-pazjenti rispettivament. 1 % tal-pazjenti mietu minħabba sepsis.
English: Following co-administration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1000 mg with oral topotecan, the AUC0-∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Maltese: Wara li topotecan mill-ħalq ingħata flimkien ma' elacridar (GF120918), inibitur ta' ABCB1 (P-gp) u ABCG2 (BCRP), b'doża ta'100 sa 1000 mg, l-AUC00-∞ ta' topotecan lactone u topotecan totali żdiedet għal bejn wieħed u ieħor 2.5 darba (ara sezzjoni 4.5 għal gwida).
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Maltese: Tnaqqis fil-piż u nuqqas t'aptit (anoressija); għeja; debbulizza.
English: HYCAMTIN 0.25 mg hard capsules topotecan
Maltese: HYCAMTIN 0.25 mg kapsuli ibsin topotecan
English: • Itching sensation.
Maltese: Sensazzjoni li trid tħokk.
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: F'pazjenti (n = 39) b'rikorrenza fi żmien 180 ġurnata wara kemoradjuterapija b'cisplatin, il-medjan ta' sopravivenza meta topotecan ingħata flimkien ma' cisplatin kien ta' 4.6 xhur (95 % CI: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: Hycamtin 1 mg capsules are pink and imprinted with “Hycamtin” and “1 mg”.
Maltese: Il-kapsuli Hycamtin 1 mg huma roża u mmarkati b'“Hycamtin” u “1 mg”.
English: Erythropoietin was administered to 10% of patients in 8% of courses.
Maltese: Erythropoietin ingħata lil 10 % talpazjenti f'8 % tal-korsijiet.
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 randomised 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 reġgħet feġġet jew fl-istat
English: The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m2/day and 4 mg/m2/day administered daily for 5 days.
Maltese: Il-farmakokinetika ta' topotecan wara li ngħata mill-ħalq ġiet evalwata f'pazjenti bil-kanċer wara dożi ta' 1.2 sa 3.1 mg/ m2/ġurnata u 4 mg/ m2/ġurnata li ngħataw kuljum għal ħamest ijiem.
English: Severe bleeding (associated with thrombocytopenia) Immune system disorders Common
Maltese: Mhux magħruf Fsada qawwija (assoċjata ma' troboċitopenija) Disturbi fis-sistema immuni
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 (hazard ratio) mhux aġġustat għall-grupp ta' topotecan mill-ħalq flimkien ma' BSC imqabbel mal-grupp ta' BSC waħdu kien 0.64 (95 % CI: 0.45, 0.90).
English: The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”.
Maltese: Il-kapsuli huma trasparenti, roża u mmarkati b' “HYCAMTIN” u “1 mg”.
English: Initial dose
Maltese: Doża inizjali
English: 1 x 1 mg 5 x 1 mg
Maltese: 5 x 1 mg
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 a final concentration of between 25 and 50 microgram/ml.
Maltese: Il-volum approprjat tat-taħlita rikostitwita jrid jerġa' jiġi dilwit ma' sodium chloride 9 mg/ml (0.9 %) jew ma' 5 % w/v glucose, biex titwassal konċentrazzjoni finali ta' bejn 25 bejn 50 mikrogramma/ml.
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Maltese: Ir-rata medjana totali ta' għejxien kienet ta' 62 ġimgħa għal topotecan, kontra 53 ġimgħa għal paclitaxel (proporzjon ta' periklu 0.9 [0.6, 1.3]).
English: Your doctor will determine the correct dose of cisplatin.
Maltese: Ittabib tiegħek se jiddetermina d-doża korretta ta' cisplatin.