FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Maltese: Olanzapine naqset irrispons kundizzjonat u ta' skansar, test indikattiv ta' l-attività antipsikotika, f'dożi anqas minn dawk li jwasslu għall-katalepsi, riżultat indikattiv ta' l-effett mhux mixtieq tas-sistema (motorjali).
English: Olanzapine Glenmark Europe 5mg is supplied as: yellow coloured circular flat bevelled edge orodispersible tablets with ‘B' debossed on one side.
Maltese: Id-dehra ta' Olanzapine Glenmark Europe u l-kontenuti tal-pakkett Olanzapine Glenmark Europe 5mg tiġi bħala: pilloli li jinħallu fil-ħalq, tondi, ċatti, kulur isfar bil-ġnub imċanfrin bi ‘B' imnaqqax fuq naħa waħda.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 June 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Ġunju 2017 EMA/450716/2017 EMEA/H/C/004455
English: What is Zafiride?
Maltese: X' inhu Zafiride?
English: Zafiride was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 June 2008 for malignant mesothelioma.
Maltese: Zafiride kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-3 ta' Ġunju 2008 għal mesoteljoma malinna.
English: Zafiride was expected to be used for treating adults with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos.
Maltese: Zafiride kien mistenni li jintuża biex jikkura adulti b'mesoteljoma plewrika malinna avvanzata, kanċer tar-rita tal-pulmun li normalment jiġi kkawżat minn esponiment għall-asbestos.
English: What was Zafiride expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Zafiride?
English: Zafiride is a medicine containing the active substance NGR-human tumour necrosis factor alpha.
Maltese: NGR-fattur tan-nekrożi tat-tumur alfa tal-bniedem.
English: It was to be available as a solution for infusion (drip) into a vein.
Maltese: Dan kellu jiġi bħala soluzzjoni għall-infużjoni (dripp) ġo vina.
English: On 1 June 2017, MolMed S.p.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma.
Maltese: Fl-1 ta' Ġunju 2017, MolMed S.p.A. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Zafiride, għall-kura ta' mesoteljoma plewrika malinna avvanzata.
English: The CHMP noted there was inadequate information in several areas of the application, including on the manufacture of the medicine, its testing in humans and animals and its safety.
Maltese: Is-CHMP innota li kien hemm informazzjoni inadegwata f'diversi partijiet tal-applikazzjoni, inkluż dwar il-manifattura tal-mediċina, l-ittestjar tagħha fil-bnedmin u l-annimali u s-sigurtà tagħha.
English: Zafiride was compared with placebo (a dummy treatment), and all patients in the study had previously been treated with pemetrexed-based chemotherapy.
Maltese: Zafiride tqabbel mal-plaċebo (kura finta), u l-pazjenti kollha f'dan l-istudju kienu ġew ikkurati preċedentement b'kimoterapija bbażata fuq pemetrexed.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Zafiride could not be approved for the second-line treatment of advanced malignant pleural mesothelioma in patients whose disease had worsened within 6 months of treatment with pemetrexed.
Maltese: Fl-ittra li bagħtet lill-Aġenzija biex tgħarrafha bl-irtirar tal-applikazzjoni, il-kumpanija sostniet li ma kinitx se tkun kapaċi tipprovdi d-data mitluba dwar il-manifattura tal-mediċina fi żmien il-perjodu meħtieġ.
English: The company's application included results from a main study in 400 patients which looked at how long patients lived when treated with Zafiride in combination with other cancer medicines.
Maltese: L-applikazzjoni tal-kumpanija inkludiet riżultati minn studju ewlieni f'400 pazjent li ħares lejn kemm għexu l-pazjenti meta ġew ikkurati b'Zafiride flimkien ma' mediċini oħra tal-kanċer.
English: Further information on Vectibix can be found on the Agency's website ema.europa.eu/ medicines/human/EPAR/vectibix.
Maltese: ema.europa.eu/ medicines/human/EPAR/vectibix.
English: This summary was last updated in 08-2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2019.
English: This was switched to a full marketing authorisation on 15 January 2015.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fil-15 ta' Jannar 2015.
English: It contains the active substance panitumumab.
Maltese: Fih is-sustanza attiva panitumumab.
English: The most common side effects with Vectibix (in more than 2 patients in 10) were diarrhoea, nausea (feeling sick), vomiting, constipation, abdominal pain (stomach ache), tiredness, fever, lack of appetite, paronychia (nail bed infection), rash, acneiform dermatitis (skin inflammation resembling acne), pruritus (itching), erythema (reddening of the skin) and dry skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Vectibix (li dehru f'iktar minn żewġ pazjenti minn kull 10) kienu dijarea, nawżja (tħossok ma tiflaħx), remettar, stitikezza, uġigħ addominali (uġigħ fl-istonku), għeja, deni, nuqqas ta' aptit, paronikija (infezzjoni fil-ġilda ta' madwar id-dwiefer), raxx, dermatite akneiformi (infjammazzjoni tal-ġilda li tixbah lill-akne), prurite (ħakk), eritema (ħmura tal-ġilda) u ġilda xotta.
English: Other information about Vectibix
Maltese: Informazzjoni oħra dwar Vectibix
English: The usual recommended infusion time is approximately 60 minutes.
Maltese: Il-ħin normali rrakkomandat għallinfużjoni huwa bejn wieħed u ieħor 60 minuta.
English: The recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks.
Maltese: Id-doża rakkomandata ta' Vectibix hija 6 mg għal kull kilogramma tal-piż tal-ġisem li tingħata darba kull ġimagħtejn.
English: • Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX had some reduction in signs of cancer in a study of 80 previously untreated patients.
Maltese: • Madwar 73 % tal-pazjenti li ngħataw Vectibix flimkien ma' FOLFIRI u 78 % ta' dawk li ngħataw Vectibix flimkien ma' FOLFOX kellhom xi tnaqqis fis-sinjali tal-kanċer fi studju fuq 80 pazjent li ma kinux ikkurati fil-passat.
English: Vectibix is available for infusion (drip) into a vein.
Maltese: Vectibix jiġi bħala infużjoni (dripp) ġol-vina.
English: The studies show Vectibix can be effective when used alone and together with the standard chemotherapy regimens FOLFOX (a combination of fluorouracil with folinic acid and the cancer medicine oxaliplatin) or FOLFIRI (fluorouracil with folinic acid and a different cancer medicine, irinotecan).
Maltese: Listudji wrew li Vectibix jista' jkun effettiv meta jintuża waħdu u flimkien mar-reġimi tal-kimoterapija standard FOLFOX (kombinazzjoni ta' fluworuraċil bl-aċidu foliniku u l-mediċina kontra l-kanċer oxaliplatin) jew FOLFIRI (fluworuraċil bl-aċidu foliniku u mediċina differenti kontra l-kanċer, irinotecan).
English: It should only be started after the presence of wild-type RAS has been confirmed by an experienced laboratory using a validated test method.
Maltese: Il-kura għandha tinbeda biss wara li lpreżenza ta' RAS tat-tip selvaġġ tkun ġiet ikkonfermata minn laboratorju espert bl-użu ta' metodu ta' eżaminazzjoni validu.
English: Vectibix received a conditional marketing authorisation valid throughout the EU on 3 December 2007.
Maltese: Vectibix irċieva awtorizzazzjoni kkundizzjonata ta' tqegħid fis-suq valida fl-UE kollha fit3 ta' Diċembru 2007.
English: • Patients given Vectibix in combination with FOLFIRI lived for 16.2 months in a study of 1,186 previously treated patients compared with 13.9 months in patients receiving FOLFIRI alone.
Maltese: • Il-pazjenti li ngħataw Vectibix f'kombinazzjoni ma' FOLFIRI għexu 16.2 xhur fi studju fuq 1,186 pazjent li ma kinux ikkurati fil-passat meta mqabbla ma' 13.9 xhur f'pazjenti li ngħataw FOLFIRI waħdu.
English: Patients given these combinations lived for an average of 14.8 months and 12.8 months respectively without their disease getting worse.
Maltese: Il-pazjenti li ngħataw dawn il-kombinazzjonijiet għexu medja ta' 14.8 xhur u ta' 12.8 xhur rispettivament mingħajr ma l-marda tagħhom marret għall-agħar.
English: • Around 59% of patients who received Vectibix plus FOLFIRI in a study of 154 previously untreated had some reduction in signs of cancer.
Maltese: • Madwar 59 % tal-pazjenti li kienu qed jirċievu Vectibix flimkien ma' FOLFIRI fi studju fuq 154 pazjent li fil-passat ma kinux ikkurati kellhom xi tnaqqis fis-sinjali tal-kanċer.
English: The active substance in Vectibix, panitumumab, is a monoclonal antibody, a type of protein that has been designed to attach to and block a target called EGFR on certain cells, including some tumour cells.
Maltese: Is-sustanza attiva f'Vectibix, il-panitumumab, hija antikorp monoklonali, tip ta' proteina li tfasslet biex teħel ma' u timblokka mira msejħa EGFR fuq ċerti ċelloli, inkluż fuq xi ċelloli tat-tumur.
English: Patients receiving Vectibix also had a longer period of time without their disease getting worse: 6.4 months versus 4.6 months.
Maltese: Il-pazjenti li ngħataw Vectibix kellhom ukoll perjodu itwal ta' żmien mingħajr ma l-marda tagħhom marret għall-agħar: 6.4 xhur meta mqabbla ma' 4.6 xhur.
English: It must not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases).
Maltese: Ma għandux jintuża f'pazjenti b'pulmonite interstizjali jew fibrożi pulmonari (mard fil-pulmun).
English: Why is Vectibix approved?
Maltese: Għaliex ġie approvat Vectibix?
English: As for all medicines, data on the use of Vectibix are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vectibix hija ssorveljata kontinwament.
English: • Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months without the disease getting worse in a study of 1,183 previously untreated patients compared with 7.9 months for those receiving FOLFOX alone.
Maltese: • Il-pazjenti li kienu qed jirċievu Vectibix f'kombinazzjoni ma' FOLFOX għexu medja ta' 10.1 xhur mingħajr ma l-marda marret għall-agħar fi studju ta' 1,183 pazjent li ma kinux ikkurati qabel meta mqabbla ma' 7.9 xhur għal dawk li kienu qed jirċievu FOLFOX waħdu.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Maltese: Peress li l-kumpanija forniet l-informazzjoni addizzjonali meħtieġa, lawtorizzazzjoni ma baqgħetx kkundizzjonata u saret sħiħa.
English: What are the risks associated with Vectibix?
Maltese: X'inhuma r-riskji assoċjati ma' Vectibix?
English: • Patients with wild-type tumours who received Vectibix alone had no disease progression for an average of 16 weeks in a study of 463 patients, compared with 8 weeks in those who did not receive Vectibix and only had supportive care.
Maltese: • Il-pazjenti b'tumuri tat-tip selvaġġ li rċevew Vectibix waħdu ma kellhom l-ebda progressjoni talmarda għal medja ta' 16-il ġimgħa fi studju fuq 463 pazjent, meta mqabbla ma' 8 ġimgħat f'dawk li ma rċevewx Vectibix u li kellhom biss kura ta' sostenn.
English: Several bowel cancer studies have shown that Vectibix is effective at prolonging life or slowing disease progression in patients with ‘wild-type' RAS tumours that have spread.
Maltese: Diversi studji dwar il-kanċer tal-musrana wrew li Vectibix huwa effettiv biex itawwal il-ħajja jew inaqqas ir-ritmu tal-progressjoni tal-marda f'pazjenti b'tumuri RAS tat-“tip selvaġġ” li jkunu nfirxu.
English: How does Vectibix work?
Maltese: Kif jaħdem Vectibix?
English: For the full list of side effects of Vectibix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Vectibix, ara l-fuljett ta' tagħrif.
English: Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal (‘wild-type') copies of a gene known as RAS.
Maltese: Vectibix jintuża waħdu jew ma' mediċini oħra kontra l-kanċer f'pazjenti b'tip ta' tumur li għandu kopji normali (“tip selvaġġ” - “wild-type”) ta' ġene magħrufa bħala RAS.
English: Patients in this study (there was no comparator treatment) lived for an average of 11.2 months without their disease getting worse.
Maltese: Il-pazjenti f'dan listudju (ma kienx hemm kura komparattiva) għexu medja ta' 11.2 xhur mingħajr ma l-marda tagħhom marret għall-agħar.
English: Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body.
Maltese: Vectibix huwa mediċina għall-kura tal-kanċer kolorettali (tal-musrana) li jkun infirex f'partijiet oħra talġisem.
English: It was later confirmed that benefit is limited only to patients with wildtype RAS tumours.
Maltese: Aktar tard ġie kkonfermat li l-benefiċċju hu limitat biss għall-pazjenti b'tumuri RAS tat-tip selvaġġ.
English: In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of these were mild or moderate.
Maltese: Fl-istudji, 93 % tal-pazjenti li ngħataw Vectibix kellhom effetti sekondarji li affettwaw il-ġilda, għalkemm fil-biċċa l-kbira tagħhom kienu ħfief jew moderati.
English: What measures are being taken to ensure the safe and effective use of Vectibix?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Vectibix?
English: Side effects reported with Vectibix are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Vectibix huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Benefit/risk balance
Maltese: Bilanċ tal-benefiċċju/riskju
English: Diclofenac is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Diclofenac huwa mediċina anti-infjammatorja mhux sterojdi (NSAID).
English: Major vascular events were increased by about one third by a coxib (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Maltese: L-istudju, li ħares lejn aktar minn 600 prova klinika każwali, ikkonkluda li r-riskji vaskulari ta' diclofenac f'doża għolja huma komparabbli ma' inibituri ta' Cox-2. Lavvenimenti vaskulari maġġuri kienu żdiedu b'madwar terz b'coxib (proporzjon tar-rata [RR] ta' 1.37, intervall ta' fiduċja ta' 95% [CI] 1.14-1.66; p=0.0009) jew b'diclofenac (1.41, 1.12-1.78; p=0.0036), l-aktar minħabba żieda f'avvenimenti koronarji maġġuri (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac:
English: With regards to cardiovascular risks, the PRAC noted that the initial signal from the MEDAL programme was confirmed by the meta-analyses of randomised clinical trials conducted by Trelle et al (2011) and Chen and Ashcroft (2007).
Maltese: Fir-rigward tar-riskji kardjovaskulari, il-PRAC innota li s-sinjal inizjali mill-programm MEDAL kien ikkonfermat mill-meta-analiżi ta' provi kliniċi każwali li saret minn Trelle et al (2011) u Chen and Ashcroft (2007).
English: 1 For more details on the MEDAL programme, including its components, please refer to the assessment report for the review conducted in 2006 at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
Maltese: 1 Għal aktar dettalji dwar il-programm MEDAL, inkluż il-komponenti tiegħu, jekk jogħġbok irreferi għar-rapport ta' valutazzjoni għar-reviżjoni li saret fl-2006 fuq http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 with regards to diclofenac containing medicinal products (systemic formulations), agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata t-13 ta' Ġunju 2013 fir-rigward ta' prodotti mediċinali li fihom diclofenac (formulazzjonijiet sistemiċi), jaqbel mar-rakkomandazzjoni fiha kif iddikjarat hawn taħt:
English: Recognised risks associated with NSAID treatment in general, and with diclofenac treatment in particular, include serious gastrointestinal effects including PUB (perforation, ulcer, bleeding), cardio-renal effects, hepatic effects and skin reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis).
Maltese: Riskji rikonoxxuti assoċjati mal-kura b'NSAID b'mod ġenerali, u b'mod partikolari b'kura b'diclofenac, jinkludu effetti gastrointestinali serji li jinkludu PUB (perforazzjoni, ulċera, fsada), effetti kardjo-renali, effetti epatiċi u reazzjonijiet tal-ġilda (inkluż is-sindromu ta' Stevens-Johnson u nekroliżi epidermali tossika).
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diclofenac containing medicinal products (systemic formulations).
Maltese: • Il-PRAC ikkunsidra l-proċedura taħt l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta minn dejta ta' farmakoviġilanza, għal prodotti mediċinali li fihom diclofenac (formulazzjonijiet sistemiċi).
English: It was observed that these are similar to those of selective Cox-2 inhibitors.
Maltese: Ġie osservat li dawn huma simili għal dawk ta' inibituri selettivi ta' COX-2.
English: The data available (in particular data from the MEDAL1 programme) suggested that the risk of arterial thrombotic events with diclofenac was similar to that for coxibs, but firm conclusions could not be drawn and further epidemiological studies were needed to obtain additional data.
Maltese: Id-dejta disponibbli (b'mod partikolari dejta mill-programm MEDAL1) issuġġeriet li r-riskju ta' avvenimenti trombotiċi arterjali b'diclofenac kien simili bħal dak għal coxibs, iżda ma setgħux jinġibdu konklużjonijiet sodi u kien hemm il-ħtieġa ta' studji epidemjoloġiċi ulterjuri biex tinkiseb dejta addizzjonali.
English: Epidemiological and clinical trial data on the cardiovascular risks of NSAIDs, including diclofenac, were previously reviewed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Dejta epidemjoloġika u minn provi kliniċi dwar ir-riskji kardjovaskulari ta' NSAIDs, inkluż diclofenac, kienet ġiet preċedentement riveduta mill-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP).
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Maltese: • Il-PRAC ikkonkluda li fid-dawl tad-dejta tas-sigurtà attwalment disponibbli sabiex jinżamm benefiċċju/riskju favorevoli, prodotti mediċinali li fihom diclofenac għandhom jiġu kontraindikati f'pazjenti b'insuffiċjenza konġestiva tal-qalb stabbilita (NYHA II-IV), mard iskemiku tal-qalb, mard arterjali periferali u/jew mard ċerebrovaskulari.
English: • The PRAC considered that diclofenac containing medicinal products are effective in their approved indications.
Maltese: • Il-PRAC ikkunsidra li prodotti mediċinali li fihom diclofenac huma effettivi fl-indikazzjonijiet approvati tagħhom.
English: Diclofenac containing medicinal products (systemic formulations) are available as tablets, capsules for oral administration, suppositories for rectal administration and solutions for intravenous or intramuscular injection.
Maltese: Prodotti mediċinali li fihom diclofenac (formulazzjonijiet sistemiċi) huma disponibbli bħala pilloli, kapsuli għall-għoti orali, suppożitorji għall-għoti ġor-rektum u soluzzjonijiet għal injezzjoni ġol-vina jew fil-muskolu.
English: Evidence available from a new meta-analysis of randomised clinical trials conducted by an independent research group was included in the review.
Maltese: Evidenza disponibbli minn meta-analiżi ġdida ta' provi kliniċi każwali li saru minn grupp indipendenti ta' riċerka kienet inkluża fir-reviżjoni.
English: The study by Krum et al 2012, a post hoc analysis of the MEDAL trial, showed that there was no significant differential effect between etoricoxib and diclofenac in relation to cardiovascular events, except for confirmed congestive heart failure.
Maltese: Listudju minn Krum et al 2012, analiżi post hoc tal-prova MEDAL, wera li ma kien hemm l-ebda effett differenzjali sinifikanti bejn etoricoxib u diclofenac fir-rigward ta' avvenimenti kardjovaskulari, ħlief għal insuffiċjenza konġestiva tal-qalb ikkonfermata.
English: Results of the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) research project funded by the European Commission under the Seventh Framework Programme were considered in the review that concluded that available evidence regarding diclofenac seemed to consistently point towards a less favourable cardiovascular risk profile compared to other NSAIDs, and similar risks as those of Cox-2 inhibitors.
Maltese: Irriżultati tal-proġett ta' riċerka dwar is-‘sigurtà ta' mediċini anti-infjammatorji mhux sterojdi' (SOS) iffinanzjat mill-Kummissjoni Ewropea taħt is-Seba' Programm Qafas kienu kkunsidrati fir-reviżjoni li kkonkludiet li l-evidenza disponibbli dwar diclofenac dehret li konsistentement tindika profil tar-riskju kardjovaskulari anqas favorevoli meta mqabbel ma' NSAIDs oħra, u riskji simili bħal dawk ta' inibituri ta' Cox-2.
English: Another evaluation conducted by the CHMP in 20122 considered all available published evidence to date from meta-analysis of clinical trials and observational studies, and also epidemiological studies.
Maltese: Evalwazzjoni oħra mwettqa mis-CHMP fl-20122 ikkunsidrat l-evidenza kollha ppubblikata disponibbli sa issa minn meta-analiżi ta' provi kliniċi u studji ta' osservazzjoni, u wkoll studji epidemjoloġiċi.
English: Overall summary of the scientific evaluation of diclofenac containing medicinal products (systemic formulations) (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom diclofenac (formulazzjonijiet sistemiċi) (ara Anness I)
English: • The PRAC considered that with regards to the arterial thrombotic risks of diclofenac, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, allow the conclusion that diclofenac is associated with increased cardiovascular risks.
Maltese: • Il-PRAC ikkunsidra li fir-rigward tar-riskji trombotiċi arterjali ta' diclofenac, id-dejta disponibbli sallum minn provi kliniċi każwali, studji ta' osservazzjoni u studji epidemjoloġiċi individwali, inkluż il meta-analiżi tagħhom, tippermetti l-konklużjoni li diclofenac huwa assoċjat ma' żieda fir-riskjikardjovaskulari.
English: The PRAC acknowledged the conclusions of previous reviews with regards to the cardiovascular safety of diclofenac.
Maltese: Il-PRAC irrikonoxxa l-konklużjonijiet tar-reviżjonijiet preċedenti fir-rigward tas-sigurtà kardjovaskulari ta' diclofenac.
English: Considering that an increased cardiovascular risk with diclofenac is observed, and this appears similar to that of selective Cox-2 inhibitors, it therefore follows that any risk minimisation in place for Cox-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Maltese: Meta jitqies li ġiet osservata żieda fir-riskju kardjovaskulari b'diclofenac, u din tidher simili għal dik ta' inibituri selettivi ta' COX-2, għalhekk isegwi likull minimizzazzjoni tar-riskju fis-seħħ għal inibituri ta' COX-2 fir-rigward ta' riskju kardjovaskulari għandhom japplikaw ukoll għal diclofenac.