FrancophonIA/ELRC3.0 huggingface dataset:
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets: o Each tablet contains 850 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: o Kull pillola fiha 850 mg ta' metformin hydrochloride, saxagliptin hydrochloride ekwivalenti għal 2.5 mg saxagliptin u dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: Rash can occur with both saxagliptin and dapagliflozin (see section 4).
Maltese: Jista' jseħħ raxx kemm b'saxagliptin kif ukoll b'dapagliflozin (ara sezzjoni 4).
English: Saxagliptin: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Maltese: Is-Cmax u l-AUC ta' saxagliptin u l-metabolit maġġuri tiegħu żdiedu proporzjonalment għad-doża ta' saxagliptin.
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively, at
Maltese: Fil-fniek, leffetti ta' saxagliptin ġew limitati għal varjazzjonijiet skeletriċi minuri li ġew osservati biss b'dożi tossiċi għall-omm (NOEL 158 u 224 darba l-esponiment fil-bniedem għal saxagliptin u l-metabolit maġġuri, rispettivament, bir-RHD.
English: Saxagliptin: Females had approximately 25% higher systemic exposure values for saxagliptin.
Maltese: In-nisa kellhom valuri ta' esponiment sistemiku li kienu madwar 25 % ogħla għal saxagliptin.
English: Effect of metformin, saxagliptin or dapagliflozin on other medicinal products
Maltese: Effett ta' metformin, saxagliptin jew dapagliflozin fuq prodotti mediċinali oħra
English: Each tablet contains 850 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Kull pillola fiha 850 mg ta' metformin hydrochloride, saxagliptin hydrochloride ekwivalenti għal 2.5 mg saxagliptin u dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: The difference in mean body weight between treatment groups was -4.06 kg (95% CI [-4.84, -3.28] p < 0.001) at week 52.
Maltese: Id-differenza fil-piż tal-ġisem medju bejn il-gruppi ta' kura kienet -4.06 kg (95% CI
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies with saxagliptin (see section 5.3).
Maltese: Ġew irrappurtati leżjonijiet tal-ġilda ulċerattivi u nekrotiċi f'estremitajiet fix-xadini fi studji tossikoloġiċi mhux kliniċi b'saxagliptin (ara sezzjoni 5.3).
English: The NOAEL for developmental toxicity is associated with a maternal systemic exposure 19 times the human values at the MRHD.
Maltese: In-NOAEL għal tossiċità għall-iżvilupp huwa assoċjat ma' esponiment sistemiku tal-omm 19-il darba l-valuri tal-bniedem tal-MRHD.
English: Avoid excessive alcohol intake while taking Qtrilmet since this may increase the risk of lactic acidosis (see “Warnings and precautions” and “Do not take Qtrilmet if you”).
Maltese: Evita teħid eċċessiv tal-alkoħol waqt li tkun qed tieħu Qtrilmet peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara “Twissijiet u prekawzjonijiet”u “Tiħux Qtrilmet jekk inti”).
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets: o Each tablet contains 1,000 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: o Kull pillola fiha 1,000 mg ta' metformin hydrochloride, saxagliptin hydrochloride ekwivalenti għal 2.5 mg saxagliptin u dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: Monitoring of renal function
Maltese: Funzjoni tal-kliewi mnaqqsa
English: Metformin is a biguanide with anti-hyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti antiipergliċemiċi, li jbaxxi kemm il-glucose fil-plażma bażali u wara l-ikel.
English: Hepatic impairment
Maltese: Disfunzjoni erettili
English: Randomised and treated patients.
Maltese: Pazjenti randomizzati u ttrattati.
English: Do not take Qtrilmet: if you are allergic to metformin, saxagliptin, dapagliflozin, or any of the other ingredients of this medicine (listed in section 6); if you have had a serious allergic reaction to some other medicines used to control your blood sugar, namely: o ‘gliptins' (or DPP-4 inhibitors) - like alogliptin, linagliptin and sitagliptin or, o ‘gliflozins' (or SGLT2 inhibitors) - like canagliflozin and empagliflozin; if you have uncontrolled diabetes, with: o severe hyperglycaemia (very high blood glucose), o nausea, vomiting, diarrhoea, rapid weight loss, o lactic acidosis (see “Risk of lactic acidosis” below),
Maltese: Tiħux Qtrilmet: - jekk inti allerġiku għal metformin, saxagliptin, dapagliflozin, jew għal xi sustanza oħra ta' din ilmediċina (imniżżla fis-sezzjoni 6). - jekk inti kellek reazzjoni allerġika serja għal xi mediċini oħra li jintużaw biex jikkontrollaw izzokkor fid-demm tiegħek, prinċipalmenet: o “gliptini” (jew inibituri ta' DPP-4) bħal alogliptin, linagliptin u sitagliptin jew o “glifolzini” (jew inibituri ta' SGLT2) bħal canagliflozin u empagliflozin. - jekk inti għandek dijabete mhux ikkontrollata, ma': o ipergliċemija severa (glucose għoli ħafna fid-demm)
English: Symptoms can include shortness of breath, rapid increase in weight, and swelling of the ankles or feet (pedal oedema).
Maltese: Is sintomi jistgħu jinkludu qtugħ ta' nifs, żieda rapida fil-piż, u nefħa tal-għekiesi jew tas-saqajn(edema pedali).
English: Uncommon thirst constipation awakening from sleep at night to pass urine dry mouth weight decrease decrease in kidney function, increases in creatinine or urea (shown in blood tests) skin rash that may include raised bumps, skin irritation, or itchiness difficulties in getting or maintaining an erection (erectile dysfunction) fungal infection mild allergic (hypersensitivity) reaction (rash) itching in the genital area (genital pruritus or vulvovaginal pruritus) or discomfort while urinating
Maltese: Waqt l-esperjenza ta' wara t-tqegħid fis-suq b'saxagliptin, inkluż rapporti spontanji u provi kliniċi, ġew irrappurtati r-reazzjonijiet avversi li ġejjin bl-użu ta' saxagliptin: reazzjonijiet ta' sensittività eċċessiva serji, inkluż reazzjoni anafilattika, xokk anafilattiku, u anġjoedema.
English: Saxagliptin/dapagliflozin combination: Malignant and unspecified neoplasms were reported in 3 subjects included in the pooled safety analysis.
Maltese: Neoplażmi malinni u mhux speċifikati ġew irrappurtati fi 3 individwi inklużi fl-analiżi tas-sigurtà miġbura.
English: Skin lesions were not observed at an increased incidence in saxagliptin clinical trials.
Maltese: Ma ġewx osservati leżjonijiet tal-ġilda f'inċidenza miżjuda fi provi kliniċi b'saxagliptin.
English: Bioequivalence has been confirmed between Qtrilmet tablets and the individual components (metformin modified-release, saxagliptin and dapagliflozin) in healthy subjects when administered in the fed state.
Maltese: Ġiet ikkonfermata bijoekwivalenza bejn pilloli Qtrilmet u l-komponenti individwali (metformin b'rilaxx modifikat, saxagliptin u dapagliflozin) f'individwi b'saħħithom meta ngħataw fl-istat mitmugħ.
English: If no adequate strength of Qtrilmet is available, individual mono-components should be used instead of the modified-release combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Qtrilmet, għandhom jintużaw il-monokomponenti individwali minflok il-kombinazzjoni ta' rilaxx modifikat.
English: The degree of renal impairment did not affect the Cmax of saxagliptin or its major metabolite.
Maltese: Iż-żieda fl-esponimenti ta' simvastatin u simvastatin acid mhijiex meqjusa bħala klinikament rilevanti.
English: The effect in HbA1c observed at week 24 was sustained at week 52.
Maltese: Leffett fl-HbA1c osservat f'ġimgħa 24 inżamm f'ġimgħa 52.
English: Erectile dysfunction pruritus genital vulvovaginal
Maltese: Effett tossiku fuq is-sistema riproduttiva u l-iżvilupp
English: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections (see section 4.8).
Maltese: It-trattament b'inibituri SGLT2 iżid ir-riskju għal infezzjonijiet fl-apparat tal-awrina (ara sezzjoni 4.8).
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres.
Maltese: F'numru ta' każijiet, ilpreżentazzjoni tal-kondizzjoni kienet atipika, fejn ġew osservati biss valuri ta' żieda moderata ta' glucose fid-demm, inqas minn 14 mmol/litri.
English: Other medicines and Qtrilmet
Maltese: Kif taħżen Qtrilmet
English: HbA1c at week 24 in active-controlled study comparing the combination of saxagliptin 5 mg and dapagliflozin 10 mg added concurrently to metformin with either saxagliptin 5 mg or dapagliflozin 10 mg added to metformin
Maltese: HbA1c f'Ġimgħa 24 fi studju kkontrollat b'mod attiv li jqabbel il-kombinazzjoni ta' saxagliptin 5 mg u dapagliflozin 10 mg miżjud b'mod konkurrenti ma' metformin jew ma' saxagliptin 5 mg jew ma' dapagliflozin 10 mg miżjud ma' metformin
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery, or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju ogħla ta' DKA jinkludu pazjenti b'riżerva tal-funzjoni taċ-ċellula beta baxxa (eż. pazjenti b'dijabete tat-tip 2 b'C-peptide baxx jew dijabete awtoimmuni latenti fl-adulti (LADA) jew pazjenti bi storja ta' pankreatite), pazjenti b'kondizzjonijiet li jwasslu għal teħid ristrett tal-ikel jew deidratazzjoni severa, pazjenti li jitnaqqsulhom id-dożi tal-insulina u pazjenti b'rekwiżiti miżjuda tal-insulina minħabba mard mediku akut, kirurġija jew abbuż mill-alkoħol.
English: Haematocrit increase was observed with dapagliflozin treatment, (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Maltese: Ġiet osservata żieda fl-ematokrit bi trattament b'dapagliflozin, (ara sezzjoni 4.8); għalhekk, hija ġġustifikata l-kawtela f'pazjenti li diġà għandhom żieda fl-ematokrit.
English: Nocturia renal impairment
Maltese: Jekk tinsa tieħu Qtrilmet
English: The no observed effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite, respectively, at the recommended human dose (RHD) of 5 mg/day.
Maltese: Il-livell bla effett osservat (NOEL) għal-leżjonijiet huwa darba u darbtejn l-esponiment fil-bniedem ta' saxagliptin u l-metabolit maġġuri, rispettivament, bid-doża rakkomandata tal-bniedem (RHD) ta' 5 mg/jum.
English: Renal function should be assessed: prior to initiation of this medicinal product and regularly thereafter (see sections 4.2, 4.8, 5.1 and prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter (see section 4.5);
Maltese: Il-funzjoni tal-kliewi għandha tiġi vvalutata: - Qabel il-bidu ta' dan il-prodott mediċinali u regolarment wara dan (ara sezzjonijiet 4.2, 4.8, 5.1 u
English: Therapy with saxagliptin 5 mg and dapagliflozin 10 mg in comparison to insulin glargine in patients inadequately controlled on metformin with or without a sulphonylurea
Maltese: Terapija ta' saxagliptin 5 mg u dapagliflozin 10 mg fi tqabbil ma' insulin glargine f'pazjenti kkontrollati b'mod inadegwat fuq metformin ma' jew mingħajr sulphonylurea
English: Vulvovaginitis, balanitis and related genital infections
Maltese: Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati
English: In the study comparing concomitant therapy of saxagliptin and dapagliflozin with glimepiride in patients inadequately controlled on metformin alone, the decrease in systolic blood pressure at week 52 in the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin group (-2.6 mmHg 95% CI [-4.4, -0.8]) was greater than in the glimepiride plus metformin group (1.0 mmHg 95% CI [-0.9, 2.9]).
Maltese: Fl-istudju li qabbel terapija konkomitanti ta' saxagliptin u dapagliflozin ma' glimepiride f'pazjenti kkontrollati b'mod inadegwat fuq metformin biss, it-tnaqqis fil-pressjoni tad-demm sistolika f'ġimgħa 52 fil-grupp ta' saxagliptin 5 mg u dapagliflozin 10 mg u metformin (-2.6 mmHg 95% CI
English: Metformin: Metformin is excreted unchanged in the urine.
Maltese: Metformin jiġi eliminat mhux mibdul fl-awrina.
English: Co-administration of metformin with: inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin; inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin; inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration; inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Maltese: - Inibituri ta' OCT2 (bħal cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) jista' jnaqqas l-eliminazzjoni mill-kliewi ta' metformin u b'hekk iwassal għal żieda fil-konċentrazzjoni fil-plażma ta' metformin.
English: Food has relatively modest effects on the pharmacokinetics of dapagliflozin in healthy subjects.
Maltese: L-ikel għandu effetti relattivament modesti fuq il-farmakokinetika ta' dapagliflozin f'individwi b'saħħithom.
English: This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Maltese: Dan huwa avveniment rari iżda serju u potenzjalment ta' periklu għall-ħajja li jeħtieġ intervent kirurġiku urġenti u trattament b'antibijotiċi.
English: Constipation dry mouth pancreatitis
Maltese: Stitikezza ħalq xott pankreastite
English: Qtrilmet must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Maltese: Qtrilmet għandu jitwaqqaf meta ssir kirurġija b'anesteżija ġenerali, spinali jew epidurali.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Maltese: It-terapija tista' terġa' tinbeda mill-ġdid mhux qabel 48 siegħa wara kirurġija jew il-bidu mill-ġdid ta' nutrizzjoni orali u diment li l-funzjoni tal-kliewi tkun ġiet evalwata mill-ġdid u nstabet li hi stabbli.
English: In a 24-week study comparing the combination of saxagliptin and dapagliflozin plus metformin with or without SU, with insulin plus metformin with or without SU, the overall incidence rates for hypoglycaemia in patients without a background treatment of SU, were 12.7% for the combination compared to 33.1% for insulin.
Maltese: Fi studju ta' 24 ġimgħa li qabbel il-kombinazzjoni ta' saxagliptin u dapagliflozin u metformin ma' jew mingħajr SU, ma' insulina u metformin ma' jew mingħajr SU, ir-rati tal-inċidenza globali għal ipogliċemija f'pazjenti mingħajr trattament ta' sfond ta' SU, kienu 12.7 % għall-kombinazzjoni meta mqabbel ma' 33.1 % għall-insulina.
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2% as unchanged dapagliflozin.
Maltese: Dapagliflozin u metaboliti relatati jiġu eliminati primarjament permezz ta' eskrezzjoni mill-awrina b'inqas minn 2 % bħala dapagliflozin mhux mibdul.
English: Adverse reactions, except for taste disturbance, reported in ≥ 2% of subjects treated with the combined use of saxagliptin + dapagliflozin + metformin in the pooled safety analysis, or if reported in < 2% in the pooled safety analysis, they were based on the individual mono-components data.
Maltese: Reazzjonijiet avversi, ħlief disturb fit-togħma, irrappurtati fi ≥ 2% ta' individwi ttrattati bl-użu kombinat ta' saxagliptin + dapagliflozin + metformin fl-analiżi tas-sigurtà miġbura, jew kif irrappurtat fi < 2% fl-analiżi tas-sigurtà miġbura, dawn kienu bbażati fuq id-data tal-monokomponenti individwali.
English: Metformin hydrochloride: No pharmacokinetic studies of metformin have been conducted in patients with hepatic impairment.
Maltese: Dawn l-effetti farmakokinetiċi mhumiex klinikament sinifikanti u ma jeħtiġux aġġustament fid-doża.
English: The effect of this medicinal product, or its components (metformin hydrochloride, saxagliptin and dapagliflozin) on fertility in humans has not been studied.
Maltese: L-effett ta' dan il-prodott mediċinali, jew il-komponenti tiegħu (metformin hydrochloride, saxagliptin u dapagliflozi) fuq il-fertilità fil-bnedmin ma ġiex studjat.
English: • a history of immunosuppressive therapy.
Maltese: • storja ta' terapija immunosuppressiva.
English: As of May 2015, 142,958 patients had received natalizumab worldwide with 432,814 patient-years of exposure.
Maltese: Sa minn Mejju 2015, 142,958 pazjent irċevew natalizumab mad-dinja kollha b'432,814 sena talpazjent ta' esponiment.
English: Natalizumab is associated with the onset of progressive multifocal leukoencephalopathy (PML), which is caused by John Cunningham Virus (JCV).
Maltese: Natalizumab huwa assoċjat mal-bidu ta' lewkoenċefalopatija multifokali progressiva (PML), li hija kkaġunata mill-virus ta' John Cunningham (JCV).
English: A total of 566 PML cases have been reported globally as of 04 June 2015, of which 133 patients died (23.5 % 0f PML patients).
Maltese: Total ta' 566 każ ta' PML kienu rrapportati globalment mill4 ta' Ġunju 2015, li minnhom mietu 133 pazjent (23.5 % tal-pazjenti b'PML).
English: Natalizumab is a humanized monoclonal antibody targeting the α-chain of the α4β1 adhesion molecule.
Maltese: Natalizumab huwa antikorp monoklonali umanizzat immirat lejn il-katina-α tal-molekula ta' adeżjoni α4β1.
English: Anti-JCV antibody ELISA
Maltese: ELISA għall-antikorp kontra l-JCV
English: Sensitivity differs very little between the index of 0.9 and 1.5 but there is improved specificity with 1.5.
Maltese: Is-sensittività ftit li xejn hija differenti bejn l-indiċi ta' 0.9 u 1.5 iżda hemm speċifiċità mtejba b'1.5.
English: Increasing evidence indicates that T2-FLAIR is the most sensitive sequence for detecting PML.
Maltese: Evidenza dejjem tiżdied tindika li T2-FLAIR huwa l-aktar sekwenza sensittiva biex tiġi rilevata PML.
English: PML risk estimation
Maltese: Stima tar-riskju tal-PML
English: While 10 cases have been reported in the US, most of the asymptomatic cases were reported from EU/ROW (83%, 52/62).
Maltese: Filwaqt li ġew irrapportati 10 każijiet fl-Istati Uniti, il-biċċa l-kbira tal-każijiet asintomatiċi kienu rrapportati millUE/ROW (83 %, 52/62).
English: • The PRAC considered Tysabri (natalizumab) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission
Maltese: • Il-PRAC ikkunsidra Tysabri (natalizumab) fil-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, li nbdiet mill-Kummissjoni Ewropea.
English: Tysabri (natalizumab) was approved in the EU on 27 June 2006 and is currently indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (MS).
Maltese: Tysabri (natalizumab) kien approvat fl-UE fis-27 ta' Ġunju 2006 u attwalment huwa indikat bħala monoterapija li timmodifika l-marda fi sklerożi multipla (MS) attiva ħafna li tirkadi u tbatti.
English: Asymptomatic PML cases were identified via routine MRI.
Maltese: Każijiet asintomatiċi ta' PML kienu identifikati permezz ta' MRI ta' rutina.
English: Since the auhtorisation of natalizumab, three main risk factors for PML have been identified:
Maltese: Sa mill-awtorizzazzjoni ta' natalizumab, ġew identifikati tliet fatturi tar-riskju ewlenin għall-PML:
English: The assumption of 55% positive serostatus for the overall natalizumab-treated population utilized in the PML risk algorithm calculations remains acceptable.
Maltese: Is-suppożizzjoni ta' serostatus pożittiv b'55 % għall-popolazzjoni globali kkurata b'natalizumab li ntużat fil-kalkolazzjonijiet tal-algoritmu tar-riskju tal-PML tibqa' aċċettabbli.
English: • As a consequence, the PRAC recommended that more frequent MRI screening for PML (e.g. every 3-6 months) using an abbreviated MRI protocol should be considered in patients at higher risk of development of PML.
Maltese: • Konsegwentement, il-PRAC irrakkomanda li għandhom jitqiesu eżamijiet tal-MRI ta' PML aktar frekwenti (eż. kull 3-6 xhur) permezz ta' protokoll imqassar tal-MRI f'pazjenti f'riskju ogħla li jiżviluppaw PML.
English: • the increasing duration of treatment (treated > 24 months),
Maltese: • iż-żieda fit-tul taż-żmien tal-kura (ikkurati > 24 xahar),
English: Although asymptomatic PML patients had generally similar baseline clinical characteristics compared with symptomatic patients, a higher proportion of asymptomatic patients presented with more localized disease (64% unilobar PML) on Magnetic Resonance Image (MRI) at the time of diagnosis compared to symptomatic PML patients (36%).
Maltese: Għalkemm pazjenti asintomatiċi b'PML ġeneralment kellhom karatteristiċi kliniċi fil-linja bażi simili meta mqabbla ma' pazjenti sintomatiċi, proporzjon ogħla ta' pazjenti asintomatiċi ppreżentaw aktar mard lokalizzat (64 % PML unilobar) fl-Immaġni tar-Reżonanza Manjetika (MRI) fiż-żmien meta saret id-dijanjożi meta mqabbla ma' pazjenti sintomatiċi b'PML (36 %).
English: Anti-JCV antibody index for guiding MRI monitoring frequency
Maltese: Indiċi tal-antikorp kontra l-JCV għall-iggwidar tal-frekwenza tal-monitoraġġ tal-MRI
English: The risk stratification algorithm in the educational material will be revised to include current estimates derived from a pooled study cohort (STRATIFY-2, TOP, TYGRIS and STRATA studies) of natalizumab-treated patients, and to incorporate anti-JCV antibody index.
Maltese: L-algoritmu tal-istratifikazzjoni tar-riskju fil-materjal edukattiv se jiġi rivedut sabiex jinkludi l-istimi attwali miksuba minn koorti ta' studji miġbura (studji STRATIFY-2, TOP, TYGRIS u STRATA) ta' pazjenti kkurati b'natalizumab, u sabiex jinkorpora l-indiċi tal-antikorp kontra l-JCV.
English: Diagnosis of PML before development of clinical symptoms
Maltese: Dijanjożi ta' PML qabel l-iżvilupp ta' sintomi kliniċi
English: • The PRAC also concluded that, in patients who have not received prior immunosuppressant therapy and are anti-JCV antibody positive, the level of anti-JCV antibody response (index) is associated with risk of developing PML.
Maltese: • Il-PRAC ikkonkluda wkoll li, f'pazjenti li ma rċevewx terapija immunosuppressanti minn qabel u huma pożittivi għall-antikorp kontra l-JCV, il-livell ta' rispons (indiċi) tal-antikorp kontra lJCV huwa assoċjat mar-riskju li tiġi żviluppata PML.
English: • the presence of JCV-specific antibodies,
Maltese: • il-preżenza ta' antikorpi speċifiċi għall-JCV,
English: Published data suggest that patients considered as having a high risk for PML development and who continue natalizumab treatment beyond 2 years of treatment may benefit from more frequent MRI screening e.g. every 3 to 6 months.
Maltese: Data ppubblikata tissuġġerixxi li pazjenti li jitqies li huma f'riskju għoli li jiżviluppaw PML u li jkomplu bil-kura ta' natalizumab wara sentejn ta' kura jistgħu jibbenefikaw minn eżamijiet tal-MRI aktar frekwenti eż. kull 3 sa 6 xhur.
English: Anti-JCV antibody testing
Maltese: Ittestjar għall-antikorp kontra l-JCV
English: The clinical presentation of natalizumab-associated PML is considered not distinct from classical PML, and consists in cognitive disorders in more than half of the patients together with motor symptoms, ataxia, neurovisual disturbances, and dysphasia or agnosia in more than 40% of cases.
Maltese: Il-preżentazzjoni klinika ta' PML assoċjata ma' natalizumab titqies mhux distinta mill-PML klassika, u tikkonsisti f'disturbi konjittivi f'aktar min-nofs il-pazjenti flimkien ma' sintomi motorji, atassja, disturbi newroviżivi, u disfażja jew anjożja f'aktar minn 40 % tal-każijiet.