FrancophonIA/ELRC3.0 huggingface dataset:
English: Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, - recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medicinal products affecting haemostasis (see section 4.5).
Maltese: Enoxaparin sodium, bħal kull terapija antikoagulanti oħra, għandu jintuża b'kawtela f'kundizzjonijiet b'possibbiltà akbar ta' fsada, bħal: - emostasi indebolita, - storja ta' ulċera fl-istonku, - puplesija iskemika riċenti, - pressjoni għolja severa fl-arterji, - retinopatija tad-dijabete riċenti, - operazzjoni newroloġika jew oftalmoloġika, - l-użu flimkien ta' prodotti mediċinali li jaffettwaw l-emostasi (ara sezzjoni 4.5).
English: When given at a dose of 4,000 IU (40 mg) once a day subcutaneously, enoxaparin sodium significantly reduced the incidence of VTE as compared to placebo.
Maltese: Meta mogħti bid-doża ta' 4,000 UI (40 mg) darba kuljum taħt il-ġilda, enoxaparin sodium naqqas b'mod sinifikanti l-inċidenza ta' VTE meta mqabbel mal-plaċebo.
English: One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (0.8 mL) fiha 8,000 UI (80 mg) enoxaparin sodium
English: The mean maximum plasma anti-Xa activity level is observed 3 to 5 hours after SC injection and achieves approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU/mL following single SC administration of 2,000 IU, 4,000 IU, 100 IU/kg and 150 IU/kg (20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg) doses, respectively.
Maltese: UI, 100 UI/kg u 150 UI/kg (20 mg, 40 mg, 1 mg/kg u 1.5 mg/kg), rispettivament.
English: The syringe can be additionally equipped with needle guard.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Maltese: Fornuti f'pakketti ta': - 2, 6, 10, 30 u 50 siringi mimlija għal- lest - 2, 6, 10, 12, 24 u 30 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra - 2 u 10 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: Activity in vitro and in vivo
Maltese: Attività in vitro u in vivo
English: Adjusted Difference (95% CI)
Maltese: Differenza Aġġustata (CI ta' 95%)
English: Unopened vial: 3 years.
Maltese: Kunjett mhux miftuħ: 3 snin.
English: ATC code: J06BB21
Maltese: J06BB21
English: Biotransformation
Maltese: Biotransformazzjoni
English: Date of first authorisation: 18 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 18 Jannar 2017
English: Manufacturer SP Labo NV
Maltese: SP Labo NV
English: Store in a refrigerator 2 °C to 8 °C.
Maltese: Aħżen fi friġġ 2 °C sa 8 °C.
English: Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Maltese: Eċċipjenti: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, ilma għall-injezzjonijiet, sodium hydroxide.
English: Sodium hydroxide (E524) (for pH adjustment).
Maltese: Sodium hydroxide (E524) (għall-aġġustment tal-pH).
English: Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi b'ZINPLAVA Klassi tas-Sistemi u tal-Organi
English: Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Maltese: L-immunoġeniċità ta' ZINPLAVA ġiet stmata bl-użu ta' assaġġ elettrokimikuluminexxenti (ECLelectrochemiluminescence) f'MODIFY I u MODIFY II.
English: The median age was 65 years, 85 % were white, 57 % were female, and 68 % were inpatients.
Maltese: Il-medjan tal-età kien ta' 65 sena, 85 % kienu bojod, 57 % kienu nisa, u 68 % kienu pazjenti rikoverati l-isptar.
English: The mean volume of distribution of bezlotoxumab was 7.33 L (CV: 16 %).
Maltese: Il-medja tal-volum ta' distribuzzjoni ta' bezlotoxumab kienet 7.33 L (CV: 16 %).
English: Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
Maltese: Kull mL ta' konċentrat fih 0.2 mmol sodium, li huwa 4.57 mg sodium.
English: Sodium citrate dihydrate (E331) Water for injections
Maltese: Sodium citrate dihydrate (E331) Ilma għall-injezzjonijiet
English: The following side effects have been reported in clinical trials:
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati fi provi kliniċi:
English: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgium
Maltese: Industriepark 30 - Zone A 2220
English: Among the 976/1554 (62 %) patients who had a positive baseline stool culture for C. difficile a hypervirulent strain (ribotypes 027, 078 or 244) was isolated in 22 % (217 of 976 patients), of which the majority (87 %, 189 of 217 strains) were ribotype 027.
Maltese: Minn fost id-976/1554 (62 %) pazjent li kellhom koltura mill-ippurgar pożittiva għal C. difficile fil-linja bażi ġiet iżolata razza ipervirulenti (ribotipi 027, 078 jew 244) fi 22 % (217 minn 976 pazjent), li l-maġġoranza tagħhom (87 %, 189 minn 217-il razza) kienu ribotip 027.
English: ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).
Maltese: ZINPLAVA huwa indikat għall-prevenzjoni ta' rikorrenza ta' infezzjoni bi Clostridium difficile (CDIClostridium difficile infection) f'adulti li għandhom riskju kbir ta' okkorrenza mill-ġdid ta' CDI (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: • It is very important that you do not miss the dose of this medicine.
Maltese: • Huwa importanti ħafna li inti ma tfallix id-doża ta' din il-mediċina.
English: The effects of various covariates on the pharmacokinetics of bezlotoxumab were assessed in a population pharmacokinetic analysis.
Maltese: L-effetti ta' diversi kovarjati fuq il-farmakokinetika ta' bezlotoxumab ġew stmati f'analiżi farmakokinetika ta' popolazzjoni.
English: Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins.
Maltese: Antiinfettivi għal użu sistemiku, immunoglobulini speċifiċi.
English: History of one or more episodes of CDI in past 6 months Immunocompromised Severe CDI
Maltese: Storja ta' episodju wieħed jew aktar ta' CDI fl-aħħar 6 xhur Immunokompromessi CDI severa
English: After a single IV dose of 10 mg/kg bezlotoxumab, mean AUC(0-∞) and Cmax were 53,000 mcg.h/mL and 185 mcg/mL, respectively, in patients with CDI.
Maltese: Wara doża waħda ta' 10 mg/kg bezlotoxumab IV, il-medja tal-AUC(0-∞) u s-Cmax kienet 53,000 mkg.siegħa/mL u 185 mkg/mL, rispettivament, f'pazjenti b'CDI.
English: • Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Maltese: • Agħti s-soluzzjoni għall-infużjoni dilwita fuq perjodu ta' 60 minuta permezz ta' filtru fil-pajp jew fitru apparti sterili, mhux piroġeniku, b'irbit baxx mal-proteini ta' 0.2 mikroni sa 5 mikroni.
English: The number of patients completing the studies and included in the full analysis set (FAS) was 781 in the ZINPLAVA group versus 773 in the placebo group.
Maltese: In-numru ta' pazjenti li temmew l-istudji u ġew inklużi fis-sett sħiħ tal-analiżi (FAS - full analysis set) kien 781 fil-grupp ta' ZINPLAVA versus 773 fil-grupp tal-plaċebo.
English: Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set
Maltese: Tabella 3: Rata ta' Rikorrenza ta' CDI skont is-Sottogrupp tal-Fattur ta' Riskju (MODIFY I u MODIFY II, Sett Sħiħ ta' Analiżi
English: Hypervirulent strain included the following: 027, 078, or 244 ribotypes
Maltese: Ir-razza ipervirulenti kienet tinkludi li ġejjin: ribotipi 027, 078, jew 244
English: The frequency of adverse reactions is defined as follows: 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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija definita kif ġej: 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), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Infusion specific adverse reactions reported in ≥ 0.5 % of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3 %), fatigue (1 %), pyrexia (1 %), dizziness (1 %), headache (2 %), dyspnoea (1 %) and hypertension (1 %).
Maltese: Ir-reazzjonijiet avversi speċifiċi għall-infużjoni rrappurtati f'≥ 0.5 % tal-individwi li rċivew ZINPLAVA u bi frekwenza aktar minn dik bil-plaċebo kienu nawsja (3 %), għeja (1 %), deni (1 %), sturdament (1 %), uġigħ ta' ras (2 %), qtugħ ta' nifs (1 %) u pressjoni għolja (1 %).
English: A similar proportion of patients were receiving oral metronidazole (48 %) or oral vancomycin (48 %) and only 4 % were receiving fidaxomicin as antibacterial treatment for CDI.
Maltese: Proporzjon simili ta' pazjenti kienu qed jirċievu metronidazole mill-ħalq (48 %) jew vancomycin millħalq (48 %) u 4 % biss kienu qed jirċievu fidaxomicin bħala trattament antibatteriku għal CDI.
English: Twenty one (21) percent of the patients were immunocompromised and 16 % presented with clinically severe CDI.
Maltese: Wieħed u għoxrin (21) fil-mija tal-pazjenti kienu immunokompromessi u 16 % kellhom CDI severa b'mod kliniku.
English: The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe
Maltese: L-effett ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' bezlotoxumab ġie vvalutat f'pazjenti b'indeboliment ħafif (eGFR 60 sa < 90 mL/min/1.73 m2), moderat (eGFR 30
English: ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6).
Maltese: ZINPLAVA għandu jingħata bħala infużjoni waħda ta' 10 mg/kg fil-vini (ara taħt u sezzjoni 6.6).
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion
Maltese: ZINPLAVA 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni
English: The efficacy of ZINPLAVA (bezlotoxumab) was investigated in two randomised, double-blind, placebo-controlled, multicentre, Phase 3 studies (MODIFY I and MODIFY II) where 810 patients were randomised to bezlotoxumab and 803 to placebo.
Maltese: L-effikaċja ta' ZINPLAVA (bezlotoxumab) ġiet investigata f'żewġ studji randomised, b'aktar minn ċentru wieħed, ikkontrollati bi plaċebo, ta' Fażi 3, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (MODIFY I u MODIFY II) fejn 810 pazjenti kienu randomised biex jirċievu bezlotoxumab u 803 biex jirċievu plaċebo.
English: - The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
Maltese: polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), ilma għall injezzjonijiet, u sodium hydroxide (E524) (għall-aġġustament tal-pH).
English: The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours.
Maltese: Is-soluzzjoni dilwita ta' ZINPLAVA tista' tinħażen f'temperatura ambjentali sa 16-il siegħa jew filfriġġ bejn 2 °C u 8 °C sa 24 siegħa.
English: ZINPLAVA with SoC Percent (n/N)
Maltese: Perċentwal (n/N)
English: Each mL contains 25 mg bezlotoxumab.
Maltese: Kull mL fih 25 mg bezlotoxumab.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
Maltese: ZINPLAVA 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni bezlotoxumab
English: Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustment fid-doża f'pazjenti li għandhom età ta' ≥ 65 sena (ara sezzjoni 5.2).
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjon 6.6.
English: How to store ZINPLAVA
Maltese: Kif jaħdem ZINPLAVA
English: No clinical data are available on the possible effects of bezlotoxumab on fertility.
Maltese: Ma hija disponibbli l-ebda dejta klinika dwar l-effetti possibbli ta' bezlotoxumab fuq il-fertilità.
English: The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Maltese: L-esperjenza b'ZINPLAVA fil-pazjenti hija limitata għal episodju wieħed ta' CDI u għoti darba (ara sezzjoni 4.4).
English: Patients received a 10- to 14-day course of oral antibacterial therapy for CDI (metronidazole, vancomycin or fidaxomicin, chosen by the investigator).
Maltese: Il-pazjenti rċivew kors ta' 10 ijiem sa 14-il jum ta' terapija antibatterika mill-ħlaq għal CDI (metronidazole, vancomycin jew fidaxomicin, magħżula mill-investigatur)
English: Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Maltese: L-istabbilità kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' 2°C - 8°C jew16-il siegħa f'temperatura ambjentali (f'temperatura ta' 25°C jew anqas).
English: There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).
Maltese: Ma kien hemm l-ebda rbit ta' bezlotoxumab ma' tessut riproduttiv fi studji dwar reattività ma' xi tessut ieħor, u ma kien hemm l-ebda effetti notevoli fl-organi riproduttivi tal-irġiel u n-nisa fi studji dwar effett tossiku minn dożi ripetuti fil-ġrieden (ara sezzjoni 5.3).
English: Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set
Maltese: Tabella 2: Rata ta' Rikorrenza ta' CDI Matul it-12-il Ġimgħa Wara l-Infużjoni (MODIFY I u MODIFY II, Sett Sħiħ ta' Analiżi
English: Adult patients had a confirmed diagnosis of CDI, which was defined as diarrhoea (passage of 3 or more loose bowel movements as defined in the Bristol stool chart as types 5 through 7 in 24 or fewer hours) and a positive stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.
Maltese: Il-pazjenti adulti kellhom dijanjosi kkonfermata ta' CDI, li kienet definita bħala dijarea (3 episodji jew aktar ta' ppurgar maħlul kif iddefinit fiċ-ċart Bristol tal-ippurgar bħala tipi minn 5 sa 7 f'24 siegħa jew anqas) u riżultat pożittiv ta' test għal C. difficile tossiġeniku fl-ippurgar minn kampjun tal-ippurgar miġbur mhux aktar minn 7 ijiem qabel id-dħul fl-istudju.
English: It binds to C. difficile toxin B.
Maltese: Huwa jintrabat mat-tossin B ta' C. difficile.
English: • You will get ZINPLAVA as an infusion (drip) into a vein.
Maltese: • Inti se tingħata ZINPLAVA bħala infużjoni (dripp) fil-vini.
English: ZINPLAVA with SoC Percent (n/m)
Maltese: Perċentwal (n/m)
English: Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity.
Maltese: Bezlotoxumab huwa antikorp antitossina monoklonali tal-bniedem li jintrabat b'affinità kbira mattossina B ta' C. difficile u jinnewtralizza l-attività tiegħu.
English: • Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Maltese: • Iġbed il-volum meħtieġ mill-kunjett(i) abbażi tal-piż tal-ġisem tal-pazjenti (f'kg) u ttrasferih ġo borża ta' għoti fil-vini li jkun fiha Injezzjoni ta' 0.9 % Sodium Chloride, jew inkella Injezzjoni ta' 5 % Dextrose, biex tipprepara soluzzjoni dilwita b'konċentrazzjoni finali b'firxa minn 1 sa 10 mg/mL.
English: The mean clearance of bezlotoxumab was 0.317 L/day (CV: 41 %) and the terminal half-life (t½) was approximately 19 days
Maltese: It-tneħħija medja ta' bezlotoxumab kienet 0.317 L/jum (CV: 41 %) u ż-żmien biex l-attività tiegħu tonqos binnofs (t½) kien ta' madwar 19-il jum (28 %).
English: ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.
Maltese: ZINPLAVA huwa mediċina li tingħata flimkien ma' antibijotiku biex tevita li infezzjoni bi Clostridium difficile (CDI - Clostridium difficile infection) tirritorna f'pazjenti ta' 18-il sena jew akbar li qegħdin f'riskju kbir li CDI tirritorna.
English: Bezlotoxumab has limited extravascular distribution.
Maltese: Bezlotoxumab għandu distribuzzjoni ekstravaskulari limitata.
English: Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
Maltese: Tabella 1 tippreżenta r-reazzjonijiet avversi rrappurtati fi żmien 4 ġimgħat mill-infużjoni f'pazjenti ttrattati b'ZINPLAVA u elenkati skont il-Klassi tas-Sistemi u tal-Organi.
English: You should not be given ZINPLAVA if:
Maltese: M'għandekx tingħata ZINPLAVA jekk:
English: Each mL of concentrate contains 25 mg bezlotoxumab.
Maltese: Kull mL ta' konċentrat fih 25 mg bezlotoxumab.
English: Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Maltese: Terapija antibatterika ta' kura standard mill-ħalq (SoC - standard of care) għal CDI ingħatat flimkien ma' ZINPLAVA.
English: The most common adverse reactions following treatment with ZINPLAVA (reported in ≥ 4 % of patients within the first 4 weeks of infusion) were nausea, diarrhoea, pyrexia and headache.
Maltese: L-aktar reazzjonijiet avversi komuni wara trattament b'ZINPLAVA (irrappurtati f'≥ 4 % tal-pazjenti fi żmien l-ewwel 4 ġimgħat tal-infużjoni) kienu nawsja, dijarea, deni u uġigħ ta' ras.
English: The following factors had no clinically meaningful effect on the exposure of bezlotoxumab and no dose adjustment is required: age (range 18 to 100 years), gender, race, ethnicity, renal impairment, hepatic impairment, and presence of co-morbid conditions.
Maltese: Il-fatturi li ġejjin ma kellhom l-ebda effett ta' sinifikat kliniku fuq l-esponiment għal bezlotoxumab u ma huwa meħtieġ l-ebda aġġustament fid-doża: età (firxa minn 18-il sena sa 100 sena), sess talpersuna, razza, etniċità, indeboliment tal-kliewi, indeboliment tal-fwied, u l-preżenza ta' kondizzjonijiet mediċi oħra fl-istess waqt.
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between elderly patients 65 years and older and patients under 65 years of age.
Maltese: Ma nstabu l-ebda differenzi li kellhom sinifikat kliniku fl-esponiment għal bezlotoxumab bejn pazjenti anzjani ta' 65 sena u aktar u pazjenti li kellhom inqas minn 65 sena.
English: See leaflet.
Maltese: TA' EĊĊIPJENTI
English: Serious adverse reactions
Maltese: Reazzjonijiet avversi serji
English: • you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: • inti allerġiku għal bezlotoxumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: The CDI recurrence rates are shown in Table 2.
Maltese: Ir-rati ta' rikorrenza ta' CDI qed jintwerew f'Tabella 2.
English: What ZINPLAVA contains - The active substance is bezlotoxumab.
Maltese: X'fih ZINPLAVA - Is-sustanza attiva hi bezlotoxumab.
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni)
English: One 40 mL vial contains 1,000 mg of bezlotoxumab.
Maltese: Kull kunjett ta' 40 mL fih 1,000 mg bezlotoxumab.
English: Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters.
Maltese: Normalment antikorpi monoklonali terapewtiċi ma jkollhomx potenzjal sinifikanti għal interazzjonijiet bejn mediċina u oħra, minħabba li huma ma jaffettwawx l-enzimi taċ-ċitokrom P450 b'mod dirett u mhumiex sustrati tattrasportaturi tal-fwied jew tal-kliewi.
English: Each vial contains 1,000 mg bezlotoxumab.
Maltese: Kull kunjett fih 1,000 mg bezlotoxumab.
English: How you are given ZINPLAVA 4.
Maltese: Kif taħżen ZINPLAVA 6.
English: The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age.
Maltese: L-effett tal-età fuq il-farmakokinetika ta' bezlotoxumab ġie vvalutat f'pazjenti li kellhom firxa ta' etajiet minn 18 sa 100 sena.
English: Infected with a hypervirulent strain
Maltese: Infettati b'razza ipervirulenti Infettati bir-ribotip 027
English: Of the total 28 % had one or more episodes of CDI within the six months prior to the episode under treatment (18 % of the patients had one, 7 % had two and a few patients had 3 or more prior episodes).
Maltese: Mit-total 28 % kellhom episodju wieħed jew aktar ta' CDI fi żmien is-sitt xhur ta' qabel l-episodju li kien qed jiġi ttrattat (18 % tal-pazjenti kellhom episodju wieħed, 7 % kellhom tnejn u ftit pazjenti kellhom 3 episodji preċedenti jew aktar).
English: The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II; see section 5.1) in which all patients received a single dose.
Maltese: Ir-reazzjonijiet avversi wara t-tieni doża ma kinux differenti ħafna minn dawk osservati wara l-ewwel doża, u huma konsistenti ma' reazzjonijiet avversi osservati fiż-żewġ provi ta' Fażi 3 (MODIFY I u MODIFY II; ara sezzjoni 5.1) fejn il-pazjenti kollha rċivew doża waħda.
English: Preparation of diluted solution
Maltese: Preparazzjoni tas-soluzzjoni dilwita
English: EXP
Maltese: SoC
English: The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences.
Maltese: L-epitop tat-tossina B li magħha jintrabat bezlotoxumab jiġi kkonservat, għalkemm mhux identiku, fis-sekwenzi magħrufa kollha tat-tossina.
English: Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) Based on the Miettinen and Nurminen method without stratification Based on medical conditions or medications received that may result in immunosuppression Zar score ≥ 2
Maltese: Sett Sħiħ ta' Analiżi = sottosett tal-individwi kollha li kienu randomised bi tħollija barra ta' dawk li: (i) ma rċivewx infużjoni tal-mediċina tal-istudju, (ii) ma kellhomx riżultat pożittiv ta' test lokali tal-ippurgar għal C. difficile tossiġeniku; (iii) ma rċivewx terapija b'kura standard definita fil-protokoll fi żmien jum wieħed mill-infużjoni SoC = Antibatteriku tal-Kura Standard (metronidazole jew vancomycin jew fidaxomicin)
English: Frequency Adverse Reaction(s)
Maltese: Frekwenza Reazzjoni(jiet) Avversi
English: In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
Maltese: Fi provi kliniċi, pazjenti b'CDI ingħataw biss doża waħda ta' ZINPLAVA (ara sezzjoni 5.1).
English: Bezlotoxumab exposures in healthy subjects increased in an approximately dose proportional manner across the 0.3 to 20 mg/kg dose range.
Maltese: Esponimenti għal bezlotoxumab f'individwi f'saħħithom żdiedu b'mod bejn wieħed u ieħor fi proporzjon mad-doża filmedda kollha tad-dożi minn 0.3 sa 20 mg/kg.