FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of adverse reactions was based on exposure in 114 UCD patients (65 adults and 49 children between the ages of 2 months and 17 years) with deficiencies in CPS, OTC, ASS, ASL, ARG, or HHH across 4 short term and 3 long term clinical studies, in which 90 patients completed 12 months duration (median exposure = 51 weeks).
Maltese: Il-valutazzjoni tar-reazzjonijiet avversi kienet ibbażata fuq espożizzjoni f'114-il pazjent UCD (65 adult u 49 tifel u tifla bejn l-età ta' xahrejn u 17-il sena) b'defiċjenzi f'CPS, OTC, ASS, ASL, ARG, jew HHH f'4 studji kliniċi għal żmien qasir u 3 studji kliniċi fit-tul, fejn 90 pazjent lestew perijodu ta' 12il xahar (espożizzjoni medjana = 51 ġimgħa).
English: Glycerol phenylbutyrate is a nitrogen-binding medicinal product.
Maltese: Glycerol phenylbutyrate huwa prodott mediċinali li jeħel man-nitroġenu.
English: RAVICTI is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Maltese: RAVICTI hu indikat għall-użu bħala terapija aġġuntiva għall-ġestjoni kronika ta' pazjenti b'disturbi fiċ-ċiklu tal-urea (UCDs - urea cycle disorders) inklużi defiċjenzi ta' carbamoyl phosphate- synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) u sindrome ta' hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) b'defiċjenza ta' ornithine translocase li ma jistgħux jiġu ġestiti b'restrizzjoni tal-proteini fid-dieta u/jew supplimentazzjoni tal-aċidi amminiċi waħedhom.
English: In a rat study, glycerol phenylbutyrate caused a statistically significant increase in the incidence of pancreatic acinar cell adenoma, carcinoma, and combined adenoma or carcinoma in males and females, at a dose of 4.7 and 8.4 times the dose in adult patients, (6.87 ml/m2/day based on combined AUCs for PBA and PAA).
Maltese: Fi studju fuq il-firien, glycerol phenylbutyrate kkawża żieda statistikament sinifikanti fl-inċidenza ta' adenoma taċ-ċelluli aċinari pankreatiċi, karċinoma, u adenoma jew karċinoma kkombinati fl-irġiel u n-nisa, f'doża ta' 4.7 u 8.4 darbiet id-doża f'pazjenti adulti (6.87 ml/m2/jum abbażi tal-AUCs ikkombinati għal PBA u PAA).
English: This corresponds to a density of 1.1 g/ml.
Maltese: Dan jikkorrispondi għal densità ta' 1.1 g/ml.
English: In the same study, following 6 ml of glycerol phenylbutyrate for 3 days (TID), mean Cmax and AUC were 100 mcg/ml and 1400 mcg•h/ml for PBA and 65 mcg/ml and 2064 mcg•h/ml for PAA, respectively.
Maltese: Fl-istess studju, wara 6 ml ta' glycerol phenylbutyrate għal 3 ijiem (TID), is-Cmax u l-AUC medji kienu 100 mcg/ml u 1400 mcg•siegħa/ml għal PBA u 65 mcg/ml u 2064 mcg•siegħa/ml għal PAA, rispettivament.
English: Constipation, Flatulence, Gastrooesophageal reflux disease
Maltese: Stitikezza, Gass, Marda ta' rifluss gastroesofagali
English: • 9000 microgram (mcg/ml) for patients under 2 years of age
Maltese: • 9000 mikrogramma (mcg/ml) għal pazjenti li għandhom anqas minn sentejn
English: • Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate tablets (g) x
Maltese: • Dożaġġ totali ta' kuljum ta' RAVICTI (ml) = dożaġġ totali ta' kuljum ta' pilloli ta' sodium phenylbutyrate (g) x 0.86
English: A potential effect on CYP2D6 isoenzyme cannot be excluded and caution is advised for patients who receive medicinal products that are CYP2D6 substrates.
Maltese: Effett potenzjali fuq l-isoenzima CYP2D6 ma jistax jiġi eskluż u hija rakkomandata kawtela għal pazjenti li jirċievu prodotti mediċinali li huma sottostrati ta' CYP2D6.
English: Of 51 adult patients participating in Study 2, 7 patients (14%) reported a total of 10 hyperammonaemic crises during treatment with glycerol phenylbutyrate as compared with 9 patients (18 %) who had reported a total of 15 crises in the 12 months prior to study entry while they were being treated with sodium phenylbutyrate.
Maltese: Minn 51 pazjenti adulti li ħadu sehem flIstudju 2, 7 pazjenti (14%) irrapportaw total ta' 10 kriżijiet iperammonemiċi waqt il-kura bi glycerol phenylbutyrate meta mqabbla ma' 9 pazjenti (18%) li kienu rrapportaw total ta' 15-il kriżi fit-12il xahar qabel ir-reġistrazzjoni fl-istudju waqt li kienu qegħdin jiġu kkurati b'phenylbutyrate sodium.
English: Glycerol phenylbutyrate and/or its metabolites, PAA and PBA, have been shown to be weak inducers of CYP3A4 enzyme in vivo.
Maltese: Glycerol phenylbutyrate u/jew il-metaboliti tiegħu, PAA u PBA, intwerew li huma indutturi dgħajfa tal-enzima CYP3A4 in vivo.
English: The efficacy of glycerol phenylbutyrate in paediatric patients 2 months to 17 years of age involving deficiencies of OTC, ASS, ASL, and ARG was evaluated in 2 fixed sequence, open-label, sodium phenylbutyrate to equivalent dosing of glycerol phenylbutyrate switchover studies (Studies 3 and 4).
Maltese: L-effikaċja ta' glycerol phenylbutyrate f'pazjenti pedjatriċi ta' età minn xahrejn sa 17-il sena li kellhom defiċjenzi ta' OTC, ASS, ASL, u ARG kienet evalwata f'żewġ studji b'sekwenza fissa, open label, bi qlib minn sodium phenylbutyrate għal dożaġġ ekwivalenti ta' glycerol phenylbutyrate (Studji 3 u 4).
English: Uncommon Ventricular arrhythmia
Maltese: Arritmija ventrikolari
English: Given that approximately 47% of dietary nitrogen is excreted as waste and approximately 70% of an administered 4phenylbutyric acid (PBA) dose will be converted to urinary phenylacetylglutamine (U-PAGN), an initial estimated glycerol phenylbutyrate dose for a 24-hour period is 0.6 ml glycerol phenylbutyrate per gram of dietary protein ingested per 24 hour period assuming all the waste nitrogen is covered by glycerol phenylbutyrate and excreted as phenylacetylglutamine (PAGN).
Maltese: Peress li madwar 47% tan-nitroġenu tad-dieta jiġi eliminat mill-ġisem bħala żejjed u madwar 70% ta' doża mogħtija ta' 4-phenylbutyric acid (PBA) tiġi kkonvertita għal phenylacetylglutamine fl-awrina (UPAGN), doża inizjali stmata ta' glycerol phenylbutyrate għal perijodu ta' 24 siegħa hija 0.6 ml glycerol phenylbutyrate għal kull gramma ta' proteini fid-dieta inġestita għal kull perijodu ta' 24 siegħa, jekk wieħed jassumi li n-nitroġenu żejjed huwa kopert minn glycerol phenylbutyrate u eliminat bħala phenylacetylglutamine (PAGN).
English: The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible.
Maltese: Il-potenzjal ta' interazzjoni ta' glycerol phenylbutyrate bħala induttur ta' CYP3A4 u dawk il-prodotti li huma mmetabolizzati b'mod predominanti mill-passaġġ CYP3A4 huwa possibbli.
English: N-acetylglutamate synthase (NAGS) and CITRIN (citrullinaemia type 2) deficiency The safety and efficacy of RAVICTI for the treatment of patients with N-acetylglutamate synthase (NAGS) and CITRIN (citrullinaemia type 2) deficiency have not been established.
Maltese: Defiċjenza ta' N-acetylglutamate synthase (NAGS) u CITRIN (citrullinaemia tat-tip 2)
English: A total of 51 adult patients involving deficiencies of CPS, OTC, ASS, ASL, ARG, and HHH were enrolled in the study and all but 6 had been converted from sodium phenylbutyrate to equivalent doses of glycerol phenylbutyrate.
Maltese: Total ta' 51 pazjent adult li kellhom defiċjenzi ta' CPS, OTC, ASS, ASL, ARG, u HHH kienu rreġistrati fl-istudju u kollha kemm huma ħlief 6 kienu nqalbu minn sodium phenylbutyrate għal dożi ekwivalenti ta' glycerol phenylbutyrate.
English: The effects of glycerol phenylbutyrate on cytochrome P450 (CYP) 2C9 isoenzyme and potential for interaction with celecoxib has been studied in humans with no evidence of an interaction observed.
Maltese: L-effetti ta' glycerol phenylbutyrate fuq l-isoenzima 2C9 taċ-ċitokroma P450 (CYP) u l-potenzjal ta' interazzjoni ma' celecoxib ġew studjati fil-bniedem u ma kienet osservata l-ebda evidenza ta' interazzjoni.
English: PAA clearance was 7.1 L/h, 10.9 L/h, 16.4 L/h, and 24.4 L/h, respectively, for UCD patients ages ≤ 2, 3 to 5, 6 to 11, and 12 to 17 years.
Maltese: L/siegħa, rispettivament, għal pazjenti UCD li għandhom ≤ 2, 3 sa 5, 6 sa 11, u 12 sa 17-il sena.
English: • if you have acute hyperammonaemia, which requires more rapid intervention.
Maltese: • jekk għandek iperammonemija akuta, li teħtieġ intervent aktar rapidu.
English: Hyperammonaemia was reported in 5 (50%) subjects age < 1 month (all serious but non-fatal) and 1 subject (16.7%) age 1-2 months (non-serious), which is consistent with more severe disease types diagnosed in the neonatal period.
Maltese: Iperammonemija ġiet irrappurtata f'5 (50%) individwi b'età minn <xahar (kollha serji iżda mhux fatali) u individwu wieħed (16.7%) b'età ta' 1-2 xhur (mhux serja), li hija konsistenti ma' tipi ta' mard aktar sever iddijanjostikati fil-perjodu eżatt wara t-twelid.
English: Abnormal skin odour, acne Uncommon Alopecia, hyperhidrosis, pruritic rash
Maltese: Alopeċja, iperidrożi, raxx pruritiku
English: Active-Controlled, 4-Week, Noninferiority, Blinded Crossover Study (Study 1) A randomised, double-blind, active-controlled, crossover, noninferiority study (Study 1) compared equivalent doses of glycerol phenylbutyrate to sodium phenylbutyrate by evaluating 24-hour venous ammonia levels in patients with UCDs who had been on sodium phenylbutyrate prior to enrolment for control of their UCD.
Maltese: Studju Blinded Crossover, ta' Nuqqas ta' Inferjorità, ta' 4 Ġimgħat, Ikkontrollat b'Mod Attiv (Studju 1) Studju ta' nuqqas ta' inferjorità, crossover, b'kontroll attiv, double-blind, randomizzat (Studju 1) qabbel dożi ekwivalenti ta' glycerol phenylbutyrate ma' sodium phenylbutyrate billi evalwa l-livelli ta' ammonja ġol-vina fuq perijodu ta' 24 siegħa f'pazjenti b'UCDs li kienu fuq sodium phenylbutyrate qabel ma ġew irreġistrati għall-kontroll tal-UCD tagħhom.
English: Probenecid Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate including PAGN.
Maltese: Probenecid jista' jinibixxi l-eliminazzjoni mill-kliewi tal-metaboliti ta' glycerol phenylbutyrate inkluż PAGN.
English: - You must follow this diet carefully.
Maltese: - Trid issegwi din id-dieta b'attenzjoni.
English: It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone.
Maltese: Huwa triglyceride li fih 3 molekuli ta' PBA mwaħħlin ma' qafas ta' glycerol.
English: Eczema Nail ridging Rash
Maltese: Xfarijiet fid-dwiefer Raxx
English: How to store RAVICTI
Maltese: Tiħux RAVICTI:
English: RAVICTI
Maltese: Pożoloġija
English: In a separate study, in patients with hepatic impairment (Child-Pugh B and C), the ratios of mean values for PAA to PAGN among all patients dosed with 6 ml and 9 ml twice daily ranged from 0.96 to 1.28 and for patients dosed with 9 ml twice daily ranged from 1.18-3.19.
Maltese: Fi studju separat, f'pazjenti b'indeboliment tal-fwied (Child-Pugh B u C), il-proporzjonijiet ta' valuri medji għal PAA ma' PAGN fost il-pazjenti kollha li ngħataw doża b'6 ml u 9 ml darbtejn kuljum varjaw minn 0.96 sa 1.28 u għall-pazjenti li ngħataw 9 ml darbtejn kuljum varjat minn 1.18 sa 3.19.
English: PAGN is subsequently eliminated in the urine.
Maltese: PAGN sussegwentement jiġi eliminat fl-awrina.
English: Special populations Elderly (65 years or older)
Maltese: Anzjani (65 sena jew aktar)
English: Three patients reported a total of 7 hyperammonemic crises defined as having signs and symptoms consistent with hyperammonemia (such as frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high venous ammonia levels and requiring medical intervention.
Maltese: Tliet pazjenti rrappurtaw total ta' 7 kriżijiet ta' iperammonemija definiti bħala li għandhom sinjali u sintomi konsistenti ma' iperammonemija (bħal rimettar frekwenti, dardir, uġigħ ta' ras, letarġija, irritabilità, aggressività u/jew ngħas) assoċjati ma' livelli għoljin ta' ammonja fil-vini u li jeħtieġu intervent mediku.
English: PBA derived from glycerol phenylbutyrate is further converted by β-oxidation to PAA.
Maltese: PBA derivat minn glycerol phenylbutyrate huwa kkonvertit ulterjorament b'β-ossidazzjoni għal PAA.
English: Hypophagia
Maltese: Ipotirojdiżmu
English: Other medicinal products such as corticosteroids, valproic acid, haloperidol and probenecid may have the potential to affect ammonia levels, see section 4.4.
Maltese: Prodotti mediċinali oħrajn bħal kortikosterojdi, valproic acid, haloperidol and probenecid jaf ikollhom il-potenzjal li jaffettwaw il-livelli ta' ammonja, ara sezzjoni 4.4.
English: Dizziness, headache, tremor Uncommon Dysgeusia, lethargy, paraesthesia, psychomotor hyperactivity, somnolence, speech disorder
Maltese: Disgewżja, letarġija, parasteżija, iperattività psikomotorja, ħedla tan-ngħas, disturbi fid-diskors
English: Reversible clinical manifestations suggestive of neurotoxicity (e.g., nausea, vomiting, somnolence) have been reportedly associated with phenylacetate levels ranging from 499-1285 mcg/ml in cancer patients who received PAA intravenously.
Maltese: Manifestazzjonijiet kliniċi riversibbli li jissuġġerixxu newrotossiċità (eż. nawsja, rimettar, ħedla ta' ngħas) allegament ġew assoċjati ma' livelli ta' phenylacetate li jvarjaw minn 499 sa 1285 mcg/ml f'pazjenti bil-kanċer li rċevew PAA ġol-vina.
English: The study enrolled a total of 45 paediatric patients between the ages of 1 and 17 years with UCD who had completed Study 2 and the safety extensions of Studies 3 and 4.
Maltese: Fl-istudju ġew irreġistrati total ta' 45 pazjent pedjatriku bejn l-età ta' sena u 17-il sena b'UCD li kienu lestew Studju 2 u l-estensjonijiet tas-sigurtà ta' Studji 3 u 4.
English: In healthy, fasting adult subjects receiving a single oral dose of 2.9 ml/m2 of glycerol phenylbutyrate, peak plasma levels of PBA, PAA, and PAGN occurred at 2 h, 4 h, and 4 h, respectively.
Maltese: F'individwi adulti fi stat sajjem, f'saħħithom li jirċievu doża orali waħdiena ta' 2.9 ml/m2 ta' glycerol phenylbutyrate, il-livelli massimi fil-plażma ta' PBA, PAA, u PAGN seħħew wara sagħtejn, 4 sigħat, u 4 sigħat, rispettivament.
English: In the pooled analysis of the short-term studies in children (Study 3 and Study 4), plasma ammonia was significantly lower after switching to glycerol phenylbutyrate; ammonia AUC0-24h was 626.79 and 871.72 (micromol/L)*hour during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 26, ratio of geometric means 0.79; 95% confidence intervals 0.647, 0.955).
Maltese: Fl-analiżi miġbura tal-istudji fuq żmien qasir fit-tfal (Studju 3 u Studju 4), il-livell ta' ammonja fil-plażma kien sinifikament aktar baxx wara l-qlib għal glycerol phenylbutyrate; l-AUC0-24h tal-ammonja kienet 626.79 u 871.72 (mikromol/L)*siegħa matul it-trattament bi glycerol phenylbutyrate u sodium phenylbutyrate, rispettivament (n = 26, proporzjon ta' medji ġeometriċi 0.79; intervalli ta' kunfidenza ta' 95% 0.647, 0.955).
English: Initial dosage in patients switching from sodium phenylbutyrate to RAVICTI:
Maltese: Id-dożaġġ inizjali f'pazjenti li jinqalbu minn sodium phenylbutyrate għal RAVICTI:
English: PAA, the active metabolite of glycerol phenylbutyrate, is associated with signs and symptoms of neurotoxicity (see section 4.4) and could accumulate in patients who receive an overdose.
Maltese: PAA, il-metabolit attiv ta' glycerol phenylbutyrate, huwa assoċjat ma' sinjali u sintomi ta' newrotossiċità (ara sezzjoni 4.4) u jista' jakkumula f'pazjenti li jieħdu doża eċċessiva.
English: Reduced phenylbutyrate absorption in pancreatic insufficiency or intestinal malabsorption Exocrine pancreatic enzymes hydrolyse glycerol phenylbutyrate in the small intestine, separating the active moiety, phenylbutyrate, from glycerol.
Maltese: Tnaqqis fl-assorbiment ta' phenylbutyrate f'insuffiċjenza tal-frixa jew assorbiment ħażin mill-imsaren Enzimi exocrine tal-frixa jidrolizzaw glycerol phenylbutyrate fil-musrana ż-żgħira, li tifred il-frazzjoni attiva, phenylbutyrate, minn glycerol.
English: The protein binding for PAGN was 7% to 12% and no concentration effects were noted.
Maltese: It-twaħħil tal-proteina għal PAGN kien ta' 7% sa 12% u ma kienu osservati l-ebda effetti fuq il-konċentrazzjoni.
English: RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
Maltese: RAVICTI għandu jintuża b'restrizzjoni tal-proteini fid-dieta u, f'xi każijiet, b'supplimenti tad-dieta (eż. aċidi amminiċi essenzjali, arginine, citrulline, supplimenti ta' kaloriji mingħajr proteini).
English: Dose adjustment and monitoring in adults and children:
Maltese: Aġġustament fid-doża u monitoraġġ f'adulti u tfal:
English: Each bottle contains 25 ml of liquid.
Maltese: Kull flixkun fih 25 ml ta' likwidu.
English: • if you are allergic to glycerol phenylbutyrate
Maltese: • jekk inti allerġiku għal glycerol phenylbutyrate
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni:jistgħu jaffettwaw sa persuna 1 minn kull 100
English: Supplemental amino acid formulations may be necessary to maintain essential amino acids and branched chain amino acids within normal range.
Maltese: Jaf ikunu meħtieġa formulazzjonijiet ta' ammino aċidi supplimentali biex jinżammu l-livelli ta' ammino aċidi essenzjali u branched chain amino acids fi ħdan il-medda normali.
English: Hyperammonemia may be induced by haloperidol and by valproic acid.
Maltese: Haloperidol u valproic acid jistgħu jinduċu iperammonemija.
English: Oral administration of glycerol phenylbutyrate during the period of organogenesis in rats and rabbits had no effects on embryo-foetal development at 2.7 and 1.9 times the dose in adult patients, respectively.
Maltese: L-għoti orali ta' glycerol phenylbutyrate matul il-perijodu ta' organoġenesi fil-firien u l-fniek ma kellu ebda effett fuq l-iżvilupp embrijo-fetali f'2.7 u 1.9 darbiet id-doża f'pazjenti adulti, rispettivament.
English: Uncommon Dysphonia, epistaxis, nasal congestion, oropharyngeal pain, throat irritation
Maltese: Disfonja, epistassi, konġestjoni nażali, uġigħ orofarinġali, irritazzjoni fil-griżmejn
English: Flatulence, diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, abdominal distension, constipation, oral discomfort, retching
Maltese: Gass, dijarea, rimettar, nawsja, uġigħ addominali, dispepsja, nefħa addominali, stitikezza, skumdità orali, tqalligħ
English: In adult UCD patients receiving multiple doses of glycerol phenylbutyrate, maximum plasma concentrations at steady state (Cmaxss) of PBA, PAA, and PAGN occurred at 8 h, 12 h, and 10 h, respectively, after the first dose in the day.
Maltese: F'pazjenti UCD adulti li kienu qegħdin jirċievu diversi dożi ta' glycerol phenylbutyrate, ilkonċetrazzjonijiet massimi fil-plażma fi stat fiss (Cmaxss) ta' PBA, PAA, u PAGN seħħew wara 8 sigħat, 12-il siegħa, u 10 sigħat, rispettivament, wara l-ewwel doża tal-jum.
English: ‘gastrostomy tube'
Maltese: X'fih RAVICTI
English: Compatibility studies have been conducted (see section 4.5).
Maltese: Twettqu studji dwar il-kompatibbiltà (ara sezzjoni 4.5).
English: • haloperidol - used to treat some mental health problems
Maltese: • haloperidol - użat biex jikkura xi problema tas-saħħa mentali
English: The upper bound of the one-sided 95% CI for the largest placeboadjusted, baseline-corrected QTc, based on individual correction method (QTcI) for glycerol phenylbutyrate, was below 10 ms, demonstrating that glycerol phenylbutyrate had no QT/QTc prolonging effect.
Maltese: L-upper bound tas-CI ta' 95% b'naħa waħda għall-akbar QTC korrett fillinja bażi, aġġustat skont il-plaċebo, ibbażat fuq metodu ta' korrezzjoni individwali (QTcI) għal glycerol phenylbutyrate, kien anqas minn 10 ms, u dan juri li glycerol phenylbutyrate ma kellu ebda effett ta' titwil fuq QT/QTc.
English: In vivo exposure to glycerol phenylbutyrate has resulted in decreased systemic exposure to midazolam of approximately 32% and increased exposure to the 1-hydroxy metabolite of midazolam, suggesting that steady-state dosing of glycerol phenylbutyrate results in CYP3A4 induction.
Maltese: L-espożizzjoni in vivo għal glycerol phenylbutyrate wasslet għal tnaqqis f'espożizzjoni sistemika għal midazolam ta' madwar 32% u żieda fl-espożizzjoni għall-metabolit 1-hydroxy ta' midazolam, li tissuġġerixxi li d-dożaġġ fi stat fiss ta' glycerol phenylbutyrate iwassal għal induzzjoni ta' CYP3A4.
English: Upon singledose administration of glycerol phenylbutyrate, plasma concentrations of PBA were quantifiable in 15 of 22 participants at the first sample time post dose (0.25 h).
Maltese: Wara għoti ta' doża waħda ta' glycerol phenylbutyrate, il-konċentrazzjonijiet ta' PBA fil-plażma kienu kwantifikabbli f'15 sa 22 parteċipanti fl-ewwel ħin tal-kampjun wara d-doża (0.25 siegħa).
English: Hyperammonemic crises were precipitated by vomiting, upper respiratory tract infection, gastroenteritis, decreased caloric intake or had no identified precipitating event (3 events).
Maltese: Kriżijiet iperammonemiċi kienu preċipitati minn rimettar, infezzjoni fl-apparat respiratorju ta' fuq, gastroenterite, tnaqqis fit-teħid ta' kaloriji jew ma kellhom l-ebda avveniment li ppreċipita identifikat (3 avvenimenti).
English: Preparation for nasogastric tube or gastrostomy tube administration: In vitro studies evaluating the percent recovery of total dose delivered with nasogastric, nasojejunal or gastrostomy tubes demonstrated the percent of dose recovered was > 99% for doses > 1 ml and 70% for a 0.5 ml dose.
Maltese: Studji in vitro li jevalwaw il-perċentwal ta' rkupru tad-doża totali mogħtija b'tubi nażogastriċi, nażoġeġunali jew gastrostomi wrew li l-perċentwal ta' doża rkuprata kien ta' > 99% għal dożi > 1 ml u 70% għal doża ta' 0.5 ml.
English: Clinical studies in paediatric patients with UCDs
Maltese: Studji kliniċi f'pazjenti pedjatriċi b'UCDs
English: It can be taken in the following ways:
Maltese: Nota importanti:
English: In 4 of the 5 subjects age < 1 month, possible risk factors included infectious precipitants, hyperammonaemic crisis at baseline, and missing dose.
Maltese: F'4 mill-5 individwi b'età ta' < xahar, ilfatturi ta' riskju possibbli kienu jinkludu preċipitanti infettivi, kriżi iperammonemika fil-linja bażi, u doża nieqsa.
English: Of the 49 paediatric patients who participated in these extension studies, 12 patients (25 %) reported a total of 17 hyperammonaemic crises during treatment with glycerol phenylbutyrate as compared with 38 crises in 21 patients (43 %) in the preceding 12 months prior to study entry, while they were being treated with sodium phenylbutyrate.
Maltese: Mid-49 pazjent pedjatriku li ħadu sehem f'dawn l-istudji ta' estensjoni, 12-il pazjent (25%) irrapportaw total ta' 17-il kriżi iperammonemika waqt il-kura bi glycerol phenylbutyrate meta mqabbla ma' 38 kriżi f'21 pazjent (43%) fit-12-il xahar preċedenti qabel id-dħul fl-istudju, waqt li kienu qed jiġu kkurati b'sodium phenylbutyrate.
English: • Utilise an oral syringe to withdraw the prescribed dosage of RAVICTI from the bottle.
Maltese: • Permezz tal-planġer tas-siringa orali, agħti RAVICTI fit-tubu.
English: Mean fasting venous ammonia values were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 17-25 micromol/L).
Maltese: Il-valuri medji tal-ammonja ġol-vina fi stat sajjem kienu fi ħdan il-limiti normali waqt kura fit-tul bi glycerol phenylbutyrate (medda: 17-25 mikromol/L).
English: Due to the rarity of the UCD population, and the small size of the medicinal product safety population database (N=114), the adverse reaction frequency for rare and very rare is not known.
Maltese: Minħabba r-rarità tal-popolazzjoni UCD, u d-daqs żgħir tad-database dwar is-sigurtà tal-prodott mediċinali (N=114), il-frekwenza ta' reazzjonijiet avversi għal 'rari' u 'mhux rari' mhijiex magħrufa.