FrancophonIA/ELRC3.0 huggingface dataset:
English: • Your daily dose will depend on your size and weight, the amount of protein in your diet, and your overall urea cycle disorder condition.
Slovenian: • Vaš dnevni odmerek bo odvisen od vaše višine in telesne mase, količine beljakovin v vaši prehrani in vašega splošnega stanja motnje ciklusa sečnine.
English: RAVICTI helps the body to eliminate waste nitrogen.
Slovenian: Zdravilo RAVICTI pomaga telesu izločiti odpadni dušik.
English: Patients should be advised to have a sufficient quantity of syringes on hand.
Slovenian: Bolniku je treba svetovati, naj ima vedno pri roki zadostno število brizg.
English: RAVICTI may have major influence on the ability to drive and use machines.
Slovenian: Zdravilo RAVICTI ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: • valproate - a medicine for epilepsy
Slovenian: • valproat - zdravilo za epilepsijo
English: Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients.
Slovenian: Odsotnost teh encimov ali prenašalcev povzroči kopičenje toksičnih ravni amoniaka v krvi in možganih bolnikov.
English: A potential effect on CYP2D6 isoenzyme cannot be excluded and caution is advised for patients who receive medicinal products that are CYP2D6 substrates.
Slovenian: Potencialnega učinka na izoencim CYP2D6 ni možno izključiti in pri bolnikih, ki prejemajo zdravila, ki so substrati CYP2D6, je potrebna previdnost.
English: EU/1/15/1062/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1062/001
English: However, the formation of mono- or bis-esters was not studied in humans.
Slovenian: Vendar pa tvorbe mono- ali bis estrov niso proučevali pri ljudeh.
English: • contraceptives
Slovenian: • kontracepcijska sredstva
English: Each gram of U-PAGN excreted over 24 hours covers waste nitrogen generated from 1.4 grams of dietary protein.
Slovenian: Vsak gram U-PAGN, ki se izloči v 24 urah, pokrije odpadni dušik, ki nastane iz 1,4 gramov prehranskih beljakovin.
English: After the first opening of the bottle, the medicinal product must be used within 14 days and the bottle and its contents discarded, even if not empty.
Slovenian: Po prvem odprtju steklenice je treba zdravilo porabiti v 14 dneh, steklenico in njeno vsebino pa nato zavreči, tudi če ni prazna.
English: • tests show abnormal ECG (‘electrocardiogram')
Slovenian: • preiskave, ki kažejo nenormalen EKG (elektrokardiogram)
English: • existing neurological conditions may get worse
Slovenian: • težave s pomnjenjem • obstoječe nevrološke težave se lahko poslabšajo
English: What RAVICTI is and what it is used for
Slovenian: Kaj je zdravilo RAVICTI in za kaj ga uporabljamo
English: If you forget a dose, take the missed dose as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek zdravila, ga zaužijte takoj, ko se spomnite.
English: Fertility (number of pregnant rats) was decreased by up to 25%, at a dose of 2.6 times the dose in adult patients.
Slovenian: Plodnost (število oplojenih podgan) se je zmanjšala do 25 % pri odmerku, ki je bil 2,6-krat večji od odmerka pri odraslih bolnikih.
English: • If you are a woman who could become pregnant, you must use an effective method of contraception, during treatment with RAVICTI.
Slovenian: • Če ste ženska v rodni dobi, morate v času zdravljenja z zdravilom RAVICTI uporabljati zanesljivo metodo kontracepcije.
English: Venous ammonia levels were monitored at a minimum of every 6 months.
Slovenian: Ravni amoniaka v venski krvi so spremljali vsaj vsakih 6 mesecev.
English: • Normally, the body turns the extra nitrogen in the protein into a waste compound called ‘ammonia'.
Slovenian: • Običajno telo spremeni odvečni dušik iz beljakovin v odpadno spojino, ki se imenuje amoniak.
English: Your doctor will tell you how to take RAVICTI oral liquid.
Slovenian: Zdravnik vam bo pojasnil, kako jemati peroralno tekočino RAVICTI.
English: • tests show prothrombin time is longer
Slovenian: • preiskave, ki kažejo podaljšan protrombinski čas
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines, which may be less effective when used with glycerol phenylbutyrate.
Slovenian: Še zlasti morate zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil, ki so morda manj učinkovita v kombinaciji z glicerol fenilbutiratom.
English: Multi-centre prospective non-interventional registry in patients with urea cycle disorders on treatment with glycerol phenylbutyrate to characterise patients` demographics, and to document long-term safety and clinical outcomes
Slovenian: Multicentričen prospektiven neintervencijski register bolnikov z motnjami ciklusa sečnine o zdravljenju z glicerol fenilbutiratom za karakterizacijo demografskih podatkov bolnikov in dokumentiranje dolgoročne varnosti in kliničnih izidov
English: Each bottle contains 25 ml of liquid.
Slovenian: Ena steklenica vsebuje 25 ml tekočine.
English: In infants and young children (generally below 6 years of age) where obtaining fasting ammonia is problematic due to frequent feedings, the first ammonia of the morning should be kept below the ULN.
Slovenian: Pri dojenčkih in mlajših otrocih (mlajših od 6 let), kjer je težko določiti raven amoniaka na tešče zaradi pogostega hranjenja, je treba raven amoniaka ob prvi jutranji meritvi vzdrževati pod ULN.
English: Preferably such patients should be started and maintained at the lowest dose necessary to control the blood ammonia levels.
Slovenian: Pri takšnih bolnikih je treba začeti in vzdrževati najmanjši odmerek, ki je potreben za nadzor ravni amoniaka v krvi.
English: Clear, colourless to pale yellow liquid.
Slovenian: Prozorna, brezbarvna do bledo rumena tekočina.
English: PAA and PBA represented minor urinary metabolites, each accounting for <1% of the administered dose of PBA.
Slovenian: PAA in PBA sta predstavljala manj zastopane presnovke v urinu, vsak < 1 % apliciranega odmerka PBA.
English: In case of overdose, the medicinal product should be discontinued and the patient monitored for any signs or symptoms of adverse reactions.
Slovenian: V primeru prevelikega odmerka prekinite zdravljenje z zdravilom in opazujete bolnika glede znakov in simptomov neželenih učinkov.
English: Remaining unused syringes should be kept for use with another bottle.
Slovenian: Preostale neuporabljene brizge shranite za uporabo z drugo steklenico.
English: However, dosing in UCD patients must be individualized based on the specific metabolic needs and residual enzyme capacity of the patient, irrespective of gender.
Slovenian: Odmerjanje pri bolnikih z UCD mora biti individualizirano in temeljiti na specifičnih presnovnih potrebah ter zmogljivosti preostalih encimov pri bolniku, ne glede na spol.
English: Valproic Acid and Haloperidol
Slovenian: Valprojska kislina in haloperidol
English: - You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Slovenian: - Zdraviti se boste morali celo življenje in se držati diete, razen v primeru uspešne presaditve jeter.
English: Also, tell your doctor if you are taking the following medicines as they may increase the amount of ammonia in your body or change how glycerol phenylbutyrate works:
Slovenian: Prav tako obvestite zdravnika, če jemljete naslednja zdravila, saj lahko le-ta zvišajo raven amoniaka v vašem telesu ali spremenijo delovanje glicerol fenilbutirata:
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.
Slovenian: V to študijo je bilo vključenih skupaj 45 pediatričnih bolnikov z UCD, starih od 1 do 17 let, ki so končali Študijo 2 in varnostna podaljška Študij 3 in 4.
English: Immedica Pharma AB SE-113 29 Stockholm Sweden
Slovenian: SE-113 29 Stockholm
English: This may be associated with increased risk of medicinal product interactions with lipase inhibitors and with lipase contained in pancreatic enzyme replacement therapies.
Slovenian: To je lahko povezano s povečanim tveganjem medsebojnih delovanj z zdravili, ki so zaviralci lipaze, in lipazo, ki se uporablja pri zdravljenju z nadomeščanjem pankreatičnih encimov.
English: The liver then removes ammonia from the body through a cycle called the ‘urea cycle'.
Slovenian: Jetra nato odstranijo amoniak iz telesa prek ciklusa, imenovanega ciklus sečnine.
English: The dose normalized mean AUC0-23h for PAA was 108% higher in females than in males.
Slovenian: Povprečna vrednost AUC0-23h PAA, normalizirana za odmerek, je bila 108 % višja pri ženskah kot pri moških.
English: Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
Slovenian: Uporaba kortikosteroidov lahko povzroči razgradnjo beljakovin v telesu in zviša ravni plazemskega amoniaka.
English: Contents of the pack and other information What RAVICTI contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo RAVICTI
English: On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion.
Slovenian: Na molarni osnovi PAGN, tako kot sečnina, vsebuje 2 molekuli dušika in predstavlja alternativni vehikel za izločanje odpadnega dušika.
English: • haloperidol - used to treat some mental health problems
Slovenian: • haloperidol - uporablja se za zdravljenje nekaterih težav z duševnim zdravjem
English: Patients should not drive or use machines whilst experiencing these side effects.
Slovenian: Bolniki naj ne vozijo ali upravljajo s stroji, dokler ti učinki ne prenehajo.
English: • bleeding between menstrual periods, acne, skin smells abnormal
Slovenian: • krvavitev med posameznimi menstruacijami, akne, nenormalen vonj kože
English: Ammonia levels should be closely monitored in patients with pancreatic insufficiency or intestinal malabsorption.
Slovenian: Ravni amoniaka je treba pri bolnikih s pankreatično insuficienco ali črevesno malabsorpcijo skrbno spremljati.
English: RAVICTI should not be used during pregnancy and in women of childbearing potential not using contraception unless the clinical condition of the woman requires treatment with glycerol phenylbutyrate, see section 4.6.
Slovenian: Zdravilo RAVICTI se ne sme uporabljati v času nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, razen če klinično stanje nosečnice zahteva zdravljenje z glicerol fenilbutiratom, glejte poglavje 4.6.
English: RAVICTI therapy may be required life long unless orthotopic liver transplantation is elected.
Slovenian: Zdravljenje z zdravilom RAVICTI je lahko potrebno celo življenje, če ne pride do odločitve za ortotopično presaditev jeter.
English: Therefore, it is recommended that nasogastric, nasojejunal or gastrostomy tubes only be used to administer doses > 1 ml.
Slovenian: Zato je priporočljivo, da se nazogastrične sonde, nazojejunalne sonde ali gastrostome uporabljajo samo za aplikacijo odmerkov > 1 ml.
English: Oral or gastroenteral use.
Slovenian: Za peroralno ali gastroenteralno uporabo.
English: This patient developed hyperammonemic crisis on day 6, and subsequently died of sepsis from peritonitis unrelated to drug.
Slovenian: Na 6. dan se je pri tem bolniku razvila hiperamoniemična kriza, nato pa je umrl za sepso zaradi peritonitisa, nepovezano z zdravilom.
English: Reversal of the pre-existing neurological impairment is unlikely following treatment and neurological deterioration may continue in some patients.
Slovenian: Ni verjetno, da bi po zdravljenju prišlo do izboljšanja obstoječih nevroloških motenj, pri nekaterih bolnikih se lahko slabšanje nevroloških stanj tudi nadaljuje.
English: For children: if the next dose is in less than 30 minutes, then skip it and give the next dose as normal.
Slovenian: Za otroke: če je naslednji odmerek na vrsti v manj kot 30 minutah, pozabljeni odmerek izpustite in normalno dajte naslednji odmerek.
English: RAVICTI should be prescribed by a physician experienced in the management of UCDs.
Slovenian: Zdravilo RAVICTI mora predpisati zdravnik, ki ima izkušnje z zdravljenjem UCD.
English: RAVICTI should be used with caution in patients with severe renal impairment.
Slovenian: Zdravilo RAVICTI je treba uporabljati previdno pri bolnikih s hudo okvaro ledvic.
English: Ask your doctor or pharmacist which type of syringes you need to obtain based on the prescribed dose volume.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom o tem, kakšen tip brizg potrebujete za dajanje svojega predpisanega odmerka.
English: Other medicinal products such as corticosteroids, valproic acid, haloperidol and probenecid may have the potential to affect ammonia levels, see section 4.4.
Slovenian: Druga zdravila, kot so kortikosteroidi, valprojska kislina, haloperidol in probenecid lahko potencialno vplivajo na ravni amoniaka; glejte poglavje 4.4.
English: The plasma PAA to PAGN (both measured in mcg/ml) ratio has been observed to be generally less than 1 in patients without PAA accumulation.
Slovenian: Razmerje med plazemsko PAA in PAGN (obe merjeni v μg/ml) je bilo na splošno manjše kot 1 pri bolnikih brez kopičenja PAA.
English: Venous ammonia levels were monitored monthly.
Slovenian: Ravni amoniaka v krvi so spremljali mesečno.
English: An open-label, long-term study (Study 5) was conducted to assess ammonia control in paediatric patients with UCD.
Slovenian: Izvedena je bila odprta dolgoročna študija (Študija 5) za ocenitev nadzora ravni amoniaka pri pediatričnih bolnikih z UCD.
English: • dry mouth, alteration of taste
Slovenian: • suha usta, sprememba okusa
English: The reclosable bottle cap should be discarded when the bottle is empty or after 14 days following opening even if the bottle is not empty.
Slovenian: Zamašek z nastavkom za brizgo je treba zavreči, ko je steklenica prazna, ali 14 dni po odprtju, tudi če steklenica ni prazna.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products ATC code: A16AX09
Slovenian: Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni prebavil in presnove, razna zdravila za zdravljenje bolezni prebavil in presnove, oznaka ATC: A16AX09
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: 1 x 25 ml bottle.
Slovenian: 1 x 25 ml steklenica
English: Once the bottle is open, you must use your medicine within 14 days of opening.
Slovenian: Po odprtju steklenice morate zdravilo porabiti v 14 dneh.
English: Tap the oral syringe to remove air bubbles, making sure you have filled it with the correct amount of liquid.
Slovenian: Potrkajte po peroralni brizgi, da odstranite zračne mehurčke, in se prepričajte, da ste jo napolnili s pravilno količino tekočine.
English: No precipitant trigger or missing dose was reported for the other 2 subjects (1 age < 1 month, 1 age 1-2- months).
Slovenian: Za druga 2 preizkušanca niso poročali o dejavniku sproženja ali izpuščenemu odmerku (1 starosti < 1 mesec, 1 starosti 1-2 meseca).
English: In 4 of the 5 subjects age < 1 month, possible risk factors included infectious precipitants, hyperammonaemic crisis at baseline, and missing dose.
Slovenian: Pri 4 od 5 preizkušancih, starih < 1 mesec, so možni dejavniki tveganja vključevali infekcijske sprožilce, hiperamoniemične krize ob izhodišču in izpuščeni odmerek.
English: • if you have problems with your pancreas, stomach or gut (‘intestines') - these organs are responsible for absorption of glycerol phenylbutyrate into the body.
Slovenian: • če imate težave s trebušno slinavko, želodcem ali prebavili - ti organi so odgovorni za absorpcijo glicerol fenilbutirata v telesu.
English: Patients were required to have a diagnosis of UCD involving deficiencies of CPS, OTC, or ASS, confirmed via enzymatic, biochemical, or genetic testing.
Slovenian: Bolniki so morali imeti potrjeno diagnozo motnje ciklusa sečnine, ki vključuje pomanjkanje CPS, OTC ali ASS, potrjene z encimskimi, biokemičnimi ali genetskimi preiskavami.
English: If you take more of this medicine than you should, talk to a doctor.
Slovenian: Če vzamete več zdravila, kot bi smeli, se morate takoj posvetovati z zdravnikom.
English: Turn the bottle upside down with the oral syringe still inserted.
Slovenian: Steklenico obrnite z glavo navzdol, pri čemer je peroralna brizga še vedno vstavljena.
English: The liquid is filled into a 25 ml clear glass bottle and capped with a plastic, child-resistant cap.
Slovenian: Tekočina je polnjena v 25 ml steklenico iz prozornega stekla, ki se zapre s plastičnim, za otroke varnim zapiralom.
English: • tests show low albumin in your blood
Slovenian: • preiskave, ki kažejo nizke vrednosti albumina v krvi
English: When taking glycerol phenylbutyrate you may feel dizzy or have a headache.
Slovenian: V času jemanja glicerol fenilbutirata ste lahko omotični ali imate glavobol.
English: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other medicinal product therapy.
Slovenian: Na splošno je treba pazljivo določiti odmerek za starejšega bolnika, pri čemer je treba začeti odmerjati pri spodnji meji razpona odmerjanja zaradi večje pogostosti zmanjšanega delovanja jeter, ledvic ali srca ali sočasnih bolezni ali zdravljenja z drugimi zdravili.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from glycerol phenylbutyrate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z glicerol fenilbutiratom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: • Hypersensitivity to the active substance.
Slovenian: • Preobčutljivost na učinkovino.
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.
Slovenian: Očistek PAA je bil 7,1 l,/h, 10,9 l/h, 16,4 l/h in 24,4 l/h, za bolnike z UCD starosti ≤ 2, 3 do 5, 6 do 11 in 12 do 17 let.
English: Glycerol phenylbutyrate given at the maximum recommended dose contains less than 0.5 g of glycerol per dose.
Slovenian: Glicerol Glicerol fenilbutirat pri največjem priporočenem odmerku vsebuje manj kot 0,5 g glicerola na odmerek.
English: After you take your full dose, have a drink of water to make sure no medicine is left in your mouth, or flush the gastrostomy or nasogastric tube with 10 ml of water using a new oral syringe.
Slovenian: Po zaužitju polnega odmerka zdravila popijte kozarec vode, da ne ostane kaj zdravila v ustih ali splaknite gastrostomo ali nazogastrično sondo z 10 ml vode in pri tem uporabite novo peroralno brizgo.
English: These findings collectively indicate that conversion of PAA to PAGN may be impaired in patients with severe hepatic impairment and that a plasma PAA to PAGN ratio > 2.5 identifies patients at risk of elevated PAA levels.
Slovenian: Ti izsledki skupaj nakazujejo, da je pretvorba PAA v PAGN lahko ovirana pri bolnikih s hudo okvaro jeter in da razmerje med plazemsko PAA in PAGN, ki znaša > 2,5, opredeljuje bolnike s tveganjem za povišane ravni PAA.
English: Wye Valley Business Park Brecon Road
Slovenian: Wye Valley Business Park
English: Hyperammonemic crises were precipitated by vomiting, upper respiratory tract infection, gastroenteritis, decreased caloric intake or had no identified precipitating event (3 events).
Slovenian: Hiperamoniemične krize so se pojavile po bruhanju, okužbi zgornjih dihal, gastroenteritisu, zmanjšanemu kaloričnemu vnosu ali pa pred tem ni bilo opredeljenih dogodkov (3 dogodki).
English: Do not stop taking glycerol phenylbutyrate without talking to your doctor.
Slovenian: Ne prenehajte jemati glicerol fenilbutirata brez predhodnega posveta z zdravnikom.
English: RAVICTI may have major influence on the ability to drive and use machines given that treatment with glycerol phenylbutyrate may cause dizziness or headaches (see section 4.8).
Slovenian: Zdravilo RAVICTI lahko ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji, saj lahko zdravljenje z glicerol fenilbutiratom lahko povzroči omotico ali glavobole (glejte poglavje 4.8).
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).
Slovenian: Ocena neželenih učinkov je temeljila na izpostavljenosti 114 bolnikov z UCD (65 odraslih in 49 otrok, starih od 2 mesecev do 17 let) s pomanjkanjem CPS, OTC, ASS, ASL, ARG ali s HHH v 4 kratkoročnih in 3 dolgoročnih kliničnih študijah, v katerih je 90 bolnikov zaključilo 12-mesečno obdobje (povprečna izpostavljenost = 51 tednov).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (STANDARD PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (STANDARDNO PAKIRANJE)
English: Although these have not been seen in clinical trials involving UCD patients, high PAA levels should be suspected in patients (particularly in children <2months) with unexplained somnolence, confusion, nausea and lethargy who have normal or low ammonia.
Slovenian: Čeprav te manifestacije niso bile opažene v kliničnih preskušanjih, ki so vključevala bolnike z UCD, je treba pri bolnikih (zlasti pri otrocih < 2 meseca) z nepojasnjeno somnolenco, zmedenostjo, slabostjo in letargijo, pri katerih je raven amoniaka normalna ali nizka, posumiti na visoke ravni PAA.
English: • increased temperature, hot flushes
Slovenian: • povišana telesna temperatura, vročinski oblivi
English: Neurotoxicity
Slovenian: Nevrotoksičnost
English: • Utilise an oral syringe to withdraw the prescribed dosage of RAVICTI from the bottle.
Slovenian: • Uporabite peroralno brizgo za odvzem predpisanega odmerka zdravila RAVICTI iz steklenice.
English: In healthy adult volunteers, a gender effect was found for all metabolites, with women generally having higher plasma concentrations of all metabolites than men at a given dose level.
Slovenian: Spol Pri zdravih odraslih prostovoljcih je bil učinek spola ugotovljen pri vseh presnovkih, pri čemer so ženske imele višje plazemske koncentracije vseh presnovkov kot moški pri določenem odmerku.
English: In such cases, increasing the dosing frequency may result in a lower plasma PAA level and PAA to PAGN ratio.
Slovenian: V takšnih primerih lahko zvišanje pogostosti odmerjanja posledično zniža raven plazemske PAA in razmerje med PAA in PAGN.
English: In healthy subjects, the systemic exposure to PAA, PBA, and PAGN increased in a dose dependent manner.
Slovenian: Pri zdravih preiskovancih se je sistemska izpostavljenost PAA, PBA in PAGN zvišala odvisno od velikosti odmerka.
English: UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+).
Slovenian: Motnje ciklusa sečnine so dedne okvare encimov ali prenašalcev, ki so potrebni za sintezo sečnine iz amoniaka (NH3, NH4+).
English: • Flush once with 10 ml of water or medical formula and allow the flush to drain after administration.
Slovenian: • Po aplikaciji sperite enkrat z 10 ml vode ali medicinskim pripravkom in pustite, da tekočina odteče.
English: The median exposure was 10 months (range 2 to 20 months).
Slovenian: Mediana izpostavljenosti je bila 10 mesecev (razpon 2 meseca do
English: The recommended daily dose schedule of 8.5 ml/m2/day - 11.2 mL/m2/day over a period of up to 24 hours for patients stabilised with no further hyperammonaemia is as follows:
Slovenian: Priporočeni načrt dnevnega odmerjanja 8,5 ml/m2/dan - 11,2 ml/m2/dan v do 24-urnem obdobju za stabilizirane bolnike, ki več nimajo hiperamoniemije, je