FrancophonIA/ELRC3.0 huggingface dataset:
English: Zerbaxa (ceftolozane / tazobactam)
Maltese: Kif jintuża Zerbaxa?
English: These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Maltese: Dawn l-enzimi jippermettu lill-batterji jkissru antibijotiċi betalattamiċi bħaċ-ċeftolożan, b'hekk il-batterji jsiru reżistenti għallazzjoni tal-antibijotiku.
English: Tazobactam blocks the action of bacterial enzymes called beta-lactamases.
Maltese: It-tażobaktam timblokka l-azzjoni ta' enzimi batteriċi msejħa betalattamażi.
English: For the full list of side effects of Zerbaxa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Zerbaxa, ara l-fuljett ta' tagħrif.
English: • complicated infections of the urinary tract (structures that carry urine, such as the bladder);
Maltese: • infezzjonijiet ikkumplikati tal-passaġġ urinarju (l-istrutturi li jġorru l-awrina, bħall-borża talawrina);
English: Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Zerbaxa huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Zerbaxa work?
Maltese: Kif jaħdem Zerbaxa?
English: One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
Maltese: Studju minnhom kien jinvolvi 1,083 pazjent li l-biċċa l-kbira tagħhom kellhom infezzjoni tal-kliewi jew f'xi każijiet infezzjoni kumplikata tal-passaġġ urinarju.
English: Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Maltese: Fir-rigward tassigurtà, l-effetti sekondarji ġew ikkunsidrati tipiċi u mistennija minn antibijotiku ta' dan it-tip.
English: By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Maltese: Billi timblokka l-azzjoni ta' dawn l-enzimi, it-tażobaktam tippermetti liċċeftolożan taġixxi kontra batterji li normalment ikunu reżistenti għaċ-ċeftolożan.
English: Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Maltese: Zerbaxa ma għandux jintuża f'persuni li jkunu ipersensittivi (allerġiċi) għal Zerbaxa jew għal xi sustanza tiegħu, jew f'dawk li jkunu ipersensittivi għal antibijotiċi ċefalosporina oħrajn jew li qatt kellhom reazzjoni allerġika severa għal antibijotiku betalattamiku ieħor.
English: Dr Barbara van Zwieten Boot (Netherlands)
Maltese: Dr Barbara van Zwieten Boot (Olanda)
English: Dr Ian Hudson (United Kingdom)
Maltese: Dr Ian Hudson (Renju Unit)
English: Ref.: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
Maltese: Londra, 22 ta' Ottubru 2009 Dok. ta' Ref.: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
English: Referral start date:
Maltese: Riferenza tad-data tal-bidu:
English: Extraneal is a solution that contains icodextrin as the active substance, as well as sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
Maltese: Extraneal huwa soluzzjoni li fih icodextrin bħala s-sustanza attiva, kif ukoll sodium lactate, sodium chloride, calcium chloride u magnesium chloride.
English: This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States).
Maltese: Din il-varjazzjoni kellha tkun rikonoxxuta fl-Awstrija, fil-Belġju, fid-Danimarka, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Irlanda, fl-Italja, filLussemburgu, fl-Olanda, fil-Portugall, fi Spanja u fl-Iżvezja (l-Istati Membri kkonċernati).
English: What is Extraneal?
Maltese: X'inhu Extraneal?
English: Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation
Maltese: 1 Artikolu 6(12) tar-Regolament (KE) 1084/2003 kif emendat, referenza fuq varjazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq
English: The review was carried out under an ‘Article 6(12)' referral1.
Maltese: Ir-reviżjoni saret taħt referenza tal-‘Artikolu 6(12)'1.
English: Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Extraneal soluzzjoni ta' 7.5% icodextrin għal dijaliżi peritoneali
English: Extraneal is a solution that is used in peritoneal dialysis.
Maltese: Extraneal huwa soluzzjoni li tintuża fid-dijaliżi peritoneali.
English: The European Medicines Agency has completed an arbitration procedure for Extraneal 7.5% solution for peritoneal dialysis.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet proċedura ta' arbitraġġ għal Extraneal soluzzjoni ta' 7.5% għal dijaliżi peritoneali.
English: Company responses provided on: 31 August 2009 Opinion date:
Maltese: It-tweġiba tal-kumpanija ngħata: 31 ta' Awwissu 2009 Data tal-opinjoni:
English: Peptidoglycans had been linked to cases of inflammation of the peritoneum (the lining of the abdomen) in some patients receiving Extraneal.
Maltese: Il-peptidoglycans kienu ġew assoċjati ma' każijiet ta' infjammazzjoni tal-peritonew (l-inforra tal-addome) f'xi wħud millpazjenti li kienu qegħdin jingħataw Extraneal.
English: Why was Extraneal reviewed?
Maltese: Għaliex ġie rivedut Extraneal?
English: The grounds for the referral were that more sensitive tests than those proposed by the company could be used to detect peptidoglycans in the medicine, and that one of the currently approved manufacturers of the active substance should modify the manufacturing process of icodextrin to ensure that peptidoglycans are removed.
Maltese: Ir-raġunijiet għar-referenza kienu li setgħu jintużaw testijiet aktar sensittivi minn dawk proposti millkumpanija biex jinstabu peptidoglycans fil-mediċina, u li wieħed mill-manifatturi tas-sustanza attiva approvati attwalment għandu jibdel il-proċess ta' manifattura ta' icodextrin sabiex jiżgura li jitneħħew il-peptidoglycans.
English: Extraneal is used in particular in patients who cannot be treated with solutions containing glucose.
Maltese: Extraneal jintuża f'pazjenti li ma jistgħux jiġu kkurati b'soluzzjonijiet li fihom il-glucose.
English: Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997.
Maltese: Extraneal huwa awtorizzat fl-Unjoni Ewropea taħt proċedura ta' rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mir-Renju Unit fl-1997.
English: Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.
Maltese: Minħabba li dawn l-Istati Membri ma setgħux jaslu għal ftehim, l-aġenzija regolatorja Olandiża tal-mediċini rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fid-9 ta' Lulju 2009.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the change to the marketing authorisation for Extraneal to include a peptidoglycan test can be granted, and that the use of the active substance icodextrin sourced from one of the currently approved manufacturers should cease.
Maltese: Il-Kumitat tal-Aġenzija għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li tista' tiġi permessa l-bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Extraneal sabiex din tkun tinkludi test tal-peptidoglycans, u li l-użu tas-sustanza attiva icodextrin mixtrija mingħand wieħed mill-manifatturi approvati attwalment għandu jieqaf.
English: This is a blood clearance technique used in patients with long-term kidney failure, when a solution is pumped into the abdomen and an internal body membrane filters the blood.
Maltese: Din hija teknika ta' tneħħija tad-demm użata f'pazjenti b'insuffiċjenza tal-kliewi fit-tul, meta soluzzjoni tiġi ppumpjata fl-addome u membrana tal-ġisem interna tiffiltra d-demm.
English: The company applied for a change (variation) to the marketing authorisation to include a test to measure the level of an impurity called peptidoglycan during the medicine's production process.
Maltese: Il-kumpanija applikat għal bidla (varjazzjoni) għall-awtorizzazzjoni għat-tqegħid fis-suq sabiex tinkludi test li jkejjel il-livell ta' impurità msejħa peptidoglycan waqt il-proċess ta' produzzjoni tal-mediċina.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Extraneal can be approved in all concerned Member States.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli attwalment u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP kkonkluda li l-varjazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Extraneal tista' tiġi approvata fl-Istati Membri kkonċernati kollha.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1037/001 Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata Il-pakkett li jmiss mal-prodott
English: Steatosis
Maltese: Stejatożi
English: Retrospectively analysed CVS risk
Maltese: Riskju kardjovaskulari retrospettivament analizzat
English: Numerical imbalance in CVS events
Maltese: Żbilanċ numeriku fl-avvenimenti kardjovaskulari
English: In absolute terms, it corresponds to a placebo-corrected reduction with mipomersen by -100 and -114 mg/dl in LDL-C at PET versus baseline, which may be considered of clinical relevance.
Maltese: F'termini assoluti, dan jikkorrispondi għal tnaqqis ikkorreġut bi plaċebo b'mipomersen ta' -100u 114 mg/dl fl-LDL-C fil-PET kontra l-linja bażi, li jista' jitqies ta' rilevanza klinika.
English: In the Open-Label Extention study, patients showed ALT increases (18%), AST increases (16%), hepatic enzyme increases (3%), abnormal liver function tests (2%), and transaminases increases (0.7%).
Maltese: Fl-istudju ta' Estensjoni b'Tikketta Miftuħa, pazjenti wrew żidiet fl-ALT (18%), żidiet fl-AST (16%), żidiet fl-enzimi epatiċi (3%), testijiet abnormali tal-funzjoni tal-fwied (2%), u żidiet fit-transaminażi (0.7%).
English: Treatment with mipomersen results in a statistically significant decline of 24.7% and 35.9% in LDL-C levels at Primary Efficacy Time point (PET) versus baseline in patients with homozygous familial hypercholesterolaemia (HoFH) and severe heterozygous familial hypercholesterolaemia (HeFH) on top of statins, respectively.
Maltese: Kura b'mipomersen twassal għal tnaqqis statistikament sinifikanti ta' 24.7% u ta' 35.9% fil-livelli tal-LDL-C fil-Punt fiż-Żmien Primarju tal-Effikaċja (PET) kontra llinja bażi f'pazjenti b'iperkolesterolemija omozigota familjali (HoFH) u b'iperkolesterolemija eterozigota familjali severa (HeFH) flimkien ma' statins, rispettivament.
English: Of the 22 patients in the mipomersen-group with ALT levels ≥ 3 x ULN, 19 experienced decreases in ALT levels below 3 x ULN during continued treatment.
Maltese: Mit-22 pazjent fil-grupp ta' mipomersen b'livelli tal-ALT ta' ≥ 3 x ULN, 19 esperjenzaw tnaqqis fil-livelli talALT taħt 3 x ULN matul kura kontinwa.
English: Otherwise, additional studies to clarify the drug effect on these parameters are mandatory.” The issue of prospective planning for CVS safety outcome is even more specifically addressed in the recent Draft Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CHMP/718840/2012).
Maltese: Il-kwistjoni ta' ippjanar prospettiv għar-riżultat tas-sigurtà kardjovaskulari ġiet saħansitra indirizzata b'mod aktar speċifiku fl-Abbozz riċenti tal-Linja Gwida dwar l-Investigazzjoni Klinika ta' Prodotti Mediċinali fil-Kura ta' Disturbi tal-Lipidi (EMA/CHMP/718840/2012).
English: Kynamro is an apolipoprotein B (apo B) synthesis inhibitor indicated as an adjunct to maximally tolerated lipid-lowering medicines and diet to reduce low density lipoprotein-cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Maltese: Kynamro huwa inibitur tas-sintesi tal-apolipoproteina B (apo B) indikat bħala żieda mal-aktar mediċini ittollerati li jbaxxu l-lipidi u mad-dieta biex inaqqas il-kolesterol b'lipoproteina ta' densità baxxa (LDL-C) f'pazjenti adulti b'iperkolesterolemija omozigota familjali (HoFH).
English: Withdrawal rate was similar in HoFH patients and in the full population of OLE CS6 (56%).
Maltese: Ir-rata ta' rtirar kienet simili f'pazjenti b'HoFH u fil-popolazzjoni sħiħa ta' OLE CS6 (56%).
English: The CHMP considered the following:
Maltese: Is-CHMP qies dan li ġej:
English: Liver enzyme increase
Maltese: Żieda fl-enzimi tal-fwied
English: Indeed, an annual event rate of 6% has been described for a composite endpoint of non-fatal MI and cardiac death in a comparable population (Scandinavian-Simvastatin Survival Study Group, 1995, Lancet).
Maltese: Tabilħaqq, rata ta' avvenimenti annwali ta' 6% ġiet deskritta għall-endpoint kompost ta' infart mijokardijaku (MI) mhux fatali u mewt kardijaku f'popolazzjoni komparabbli (Grupp Skandinavu ta' Studju ta' Sopravivenza b'Simvastatin, 1995, Lancet).
English: The CHMP noted that in two phase 3 studies (ISIS 301012-CS7 and ISIS 301012CS12) hepatic fat fraction was assessed with magnetic resonance imaging (MRI) at baseline and Week 28 (or early termination):
Maltese: Is-CHMP innota li f'żewġ studji tal-fażi 3 (ISIS 301012-CS7 u ISIS 301012-CS12) lammont ta' xaħam fil-fwied ġie evalwat b'immaġni b'riżonanza manjetika (MRI) fillinja bażi u fil-Ġimgħa 28 (jew terminazzjoni bikrija):
English: Exclusion criteria were also in place to ensure adequate hepatic function based on laboratory values (ALT, ALT > 1.5 x ULN).
Maltese: Kien hemm ukoll fis-seħħ kriterji ta' esklużjoni biex jiżguraw funzjoni epatika adegwata abbażi ta' riżultati tal-laboratorju (ALT, ALT > 1.5 x ULN).
English: - 61.8% (63/102) of mipomersen treated patients with paired MRI studies experienced a ≥5% increase from baseline in hepatic fat.
Maltese: - 61.8% (63/102) tal-pazjenti li rċevew kura b'mipomersen meta mqabbla ma' studji b'MRI esperjenzaw żieda ta' ≥5% mil-linja bażi fix-xaħam fil-fwied.
English: A similar or even higher event rate might be expected for MACE (including acute myocardial infarction, stroke or CVA, unstable angina, PCI, and CABG) in a patient population such as the one enrolled in the pivotal phase 3 studies (HoFH and severe HeFH patients).
Maltese: Rata simili jew anke ogħla ta' avvenimenti tista' tiġi mistennija għal MACE (inkluż infart mijokardijaku akut, puplesija jew CVA, anġina instabbli, PCI, u CABG) f'popolazzjoni ta' pazjenti bħal dik li ħadet sehem fl-istudji pivotali tal-fażi 3 (pazjenti b'HoFH u b'HeFH severa).
English: This corresponds to a reduction by 21% and 48% with mipomersen when corrected with placebo (for HoFH and HeFH, respectively).
Maltese: Dan jikkorrispondi għal tnaqqis ta' 21% u ta' 48% b'mipomersen meta kkoreġut bi plaċebo (għal HoFH u HeFH, rispettivament).
English: The CHMP assessed all the detailed grounds for re-examination and argumentations presented by the applicant and considered the views of the PRAC (PRAC meeting 4-7 February 2013) and the advisory expert group held on 12 March 2013.
Maltese: Is-CHMP evalwa r-raġunijiet dettaljati kollha għal eżaminazzjoni mill-ġdid u largumentazzjonijiet ippreżentati mill-applikant u kkunsidra l-opinjonijiet tal-PRAC (laqgħa tal-PRAC tal-4-7 ta' Frar 2013) u tal-grupp konsultattiv ta' esperti li sar fit12 ta' Marzu 2013.
English: According to literature (e.g. as summarised in the AWMF guideline on the histopathology of non-alcoholic and alcoholic fatty liver disease; German Society of Pathology, 2009), the natural course of hepatic steatosis/non-alcoholic fatty liver disease (NAFLD) in individual patients is not predictable; it is indicated that steatosis may progress to steatohepatitis/NASH in about 10-20% of cases, and of these less than 5% ultimately develop cirrhosis.
Maltese: Skont il-letteratura (eż. kif imqassar fil-linja gwida tal-AWMF dwar l-istopatoloġija ta' mard tal-fwied xaħmi mhux alkoħoliku u alkoħoliku; Soċjetà Ġermaniża talPatoloġija, 2009), il-kors naturali tal-istejatożi epatika/mard ta' xaħam fil-fwied mhux alkoħoliku (NAFLD) f'pazjenti individwali mhuwiex prevedibbli; huwa indikat li listejatożi tista' tipprogressa għal steatohepatitis/NASH f'madwar 10-20% tal-każijiet, u minn dawn inqas minn 5% eventwalment jiżviluppaw ċirrożi.
English: The applicant argues that the degree of LDL reduction observed with mipomersen treatment is expected to result in a potential reduction in coronary heart disease risk greater than 50%, which is based on meta-analyses of data from multiple studies (Baigent, 2010, the Lancet).
Maltese: L-applikant isostni li l-grad ta' tnaqqis fl-LDL osservat bil-kura b'mipomersen huwa mistenni li jwassal għal tnaqqis potenzjali fir-riskju ta' mard koronarju tal-qalb ta' aktar minn 50%, li huwa bbażat fuq meta analiżi ta' dejta minn bosta studji (Baigent, 2010, the Lancet ).
English: CHMP position on ground 3
Maltese: Il-pożizzjoni tas-CHMP fuq raġuni 3
English: For 14 (5.4%) of these patients, dosing with mipomersen was stopped (stopping rules were ≥8 x ULN for AST/ALT on one occasion, ≥5 x ULN for AST/ALT over 7 days, or ≥3 x ULN for AST/ALT and elevated bilirubin).
Maltese: Għal 14 (5.4%) minn dawn ilpazjenti, l-għoti ta' dożi ta' mipomersen twaqqaf (regoli għat-twaqqif kienu ta' ≥8 x ULN għall-AST/ALT f'okkażjoni waħda, ta' ≥5 x ULN għall-AST/ALT fuq 7 ijiem, jew ta' ≥3 x ULN għall-AST/ALT u żieda fil-bilirubin).
English: • A statistically significant mean reduction in LDL-C of approximately 25% (absolute change -2.92mmol/L) in patients with HoFH already receiving maximally tolerated lipid-lowering therapy is highly relevant for this small group of patients with a high unmet medical need;
Maltese: • It-tnaqqis medju statistikament sinifikanti fl-LDL-C ta' madwar 25% (tibdil assolut ta' 2.92mmol/L) f'pazjenti b'HoFH li diġà qed jirċievu t-terapija massima ttollerata li tbaxxi l-lipidi huwa rilevanti ħafna għal dan il-grupp żgħir ta' pazjenti bi ħtieġa medika għolja mhux sodisfatta;
English: CHMP position on ground 1
Maltese: Il-pożizzjoni tas-CHMP dwar raġuni 1
English: In the clinical development programme increases in hepatic transaminases (ALT, AST) and liver fat were observed frequently in patients who received mipomersen therapy.
Maltese: Fil-programm ta' żvilupp kliniku żidiet fit-transaminażi epatiċi (ALT, AST) u xaħam filfwied kienu osservati b'mod frekwenti f'pazjenti li rċevew terapija b'mipomersen.
English: Potential negative effects, in particular inflammatory effects, immunological reactivity, increase in blood pressure and renal toxicity (as shown by proteinuria) on other cardiovascular risk factors may counteract the potential beneficial effect on CV outcome due to reduction in LDL-C;
Maltese: Effetti negattivi potenzjali, b'mod partikolari, effetti infjammatorji, reattività immunoloġika, żieda fil-pressjoni tad-demm u tossiċità renali (kif jidher minn proteinurja) fuq fatturi oħra ta' riskju kardjovaskulari jistgħu jinnewtralizzaw l-effett ta' benefiċċju potenzjali fuq l-effett kardjovaskulari minħabba tnaqqis fl-LDL-C;
English: In case of the pivotal study in HoFH patients (ISIS 301012-CS5) patients with a documented history of hepatic disease, liver cirrhosis, or liver steatosis were also excluded.
Maltese: Fil-każ tal-istudju pivotali fuq pazjenti b'HoFH (ISIS 301012-CS5) pazjenti bi storja dokumentata ta' mard tal-fwied, ċirrożi tal-fwied, jew stejatożi tal-fwied kienu wkoll esklużi.
English: A detrimental effect of mipomersen on CVS risk has not been shown but cannot be excluded since data are too limited.
Maltese: Effett detrimentali ta' mipomersen fuq ir-riskju kardjovaskulari ma ntweriex imma ma jistax jiġi eskluż peress li d-dejta hija limitata wisq.
English: Potential effect of LDL reduction
Maltese: Effett potenzjali ta' tnaqqis fl-LDL
English: The CHMP also noted that the experts were not reassured that mipomersen is not conclusively linked to renal and CVS harm, and concluded that a >50% reduction in 5-year CHD risk as envisaged by the applicant for mipomersen treatment is purely hypothetical.
Maltese: Is-CHMP innota wkoll li lesperti ma ġewx assigurati li mipomersen mhuwiex konklussivament marbut ma' ħsara renali u kardjovaskulari, u kkonkluda li t-tnaqqis ta' >50% fir-riskju ta' mard koronarju tal-qalb fuq 5-snin kif previst mill-applikant għall-kura b'mipomersen huwa purament ipotetiku.
English: CHMP position on ground 2:
Maltese: Il-pożizzjoni tas-CHMP dwar raġuni 2:
English: Following discussions at the Scientific Advisory Group (SAG) meeting in September 2012, the applicant restricted the indication to HoFH patients only, in which the lifetime exposure to extremely high low density lipoprotein cholesterol (LDL-C) levels is responsible for CVS morbidity and early age mortality.
Maltese: Wara diskussjonijiet waqt il-laqgħa tal-Grupp ta' Konsulenza Xjentifika (SAG) f'Settembru 2012, l-applikant illimita l-indikazzjoni għal pazjenti b'HoFH biss, li fihom l-espożizzjoni tul il-ħajja għal livelli estremament għoljin ta' kolesterol b'lipoproteina ta' densità baxxa (LDL-C) hija responsabbli għal morbidità kardjovaskulari u mortalità f'età bikrija.
English: This is regarded by the CHMP as a major deficiency, and was also criticized by the expert advisory group.
Maltese: Dan huwa meqjus mis-CHMP bħala nuqqas kbir, u ġie kkritikat ukoll mill-grupp konsultattiv ta' esperti.
English: Therefore, the CHMP concluded on 13 December 2012 that the benefit/risk ratio of mipomersen is negative.
Maltese: Għalhekk, fit-13 ta' Diċembru 2012 is-CHMP ikkonkluda li l-proporzjon talbenefiċċju/riskju ta' mipomersen huwa negattiv.
English: Overall, based on the assessment of the detailed grounds for re-examination submitted by the applicant, including the revised risk management proposals for monitoring of liver lipids and liver toxicity, and the revised restricted indication, as applied for by the applicant, the CHMP concluded that the benefit/risk of Kynamro remains unfavourable.
Maltese: B'mod ġenerali, abbażi tal-evalwazzjoni tar-raġunijiet dettaljati għal eżaminazzjoni mill-ġdid sottomessa mill-applikant, inkluż il-proposti riveduti għall-ġestjoni tar-riskju għall-monitoraġġ tal-lipidi fil-fwied u t-tossiċità tal-fwied, u l-indikazzjoni restritta riveduta, kif applikata mill-applikant, is-CHMP ikkonkluda li l-benefiċċju/riskju ta' Kynamro jibqa' sfavorevoli.
English: With regard to ALT and AST elevations, results from the pooled phase 3 studies (mipomersen n=261, placebo n=129, including patients with HoFH and HeFH) are summarized.
Maltese: Fir-rigward taż-żidiet fl-ALT u fl-AST, ir-riżultati mill-istudji miġbura tal-fażi 3 (mipomersen n=261, plaċebo n=129, li kienu jinkludu pazjenti b'HoFH u b'HeFH) ġew imqassra.
English: The benefits of mipomersen-induced reductions in LDL-C in this population, which is at great risk of premature death, are anticipated to be large (potentially greater than 50% risk reduction of CHD, based on meta-analysis of multiple clinical trials), in contrast to the known and hypothetical risks of treatment with mipomersen.
Maltese: Il-benefiċċji ta' tnaqqis fl-LDL-C indott minn mipomersen f'din il-popolazzjoni, li qiegħda f'riskju kbir ta' mewt prematur, huma antiċipati li jkunu kbar (potenzjalment aktar minn tnaqqis ta' 50% fir-riskju ta' mard koronarju tal-qalb, abbażi ta' meta-analiżi ta' bosta provi kliniċi), b'kuntrast mar-riskji magħrufa u ipotetiċi ta' kura b'mipomersen.
English: In the HoFH, the retention rate was only 8% at 3 years, with 63% withdrawing due to adverse events.
Maltese: Fl-HoFH, ir-rata ta' żamma kienet biss ta' 8% wara 3 snin, b'63% jirtiraw minħabba avvenimenti avversi.