FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first study, the average time from surgery to wound closure was 17.1 days for the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with Episalvan.
Maltese: Fl-ewwel studju, il-ħin medju mill-kirurġija għall-għeluq tal-ġerħa kien ta' 17.1 jiem għall-ġrieħi kkurati biss b'faxxa standard tal-ġrieħi u 15.
English: What measures are being taken to ensure the safe and effective use of Episalvan?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Episalvan?
English: For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Episalvan, ara l-fuljett ta' tagħrif.
English: Although the differences were small they were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and for which treatment options are limited.
Maltese: Għalkemm id-differenzi kienu żgħar, tqiesu li huma rilevanti għall-pazjenti bi ġrieħi ta' ħxuna parzjali, li jistgħu jkunu diffiċli biex jitfejqu u li għalihom, l-opzjonijiet ta' kura huma limitati.
English: Episalvan contains a dry extract from birch bark.
Maltese: Episalvan fih estratt xott miz-zokk tal-betula.
English: Episalvan is a medicine used in adults to treat partial-thickness skin wounds.
Maltese: Episalvan huwa mediċina li tintuża fl-adulti għall-kura ta' ġrieħi tal-ġilda ta' ħxuna parzjali.
English: The patients received Episalvan together with wound dressing on one half of the wound, while the other half of the wound was treated with standard wound dressing only.
Maltese: Il-pazjenti rċevew Episalvan u mbagħad kellhom nofs il-ġerħa nfaxxata, filwaqt li n-nofs l-ieħor tal-ġerħa ġie kkurat biss b'faxxa standard għallġrieħi.
English: 15 September 2017 EMA/577551/2017 EMEA/H/C/004262
Maltese: 15 ta' Settembru 2017 EMA/577551/2017 EMEA/H/C/004262
English: Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) EMA/577551/2017
Maltese: (pegfilgrastim) EMA/577551/2017
English: Fulphila is a medicine that contains the active substance pegfilgrastim.
Maltese: Fulphila huwa mediċina li fiha s-sustanza attiva pegfilgrastim.
English: What is Fulphila?
Maltese: X'inhu Fulphila?
English: Fulphila was developed as a ‘biosimilar' medicine.
Maltese: Fulphila ġie żviluppat bħala mediċina “bijosimili”.
English: Filgrastim is very similar to a human
Maltese: Filgrastim huwa simili ħafna għal
English: The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Is-sustanza attiva f'Fulphila u Neulasta, il-pegfilgrastim, hija magħmula minn filgrastim li jkun ġie “pegilat” (imwaħħal ma' sustanza kimika msejħa polietilenglikol).
English: protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: proteina tal-bniedem imsejħa fattur li jistimula l-kolonji ta' granuloċiti (G-CSF).
English: In addition, one study in 194 patients receiving cancer medicines compared the safety, effectiveness and immunogenicity, meaning the medicine's ability to trigger the production of antibodies, of Fulphila and Neulasta.
Maltese: Barra dan, studju wieħed fuq 194 pazjent li jirċievu mediċini kontra l- kanċer qabbel is-sigurtà, l-effettività u l-immunoġeniċità, li jfisser il-kapaċità tal-mediċina li tistimula lproduzzjoni ta' antikorpi, ta' Fulphila u Neulasta.
English: Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Fulphila (pegfilgrastim)
English: What was Fulphila expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Fulphila?
English: Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product.
Maltese: Tħassib ieħor kien relatat mad-deskrizzjoni tal-proċess ta' manifattura, il-kontroll tal-impuritajiet fis-sustanza attiva u l-isterilizzazzjoni tal-prodott finali.
English: Fulphila was to be used in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever).
Maltese: Fulphila ntuża f'pazjenti bil-kanċer biex inaqqas id-dewmien tan-newtropenija (livelli baxxi ta' newrofili, tip ta' ċellulla tad-demm bajda li tiġġieled l-infezzjoni) u l-okkorrenza ta' newtropenija bid-deni.
English: The company presented results of studies designed to show that Fulphila is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Maltese: Il-kumpanija ppreżentat riżultati ta' studji li saru biex juru li Fulphila huwa simili ħafna għall-mediċina ta' referenza tiegħu, Neulasta, f'termini ta' struttura kimika, purità, il-mod kif jaħdem u l-mod kif ilġisem juża l-mediċina.
English: One of the CHMP's main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product.
Maltese: Tħassib ewlieni wieħed tas-CHMP kien in-nuqqas ta' ċertifikat ta' Prassi Tajba ta' Manifattura (PTM) għall-post tal-manifattura tal-prodott.
English: This means that Fulphila was intended to be highly similar to a biological medicine already authorised in the European Union (the ‘reference medicine') called Neulasta.
Maltese: Dan ifisser li Fulphila kien maħsub li jkun simili għal mediċina bijoloġika li diġà hija awtorizzata fl-Unjoni Ewropea (il-“mediċina ta' referenza”) msejħa Neulasta.
English: Powder : 200mg Solvent: 20 ml (10 mg/ml)
Maltese: Trab: 200mg Solvent: 20ml (10 mg/ml)
English: 1 vial +1 infusion bag +1 syringe +1 vial adaptor
Maltese: Kunjett wieħed + borża għallinfużjoni waħda + siringa waħda+ adattatur ghall-kunjett wieħed
English: Intravenous use Powder: vial (glass) Solvent: infusion bag
Maltese: Trab: kunjett (ħġieġ) Solvent: borża għallinfużjoni
English: 1 vial
Maltese: Użu orali
English: Film-coated tablet
Maltese: Kunjett wieħed
English: Intravenous use vial (glass)
Maltese: Flixkun wieħed
English: Powder and solvent for solution for infusion
Maltese: Trab u solvent għal soluzzjoni għallinfużjoni
English: Lonsurf (trifluridine / tipiracil)
Maltese: Lonsurf (trifluridina / tipirasil)
English: Colorectal cancer
Maltese: Kanċer kolorettali
English: Further information on Lonsurf can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lonsurf.
Maltese: ema.europa.eu/medicines/human/EPAR/lonsurf.
English: Gastric cancer
Maltese: Kanċer gastriku
English: Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days.
Maltese: Lonsurf jiġi bħala pilloli (15 mg trifluridina u 6.14 mg tipirasil; 20 mg trifluridina u 8.19 mg tipirasil) u jingħata f'ċikli ta' kura ta' 28 jum.
English: Other information about Lonsurf
Maltese: Informazzjoni oħra dwar Lonsurf
English: Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016.
Maltese: Lonsurf irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fil-25 ta' April 2016.
English: In a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo.
Maltese: Fi studju li kien jinvolvi 507 adulti li jbatu minn kanċer gastriku metastatiku, il-pazjenti kkurati b'Lonsurf għexu medja ta' 5.7 xhur meta mqabbla ma' 3.6 xhur għall-pazjenti li rċevew il-plaċebo.
English: What are the risks associated with Lonsurf?
Maltese: X'inhuma r-riskji assoċjati ma' Lonsurf?
English: Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer.
Maltese: Lonsurf huwa mediċina li tintuża għall-kura ta' adulti li jkollhom kanċer kolorettali (kanċer tal-musrana l-kbira) u kanċer gastriku (fl-istonku).
English: In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells.
Maltese: Fil-ġisem, it-trifluridina tinbidel f'forma attiva li hija inkorporata fid-DNA, il-materjal ġenetiku taċċelloli.
English: The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-konverżjoni tat-trifluridina għall-forma attiva tagħha ssir iktar malajr fiċ-ċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla tal-forma attiva tal-mediċina u li l-azzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: Lonsurf contains the active substances trifluridine and tipiracil.
Maltese: Lonsurf fih iż-żewġ sustanzi attivi trifluridina u tipirasil.
English: As for all medicines, data on the use of Lonsurf are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Lonsurf hija ssorveljata kontinwament.
English: It contains two active substances: trifluridine and tipiracil.
Maltese: Fih żewġ sustanzi attivi: it-trifluridina u t-tipirasil.
English: For the full list of side effects and restrictions of Lonsurf, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Lonsurf, ara l-fuljett ta' tagħrif.
English: The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts).
Maltese: L-effetti sekondarji l-aktar komuni b'Lonsurf (li jistgħu jaffetwaw aktar minn 3 persuni minn kull 10) huma newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm li tiġġieled l-infezzjoni), tħossok ma tiflaħx, għejja u anemija (għadd baxx ta' ċelloli ħomor tad-demm).
English: Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Lonsurf huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How is Lonsurf used?
Maltese: Kif jaħdem Lonsurf?
English: In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment).
Maltese: Fi studju wieħed ewlieni li kien jinvolvi 800 pazjent, dawk ikkurati b'Lonsurf għexu medja ta' 7.1 xhur meta mqabbla ma' 5.3 xhur għal pazjenti li kienu kkurati bil-plaċebo (kura finta).
English: The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).
Maltese: L-effetti sekondarji laktar serji huma soppressjoni tal-mudullun (meta l-mudullun jipproduċi inqas ċelloli tad-demm minnormal) u effetti fuq l-imsaren (dijarea u tħossok ma tiflaħx).
English: What measures are being taken to ensure the safe and effective use of Lonsurf?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Lonsurf?
English: Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells).
Maltese: Lonsurf huwa mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jinqasmu, bħaċ-ċelloli talkanċer).
English: The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.
Maltese: L-Aġenzija kkunsidrat li l-benefiċċju ta' Lonsurf li jtawwal issopravivenza f'pazjenti li jbatu mill-kanċer kolorettali metastatiku u mill-kanċer gastriku metastatiku li rċevew kura preċedenti kien importanti.
English: All patients received supportive care.
Maltese: Ilpazjenti kollha kienu rċevew mill-inqas żewġ kuri preċedenti.
English: The European Medicines Agency decided that Lonsurf's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Lonsurf huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: This reduces the growth of cancer cells, while normal cells are only slightly affected.
Maltese: Dan inaqqas it-tkabbir taċ-ċelloli tal-kanċer, filwaqt li ċ-ċelloli normali jkunu affettwati biss ftit.
English: North Carolina 27712 U.S.A
Maltese: North Carolina 27712
English: VE % (95% CI)
Maltese: (95% CI)
English: See sections 4.3 and 4.4.
Maltese: Ara sezzjonijiet 4.3 u 4.4.
English: • Active untreated tuberculosis.
Maltese: • Tuberkolożi attiva mhux trattata.
English: Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Maltese: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, L-Olanda
English: ZOSTAVAX Efficacy and Safety Trial (ZEST)
Maltese: Prova ta' Effikaċja u Sigurtà ta' ZOSTAVAX (ZEST - ZOSTAVAX Efficacy and Safety Trial)
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Maltese: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Franza
English: See sections 4.8 and 5.1.
Maltese: Ara sezzjonijiet 4.8 u 5
English: Lymphadenopathy (cervical, axillary)
Maltese: Limfadenopatija (ċervikali, axxillari)
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Maltese: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Franza
English: Rare (≥1/10,000 to <1/1,000);
Maltese: Rari (≥1/10,000 sa <1/1,000);
English: Age at vaccination* 50-59 years 60-69 years 70-79 years 80+ years Among all age groups
Maltese: Età tal-persuna meta ġiet ilaqqma * 50-59 sena 60-69 sena 70-79 sena 80+ sena Fost ilgruppi tal etajiet kollha
English: MedDRA System Organ Class
Maltese: Klassi tas-Sistemi u tal-Organi
English: ZOSTAVAX contains sodium
Maltese: ZOSTAVAX fih sodium
English: Necrotizing retinitis (patients on immunosuppressive therapy)
Maltese: Retinite li tinnekrotizza (pazjenti fuq terapija immunosoppressiva)
English: Produced in human diploid (MRC-5) cells
Maltese: 1Prodott f'ċelloli diploid umani (MRC-5)
English: Common (≥1/100 to <1/10);
Maltese: Komuni (≥1/100 sa <1/10);
English: Magyarország MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com
Maltese: MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com
English: In the LTPS, there were 263 evaluable zoster cases reported among 261 patients [10.3/1000 person-years].
Maltese: Fl-LTPS, kien hemm 263 każ ta' zoster li setgħu jiġu evalwati rrappurtati fost 261 pazjent [10.3/1,000 sena ta' persuna].
English: Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide (to adjust pH), and urea.
Maltese: Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide (għall-aġġustament tal-pH), u urea.
English: The VZV-specific immune responses following Doses 1 and 2 were similar (see section 4.3).
Maltese: Ir-risponsi immuni speċifiċi għal VZV wara Dożi 1 u 2 kienu simili (ara sezzjoni 4.3).
English: Age group
Maltese: Grupp ta' età†
English: What is PHN?
Maltese: X'inhu PHN?
English: The estimated vaccine efficacy during the STPS follow-up period was 40% (95% CI: [18 to 56%]) for zoster incidence, 60% (95% CI: [-10 to 87%]) for PHN incidence and 50% (95% CI: [14 to 71%]) for zoster BOI.
Maltese: Leffikaċja tat-tilqima stmata waqt il-perjodu li fih ġew segwiti l-pazjenti fl-STPS kienet ta' 40% (95% CI: [18 sa 56%]) għall-inċidenza ta' zoster, 60% (95% CI: [-10 sa 87%]) għall-inċidenza ta' PHN u 50% (95% CI: [14 sa 71%]) għall-BOI ta' zoster.
English: MSD VACCINS
Maltese: OĦRAJN MSD VACCINS
English: Zostavax persistence of protection
Maltese: Il-persistenza tal-protezzjoni ta' Zostavax
English: Final determination of zoster cases was made by Polymerase Chain Reaction (PCR) [86%], or in the absence of virus detection, as determined by a clinical evaluation committee [14%].
Maltese: Id-determinazzjoni finali ta' każijiet ta' zoster saret permezz ta' Polymerase Chain Reaction (PCR) [86%], jew fin-nuqqas ta' sejba tal-virus, kif ġie stabbilit minn kumitat ta' valutazzjoni klinika [14%].
English: EU/1/06/341/001 EU/1/06/341/002 EU/1/06/341/003 EU/1/06/341/004 EU/1/06/341/005 EU/1/06/341/006 EU/1/06/341/007 EU/1/06/341/008 EU/1/06/341/009 EU/1/06/341/010 EU/1/06/341/011 EU/1/06/341/012 EU/1/06/341/013
Maltese: EU/1/06/341/005 EU/1/06/341/006 EU/1/06/341/007 EU/1/06/341/008 EU/1/06/341/009 EU/1/06/341/010
English: • History of hypersensitivity to the active substance, to any of the excipients or trace residuals (e.g. neomycin) (see sections 4.4 and 6.1).
Maltese: • Passat mediku ta' sensittività eċċessiva għas-sustanza attiva, jew għal kwalunkwe sustanza mhux attiva jew residwi ta' traċċa (eż. neomycin) (ara sezzjonijiet 4.4 u 6.1).
English: ZOSTAVAX is indicated for prevention of herpes zoster (“zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
Maltese: ZOSTAVAX huwa indikat għall-prevenzjoni ta' herpes zoster (“zoster” jew ħruq ta' Sant'Antnin) u post-herpetic neuralgia relatata ma' herpes zoster (PHN).
English: Warmth 1, Rash, Pyrexia
Maltese: Ebusija1, Ematoma1, Sħana1, Raxx, Deni
English: Persistence of ZOSTAVAX efficacy was studied 4 to 7 years post-vaccination in the STPS, which included 7,320 subjects previously vaccinated with ZOSTAVAX and 6,950 subjects previously vaccinated with placebo in the SPS (mean age at enrollment was 73.3 years); and 7 to 10 years postvaccination in the Long-term Persistence Substudy (LTPS), which included 6,867 subjects previously vaccinated with ZOSTAVAX (mean age at enrollment into the LTPS was 74.5 years).
Maltese: Il-persistenza tal-effikaċja ta' ZOSTAVAX ġiet studjata minn 4 sa 7 snin wara t-tilqim fl-STPS, li kien jinkludi 7,320 individwu li kienu ġew imlaqqma b'ZOSTAVAX u 6,950 individwu li kienu ġew imlaqqma bi plaċebo fl-SPS (età medja meta ġew irreġistrati fl-istudju kienet ta' 73.3 snin); u minn 7 sa 10 snin wara t-tilqim fis-Sottostudju ta' Persistenza għal Żmien Twil (LTPS - Long-term Persistence Substudy), li kien jinkludi 6,867 individwu li kienu ġew imlaqqma b'ZOSTAVAX (età medja meta ġew irreġistrati fl-LTPS kienet ta' 74.5 snin).
English: In an interim analysis of the 2007 to 2014 study period, out of 1,355,720 study individuals, 392,677 received ZOSTAVAX.
Maltese: F'analiżi interim tal-perjodu tal-istudju mill-2007 sal-2014, minn 1,355,720 individwu fl-istudju, 392,677 rċivew ZOSTAVAX.
English: • Pregnancy.
Maltese: • Tqala.
English: The adjusted hazard ratio comparing the incidence rate of HZ in the two groups was 1.04 (95% CI, 0.92, 1.16) over a median follow-up of 4.7 years.
Maltese: Il-proporzjon ta' periku aġġustat li qabbel ir-rata ta' inċidenza ta' HZ fiż-żewġ gruppi kien 1.04 (95% CI, 0.92, 1.16) fuq medjan ta' segwitu ta' 4.7 snin.
English: The estimated vaccine efficacy during the LTPS follow-up period was 21% (95% CI: [11 to 30%]) for zoster incidence, 35% (95% CI: [9 to 56%]) for PHN incidence and 37% (95% CI: [27 to 46%]) for zoster BOI.
Maltese: L-effikaċja tat-tilqima stmata waqt il-perjodu li fih ġew segwiti lpazjenti fl-LTPS kienet ta' 21% (95% CI: [11 sa 30%]) għall-inċidenza ta' zoster, 35% (95% CI: [9 sa 56%]) għall-inċidenza ta' PHN u 37% (95% CI: [27 sa 46%]) għall-BOI ta' zoster.
English: In the vaccine group, the risk of developing PHN after zoster was 9 % (27/315), while in the placebo group it was 13 % (80/642).
Maltese: żvilupp ta' zoster kien ta' 9 % (27/315), filwaqt li fil-grupp tal-placebo, dan kien ta' 13 % (80/642).
English: In the STPS, there were 84 evaluable zoster cases [8.4/1,000 person-years] in the ZOSTAVAX group and 95 evaluable cases [14.0/1,000 person-years] in the placebo group.
Maltese: Fl-STPS, kien hemm 84 każ ta' zoster li setgħu jiġu evalwati [8.4/1,000 sena ta' persuna] fil-grupp ta' ZOSTAVAX u 95 każ li setgħu jiġu evalwati [14.0/1,000 sena ta' persuna] fil-grupp tal-plaċebo.
English: In ZEST, the overall incidence of vaccine-related injection site adverse reactions were 63.9% for ZOSTAVAX and 14.4% for placebo in subjects 50 to 59 years of age.
Maltese: F'ZEST, l-inċidenza totali ta' reazzjonijiet avversi fis-sit tal-injezzjoni marbuta mat-tilqima kienet 63.9% għal ZOSTAVAX u 14.4% għall-plaċebo f'individwi ta' età minn 50 sa 59 sena.
English: In the period from 90 days after rash onset to the end of follow-up, there was a 57% reduction in the severity-by-duration score (average scores of 347 for ZOSTAVAX and 805 for placebo; p=0.016).
Maltese: Fil-perjodu minn 90 jum wara l-bidu tar-raxx sat-tmiem tal-follow-up, kien hemm tnaqqis ta' 57% fl-iskor tas-severità skond it-tul ta' żmien (skor medju ta' 347 għal ZOSTAVAX u 805 għal placebo; p=0.016).
English: However in a US effectiveness cohort study of 35,025 adults ≥ 60 years old, no increased risk of herpes zoster was observed in individuals who received ZOSTAVAX and 23-valent pneumococcal polysaccharide vaccine concomitantly (n=16,532) as compared to individuals receiving ZOSTAVAX one month to one year after 23-valent pneumococcal polysaccharide vaccine (n=18,493) in routine practice.
Maltese: Madankollu fi studju ta' koorti ta' 35,025 adult ≥ 60 sena fl-Istati Uniti dwar l-effikaċja, ma ġiet osservata l-ebda żieda fir-riskju ta' herpes zoster f'individwi li rċivew ZOSTAVAX u vaċċin polisakkaride pnewmokokkali ta' 23 valenti fl-istess waqt (n=16,532) meta mqabbla ma' individwi li rċivew ZOSTAVAX minn xahar sa sena wara vaċċin polisakkaride pnewmokokkali ta' 23 valenti (n=18,493) fi prattika ta' rutina.
English: This is a theoretical risk for vaccination with ZOSTAVAX.
Maltese: Dan huwa riskju teoretiku għal tilqima b'ZOSTAVAX.
English: Uncommon (≥1/1,000 to <1/100);
Maltese: Mhux Komuni (≥1/1000 sa <1/100);
English: Table 1: Adverse Reactions from Clinical Trial Experience and Post-Marketing Surveillance
Maltese: Tabella 1: Reazzjonijiet avversi minn Esperjenza minn Prova Klinika u Sorveljanza wara tTqegħid fis-Suq
English: Monosodium L-glutamate monohydrate Disodium phosphate Sodium hydroxide (to adjust pH) Urea
Maltese: Monosodium L-glutamate monohydrate Disodium phosphate
English: Prevention of HZ cases with severe pain in the entire SPS study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score >600) by 73% (95% CI: [46 to 87%]) compared with placebo (11 vs. 40 cases, respectively).
Maltese: Il-prevenzjoni ta' każijiet HZ b'uġigħ qawwi fil-popolazzjoni SPS kollha tal-istudju ZOSTAVAX naqqas l-inċidenza ta' zoster b'uġigħ qawwi u fit-tul (skor ta' severità skond it-tul ta' żmien >600) b' 73 % (95 % CI: [46 għal 87 %]) meta mqabbel mal-placebo (11 kontra 40 każ, rispettivament).
English: In clinical trials, general safety has been evaluated in more than 57,000 adults vaccinated with ZOSTAVAX.
Maltese: Fi provi kliniċi, is-sigurtà ġenerali ġiet evalwata f'aktar minn 57,000 adult imlaqqma b'ZOSTAVAX.
English: dkmail@merck.com malta_info@merck.com
Maltese: dpoc_czechslovak@merck.com hungary_msd@merck.com
English: • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS (see sections 4.4, 4.8 and 5.1); cellular immune deficiencies.
Maltese: • Stati ta' immunodefiċjenza primarja u akkwistata minħabba kundizzjonijiet bħal: lewkimja akuta u kronika; lymphoma; kundizzjonijiet oħra li jaffettwaw il-mudullun jew is-sistema limfatika; immunosuppressjoni dovuta għal HIV/AIDS (ara sezzjonijiet 4.4, 4.8 u 5.1); defiċjenzi ta' immunità taċ-ċelloli.
English: Ophthalmic zoster occurred in 35 subjects vaccinated with ZOSTAVAX vs. 69 subjects who received placebo.
Maltese: Zoster oftalmiku seħħ f'35 suġġett imlaqqma b'ZOSTAVAX vs. 69 suġġett li irċevew placebo.