FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Ud af 51 voksne patienter, som deltog i studie 2, rapporterede 7 patienter (14 %) i alt 10 hyperammoniæmiske kriser under behandling med glycerolphenylbutyrat sammenlignet med 9 patienter (18 %), som havde rapporteret i alt 15 kriser under behandling med natriumphenylbutyrat i de 12 måneder forud for studieinklusion.
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.
Danish: Reduceret absorption af phenylbutyrat ved pancreasinsufficiens eller intestinal malabsorption Eksokrine pancreasenzymer hydrolyserer glycerolphenylbutyrat i tyndtarmen og spalter den aktive del, phenylbutyrat, fra glycerol.
English: • corticosteroids - used to treat inflamed areas of the body
Danish: • kortikosteroider - anvendes til behandling af inflammation (betændelseslignende tilstande) i kroppen
English: Pharmacological effects
Danish: Farmakologisk virkning
English: The syringe used to flush the gastrostomy or nasogastric tube shall not be used for measuring the dose of RAVICTI to avoid introduction of water into the medicinal product.
Danish: For at undgå at der kommer vand i lægemidlet, skal sprøjten der bruges til at gennemskylle gastrostomisonden eller den nasogastriske sonde ikke bruges til afmåling af doser af RAVICTI.
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).
Danish: De gennemsnitlige glutaminniveauer i blodet var ligeledes ikke-signifikant lavere efter behandling med glycerolphenylbutyrat sammenlignet med natriumphenylbutyrat med -45,2 ± 142,94 mikromol/l (p = 0,135, parret t-test; p = 0,114, Wilcoxon-test).
English: The RAVICTI pack contains the medicinal product and a reclosable bottle cap adapter.
Danish: RAVICTI-pakningen indeholder lægemidlet og en genlukkelig lågadapter.
English: Important note: Do not add or stir RAVICTI into larger volumes of liquid such as water or juice as the introduction of water causes glycerol phenylbutyrate to degrade.
Danish: Vigtigt: Bland ikke RAVICTI med større mængder væske, såsom vand eller juice, da vand forårsager nedbrydning af glycerolphenylbutyrat.
English: • Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate powder (g) x 0.81
Danish: • Samlet daglig dosis RAVICTI (ml) = samlet daglig dosis natriumphenylbutyrat-pulver (g) x
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.
Danish: Et langvarigt (12-måneders), ukontrolleret åbent studie (studie 2) blev udført for at vurdere månedlig ammoniakkontrol og hyperammoniæmisk krise i løbet af en periode på 12 måneder.
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.
Danish: Den anbefalede dosis til patienter, som ikke tidligere er blevet behandlet med phenylbutansyre, og til patienter, som skifter fra natriumphenylbutyrat eller fra injektion med natriumphenylacetat/natriumbenzoat til RAVICTI, er forskellig.
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
Danish: • menstruationer stopper eller er uregelmæssige, hæs stemme, næseblod, tilstoppet næse, øm hals eller ondt i halsen, hårtab, svedtendens, kløende udslæt, uregelmæssige hjerteslag (puls), nedsat funktion af skjoldbruskkirtlen
English: • reflux of stomach contents
Danish: • tilbageløb af maveindhold
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).
Danish: Overensstemmende med ammoniak i plasma var glutamin-niveauet i blodet lavere under behandling med glycerolphenylbutyrat sammenlignet med natriumphenylbutyrat i hver behandlingsgruppe i overkrydsningsforsøget (reduktion på 44,3 ± 154,43 mikromol/l efter glycerolphenylbutyrat sammenlignet med natriumphenylbutyrat; p = 0,064, parret t-test; p = 0,048, Wilcoxon-test).
English: Based on prescribed dosing volume, patients should be advised to obtain CE marked oral syringes with suitable size for the dosage and compatible with the reclosable bottle cap adapter from the pharmacy.
Danish: Patienterne skal adviseres om at anskaffe CE-mærkede orale sprøjter af en størrelse, der passer til den ordinerede dosis og som er kompatible med den genlukkelige lågadapter, fra apoteket.
English: • Step 3: sodium phenylacetate/sodium benzoate discontinued and full dose RAVICTI
Danish: • Trin 3: seponering af natriumphenylacetat/natriumbenzoat og fuld dosis af RAVICTI
English: Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3).
Danish: Glycerolphenylbutyrat havde ingen indvirkning på fertilitet eller reproduktion hos han- og hunrotter (se pkt.
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.
Danish: I et separat studie hos patienter med nedsat leverfunktion (Child-Pugh B og C) var ratioen mellem middelværdierne af PAA og PAGN mellem 0,96 og 1,28 for alle patienter, som fik en dosis på 6 ml og 9 ml to gange dagligt, og mellem 1,18 og 3,19 for patienter, som fik 9 ml to gange dagligt.
English: Tightly close the tethered tab on the reclosable bottle adapter after use.
Danish: Sæt omhyggeligt den tøjrede hætte på adapteren efter brug.
English: Two patients were treatment naïve and one additional patient was gradually discontinued from intravenous sodium benzoate and sodium phenylacetate while RAVICTI was initiated.
Danish: To patienter var behandlingsnaive og hos 1 yderligere patient blev intravenøs natriumbenzoat og natriumphenylacetat gradvist seponeret, mens RAVICTI blev påbegyndt.
English: • contraceptives
Danish: • præventionsmidler
English: Constipation Diarrhoea
Danish: Forstoppelse Diarré
English: • feeling disorientated
Danish: • desorientering
English: Impairment of fertility
Danish: Påvirkning af fertilitet
English: CE marked oral syringes compatible with the reclosable bottle cap adapter can be obtained from a pharmacy.
Danish: CE-mærkede orale sprøjter kompatible med den genlukkelige lågadapter kan fås på apoteket.
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
Danish: Ikke almindelig Forhøjet kalium i blodet, forhøjede triglycerider i blodet, unormalt elektrokardiogram, forhøjet low density lipoprotein, forlænget protrombintid, forhøjet leukocyttælling, vægtstigning, vægttab
English: • lipase inhibitors - used to treat obesity
Danish: • lipase-hæmmere - anvendes til at behandle fedme
English: Intact glycerol phenylbutyrate was not detectable in plasma in UCD patients.
Danish: Der blev ikke detekteret uomdannet glycerolphenylbutyrat i plasma hos UCDpatienter.
English: The plasma PAA to PAGN ratio may be useful in dosage monitoring.
Danish: Plasma-PAA:PAGN-ratioen kan være nyttig ved dosisovervågning (se pkt.
English: Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by pancreatic lipases.
Danish: Efter oral indtagelse frigøres PBA fra glycerol-skelettet i mavetarm-kanalen af pancreaslipaser.
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.
Danish: PAA, den aktive metabolit af glycerolphenylbutyrat, er forbundet med tegn og symptomer på neurotoksicitet (se pkt.
English: Twist the reclosable bottle cap adapter onto the bottle.
Danish: Drej den lukbare adapter på flasken.
English: 1 reclosable bottle cap adapter.
Danish: 1 lukbar adapter
English: In order to ensure correct dosing of RAVICTI, CE-marked oral syringes with suitable size for the dosage and compatible with the reclosable bottle cap adapter can be obtained from the pharmacy.
Danish: For at sikre korrekt dosering af RAVICTI kan du på apoteket købe CE-mærkede orale sprøjter i en størrelse, der passer til din dosis, og som er kompatible med den lukbare adaptor til flaskelåget.
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).
Danish: Kliniske studier hos pædiatriske patienter med UCD'er Virkningen af glycerolphenylbutyrat hos pædiatriske patienter i alderen fra 2 måneder til 17 år, som havde defekter i OTC, ASS, ASL eller ARG, blev evalueret i 2 åbne studier med fastlagt rækkefølge og skift fra natriumphenylbutyrat til ækvivalent dosis glycerolphenylbutyrat (studie 3 og 4).
English: ADRs in patients 2 months to less than 2 years of age
Danish: Udslæt Bivirkninger hos patienter i alderen 2 måneder til under 2 år
English: The reclosable bottle cap adapter can be used until the bottle is empty.
Danish: Adapteren bruges, indtil flasken er tom.
English: Hyperammonemia may be induced by haloperidol and by valproic acid.
Danish: Valproinsyre og haloperidol kan inducere hyperammoniæmi.
English: • stomach bloating or pain, constipation, diarrhoea, heartburn, wind, feeling sick (nausea), pain in the mouth, retching
Danish: • oppustethed eller mavesmerter, forstoppelse, diarré, halsbrand, luft i maven, kvalme, smerter i munden, opkastningsfornemmelser
English: The daily dose should be individually adjusted according to the patient's estimated urea synthetic capacity, if any, amino acid profile, protein tolerance and the daily dietary protein intake needed to promote growth and development.
Danish: Den daglige dosis skal justeres individuelt i henhold til patientens estimerede urinstofsyntesekapacitet, om nogen, aminosyreprofil, proteintolerance og den daglige proteinindtagelse gennem kosten, som er nødvendig for at fremme vækst og udvikling.
English: Abnormal skin odour, acne Uncommon Alopecia, hyperhidrosis, pruritic rash
Danish: Almindelig Unormal lugt fra huden, acne Ikke almindelig Alopeci, hyperhidrose, kløende udslæt
English: Cardiac electrophysiology
Danish: Elektrofysiologisk påvirkning af hjertet
English: • 7000 microgram (mcg/ml) for patients >2 years of age with a BSA of ≤1.3
Danish: • 7.000 mikrogram/ml for patienter >2 år med BSA ≤1,3
English: Women of childbearing potential/contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential (see section 4.6).
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Kvinder i den fertile alder skal anvende sikker kontraception (se pkt.
English: • 5000 microgram (mcg/ml) for patients >2 years of age with a BSA of >1.3
Danish: • 5.000 mikrogram/ml for patienter >2 år med BSA >1,3
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).
Danish: Gennemsnitlige 24-timers-AUC'er for venøs ammoniak ved steady state dosering var 866 mikromol/l•time og 977 mikromol/l•time for hhv. glycerolphenylbutyrat og natriumphenylbutyrat (n = 44, forhold mellem de geometriske middelværdier 0,91; 95 % konfidensinterval 0,799; 1,034).
English: Uncommon Abdominal discomfort, abnormal faeces, dry mouth, eructation, defaecation urgency, upper abdominal pain and/or lower abdominal pain, painful defaecation, steatorrhoea, stomatitis
Danish: Ikke almindelig Abdominalt ubehag, unormal afføring, mundtørhed, ructus, afføringstrang, smerter i øvre og/eller nedre abdomen, smerter ved afføring, steatoré, stomatitis
English: About urea cycle disorders
Danish: Om urinstofcyklus-defekter
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).
Danish: I den puljede analyse af forsøg, hvor patienter skiftede fra natriumphenylbutyrat til glycerolphenylbutyrat, var ammoniak-AUC0-24t 774,11 og 991,19 [(mikromol/l)•time] ved behandling med hhv. glycerolphenylbutyrat og natriumphenylbutyrat (n = 80, forhold mellem de geometriske middelværdier 0,84; 95 % konfidensinterval 0,740; 0,949).
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).
Danish: I den puljede analyse af de kortvarige studier med børn (studie 3 og studie 4) var plasma-ammoniak signifikant lavere efter skift til glycerolphenylbutyrat; ammoniak AUC0-24t var 626,79 og 871,72 (mikromol/l)∙time under behandling med hhv. glycerolphenylbutyrat og natriumphenylbutyrat (n = 26, forhold mellem de geometriske middelværdier 0,79; 95 % konfidensinterval 0,647, 0,955).
English: • Step 1: 100% dose sodium phenylacetate/sodium benzoate and 50% dose of RAVICTI for 4-8
Danish: • Trin 1: 100 % dosis af natriumphenylacetat/natriumbenzoat og 50 % dosis af RAVICTI i
English: • gallbladder, bladder or back pain
Danish: • galdeblære-, blære- eller rygsmerter
English: How to take RAVICTI
Danish: Sådan skal du tage RAVICTI
English: Flatulence, diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, abdominal distension, constipation, oral discomfort, retching
Danish: Almindelig Flatulens, diarré, opkastning, kvalme, abdominalsmerter, dyspepsi, oppustethed, forstoppelse, orale gener, opkastningsfornemmelse
English: Place the tip of the oral syringe into the reclosable bottle cap adapter.
Danish: Anbring spidsen af den orale sprøjte i adapteren.
English: The daily dose should be individually adjusted according to the patient's estimated urea synthetic capacity, if any, protein tolerance and the daily dietary protein intake needed to promote growth and development.
Danish: Den daglige dosis skal justeres individuelt i henhold til den skønnede kapacitet af patientens urinstofsyntese, om nogen, patientens proteintolerance samt den daglige proteinindtagelse, som er nødvendig for patientens vækst og udvikling.
English: A new reclosable bottle cap adapter should be used for each new bottle that is opened.
Danish: En ny adapter skal anvendes, hver gang en ny flaske åbnes.
English: Respiratory, thoracic and mediastinal disorder
Danish: Luftveje, thorax og mediastinum
English: Dizziness, headache, tremor Uncommon Dysgeusia, lethargy, paraesthesia, psychomotor hyperactivity, somnolence, speech disorder
Danish: Almindelig Svimmelhed, hovedpine, tremor Ikke almindelig Dysgeusi, letargi, paræstesi, psykomotorisk hyperaktivitet, døsighed, taleforstyrrelse Ikke almindelig Konfusion, sænket stemningsleje
English: However, for adults, if the next dose is in less than 2 hours, then skip it and take your next dose as normal.
Danish: Hvis du har glemt at tage en dosis, skal du tage den glemte dosis, så snart du husker det. For voksne gælder, at hvis den næste dosis er om mindre end 2 timer, skal du springe den over og tage den næste dosis som normalt.
English: RAVICTI must be used with a special low protein diet. - This diet will be designed for you by your doctor and dietician.
Danish: - Denne kostplan vil blive sammensat til dig af din læge og diætist.
English: • burping, stomach ache, changes in your stools such as being oily, urgent need for bowel movements, painful bowel movements
Danish: • bøvsen, mavesmerter, ændringer i afføringen såsom olieret afføring, afføringstrang, smerter ved afføring
English: If U-PAGN excretion is insufficient to cover daily dietary protein intake and the fasting ammonia is greater than half the recommended ULN, the glycerol phenylbutyrate dose should be adjusted upward.
Danish: Hvis U-PAGN-udskillelsen er utilstrækkelig til at redegøre for den daglige proteinindtagelse i kosten, og det fastende ammoniakniveau er højere end halvdelen af anbefalet ULN, skal glycerolphenylbutyrat-dosen justeres op. Ved dosisjustering skal der tages hensyn til mængden af protein i kosten, som ikke er blevet dækket, angivet som U-PAGN-niveauet over et døgn, samt den estimerede nødvendige dosis glycerolphenylbutyrat pr. gram protein i kosten.
English: • Utilising the plunger of the oral syringe, administer RAVICTI into the tube.
Danish: • Administrér lægemidlet ved at bruge stemplet i den orale sprøjte til at sprøjte RAVICTI ind i sonden.
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.
Danish: I det samme studie var gennemsnitlig Cmax og AUC hhv. 100 mikrogram/ml og 1.400 mikrogram•time/ml for PBA og 65 mikrogram/ml og 2.064 mikrogram•time/ml for PAA efter 6 ml glycerolphenylbutyrat i 3 dage (3 gange daglig).
English: Uncommon Back pain, joint swelling, muscle spasm, pain in extremity, plantar fasciitis
Danish: Ikke almindelig Rygsmerter, hævede led, muskelspasmer, ekstremitetssmerter, plantar fasciitis
English: Diarrhoea,
Danish: Diarré
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.
Danish: PBA gennemgår β-oxidation til PAA, som konjugeres med glutamin i leveren og nyrerne af enzymet phenylacetyl-CoA: Lglutamin-N-acetyltransferase og danner PAGN.
English: • Each ml of liquid contains 1.1 g of glycerol phenylbutyrate.
Danish: • Hver ml væske indeholder 1,1 g glycerolphenylbutyrat.
English: Mean venous ammonia values in paediatric patients in Study 5 were within normal limits during long-term (24 months) treatment with glycerol phenylbutyrate (range: 1525 micromol/L).
Danish: De gennemsnitlige venøse ammoniakværdier hos pædiatriske patienter i studie 5 lå inden for normalgrænsen under langtidsbehandlingen (24 måneder) med glycerolphenylbutyrat (interval 15-25 mikromol/l).
English: Recommended starting dosage in phenylbutyrate-naïve patients:
Danish: Anbefalet begyndelsesdosis til patienter, som ikke tidligere er blevet behandlet med phenylbutyrat:
English: Each ml contains 1.1 g of glycerol phenylbutyrate.
Danish: Hver ml indeholder 1,1 g glycerolphenylbutyrat.
English: Uncommon Gallbladder pain
Danish: Ikke almindelig Blæresmerter
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).
Danish: Den gennemsnitlige, normaliserede venøse ammoniakværdi hos pædiatriske patienter under 2 måneder var inden for de normale grænser under langtidsbehandling med glycerolphenylbutyrat (interval: 35-94 mikromol/l).
English: Mean fasting venous ammonia values were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 17-25 micromol/L).
Danish: De gennemsnitlige fastende venøse ammoniakværdier lå inden for normalgrænsen under den langvarige behandling med glycerolphenylbutyrat (interval 17-25 mikromol/l).
English: The ratio of mean values for PAA to PAGN among all patients dosed with 6 ml BID ranged from 0.96 to 1.28 and for patients dosed with 9 ml twice daily ranged from 1.18-3.19.After multiple doses, a PAA concentration >200 mcg/L was associated with a ratio of plasma PAA to PAGN concentrations higher than 2.5.
Danish: Ratioen mellem gennemsnitsværdierne af PAA og PAGN lå i intervallet 0,96-1,28 for alle patienter, doseret med 6 ml 2 gange daglig, og i intervallet 1,18-3,19 for patienter, doseret med 9 ml to gange dagligt.
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).
Danish: De gennemsnitlige fastende venøse ammoniakværdier hos voksne i studie 2 lå inden for normalgrænsen under den langvarige behandling med glycerolphenylbutyrat (interval 6-30 mikromol/l).
English: Do not rinse the reclosable bottle cap or the oral syringe between daily doses, as the presence of water causes glycerol phenylbutyrate to degrade.
Danish: Skyl ikke den lukbare adapter eller den orale sprøjte mellem de daglige doser, da tilstedeværelsen af vand kan forårsage nedbrydning af glycerolphenylbutyrat.
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,
Danish: 66 mikrogram/ml og 930 mikrogram•time/ml 28 mikrogram/ml for PBA og 942 mikrogram•time/ml for PAA.
English: In healthy subjects, intact glycerol phenylbutyrate was not detected in plasma.
Danish: Der blev ikke detekteret uomdannet glycerolphenylbutyrat i plasma hos raske forsøgspersoner.
English: Uncommon Dysphonia, epistaxis, nasal congestion, oropharyngeal pain, throat irritation
Danish: Ikke almindelig Dysfoni, næseblod, næsetilstopning, orofaryngeale smerter, halsirritation
English: Important note: Do not rinse the reclosable bottle cap adapter or the oral syringe between daily doses as the introduction of water causes glycerol phenylbutyrate to degrade.
Danish: Vigtigt: Skyl ikke adapteren eller den orale sprøjte mellem de daglige doser, da vand forårsager nedbrydning af glycerolphenylbutyrat.
English: Do not rinse the reclosable bottle cap adapter or the oral syringe between daily doses as the introduction of water causes glycerol phenylbutyrate to degrade.
Danish: Skyl ikke adapteren eller den orale sprøjte mellem de daglige doser, da vand forårsager nedbrydning af glycerolphenylbutyrat.
English: Each ml of liquid contains 1.1g of glycerol phenylbutyrate.
Danish: Hver ml væske indeholder 1,1 g glycerolphenylbutyrat.
English: Close the tab on the reclosable bottle cap adapter.
Danish: Sæt hætten på den lukbare adapter.
English: Saturation of conjugation of PAA and glutamine to form PAGN was suggested by increases in the ratio of plasma PAA to PAGN with increasing dose and with increasing severity of hepatic impairment.
Danish: Stigning i plasma-PAA:PAGN-ratioen med stigende doser og med stigende sværhedsgrad af nedsat leverfunktion antyder mætning af PAA-glutamin-konjugeringen til dannelse af PAGN.