FrancophonIA/ELRC3.0 huggingface dataset:
English: If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Maltese: Jekk jingħataw cisplatin jew carboplatin lill-pazjent fil-jum 1 tad-dożaġġ ta' topotecan, trid tingħata doża iktar baxxa ta' kull aġent, biex tkun tista' titjieb it-tollerabilità mqabbla mad-doża ta' kull aġent jekk l-aġent tal-platinu jingħata fil-jum 5 tad-dożaġġ tat-topotecan.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn 10,000)
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Maltese: Id-doża rakkommandata ta' topotecan hija ta' 0.75 mg/m2/jum amministrata bħala infużjoni ġol-vina ta' 30 minuta fil-jiem 1, 2 u 3. Cisplatin huwa amministrat bħala infużjoni ġol-vina fil-jum 1 f'doża ta'
English: (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/m2 fi tfal (n = 18), adoloxxenti (n = 3) u adulti żgħażagħ (n = 3) b'lewċemija.
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Maltese: Fil-pazjenti li ma wiġbux għat-trattament, jew li reġgħet feġġitilhom il-marda fi żmien 3 xhur wara t-terapija b'cisplatin (n = 186), ir-rata ta' rispons kienet 10 %.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Maltese: Il-monoterapija b'topotecan u topotecan flimkien ma' cisplatin huma assoċjati b'mod komuni ma' tromboċitopenja klinikament rilevanti.
English: Each vial contains 0.52 mg (0.0225 mmol) sodium.
Maltese: Sustanza mhux attiva b'effett magħruf Kull fjala fiha 0.52 mg (0.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Maltese: Anoreksja (12 %), telqa (3 %) u iperbilirubinimja (1 %) kienu ġrajjiet serji oħra li kienu, jew setgħu kienu, assoċjati ma' kura b'topotecan.
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Maltese: Fl-istudji dwar it-tossiċita riproduttiva b'topotecan fil-firien, ma kien hemm l-ebda effett fuq il-fertilità maskili jew femminili; madankollu, fin-nisa ġew osservati superovulazzjoni u telf kemmxejn akbar fil pre-implantazzjoni.
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Maltese: TAL-PRODOTT MEDIĊINALI Potactasol 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan IV
English: The volume of reconstituted concentrate corresponding to the calculated individual dose should be further diluted with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose, to give a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Maltese: Il-volum tal-konċentrat rikostitwit li jikkorrispondi għad-doża individwali kkalkulata, għandu jkompli jiġi dilwit jew b'klorur tas-sodju 9 mg/ml (0.9 %) jew 5 % w/v glukożju biex jagħti konċentrazzjoni finali ta' bejn 25 u 50 mikrogramma kull ml fis-soluzzjoni għall-infużjoni, per eżempju:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: il-ħin u il-kundizzjonijiet tal-ħażna ta' waqt l-użu qabel jintuż huma r-responsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C sa 8°C, sakemm ir rikostituzzjoni/dilwizzjoni ma tkunx saret f'kundizzjonijiet asettiċ ikkontrollati u vvalidati.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Maltese: Qabel ma jingħata l-ewwel kors ta' topotecan, il-pazjenti irid ikollhom linja bażi tal-għadd ta' newtrofili ta' ≥ 1.5 x 109/l, għadd ta' plejtlits ta' ≥ 100 x 109/l, u livell ta' emoglobina ta' ≥ 9 g/dl (wara t-trasfużjoni, jekk ikun hemm bżonn).
English: Vials contain either 1 mg or 4 mg of topotecan.
Maltese: 4 ml of 1 mg/ml soluzzjoni topotecan
English: gastrointestinal perforation Hepatobiliary disorders Common:
Maltese: Disturbi fil-fwied u fil-marrara Komuni:
English: - Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
Maltese: • Tħossok ġeneralment debboli u għajjien/a, li jistgħu jkunu sintomi ta' tnaqqis fl-għadd taċ ċelloli ħomor tad-demm (anemija temporanja).
English: mucositis
Maltese: Ċitotossiku
English: Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Maltese: - Potactasol 4 mg b'4 ml ilma għall-injezzjonijiet
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Maltese: M'hemmx biżżejjed esperjenza bl-użu ta' topotecan f'pazjenti b'indeboliment sever tal-funzjoni tal fwied (bilirubin fis-serum ≥ 10 mg/dl) minħabba ċirrożi.
English: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Maltese: Il-profil tas-sigurtà ta' topotecan meta jingħata flimkien ma cisplatin fi studji kliniċi tal-kanċer ċervikali huwa konsistenti ma' dak li ntwera b'monoterapija ta' topotecan.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Maltese: Pazjenti li ma ħadu l-ebda kimoradjuterapija b'cisplatin qabel Cisplatin
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Maltese: Potactasol 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Potactasol 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Metabolism and nutrition disorders Very common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Maltese: Għeja kienet irrappurtata bejn wieħed u ieħor f'25 % tal-pazjenti u astenija f'bejn wieħed u ieħor 16 % tal-pazjenti li kienu qed jieħdu topotecan.
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Maltese: - Potactasol 1 mg b'1.1 ml ilma għall-injezzjonijiet (billi għandu 10 % żejjed)
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Maltese: Fi studji kliniċi, ġie irrapurtat raxx f'4 % tal-pazjenti u ħakk f'1.5 %
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Maltese: Hemm ftit jew l-ebda akkumulazzjoni ta' topotecan b'dożaġġ ripetut ta' kuljum u ma hemm ebda evidenza ta' bidla fil-farmakokinetika wara dożi multipli.
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: 39 ml/min hija ta' 0.75 mg/m2/jum għal ħamest ijiem konsekuttivi.
English: Mild abdominal pain was reported in 4 % of patients.
Maltese: Bejn wieħed u ieħor 51 %
English: Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Potactasol 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Fjala Tip I tal-ħġieġ bla kulur (5 ml), tapp brombutiliku griż u siġill tal-aluminju b'għatu tal-plastik li jitfaqqa' li jkun fih 1 mg topotecan.
English: MedDRA version 21.0.
Maltese: MedDRA verżjoni 21.0.
English: See Table 3.
Maltese: Ara Tabella 3.
English: Berkshire SL1 4DX United Kingdom
Maltese: Berkshire SL1 4DX
English: For adults:
Maltese: Pazjenti Adulti:
English: P - Value Mean (SD) Wilcoxon Signed Rank
Maltese: Valur P Medja (SD) Wilcoxon Signed Rank
English: 3 Based on a stratified log-rank test.
Maltese: 3 Abbażi ta' test log-rank stratifikat.
English: Meningococcal infection b, Sepsis,
Maltese: Infezzjoni meningokokkali b,Sepsis,
English: Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italy
Maltese: Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900
English: ECU-MG-302
Maltese: u ECU-MG-302
English: Leukopenia, Anaemia
Maltese: Lewkopenija, Anemija
English: 2 Based on the complementary log-log transformation.
Maltese: 2 Abbażi tat-trasformazzjoni log-log komplementari.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Axxess fir-riġlejn/dirgħajn, Axxess fil-kolon, Axxess renali, Axxess taħt il-ġilda, Axxess fis-snien, Axxess epatospleniku, Axxess perirettali, axxess fir-rektum.
English: Included Studies: Asthma (C07-002), aHUS(C08-002, C08-003, C10-003, C10-004), Dermatomyositis (C99-006), gMG (C08-001, ECU-MG-301, ECU-MG-302 data cut as of 31Dec2017), Neuromyelitis Optica Spectrum Disorder (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05001, E07-001, M07-005, X03-001, X03-001A), Psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
Maltese: Inklużi: Ażżma (C07-002), aHUS (C08-002, C08-003, C10-003, C10-004), Dermatomijosite (C99-006), gMG (C08-001, ECU-MG-301, ECU-MG-302 waqaf il-ġbir tad-dejta fil-31Diċ2017), Disturb ta' Newromajelite Optica Spectrum (ECU-NMO-301), glomerulopatija tal-membrana idjopatika (IMG - idiopathic membranous glomerulopathy), (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05001, E07-001, M07-005, X03-001, X03-001A), Psorjasi (C99-007), artrite rewmatojde (RA - rheumatoid arthritis) (C01-004, C97-001, C99-001, E01-004, E99-001), Escherichia coli li tipproduċi t-tossina Shigasindrome uremiku emolitiku (STEC-HUS - Shiga toxin-producing Escherichia coli-hemolytic uremic syndrome)(C11-001), Lupus erythematosus sistemiku (SLE - Systemic lupus erythematosus) (C97-002).
English: Date of latest renewal : 18 June 2012
Maltese: Data tal-aħħar tiġdid: 18 ta' Ġunju 2012
English: Mean Age (SD)
Maltese: Età medja (SD)
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA25
Maltese: Immunosoppressanti selettivi, Kodiċi ATC: L04AA25.
English: 1 Based on the Kaplan-Meier product limit method.
Maltese: 1 Abbażi tal-metodu tal-limitu tal-prodott ta' Kaplan-Meier.
English: Placebo (n=63)
Maltese: Plaċebo (n=63)
English: LDH AUC (U/L x Day)
Maltese: LDH AUC (U/L x Jum)
English: In Paroxysmal Nocturnal Haemoglobinuria (PNH):
Maltese: F'Emoglobinurja Notturna Parossimali (PNH):
English: Rate 95% CI
Maltese: Rata 95% CI
English: Pharmacokinetic Parameters
Maltese: Parametri Farmakokinetiċi
English: Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Maltese: Każijiet oħra ta' speci ta' Neisseria ġew irrappurtati inklużi sepsis b'Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp mhux speċifikati.
English: Refractory gMG
Maltese: gMG refrattorja
English: Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections.
Maltese: Sodium bħala chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 u ilma għall-injezzjonijiet.
English: (rhinorrhoea)
Maltese: (ġenituri)
English: p-value (using repeated measures analysis)
Maltese: valur p (bl-użu ta' analiżi ta' kejl ripetut)
English: Lonza Biologics Porriño, S.L.
Maltese: Lonza Biologics Porriño, S.L. C/ La Relba, s/n.
English: • menstrual disorder
Maltese: • disturb menstruwali
English: Clear, colorless, pH 7.0 solution.
Maltese: Soluzzjoni ċara, bla kulur, pH 7.0.
English: Malignant melanoma, Myelodysplastic syndrome
Maltese: Melanoma malinna, Sindrome majelodisplastiku
English: 228 Bath Road Slough
Maltese: Lonza Biologics, plc. 228 Bath Road Slough
English: Parameter aHUS Study C10-004 N = 41
Maltese: Studju aHUS C10-004 N = 41
English: At data cut off (20 April 2012)
Maltese: Fid-data li fiha ma baqgħetx tinżamm l-informazzjoni (20 t'April, 2012)
English: • Signs and symptoms of infection and sepsis.
Maltese: • Sinjali u sintomi ta' infezzjoni u sepsis.
English: Thrombocytopenia, Lymphopenia
Maltese: Tromboċitopenija, Limfopenija
English: SEM= Standard Error of the Mean CI= Confidence Interval, MGC= Myasthenia Gravis Composite, MG-QoL15= Myasthenia Gravis Qualtiy of Life 15
Maltese: Kunfidenza), MGC = Myasthenia Gravis Composite, MG-QoL15= Myasthenia Gravis Quality of Life 15.
English: Efficacy Parameter aHUS Study C10-004 (N = 41)
Maltese: Studju aHUS C10-004 (N = 41)
English: In atypical Haemolytic Uremic Syndrome (aHUS), refractory generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD):
Maltese: F'Sindrome Uremiku Emolitku atipiku (aHUS), Mijastenija Gravis refrattorja ġeneralizzata (gMG) u Disturb ta' Newromajelite Optica Spectrum (NMOSD):
English: • Maintenance Phase:
Maltese: • Fażi ta' manteniment:
English: Soliris was administered as an intravenous infusion over 25 - 45 minutes.
Maltese: Soliris ingħata bħala infużjoni fil-vini fuq 25-45 minuta.
English: Table 11: Clinical deterioration and rescue therapy in ECU-MG-301 Variable
Maltese: Tabella 11: Deterjorament kliniku u terapija ta' salvataġġ f'ECU-MG-301 Varjabbli
English: PNH Laboratory Monitoring
Maltese: Monitoraġġ fil-laboratorju ta' PNH
English: The safety profiles in the different paediatric subsets of age appear similar.
Maltese: Il-profili ta'sigurtà fis-sottosetts pedjatriċi differenti ta' età dehru simili.
English: • spontaneous penile erection
Maltese: • erezzjoni spontanja tal-pene
English: Paediatric patients in PNH and aHUS:
Maltese: Pazjenti pedjatriċi f'PNH u aHUS:
English: 30 to <40 kg 600 mg weekly x 2 900 mg at week 3; then 900 mg every 2 weeks 20 to <30 kg 600 mg weekly x 2 600 mg at week 3; then 600 mg every 2 weeks 10 to <20 kg 600 mg weekly x 1 300 mg at week 2; then 300 mg every 2 weeks 5 to <10 kg 300 mg weekly x 1 300 mg at week 2; then 300 mg every 3 weeks
Maltese: 30 sa <40 kg 600 mg kull ġimgħa x 2 900 mg f'ġimgħa 3; imbagħad 900 mg kull ġimagħtejn 20 sa <30 kg 600 mg kull ġimgħa x 2 600 mg f'ġimgħa 3; imbagħad 600 mg kull ġimagħtejn 10 sa <20 kg 600 mg kull ġimgħa x 1 300 mg f'ġimgħa 2; imbagħad 300 mg kull ġimagħtejn 5 sa <10 kg 300 mg kull ġimgħa x 1 300 mg f'ġimgħa 2; imbagħad 300 mg kull 3 ġimgħat
English: Refractory Generalized Myasthenia Gravis
Maltese: Mijastenija Gravis Ġeneralizzata Refrattorja
English: The majority (90.9%) of patients were female.
Maltese: Il-maġġoranza (90.9%) tal-pazjenti kienu nisa.
English: (≥1/100 to <1/10)
Maltese: Komuni (≥1/100 sa <1/10)
English: - sodium phosphate dibasic - sodium chloride
Maltese: Sodium phosphate dibasic
English: Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000) frequency with eculizumab, are listed by system organ class and preferred term.
Maltese: Reazzjonijiet avversi rrappurtati bi frekwenza komuni ħafna (≥1/10) komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) jew rari (≥1/10,000 sa <1/1,000) b'eculizumab huma elenkati skont il-klassi tal-organi tassistema u t-terminu ppreferut.
English: Treatment monitoring aHUS patients should be monitored for signs and symptoms of thrombotic microangiopathy (TMA) (see section 4.4 aHUS laboratory monitoring).
Maltese: Pazjenti b'aHUS għandhom jiġu mmonitorjati għal sinjali u sintomi ta' mikroanġjopatija trombotika (TMA) (ara sezzjoni 4.4 Monitoraġġ tal-laboratorju ta' aHUS).
English: n (%) (95% CI)
Maltese: LS (95% CI)
English: Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Maltese: Il-medikazzjonijiet konkomitanti kienu jinkludu sustanzi anti-trombotiċi fi 63% tal-pazjenti u kortikosterojdi sistemiċi f'40% tal-pazjenti.
English: • The risk of developing antibodies to eculizumab.
Maltese: • Ir-riskju li jiżviluppaw antikorpi għal eculizumab.
English: Figure 1: Mean changes from baseline in MG-ADL (1A) and QMG (1B) over Studies ECU-MG-301 and ECU-MG-302
Maltese: Figura 1: Tibdil medju mil-linja bażi f'MG-ADL (1A) u QMG (1B) matul Studji ECU-MG-301
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation : 20 June 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Ġunju 2007
English: Soliris is indicated in adults and children for the treatment of: - Paroxysmal nocturnal haemoglobinuria (PNH).
Maltese: Soliris huwa indikat fl-adulti u t-tfal għat-trattament ta': - Emoglobinurja notturna parossimali (paroxymal nocturnal haemoglobinuria - PNH).
English: • infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system
Maltese: • infezzjoni tal-pulmun (pnewmonja), riħ komuni (nażofarinġite), infezzjoni fis-sistema urinarja
English: Soliris contains sodium
Maltese: Soliris fih sodium
English: *See paragraph Description of selected adverse reactions.
Maltese: *Ara l-paragrafu Deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: • Enrolment in the PNH and aHUS registries.
Maltese: • Reġistrazzjoni fir-reġistri PNH u aHUS.
English: 300 mg per infusion of fresh frozen plasma
Maltese: 300 mg għal kull infużjoni ta' plażma ffriżata friska
English: In PNH placebo controlled studies low antibody responses have been reported with a frequency (3.4%) similar to that of placebo (4.8%).
Maltese: Fi studji PNH kkontrollati bi plaċebo, ġew irrappurtati risponsi ta' antikorpi baxxi bi frekwenza (3.4%) simili għal dik ta' plaċebo (4.8%).
English: Table 2: Patient Demographics and Characteristics in C04-001 and C04-002 C04-001
Maltese: Tabella 2: Demografiċi u Karatteristiċi tal-Pazjenti f'C04-001 u C04-002
English: • Do not administer Soliris as an intravenous push or bolus injection.
Maltese: • Tagħtix Soliris bħala intravenous push jew injezzjoni bolus.
English: Mean Hgb level (g/dL) at setpoint (SD)
Maltese: Livell medju ta' Hgb (g/dL) fil-punt stabbilit(SD)
English: <12 years (n=15)
Maltese: <12-il sena (n=15)
English: The distribution of changes from Baseline to End of Study on other secondary endpoints favored eculizumab treatment over placebo across all neurologic disability (EDSS score [nominal p=0.0597] and mRS [nominal p=0.0154]), functional disability (HAI [nominal p=0.0002]) and quality of life (EQ-5D VAS [nominal p=0.0309] and EQ-5D Index [nominal p= 0.0077]) measures.
Maltese: Id-distribuzzjoni ta' bidliet mil-Linja Bażi għat-Tmiem tal-Istudju fuq punti aħħarin sekondarji oħra kienet tiffavorixxi l-kura b'eculizumab kontra plaċebo għall-miżuri kollha ta' diżabilità newroloġika (punteġġ ta' EDSS [nominali p=0.0597] u mRS (modified Rankin Scale - Skala ta' Rankin immodifikata) [nominali p=0.0154]), diżabilità funzjonali (HAI (Hauser Ambulation Index - Indiċi talMixi ta' Hauser) [nominali p=0.0002]) u kwalità tal-ħajja (EQ-5D VAS [nominali p=0.0309] u Indiċi EQ-5D [nominali p= 0.0077]).
English: Menstrual disorder
Maltese: Disturb menstruwali
English: Primary endpoints included platelet count change from baseline in study C08-002A/B and thrombotic microangiopathy (TMA) event-free status in study C08-003A/B.
Maltese: Punti aħħarin primarji kienu jinkludu bidla fl-għadd tal-plejtlits fi studju C08-002A/B u stat mingħajr każijiet ta' mikroanġjopatija trombotika (TMA) fi studju C08-003A/B.
English: Pharmacokinetics and Drug Metabolism
Maltese: Farmakokinetika u Metaboliżmu tal-Mediċina
English: − The other ingredients are: - sodium phosphate monobasic
Maltese: Sodium phosphate monobasic
English: Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids.
Maltese: L-antikorpi umani huma katabolizzati l-aktar minn enzimi lisożomali għal peptidi żgħar u aċidi amminiċi.
English: Spontaneous penile erection,
Maltese: Erezzjoni spontanja talpene
English: Paroxysmal Nocturnal Haemoglobinuria
Maltese: Emoglobinurija Notturna Parossimali
English: An interim analysis of Study ECU-NMO-302 demonstrates a significant and clinically meaningful reduction in On-trial ARR (as determined by the Treating Physician) on eculizumab treatment, based on the median (min, max) change (-1.829 [-6.38, 1.63], p<0.0001) from historical ARR (24 months prior to screening in Study ECU-NMO-301).
Maltese: Analiżi interim ta' Studju ECU-NMO-302 turi tnaqqis statistikament sinifikanti u klinikament sinifikanti fl-ARR matul il-prova (kif iddeterminat mit-Tabib Kuranti) fil-kura b'eculizumab, abbażi tal-bidla medjana (min, mass) (-1.829 [-6.38, 1.63], p<0.0001) minn ARR li seħħet fil-passat (24 xahar qabel l-iscreening fi Studju ECU-NMO-301).
English: Basedow's disease
Maltese: Marda ta' Basedow
English: (≥1/10,000 to <1/1,000)
Maltese: (≥1/10,000 sa
English: Haematologic normalization, n (%) (95% CI)
Maltese: Normalizzazzjoni ematoloġika, n (%) (95% CI)
English: In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 3/100 (3%) by the ECL bridging format assay.
Maltese: F'pazjenti b'aHUS ikkurati b'Soliris, l-antikorpi għal Soliris kienu rilevanti fi 3/100 (3%) permezz ta' analiżi b'ECL bridging format assay.
English: Twenty-two (22) (17.6%) elderly refractory gMG patients (> 65 years of age) were treated with Soliris in the clinical trials.
Maltese: Tnejn u għoxrin (22) (17.6%) pazjenti anzjani refrattorji għal gMG (> 65 sena) kienu ttrattati b'Soliris fil-provi kliniċi.
English: • Diluted solution of Soliris may be stored at 2°C - 8°C for up to 24 hours prior to administration.
Maltese: • Soluzzjonijiet dilwiti ta' Soliris jistgħu jinħażnu f'temperatura ta' 2°C - 8°C sa 24 siegħa qabel ma jingħataw.
English: * Immunosuppressant's included, but are not limited to, corticosteroids, azathioprine, mycophenolate, methotrexate , cyclosporine, tacrolimus, or cyclophosphamide.
Maltese: Kwalunkwe intubazzjoni minn meta saret id-dijanjosi (MGFA klassi V), n (%) * Immunosoppressanti inklużi, iżda mhux limitati għal, kortikosterojdi, azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, jew cyclophosphamide.
English: Table 18: Efficacy Outcomes in Prospective aHUS Study C10-003
Maltese: Tabella 18: Riżultati ta' Effikaċja fi Studju Prospettiv aHUS C10-003
English: Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using sodium chloride 9 mg/ml (0.9%) solution for injection, sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% dextrose in water, as the diluent.
Maltese: Iddilwa Soliris għal konċentrazzjoni finali ta' 5 mg/mL b'żieda mal-borża ta' infużjoni billi tuża sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, sodium chloride 4.5 mg/mL (0.45%) soluzzjoni għall-injezzjoni, jew 5% dextrose fl-ilma, bħala d-dilwent.
English: • Diluents are Sodium chloride 9 mg/ml (0.9%) solution for injection, Sodium chloride 4.5 mg/ml
Maltese: • Id-dilwenti huma Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, Sodium chloride 4.5 mg/mL (0.45%) soluzzjoni għall-injezzjoni jew 5% dextrose fl-Ilma.