FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegasys 135 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 135 mcg, 90 mcg and 45 mcg.
Maltese: Is-siringa hija ttikkettjata bi gradwazzjonijiet li jikkorrispondu għal dożi ta' 135 mcg, 90 mcg u 45 mcg.
English: Dyspnoea, cough
Maltese: irritabilità, għeja
English: Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
Maltese: Rati (%) ta' serokonverżjoni ta' HbeAg skont it-tnaqqis fid-DNA ta' HBV mil-linja bażi sa Ġimgħa 12 tat-trattament b'Pegasys f'pazjenti pedjatriċi
English: The use of Pegasys and ribavirin combination therapy in CHC patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for haematological adverse reactions.
Maltese: Terapija anti-infettiva xierqa għandha tinbeda minnufih u t-twaqqif tat-terapija għandu jiġi kkunsidrat.
English: NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe
Maltese: Informazzjoni għall-utent Pegasys 90 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Pegasys 135 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 14 and 15).
Maltese: Ir-riżultati tal-istudju NV15942 jipprovdu r-raġunijiet wara l-għażla tal korsijiet ta' kura rakkomandati skont il-ġenotip, il-viral load fil-linja bażi u r-rispons viroloġiku f'ġimgħa 4 (ara Tabelli 1, 14 u 15).
English: Pegasys is administered subcutaneously in the abdomen or thigh.
Maltese: Pegasys huwa maħsub għal użu taħt il-ġilda (għal taħt il-ġilda).
English: Liver and renal graft rejection, VogtKoyanagiHarada disease
Maltese: konġestjoni talimnieħer, rinite, uġigħ fil-griżmejn
English: Psychiatric and nervous system disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning),peripheral neuropathy (disorder of the nerves affecting the extremities)
Maltese: Disturbi psikjatriċi u fis-sistema nervuża: Ħsibijiet ta' suwiċidju, alluċinazzjonijiet (problemi severi bil-personalità u deterjorament fil-funzjoni soċjali normali), newropatija periferali (disturbi finnervituri li jaffettwaw l-estremitajiet)
English: May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Maltese: Jista' jikkawża reazzjonijiet tossiċi u allerġiċi fi trabi u tfal ta' età ta' mhux aktar minn 3 snin.
English: Pegasys 180 micrograms solution for injection Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*.
Maltese: Kull kunjett ta' 1 ml ta' soluzzjoni fih 180 mikrogramma peginterferon alfa-2a*.
English: Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle.
Maltese: Pegasys huwa ppreżentat bħala soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (0.5 ml) b'labra għall-injezzjoni separata.
English: However, several independent studies have demonstrated the 135mcg dose to be safe, efficacious and well tolerated, in patients with ESRD (see section 4.2).
Maltese: Madankollu, diversi studji indipendenti wrew li d-doża ta' 135 mcg hija sikura, effikaċi u ttollerata tajjeb, f'pazjenti b'ESRD (ara sezzjoni 4.2).
English: Hypothyroidis m, hyperthyroidi sm
Maltese: kolanġite, fwied xaħmi
English: In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/week and ribavirin 800 milligrams/day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
Maltese: Fl-istudju NR16071, pazjenti b'HCV b'valuri ta' ALT normali kienu randomised biex jirċievu Pegasys 180 mikrogramma/ġimgħa u ribavirin 800 milligramma/jum għal 24 jew 48 ġimgħa seġwit minn perjodu ta' segwitu ta' 24 ġimgħa mingħajr kura jew bla kura għal 72 ġimgħa.
English: Low viral load High viral load Genotype 4 RVR
Maltese: Viral load baxxa Viral load għolja
English: Patients with these conditions who cannot be effectively controlled by medication should not begin Pegasys monotherapy or Pegasys/ribavirin combination therapy.
Maltese: Pazjenti b'dawn il-kondizzjonijiet li ma jistgħux jiġu kkontrollati b'mod effettiv permezz ta' medikazzjoni, m'għandhomx jibdew monoterapija b'Pegasys jew terapija kombinata b'Pegasys/ribavirin.
English: The recommended duration of Pegasys monotherapy is 48 weeks.
Maltese: It-tul rakkomandat ta' monoterapija b'Pegasys huwa ta' 48 ġimgħa.
English: Chronic Hepatitis C: Pegasys is used in combination with other medicines, for the treatment of chronic hepatitis C (CHC).
Maltese: Għall-kura ta' epatite Ċ kronika (CHC - chronic hepatitis C) Pegasys jintuża flimkien ma' mediċini oħrajn.
English: General
Maltese: Globali
English: Roche Polska Sp.z o.o.
Maltese: Česká republika Roche s. r. o.
English: Patients infected with HCV genotypes other than genotype 1 should receive 800 mg daily of ribavirin.
Maltese: Pazjenti nfettati b'ġenotipi ta' HCV, minbarra ġenotip 1, għandhom jirċievu 800 mg kuljum ta' ribavirin.
English: Pegasys 180 micrograms solution for injection 4 years.
Maltese: U KWANTITATTIVA Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni
English: • Neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.4 for benzyl alcohol)
Maltese: • Trabi tat-twelid u tfal żgħar b'età sa 3 snin, minħabba l-eċċipjent benzyl alcohol (ara sezzjoni
English: If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure.
Maltese: Ma sarux studji b'Pegasys dwar it-tossiċità fuq is-sistema riproduttiva.
English: Growth inhibition was observed in paediatric patients (see section 4.4).
Maltese: F'pazjenti pedjatriċi kien osservat inibizzjoni tat-tkabbir (ara sezzjoni 4.4).
English: 6) Place pre-filled pen on injection site 7) Give injection
Maltese: 4) Agħżel u pprepara sit għall-injezzjoni 5) Neħħi l-għatu
English: Chronic hepatitis C in adult patients
Maltese: Epatite Ċ kronika f'pazjenti adulti
English: Psychiatric evaluation abnormal
Maltese: Grad ta' anormalità Punteġġ
English: The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).
Maltese: Ir-rata ta' rispons kienet aktar baxxa f'pazjenti mingħajr żieda jew b'żieda minima fillivell ta' ALT fil-linja bażi (ara Sezzjoni 5.1).
English: Pegasys 180 micrograms solution for injection in pre-filled syringe 4 years
Maltese: Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/005
Maltese: FIS-SUQ EU/1/02/221/005
English: Common side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10 people) are:
Maltese: Effetti sekondarji komuni bit-taħlita ta' Pegasys u ribavirin (jistgħu jaffettwaw sa persuna waħda minn kull 10) huma:
English: 1 x 200 mg tablets A.M.
Maltese: 2 pilloli x 200 mg P.M.
English: All patients received ribavirin (1000 or 1200 mg/day) in combination with Pegasys.
Maltese: Il-pazjenti kollha rċevew ribavirin (1000 jew 1200 mg/jum) flimkien ma' Pegasys.
English: Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
Maltese: segwitu fit-tul, ir-rata ta' serokonverżjoni sostenuta ta' HBeAg, 12-il xahar wara t-tmiem tat-terapija kienet ta' 48% (73/153).
English: During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Maltese: Waqt it-terapija b'Pegasys +/- ribavirin li damet sa 48 ġimgħa f'pazjenti b'età minn 3 snin sa 17-il sena, telf ta' piż u inibizzjoni tat-tkabbir kienu komuni (ara sezzjonijiet 4.8 u 5.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/009
Maltese: FIS-SUQ EU/1/02/221/009
English: The posology of Pegasys in paediatric patients is based on the Body Surface Area (BSA).
Maltese: Il-pożoloġija ta' Pegasys f'pazjenti pedjatriċi hija bbażata fuq l-Erja tas-Superfiċje tal-Ġisem (BSABody Surface Area).
English: The terminal half-life may not only reflect the elimination phase of the compound, but may also reflect the sustained absorption of Pegasys.
Maltese: Il-half life terminali tista' ma tkunx qed tirrifletti biss il-fażi tal-eliminazzjoni tas-sustanza, iżda tista' tirrifletti wkoll l-assorbiment sostenut ta' Pegasys.
English: Skin disorders: Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Muscle and bone disorders: Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq, bronkite, infezzjoni tal-fungu fil-ħalq u herpes (infezzjoni virali rikorrenti, li sseħħ b'mod komuni, li taffettwa x-xufftejn, ħalq)
English: The clinical significance of this finding is unknown; nonetheless, patients should be monitored for the signs and symptoms of methadone toxicity.
Maltese: Is-sinifikat kliniku ta' din is-sejba mhux magħruf; madanakollu, l-pazjenti għandhom jiġu sorveljati għal sinjali u sintomi ta' tossiċità ta' methadone.
English: Pegasys 180 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Maltese: Kull pinna mimlija għal-lest ta' 0.5 ml ta' soluzzjoni fiha 180 mikrogramma peginterferon alfa-2a*.
English: 1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT soluzzjoni għall-injezzjoni kunjett wieħed 180 mikrogramma/1 ml
English: Vision blurred, eye pain, eye inflammation, xerophthalmia
Maltese: Vista imċajpra, uġigħ fl-għajn,
English: Digestive system disorders: Stomach ulcer, inflammation of the pancreas Liver disorders: Liver failure, bile duct inflammation, fatty liver Muscle and bone disorders: Inflammation of the muscles Kidney disorders: Kidney failure
Maltese: Disturbi psikjatriċi u fis-sistema nervuża: Ħsibijiet ta' suwiċidju, alluċinazzjonijiet (problemi severi bil-personalità u deterjorament fil-funzjoni soċjali normali), newropatija periferali (disturbi fin nervituri li jaffettwaw l-estremitajiet) Disturbi fl-għajnejn:
English: See section 6.6.
Maltese: Ara sezzjoni 6.6.
English: Reykjavíkurvegi 76-78
Maltese: Rekjavíkurvegi 76-78
English: CI = Confidence interval.
Maltese: CI = Intervall ta' kunfidenza.
English: Summary of the safety profile
Maltese: Summarju tal-profil tas-sigurtà
English: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Iceland
Maltese: Rekjavíkurvegi 76-78 IS-220 Hafnarfjörður L-Iżlanda
English: Table 2 Study results Study GOG-0179
Maltese: Tabella 2 Riżultati tal-Istudju Studju GOG-0179
English: Ελλάδα Specifar ABEE
Maltese: Specifar ABEE
English: Date of latest renewal: 6 June 2014
Maltese: Data ta' l-aħħar tiġdid tal-awtorizzazzjoni: 6 ta' Ġunju 2014
English: ITT population Cisplatin 50 mg/m d.1 q21 d.
Maltese: Popolazzjoni ITT Cisplatin 50 mg/m2 d.1 q21 d.
English: 1 x 1 mg vial; 5 x 1 mg vial 1 x 4 mg vial; 5 x 4 mg vial
Maltese: 1 x 1 mg fjala; 5 x 1 mg fjala 1 x 4 mg fjala; 5 x 4 mg fjala
English: See leaflet for further information.
Maltese: Ara lfuljett għal aktar informazzjoni.
English: Extravasation has been reported very rarely.
Maltese: 3Estravażazzjoni ġiet irrappurtata rarament.
English: 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Maltese: sa 12-il sena, n = 18), adoloxxenti (età minn 12 sa 16-il sena, n = 9),u adulti żgħażagħ (età minn 16-il sena sa 21 sena, n = 9) b'tumuri solidi refrattarji.
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 inibixxiex l-enżimi P450 umani CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A, jew CYP4A u lanqas inibizzjoni tal-enżimi ċitostoliċi umani diidropirimidina jew ossidasi tal-ksantina (xanthine oxidase).
English: Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3
Maltese: Cisplatin 50 mg/m2 d.1 + Topotecan 0,75 mg/ m2 dx3 q21
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Maltese: Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bucharest Romania
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.
Maltese: Soppravivenza medjana (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) Rata ta' reazzjoni (%) (95 % CI) Differenza fir-rata ta' reazzjoni (95 % CI) Żmien medjan għallprogressjoni (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) N = numru totali ta' pazjenti ttrattati.
English: België/Belgique/Belgien ALL-in-1 bvba
Maltese: Luxembourg/Luxemburg ALL-in-1 bvba Belgique/Belgien
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Maltese: Il- half-life medja żdied minn 1.9 sigħat għal 4.9 sigħat.
English: Combination therapy (Cervical carcinoma)
Maltese: Terapija kkombinata (Karċinoma ċervikali)
English: 4.3 Contraindications
Maltese: 4.3 Kontroindikazzjonijiet
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 aġġustat tal-periklu għat-topotecan orali mal-grupp BSC relattiva għall-grupp BSC waħdu kien 0.64 (95 % CI: 0.45, 0.90).
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Maltese: Alopeċja kompleta jew qawwija ġiet osservata f'30 % tal-pazjenti u alopeċja parzjali f'15 % talpazjenti.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Maltese: Ma sarux studji ta' interazzjoni farmakokinetiċi umani in vivo.
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Maltese: Moderata sa severa (Hb ≤ 8.0 g/dl) f'37 % tal-pazjenti (14 % tal-korsijiet).
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 magħrufa (ma jistgħux jiġu stmati mid-dejta disponibbli).
English: Infections and infestations Very common:
Maltese: Infezzjonijiet u Infestazzjonijiet Komuni ħafna:
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Maltese: Peress li din il-mediċina qed tingħata mit-tabib jew infermier tiegħek, huwa improbabbli li inti ser tingħata iżżejjed.
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 mukożite (14 %).
English: Each vial contains 2.07 mg (0.09 mmol) sodium.
Maltese: Kull fjala fiha 2.07 mg (0.09 mmol) sodju.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Maltese: Barra minn hekk, 5 % tal-pazjenti ttrattati (1 % tal-korsijiet) kellhom sepsis (ara sezzjoni 4.4).
English: 5 x 4 mg vial
Maltese: 5 x 4 mg fjala
English: - Serious blood infection, which can be fatal.
Maltese: • Infezzjoni serja tad-demm, li tista' tkun fatali.
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Maltese: Topotecan huwa kontroindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: One study included a dose range of 1.4 mg/m to 2.4 mg/m in children (aged 2 up to
Maltese: Studju wieħed inkluda limiti tad-doza bejn 1.4 mg/m2 u 2.4 mg/m2 fi tfal (età minn 2
English: General disorders and administration site conditions Very common:
Maltese: Disturbi ġenerali u kundizzjonijiet ta' amministrazzjoni Komuni ħafna:
English: hypersensitivity reaction including rash
Maltese: reazzjoni ta' sensittività eċċessiva inkluż raxx.
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 rabdomijosarkoma.
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Maltese: Metabolit O-glucuronidation ta' topotecan u N-desmethyl topotecan ġew identifikati fl-awrina.
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leukopenia
Maltese: newtropenija bid-deni newtropenija (ara disturbi gastrointestinali taħt) tromboċitopenija anemija lewkopenija
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' N-desmethyl topotecan fl-awrina kienu anqas minn 2.0 %.
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/jum għal 5 ijiem konsekuttivi) u cisplatin (60 mg/m2/jum fil-Jum 1) ġew amministrati lil 13-il pazjent b'kanċer tal-ovarji, żieda żgħira fl-AUC (12 %, n=9) u Cmax (23 %, n=11) kienet innutata fil-jum 5.
English: - Weight loss and loss of appetite (anorexia); tiredness; weakness.
Maltese: • Tnaqqis fil-piż u nuqqas t'aptit (anoressija); għeja; debbulizza
English: Topotecan Actavis is available in cartons containing 1 vial and 5 vials.
Maltese: Topotecan Actavis huwa disponibbli f'kartun li fihom 1 fjala u 5 fjali.
English: Median (95 % C.I.)
Maltese: Medjana (95 % C
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' mjelosuppressjoni li tillimita d-doża, iddoża massima tollerata (MTD) kienet stabbilita bħala 2.0 mg/m2/jum ma' G-CSF u 1.4 mg/m2/jum mingħajr G-CSF fi studju farmakokinetiku f'pazjenti pedjatriċi b'tumuri solidi refrattarji (ara sezzjoni 5.2).
English: Median (95 % C.I) Hazard ratio (95 % C.I.)
Maltese: Medjana (95 % C.I.) Proporzjon ta' periklu (95 % C.I.)
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluż raxx, urtikarja, anġjodima u reazjonijiet anafilattiċi ġew irrappurtati f'każijiet rari.
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 5 ijiem kienet evalwata f'żewġ studji.
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 tal-Onkoloġija Ġinekoloġika(GOG 0179), topotecan flimkien ma' cisplatin (n = 147) ġie mqabbel ma' cisplatin waħdu (n = 146) għat-trattament ta' karċinoma ċervikali, persistenti, li reġgħet feġġet jew fl-istat
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' mukożite kienet ta' 4, 3, 2 u 1 % rispettivament.
English: Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Maltese: It-topotecan orali mal-grupp BSC kellu titjib statistiku sinifikanti fis-soppravivenza kumplessiva meta mqabbel mal-grupp BSC waħdu (Log-rank p = 0.0104).
English: Volume for 50 microgram/ml solution
Maltese: Volum għal soluzzjoni ta' 50 mikrogrammi/ml
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: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Maltese: Stabilità kimika u fiżika tal-konċentrat intweriet għal 24 siegħa f'temperatura ta' 25 ± 2 ° C, filkondizzjonijiet normali tad-dawl u 24 siegħa f'2°C sa 8°C, protetti mid-dawl.
English: Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Maltese: Fih mannitol (E421), aċdu tartariku (E334), aċdu idrokloriku (E507), u idrossidu tas-sodju.
English: infection
Maltese: infezzjoni
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-metabolit N-desmethyl ikkontribbwixxiet għal medja (mean) 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: 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 sottostanti jinkludu storja ta' ILD, fibrożi pulmonari, kanċer tal-pulmuni, esponiment toraċiku għar-radjazzjoni u użu ta' sustnazi pnewmotossiċi u/jew fatturi ta' stimolu ta' kolonji.
English: anaphylactic reaction angioedema urticaria
Maltese: reazzjoni anafilattika, anġodema urtikarja.
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: 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-jum 1, topotecan fil-jiem 1 sa 5), it-tneħħija ta' topotecan kienet imnaqqsa fil-jum 5 meta mqabbla mal-jum 1 (19.1 l/h/m2 meta mqabbel ma' 21.3 l/h/m2 [n = 9]) (ara sezzjoni 4.5).
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Maltese: fsada severa (assoċjata ma' tromboċitopenja) Disturbi fis-sistema immuni Komuni: