FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of tetrazepam-containing medicines was initiated in January 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Maltese: Il-valutazzjoni tal-mediċini li fihom tetrazepam inbdiet f'Jannar 2013 fuq talba ta' Franza, skont lArtikolu 107i tad-Direttiva 2001/83/KE, magħrufa wkoll bħala l-proċedura urġenti tal-Unjoni.
English: On 24 April 2013, following the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
Maltese: Fl-24 ta' April 2013, wara r-rakkomandazzjoni tal-Kumitat Konsultattiv dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh) approva b'maġġoranza r-rakkomandazzjoni tal-PRAC għas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq tal-mediċini li fihom tetrazepam fl-Unjoni Ewropea (UE) kollha.
English: Benzodiazepines work by attaching to certain receptors in the brain, thereby increasing the activity of a substance called gamma-amino butyric acid (GABA).
Maltese: Il-benzodiazepines jaħdmu billi jeħlu ma' ċerti riċetturi fil-moħħ, u b'hekk iżidu l-attività ta' sustanza msejħa aċidu gamma-aminobutiriku (GABA).
English: The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
Maltese: L-effikaċja ta' tetrazepam għall-kontrazzjonijiet bl-uġigħ hija appoġġjata prinċipalment minn żewġ provi kliniċi żgħar double-blind, ikkontrollati bil-plaċebo, li wrew effikaċja limitata.
English: • As a result of the risk of unpredictable, serious skin reactions identified, tetrazepam-containing medicines will no longer be available in the EU.
Maltese: • Minħabba r-riskju ta' reazzjonijiet imprevedibbli serji tal-ġilda li ġew identifikati, il-mediċini li fihom tetrazepam mhux se jkunu aktar disponibbli fl-UE.
English: In view of the serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Maltese: Minħabba r-reazzjonijiet tal-ġilda serji u potenzjalment fatali u l-effikaċja limitata ta' tetrazepam, ilbilanċ bejn il-benefiċċju u r-riskju tal-mediċini li fihom tetrazepam m'għadux meqjus bħala favorevoli.
English: Relaxam, Spasmorelax, Tetra-saar, Tetramdura and Tetraratio.
Maltese: B'mod partikolari, tetrazepam jintuża għall-effetti rilassanti tiegħu fuq il-muskoli.
English: Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles).
Maltese: Stati Membri tal-UE għall-kura ta' kontrazzjonijiet bl-uġigħ (bħal uġigħ fil-parti ta' isfel tad-dahar u wġigħ fl-għonq) u spastiċità (ebusija eċċessiva tal-muskoli).
English: • The risk of skin reaction is higher with tetrazepam than with other benzodiazepines.
Maltese: • Ir-riskju ta' reazzjoni tal-ġilda huwa akbar b'tetrazepam milli b'benzodiazepines oħra.
English: It is taken by mouth to treat painful contractures (sustained shortening of muscle tissue), and spasticity (excessive stiffness of muscles).
Maltese: Huwa jittieħed mill-ħalq għallkura ta' kontrazzjonijiet bl-uġigħ (tqassir sostnut tat-tessut tal-muskoli), u spastiċità (ebusija eċċessiva tal-muskoli).
English: By increasing GABA activity, benzodiazepines have a calming effect on various functions of the brain.
Maltese: Billi jżidu l-attività tal-GABA, il-benzodiazepines għandhom effett kalmanti fuq diversi funzjonijiet talmoħħ.
English: As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Billi l-mediċini li fihom tetrazepam huma kollha awtorizzati fuq livell nazzjonali, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adotta pożizzjoni finali.
English: The full list is available in Annex I on the EMA website, under the ‘All documents' tab.
Maltese: Illista sħiħa hija disponibbli fl-Anness I fis-sit elettroniku tal-EMA, taħt it-tab ‘Id-dokumenti kollha'.
English: The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications:
Maltese: Il-pożizzjoni tas-CMDh hija bbażata fuq ir-reviżjoni, min-naħa tal-PRAC, tad-dejta kollha disponibbli dwar ir-riskju ta' reazzjonijiet tal-ġilda b'tetrazepam, inkluża d-dejta ta' wara t-tqegħid fis-suq fl-UE u l-litteratura ppubblikata, u l-informazzjoni disponibbli dwar l-effikaċja fl-indikazzjonijiet li għalihom ingħatat il-liċenzja:
English: As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision.
Maltese: Billi l-pożizzjoni tas-CMDh kienet adottata b'vot tal-maġġoranza, din intbagħtet lill-Kummissjoni Ewropea, li approvatha u adottat deċiżjoni legalment vinkolanti fl-UE kollha.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jassigura standards armonizzati tas-sigurtà għall-mediċini awtorizzati permezz tal-proċeduri nazzjonali tal-awtorizzazzjoni għat-tqegħid fis-suq fl-UE kollha.
English: • Tetrazepam is a muscle relaxant used in painful conditions such as low back pain and neck pain as well as spasticity (excessive stiffness of muscles).
Maltese: • Tetrazepam huwa rilassant tal-muskoli li jintuża f'kundizzjonijiet bl-uġigħ bħall-uġigħ fil-parti ta' isfel tad-dahar u l-uġigħ fl-għonq kif ukoll l-ispastiċità (ebusija eċċessiva tal-muskoli).
English: Severe infection (sepsis).
Maltese: - Infezzjoni severa (sepsis)
English: N = total number of patients treated.
Maltese: N = Numru totali ta' pazjenti trattati.
English: - The active substance is topotecan hydrochloride.
Maltese: - Is-sustanza attiva hi topotecan hydrochloride.
English: Extravasation3
Maltese: Ekstravażazzjoni3
English: Response rate (%)
Maltese: Rata ta' rispons (%)
English: CI = confidence interval.
Maltese: CI = intervall ta' kunfidenza.
English: pH = 2.0-2.6.
Maltese: Soluzzjoni safranija ċara. pH = 2.0-2.6.
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 inpedixxiex l-enżimi P450 umani CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A jew CYP4A, u lanqas ma impedixxa lenżimi ċistoliċi umani dihydropyrimidine jew xanthine oxidase.
English: Topotecan Teva contains sodium
Maltese: Topotecan Teva fih sodium
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2009 Data tal-aħħar tiġdid: 19 ta' Ġunju 2014
English: Combination therapy (cervical carcinoma)
Maltese: Terapija ta' kombinazzjoni (karċinoma ċervikali)
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Maltese: Topotecan ma jimpedixxiex l-enżimi umani P450 (ara sezzjoni 5.2).
English: Anaphylactic reaction, angioedema, urticaria
Maltese: Reazzjoni anafilattika, anġoedima, urtikarja
English: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Maltese: Moderati għal severi (Hb ≤ 8.0 g/dl) f'37 % ta' pazjenti (14 % ta' korsijiet).
English: uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rare (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħrufa (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Toxicity was predictable and reversible.
Maltese: It-tossiċità kienet prevedibbli u riversibbli.
English: Relapsed SCLC
Maltese: SCLC Rikadut
English: Breast-feeding (see section 4.6).
Maltese: Qed ireddgħu (ara sezzjoni 4.6).
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 on days 1-3, every 21 days
Maltese: Cisplatin 50 mg/m2 f'jum 1 + Topotecan 0.75 mg/m2 f'jiem 1
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Maltese: Is-sopravivenza medjana kienet ta' 30.3 ġimgħa (95 % CI: 27.6, 33.4).
English: Oral topotecan
Maltese: Topotecan orali
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Maltese: Alopeċja totali jew pronunċjata ġiet osservata fi 30 % ta' pazjenti u alopeċja parzjali fi 15 % ta'
English: Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7 %.
Maltese: L-eliminazzjoni ta' topotecan totali fl-ippurgar kienet ta' 18 % filwaqt li l-eliminazzjoni ta' N-desmethyl topotecan fl-ippurgar kienet ta' 1.7 %.
English: Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Maltese: Komuni ħafna Newtropenija bid-deni, newtropenija (ara “Disturbi gastro-intestinali”), tromboċitopenija, anemija, lewkopenja
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Maltese: Il-half-life medju żdied b'1.9 sigħat għal 4.9 sigħat.
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 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/m2 [n = 9]) (ara sezzjoni 4.5).
English: The mean metabolite: parent AUC ratio was < 10% for both total topotecan and topotecan lactone.
Maltese: Il-metabolit medju: proporzjon tal-AUC ġenitur kien < 10 % kemm għal topotecan totali u topotecan lactone.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7% (range 4-9%) of the total topotecan related material accounted for in the urine and faeces.
Maltese: Globalment, il-metabolit N-desmethyl ikkontribwixxa medja ta' anqas minn 7 % (firxa ta' 4-9 %) tattotal tal-materjal relatat ma' topotecan li nstab fl-awrina u fl-ippurgar.
English: Median (95% CI)
Maltese: Medjan (95 % CI)
English: Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Maltese: Topotecan ukoll kellu volum għoli ta' distribuzzjoni, madwar 132 1 (SD 57), u half-life relattivament qasira ta' 2-3 sigħat.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Maltese: Barra minn hekk, 5 % tal-pazjenti kollha trattati (1 % ta' korsijiet) żviluppaw sepsis (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, aġenti antineoplastiċi oħra, Kodiċi ATC:
English: Oral topotecan Intravenous topotecan
Maltese: Topotecan orali Topotecan ġol-vina
English: Very common Anorexia (which may be severe)
Maltese: Komuni ħafna Anoreksja (li tista' tkun serja)
English: Based on the doselimiting 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: Skont it-tossiċità limitata bid doża ta' majelosuppressjoni, id-doża massima tollerata (MTD) ġiet stabbilita f'2.0 mg/m2/kuljum b'GCSF u 1.4 mg/m2/kuljum mingħajr G-CSF fi studju farmakokinetiku f'pazjenti pedjatriċi b'tumuri refrattorji solidi (ara sezzjoni 5.2).
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Maltese: Pazjenti li kellhom kimoradjuterapija b'cisplatin qabel Cisplatin Topotecan/Cisplatin
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,
Maltese: Fi studju komparattiv ta' topotecan u paclitaxel f'pazjenti li qabel kienu trattati għal karċinoma ovarjana b'kimoterapija bażata fuq il-platinu (n = 112 u 114, rispettivament), ir-rata ta' rispons (95 % CI) kienet ta' 20.5 % (13 %, 28 %) kontra 14 % (8 %, 20 %) u l-linja medjana għal progressjoni kienet ta' 19-il ġimgħa kontra 15-il ġimgħa (proporzjon ta' periklu 0.7 [0.6, 1.0]), għal topotecan u paclitaxel, rispettivament.
English: The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Maltese: L-ammont ta' topotecan-Oglucuronide u N-desmethyl topotecan-O-glucuronide fl-awrina kien inqas minn 2.0 %.
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Maltese: (32 %), dijarea (18 %), stitikezza (9 %) u mukożite (14 %).
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 għal grupp li ħa topotecan orali flimkien ma' BSC meta mqabbel mal-grupp ta' BSC waħdu kien ta' 0.64 (95 % CI: 0.45, 0.90).
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Maltese: Il-farmakokinetiċi ta' topotecan li tingħata bħala infużjoni ta' 30 minuta għal 5 ijiem ġiet evalwata fuq żewġ studji.
English: Discharge of blood into tissues (extravasation).
Maltese: Id-demm inixxi fit-tessut (ekstravażazzjoni).
English: Platelet transfusions were given in 4 % of courses.
Maltese: Trasfużjonijiet tal-plejtlets ingħataw f'4 % ta' korsijiet.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Maltese: It-tipi ta' tumur kienu jinkludu s-sarkoma ta' Ewing/tumur newroektodermali primittiv, newroblastoma, osteoblastoma, u rabdomajosarkoma.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Maltese: Pazjenti li ma kellhomx kimoradjuterapija b'cisplatin qabel Cisplatin Topotecan/Cisplatin
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: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Maltese: L-inċidenza ta' tqalligħ qawwi, remettar, dijarea u mukosite severi (grad 3 jew 4) kienu 4, 3, 2 u 1 % rispettivament.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Maltese: Il-ħin medjan għal progressjoni kien simili fiż-żewġ gruppi (13.3 ġimgħat u 12.3 ġimgħat, rispettivament).
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Maltese: Flimkien ma' newtropenja severa, id-deni jew infezzjoni seħħet f'16 % tal-pazjenti waqt kors 1 u globalment f'23 % tal-pazjenti (6 % ta' korsijiet).
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Maltese: parametri farmakokinetiċi ma ssuġġeritx bidla fil-farmakokinetiċi fuq il-5 ijiem ta' dożaġġ.
English: Difference in response rate (95% CI)
Maltese: Differenza fir-rata ta' rispons (95 % CI)
English: An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine.
Maltese: Metaboliti ta' o-glucuronidation ta' topotecan u N-desmethyl topotecan ġew identifikati fl-awrina.
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (E507) (għal aġġustament ta' pH) Sodium hydroxide (E524) (għal aġġustament ta' pH)
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Maltese: Topotecan huwa kontraindikat waqt it-treddigħ (ara wkoll 4.3).
English: Other medicines and Topotecan Teva
Maltese: Mediċini oħra u Topotecan Teva
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Maltese: Każijiet severi oħra li ġew reġistrati bħala relatati jew possibilment relatati mat-trattament b'topotecan kienu anoreksja (12 %), tħossok ma tiflaħx (3 %) u iperbilirubinemija (1 %).
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: III (Studju 478) qabbel topotecan mogħti mill-ħalq flimkien ma' l-aħjar kura t'appoġġ (Best Supportive Care - BSC) (n = 71) ma' BSC waħdu (n = 70) f'pazjenti li rkadew wara li ngħataw it-terpaija preferenzjali (ħin medjan għal progressjoni [TTP] mit-terapija preferenzjali: 84 jum għal topotecan li jittieħed mill-ħalq flimkien ma' BSC, 90 jum għal BSC waħdu) u għal min it-trattament mill-ġdid b'kemoterapija ġol-vina. ma kinetx ikkonsidrata xierqa.
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'rikorenza fi żmien 180 jum wara l-kimoradjuterapija b'cisplatin, is-sopravivenza medjana fid-driegħ ta' topotecan flimkien ma' cisplatin kienet ta' 4.6 xhur (95 % CI: 2,6, 6.1) kontra 4.5 xhur (95 % CI: 2.9, 9.6) għad-driegħ ta' cisplatin, bi proporzjon ta' periklu ta' 1.15 (0.59, 2.23).
English: The response rate to topotecan in the combined small cell lung cancer programme (n=480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Maltese: Ir-rata ta' rispons ta' topotecan fil-programm ikkombinat ta' mikroċitoma pulmonari (n = 480) għal pazjenti b'mard li rkada u sensittivi għat-terapija ta' preferenza, kienet ta' 20.2 %.
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Maltese: Il-proporzjon ta' periklu għas-sopravivenza b'topotecan IV meta mqabbel ma' CAV kien ta' 1.04 (95 % CI: 0.78,
English: Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Maltese: Aktar dilwazzjoni tal-volum xieraq tal-konċentrat jista' jsir jew b'soluzzjoni ta' 9 mg/ml (0.9 %) sodium chloride għall-injezzjoni jew soluzzjoni soluzzjoni ta' 50 mg/ml (5 %) % glukosju għall-injezzjoni għal konċentrazzjoni finali ta' soluzzjoni għall-infużjoni ta' bejn 25 u 50 mikrogramm/ml kull ml.
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: III li saret mill-Gynecologic Oncology Group (GOG 0179), topotecan flimkien ma' cisplatin (n = 147) ġie mqabbel ma' cisplatin waħdu (n = 146) għat-trattament ta'
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 fil-programm sħiħ ta' karċinoma ovarjana (n = 392, li qabel kienu lkoll trattati b'cisplatin jew cisplatin u paclitaxel) kienet ta' 16 %.
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva severa għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
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 b'funzjonament renali severament indebolit (tneħħija ta' kreatinina < 20 ml/min) jew funzjoni epatika severament indebolita (bilirubin fis-serum ≥ 10 mg/dl) minħabba ċirrosi.
English: How to store Topotecan Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Maltese: III randomised li qabbel topotecan ġol-vina (IV) ma' cyclophosphamide, doxorubicin u vincristine (CAV) f'pazjenti sensittivi għal SCLC, u li rkadew, ir-rata ta' rispons globali kienet ta' 24.3 % għal topotecan meta mqabbla ma' 18.3 % għall-grupp CAV.
English: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Maltese: Qawwija (għadd ta' newtrofili < 0.5 x 109/l) waqt kors 1 f'55 % tal-pazjenti, u damet għal ≥ sebat ijiem f'20 % u globalment f'77 % tal-pazjenti (39 % ta' korsijiet).
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' monterapija rakkomandata ta' topotecan f'pazjenti b'karċinoma ovarjana jew mikroċitoma pulmonari u tneħħija tal-kreatinina ta' bejn 20 u 39 ml/min hi ta' 0.75 mg/m2/kuljum għal ħamest ijiem konsekuttivi.
English: Concentrate for solution for infusion 1 vial of 4 ml (4 mg topotecan) 5 vials of 4 ml (4 mg topotecan)
Maltese: Kunjett 1 ta' 4 ml (4 mg ta' topotecan) 5 kunjett ta' 4 ml (4 mg ta' topotecan)
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 li ħa topotecan orali flimkien ma' BSC kien hemm titjib statistikament sinifikanti fis-sopravivenza globali meta dan tqabbel mal-grupp BSC waħdu (grad ta' Log p = 0.0104).
English: Pancytopenia
Maltese: Newtropenja
English: Concentrate for solution for infusion 1 vial of 1 ml (1 mg topotecan) 5 vials of 1 ml (1 mg topotecan)
Maltese: Kunjett 1 ta' 1 ml (1 mg ta' topotecan) 5 kunjett ta' 1 ml (1 mg ta' topotecan)