FrancophonIA/ELRC3.0 huggingface dataset:
English: • Codeine for cough and cold is now contraindicated in children below 12 years, and not recommended in children between 12 and 18 years with compromised respiratory function.
Maltese: • Il-kodeina għal sogħla u rjiħat issa hija kontraindikata fit-tfal taħt 12-il sena, u mhijiex rakkomandata fit-tfal bejn it-12 u t-18-il sena b'funzjoni respiratorja kompromessa.
English: • Patients of all ages who are known to be ‘ultra-rapid metabolisers', which means that they convert codeine into morphine very rapidly, must not use codeine for cough and cold as they are more at risk of serious side effects with codeine.
Maltese: • Pazjenti ta' kull età li huma magħrufin li huma ‘metabolizzaturi ultrarapidi', li jfisser li jikkonvertu lkodeina f'morfina malajr ħafna, m'għandhomx jużaw il-kodeina għas-sogħla u għall-irjiħat peress li qegħdin f'riskju akbar ta' effetti sekondarji serji bil-kodeina.
English: • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.
Maltese: • Fi tfal u adolexxenti bejn it-12 u t-18-il sena li għandhom problemi bin-nifs tagħhom, il-kodeina mhijiex rakkomandata peress li din il-popolazzjoni tista' tkun aktar suxxettibbli għal problemi tannifs minħabba l-kodeina.
English: The PRAC considered that, although morphine-induced side effects may occur in patients of all ages, the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of such side effects.
Maltese: Il-PRAC qies li, għalkemm effetti sekondarji kkawżati mill-morfina jistgħu jseħħu f'pazjenti ta' kull età, il-mod kif il-kodeina tiġi konvertita f'morfina fit-tfal taħt it-12-il sena huwa aktar varjabbli u imprevedibbli, u dan ipoġġi lil din il-popolazzjoni f'riskju speċjali ta' effetti sekondarji bħal dawn.
English: In addition to the new measures for children, codeine must also not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal (‘ultra-rapid metabolisers') nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk.
Maltese: Minbarra l-miżuri l-ġodda għat-tfal, il-kodeina m'għandhiex tintuża wkoll fuq persuni ta' kull età li huma magħrufin li jikkonvertu l-kodeina f'morfina b'rata aktar mgħaġġla min-normal (‘metabolizzaturi ultrarapidi') u lanqas fuq ommijiet li jkunu qed ireddgħu, peress li l-kodeina tista' tagħmel ħsara littarbija minħabba li tgħaddi ġol-ħalib tas-sider.
English: • Codeine-containing medicines for cough and cold must not be used in children below 12 years of age because of the risk of serious side effects, including breathing problems.
Maltese: • Mediċini li fihom il-kodeina għas-sogħla u għall-irjiħat m'għandhomx jintużaw fuq tfal taħt it-12-il sena minħabba r-riskju ta' effetti sekondarji serji, inklużi problemi tan-nifs.
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the CMDh for its position.
Maltese: Fl-UE, mediċini li fihom il-kodeina ġew approvati permezz ta' proċeduri nazzjonali, u huma disponibbli jew b'riċetta jew mingħajr riċetta ta' tabib fl-Istati Membri differenti.
English: The CMDh1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children.
Maltese: Is-CMDh1 qabel b'kunsens fuq miżuri ġodda biex jitnaqqas ir-riskju ta' effetti sekondarji serji, inklużi problemi tan-nifs, b'mediċini li fihom il-kodeina meta jintużaw għal sogħla u rjiħat fit-tfal.
English: 5 ml 3 mg/ml
Maltese: 5 mg 3 mg/ml
English: Total dose (mg)
Maltese: Doża totali (mg)
English: Study results Study GOG-0179
Maltese: Riżultati tal-istudju GOG-0179
English: 1 ml
Maltese: 1 mg
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: Metabolism accounts for < 10 % of the elimination of topotecan.
Maltese: Il-metaboliżmu jispjega < 10 % tal-eliminazzjoni ta' topotecan.
English: Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria
Maltese: Komuni: reazzjoni ta' sensittività eċċessiva inkluż raxx Rari : reazzjoni anafilattika, anġoedima, urtikarja
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Maltese: Eliminazzjoni mal-ħmieġ ta' topotecan totali kienet ta' 18 % filwaqt li eliminazzjoni mal-ħmieġ ta' Ndesmethyl topotecan kienet ta' 1.7 %.
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/m2 compared to 21.3 l/h/m2 [n = 9]) (see section 4.5).
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/m2 meta mqabbel ma' 21.3 l/s/m2 [n=9]) (ara sezzjoni 4.5).
English: - This treatment cycle will normally be repeated every 3 weeks.
Maltese: - Normalment dan iċ-ċiklu ta' kura jiġi ripetut kull 3 ġimgħat.
English: Hazard ratio (95 % CI) Response rate (%)
Maltese: Proporzjon ta' periklu (95 % CI) Rata ta' rispons (%)
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and 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 %) u dijarrea (18 %), stitikezza (9 %) u mukosite (14 %).
English: VIAL 1 ml
Maltese: FJALA ta' 1 ml
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), including isolated reports 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) inklużi rapporti iżolati u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/002
Maltese: FIS-SUQ EU/1/11/744/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/001
Maltese: FIS-SUQ EU/1/11/744/001
English: Anaemia: 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: The second study included a dose range of 2.0 mg/m2 to 5.2 mg/m2 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 mg/m2 u 5.2 mg/m2 fi tfal (n=18), adoloxxenti (n=3) u adulti ż-żgħar (n=3) b'lewkimja.
English: Intravenous use.
Maltese: injezzjonijiet.
English: VIAL 5 ml
Maltese: FJALA ta' 5 ml
English: • Infections (very common) - because Topotecan Eagle may reduce your ability to fight infections.
Maltese: • Infezzjonijiet (komuni ħafna) - minħabba li Topotecan Eagle jista' jnaqqaslek il-kapaċità tiegħek
English: Topotecan Eagle must be diluted to a final concentration between 25 µg/ml and 50 µg/ml (see section 6.6 for dilution instructions).
Maltese: Topotecan Eagle għandu jiġi dilwit għal konċentrazzjoni finali ta' bejn 25 µg/ml u 50 µg/ml (ara sezzjoni 6.6 għal istruzzjonijiet dwar iddilwizzjoni).
English: surface area
Maltese: Station Approach
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: Topotecan is contra-indicated during breast-feeding (see section 4.3).
Maltese: Topotecan huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: A clear light yellow to orange solution, pH ≤ 1.2.
Maltese: Konċentrat għal soluzzjoni għall-infużjoni. Soluzzjoni safra ċara fl-oranġjo, pH ≤1.2.
English: Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Maltese: Dardir qawwi (skala 3 jew 4), rimettar, dijarrea u inċidenza ta' mukosite kienet ta' 4, 3, 2 u 1 % rispettivament.
English: When topotecan (0.75 mg/m2/day for five 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: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Maltese: Prodotti antinejoplastiċi oħra: Kodiċi ATC:
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 G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Maltese: Ibbażata fuq it-tossiċità ta' majelosuppressjoni li tillimita d-doża, id-doża massima tollerata (MTD) kienet stabbilita bħala 2.0 mg/m2 /ġurnata ma' GCSF u 1.4 mg/m2 /ġurnata mingħajr G-CSF fi studju farmakokinetiku f'pazjenti pedjatriċi b'tumuri solidi refrattarji (ara sezzjoni 5.2).
English: The unadjusted hazard ratio for oral topotecan plus BSC group relative to 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 mqabbel mal-grupp ta' BSC waħdu kien 0.64 (95 % CI: 0.45, 0.90).
English: Body surface area (m
Maltese: Erja tassuperfiċje tal-ġisem (m
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: 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 lO-glucuronide ta' N-desmethyl topotecan fl-awrina kienu anqas minn 2.0 %.
English: Hydrochloric acid (E507) Water for injections
Maltese: Hydrochloric acid (E507) Ilma għall-injezzjonijiet
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total medicinal product 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 mal-prodott mediċinali li nstabu fl-awrina u fil-ħmieġ.
English: Each 5 ml multi dose vial contains 15 mg of topotecan.
Maltese: Kull fjala ta'diversi dożi ta' 5 ml fiha 15 mg topotecan.
English: For reduced dose '0.45 mg/m
Maltese: Għad-doża rakkomandata '0.75 mg/m
English: In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Maltese: Fi provi kliniċi, ġie irrapurtat raxx f'4 % tal-pazjenti u ħakk f'1.5 % talpazjenti.
English: A phase III trial (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 + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Maltese: III (studju 478) qabblet topotecan mill-ħalq flimkien mal-Aħjar Kura ta' Appoġġ (BSC) (n=71) ma' BSC waħdu (n=70) f'pazjenti li l-kanċer tagħhom reġa' feġġ wara t-terapija ewlenija (żmien medjan għall-progressjoni [TTP] mit-terapija ewlenija: 84 ġurnata għal-terapija b'topotecan + BSC, 90 ġurnata għal-BSC) u li għalihom trattament ieħor b'kimoterapija li tingħata filvina ma kienx ikkunsidrat xieraq.
English: In a randomised, comparative phase III trial conducted by the Gynaecological Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
Maltese: III immexxija 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: Eagle Laboratories Limited The Clock House Station Approach Marlow, Buck, SL7 1NT United Kingdom
Maltese: Eagle Laboratories Limited The Clock House Station Approach Marlow, Buck, SL7 1NT Ir-Renju Unit.
English: Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom
Maltese: Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT Ir-Renju Unit
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
Maltese: Rapporti miġbura mill-pazjenti stess permezz ta' assessjar unblinded urew benefiċju konsistenti fuq sintomi b' topotecan mill-ħalq + BSC.
English: Patients without prior Cisplatin chemoradiotherapy Cisplatin
Maltese: Pazjenti li qabel kienu ħadu Kimoradjuterapija b'Cisplatin Cisplatin Topotecan/Cisplatin
English: The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Maltese: Ilproporzjon ta' periklu għas-sopravivenza ta' topotecan li jingħata fil-vina meta mqabbel ma' CAV kien 1.04 (95 % CI 0.78 -1.40).
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: q21 d.
Maltese: L01XX17.
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' Celluli Ħomor tad-Demm Ippakkjati u ħamsin (46 %) irċevew plejtlits fuq medda ta' 139 u 159 kors (30.5 u 34.9 %) rispettivament.
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 talpulmun, espożizzjoni toraċika għal radjazzjoni u l-użu ta' mediċini pnewmotossiċi u/jew fatturi li jistimulaw kolonji.
English: Immune system disorders
Maltese: Disturbi gastro-intestinali
English: Each pack contains 1 vial.
Maltese: Kull pakkett fih fjala waħda.
English: One Phase 2 study (Study 065) and one Phase 3 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 2 (Studju 065) u studju tal-fażi 3 (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: - abnormally low white blood cell count (neutropenia) which may be accompanied with fever and signs of infection (febrile neutropenia) - weight loss and loss of appetite, feeling tired or weak - feeling or being sick, diarrhoea, stomach pain, constipation - inflammation and ulcers of the mouth, throat, tongue or gums (mucositis) - high body temperature (fever) - infections - hair loss.
Maltese: Dan huwa kkawżat minn tnaqqis fin numru ta' ċelloli li jgħaqqdu d-demm (plejtlits). - għadd abnormalment baxx ta' ċelloli bojod tad-demm (newtropenja) li jista' jkun akkumpanjat minn deni u sinjali ta' infezzjoni (newtropenja bid-deni) - tnaqqis fil-piż u telf ta' aptit, tħossok għajjien jew dgħajjef tħossok jew tkun ma tiflaħx, dijarea, uġigħ fl-istonku, stitikezza infjammazzjoni u ulċeri fil-ħalq, fil-ġriżmejn, fl-ilsien jew fil-ħanek (mukożite) - temperatura għolja tal-ġisem (deni) - infezzjonijiet - telf ta' xagħar.
English: Other side effects may include:
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: ITT population Cisplatin 50mg/m d.1
Maltese: Cisplatin 50 mg/m2 d. 1 q21 d.
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 statitstikament sinifikanti meta mqabbel ma' monoterapija b'cisplatin wara aġġustament għall-analiżi interim (Log-rank p=0.033).
English: Each vial contains 15 mg topotecan (as hydrochloride) in 5 ml concentrate.
Maltese: Kull fjala fiha 15 mg topotecan (bħala hydrochloride) f'konċentrat ta' 5 ml.
English: Thrombocytopenia: Severe (platelets less than 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: Serja (plejtlits inqas minn 25 x 109/l) f'25 % tal-pazjenti (8 % tal-korsijiet); moderata (plejtlits bejn 25.0
English: Topotecan/Cisplatin
Maltese: Topotecan ġolvina
English: The 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: • The anticipated effects of overdose (e.g. bone marrow suppression).
Maltese: • L-effetti antiċipati ta‘ doża eċċessiva (eż. it-trażżin tal-mudullun).
English: In another randomised phase III trial which compared intravenous topotecan to cyclophosphamide, Adriamycin (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 randomised li qabblet topotecan amministrat ġol-vina ma' cyclophosphamide, Adriamycin (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: 1 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4)
Maltese: 1Kolite tan-newtropenja, inkluża l-kolite tan-newtropenja fatali, ġiet irrappurtata bħala kumplikazzjoni tan-newtropenja kkawżata minn topotecan (ara sezzjoni 4.4)
English: Concentrate for solution for infusion (3 mg/ml)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (3mg/ml)
English: Hydrochloric acid (E507) (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (E507) (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: How Topotecan Eagle is given Topotecan Eagle is normally given by a doctor or nurse: - as a drip (infusion) for about 30 minutes - usually into your arm.
Maltese: Normalment Topotecan Eagle jingħata minn tabib jew infermier: - bħala dripp (infużjoni) għal madwar nofs siegħa - ġeneralment ġo driegħek.
English: Further dilution of Topotecan Eagle is required with either sodium chloride 9 mg/ml (0.9 % w/v) solution for injection or glucose 50 mg/ml (5 % w/v) solution for injection in order to reach a final topotecan concentration of between 25 µg/ml and 50 µg/ml in the solution for infusion to the patient.
Maltese: Hemm il-ħtieġa li Topotecan Eagle jiġi dilwit ulterjorment jew b'klorur tas-sodju 9 mg/ml (0.9 % w/v) soluzzjoni għal injezzjoni jew bi glukosju 50 mg/ml (5 % w/v) soluzzjoni għal injezzjoni sabiex tintlaħaq konċentrazzjoni finali ta' topotecan ta' bejn il-25 µg/ml u l-50 µg/ml fis-soluzzjoni għallinfużjoni għall-pazjent.
English: Topotecan Eagle contains a higher dose concentration (3 mg/ml) than other topotecan products for intravenous infusion (usually 1 mg/ml).
Maltese: Topotecan Eagle fih konċentrazzjoni ta' doża ogħla (3 mg/ml) minn prodotti oħra ta' topotecan għal infużjoni ġol-vini (ġeneralment 1 mg/ml).
English: Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Maltese: Bejn wieħed u ieħor 51 % tneħħa bħala topotecan totali u 3 % tneħħa bħala N-desmethyl topotecan fl-awrina.
English: Difference in response rate (95 % CI) Median time to progression (weeks)
Maltese: Differenza fir-rata ta' rispons (95 % CI)
English: 3 Extravasation has been reported very rarely.
Maltese: 3Estravażazzjoni ġiet irrappurtata b'mod rari ħafna.
English: Each vial contains 3 mg topotecan (as hydrochloride) in 1 ml concentrate.
Maltese: Kull fjala fiha 3 mg topotecan (bħala hydrochloride) f'konċentrat ta'1 ml.
English: The mean metabolite:parent 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 ta' anqas minn 10 % kemm għal topotecan kif ukoll għal topotecan lactone.
English: Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered intravenous dose.
Maltese: Il-ġbir totali ta' materjali li għandhom x'jaqsmu mal-prodott mediċinali wara l-ħames dożi ta' topotecan li ingħataw darba kuljum kien ta' 71-76 % tad-doża amministrata fil-vina.
English: Not known: severe bleeding (associated with thrombocytopenia) Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease (some cases have been fatal)
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari: mard fiċ-ċelluli interstitial tal-pulmun (xi każijiet kienu fatali)
English: The following information is intended for medical or healthcare professionals only:
Maltese: Jista' jkollok bżonn kura medika urġenti:
English: n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Maltese: Studju wieħed inkluda limiti tad-doza bejn 1.4 mg/m2 u 2.4 mg/m2 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 concentration of topotecan in Topotecan Eagle differs from other topotecan products (see section 6.6 for further instructions on dilution).
Maltese: Il-konċentrazzjoni ta'topotecan f'Topotecan Eagle tvarja minn dik ta' prodotti oħra ta' topotecan (ara sezzjoni 6.6 għal istruzzjonijiet ulterjuri dwar id-dilwizzjoni).
English: Dosage in renally impaired patients
Maltese: Id-doża f'pazjenti b'indeboliment renali
English: Metabolism and nutrition disorders Very common: anorexia (which may be severe)
Maltese: Komuni ħafna: anoreksja (li tista' tkun serja)
English: Opened on: DD/MM/YY
Maltese: Infetaħ fi: JJ/XX/SS
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Maltese: M'hemmx biżżejjed esperjenza dwar l-użu ta' topotecan f'pazjenti li għandhom indeboliment serju talkliewi (tneħħija tal-krejatinina < 20 ml/min) jew li jbatu minn indeboliment serju tal-fwied (bilirubin fis-serum  10 mg/dl) minħabba ċirrożi.