FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 49 children ages 2 months to 17 years with deficiencies of OTC, ASS, ASL, and ARG were enrolled, and all but 1 had been converted from sodium phenylbutyrate to glycerol phenylbutyrate.
Maltese: Total ta' 49 tifel u tifla li għandhom bejn xahrejn u 17-il sena b'defiċjenzi ta' OTC, ASS, ASL, u ARG ġew irreġistrati, u kollha ħlief wieħed kienu kkonvertiti minn sodium phenylbutyrate għal glycerol phenylbutyrate.
English: Consistent with plasma ammonia, blood glutamine levels were lower during glycerol phenylbutyrate treatment as compared with sodium phenylbutyrate in each arm of the crossover study (decrease of 44.3 ± 154.43 micromol/L after glycerol phenylbutyrate compared with NaPBA; p = 0.064, paired t-test; p = 0.048, Wilcoxon signed-rank test).
Maltese: B'mod konsistenti mal-ammonja fil-plażma, il-livelli ta' glutamine fid-demm kienu aktar baxxi matul il-kura bi glycerol phenylbutyrate meta mqabbla ma' sodium phenylbutyrate f'kull fergħa tal-istudju crossover (tnaqqis ta' 44.3 ± 154.43 mikromol/L wara li glycerol phenylbutyrate tqabbel ma' NaPBA; p = 0.064, test t imqabbel; p = 0.
English: • Each ml of liquid contains 1.1 g of glycerol phenylbutyrate.
Maltese: • Kull ml ta' likwidu fih 1.1 g ta' glycerol phenylbutyrate.
English: Glycerol phenylbutyrate is hydrolysed by pancreatic lipases to yield, PBA, which is converted by beta oxidation to PAA, the active moiety of glycerol phenylbutyrate.
Maltese: Glycerol phenylbutyrate huwa idrolizzat minn lipases pankreatiċi biex jipproduċi PBA, li huwa kkonvertit permezz ta' ossidazzjoni beta għal PAA, il-frazzjoni attiva ta' glycerol phenylbutyrate.
English: Each ml contains 1.1 g of glycerol phenylbutyrate.
Maltese: Kull ml fih 1.1 g ta' glycerol phenylbutyrate.
English: PAA conjugates with glutamine (which contains 2 molecules of nitrogen) via acetylation in the liver and kidneys to form PAGN, which is excreted by the kidneys.
Maltese: PAA jikkonjuga ma' glutamine (li fih 2 molekuli ta' nitroġenu) permezz ta' aċetilazzjoni fil-fwied u l-kliewi biex jifforma PAGN, li jiġi eliminat mill-kliewi.
English: Glycerol phenylbutyrate given at the maximum recommended dose contains less than 0.5 g of glycerol per dose.
Maltese: Glycerol phenylbutyrate mogħti fid-doża massima rakkomandata fih anqas minn 0.5 g ta' glycerol f'kull doża.
English: The mean peak ratio of PAA to PAGN in UCD patients aged birth to less than 2 months was higher (mean: 1.65; range 0.14 to 7.07) than for UCD patients aged 2 months to less than 2 years (mean 0.59; range 0.17 to 1.21).
Maltese: Il-medja tal-proporzjon massimu ta' PAA għal PAGN f'pazjenti b'UCD b'età mit-twelid sa inqas minn xaharejn kienet ogħla (medja: 1.65; firxa 0.14 sa 7.07) milli għall-pazjenti b'UCD b'età minn xaharejn sa inqas minn sentejn (medja 0.59; firxa 0.17 sa 1.21).
English: The recommended dosages for patients naïve to phenylbutyric acid and for patients switching from sodium phenylbutyrate or from sodium phenylacetate/sodium benzoate injection to RAVICTI are different.
Maltese: Dożaġġ inizjali f'pazjenti li jinqalbu minn injezzjoni ta' sodium phenylacetate/sodium benzoate għal RAVICTI:
English: Uncommon Back pain, joint swelling, muscle spasm, pain in extremity, plantar fasciitis
Maltese: Uġigħ fid-dahar, nefħa fil-ġogi, spażmi filmuskoli, uġigħ fl-estremitajiet, fasciitis plantar
English: • menstrual periods stop or are irregular, hoarse voice, nosebleeds, stuffy nose, sore or painful throat, hair loss, sweating more than usual, itchy rash, uneven heartbeat, reduced thyroid function
Maltese: • jieqfulek il-pirjids menstrwali jew ikunu irregolari, tkun maħnuq, tinfaraġ, imnieħrek misdud, uġigħ fil-griżmejn, telf ta' xagħar, tgħereq aktar mis-soltu, raxx bil-ħakk, taħbit tal-qalb irregolari, tnaqqis fil-funzjoni tat-tirojde
English: Nine patients successfully transitioned to RAVICTI within 4 days, followed by 3 days of observation for a total of 7 days, where successful transition was defined as no signs and symptoms of hyperammonemia and a venous ammonia value less than 100 micromol/L.
Maltese: Disa' pazjenti inqalbu b'suċċess għal RAVICTI fi żmien 4 ijiem, segwiti minn 3 ijiem ta' osservazzjoni għal total ta' 7 ijiem, fejn transizzjoni b'suċċess kienet definita bħala l-ebda sinjali u sintomi ta' iperammonemija u valur ta' ammonja fil-vini ta' inqas minn 100 mikromol/L.
English: Glycerol phenylbutyrate has been tested in a range of in vitro and in vivo genotoxicity studies, and shown no genotoxic activity.
Maltese: Glycerol phenylbutyrate ġie ttestjat f'firxa ta' studji ġenotossiċi in vitro u in vivo, u ma wera l-ebda attività ġenotossika.
English: Study 3 was 14 days in duration and Study 4 was 10 days in duration.
Maltese: L-istudju 3 dam 14-il jum u l-istudju 4 dam 10t ijiem.
English: If symptoms of vomiting, nausea, headache, somnolence, confusion, or sleepiness are present in the absence of high ammonia or other intercurrent illnesses, measure plasma PAA and plasma PAA to PAGN and consider reduction of glycerol phenylbutyrate dosage or increase the frequency of dosing if the PAA level exceeds 500 mcg/L and the plasma PAA to PAGN ratio exceeds 2.5.
Maltese: Jekk ikunu preżenti sintomi ta' rimettar, nawsja, uġigħ ta' ras, ħedla ta' ngħas, konfużjoni jew ngħas fin-nuqqas ta' livell għoli ta' ammonja jew mard ieħor fl-istess waqt, kejjel il-PAA fil-plażma u l-PAA għal PAGN fil-plażma u kkunsidra tnaqqis fid-dożaġġ ta' glycerol phenylbutyrate jew żid il-frekwenza ta' dożaġġ jekk il-livell ta' PAA jaqbeż 500 mcg/L u l-proporzjon ta' PAA għal PAGN fil-plażma jaqbeż 2.5.
English: Anaemia, Thrombocytosis
Maltese: Disturbi tad-demm u tas-sistema limfatika Anemija, Tromboċitożi
English: Open-Label Uncontrolled Extension Study in Adults A long-term (12-month), uncontrolled, open-label study (Study 2) was conducted to assess monthly ammonia control and hyperammonaemic crisis over a 12-month period.
Maltese: Twettaq studju open label, mhux ikkontrollat, fit-tul (12-il xahar) (Studju 2) biex jiġi vvalutat ilkontroll tal-ammonja u l-kriżi iperammonemika fuq perijodu ta' 12-il xahar.
English: • lipase inhibitors - used to treat obesity
Maltese: • inibituri ta' lipase - użati biex jikkuraw obeżità
English: In a juvenile rat study with daily oral dosing performed on postpartum day 2 through mating and pregnancy after maturation, terminal body weight was dose-dependently reduced in males and females, by up to 16% and 12% respectively.
Maltese: Fi studju fuq firien li għadhom żgħar b'dożaġġ orali ta' kuljum imwettaq fit-tieni jum wara l-ħlas sattgħammir u t-tqala wara l-maturazzjoni, il-piż tal-ġisem terminali tnaqqas skont id-doża fl-irġiel u nnisa, b'sa 16% u 12% rispettivament.
English: Adjustment based on plasma phenylacetate and phenylacetylglutamine Symptoms of vomiting, nausea, headache, somnolence, confusion, or sleepiness in the absence of high ammonia or intercurrent illness may be signs of phenylacetic acid (PAA) toxicity (see section 4.4, PAA toxicity).
Maltese: Aġġustament ibbażat fuq phenylacetate u phenylacetylglutamine fil-plażma Sintomi ta' rimettar, nawsja, uġigħ ta' ras, ħedla tan-ngħas, konfużjoni jew ngħas f'nuqqas ta' livell għoli ta' ammonja jew mard interkorrenti jistgħu jkunu sinjali ta' tossiċità minn phenylacetic acid (PAA) (ara sezzjoni 4.4, tossiċità PAA).
English: Concomitant use of medicinal products known to inhibit lipase should be given with caution as glycerol phenylbutyrate is hydrolysed by digestive lipase into phenylbutyrate acid and glycerol.
Maltese: L-użu konkomitanti ta' prodotti mediċinali magħrufa li jinibixxu lipase għandu jingħata b'kawtela peress li glycerol phenylbutyrate huwa idrolizzat permezz ta' lipase diġestiv f'phenylbutyrate acid u glycerol.
English: Upon oral administration, pancreatic lipases hydrolyse glycerol phenylbutyrate and release PBA. PBA undergoes β-oxidation to PAA, which is conjugated with glutamine in the liver and in the kidney through the enzyme phenylacetyl-CoA: Lglutamine- N-acetyltransferase to form PAGN.
Maltese: Aġġustament ibbażat fuq phenylacetylglutamine fl-awrina Il-kejl ta' U-PAGN jista' jintuża biex iservi bħala gwida fl-aġġustament tad-doża ta' glycerol phenylbutyrate u jivvaluta l-konformità.
English: You must follow a special low protein diet during treatment with glycerol phenylbutyrate.
Maltese: Dejjem trid issegwi dieta speċjali bi ftit proteini waqt il-kura bi glycerol phenylbutyrate.
English: Tabulated list of adverse reactions The adverse reactions are listed below, by system organ class and by frequency.
Maltese: Ir-reazzjonijiet avversi rrapportati huma mniżżla hawn taħt, skont is-sistema tal-klassifika tal-organi u skont il-frekwenza.
English: Although two patients had day 7 ammonia values of 150 micromol/L and 111 micromol/L respectively, neither had associated signs and symptoms of hyperammonemia.
Maltese: Għalkemm żewġ pazjenti kellhom valuri ta' ammonja f'jum 7 ta' 150 mikromol/L u 111-il mikromol/L rispettivament, ħadd minnhom ma kellu sinjali u sintomi assoċjati ta' iperammonemija.
English: On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion.
Maltese: Fuq bażi molari, PAGN, bħall-urea, fih 2 moles ta' nitroġenu u jipprovdi metodu alternattiv għat-tneħħija tan-nitroġenu żejjed mill-ġisem.
English: Hepatobiliary disorders
Maltese: Metrorraġija
English: Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3).
Maltese: Glycerol phenylbutyrate ma kellu ebda effett fuq il-fertilità jew il-funzjoni riproduttiva fil-firien irġiel u nisa (ara sezzjoni 5.3). M'hemm ebda dejta dwar il-fertilità fil-bniedem.
English: A total of 16 paediatric patients with UCDs aged less than 2 months participated in a long-term (24 months), uncontrolled, open-label study, of which 10 patients converted from sodium phenylbutyrate to RAVICTI.
Maltese: Total ta' 16-il pazjent pedjatriku b'UCDs b'età inqas minn xaharejn ipparteċipaw fi studju fit-tul (24 xahar), mhux ikkontrollat, open-label, li minnhom 10 pazjenti qalbu minn sodium phenylbutyrate għal RAVICTI.
English: Increased aspartate aminotransferase, alanine aminotransferase increased, increased anion gap, decreased lymphocyte count, decreased vitamin D Uncommon Blood potassium increased, blood triglycerides increased, electrocardiogram abnormal, low density lipoprotein increased, prothrombin time prolonged, white blood cell count increased, weight increased, weight decreased
Maltese: Żieda fl-aspartate aminotransferase, żieda fl-alanine aminotransferase, żieda fl-anion gap, tnaqqis fl-għadd tal-limfoċiti, tnaqqis fil-vitamina D
English: Additional adverse reactions have been evaluated in a clinical study including 16 UCD patients less than 2 months of age.
Maltese: Reazzjonijiet avversi addizzjonali ġew evalwati fi studju kliniku li kien jinkludi 16-il pazjent b'UCD b'età inqas minn xaharejn.
English: Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure.
Maltese: Flixkun tal-ħġieġ ċar, tat-Tip III, b'polyethylene ta' densità għolja (HDPE) li ma jistax jinfetaħ mit-tfal.
English: Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats at clinical exposure levels, however at oral doses up to approximately 7 times the dose in adult patients, maternal as well as male toxicity was observed and the number of nonviable embryos was increased.
Maltese: Glycerol phenylbutyrate ma kellu ebda effett fuq il-fertilità jew il-funzjoni riproduttiva fil-firien irġiel jew nisa f'livelli ta' espożizzjoni klinika, madankollu f'dożi orali sa madwar 7 darbiet id-doża f'pazjenti adulti, kienet osservata tossiċità fl-omm kif ukoll fl-irġiel u n-numru ta' embrijuni mhux vijabbli żdiedu.
English: B. PACKAGE LEAFLET (PL)
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Do not use RAVICTI after the expiry date which is stated on the carton and the bottle label after the letters “EXP”.
Maltese: Tużax RAVICTI wara d-data ta' meta jiskadi li tidher fuq il-kartuna u t-tikketta tal-flixkun wara l-ittri “EXP”.
English: In vitro studies evaluating the percent recovery of total dose delivered with nasogastric 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 jevalvaw il-peċentwal ta' rkupru tad-doża totali mogħtija b'tubi nażogastriċi jew gastrostomi wrew li l-perċentwal ta' doża rkuprata kienet ta' >99% għal dożi > 1 ml u madwar 70% għal doża ta' 0.5 ml.
English: Study in Children 2 Months to Less than 2 Years of Age A total of 10 paediatric patients with UCDs aged 2 months to less than 2 years participated in a long term (24 months) uncontrolled, open label study, of which 6 patients converted from sodium phenylbutyrate to RAVICTI and 1 patient converted from sodium phenylbutyrate and sodium benzoate.
Maltese: Studju fi Tfal b'Età minn Xaharejn sa Inqas minn Sentejn Total ta' 10 pazjenti pedjatriċi b'UCDs b'età minn xaharejn sa inqas minn sentejn ipparteċipaw fi studju fit-tul (24 xahar), mhux ikkontrollat, open-label, li minnhom 6 pazjenti inqalbu minn sodium phenylbutyrate għal RAVICTI u pazjent wieħed inqaleb minn sodium phenylbutyrate u sodium benzoate.
English: Initial dosage in patients switching from sodium phenylacetate/sodium benzoate injection to RAVICTI: Once stable with controlled ammonia, patients switching from sodium phenylacetate/sodium benzoate to RAVICTI should receive a dose of RAVICTI at the higher end of the treatment range (11.2 ml/m2/day) with measurements of plasma ammonia to guide further dosing.
Maltese: Ladarba stabbli b'ammonja kkontrollata, pazjenti li jinqalbu minn sodium phenylacetate/sodium benzoate għal RAVICTI għandhom jirċievu doża ta' RAVICTI fl-ogħla livell tal-firxa tat-trattament (11.2 ml/m2/jum) b'kejl tal-ammonja fil-plażma biex jiggwida aktar dożaġġ.
English: • increased number of platelets (tends to cause blood clot)
Maltese: • żieda fin-numru ta' plejtlits (tendenza li tikkawża embolu)
English: • If you are a woman who could become pregnant, you must use an effective method of contraception, during treatment with RAVICTI.
Maltese: • Jekk inti mara li tista' tinqabad tqila, trid tuża metodu ta' kontraċezzjoni effikaċi, waqt il-kura b'RAVICTI.
English: Amino acid level decreased Gamma-glutamyltransferase increased Hepatic enzyme increased Transaminases increased
Maltese: Tnaqqis fil-livell ta' aċidi amminiċi Żieda ta' gamma-glutamyltransferase Żieda tal-enzimi tal-fwied Żieda ta' transaminases Disturbi fil-metaboliżmu u n-nutrizzjoni Ipofaġija
English: Glycerol phenylbutyrate was non-inferior to sodium phenylbutyrate with respect to the 24-hour AUC for ammonia.
Maltese: Glycerol phenylbutyrate ma kienx inferjuri għal sodium phenylbutyrate fir-rigward ta' AUC fuq 24 siegħa għall-ammonja.
English: The pharmacokinetics of glycerol phenylbutyrate in patients with impaired renal function, including those with end-stage renal disease (ESRD) or those on haemodialysis, have not been studied.
Maltese: Il-farmakokinetika ta' glycerol phenylbutyrate f'pazjenti b'indeboliment fil-funzjoni tal-kliewi, inklużi dawk b'mard tal-kliewi fi stadju finali (ESRD) jew dawk fuq emodijaliżi, ma ġietx studjata.
English: Mean fasting venous ammonia values in adults in Study 2 were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 630 micromol/L).
Maltese: Il-valuri medji talammonja fid-demm fi stat sajjem fl-adulti fl-Istudju 2 kienu fi ħdan il-limiti normali matul kura fit-tul bi glycerol phenylbutyrate (medda: 6-30 mikromol/L).
English: RAVICTI can be added to a small amount of soft foods, such as ketchup, medical formulas, apple sauce or squash puree.
Maltese: RAVICTI jista' jiżdied ma' ammont żgħir ta' ikel artab, bħal ketchup, formoli mediċi, zalza tat-tuffieħ, jew puree tal-qargħa.
English: In healthy subjects, the systemic exposure to PAA, PBA, and PAGN increased in a dose dependent manner.
Maltese: F'individwi f'saħħithom, l-espożizzjoni sistemika għal PAA, PBA, u PAGN żdiedet skont id-doża.
English: Uncommon Abdominal discomfort, abnormal faeces, dry mouth, eructation, defaecation urgency, upper abdominal pain and/or lower abdominal pain, painful defaecation, steatorrhoea, stomatitis
Maltese: Skumdità addominali, ippurgar mhux normali, ħalq xott, tifwiq, urġenza biex tipporga, uġigħ fil-parti ta' fuq tal-addome u/jew fil-parti t'isfel tal-addome, ippurgar b'uġigħ, steatorea, stomatite
English: The incidence of the following tumours was also increased in female rats: thyroid follicular cell adenoma, carcinoma and combined adenoma or carcinoma, adrenal cortical combined adenoma or carcinoma, cervical schwannoma, uterine endometrial stromal polyp, and combined polyp or sarcoma.
Maltese: L-inċidenza tat-tumuri li ġejjin, żdiedet ukoll fil-firien nisa: adenoma taċ-ċelluli follikulari tat-tirojde, karċinoma u adenoma jew karċinoma kkombinati, adenoma jew karċinoma kkombinati adrenali kortikali, schwannoma ċervikali, polipi stromali endometrijali fl-utru, u polipi jew sarkoma kkombinati.
English: No PAA toxicity was observed in the subjects age < 2 months.
Maltese: Ma ġiet osservata l-ebda tossiċità ta' PAA f'individwi b'età ta' < xaharejn.
English: • Normally, the body turns the extra nitrogen in the protein into a waste compound called ‘ammonia'.
Maltese: • Normalment, il-ġisem jaqleb in-nitroġenu żejjed fil-proteina għal kompost żejjed imsejjaħ
English: • viral infection in the gut
Maltese: • infezzjoni virali fil-musrana
English: Further adjustment may be based on monitoring of plasma ammonia, glutamine, U-PAGN and/or plasma PAA and PAGN as well as the ratio of plasma PAA to PAGN (see section 4.2).
Maltese: Aġġustament ulterjuri jista' jkun ibbażat fuq ilmonitoraġġ tal-ammonja, glutamine, U-PAGN fil-plażma u/jew PAA u PAGN fil-plażma kif ukoll ilproporzjon ta' PAA ma' PAGN fil-plażma (ara sezzjoni 4.2).
English: Patients had to have no clinical evidence of hyperammonaemia at enrolment and were not allowed to receive medicinal products known to increase ammonia levels (e.g., valproate), increase protein catabolism (e.g., corticosteroids), or significantly affect renal clearance (e.g., probenecid).
Maltese: Il-pazjenti ma ried ikollhom l-ebda evidenza klinika ta' iperammonemija mar-reġistrazzjoni u ma tħallewx jirċievu prodotti mediċinali magħrufa li jżidu l-livelli ta' ammonja (eż. valproate), żieda fil-kataboliżmu tal-proteina (eż. kortikosterjodi), jew jaffettwaw b'mod sinifikanti t-tneħħija mill-kliewi (eż. probenecid).
English: • tests show higher triglycerides, low density lipo-protein or white cells in your blood
Maltese: • testijiet juru livell ogħla ta' trigliċeridi, lipo-proteina ta' densità baxxa jew ċelloli bojod fiddemm tiegħek
English: The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed.
Maltese: Ser ikollok tieħu din il-mediċina u ssegwi dieta speċjali bi ftit proteini tul ħajtek.
English: If spot U-PAGN concentrations fall below these levels, assess compliance with medicinal product and/or effectiveness of medicinal product administration (e.g., via feeding tube) and consider increasing the glycerol phenylbutyrate dose in compliant patients to achieve optimal ammonia control (within normal limit for patients under 2 years of age and less than half ULN in older patients when fasted).
Maltese: Jekk il-konċentrazzjonijiet ta' U-PAGN f'punti ta' ħin jaqgħu taħt dawn il-livelli, ivvaluta lkonformità mal-prodott mediċinali u/jew l-effikaċja tal-għoti tal-prodott mediċinali (eż. permezz ta' tubu għat-tmigħ) u kkunsidra li żżid id-doża ta' glycerol phenylbutyrate f'pazjenti konformi biex tilħaq kontroll ottimali tal-ammonja (fi ħdan il-limitu normali għal pazjenti li għandhom anqas minn sentejn u anqas minn nofs l-ULN f'pazjenti akbar fl-età meta jkunu fi stat sajjem).
English: The dose normalized mean AUC0-23h for PAA was 108% higher in females than in males.
Maltese: L-AUC0-23h medja normalizzata għad-doża għal PAA kienet 108% ogħla fin-nisa milli fl-irġiel.
English: Women of childbearing potential/contraception in males and females The use of RAVICTI in women of childbearing potential must be accompanied by the use of effective contraception (see section 4.4).
Maltese: Nisa li jistgħu joħorġu tqal/kontraċezzjoni fl-irġiel u n-nisa L-użu ta' RAVICTI fin-nisa li jista' jkollhom it-tfal irid jiġi akkumpanjat mal-użu ta' kontraċezzjoni effettiva (ara sezzjoni 4.4).
English: Venous ammonia levels were monitored at a minimum of every 6 months.
Maltese: Il-livelli ta' ammonja ġol-vini kienu mmonitorjati mill-inqas kull 6 xhur.
English: • if you have problems with your pancreas, stomach or gut (‘intestines') - these organs are responsible for absorption of glycerol phenylbutyrate into the body.
Maltese: • jekk għandek problemi bil-frixa, l-istonku jew il-musrana (‘intestini') tiegħek - dawn l-organi huma responsabbli għall-assorbiment ta' glycerol phenylbutyrate f'ġismek.
English: Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients.
Maltese: Anki waqt trattament bi glycerol phenylbutyrate, tista' sseħħ iperammonemija akuta inkluża enċefalopatija iperammonemika fi proporzjon ta' pazjenti.
English: Glycerol phenylbutyrate was found to be non-inferior to sodium phenylbutyrate with respect to ammonia control in both of these paediatric studies.
Maltese: Glycerol phenylbutyrate instab li mhuwiex inferjuri għal sodium phenylbutyrate fir-rigward talkontroll tal-ammonja f'dawn iż-żewġ studji pedjatriċi.
English: Paediatric population Posology is the same for adult and paediatric patients.
Maltese: Il-pożoloġija hija l-istess għal pazjenti adulti u pedjatriċi.
English: In an additional long term (24 month), uncontrolled, open-label clinical study the safety of RAVICTI has been evaluated in 16 UCD patients less than 2 months of age and 10 pediatric patients with UCDs aged 2 months to less than 2 years.
Maltese: Fi studju kliniku addizzjonali fit-tul (24 xahar), mhux ikkontrollat, open-label, is-sigurtà ta' RAVICTI ġiet evalwata f'16-il pazjent b'UCD b'età inqas minn xaharejn u 10 pazjenti pedjatriċi b'UCDs b'età minn xaharejn sa inqas minn sentejn.
English: Skin and subcutaneous tissue disorders
Maltese: Dwar id-disturbi fiċ-ċiklu tal-urea
English: In the pooled analysis of studies where patients switched from sodium phenylbutyrate to glycerol phenylbutyrate, ammonia AUC0-24h was 774.11 and 991.19 [(micromol/L)*hour] during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 80, ratio of geometric means 0.84; 95% confidence intervals 0.740, 0.949).
Maltese: [(mikromol/L)*siegħa] matul ittrattament bi glycerol phenylbutyrate u sodium phenylbutyrate, rispettivament (n = 80, proporzjon talmedji ġeometriċi 0.84; intervalli ta' kunfidenza ta' 95% 0.740, 0.949).
English: • tests show increased liver enzyme levels, imbalance of salts in the blood, low levels of a type of white blood cell (‘lymphocytes') or low levels of vitamin D
Maltese: • it-testijiet juru żieda fil-livelli ta' enzimi fil-fwied, żbilanċ ta' melħ fid-demm, livelli baxxi ta' tip ta' ċelloli bojod tad-demm ('limfoċiti') jew livelli baxxi ta' vitamina D
English: • increased temperature, hot flushes
Maltese: • żieda fit-temperatura, fwawar ta' sħana
English: However, maternal toxicity and adverse effects on embryo-foetal development including reduced foetal weights and cervical ribs were observed in a rat study with a dose approximately 6 times the dose in adult patients, based on combined AUCs for PBA and PAA.
Maltese: Madankollu, kienet osservata tossiċità fl-omm u effetti avversi fuq l-iżvilupp embrijo-fetali inkluż tnaqqis fil-piż tal-fetu u kustilji ċervikali fi studju fuq il-firien b'doża ta' madwar 6 darbiet id-doża f'pazjenti adulti, abbażi ta' AUCs ikkombinati għal PBA u PAA.
English: Clinical studies of RAVICTI did not include sufficient numbers of subjects ≥ 65 years of age to determine whether they respond differently than younger subjects.
Maltese: L-istudji kliniċi ta' RAVICTI ma kinux jinkludu numru biżżejjed ta' individwi ≥ 65 sena ta' età biex jiġi determinat jekk dawn jirrispondux b'mod differenti minn individwi iżgħar fl-età.