FrancophonIA/ELRC3.0 huggingface dataset:
English: The persistence of protection following vaccination has been evaluated through longer-term follow-up in Short-term Persistence Substudy (STPS) and Long-term Persistence Substudy (LTPS) and supports the continued benefit of ZOSTAVAX throughout the follow-up periods studied.
Maltese: Il-persistenza tal-protezzjoni wara t-tilqim ġiet ivvalutata permezz ta' segwitu għal żmien itwal f'Sottostudju ta' Presistenza għal Żmien Qasir (STPS - Short-term Persistence Substudy) u Sottostudju ta' Persistenza għal Żmien Twil (LTPS - Long-term Persistence Substudy) u ssostni l-benefiċċju kontinwu ta' ZOSTAVAX matul il-perjodi kollha ta' segwitu studjati.
English: There is no relevant use of ZOSTAVAX in children and adolescents for prevention of primary varicella infection (chickenpox).
Maltese: M'hemm l-ebda użu rilevanti ta' ZOSTAVAX fit-tfal u l-adoloxxenti għall-prevenzjoni ta' infezzjoni primarja bil-variċella (ġidri r-riħ).
English: Injection site: Erythema
Maltese: Post tal-injezzjoni:
English: Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (30 years of age or older) receiving live attenuated zoster vaccine, injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Maltese: Abbażi ta' dejta limitata minn 2 provi kliniċi li fihom ġew reġistrati individwi seronegattivi jew seropożittivi b'livelli baxxi għal VZV (b'età ta' 30 sena jew aktar) li rċivew tilqima zoster ħajja attenwata, l-esperjenzi avversi fil-post tal-injezzjoni u dawk sistemiċi ġeneralment kienu simili għal dawk irrappurtati minn individwi oħra li rċivew ZOSTAVAX fi provi kliniċi, bi 2 mis-27 individwu jirrappurtaw deni.
English: Store and transport refrigerated (2C - 8C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2°C - 8°C).
English: VE estimates by age at vaccination and average VE estimates over the first 3 and 5 years postvaccination are shown below (see Table 6).
Maltese: VE stmata skont l-età tal-persuna meta tlaqqmet u stimi medji ta' VE fuq l-ewwel 3 sa 5 snin wara ttilqim qed jintwerew taħt (ara Tabella 6).
English: This vaccine may contain traces of neomycin.
Maltese: Din it-tilqima jista' jkun fiha traċċi ta' neomycin.
English: Of the 295 ZOSTAVAX recipients, one case of serious vaccine related maculo-papular rash was reported on Day 4 following Dose 1 of ZOSTAVAX (see section 4.3).
Maltese: Mill-295 persuna li rċivew ZOSTAVAX, każ wieħed ta' raxx makulopapulari serju marbut mal-vaċċin ġie rrappurtat f'Jum 4 wara d-Doża 1 ta' ZOSTAVAX (ara sezzjoni 4.3).
English: The protective clinical efficacy of ZOSTAVAX was demonstrated in two large, randomised, placebo controlled clinical trials where subjects received ZOSTAVAX subcutaneously (see Tables 2 and 3).
Maltese: L-effikaċja klinika protettiva ta' ZOSTAVAX intweriet f'żewġ provi kliniċi kbar ikkontrollati bi plaċebo fejn l-individwi ntgħażlu b'mod każwali biex jirċievu ZOSTAVAX taħt il-ġilda (ara Tabelli 2 u 3).
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 needle 10 vials (powder) + 10 pre-filled syringes (solvent) + 10 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 20 needles
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni f'siringa mimlija għal-lest kunjett wieħed (trab) + siringa waħda mimlija għal-lest (solvent) + labra waħda 10 kunjetti (trab) + 10 siringi mimlijin għal-lest (solvent) + 10 labriet 20 kunjett (trab) + 20 siringa mimlijin għal-lest (solvent) + 20 labra
English: EU/1/06/341/011 - pack of 1
Maltese: EU/1/06/341/012 - pakkett ta' 10
English: Herpes zoster/herpes zoster-like rashes and Varicella/varicella-like rashes in clinical trials In clinical trials the number of herpes zoster/herpes zoster-like rashes within the 42-day postvaccination was low in both ZOSTAVAX and placebo groups.
Maltese: Fi provi kliniċi n-numru ta' każijiet ta' raxx ta' herpes zoster/jixbah dak ta' herpes zoster fil-perjodu ta' 42 jum wara t-tilqim kien baxx kemm fil-gruppi ta' ZOSTAVAX kif ukoll f'dak tal-plaċebo.
English: ZOSTAVAX significantly decreased the incidence of zoster compared to placebo (see Table 2).
Maltese: ZOSTAVAX naqqas b'mod sinifikanti l-inċidenza ta' zoster meta mqabbel mal-plaċebo (ara Tabella 2).
English: Average VE§
Maltese: Medja ta' VE§
English: • Uncommon (may affect up to 1 in 100 people): Nausea; swollen gland (neck, armpit)
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: The requirements for submission of periodic safety update reports for this medicinal products are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Tel: +386.1.520.4201 msd.slovenia@merck.com
Maltese: +370.5.2780.247 msd_lietuva@merck.com
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1, 10 or 20.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u għatu tat-tip flip off (aluminju) u solvent f'siringa mimlija għal-lest (ħġieġ) b'tapp tal-planġer (lastku chlorobutyl) u għatu tat-tarf (lastku styrene-butadiene) mingħajr labra f'pakkett b'daqs ta' 1, 10 jew 20.
English: VZV-seronegative adults
Maltese: TAL-PRODOTT MEDIĊINALI
English: Arthralgia, Myalgia, Pain in extremity
Maltese: Artralġja, Mijalġja, Uġigħ fl-id u s-sieq1
English: Adverse events were followed up to Day 42 post vaccination and serious adverse events throughout the entire study period (i.e. through Day 180).
Maltese: Avvenimenti avversi komplew jiġu segwiti sa Jum 42 wara t-tilqim u avvenimenti avversi serji komplew jiġu segwiti matul il-perjodu kollu tal-istudju (jiġifieri. sa Jum 180).
English: ZOSTAVAX powder and solvent for suspension for injection ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)
Maltese: ZOSTAVAX trab u solvent għal suspensjoni għall-injezzjoni ZOSTAVAX trab u solvent għal suspensjoni għall-injezzjoni f'siringa mimlija għal-lest vaċċin kontra l-ħruq ta' Sant'Antnin (herpes zoster) (ħaj)
English: Table 3: Efficacy of ZOSTAVAX on zoster incidence compared with placebo in the SPS in subjects 60 years of age and older*
Maltese: Tabella 3: Effikaċja ta' ZOSTAVAX fuq l-inċidenza ta' zoster imqabbel mal-plaċebo fl-SPS f'individwi ta' età ta' 60 sena jew aktar*
English: • Official batch release
Maltese: • jekk għandek id-deni
English: ZOSTAVAX significantly reduced the zoster pain Burden of Illness (BOI) score (see Table 5).
Maltese: ZOSTAVAX naqqas b'mod sinifikanti il-punteġġ tat-Toqol tal-Marda (BOI - Burden of Illness) minħabba uġigħ ta' zoster (ara Tabella 5).
English: ZOSTAVAX is a vaccine used to prevent shingles (zoster) and zoster-related post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
Maltese: ZOSTAVAX huwa vaċċin użat biex jimpedixxi l-ħruq ta' Sant'Antnin (zoster) u post-herpetic neuralgia relatata ma' zoster (PHN), l-uġigħ fin-nervituri li jdum sewwa li jsegwi l-ħruq ta' Sant'Antnin.
English: EU/1/06/341/003 - pack of 1 EU/1/06/341/004 - pack of 10
Maltese: EU/1/06/341/001 EU/1/06/341/002 EU/1/06/341/003 EU/1/06/341/004
English: Immunogenicity of ZOSTAVAX
Maltese: Effikaċja tattilqima
English: Shingles Prevention Study (SPS)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Shingles Prevention Study (SPS) in Subjects 60 years of age and older:
Maltese: Studju dwar il-Prevenzjoni tal-Ħruq ta' Sant'Antnin (SPS - Shingles Prevention Study) f'Individwi ta' età minn 60 sena'l fuq:
English: † PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI).
Maltese: PHN ġiet iddefinita bħala uġigħ assoċjat ma' zoster ikklassifikat li huwa ta' ≥3 (fuq skala minn 0-10), li jippersisti, jew jidher iktar minn 90 jum wara l-bidu tar-raxx ta' zoster bl-użu tal-Inventarju Qasir tal-Uġigħ ta' Zoster (ZBPI - Zoster Brief
English: A risk to the newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tattwelid/trabi mhux eskluż.
English: The SPS study was a placebo-controlled, double-blind clinical trial in which 38,546 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 3.1 years (range 31 days to 4.9 years).
Maltese: L-istudju SPS kien prova klinika kkontrollata bi plaċebo, fejn 38,546 individwu ntagħżlu b'mod każwali biex jirċievu doża waħda ta' ZOSTAVAX jew plaċebo li la huma u lanqas l-investigaturi ma kienu jafu liema doża ingħatat u li ġew segwiti għall-iżvilupp ta' zoster għal medjan ta' 3.1 snin (firxa minn 31 jum sa 4.9 snin).
English: Subjects who received ZOSTAVAX by SC (subcutaneous) or IM (intramuscular) route In an open-label, randomised, controlled clinical trial, ZOSTAVAX was administered either by SC route or by IM route to 353 subjects 50 years of age or older.
Maltese: Individwi li rċivew ZOSTAVAX permezz tar-rotta SC (taħt il-ġilda) jew IM (ġol-muskoli) Fi prova klinika kkontrollata, ZOSTAVAX ingħata permezz tar-rotta SC jew IM lil 353 individwu ta' età ta' 50 sena jew aktar li ntagħżlu b'mod każwali u li flimkien mal-investigaturi kienu jafu liema sustanza qed tintuża.
English: Long-term effectiveness study in individuals 50 years of age or older In a large-scale ongoing US prospective observational cohort study of the long-term effectiveness of ZOSTAVAX, individuals 50 years of age or older at the time of vaccination are being followed for the occurrence of HZ and PHN using validated endpoints.
Maltese: Studju dwar l-effikaċja fit-tul f'individwi li għandhom 50 sena jew aktar Fi studju fuq skala kbira prospettiv ta' osservazzjoni ta' koorti li għandu għaddej fl-Istati Uniti dwar leffikaċja ta' ZOSTAVAX, individwi li kellhom 50 sena jew aktar fiż-żmien meta tlaqqmu qed jiġu segwiti għall-okkorrenza ta' HZ u PHN bl-użu ta' skopijiet finali validati.
English: This effect was more prominent in the group of older subjects (≥70 years of age), where the risk of developing PHN after zoster was reduced to 10% in the vaccine group vs. 19% for the placebo group.
Maltese: Dan l-effett kien aktar prominenti fil-grupp ta' suġġetti ikbar fl-età (≥70 sena), fejn ir-riskju li jiżviluppaw PHN wara zoster tnaqqas għal 10 % fil-grupp tal-vaċċin meta mqabbel ma' 19 % għallgrupp tal-plaċebo.
English: Concomitant administration
Maltese: Għoti konkomitanti
English: In an open-label study, ZOSTAVAX was administered as: (1) a booster dose to 201 zoster history-negative subjects 70 years of age or older who had received a first dose approximately 10 years previously as participants in the SPS, and (2) a first dose to 199 zoster history-negative subjects 70 years of age or older.
Maltese: (1) doża ta' rinforz lill-201 individwu li ma kellhomx zoster fil-passat b'età ta' 70 sena jew aktar li kienu rċivew l-ewwel doża madwar 10 snin qabel bħala parteċipanti fl-SPS, u (2) bħala l-ewwel doża lill-199 individwu li ma kellhomx zoster filpassat b'età ta' 70 sena jew aktar.
English: Pruritus
Maltese: MedDRA
English: Varicella-zoster virus
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: After reconstitution, 1dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live, attenuated) ≥19,400 PFU
Maltese: Virus variċella-zoster, razza Oka/Merck, (ħaj, attenwat) ≥19,400
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber), in a pack size of 1 or 10.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u għatu tat-tip flip off (aluminju) u solvent f'siringa mimlija għal-lest (ħġieġ) b'tapp tal-planġer (lastku chlorobutyl) u bi protezzjoni għal-labra (lastku naturali) f'pakkett b'daqs ta' 1 jew 10.
English: The ZEST study was a placebo-controlled, double-blind clinical trial in which 22,439 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 1.3 years (range 0 to 2 years).
Maltese: L-istudju ZEST kien prova klinika, ikkontrollata bi plaċebo, fejn 22,439 individwu ntagħżlu b'mod każwali biex jirċievu doża waħda ta' ZOSTAVAX jew plaċebo li la huma u lanqas l-investigaturi ma kienu jafu liema doża ingħatat u ġew segwiti għall-iżvilupp ta' zoster għal medjan ta' 1.3 snin (firxa minn 0 sa sentejn).
English: Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
Maltese: B'mod inqas komuni, jista' jkun hemm infezzjonijiet tal-ġilda b'batterji, debbulizza, paraliżi tal-muskoli, telf tas-smigħ jew tal-vista.
English: ZOSTAVAX powder and solvent for suspension for injection shingles (herpes zoster) vaccine (live)
Maltese: ZOSTAVAX trab u solvent għal suspensjoni għall-injezzjoni vaċċin kontra l-ħruq ta' Sant'Antnin (herpes zoster) (ħaj)
English: In subjects who developed zoster, ZOSTAVAX decreased the risk of subsequently developing PHN.
Maltese: F'individwi li żviluppaw zoster, ZOSTAVAX naqqas ir-riskju li sussegwentament jiżviluppaw PHN.
English: ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
Maltese: ZOSTAVAX jista' jingħata fl-istess ħin ma' vaċċin kontra l-influwenza mhux attivat bħala tilqim separat u f'postijiet differenti tal-ġisem (ara sezzjoni 5.1).
English: Disease information on shingles:
Maltese: RMP aġġornat għandu jiġi ppreżentat:
English: The majority of rashes have been rated as mild to moderate; no complications from rash have been observed in the clinical setting.
Maltese: Ilmaġġoranza tal-każijiet ta' raxx kienu ikklassifikati bħala ħfief sa moderati; ma ġew osservati l-ebda kumplikazzjonijiet minn raxx fl-ambjent kliniku.
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u għatu tat-tip flip off (aluminju) u solvent f'siringa mimlija għal-lest (ħġieġ) b'tapp tal-planġer (lastku chlorobutyl) u għatu tat-tarf (lastku styrene-butadiene) b'labra waħda jew tnejn mhux imwaħħla/imwaħħlin f'pakkett b'daqs ta' 1, 10 jew 20.
English: Across all other clinical trials, the Oka/Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
Maltese: Matul il-provi kliniċi l-oħra kollha, ir-razza Oka/Merck ġiet identifikata permezz ta' analiżi b'PCR mill-kampjuni tal-leżjonijiet ta' żewġ individwi biss li rrappurtaw każijiet ta' raxx jixbah dak tal-variċella (il-bidu tagħhom kien f'Jum 8 u 17).
English: ZOSTAVAX Powder and solvent for suspension for injection shingles (herpes zoster) vaccine (live)
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni vaċċin kontra l-ħruq ta' Sant'Antnin (herpes zoster) (ħaj)
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (gomma tal-butyl) u kappa tat-tip flip off (aluminju) u solvent f'kunjett (ħġieġ) b'tapp (gomma tal-chlorobutyl) u kappa tat-tip flip off (aluminju) f'pakkett ta' daqs 1 jew 10.
English: The results showed that ZOSTAVAX is effective in reducing HZ and PHN incidence in vaccinated individuals as compared to an unvaccinated reference group.
Maltese: L-effikaċja tat-tilqima (VE, vaccine effectiveness) kontra HZ ġiet stmata sa tmien snin wara t-tilqim.
English: The powder is a white to off-white compact crystalline plug.
Maltese: It-trab huwa plug kristallin kumpatt bajdani għal abjad fl-isfar.
English: This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections.
Maltese: Individwi bi tromboċitopenija severa jew kwalunkwe disturb ieħor ta' koagulazzjoni ġew esklużi.
English: The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90) to secure the connection.
Maltese: Il-labra għandha tiġi mbuttata flestremità tas-siringa u mdawwra kwart ta' dawra (90°) biex titqabbad tajjeb.
English: ZOSTAVAX elicited significantly higher VZV-specific immune responses at 6 weeks post-vaccination compared with placebo.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: No subjects reported varicella-like or herpes zoster-like rashes.
Maltese: L-ebda individwu ma rrapporta raxx jixbah dak tal-variċella jew tal-herpes zoster.
English: VIAL OF POWDER
Maltese: Studji oħra
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe with needle (solvent) 10 vials (powder) + 10 pre-filled syringes with needle (solvent)
Maltese: U KONTENUT Trab u solvent għal suspensjoni għall-injezzjoni f'siringa mimlija għal-lest kunjett 1 (trab) + siringa waħda mimlija għal-lest b'labra (solvent) 10 kunjetti (trab) + 10 siringi mimlijin għal-lest b'labra (solvent)
English: Varicella, Herpes zoster (vaccine strain)
Maltese: Infezzjonijiet u infestazzjonijiet Ġidri r-riħ, Herpes zoster (razza tat-tilqima)
English: After reconstitution, 1dose (0.65 mL) contains: Varicella-zoster virus Oka/Merck strain, (live, attenuated) ≥19,400 PFU
Maltese: Virus tal-Varicella-zoster1, razza Oka/Merck, (ħaj, attenwat) mhux inqas minn 19,400
English: Further information on Cablivi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Cablivi tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cablivi contains the active substance caplacizumab.
Maltese: Cablivi fih is-sustanza attiva caplacizumab.
English: aTTP is rare, and Cablivi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Maltese: aTTP hija rari, u Cablivi ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit30 ta' April 2009.
English: Other information about Cablivi
Maltese: Informazzjoni oħra dwar Cablivi
English: What are the risks associated with Cablivi?
Maltese: X'inhuma r-riskji assoċjati ma' Cablivi?
English: As for all medicines, data on the use of Cablivi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Cablivi hija ssorveljata kontinwament.
English: Cablivi is a medicine used for treating adults who have an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a blood clotting disorder.
Maltese: Cablivi huwa mediċina li tintuża għall-kura ta' adulti li jkollhom episodju ta' purpura tromboċitopenika trombotika akkwistata (aTTP), disturb tal-koagulazzjoni tad-demm.
English: In patients with aTTP, levels of a substance called von Willebrand factor are increased.
Maltese: F'pazjenti b'aTTP, il-livelli ta' sustanza msejħa fattur von Willebrand huma elevati.
English: In the first study, involving 75 patients, platelet counts returned to the normal range after 3 days on average in patients treated with Cablivi, compared with nearly 5 days in those receiving placebo (a dummy treatment).
Maltese: Fl-ewwel studju, li involva 75 pazjent, l-għadd ta' pjastrini reġa' lura għall-medda normali wara medja ta' 3 ijiem f'pazjenti li kienu qed jingħataw kura b'Cablivi, meta mqabbel ma' kważi 5 ijiem f'dawk li kienu qed jingħataw plaċebo (kura finta).
English: All patients were receiving standard treatment.
Maltese: Il-pazjenti kollha kienu qed jirċievu kura standard.
English: The Agency considered that, in patients with aTTP, Cablivi combined with plasma exchange and immunosuppression can reduce the time it takes for platelet counts to return to the normal range, which is associated with shorter duration of plasma exchange treatment and shorter stay in intensive care facility.
Maltese: L-Aġenzija qieset li, f'pazjenti b'aTTP, Cablivi flimkien ma' skambju tal-plażma u immunosuppressjoni jista' jnaqqas iż-żmien biex l-għadd tal-pjastrini jerġa' lura għallmedda normali, li huwa assoċjat ma' kura iqsar ta' skambju tal-plażma u żmien inqas ta' kura ġewwa faċilità ta' kura intensiva.
English: The second study, involving 145 patients, measured how long it took for the platelet count to return to the normal range and for sufficient improvement in the condition to allow daily plasma exchange to be stopped within 5 days.
Maltese: It-tieni studju, li involva 145 pazjent, kejjel it-tul ta' żmien biex l-għadd ta' pjastrini jerġa' lura għallmedda normali u għal titjib suffiċjenti fil-kundizzjoni sabiex jippermetti li l-iskambju tal-plażma ta' kuljum jitwaqqaf wara 5 ijiem.
English: What measures are being taken to ensure the safe and effective use of Cablivi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cablivi?
English: Caplacizumab, the active substance in Cablivi, is a nanobody (a small antibody) which has been designed to attach to von Willebrand factor in a way that stops it acting on platelets.
Maltese: IlCaplacizumab, is-sustanza attiva f'Cablivi, hija nanokorp (antikorp żgħir) li ġiet iddisinjata biex teħel mal-fattur von Willebrand b'mod li jwaqqfu milli jaġixxi fuq il-pjastrini.
English: Treatment is continued with 10 mg daily given by injection under the skin in the belly after daily plasma exchange and continued for 30 days after daily plasma exchange is stopped.
Maltese: Il-kura titkompla b'10 mg kuljum li tingħata permezz ta' injezzjoni taħt il-ġilda fiż-żaqq wara liskambju tal-plażma ta' kuljum u titkompla għal 30 jum wara li jitwaqqaf l-iskambju tal-plażma ta' kuljum.
English: The company that markets Cablivi will provide materials, including a patient alert card, on the risk of serious bleeding and how the risk should be managed.
Maltese: Il-kumpanija li tqiegħed Cablivi fis-suq ser tipprovdi materjali, inkluża skeda ta' twissija għall-pazjent, dwar ir-riskju ta' fsada serja u dwar kif ir-riskju għandu jiġi ġestit.
English: Cablivi is started with a dose of 10 mg given by injection into a vein before plasma exchange.
Maltese: Cablivi jinbeda b'doża ta' 10 mg li tingħata permezz ta' injezzjoni ġo vina qabel l-iskambju tal-plażma.
English: Cablivi is used together with plasma exchange (in which certain antibodies are removed from the blood) and treatments to reduce the activity of the immune system (the body's defences).
Maltese: Cablivi jintuża flimkien ma' skambju tal-plażma (li fih ċerti antikorpi jitneħħew mid-demm) u kuri biex titnaqqas l-attività tas-sistema immunitarja (id-difiżi tal-ġisem).
English: Side effects reported with Cablivi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Cablivi huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa biex tipproteġi lill-pazjenti.
English: How does Cablivi work?
Maltese: Kif jintuża Cablivi?
English: The most common side effects with Cablivi (which may affect more than 1 in 10 people) are nosebleeds, headache and bleeding from gums.
Maltese: L-effetti sekondarji l-aktar komuni b'Cablivi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma fġir tal-imnieħer, uġigħ ta' ras u fsada mill-ħanek.