FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant claimed that alfacalcidol 1 μg daily and of calcitriol 0.25 μg twice a day are therapeutically equivalent, and therefore they considered that the results of this randomised clinical trial can be directly extrapolated to alfacalcidol.
Maltese: L-applikant sostna li alfakalċidol 1 μg kuljum u calcitriol 0.25 μg darbtejn kuljum huma terapewtikament ekwivalenti, u għalhekk qiesu li rriżultati ta' din il-prova klinika każwali jistgħu jiġu direttament estrapolati għal alfakalċidol.
English: Other studies had been performed to specifically investigate the efficacy and safety of alfacalcidol in monotherapy and combination therapy on the reduction of falls in elderly and patients with PMO (Dukas, 20043; Gallagher, 20044; Ringe, 20075).
Maltese: Kienu saru studji oħra biex b'mod speċifiku jinvestigaw l-effikaċja u s-sigurtà ta' alfakalċidol f'monoterapija u f'terapija kkombinata fuq it-tnaqqis ta' waqgħat fl-anzjani u f'pazjenti b'PMO (Dukas, 20043; Gallagher, 20044;
English: A post hoc analyses by medians of total calcium intake detected statistically significant differences.
Maltese: Analiżi post hoc bil-medjani tat-teħid totali ta' kalċju sabet differenzi statistikament sinifikanti.
English: The applicant has analysed pharmacokinetics data of alfacalcidol and calcitriol dosed independently from two bioequivalence studies.
Maltese: L-applikant analizza dejta farmakokinetika ta' alfakalċidol u calcitriol dożati b'mod indipendenti minn żewġ studji ta' bijoekwivalenza.
English: Systemic levels are shown to be equivalent at steady state under scaled dosing and there is no significant difference in predicted AUC's (Area Under the Curve) at six months between alfacalcidol 1 μg once-aday (QD) and calcitriol 0.25 μg twice-daily (BID).
Maltese: Il-livelli sistemiċi huma murija bħala ekwivalenti fi stat stabbli taħt dożaġġ skalat u m'hemm l-ebda differenza sinifikanti fl-AUC imbassra (l-Erja Taħt il-Kurva) wara sitt xhur bejn alfakalċidol 1 μg darba kuljum (QD) u calcitriol 0.25 μg darbtejn kuljum (BID).
English: The proposed indication by the applicant for Valebo was the “Treatment of postmenopausal osteoporosis.
Maltese: L-indikazzjoni proposta mill-applikant għal Valebo kienet il-“Kura ta' osteoporożi wara l-menopawża.
English: Alfacalcidol is a vitamin D analogue which acts as a regulator of calcium and phosphate metabolism.
Maltese: Alfakalċidol huwa analogu tal-vitamina D li jaġixxi bħala regolatur tal-metaboliżmu tal-kalċju u l-fosfat.
English: Alfacalcidol improves muscle power, muscle function and balance in elderly patients with reduced bone mass. Rheumatol Int 2012;32(1):207-15.
Maltese: Schacht E, Ringe JD. Alfacalcidol improves muscle power, muscle function and balance in elderly patients with reduced bone mass.
English: Bisphosphonates have strong pharmacodynamic action on osteoclast activity.
Maltese: Il-bisfosfonati għandhom azzjoni farmakodinamika qawwija fuq l-attiva tal-osteoklasti.
English: The open, multi-centre, prospective studies (Schacht and Ringe, 20121, Schacht and Ringe, 20112) demonstrated that treatment with alfacalcidol 1 μg resulted in significant increases in physical performance and balance in elderly women and men with and without an increased risk of falls as well as with and without Vitamin D insufficiency/deficiency.
Maltese: L-istudji miftuħa, multi-ċentri, prospettivi (Schacht u Ringe, 20121, Schacht u Ringe, 20112) wrew li kura b'alfakalċidol 1 μg wasslet għal żidiet sinifikanti fil-prestazzjoni fiżika u fil-bilanċ f'nisa u rġiel anzjani bi u mingħajr żieda fir-riskju ta' waqgħat kif ukoll bi u mingħajr insuffiċjenza/defiċjenza talVitamina D.
English: Dukas et al (2004) presented a randomised, double-blind, placebo controlled trial with ‘number of fallers' as primary endpoint and an adequate number of patients.
Maltese: Dukas et al (2004) ippreżenta prova każwali, bi blindaġġ doppju, ikkontrollata bi plaċebo bl-‘għadd ta' persuni li waqgħu' bħala l-endpoint primarju u għadd adegwat ta' pazjenti.
English: Dukas L, Bischoff HA, Lindpainter LS, Schacht E, Birkner-Binder D, Damm TN, Thalman B, Stähelin HB. Alfacalcidol reduces the number of fallers in a community-dwelling elderly population with a minimum calcium intake of more than 500 mg daily.
Maltese: Dukas L, Bischoff HA, Lindpainter LS, Schacht E, Birkner-Binder D, Damm TN, Thalman B, Stähelin HB.
English: In addition, the results of these studies, showing a significant reduction in fall-related non-vertebral fractures, have been confirmed by independent meta-analyses (Bischoff-Ferrari, 2004b6; BischoffFerrari, 20097; O'Donnell, 20088; Richy, 20089).
Maltese: Barra minn hekk, ir-riżultati ta' dawn l-istudji, li juru tnaqqis sinifikanti fi ksur mhux vertebrali relatat ma' waqgħat, ġew ikkonfermati minn meta-analiżi indipendenti (Bischoff-Ferrari, 2004b6;
English: Having considered that data submitted by the applicant, the CHMP considered that there is sufficient evidence to conclude that in some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Maltese: Wara li kkunsidra dik id-dejta ppreżentata mill-applikant, is-CHMP ikkunsidra li hemm biżżejjed evidenza biex tikkonkludi li f'xi studji kliniċi, alfakalċidol intwera li jnaqqas ir-riskju ta' waqgħat flanzjani.
English: Meta-analysis of trials on alfacalcidol and calcitriol investigating fallers
Maltese: Systematic review of the benefits and harms of calcitriol and alfacalcidol for fractures and falls.
English: The applicant performed a meta-analysis of the most relevant clinical studies (Gallagher, 2004; Dukas, 2004; Ringe, 201310 and Kaya, 201111) reporting the number of fallers following either alfacalcidol or calcitriol therapy.
Maltese: L-applikant wettaq meta-analiżi tal-istudji kliniċi l-aktar rilevanti (Gallagher, 2004; Dukas, 2004;
English: The applicant further performed a meta-analysis of trials with alfacalcidol and calcitriol investigating fallers.
Maltese: L-effett talkura kien dejjem sinifikanti meta provi maġġuri rrappurtati ġew analizzati flimkien.
English: The applicant claimed that since no significant difference in numbers of falls was found between the groups treated with the combination of ‘alendronate + alfacalcidol' and ‘alfacalcidol alone', this underlines the efficacy of alfacalcidol as monotherapy as well as in combination with alendronate for the reduction of falls.
Maltese: L-applikant iddikjara li peress li ma nstabet l-ebda differenza sinifikanti fl-għadd ta' waqgħat bejn il-gruppi ttrattati bilkombinazzjoni ta' ‘alendronat + alfakalċidol' u ‘alfakalċidol waħdu', dan jenfasizza l-effikaċja ta' alfakalċidol bħala monoterapija kif ukoll flimkien ma' alendronat fit-tnaqqis ta' waqgħat.
English: Date of first authorisation: 06/11/2015.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 06/11/2015
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Maltese: Zoetis Belgium SA Rue Laid Burniat, 1 1348 Louvain-la-Neuve IL-BELĠJU
English: 1 tablet 3 tablets 6 tablets
Maltese: Pillola waħda 3 pilloli
English: Half-life was comparable for the intravenous and oral routes at 12 and 11 days, respectively.
Maltese: Il-half-life għar-rotot intravenuż u orali kienu komparabbli b'12 u 11-il ġurnata, rispettivament.
English: EU/2/15/191/011 (40 mg, 3 tablets) EU/2/15/191/012 (40 mg, 6 tablets) EU/2/15/191/013 (80 mg, 1 tablet) EU/2/15/191/014 (80 mg, 3 tablets) EU/2/15/191/015 (80 mg, 6 tablets) EU/2/15/191/016 (120 mg, 1 tablet) EU/2/15/191/017 (120 mg, 3 tablets) EU/2/15/191/018 (120 mg, 6 tablets)
Maltese: EU/2/15/191/010 (40 mg, Pillola 1) EU/2/15/191/011 (40 mg, 3 pilloli) EU/2/15/191/012 (40 mg, 6 pilloli) EU/2/15/191/013 (80 mg, Pillola 1) EU/2/15/191/014 (80 mg, 3 pilloli) EU/2/15/191/015 (80 mg, 6 pilloli)
English: EU/2/15/191/001 (5 mg, 1 tablet) EU/2/15/191/002 (5 mg, 3 tablets) EU/2/15/191/003 (5 mg, 6 tablets) EU/2/15/191/004 (10 mg, 1 tablet) EU/2/15/191/005 (10 mg, 3 tablets) EU/2/15/191/006 (10 mg, 6 tablets) EU/2/15/191/007 (20 mg, 1 tablet) EU/2/15/191/008 (20 mg, 3 tablets) EU/2/15/191/009 (20 mg, 6 tablets) EU/2/15/191/010 (40 mg, 1 tablet)
Maltese: EU/2/15/191/001 (5 mg, Pillola 1) EU/2/15/191/002 (5 mg, 3 pilloli) EU/2/15/191/003 (5 mg, 6 pilloli) EU/2/15/191/004 (10 mg, Pillola 1) EU/2/15/191/005 (10 mg, 3 pilloli) EU/2/15/191/006 (10 mg, 6 pilloli)
English: Simparica chewable tablets sarolaner (mg)
Maltese: Simparica pilloli li jintmagħdu sarolaner (mg)
English: During clinical field trials, no interactions between Simparica chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Maltese: Waqt provi kliniċi, ma ġew osservati l-ebda interazzjonijiet bejn Simparica pilloli li jintmagħdu għal klieb u prodotti mediċinali veterinarji użati b'mod ta' rutina.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.emea.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg sarolaner
Maltese: Simparica 5 mg pilloli li jintmagħdu għal klieb 1.3-2.5 kg Simparica 10 mg pilloli li jintmagħdu għal klieb >2.5-5 kg Simparica 20 mg pilloli li jintmagħdu għal klieb >5-10 kg Simparica 40 mg pilloli li jintmagħdu għal klieb >10-20 kg Simparica 80 mg pilloli li jintmagħdu għal klieb >20-40 kg Simparica 120 mg pilloli li jintmagħdu għal klieb >40-60 kg sarolaner
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg
Maltese: Simparica 5 mg pilloli li jintmagħdu għal klieb 1.3-2.5 kg Simparica 10 mg pilloli li jintmagħdu għal klieb >2.5-5 kg Simparica 20 mg pilloli li jintmagħdu għal klieb >5-10 kg Simparica 40 mg pilloli li jintmagħdu għal klieb >10-20 kg Simparica 80 mg pilloli li jintmagħdu għal klieb >20-40 kg Simparica 120 mg pilloli li jintmagħdu għal klieb >40-60 kg
English: For each strength, the chewable tablets are available in the following pack sizes: carton with 1 blister of 1, 3 and 6 tablets.
Maltese: Għal kull saħħa, il-pilloli li jintmagħdu huma disponibbli f'qisien ta' pakketti kif ġej: kaxxa tal kartun fiha strixxa waħda ta' pillola waħda, 3 u 6 pilloli.
English: Lot{number}
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: One carton contains one blister of 1, 3 or 6 tablets.
Maltese: Kaxxa tal kartun waħda fiha strixxa waħda ta' pillola waħda, 3 jew 6 pilloli.
English: Parasites need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
Maltese: Il-parassiti jridu jibdew jieklu minn fuq l-annimal ospitanti sabiex jiġu esposti għal sarolaner; għalhekk ir-riskju li jiġi trasmess mard li jinġarr mill-parassiti ma jistax jiġi eskluż.
English: 250 tablets 30 tablets
Maltese: 250 pilloli 30 pilloli
English: Tablet Tablet
Maltese: Pillola Pillola
English: Oral use Oral use bottle (HDPE) blister (alu/alu)
Maltese: Użu orali Użu orali kontenitur (HDPE) folja (alu/alu)
English: • Contraindication in patients with creatinine clearance < 35 ml/min
Maltese: Teva PharmaKontraindikazzjoni f'pazjenti bit-tneħħija tal-kreatinina ta' < 35 ml/min
English: The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jipprovdi programm edukattiv immirat għat-tobba kollha li mistennija li jagħtu/jużaw Zoledronic acid Teva Pharma għattrattament tal-osteoporożi qabel ma jitnieda fl-Istati Membri.
English: • Need to measure serum creatinine before treatment with Zoledronic acid Teva Pharma
Maltese: • Il-bżonn li titkejjel il-kreatinina fis-serum qabel ma jingħata t-trattament b'Zoledronic acid
English: • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
Maltese: • Kontraindikazzjoni f'nisa tqal u li qed ireddgħu • Il-bżonn ta' suppliment xieraq ta' kalċju u vitamina D, attività fiżika tajba, xejn tipjip u dieta
English: o Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet o Key signs and symptoms of serious adverse events o When to seek attention from the health care provider
Maltese: o Il-bżonn ta' suppliment xieraq ta' kalċju u vitamina D, attività fiżika tajba, xejn tipjip u o Sinjali u sintomi ewlenin ta' episodji avversi serji o Meta għandhom ifittxu l-għajnuna mingħand il-professjonist fil-qasam tal-kura tas-saħħa
English: • One-yearly dosing regime
Maltese: • Doża waħda f'sena
English: • Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
Maltese: • Kontraindikazzjoni f'nisa tqal u li qed ireddgħu minħabba potenzjal ta' teratoġeniċità
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in Member States prior to distribution of the educational programme.
Maltese: L-MAH għandu jaqbel dwar ilkontenut u l-format tal-materjal edukattiv, kif ukoll mal-pjan ta' komunikazzjoni, mal-awtoritajiet kompetenti nazzjonali fl-Istati Membri qabel ma jitqassam il-programm edukattiv.
English: • Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes
Maltese: • Il-bżonn li Zoledronic acid Teva Pharma jiġi injettat bil-mod fuq medda ta' mhux inqas minn
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD L-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: The educational programme contains the following:
Maltese: Il-programm edukattiv fih dan li ġej:
English: • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Maltese: • Sinjali u sintomi ewlenin ta' episodji avversi serji • Meta għandhom ifittxu l-għajnuna mingħand il-professjonist fil-qasam tal-kura tas-saħħa
English: Orencia (abatacept)
Maltese: Orencia (abataċett)
English: Further information on Orencia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/orencia.
Maltese: ema.europa.eu/medicines/human/EPAR/orencia.
English: Orencia received a marketing authorisation valid throughout the EU on 21 May 2007.
Maltese: Orencia ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-21 ta' Mejju 2007.
English: Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis.
Maltese: Orencia nstab effettiv fi studju ewlieni wieħed li involva 424 pazjent adult b'artrite psorjatika.
English: What are the risks associated with Orencia?
Maltese: X'inhuma r-riskji assoċjati ma' Orencia?
English: Orencia contains the active substance abatacept.
Maltese: Orencia fih is-sustanza attiva l-abataċett.
English: Other information about Orencia
Maltese: Informazzjoni oħra dwar Orencia
English: Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis.
Maltese: Erba' studji ewlenin li involvew total ta' 1,733 adult sabu li Orencia kien effettiv fl-artrite rewmatojde.
English: The study included 259 patients who had previously been treated with a TNF alpha blocker.
Maltese: L-istudju kien jinkludi 259 pazjent li preċedentement kienu ġew ikkurati b'imblokkatur alfa TNF.
English: Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.
Maltese: Orencia mogħti b'injezzjoni taħt il-ġilda naqqas is-sintomi f'39 % tal-pazjenti (84 minn 213) meta mqabbla ma' 22 % tal-pazjenti (47 minn 211) li ngħataw plaċebo.
English: In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.
Maltese: Fi studju ieħor li kien jinvolvi 170 pazjent b'artrite psorjatika, Orencia mogħti b'infużjoni bid-doża rakkomandata naqqas is-sintomi b'mill-anqas 20 % wara 24 ġimgħa f'aktar minn 47 % tal-pazjenti (19 minn 40) meta mqabbla ma' 19 % tal-pazjenti (8 minn 42) li ngħataw plaċebo.
English: Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, compared with 20% of the patients adding placebo (26 out of 133).
Maltese: Iż-żieda ta' Orencia ma' kura eżistenti wasslet għal tnaqqis tas-sintomi f'50 % tal-pazjenti (129 minn 256) wara sitt xhur meta mqabbla ma' 20 % tal-pazjenti li żiedu plaċebo (26 minn 133).
English: • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker' have not worked well enough;
Maltese: • artrite rewmatojde attiva minn moderata għal severa (marda fis-sistema immunitarja li tikkawża ħsara u infjammazzjoni fil-ġogi) fl-adulti, jintuża flimkien ma' methotrexate meta mediċini oħra inkluż methotrexate jew “imblokkatur tal-fattur ta' nekrożi tumurali (TNF)” ma jkunux ħadmu tajjeb biżżejjed;
English: In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis.
Maltese: Fir-raba' studju, Orencia flimkien ma' methotrexate tqabbel ma' Orencia waħdu u ma' methotrexate waħdu fi 351 adult li ma kinux ġew ikkurati b'methotrexate (jew bi kwalunkwe aġent bijoloġiku ieħor bħall-imblokkaturi alfa TNF), iżda forsi kienu fuq mediċini oħra għall-ġestjoni tal-artrite rewmatojde.
English: Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).
Maltese: Iż-żieda ta' Orencia u l-methotrexate mal-kura eżistenti għal 12-il xahar wasslet għal tnaqqis fissintomi f'61 % tal-pazjenti (70 minn 115), meta mqabbla ma' 42 % tal-pazjenti li ħadu Orencia waħdu (48 minn 113) u 45 % tal-pazjenti li ħadu methotrexate waħdu (52 minn 115).
English: • highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
Maltese: • artrite rewmatojde progressiva u attiva ħafna, jintuża flimkien ma' methotrexate f'adulti li ma kinux ikkurati b'methotrexate preċedentement;
English: A further study in 219 children with polyarticular juvenile idiopathic arthritis aged 2 to 17 years showed that Orencia given by injection under the skin produced expected levels of active substance in the blood based on data with Orencia given into a vein for other conditions.
Maltese: Studju ieħor fuq 219-il tifel u tifla b'artrite idjopatika ġuvenili poliartikulata li kellhom bejn sentejn u 17-il sena wera li Orencia mogħti b'injezzjoni taħt il-ġilda pproduċa livelli mistennija ta' sustanza attiva fid-demm abbażi ta' data b'Orencia mogħti fil-vina għal kundizzjonijiet oħra.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Ħarsa ġenerali lejn Orencia u għalfejn huwa awtorizzat fl-UE
English: As for all medicines, data on the use of Orencia is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Orencia hija ssorveljata kontinwament.
English: In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment).
Maltese: Fl-ewwel studju, is-sintomi tal-marda tnaqqsu f'61 % (70 minn 115) tal-pazjenti li żiedu ddoża rakkomandata ta' Orencia ma' methotrexate għal 6 xhur, meta mqabbla ma' 35 % (42 minn 119) tal-pazjenti li żiedu plaċebo (kura finta).
English: By attaching to signal molecules called CD80 and CD86, abatacept stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.
Maltese: Billi jeħlu ma' molekuli ta' sinjal bl-isem ta' CD80 u CD86, l-abataċett twaqqafhom milli jattivaw iċ-ċelloli T, u dan jgħin sabiex titnaqqas linfjammazzjoni u sintomi oħra tal-mard.
English: Orencia was also shown to reduce symptoms of psoriatic arthritis.
Maltese: Intwera wkoll li Orencia naqqas is-sintomi tal-artrite psorjatika.
English: Over 6 months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).
Maltese: Tul sitt xhur, 20 % tal-pazjenti li ngħataw Orencia reġgħet feġġitilhom il-marda (12 minn 60), meta mqabbla ma' 53 % ta' dawk li ngħataw ilplaċebo (33 minn 62).
English: In around 60% of these patients the TNF alpha blocker had not worked well enough.
Maltese: F'madwar 60 % ta' dawn il-pazjenti, l-imblokkatur alfa TNF ma kienx ħadem tajjeb biżżejjed.
English: The Agency decided that Orencia's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: LAġenzija ddeċidiet li l-benefiċċji ta' Orencia huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għallużu fl-UE.
English: The most common side effects with Orencia (seen in more than 1 patient in 10) are upper respiratory tract infections (nose and throat infection).
Maltese: L-effetti sekondarji l-aktar komuni b'Orencia (li dehru f'iktar minn pazjent wieħed minn kull 10) huma infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (infezzjonijiet fl-imnieħer u l-gerżuma).
English: • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough.
Maltese: • artrite idjopatika ġuvenili poliartikulata attiva minn moderata għal severa (marda rari fit-tfulija li tikkawża l-infjammazzjoni ta' bosta ġogi), fl-adolexxenti u fit-tfal mill-età ta' sentejn ‘il fuq li fuqhom mediċini oħra ma jkunux ħadmu tajjeb biżżejjed.
English: Orencia must not be used in patients with severe and uncontrolled infections, such as sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) or ‘opportunistic' infections (infections seen in patients with a weakened immune system).
Maltese: Orencia ma għandux jintuża f'pazjenti li jkollhom infezzjonijiet gravi u mhux ikkontrollati, bħas-sepsi (meta l-batterji u t-tossini tagħhom jiċċirkolaw fid-demm u jibdew jikkaġunaw ħsara fl-organi) jew infezzjonijiet “opportunistiċi” (infezzjonijiet li jidhru f'pazjenti b'sistema immunitarja dgħajfa).
English: What measures are being taken to ensure the safe and effective use of Orencia?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Orencia?
English: Orencia is a medicine that is often used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:
Maltese: Orencia huwa mediċina li spiss tintuża flimkien ma' methotrexate (mediċina li taħdem fuq is-sistema immunitarja) biex tikkura l-mard li ġej: