FrancophonIA/ELRC3.0 huggingface dataset:
English: Ribavirin in combination with peginterferon alfa-2b Multiple-dose pharmacokinetic properties for ribavirin and peginterferon alfa-2b in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Maltese: Il-karatteristiċi tal-farmakokinetika b'ħafna dożi ta' ribavirin u peginterferon alfa-2b f'pazjenti tfal u adolexxenti b'epatite Ċ kronika kienu evalwati waqt studju kliniku.
English: difficulty concentrating, feeling anxious or nervous, mood swings, feeling depressed or irritable, tired feeling, trouble falling asleep or staying asleep, cough, dry mouth, pharyngitis (sore throat), diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking chills, virus infection, vomiting, weakness, loss of appetite, loss of weight, stomach pain, dry skin, irritation, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Maltese: dijarea, sturdament, temperatura għolja, sintomi bħal ta' l-influwenza, uġigħ ta' ras, nuqqas jew żieda fl-aptit, tnaqqis fil-piż, tnaqqis fir-rata ta' tkabbir (tul u piż), uġigħ fin-naħa tal-lemin tal-kustilji, farinġite, (grieżem misluħin), dehxiet bi tregħid, uġigħ fl-istonku, rimettar ġilda xotta, jeħfief ix-xagħar, irritazzjoni, telf tax-xagħar, ħakk tal-ġilda, weġgħat tal-muskoli, uġigħ fil-ġogi u fil-muskoli, raxx.
English: Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement,
Maltese: F'pazjenti li kienu ko-infettati b'HCV/HIV li kienu qed jirċievu cART, l-effetti sekondarji oħra li ġejjin seħħew bil-kombinazzjoni ta' ribavirin u peginterferon alfa-2b (mhux elenkati hawn fuq taħt l-effetti sekondarji fl-adulti): tnaqqis fl-aptit, uġigħ fid-dahar, tnaqqis fl-għadd ta' limfoċiti CD4, metaboliżmu diffettuż tax-xaħam, epatite, uġigħ fid-driegħ/riġel, kandidjasi orali (thrush orali),
English: Table 5 Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b System Organ Class
Maltese: Reazzjonijiet avversi rrapurtati waqt provi kliniċi jew wara l-użu ta' wara t-tqegħid fis suq ta' ribavirin ma' interferon alfa-2b pegilat jew interferon alfa-2b.Sistema tal-klassifika tal-organi
English: From pre-treatment to end of long-term follow-up among children treated for 24 or 48 weeks, height-for-age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Maltese: Minn qabel il-kura sat-tmiem tal-followup fit-tul fost tfal ikkurati għal 24 jew 48 ġimgħa, il-percentiles tat-tul skont l-età naqsu b'1.3 u 9.0 percentiles, rispettivament.
English: In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Maltese: Fi prova mhux kumparattiva, 2,293 pazjent b'fibrożi moderata għal severa li kienu fallew għall-kura li ngħataw qabel b'taħlita ta' interferon alfa/ribavirin kienu kkurati mill-ġdid b'peginterferon alfa-2b, 1.5 mikrogramma/kg mogħtija taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin mogħti skont ilpiż tal-pazjent.
English: Ribavirin 800-1,400 mg/day plus peginterferon alfa-2b 1.5 μg/kg once weekly
Maltese: Ribavirin (800 mg/jum) + peginterferon alfa-2b (1.5 µg/kg/ ġimgħa)
English: Chest pain, chest discomfort, peripheral oedema, malaise, feeling abnormal, thirst
Maltese: Uġigħ tas-sider, skumdità fis-sider, edema periferali, tħossok ma tiflaħx, tħossok anormali, għatx
English: The haemolytic anaemia associated with ribavirin therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Maltese: L-anemija emolitika assoċjata mat-terapija b'ribavirin tista' tirriżulta fid-deterjorazzjoni talfunzjoni kardijaka u/jew aggravament ta' mard kardijaku pre-eżistenti.
English: In those patients that received >10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg Ribavirin (Table 7), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Maltese: F'dawk il-pazjenti li rċevew > 10.6 mg/kg ribavirin (doża ta' 800 mg f'pazjent tipiku ta' 75 kg), mingħajr ma jingħata każ tal-ġenotip jew tal-viral load, ir-rati ta' rispons kienu ogħla b'mod sinifikanti milli f'dawk il-pazjenti li rċevew  10.6 mg/kg ta' ribavirin (Tabella 7), filwaqt li r-rati ta' rispons f'pazjenti li rċevew > 13.2 mg/kg ta' ribavirin kienu aktar għolja.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa2b (with or without ribavirin), respectively.
Maltese: Żewġ studji kbar ta' follow up fit-tul ta' 1,071 pazjent u 567 pazjent wara kura fi studji minn qabel b'interferon alfa-2b mhux pegilat (b'ribavirin jew mingħajru) u interferon alfa-2b pegilat (b'ribavirin jew mingħajru), rispettivament.
English: tel: + 34 900 102 712
Maltese: Mylan Pharmaceuticals, S.L. tel: + 34 900 102 712
English: Volume of distribution is approximately 5,000 l. Ribavirin does not bind to plasma proteins.
Maltese: Ribavirin ma tintrabatax mal-proteini tal-plażma.
English: • Genotype 2 or 3: The recommended duration of treatment is 24 weeks.
Maltese: • Ġenotip 2 jew 3: It-tul ta' żmien rakkomandat tal-kura hu ta' 24 ġimgħa.
English: Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be stopped (see section 4.2).
Maltese: L-istat kardijaku għandu jkun eżaminat qabel tinbeda tterapija u osservat klinikament waqt it-terapija; jekk iseħħ xi deterjorament, it-terapija għandha titwaqqaf (ara sezzjoni 4.2).
English: However, absolute bioavailability is approximately 45%-65%, which appears to be due to first pass metabolism.
Maltese: Madankollu, ir-rata assoluta tal-bijodisponibilità hija ta' madwar 45 %-65 %, li tidher li hi minħabba lmetaboliżmu ta' l-ewwel passaġġ .
English: Only the description of the use of ribavirin from the original development with (peg)interferon alfa-2b is detailed in the current SmPC.
Maltese: Hija biss id-deskrizzjoni tal-użu ta' ribavirin mill-iżvilupp oriġinali b'(peg)interferon alfa-2b li hija dettaljata fis-SmPC kurrenti.
English: In a separate trial, 224 patients with genotype 2 or 3 received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg-1,400 mg p.o. for 6 months
Maltese: Fi prova separata, 224 pazjent b'ġenotip 2 jew 3 ingħataw peginterferon alfa-2b, 1.5 mikrogramma/kg minn taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin bejn 800 mg u 1,400 mg p.o. għal 6 xhur (bażat fuq il-piż tal-ġisem, kien hemm tlett pazjenti biss li kienu jiżnu > 105 kg, irċevew id-doża ta' 1,400 mg) (Tabella 8).
English: The pharmacokinetics of ribavirin (dose-normalized) in this trial was similar to those reported in a prior study of ribavirin in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Maltese: Il-farmakokinetika ta' ribavirin (miġjuba għan-normal skont id-doża) f'din il-prova kienet simili għal dawk irrappurtati fi studju ieħor b' ribavirin li sar qabel f'taħlita ma' interferon alfa-2b f'pazjenti tfal u adolexxenti u f'pazjenti adulti.
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Maltese: Żieda ta' l-ormon li jistimula t-tirojde fid-demm, żieda fittajroglobulin
English: Epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain, nonproductive cough
Maltese: Epistassi, disturb respiratorju, konġestjoni fil-passaġġ tannifs, konġestjoni tas-sinus, konġestjoni nażali, rinorreja, żieda fil-parti ta' fuq tal-passaġġ tan-nifs, uġigħ fil-farinġi u fil-larinġi, sogħla fil-vojt
English: • Inability to achieve full adult height may occur in some children and adolescents
Maltese: • Ċerti tfal u adolexxenti jistgħu ma jilħqux it-tul sħiħ ta' adult
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Maltese: Minbarra hekk, ħsibijiet dwar suwiċidju jew attentati ta' suwiċidju kienu rrappurtati aktar ta' spiss meta mqabbla ma' pazjenti adulti (2.4 % vs 1 %) waqt il-kura u fis-6 xhur tal-follow-up wara l-kura.
English: NR: Non-responder- defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Maltese: NR: Ma wrewx rispons definit bħala HCV-RNA fis-serum/plażma pożittiv fi tmiem it-12-il ġimgħa ta' kura.
English: For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with Ribavirin Mylan.
Maltese: Għall-użu f'pazjenti b'ċirrożi mhux kumpensata, ara s-SmPC korrispondenti tal-prodotti mediċinali użati flimkien ma' Ribavirin Mylan.
English: Renal failure, renal insufficiency*
Maltese: Indeboliment tal-kliewi, insuffiċjenza tal-kliewi*
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Maltese: Falliment għal terapija li tkun ingħatat qabel kien definit bħala irkadar jew nuqqas ta' rispons (HCV-RNA pożittivi fi tmiem ta' mill-anqas 12-il ġimgħa ta' kura).
English: Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a ChildPugh score ≥ 6.
Maltese: Pazjenti infettati fl-istess ħin b'HCV/HIV
English: No interaction studies have been conducted with ribavirin and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Maltese: Ma saru l-ebda studji dwar l-interazzjoni bejn ribavirin u prodotti mediċinali oħra, ħlief għallpeginterferon alfa-2b, interferon alfa-2b u mediċini kontra l-aċidu fl-istonku.
English: Ribavirin Mylan must be used in combination with interferon alfa-2b.
Maltese: Ribavirin Mylan irid jintuża flimkien ma' interferon alfa-2b.
English: Cardiac murmur * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or non-pegylated).
Maltese: *Minħabba li ribavirin dejjem ġie ordnat ma' prodott alfa interferon, u r-reazzjonijiet avversi tal-mediċina elenkati li kienu inklużi kienu jirriflettu esperjenza ta' wara t-tqegħid fis-suq li ma tippermettix li tiġi kwantifikata b'mod preċiż il-frekwenza, il-frekwenza irrappurtata hawn fuq inkisbet minn provi kliniċi fejn intuża ribavirin f'taħlita ma' interferon alfa-2b (pegilat jew mhux pegilat).
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Maltese: Dejta fittul disponibbli fi tfal ikkurati bit-terapija kombinata ta' pegylated interferon/ribavirin tindika dewmien sostanzjali tat-tkabbir.
English: Separation between curves is apparent at Year 3 (Year 3 - 144 metres, p=0.0055; Year 4 - 161 metres, p=0.0007).
Maltese: Sena - 161 metru, p=0.0007).
English: • Grounds for refusal
Maltese: • Kwistjonijiet ta' effikaċja
English: • The provided additional comparative data from a variety of external controls, derived from different studies and populations, suffer from important limitations related to the nature of the methodology used (non-concurrent, retrospectively selected, post-hoc defined).
Maltese: • Id-data komparattiva addizzjonali minn varjetà ta' kontrolli esterni, li ġiet minn studji u minn popolazzjonijiet differenti, tbati minn limitazzjonijiet importanti relatati man-natura talmetodoloġija użata (mhux konkorrenti, użata retrospettivament, definita post-hoc).
English: The Applicant has defined post-hoc several external controls that have been used for different comparisons.
Maltese: L-Applikant iddefinixxa diversi kontrolli esterni post-hoc li ntużaw għal paraguni differenti.
English: For this application clinical data were provided from a randomized, double-blinded, placebo controlled 24week Phase IIb study (study 201) and its open label extension Study 202 in a total of 12 DMD patients.
Maltese: Għal din l-applikazzjoni ġiet ipprovduta data klinika minn studju randomizzat, double-blinded, ikkontrollat bi plaċebo ta' 24 ġimgħa, tal-Fażi IIb (studju 201) u fl-estensjoni bi prova miftuħa tiegħu, l-Istudju 202 f'total ta' 12-il pazjent DMD.
English: All patients (100%) included in the pivotal trial and around 50% of all patients treated with any dose of eteplirsen reported AEs, mainly hypokaliemia, dermatitis contact, oropharyngeal pain, procedural pain, vomiting, balance disorder and cough.
Maltese: Il-pazjenti kollha (100%) inklużi fil-prova kruċjali u madwar 50% tal-pazjenti kollha kkurati bi kwalunkwe doża ta' eteplirsen irrappurtaw AEs, l-aktar ipokalimja, kuntatt tad-dermatite, uġigħ orofarinġeali, uġigħ proċedurali, rimettar, disturb fil-bilanċ u sogħla.
English: The limitation of the database size does not allow for the identification of frequent AEs (≥10%) and the lack of a comparator placebo arm makes it impossible to distinguish between AEs related to the disease or the age of the population and those related to the drug.
Maltese: Il-limitazzjoni taddaqs tal-bażi tad-data ma jippermettix l-identifikazzjoni ta' AEs frekwenti (≥10%) u n-nuqqas ta' fergħa ta' plaċebo bħala komparatur jagħmilha impossibbli li ssir distinzjoni bejn AEs relatati mal-marda jew mal-età tal-popolazzjoni u dawk relatati mal-mediċina.
English: The primary analysis of this pivotal trial provided a 24-week comparison of only 4 patients on eteplirsen exposed to the proposed dose of 30mg/kg/week versus placebo (n=4), and additionally 4 patients exposed to 50 mg/kg/week, in which no difference was observed in the 6MWD.
Maltese: L-analiżi primarja ta' din il-prova pivotali pprovdiet paragun ta' 24 ġimgħa ta' 4 pazjenti biss fuq eteplirsen esposti għad-doża proposta ta' 30mg/kg/ġimgħa kontra plaċebo (n=4), u addizzjonalment 4 pazjenti esposti għal 50 mg/kg/ġimgħa, li fihom ma ġiet osservata l-ebda differenza fis-6MWD.
English: Interim analysis became available for one of them, the PROMOVI (study 301) an open-label, multicentre study performed in DMD patients with genetically confirmed DMD with exon deletions amenable to exon 51 skipping.
Maltese: Ġiet disponibbli analiżi interim għal wieħed minnhom, ilPROMOVI (studju 301) studju bi prova miftuħa, f'ħafna ċentri li sar fuq pazjenti DMD b'DMD ġenetikament ikkonfermati bi tħassir exon soġġett għal exon 51 skipping.
English: Both groups (eteplirsen treated patients and untreated external controls) experienced a decline in ambulation.
Maltese: Iż-żewġ gruppi (il-pazjenti kkurati b'eteplirsen u l-kontrolli esterni mhux ikkurati) esperjenzaw tnaqqis fl-ambulazzjoni.
English: In conclusion, the safety profile of eteplirsen has not been thoroughly characterized.
Maltese: Bħala konklużjoni, il-profil tas-sigurtà ta' eteplirsen ma ġiex ikkaratterizzat sewwa.
English: There are data available from the extension study 202 in which only 6 patients were treated with eteplirsen, 30 mg/kg and 6 with eteplirsen 50 mg/kg for approximately 3 additional years.
Maltese: Hemm data disponibbli mill-istudju ta' estensjoni 202 li fih 6 pazjenti biss ġew ikkurati b'etiplirsen 30 mg/kg u 6 b'eteplirsen 50 mg/kg għal madwar 3 snin addizzjonali.
English: For the long-term safety assessment, safety data are available only for a small set of patients (6 on eteplirsen 30 mg/kg and 6 on 50 mg/kg).
Maltese: Għall-valutazzjoni tas-sigurtà fit-tul, id-data dwar is-sigurtà hi disponibbli biss għal sett żgħir ta' pazjenti (6 fuq eteplirsen 30 mg/kg u 6 fuq 50 mg/kg).
English: The applicant requested a Conditional marketing authorisation based on their claim that their application fulfils all the requirements from in Regulation (EC) No 507/2006.
Maltese: L-applikant talab awtorizzazzjoni għat-tqegħid fis-suq Kondizzjonali bbażata fuq it-talba li l-applikazzjoni tiegħu tissodisfa r-rekwiżiti kollha tar-Regolament (KE) Nru 507/2006.
English: In terms of the pharmacodynamic proof of concept, a modest increase in dystrophin (truncated) production has been shown in some patients, while in a number of them no production was detected.
Maltese: F'termini ta' prova farmakodinamika tal-kunċett, intweriet żieda modesta fil-produzzjoni ta' distrofina (maqtugħa) f'xi pazjenti, waqt li f'numru minnhom ma ġiet innotata l-ebda produzzjoni.
English: A trend favouring eteplirsen treated patients was observed in loss of ambulation (2/12 in eteplirsen treated patients vs. 10/13 in external controls at Year 4), North Star Ambulatory Assessment and ability to rise from supine.
Maltese: Xejra li tiffavorixxi lill-pazjenti kkurati b'eteplirsen ġiet osservata fit-telf ta' ambulazzjoni (2/12 f'pazjenti kkurati b'eteplirsen vs 10/13 f'kontrolli esterni fir-4
English: Longer comparisons (up to 4 years) with 12 DMD patients on eteplirsen were subsequently performed versus two post-hoc defined, external and non-concurrent cohorts (Italian Telethon DMD Registry and Leuven Neuromuscular Reference Center Registry) in an open label extension study.
Maltese: Saru paraguni itwal (sa 4 snin) bi 12-il pazjent DMD fuq eteplirsen kontra żewġ koorti post-hoc definiti, esterni u mhux paralleli (Reġistru
English: The only comparative data comes from study 201 (n=12) in which 4 subjects were randomized to 30 mg/kg, 4 to 50 mg/kg and 4 to placebo for 24 weeks.
Maltese: Il-valutazzjoni tal-profil ta' sigurtà ta' eteplirsen kienet ostakolata mil-limtazzjonijet tal-bażi tad-data tassigurtà L-unika data komparattiva ġejja min studju 201 (n=12) li fih 4 suġġetti ġew randomizzati għal 30mg/kg, 4 għal 50 mg/kg u 4 għal plaċebo għal 24 ġimgħa.
English: Other findings already seen for other antisense oligonucleotides, like elevation of transaminases have also been identified.
Maltese: Sejbiet oħra li diġà ġew innotati għal antisense oligonucleotides, bħal elevazzjoni ta' transaminażi ġew identifikati wkoll.
English: • Due to the limited number of patients exposed to eteplirsen the safety profile remains not thoroughly characterised.
Maltese: • Minħabba n-numru limitat ta' pazjenti esposti għal eteplirsen, il-profil tas-sigurtà għadu ma ġiex ikkaratterizzat sewwa.
English: A comparison versus a different external and non-concurrent cohort was provided (DMD patients on placebo from the pivotal trial of another medicinal product) for both the whole population and that restricted to those DMD patients walking between 300 and 450 m., and similar shortcomings regarding the comparison groups were identified there.
Maltese: DMD li jimxu bejn 300 u 450 m, u hemmhekk ġew identifikati nuqqasijiet simili rigward il-gruppi ta' paragun.
English: The additional data provided from the open-label phase, a 4-year period of treatment, do not allow to convincingly conclude on a relevant effect of eteplirsen in this population.
Maltese: Id-data addizzjonali pprovduta mill-fażi miftuħa, perjodu ta' 4 snin kura, ma tippermettix li ssir konklużjoni konvinċenti fuq l-effett rilevanti ta' eteplirsen fuq din il-popolazzjoni.
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the efficacy and the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Maltese: Is-CHMP huwa tal-opinjoni li skont l-Artikolu 12 tar-Regolament (KE) Nru 726/2004, l-effikaċja u ssigurtà tal-prodott mediċinali msemmi hawn fuq ma ntwerewx b'mod xieraq jew suffiċjenti.
English: The CHMP considered that with the currently available data it is not possible to conclude that the benefit/risk balance of eteplirsen is positive in DMD patients with mutations amenable to exon 51 skipping, since:
Maltese: Is-CHMP ikkunsidra li bid-data disponibbli bħalissa, mhux possibbli li tinstilet konklużjoni li l-bilanċ bejn ilbenefiċċju u r-riskju ta' eteplirsen hu pożittiv f'pazjenti DMD b'mutazzjonijiet soġġetti għal exon 51 skipping, billi:
English: The comparison was done with an untreated control arm of DMD patients amenable to exon skipping of an exon other than exon 51.
Maltese: Il-paragun sar b'fergħa ta' kontroll mhux ikkurata ta' pazjenti DMD soġġetti għal exon skipping ta' exon ieħor minbarra exon 51.
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the proposed SmPC.
Maltese: Il-kwalità ta' dan il-prodott hija kkunsidrata aċċettabbli meta jintuża skont il-kundizzjonijiet definiti flSmPC propost.
English: Although the evidence of truncated dystrophin production may support the mechanism of action of the product, convincing demonstration of sustained functional effect is necessary to support the claim for efficacy of the medicinal product in the intended indication.
Maltese: Għalkemm l-evidenza tal-produzzjoni ta' distrofina maqtugħa tista' tappoġġja l-mekkaniżmu ta' azzjoni talprodott, hemm bżonn ta' dimostrazzjoni konvinċenti ta' effett funzjonali sostnut biex tiġi appoġġjata d-dikjarazzjoni tal-effikaċja tal-prodott mediċinali fl-indikazzjoni intenzjonata.
English: • It remains unknown whether expression of the observed very low amount of truncated dystrophin after treatment with eteplirsen can translate into any clinical benefit to patients.
Maltese: • Għadu mhux magħruf jekk l-espressjoni tal-ammont baxx ħafna ta' distrofina maqtugħa osservata wara l-kura b'eteplirsen tistax tirriżulta f'xi benefiċċju kliniku għall-pazjenti.
English: This increases the uncertainty about the reliability of such comparisons rather than providing confirmatory data for efficacy.
Maltese: Dan iżid linċertezza dwar l-affidabilità ta' tali paraguni aktar milli jipprovdi data li tikkonferma l-effikaċja.
English: Without an appropriate concurrent control it is not possible to conclude that the results are reflecting a true and clinically meaningful change (slowing the progression) in the course of the condition.
Maltese: Mingħajr kontroll konkorrenti xieraq, mhuwiex possibbli li tinstilet konklużjoni li r-riżultati qed jirriflettu bidla vera u klinikament sinifikanti (li jnaqqsu l-progressjoni) fil-kors tal-kundizzjoni.
English: A more pronounced deterioration was observed in the external control groups (both the amenable to exon 51 skipping control group and the one including amenable to any exon skipping patients) than in eteplirsen treated patients.
Maltese: Ġiet osservata deterjorazzjoni aktar qawwija fil-gruppi ta' kontroll esterni (kemm il-grupp ta' kontroll soġġett għal exon 51 skipping u dak li jinkludi pazjenti soġġetti għal kwalunkwe exon skipping) milli fil-pazjenti kkurati b'eteplirsen.
English: There was no difference in 6MWD between eteplirsen and placebo during this 24 week treatment period.
Maltese: Ma kien hemm l-ebda differenza f'6MWD bejn eteplirsen u lplaċebo matul dan il-perjodu ta' 24 ġimgħa kura.
English: 25, 25, 8 micrograms 10 micrograms 40, 8, 32 DU
Maltese: 25, 25, 8 mikrogrammi 10 mikrogrammi 40, 8, 32 DU
English: (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
Maltese: (Toxoid tal-Pertussis1, Filamentous Haemagglutinin1, Periactin1)
English: months N= 1146)
Maltese: xhur N= 1146)
English: 25 micrograms 25 micrograms
Maltese: 25 mikrogrammi 25 mikrogrammi
English: • Polio - a viral infection.
Maltese: • Poljo: infezzjoni virali.
English: months N= 884
Maltese: xhur N= 884