FrancophonIA/ELRC3.0 huggingface dataset:
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Maltese: Fis-seba' studju, pazjenti b'ċikatriċi fil-fwied iżda b'funzjoni stabbli tal-fwied (ċirrożi kompensata) li kellhom l-infezzjoni ta' ġenotip 1b ġew ikkurati b'Exviera u b'Viekirax mingħajr ribavirin u 100 % talpazjenti (60 minn 60 pazjent) tneħħielhom il-virus mid-demm.
English: When Viekirax was given with dasabuvir, the virus was cleared from the blood in 91% of the patients.
Maltese: Meta Viekirax ingħata ma' dasabuvir biss, il-virus tneħħa mid-demm f'91 % tal-pazjenti.
English: Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.
Maltese: Viekirax dejjem jintuża flimkien ma' mediċini oħrajn għal epatite Ċ kronika, bħal dasabuvir u ribavirin.
English: Several varieties (genotypes) of hepatitis C virus exist, and Viekirax is recommended for patients with virus of genotypes 1a, 1b and 4.
Maltese: Jeżistu bosta varjetajiet (ġenotipi) tal-virus tal-epatite Ċ, u Viekirax huwa rrakkomandat għal pazjenti b'virus ta' ġenotipi 1a, 1b u 4.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Viekirax in combination with dasabuvir was effective in clearing the virus from the blood.
Maltese: F'6 studji ewlenin tal-bidu li involvew madwar 2,300 pazjent infettati bil-virus tal-epatite Ċ ta' ġenotip 1a jew 1b, Viekirax flimkien ma' dasabuvir kien effettiv fit-tneħħija tal-virus mid-demm.
English: How does Viekirax work?
Maltese: Kif jaħdem Viekirax?
English: Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Maltese: Viekirax huwa mediċina antivirali li tintuża flimkien ma' mediċini oħrajn biex tikkura adulti b'epatite Ċ kronika (fit-tul), marda infettiva tal-fwied ikkawżata mill-virus tal-epatite Ċ.
English: In patients with liver scarring, Viekirax treatment in combination with dasabuvir and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Maltese: F'pazjenti b'ċikatriċi tal-fwied, il-kura b'Viekirax flimkien ma' dasabuvir u ribavirin irriżultat f'rata ta' eliminazzjoni ta' bejn 93% u 100% wara 24 ġimgħa ta' kura.
English: How is Viekirax used?
Maltese: Kif jintuża Viekirax?
English: The European Medicines Agency noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Maltese: L-Aġenzija Ewropea għall-Mediċini nnotat li Viekirax flimkien ma' mediċini oħrajn huwa effettiv biex ineħħi l-virus tal-epatite Ċ ta' ġenotipi 1a, 1b u 4, inkluż f'pazjenti b'ċikatriċi tal-fwied.
English: An additional study showed Viekirax to be effective against genotype 4: when given with ribavirin, Viekirax cleared this genotype from the blood of all the 91 patients infected with it after 12 weeks.
Maltese: Studju addizzjonali wera li Viekirax kien effettiv kontra l-ġenotip 4: meta mogħti ma' ribavirin, Viekirax neħħa dan il-ġenotip mid-demm tal-91 pazjent li kienu kollha infettati bih wara 12-il ġimgħa.
English: The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 5 people) are tiredness and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Viekirax flimkien ma' dasabuvir u ribavirin (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma għeja u dardir (tħossok li se tirremetti).
English: Viekirax must not be used in patients with moderate to severe liver impairment and in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Maltese: Viekirax m'għandux jintuża f'pazjenti b'indeboliment tal-fwied moderat sa gravi u f'nisa li jkunu qed jieħdu ethinylestradiol, estroġenu li jinsab f'kontraċettivi ormonali.
English: For the full list of side effects and restrictions of Viekirax, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Viekirax, ara l-fuljett ta' tagħrif.
English: Although there were some cases of raised liver enzymes in patients treated with Viekirax in combination with dasabuvir and ribavirin, side effects with this combination were generally well tolerated.
Maltese: Għalkemm kien hemm xi każijiet ta' enzimi tal-fwied għoljin f'pazjenti kkurati b'Viekirax flimkien ma' dasabuvir u ribavirin, l-effetti sekondarji li dehru b'din il-kombinazzjoni kienu ġeneralment ittollerati sew.
English: The clearance rate was particularly high in patients infected with genotypes 1b and 4.
Maltese: Ir-rati ta' tneħħija kienu partikolarment għoljin f'pazjenti infettati b'ġenotipi 1b u 4.
English: This slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.
Maltese: Din tirrallenta t-tneħħija ta' paritaprevir millġisem, b'hekk tippermetti lil paritaprevir biex jaġixxi kontra l-virus aktar fit-tul.
English: The combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus infecting the patient, the nature of the patient's liver problems, for example if they have liver cirrhosis (scarring) or their liver is not working properly, and whether they have received previous treatment.
Maltese: Il-kombinazzjoni ta' mediċini użati u t-tul tal-kura tiddependi millġenotip tal-virus tal-epatite Ċ li jkun qed jinfetta lill-pazjent, in-natura tal-problemi tal-fwied talpazjent, pereżempju jekk ikollhom ċirrożi fil-fwied (ċikatriċi) jew il-fwied tagħhom ma jkunx qed jaħdem sew, u jekk irċevewx kura qabel.
English: The company that markets Viekirax will carry out a study in patients who have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Viekirax.
Maltese: Il-kumpanija li tqiegħed Viekirax fis-suq se tagħmel studju fuq pazjenti li kellhom kanċer tal-fwied sabiex tevalwa r-riskju li jirritorna l-kanċer tal-fwied wara kura b'antivirali b'azzjoni diretta bħal Viekirax.
English: As for all medicines, data on the use of Viekirax are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Viekirax hija ssorveljata kontinwament.
English: Total (N=16)
Maltese: (N=16)
English: Total (N=10)
Maltese: (N=10)
English: Unimedic AB Storjordenvägen 2 SE-864 31 Matfors Sweden
Maltese: Unimedic AB Storjordenvägen 2 SE-864 31 Matfors L-Iżvezja
English: Valproic Acid and Haloperidol
Maltese: Valproic Acid u Haloperidol
English: • Hypersensitivity to the active substance.
Maltese: • Sensittività eċċessiva għas-sustanza attiva.
English: • lipase in pancreatic replacement therapies
Maltese: • lipase f'terapiji ta' sostituzzjoni pankreatika
English: • tests show abnormal ECG (‘electrocardiogram')
Maltese: • testijiet juru ECG anormali (“elettrokardjogramma”)
English: Hereford, Herefordshire, HR3 5PG United Kingdom
Maltese: Hereford, Herefordshire, HR3 5PG Ir-Renju Unit
English: 1 x 25 ml bottle.
Maltese: 1 x 25 ml flixkun.
English: RAVICTI is a pro-drug of PBA.
Maltese: RAVICTI huwa pro-mediċina ta' PBA.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products ATC code: A16AX09
Maltese: Prodotti oħrajn tal-passaġġ alimentari u tal-metaboliżmu, diversi prodotti tal-passaġġ alimentari u tal-metaboliżmu Kodiċi ATC: A16AX09
English: Date of first authorisation: 27 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Novembru 2015
English: • contraceptives
Maltese: • kontraċettivi
English: • valproate - a medicine for epilepsy
Maltese: • valproate - mediċina għall-epilessija
English: RAVICTI 1.1 g/ml oral liquid
Maltese: RAVICTI 1.1 g/ml likwidu orali
English: • The active substance is glycerol phenylbutyrate.
Maltese: • Is-sustanza attiva hi glycerol phenylbutyrate.
English: Oral liquid.
Maltese: U KONTENUT Likwidu orali.
English: Uncommon Gastrointestinal viral infection
Maltese: Infezzjoni virali gastrointestinali
English: EU/1/15/1062/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1062/001
English: RAVICTI 1.1 g/ml oral liquid Glycerol phenylbutyrate
Maltese: RAVICTI 1.1 g/ml likwidu orali Glycerol phenylbutyrate
English: Mean maximum concentration (Cmax) for PBA, PAA, and PAGN was 37.0 micrograms/ml, 14.9 micrograms/ml, and 30.2 micrograms/ml, respectively.
Maltese: Il-konċentrazzjoni medja massima (Cmax) għal PBA, PAA, u PAGN kienet 37.0 mikrogramma/ml, 14.9 mikrogramma/ml, u 30.2 mikrogramma/ml, rispettivament.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE RAVICTI
English: The UCDs include 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).
Maltese: UCDs jinkludu 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.
English: The mean (SD) percentage of administered PBA eliminated as PAGN was approximately 68.9% (17.2) in adults and 66.4% (23.9) in paediatric UCD patients at steady state.
Maltese: Il-perċentwal medju (SD) ta' PBA mogħti li ġie eliminat bħala PAGN kien ta' madwar 68.9% (17.2) fl-adulti u 66.4% (23.9) fil-pazjenti UCD pedjatriċi fi stat fiss.
English: Dietary protein is approximately 16% nitrogen by weight.
Maltese: Il-proteina fid-dieta hija madwar 16% nitroġenu mill-piż.
English: The length of study participation ranged from 0.2 to 5.9 years.
Maltese: It-tul talparteċipazzjoni fl-istudju kien ivarja minn 0.2 sa 5.9 snin.
English: Fertility (number of pregnant rats) was decreased by up to 25%, at a dose of 2.6 times the dose in adult patients.
Maltese: Il-fertilità (numru ta' firien tqal) tnaqqset b'sa 25%, f'doża ta' 2.6 darbiet id-doża fil-pazjenti adulti.
English: Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza hija definita bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Uncommon Confusional state, depressed mood
Maltese: Stat konfuż, burdata depressa
English: 1 (6.3%) each
Maltese: 1 (6.3%) kull wieħed
English: • Place the tip of the oral syringe onto the tip of the gastrostomy/nasogastric tube.
Maltese: • Poġġi l-ponta tas-siringa orali fil-ponta tat-tubu gastrostomu/nażogastriku.
English: UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+).
Maltese: UCDs huma defiċjenzi li jintirtu ta' enzimi jew trasportaturi meħtieġa għas-sintesi tal-urea millammonja (NH3, NH4+).
English: Pharmacological effects
Maltese: Effetti farmakoloġiċi
English: • Step 2: 50% dose sodium phenylacetate/sodium benzoate and 100% RAVICTI for 4-8 hours;
Maltese: • It-tieni pass: 50% tad-doża ta' sodium phenylacetate/sodium benzoate u 100% ta' RAVICTI għal 4-8 sigħat;
English: Oral or gastroenteral use.
Maltese: Użu orali jew għas-sistema gastroenterali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (STANDARD PACK)
Maltese: KARTUNA TA' BARRA (PAKKETT STANDARD)
English: • Urea cycle disorders are rare.
Maltese: • Disturbi fiċ-ċiklu tal-urea huma rari.
English: In in vitro studies, the specific activity of lipases for glycerol phenylbutyrate was seen in the following decreasing order: pancreatic triglyceride lipase, carboxyl ester lipase, and pancreatic lipase-related protein 2.
Maltese: Fi studji in vitro, l-attività speċifika ta' lipases għal glycerol phenylbutyrate kienet osservata fl-ordni dejjem tonqos kif ġej: lipase tat-trigliċeridi pankreatiċi, carboxyl ester lipase, u proteina 2 relatata mal-lipase pankreatiku.
English: Assay sensitivity was confirmed by significant QTc prolongation of the positive control, moxifloxacin.
Maltese: Is-sensittività tal-assaġġ kienet ikkonfermata b'titwil sinifikanti fil-QTc tal-kontroll pożittiv, moxifloxacin.
English: In a study in patients with clinically decompensated cirrhosis and hepatic encephalopathy (Child-Pugh B and C), mean Cmax of PAA was 144 mcg/ml (range: 14-358 mcg /ml) after daily dosing of 6 ml of glycerol phenylbutyrate twice daily, while mean Cmax of PAA was 292 mcg /ml (range: 57-655 mcg/ml) after daily dosing of 9 ml of glycerol phenylbutyrate twice daily.
Maltese: Fi studju f'pazjenti b'ċirrosi klinikament mhux ikkumpensata (Child-Pugh B u C), is-Cmax medju ta' PAA kien 144 mcg/ml (medda: 14-358 mcg/ml) wara dożaġġ ta' kuljum ta' 6 ml, filwaqt li s-Cmax medju ta' PAA kien 292 mcg/ml (medda: 57-655 mcg/ml) wara dożaġġ ta' kuljum ta' 9 ml ta' glycerol phenylbutyrate darbtejn kuljum.
English: Clinical studies in adult patients with UCDs
Maltese: Studiji kliniċi f'pazjenti adulti b'UCD
English: This may be associated with increased risk of medicinal product interactions with lipase inhibitors and with lipase contained in pancreatic enzyme replacement therapies.
Maltese: Dan jista' jkun assoċjat ma' żieda fir-riskju ta' interazzjonijiet tal-prodotti mediċinali ma' inibituri ta' lipase u ma' lipase inklużi f'terapiji ta' sostituzzjoni tal-enzima pankreatika.
English: In vitro, the extent of human plasma protein binding for 14C-labeled metabolites was 80.6% to 98.0% for PBA (over 1-250 microgram/ml), and 37.1% to 65.6% for PAA (over 5-500 microgram /ml).
Maltese: 6% sa 98.0% għal PBA (aktar minn 1-250 mikrogramma/ml), u 37.1% sa 65.6% għal PAA (aktar minn 5-500 mikrogramma/ml).
English: In healthy subjects, after administration of 4 ml, 6 ml, and 9 ml 3 times daily for 3 days, the ratio of mean AUC0-23h of PAA to PAGN was 1, 1.25, and 1.6, respectively.
Maltese: F'individwi f'saħħithom, wara l-għoti ta' 4 ml, 6 ml, u 9 ml 3 darbiet kuljum għal 3 ijiem, il-proporzjon tal-AUC0-23h medja ta' PAA ma' PAGN kien 1, 1.25, u 1.6, rispettivament.
English: Non-interventional post-authorisation safety study (PASS):
Maltese: Studju dwar is-sigurtà wara l-awtorizzazzjoni mhux intervenzjonali (PASS - Noninterventional post-authorisation safety study):
English: • midazolam and barbiturates - used for sedation, trouble sleeping or epilepsy
Maltese: • midazolam u barbiturati - użati għal sedazzjoni, problemi fl-irqad jew epilessija
English: The most frequently reported adverse reactions (>5%) during glycerol phenylbutyrate treatment were diarrhoea, flatulence, and headache (8.8% each); decreased appetite (7.0%), vomiting (6.1%); and fatigue, nausea and, skin odour abnormal (5.3% each).
Maltese: L-aktar reazzjonijiet avversi (>5%) irrapportati b'mod frekwenti waqt il-kura bi glycerol phenylbutyrate kienu dijarea, gass, u uġigħ ta' ras (8.8% kull waħda); tnaqqis fl-aptit (7.0%), rimettar (6.1%); u għeja, nawsja u, riħa anormali tal-ġilda (5.3% kull waħda).
English: • Step 1: 100% dose sodium phenylacetate/sodium benzoate and 50% dose of RAVICTI for 4-8
Maltese: • L-ewwel pass: 100% tad-doża ta' sodium phenylacetate/sodium benzoate u 50% tad-doża ta' RAVICTI għal 4-8 sigħat;
English: Glycerol phenylbutyrate was not tumourigenic at doses up to 1000 mg/kg/day in a 26-week mouse study.
Maltese: Glycerol phenylbutyrate ma kienx tumuroġeniku f'dożi sa 1000 mg/kg/jum fi studju fuq firien ta' 26 ġimgħa.
English: Following 4 ml of glycerol phenylbutyrate for 3 days (3 times a day [TID]), mean Cmax and AUC were 66 mcg/ml and 930 mcg•h/ml for PBA and 28 microgram /ml and 942 mcg•h/ml for PAA,
Maltese: Wara 4 ml ta' glycerol phenylbutyrate għal 3 ijiem (3 darbiet kuljum [TID]), is-Cmax u l-AUC medji kienu 66 mcg/ml u 930 mcg•siegħa/ml għal PBA u 28 mikrogramma /ml u 942 mcg•siegħa/ml għal PAA, rispettivament.
English: Monitoring and laboratory tests
Maltese: Monitoraġġ u testijiet fil-laboratorju
English: For data regarding pharmacodynamic and pharmacokinetic properties in this age group, see sections 5.1 and 5.2.
Maltese: Għal data dwar il-kwalitajiet farmakodinamiċi u farmakokinetiċi f'dan il-grupp ta' età, ara sezzjonijiet 5.1 u 5
English: Metrorrhagia Uncommon Amenorrhoea, irregular menstruation
Maltese: Amenorrea, mestrwazzjoni irregolari
English: • Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate powder (g) x 0.81
Maltese: • Dożaġġ totali ta' kuljum ta' RAVICTI (ml) = dożaġġ totali ta' kuljum ta' trab ta' sodium phenylbutyrate (g) x 0.81
English: Other medicines and RAVICTI
Maltese: Mediċini oħra u RAVICTI
English: • 7 ml/m2/day (8 g/m2/day) in patients with a BSA ≥ 1.3 m2
Maltese: • 7 ml/m2/jum (8 g/m2/jum) f'pazjenti b'BSA < 1.3 m2
English: • 5000 microgram (mcg/ml) for patients >2 years of age with a BSA of >1.3
Maltese: • 5000 mikrogramma (mcg/ml) għal pazjenti b'età ta' > sentejn b'BSA ta' >1.3
English: • 8.5 ml/m2/day (9.4 g/m2/day) in patients with a body surface area (BSA) < 1.3 m2
Maltese: • 8.5 ml/m2/jum (9.4 g/m2/jum) f'pazjenti b'erja tas-superfiċje tal-ġisem (BSA) < 1.3 m2
English: The medicinal product may be mixed with medical formulas (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree and Citrulline) and used within 2 hours when stored at 25° C, or up to 24 hours, refrigerated.
Maltese: Il-prodott mediċinali jista' jitħallat ma' formoli mediċi (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree u Citrulline) u jintuża fi żmien sagħtejn meta jinħażen f'temperatura ta' 25°C, jew sa 24 siegħa, fil-friġġ.
English: Adverse reactions reported in more paediatric than adult patients during long-term treatment with glycerol phenylbutyrate included upper abdominal pain (3 of 49 paediatric [6.1%] versus 1 of 51 adults [2.0%] and increased anion gap (2 of 49 paediatric [4.1%] versus 0 of 51 adults [0%].
Maltese: Reazzjonijiet avversi rrapportati f'aktar pazjenti pedjatriċi milli adulti matul kura fit-tul bi glycerol phenylbutyrate kienu jinkludu uġigħ fl-addome fin- ta' fuq (3 minn 49 pazjent pedjatriku [6.1%] meta mqabbel ma' 1 minn 51 adult [2.0%] u żieda fl-anion gap (2 minn 49 pazjent pedjatriku [4.1%] meta mqabbel ma' 0 minn 51 adult [0%].
English: Of the 45 paediatric patients participating in the open-label treatment with glycerol phenylbutyrate, 11 patients (24%) reported a total of 22 hyperammonemic crises.
Maltese: Mill-45 pazjent pedjatriku li kienu qed jipparteċipaw fit-trattament openlabel bi glycerol phenylbutyrate, 11-il pazjent (24%) irrappurtaw total ta' 22 kriżi ta' iperammonja.
English: • 7000 microgram (mcg/ml) for patients >2 years of age with a BSA of ≤1.3
Maltese: • 7000 mikrogramma (mcg/ml) għal pazjenti b'età ta' > sentejn b'BSA ta' ≤1.3
English: • nail ridging
Maltese: TAGĦRIF
English: − Note: If possible, use the oral syringe ml size that is nearest to (but not smaller than) the recommended dose (for example, if the dose is 0.8 ml, use a 1 ml oral syringe).
Maltese: - Nota: Jekk ikun possibbli, uża d-daqs ml tas-siringa orali li huwa l-eqreb (iżda mhux iżgħar minn) għad-doża rakkomandata (pereżempju, jekk id-doża hija 0.8 ml, uża siringa orali ta' 1 ml).
English: RAVICTI contains the active substance ‘glycerol phenylbutyrate' which is used to treat six known ‘urea cycle disorders' (UCDs) in adults and children.
Maltese: RAVICTI fih is-sustanza attiva ‘glycerol phenylbutyrate' li tintuża biex tikkura sitt ‘disturbi fiċ-ċiklu tal-urea' (UCDs - urea cycle disorders) magħrufa f'adulti u tfal.
English: The mean normalized venous ammonia values in pediatric patients aged less than 2 months were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 35 to 94 micromol/L).
Maltese: Il-valuri medji normalizzati ta' ammonja fil-vini f'pazjenti pedjatriċi b'età inqas minn xaharejn kienu fil-limiti normali waqt trattament fit-tul bi glycerol phenylbutyrate (firxa: 35 sa 94 mikromol/L).
English: The recommended total daily dose of RAVICTI is based on body surface area and ranges from 4.5 ml/m2/day to 11.2 ml/m2/day [5.3 g/m2/day to 12.4 g/m2/day) and should take into account the following:
Maltese: Id-doża totali ta' kuljum rakkomandata ta' RAVICTI hija bbażata fuq l-erja tas-superfiċje tal-ġisem u tvarja minn 4.5 ml/m2/jum sa 11.2 ml/m2/jum [5.3 g/m2/jum sa 12.4 g/m2/jum) u għandu jitqies dan li ġej:
English: Mean blood glutamine levels were also non-significantly lower after glycerol phenylbutyrate treatment compared with sodium phenylbutyrate treatment by -45.2 ± 142.94 micromol/L (p = 0.135, paired ttest; p = 0.114, Wilcoxon signed-rank test).
Maltese: Il-livelli medji ta' glutamine fid-demm kienu aktar baxxi b'mod mhux sinifikanti wara l-kura bi glycerol phenylbutyrate meta mqabbel mal-kura b'sodium phenylbutyrate -45.2 ± 142.94 mikromol/L (p = 0.135, test t imqabbel; p = 0.114, test signed-rank ta' Wilcoxon).
English: Each gram of U-PAGN excreted over 24 hours covers waste nitrogen generated from 1.4 grams of dietary protein.
Maltese: Kull gramma ta' U-PAGN li titneħħa fuq perijodu ta' 24 siegħa tkopri n-nitroġenu ġġenerat minn 1.4 grammi ta' proteina fid-dieta.
English: The effect of multiple doses of glycerol phenylbutyrate 13.2 g/day and 19.8 g/day (approximately 69% and 104% of the maximum recommended daily dosage) on QTc interval was evaluated in a randomised, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment-arm, crossover study in 57 healthy subjects.
Maltese: L-effett ta' diversi dożi ta' glycerol phenylbutyrate 13.2 g/jum u 19.8 g/jum (madwar 69% u 104% tad-dożaġġ massimu rakkomandat ta' kuljum) fuq l-intervall QTc kien evalwat fi studju crossover, b'erba' fergħat ta' kura, b'kontroll attiv (moxifloxacin 400 mg) u bi plaċebo, randomizzat, f'57 individwu f'saħħithom.
English: In healthy female volunteers, mean Cmax for PAA was 51% and 120% higher than in male volunteers after administration of 4 ml and 6 ml 3 times daily for 3 days, respectively.
Maltese: F'voluntiera nisa f'saħħithom, is-Cmax medju għall-PAA kien 51% u 120% ogħla milli f'voluntiera rġiel wara l-għoti ta' 4 ml u 6 ml 3 darbiet kuljum għal 3 ijiem, rispettivament.
English: Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with the following foods and nutritional supplements: apple sauce, ketchup, squash puree, and five medical formulas (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree and Citrulline) typically consumed by UCD patients (see section 4.2).
Maltese: L-istudji ta' kompatibbiltà urew li l-istabbiltà kimika u fiżika waqt l-użu ta' glycerol phenylbutyrate mal-ikel u s-supplimenti nutrizzjonali li ġejjin: zalza tat-tuffieħ, ketchup, puree tal-qargħa, u ħames formoli mediċi oħrajn (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree u Citrulline) li huma tipikament ikkunsmati minn pazjenti UCD (ara sezzjoni 4.2).
English: Final study report expected end of July 2030.
Maltese: Rapport finali tal-istudju mistenni flaħħar ta' Lulju 2030.
English: Mean 24-hour AUCs for venous ammonia during steady-state dosing were 866 micromol/L*hour and 977 micromol/L*hour with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 44, ratio of geometric means 0.91; 95% confidence intervals 0.799, 1.034).
Maltese: 24 siegħa għall-ammonja ġol-vina waqt id-dożaġġ fi stat fiss kienu 866 mikromol/L*siegħa u 977 mikromol/L*siegħa bi glycerol phenylbutyrate u sodium phenylbutyrate, rispettivament (n = 44, proporzjon ta' medji ġeometriċi 0.91; intervalli ta' kunfidenza ta' 95% 0.799, 1.034).