FrancophonIA/ELRC3.0 huggingface dataset:
English: In the placebo-controlled study, 62 (41.9%) patients treated with Onpattro were ≥ 65 years of age and
Maltese: Fl-istudju kkontrollat bil-plaċebo, 62 (41.9%) tal-pazjenti ttrattati b'Onpattro kellhom età ta' ≥ 65 u 9 (6.1%) pazjenti kellhom età ta' ≥ 75.
English: Greater than 95% of patisiran in the circulation is associated with lipid nanoparticles.
Maltese: Aktar minn 95% ta' patisiran fiċ-ċirkulazzjoni hu assoċjat ma' nanopartikuli lipidi.
English: Exposure to patisiran and the lipid components (DLin-MC3-DMA and PEG2000-C-DMG) increased proportionally with increase in dose over the range evaluated in clinical studies (10 to 500 micrograms per kg).
Maltese: L-esponiment għal patisiran u l-komponenti lipidi (DLin-MC3-DMA u PEG2000-C-DMG) żied proporzjonalment maż-żieda fid-doża matul il-medda vvalutata fl-istudji kliniċi (bejn 10 u 500 mikrogramma għal kull kilo).
English: • Steps to consider to prevent further IRRs;
Maltese: • Passi li għandhom jiġu kkunsidrati għall-prevenzjoni ta' IRRs ulterjuri;
English: Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva severa (eż. reazzjonijiet anafilassi ) għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: In the study, 148 patients received Onpattro and 77 patients received placebo.
Maltese: Fl-istudju, 148 pazjent irċivew Onpattro u 77 pazjent irċivew plaċebo.
English: The pharmacokinetic properties of Onpattro were characterised by measuring the plasma concentrations of patisiran and the lipid components DLin-MC3-DMA and PEG2000-C-DMG.
Maltese: Il-propjetajiet farmakokinetiċi ta' Onpattro kienu kkaratterizzati bil-kejl tal-konċentazzjonijiet ta' plażma ta' patisiran u l-komponenti lipidi DLin-MC3-DMA u PEG2000-C-DMG.
English: Anti-drug antibodies to Onpattro were evaluated by measuring antibodies specific to PEG2000-C-DMG, a lipid component exposed on the surface of Onpattro.
Maltese: L-antikorpi ta' kontra l-mediċina Onpattro ġew evalwati bil-kejl tal-antikorpi speċifiċi għal PEG2000-C-DMG, komponent lipidu espost fuq is-superfiċje ta' Onpattro.
English: Patisiran is not a substrate of cytochrome P450 enzymes.
Maltese: ċitokrom P450.
English: Rhinitis
Maltese: Tqala
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (IV), or equivalent.
Maltese: Jekk indikat klinikament, il-kortikosterojde jista' jiġi mnaqqas ftit ftit fi tnaqqis ta' mhux akbar minn 2.5 mg għal doża minima ta' 5 mg ta' dexamethasone (IV), jew ekwivalenti.
English: dmBMI: body mass index (BMI; kg/m2) multiplied by serum albumin (g/L); a higher number indicates better nutritional status; nutritional status favoured Onpattro as early as 3 months.
Maltese: cNumru ogħla jindika inqas diżabbiltà/indeboliment dmBMI: indiċi tal-piż tal-ġisem (BMI; kg/m2) multiplikat bis-serum albumin (g/L); numru ogħla jindika status nutrizzjonali itjeb; l-istatus nutrittiv wera li kien favorevoli lejn Onpattro sa minn 3 xhur kmieni.
English: Treatment with Onpattro reduces serum TTR levels, which results in reduced levels of retinol binding protein and vitamin A in the serum.
Maltese: It-trattament b'Onpattro jnaqqas il-livelli ta' TTR fis-serum, li jirriżulta f'livelli mnaqqsa ta' proteini li jorbtu r-retinol u ta' vitamina A fis-serum.
English: • Onpattro will be given to you by a doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: In the event of an unplanned pregnancy, Onpattro should be discontinued (see section 4.6).
Maltese: F'każ ta' tqala mhux ippjanata, Onpattro għandu jitwaqqaf (ara sezzjoni 4.6).
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (intravenous, IV), or equivalent.
Maltese: Jekk indikat klinikament, il-kortikosterojde jista' jitnaqqas ftit ftit fi tnaqqis ta' mhux akbar minn 2.5 mg għal doża minima ta' 5 mg ta' dexamethasone (ġol-vini, IV), jew ekwivalenti.
English: The estimated DLin-MC3-DMA mean ± SD steady-state CLss was 2.1 ± 0.8 mL/h/kg.
Maltese: Il-medja stmata ta' CLss tal-istat fiss ± SD ta' DLin-MC3-DMA kienet ta' 2.1 ± 0.8 mL/h/kg.
English: Vitamin A supplementation should be discontinued during the first trimester, unless the pregnant woman has clinical signs of vitamin A deficiency.
Maltese: vitamina A għandha titwaqqaf matul l-ewwel trimestru, sakemm il-mara tqila ma jkollhiex sinjali kliniċi ta' defiċjenza ta' vitamina A.
English: The only adverse reaction resulting in the discontinuation of Onpattro was an infusion-related reaction (0.7%).
Maltese: L-unika reazzjoni avversa li wasslet għat-twaqqif ta' Onpattro kienet reazzjoni relatata mal-infużjoni (0.7%).
English: Onpattro 2 mg/mL concentrate for solution for infusion patisiran
Maltese: Onpattro 2 mg/mL konċentrat sterili patisiran
English: Available toxicological data in animals have shown excretion of small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG in milk (see section 5.3).
Maltese: Id-data tossikoloġika disponibbli fl-annimali turi l-eliminazzjoni ta' ammonti żgħar tal-komponenti lipidiċi Dlin-MC3-DMA u PEG2000-C-DMG fil-ħalib (ara sezzjoni 5.3).
English: This medicinal product contains 3.99 mg sodium per mL, equivalent to 0.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 3.99 mg ta' sodium għal kull millilitru, ekwivalenti għal 0.2% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g ta' sodium għal persuna adulta.
English: If not used immediately, store the diluted solution in the infusion bag at room temperature (up to 30°C) or at 2°C to 8°C for up to 16 hours (including infusion time).
Maltese: Jekk ma tintużax immedjatament, aħżen is-soluzzjoni dilwita fil-borża tal-infużjoni f'temperatura tal-kamra (sa 30°C) jew f'temperatura ta' 2°C sa 8°C għal massimu ta' 16-il siegħa (inkluż il-ħin għall-infużjoni).
English: Uncommon: may occur in up to 1 in 100 infusions
Maltese: Mhux komuni: jistgħu jseħħu f'sa 1 minn kull 100 infużjoni
English: Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Maltese: Onpattro hu indikat għat-trattament amilojdjożi ereditarja bil-medjazzjoni tat-transthyretin (amilojdjożi hATTR) f'pazjenti adulti b'polinewropatija ta' stadju 1 jew stadju 2.
English: Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
Maltese: It-TTR fis-serum hi carrier ta' proteina li torbot ir-retinol, li tiffaċilita t-trasport tal-vitamina A fid-demm.
English: Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles.
Maltese: Kull kunjett fih patisiran sodium ekwivalenti għal 10 mg ta' patisiran ifformulat bħala nanopartikuli lipidi.
English: • Intravenous H2 blocker (ranitidine 50 mg, or equivalent)
Maltese: • Imblokkatur tal-H2 ġol-vini (ranitidine 50 mg, jew ekwivalenti)
English: • Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Maltese: • Kull mL fih patisiran sodium ekwivalenti għal 2 mg ta' patisiran.
English: Marketing Authorisation Holder Alnylam Netherlands B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Alnylam Netherlands B.V.
English: Onpattro is a medicine that treats an illness which runs in families called hereditary ATTR (hATTR) amyloidosis.
Maltese: Onpattro hi mediċina li tittratta marda preżenti fil-familji li tissejjaħ amilojdjożi ereditarja ATTR (hATTR).
English: Serum vitamin A levels should not be used to guide vitamin A supplementation during treatment with Onpattro (see section 4.5).
Maltese: vitamina A waqt trattament b'Onpattro (ara sezzjoni 4.5).
English: • Dilute the required volume of filtered Onpattro into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for a total volume of 200 mL.
Maltese: • Iddilwixxi l-volum meħtieġ ta' Onpattro ffiltrat f'borża ta' infużjoni li jkun fiha soluzzjoni ta' 9 mg/mL (0.9%) sodium chloride għal volum totali ta' 200 mL.
English: A statistically significant benefit in mNIS+7 with Onpattro relative to placebo was observed at 18 months (Table 2).
Maltese: Fit-18-il xahar, kien osservat benefiċċju statistikament sinifikanti f'mNIS+7 b'Onpattro relattiv għall-plaċebo (Tabella 2).
English: Disodium hydrogen phosphate, heptahydrate
Maltese: Disodium hydrogen phosphate, heptahydratePotassium dihydrogen phosphate, anhydrous Sodium chloride
English: As a precautionary measure, vitamin A and thyroid stimulating hormone (TSH) levels should be obtained early in pregnancy (see section 5.3).
Maltese: vitamina A u l-livelli materni tal-ormon li jistimula t-tirojde (TSG, thyroid stimulating hormone)
English: In a threshold analysis of mNIS+7 (change from baseline of < 0 points), 56.1% of Onpattro-treated patients versus 3.9% of placebotreated patients experienced improvement in mNIS+7 (p <0.001).
Maltese: (tibdil mil-linja bażi ta' < 0 punti), 56.1% tal-pazjenti ttrattati b'Onpattro kontra 3.9% tal-pazjenti ttrattati bil-plaċebo esperjenzaw titjib f'mNIS+7 (p <0.
English: The estimated PEG2000-C-DMG mean ± SD steady-state CLss was 2.1 ± 0.6 mL/h/kg.
Maltese: Il-medja stmata ta' CLss tal-istat fiss ± SD ta' PEG2000-C-DMG kienet ta' 2.1 ± 0.6 mL/h/kg.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: The net effect on CYP2B6 substrates (e.g., bupropion and efavirenz) in vivo is unknown.
Maltese: L-effett nett ta' substrati ta' CYP2B6 (eż., bupropion u efavirenz) in vivo mhuwiex magħruf.
English: At 18 months, a benefit with Onpattro to placebo was observed across all domains of Norfolk QoL-DN, and 51.4% of Onpattro-treated patients experienced an improvement in quality of life (Norfolk QoL-DN change from baseline of < 0 points) compared to 10.4% of placebo-treated patients.
Maltese: Fit-18-il xahar, kien osservat benefiċċju b'Onpattro għall-plaċebo fl-oqsma kollha ta' Norfolk QoL-DN, u 51.4% tal-pazjenti ttrattati b'Onpattro esperjenzaw titjib fil-kwalità tal-ħajja (bidla ta' Norfolk QoL-DN mil-linja bażi ta' < 0 punti) meta mqabbla ma' 10.
English: Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion.
Maltese: Onpattro jrid jiġi dilwit b'soluzzjoni ta' 9 mg/mL (0.9%) sodium chloride qabel l-infużjoni ġol-vini.
English: • Headache
Maltese: • Sturdament
English: A97S (9%), T60A (7%), E89Q (6%), and S50R (5%).
Maltese: Disa' u tletin (39) mutazzjonijiet differenti tat-TTR kienu rappreżentati; l-aktar komuni (≥ 5%) kienu V30M (43%), A97S (9%), T60A (7%), E89Q (6%), u S50R (5%). Madwar 10% tal-pazjenti kellhom il-mutazzjoni V30M u bidu minn kmieni tas-sintomi (< 50 sena ta' età).
English: Patient demographics and baseline characteristics were balanced between treatment groups, except that a higher proportion of patients in the Onpattro group had a non-V30M mutation (62% vs. 48%).
Maltese: Id-demografiċi tal-pazjenti u l-karatteristiċi tal-linja bażi ġew ibbilanċjati bejn il-gruppi ta' trattament, minbarra li proporzjon ogħla ta' pazjenti fil-grupp ta' Onpattro kelhom mutazzjoni li mhux V30M (62% vs. 48%) .
English: Approximately half (53%) of patients had prior treatment with tafamidis meglumine or diflunisal.
Maltese: Madwar in-nofs (53%) tal-pazjenti kellhom trattament preċedenti b'tafamidis meglumine jew diflunisal.
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild or moderate renal impairment (eGFR ≥ 30 to < 90 mL/min/1.73m2) on patisiran exposure or TTR reduction compared to subjects with normal renal function.
Maltese: L-analiżi tal-populazzjonijiet farmakokinetiċi u farmakodinamiċi ma indikaw l-ebda impatt talindeboliment renali ħafif jew moderat (eGFR ≥ 30 to < 90 mL/min/1.73 m2) fuq l-esponiment ta' patisiran jew it-tnaqqis ta' TTR meta mqabbel ma' pazjent b'funzjoni renali normali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Maltese: Kull mL fih patisiran sodium ekwivalenti għal 2 mg ta' patisiran.
English: • The potential for IRRs to occur;
Maltese: • Il-potenzjal li jseħħu IRRs;
English: 30 months.
Maltese: 30-il xahar.
English: Onpattro is not expected to be affected by inhibitors or inducers of cytochrome P450 enzymes or to cause drug-drug interactions, except for induction and time-dependent inhibition of CYP2B6 in vitro.
Maltese: Mhuwiex mistenni li Onpattro jiġi affettwat mill-inibituri jew l-indutturi tal-enzimi ta' ċitokrom P450 jew li jikkawża interazzjonijiet bejn mediċina u oħra, ħlief għall-induzzjoni u l-inibizzjoni li tiddependi fuq il-ħin ta' CYP2B6 in vitro.
English: Tel: 800 90 25 37 (+39 02 89 73 22 91) medinfo@alnylam.com
Maltese: 37 (+39 02 89 73 22 91) medinfo@alnylam.com
English: • Irritation or infection of the airways (sinusitis, bronchitis)
Maltese: • Irritazzjoni jew infezzjoni tal-passaġġ tan-nifs (sinożite, bronkite)
English: In the double-blind placebo-controlled study, 18.9% of Onpattro-treated patients experienced IRRs, compared to 9.1% of placebo-treated patients.
Maltese: Fl-istudju double-blind ikkontrollat bil-plaċebo, 18.9% tal-pażjenti ttrattati b'Onpattro esperjenzaw IRRs, meta mqabbel ma' 9.1 % tal-pazjenti ttrattati bil-plaċebo.
English: IRRs have been observed in patients treated with Onpattro.
Maltese: IRRs ġew osservati f'pazjenti ttrattati b'Onpattro.
English: With repeat dosing every 3 weeks, mean reductions of serum TTR after 9 and 18 months of treatment were 83% and 84%, respectively.
Maltese: B'doża ripetuta kull 3 ġimgħat, it-tnaqqis medju tat-TTR fis-serum wara 9 u 18-il xahar ta' trattament kien ta' 83% u 84% rispettivament.
English: Do not shake.
Maltese: IU kuljum.
English: Through a natural process called RNA interference (RNAi), patisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in a reduction of serum TTR protein.
Maltese: Permezz ta' proċess naturali msejjaħ interferenza tal-RNA (RNAi), patisiran jikkawża d-degradazzjoni katalitika tat-TTR mRNA fil-fwied, li tirriżulta fi tnaqqis tal-proteina TTR fis-serum.
English: • Feeling dizzy or faint (vertigo)
Maltese: • Tħoss sturdament jew ħass ħażin (vertigo)
English: • Requirements for home infusion, including availability and timely administration of the appropriate premedication;
Maltese: • Rekwiżiti għall-infużjoni mid-dar, inkluż disponibbiltà u għoti f'waqtu tal-premedikazzjoni xierqa;
English: At baseline, 46% of patients had stage 1 disease (unimpaired ambulation; mostly mild sensory, motor and autonomic neuropathy in the lower limbs), and 53% had stage 2 disease (assistance with ambulation required; mostly moderate impairment progression to the lower limbs, upper limbs, and trunk).
Maltese: Fil-linja bażi, 46% tal-pazjenti kellhom marda tal-ewwel stadju (ambulazzjoni mhux mittiefsa; fil-biċċa l-kbira newropatija sensorja, motriċi u awtonomika ħafifa fir-riġlejn), u 53% kellhom marda tat-tieni stadju (ħtieġa għall-assistenza bl-ambulazzjoni; fil-biċċa l-kbira progressjoni moderata tal-indeboliment fir-riġlejn, id-dirgħajn u t-torso).
English: aAll endpoints analysed using the mixed-effect model repeated measures (MMRM) method.
Maltese: aIl-punti aħħarin kollha ġew analizzati permezz tal-metodu ta' kejl ripetut tal-mudell tal-effetti mħallta
English: Patients receiving Onpattro should take oral supplementation of approximately 2500 IU vitamin A per day to reduce the potential risk of ocular toxicity due to vitamin A deficiency.
Maltese: IU vitamina A kuljum sabiex inaqqsu r-riskju potenzjali ta' tossiċità okulari minħabba defiċjenza ta' vitamina A.
English: Patients receiving Onpattro experienced similar benefits relative to placebo in mNIS+7 and Norfolk QoL-DN score across all subgroups including age, sex, race, region, NIS score, V30M mutation status, prior tafamidis meglumine or diflunisal use, disease stage, and patients with pre-defined cardiac involvement.
Maltese: Il-pazjenti li rċevew l-Onpattro esperjenzaw benefiċċji simili relattivi għall-plaċebo f'mNIS+7 u l-punteġġ Norfolk QoL-DN fis-sottogruppi kollha inklużi l-età, is-sess, ir-razza, ir-reġjun, il-punteġġ NIS, l-istatus ta' mutazzjoni V30M, użu preċedenti ta' tafamidis meglumine jew diflunisal, stadju tal-marda, u pazjenti b'involviment kardijaku predefinit.Il-pazjenti esperjenzaw benefiċċju fil-mutazzjonijiet kollha tat-TTR u fil-medda kollha ta' severità tal-marda.
English: SD, standard deviation; LS mean, least squares mean; SEM, standard error of the mean; CI, confidence interval, NIS-W, NIS-weakness (motor strength); R-ODS, Rasch-Built Overall Disability (patient reported ability to perform activities of daily living); 10-metre walk test (gait speed); mBMI, modified body mass index (nutritional status); COMPASS 31, Composite Autonomic Symptom Score 31 (patient reported symptom score)
Maltese: Disability (ħila biex jitwettqu attivitajiet tal-ħajja ta' kuljum irrappurtata mill-pazjenti ); test tal-mixi ta' 10 metri (veloċità tal-mixja); mBMI, indiċi tal-piż tal-ġisem immodifikat (stat nutrittiv);
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild hepatic impairment (bilirubin ≤ 1 x ULN and AST > 1 x ULN, or bilirubin > 1.0 to 1.5 x ULN and any AST) on patisiran exposure or TTR reduction compared to patients with normal hepatic function.
Maltese: L-analiżi tal-populazzjonijiet farmakokinetiċi u farmakodinamiċi ma indikaw l-ebda impatt talindeboliment epatiku ħafif (bilirubina ≤ 1 x ULN u AST > 1 x ULN, jew bilirubina > 1.0 sa 1.5 x ULN u kull AST) fuq l-esponiment għall-patisiran jew it-tnaqqis ta' TTR meta mqabbel ma' pazjenti b'funzjoni epatika normali.
English: The safety and efficacy of Onpattro in children or adolescents < 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Onpattro fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-mediċini http://www.ema.europa.eu
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet tal-ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: In spleen, lymphoid atrophy/necrosis and histiocytosis in the white pulp was observed in rats and hypocellularity of the red pulp was observed in monkeys.
Maltese: Fil-milsa, atrofija/nekrożi tal-limfojde u istoċitożi tal-polpa bajda ġew osservati fil-firien, u ipoċellularità tal-polpa l-ħamra ġiet osservata fix-xadini.
English: Onpattro contains patisiran, a double-stranded small interfering ribonucleic acid (siRNA) that specifically targets a genetically conserved sequence in the 3' untranslated region of all mutant and wild-type TTR mRNA.
Maltese: L-estravażjoni suspettata għandha tiġi ttrattata skont il-prattiċi lokali standard għall-fluwidi mhux viżikanti.
English: Each mL contains 2 mg patisiran.
Maltese: Kull mL fih 2 mg ta' patisiran.
English: Do not shake or vortex.
Maltese: Tħawdux jew tagħmilx vortex.
English: No data are available for patients weighing ≥ 110 kg.
Maltese: Piż M'hemm l-ebda data disponibbli għal pazjenti li jiżnu ≥ 110 kg.
English: Patisiran is formulated as lipid nanoparticles to deliver the siRNA to hepatocytes, the primary source of TTR protein in the circulation.
Maltese: Patisiran hu fformulat bħala nanopartikuli lipidi biex iwassal is-siRNA liċ-ċelluli epatiċi, is-sors primarju tal-proteina TTR fiċ-ċirkulazzjoni.
English: The duration of infusion may be extended in the event of an IRR (see section 4.4).
Maltese: It-tul tal-infużjoni jista' jiġi estiż fil-każ ta' IRR (ara sezzjoni 4.4).
English: At 18 months, the adjusted geometric mean ratio to baseline was 0.89 with Onpattro and 1.97 with placebo (ratio, 0.45; p < 0.001), representing a 55% difference in favour of Onpattro.
Maltese: Wara 18-il xahar, il-proporzjon medju ġeometriku aġġustat għal-linja bażi kien 0.89 b'Onpattro u 1.97 bil-plaċebo (proporzjon, 0.45;
English: Signs and symptoms included phlebitis or thrombophlebitis, infusion or injection site swelling, dermatitis (subcutaneous inflammation), cellulitis, erythema or injection site redness, burning sensation, or injection site pain.
Maltese: Is-sinjali u s-sintomi kienu jinkludu l-flebite jew it-tromboflebite, nefħa fil-post ta' injezzjoni jew infużjoni, dermatite (infjammazzjoni taħt il-ġilda), ċellulite, eritema jew ħmura tas-sit ta' injezzjoni, sensazzjoni ta' ħruq, jew uġigħ fil-post ta' injezzjoni.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: All events were mild or moderate in severity and did not lead to treatment discontinuation.
Maltese: L-avvenimenti kollha kienu ta' severità ħafifa jew moderata u ma wasslux għall-waqfien tat-trattament.
English: • Feeling sick (nausea)
Maltese: • Qtugħ ta' nifs (dispneja)
English: The key secondary endpoint was the change from baseline to 18 months in Norfolk Quality of LifeDiabetic Neuropathy (QoL-DN) total score.
Maltese: Il-punt aħħari sekondarju ewlieni kien il-bidla mil-linja bażi għal 18-il xahar fil-punteġġ totali tal-Kwalità tal-Ħajja Newropatija Dijabetika ta' Norfolk (Quality of Life-Diabetic Neuropathy, QoL-DN).
English: • Decrease in night vision, dry eyes, poor vision, hazy or cloudy vision
Maltese: • Tnaqqis fil-vista billejl, għajnejn xotti, vista batuta, vista mċajpra
English: • Muscle spasms
Maltese: • Spażmi tal-muskoli
English: • Withdraw the required volume of filtered Onpattro from the sterile container using a sterile syringe.
Maltese: • Iġbed il-volum meħtieġ ta' Onpattro ffiltrat mill-kontenitur sterili bl-użu ta' siringa sterili.
English: Infusion-related reaction
Maltese: Reazzjonijiet relatati mal-infużjoni
English: Antidrug antibody titres were low and transient with no evidence of an effect on clinical efficacy, the safety profile, or the pharmacokinetic or pharmacodynamic profiles of Onpattro.
Maltese: It-titers tal-antikorpi ta' kontra l-mediċina kienu baxxi u temporanji bl-ebda evidenza ta' effett fuq l-effikaċità klinika, il-profil ta' sikurezza, jew il-profili farmakokinetiċi jew farmakodinamiċi ta' Onpattro.
English: Muscle spasms
Maltese: Premedikazzjoni meħtieġa
English: Symptoms of IRRs include, but are not limited to: arthralgia or pain (including back, neck, or musculoskeletal pain), flushing (including erythema of face or skin warm), nausea, abdominal pain, dyspnoea or cough, chest discomfort or chest pain, headache, rash, chills, dizziness, fatigue, increased heart rate or palpitations, hypotension, hypertension, facial oedema.
Maltese: Is-sintomi tal-IRRs jinkludu, iżda mhumiex limitati għal: artralġija jew uġigħ (inkluż uġigħ tad-dahar, tal-għonq, jew muskoloskeletali), ħmura tal-wiċċ (inkluż eritema tal-wiċċ jew sħana tal-ġilda), dardir, uġigħ addominali, qtugħ ta' nifs jew sogħla, skumdità tas-sider jew uġigħ tas-sider, uġigħ ta' ras, raxx, tertir ta' bard, sturdament, għeja, rata tal-qalb mgħaġġla jew palpitazzjonijiet, pressjoni baxxa, pressjoni għolja u edema tal-wiċċ.