FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes (very common) stomatitis, mouth ulceration, aphthous ulcer; (common) tongue ulceration, lip ulceration and (uncommon) gingival pain, glossitis c
Maltese: Jinkludi (komuni ħafna) stomatite, ulċeri fil-ħalq, ulċera bl-afte;
English: Votubia 2 mg dispersible tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli li jinxterdu Votubia ta' 2 mg huma disponibbli f'pakketti li fihom 10 x 1, 30 x 1 jew 100 x 1 pillola f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: The effect of everolimus on infantile/epileptic spasms or on seizures associated with Lennox-Gastaut syndrome has not been studied and is not established for generalised-onset seizures and subjects without cortical tubers.
Maltese: L-effett ta' everolimus fuq spażmi fl-infanzja/epilettiċi jew fuq attakki epilettiċi assoċjati mas-sindrome Lennox-Gastaut ma ġiex studjat u mhuwiex stabbilit għal attakki epilettiċi tat-tip ġeneralizzat u pazjenti mingħajr tuberi kortikali.
English: These instructions are for taking a dose between 1 mg and 10 mg.
Maltese: Dawn l-istruzzjonijiet qed jingħataw biex tieħu doża ta' bejn 1 mg u 10 mg.
English: Dosing recommendations for paediatric patients with seizures are consistent with those for the adult population, except for patients in the range from 2 years to less than 6 years of age, and those with hepatic impairment (see section “Hepatic impairment” below and section 5.2).
Maltese: Id-dożi rrakkomandati għal pazjenti pedjatriċi b' b'attakki epilettiċi huma konsistenti ma' dawk għallpopolazzjoni adulta, ħlief għal pazjenti li għandhom bejn sentejn u anqas minn 6 snin, u dawk b'indeboliment epatiku (ara s-sezzjoni “Indeboliment tal-fwied” hawn taħt u sezzjoni 5.2).
English: In the study, partial-onset seizures were defined as all electroencephalogram (EEG)-confirmed sensory seizures or motor seizures in which a generalised onset had not been demonstrated on a past EEG.
Maltese: Fl-istudju, attakki epilettiċi tat-tip parzjali kienu definiti bħala kull attakk epilettiku sensorju kkonfermat b'elettroenċefalogramm (EEG) jew attakk epilettiku sensorju li fih bidu ġeneralizzat ma kienx intwera f'EEG preċedenti.
English: Votubia contains lactose
Maltese: GĦAMLA KWALITATTIVA
English: The entire contents of the syringe should be administered.
Maltese: Għandu jingħata l-kontenut kollu tas-siringa.
English: At the time of the final analysis (4 years following the last patient randomisation), the median duration of exposure to everolimus was 204.1 weeks (range 2 to 278).
Maltese: Fiż-żmien tal-analiżi finali (4 snin wara l-aħħar għażla tal-pazjenti b'mod arbitrarju), it-tul medju tal-esponiment għal everolimus kien 204.1 ġimgħat (medda 2-278).
English: Votubia dose adjustment
Maltese: Tfal u adolexxenti
English: Proteinuria
Maltese: Emorraġija
English: Votubia 2 mg dispersible tablets everolimus
Maltese: Votubia 2 mg pilloli li jinxterdu everolimus
English: Assess the everolimus trough level 2 weeks after discontinuation of one of multiple strong CYP3A4 inducers.
Maltese: Evalwa l-inqas livell ta' everolimus ġimagħtejn wara t-twaqqif ta' wieħed mill-indutturi qawwija multipli ta' CYP3A4.
English: They are engraved with “5” on one side and “NVR” on the other.
Maltese: Huma mnaqqxin b'“5” fuq naħa waħda u b'“NVR” fuq in-naħa l-oħra.
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Maltese: Għar-reazzjonijiet avversi ta' Grad 1, normalment mhux meħtieġ aġġustament tad-doża.
English: Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Maltese: Mhux komuni Herpes zoster, sepsi, bronkite virali Disturbi tad-demm u tas-sistema limfatika Komuni
English: The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m 2.
Maltese: Id-doża inizjali rrakkomandata għal Votubia għall-kura ta' pazjenti b'SEGA hi ta' 4.5 mg/m 2.
English: Votubia 1 mg dispersible tablets are available in packs containing 30 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli li jinxterdu Votubia ta' 1 mg huma disponibbli f'pakketti li fihom 30 pillola f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Maltese: Kull pillola li tinxtered ta' Votubia 1 mg fiha 1 mg ta' everolimus.
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) may be considered.
Maltese: Għal pazjenti li jeħtieġu l-użu ta' kortikosterojdi għall-kura ta' pulmonite mhux infettiva, tista' tiġi kkunsidrata profilassi għal pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP).
English: They are engraved with “D2” on one side and “NVR” on the other.
Maltese: Huma mnaqqxin b'“D2” fuq naħa waħda u b'“NVR” fuq in-naħa l-oħra.
English: Month 12 n=26
Maltese: 12-il Xahar n=26
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 3 below.
Maltese: F'Tabella 3 hawn taħt hemm lista ta' interazzjonijiet magħrufa u teoretiċi ma' impedituri u indutturi magħżula ta' CYP3A4 u PgP.
English: White to slightly yellowish, round, flat tablets of approximately 9.1 mm in diameter, with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other.
Maltese: Pilloli minn bojod sa kemxejn fl-isfar, tondi u ċatti ta' dijametru ta' madwar 9.1 mm, b'ġenb tasturat u bl-ebda sinjal dritt, imnaqqxin b'“D2” fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Votubia 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Maltese: Votubia 2 mg pilloli li jinxterdu huma minn bojod sa kemxejn sofor, pilloli tondi u ċari b'ġenb tasturat u bl-ebda sinjal dritt.
English: Response rate
Maltese: MANIFATTUR RESPONSABBLI
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Maltese: Everolimus mhuwiex irrakkomandat waqt it-tqala u f'nisa li jistgħu joħorġu tqal li mhux qed jużaw mezzi kontraċettivi.
English: Uncommon side effects (may affect up to 1 in 100 people) Muscle spasms, fever, red-brown urine which may be symptoms of a muscle disorder (rhabdomyolysis)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) Spażmi fil-muskoli, deni, awrina ħamra fil-kannella li jistgħu jkunu sintomi ta' disturb muskulari (rabdomijoli)
English: Votubia is not recommended for patients <18 years of age with SEGA or refractory seizures and hepatic impairment.
Maltese: Votubia mhuwiex irrakkomandat għal pazjenti <18-il sena b'SEGA jew b'attakki epilettiċi refrattorji u b'indeboliment tal-fwied.
English: • ≥18 years of age with SEGA or refractory seizures and concomitant severe hepatic impairment (Child-Pugh C) unless the potential benefit outweighs the risk (see sections 4.2 and
Maltese: • ta' ≥18-il sena b'SEGA jew b'attakki epilettiċi refrattorji u fl-istess ħin indeboliment qawwi tal-fwied (Child-Pugh Ċ) sakemm il-benefiċċju potenzjali ma jkunx akbar mir-riskju (ara sezzjonijiet 4.2 u 5.2).
English: Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
Maltese: Votubia huwa indikat għat-trattament ta' pazjenti adulti b'anġjomijolipoma assoċjata mal-kumpless sklerożi tuberoża (TSC) li jinsabu f'riskju ta' kumplikazzjonijiet (imsejjes fuq fatturi bħalma huma ddaqs tat-tumur jew il-preżenza ta' anewriżmu, jew il-preżenza ta' tumuri multipli jew bilaterali) li ma jeħtiġux operazzjoni immedjata.
English: Each Votubia 3 mg dispersible tablet contains 3 mg of everolimus.
Maltese: Kull pillola li tinxtered ta' Votubia 3 mg fiha 3 mg ta' everolimus.
English: Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
Maltese: L-analiżi finali tinkludi pazjenti li qalbu l-kura mill-grupp tal-plaċebo; tul medjan ta' espożizzjoni għal everolimus ta' 204.1 ġimgħat
English: • The active substance is patisiran.
Maltese: • Is-sustanza attiva hi patisiran.
English: 1077 ZX Amsterdam Netherlands
Maltese: 1077 ZX Amsterdam
English: • Oral paracetamol (500 mg)
Maltese: • Paracetamol orali (500 mg)
English: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska,
Maltese: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ireland, Ísland, Κύπρος, Latvija, Lietuva,
English: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) Cholesterol
Maltese: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
English: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands
Maltese: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen L-Olanda
English: Placebo N=77
Maltese: Placebo N=77 Onpattro Plaċebo
English: 10-metre walk test (m/sec)c p < 0.001
Maltese: test ta' mixi ta' 10 metri (m/sec)c p < 0.00
English: The active substance in Onpattro is patisiran.
Maltese: Is-sustanza attiva f'Onpattro hi patisiran.
English: INFORMATION IN BRAILLE Onpattro
Maltese: INFORMAZZJONI BIL-BRAILLE Onpattro
English: • Signs and symptoms of IRRs;
Maltese: • Sinjali u sintomi ta' IRRs;
English: Peripheral oedema
Maltese: Edema periferali
English: Table 1: Adverse reactions reported for Onpattro 300 micrograms per kg System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati għal 300 mikrogramma Onpattro għal kull kilo Sistema tal-Klassifika tal-Organi
English: For clinical management of IRRs, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' IRRs, ara sezzjoni 4.4.
English: • Indigestion (dyspepsia)
Maltese: • Indiġestjoni (dispepsija)
English: Alnylam Italy S.r.l.
Maltese: Italy S.r.l.
English: Gender and race
Maltese: Sess u razza
English: Patisiran is metabolized by nucleases to nucleotides of various lengths.
Maltese: Patisiram jiġi metabolizzat min-nucleases san-nukleotidi ta' tul differenti.
English: (OnpattroPlacebo) Treatment Difference, LS Mean (95% CI)
Maltese: Differenza fit-Trattament , Medja LS (95% CI)
English: Primary mNIS+7b
Maltese: Primarju mNIS+7b p < 0.00
English: • Onpattro does not contain preservatives.
Maltese: • Onpattro ma fihx preservattivi.
English: Extravasation was observed in < 0.5% of infusions in clinical studies.
Maltese: L-estravażjoni ġiet osservata f'< 0.5% tal-infużjonijiet fl-istudji kliniċi.
English: DLin-MC3-DMA is primarily metabolised to 4-dimethylaminobutyric acid (DMBA) by hydrolysis.
Maltese: DLin-MC3-DMA jiġi metabolizzat primarjament għal 4-dimethylaminobutyric acid (DMBA) permezz ta' idroliżi.
English: What is in this leaflet:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: The mean ± SD terminal elimination half-life (t1/2β) of patisiran was 3.2 ± 1.8 days.
Maltese: Il-medja tal-half-life tal-eliminazzjoni terminali ±SD (t1/2β) ta' patisiran kienet ta' 3.2 ± 1.8 jiem.
English: Forty-nine percent (49%) and 50% of patients had a New York Heart Association (NYHA) Class of I or II, respectively.
Maltese: Disa' u erbgħin fil-mija (49%) u 50% tal-pazjenti kellhom Klassi I jew II rispettivament tan-New York Heart Association (NYHA).
English: Baseline, Mean (SD)
Maltese: Linja Bażi, Medja (SD)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 August 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 Awwissu 2018
English: Secondary Norfolk QoL-DNb
Maltese: Sekondarju Norfolk QoL
English: • Filter Onpattro through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
Maltese: • Iffiltra l-Onpattro permezz ta' filtru tas-siringa ta' 0.45 micron polyethersulfone (PES) f'kontenitur sterili.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti ara sezzjoni 6.1.
English: • The other ingredients are DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4- (dimethylamino) butanoate), PEG2000-C-DMG (α- (3'-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene), DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), cholesterol, disodium hydrogen phosphate, heptahydrate, potassium dihydrogen phosphate, anhydrous, sodium chloride, and water for injections (see “Onpattro contains sodium” in section 2).
Maltese: • Is-sustanzi mhux attivi l-oħra huma DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoate), PEG2000-C-DMG (α-(3'-{[1,2-di(myristyloxy) propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene), DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), kolesterol, disodium hydrogen phosphate, heptahydrate, potassium dihydrogen phosphate, sodium chloride, u ilma għall-injezzjonijiet (ara “Onpattro fih is-sodium” f'sezzjoni 2).
English: • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to < 1/100)
Maltese: • Komuni (≥ 1/100 sa < 1/10)
English: Genotoxicity/Carcinogenicity
Maltese: Ġenotossiċità/Karċinoġeniċità
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class (SOC) by frequency.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati bħala termini ppreferuti MedDRA taħt is-Sistema tal-Klassifika tal-Organi MedDRA (SOC) skont il-frekwenza.
English: Each mL of concentrate contains 3.99 mg sodium.
Maltese: Kull millilitru ta' konċentrat fih 3.99 mg ta' sodium.
English: There were no significant differences in steady state pharmacokinetic parameters or TTR reduction between patients < 65 years of age and ≥ 65 years of age.
Maltese: Ma kien hemm l-ebda differenzi sinifikanti fil-parametri farmakokinetiċi tal-istat fiss jew fit-tnaqqis ta' TTR bejn pazjenti ta' età < 65 u ta' età ta' ≥ 65.
English: IRRs resulted in permanent discontinuation of Onpattro in < 1% of patients in clinical studies.
Maltese: L-IRRs wasslu għall-waqfien permanenti ta' Onpattro f'< 1% tal-pazjenti fl-istudji kliniċi.
English: By reducing serum TTR protein, Onpattro treatment leads to a decrease in serum vitamin A (retinol) levels (see section 5.1).
Maltese: Billi jnaqqas il-proteina TTR fis-serum, it-trattament b'Onpattro jwassal għal tnaqqis fil-livelli ta' vitamina A (retinol) fis-serum (ara sezzjoni 5.1).
English: Approximately 5.5% of DLin-MC3-DMA was recovered after 96 hours as its metabolite (DMBA) in urine.
Maltese: Madwar 5.5% ta' DLin-MC3-DMA kien irkuprat wara 96 siegħa bħala l-metabolita tiegħu (DMBA) fl-awrina.
English: DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoate) PEG2000-C-DMG (α-(3'-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene)
Maltese: DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoate)
English: Bronchitis
Maltese: Bronkite
English: • Very common (≥ 1/10)
Maltese: • Komuni ħafna (≥ 1/10)
English: • Intravenous corticosteroid (dexamethasone 10 mg, or equivalent)
Maltese: • Kortikosterojdi ġol-vini (dexamethasone 10 mg, jew ekwivalenti)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/5 mL
Maltese: INDIVIDWALI 10 mg/5 mL
English: The most frequently occurring adverse reactions reported in Onpattro-treated patients were peripheral oedema (29.7%) and infusion-related reactions (18.9%).
Maltese: L-aktar reazzjonijiet avversi frekwenti rrappurtati fil-pazjenti ttrattati b'Onpattro kienu edema periferali (29.7%) u reazzjonijiet relatati mal-infużjoni (18.9%).
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4).
Maltese: Il-pazjenti kollha għandhom jirċievu premedikazzjoni qabel ma jingħata Onpattro sabiex jitnaqqas ir-riskju tar-reazzjonijiet relatati mal-infużjoni (Infusion-Related Reactions, IRRs) (ara sezzjoni 4.4).
English: Vitamin A deficiency
Maltese: Defiċjenza ta' vitamina A
English: Mean reductions in serum retinol binding protein of 45% and serum vitamin A of 62% were observed over 18 months (see sections 4.4 and 4.5).
Maltese: Matul 18-il xahar ġie osservat tnaqqis medju tal-proteina li torbot ir-retinol fis-serum ta' 45% u ta' vitamina A fis-serum ta' 62% (ara sezzjonijiet 4.4 u 4.5)
English: There is little to no metabolism of PEG2000-C-DMG.
Maltese: Hemm ftit sa l-ebda metaboliżmu ta' PEG2000-C-DMG.
English: p-value
Maltese: valur-p
English: The efficacy of Onpattro was studied in a randomised, double-blind, placebo-controlled study in 225 hATTR amyloidosis patients with a TTR mutation and symptomatic polyneuropathy.
Maltese: L-effikaċja ta' Onpattro ġiet studjata fi studju randomised, double-blind u kkontrollat bil-plaċebo f'225 pażjenti b'amilojdjożi hATTR b'mutazzjoni tat-TTR u polinewropatija sintomatika.
English: Pharmacotherapeutic group: Other nervous System Drugs; ATC code: N07XX12.
Maltese: Mediċini oħra għas-sistema nervuża; Kodiċi ATC:
English: N-terminal pro-B type natriuretic peptide (NT-proBNP) was 727 ng/L and 711 ng/L at baseline (geometric mean) in Onpattro-treated and placebo-treated patients, respectively.
Maltese: Il-peptid natrijuretiku tat-tip pro B terminali N (NT-proBNP, N-terminal pro-B type natriuretic peptide) kienet 727 ng/L u 711 ng/L fil-linja bażi (medja ġeometrika) tal-pazjenti ttrattati b'Onpattro u l-pazjenti ttrattati bil-plaċebo, rispettivament.
English: White to off-white, opalescent, homogeneous solution (pH: 6.3 - 7.5).
Maltese: Soluzzjoni omoġena ta' lewn abjad għal abjad jagħti fil-griż, opalexxenti, (pH: 6.3 - 7.5).
English: Mean serum TTR was reduced by approximately 80% within 10 to 14 days after a single dose with 300 micrograms per kg Onpattro.
Maltese: Il-medja ta' TTR fis-serum tnaqqset b'madwar 80% bejn 10 u 14-il jum wara doża waħda bi 300 milligrammi għal kull kg ta' Onpattro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1320/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1320/001
English: hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin' (TTR).
Maltese: L-amilojdjożi hATTR hi kkawżata minn problemi bi proteina fil-ġisem li tissejjaħ ‘transthyretin' (TTR).
English: The median patient age at baseline was 62 (range, 24 to 83) years and 74% of patients were male, 26% were female.
Maltese: L-età medja tal-pazjenti fil-linja bażi kienet ta' 62 (medda, bejn 24 u 83) sena u 74% tal-pazjenti kienu rġiel, 26% kienu nisa.
English: Onpattro did not exhibit a genotoxic potential in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Maltese: Onpattro ma inibixxiex potenzjal ġenotossiku in vitro u in vivo u ma kienx karċinoġenu fil-firien rasH2 transġeniċi.
English: The components of Onpattro are not inhibitors or inducers of cytochrome P450 enzymes or transporters, except for CYP2B6 (see Section 4.5).
Maltese: Il-komponenti ta' Onpattro mhumiex inibituri jew indutturi tal-enzimi jew it-trasportaturi ta' ċitokrom P450, ħlief għal CYP2B6 (ara Sezzjoni 4.5).
English: In the placebo-controlled and open-label clinical studies, 7 of 194 (3.6%) patients with hATTR amyloidosis developed anti-drug antibodies during treatment with Onpattro.
Maltese: Fl-istudji kliniċi kkontrollati bil-plaċebo u open-label, 7 minn 194 (3.6%) pazjenti bl-amilojdjożi hATTR żviluppaw antikorpi ta'
English: All patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers.
Maltese: Il-pazjenti kollha rċevew premedikazzjoni b'kortikosterojde, paracetamol, u mblokkaturi tal-H1 u H2.
English: • It is given as a drip into a vein (‘intravenous infusion') usually over about 80 minutes.
Maltese: • Jingħata minn dripp ġol-vini (‘infużjoni ġol-vini') normalment għal madwar 80 minuta.
English: In patients with pre-defined cardiac involvement, centrally-assessed echocardiograms showed decreases in LV wall thickness (LS mean difference: −0.9 mm [95% CI −1.7, −0.2]) and longitudinal strain (LS mean difference: −1.37% [95% CI -2.48, -0.27]) with Onpattro treatment relative to placebo.
Maltese: −0.9 mm [95% CI −1.7, −0.2]) u ġbid lonġitudinali (differenza Medja LS: −1.37% [95%CI -2.48, -0.27]) bit-trattament Onpattro relattiv għall-plaċebo.
English: Plasma protein binding of Onpattro is low, with ≤ 2.1% binding observed in vitro with human serum albumin and human α1-acid glycoprotein.
Maltese: Il-proteina tal-plażma li torbot l-Onpattro hi baxxa, b'≤ 2.1% ta' rbit osservat in vitro bl-albumina fis-serum tal-bniedem u l-glikoproteina α1-acid tal-bniedem.
English: Vitamin A testing
Maltese: Testijiet tal-vtamina A
English: The estimated DLin-MC3-DMA mean ± SD steady-state Cmax, Ctrough and AUCτ were 40.2 ± 11.5 µg/mL, 1.75 ± 0.698 µg/mL, and 1403 ± 105 µg·h/mL, respectively.
Maltese: Il-medja stmata ta' Cmax, Ctrough u AUCτ tal-istat fiss ± SD ta' DLin-MC3-DMA kienet 40.2 ± 11.5 µg/mL, 1.75 ± 0.698 µg/mL, u 1403 ± 105 µg h/mL, rispettivament.
English: The estimated PEG2000-C-DMG mean ± SD steady-state Cmax, Ctrough and AUCτ were 4.22 ± 1.22 µg/mL, 0.0236 ± 0.0093 µg/mL, and 145 ± 64.7 µg·h/mL, respectively.
Maltese: Il-medja stmata ta' Cmax, Ctrough u AUCτ tal-istat fiss ± SD ta' PEG2000-C-DMG kienet ta' 4.22 ± 1.22 µg/mL, 0.0236 ± 0.0093 µg/mL, u 145 ± 64.7 µg h/mL, rispettivament.
English: The estimated patisiran mean ± SD steady-state peak concentration (Cmax), trough concentration (Ctrough), and area under the curve (AUCτ) were 7.15 ± 2.14 µg/mL, 0.021 ± 0.044 µg/mL, and 184 ± 159 µg·h/mL, respectively.
Maltese: Il-medja stmata ta' konċentrazzjoni massima tal-istat fiss ± SD (Cmax) ta' patisiran, il-konċentrazzjoni baxxa (Ctrough), u ż-żona ta' taħt il-kurva (AUCτ) kienu ta' 7.15 ± 2.14 µg/mL, 0.021 ± 0.044 µg/mL, u 184 ± 159 µg h/mL, rispettivament.
English: Table 2: Clinical Efficacy Results from the Placebo-Controlled Study
Maltese: Tabella 2: Riżultati tal-Effikaċja Klinika mill-Istudju Kkontrollat bil-Plaċebo
English: For patients weighing ≥ 100 kg, the maximum recommended dose is 30 mg.
Maltese: Għall-pazjenti li jiżnu ≥ 100 kg, id-doża massima rakkomandata hi ta' 30 mg.
English: This is 0.2% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan hu 0.2% tad-doża massima ta' kuljum ta' sodju rakkomandata għal persuna adulta.
English: • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent)
Maltese: • Imblokkatur H1 ġol-vini (diphenhydramine 50 mg, jew ekwivalenti)
English: Dyspnoea
Maltese: Dispepsija
English: This medicine contains 3.99 milligrams (mg) of sodium (main component of cooking/table salt) per millilitre (mL).
Maltese: Din il-mediċina fiha 3.99 milligrammi (mg) ta' sodium (komponent prinċipali tat-tisjir/melħ talmejda) f'kull millilitru (mL).
English: In the placebo-controlled study, peripheral oedema was reported in 29.7% of Onpattro-treated patients and 22.1% of placebo-treated patients.
Maltese: Fl-istudju kkontrollat bil-plaċebo, l-edema periferali kienet irrappurtata fi 29.7% tal-pazjenti ttrattati b'Onpattro u 22.1% tal-pazjenti ttrattati bil-plaċebo.
English: • Each 5 mL vial contains patisiran sodium equivalent to 10 mg patisiran.
Maltese: • Kull kunjett ta' 5 mL fih patisiran sodium, ekwivalenti għal 10 mg ta' patisiran.
English: Onpattro contains sodium
Maltese: Onpattro fih is-sodium
English: Alnylam Netherlands B.V. Strawinskylaan 3051
Maltese: Alnylam Netherlands B.V. Strawinskylaan 3051 1077 ZX Amsterdam L-Olanda
English: In rabbits, Onpattro generated spontaneous abortions, reduced embryo-foetal survival, and reduced foetal body weights at maternally toxic doses ≥ 1 mg/kg (HED 3.2 times the RHD).
Maltese: Fil-fniek, Onpattro ġġenera aborti spontanji, sopravivenza mnaqqsa tal-embrijun-fetu, u piżijiet tal-ġisem fetali mnaqqsa b'dożi tossiċi għall-omm ta' ≥ 1 mg/kg (HED 3.2 darbiet il-RHD).