FrancophonIA/ELRC3.0 huggingface dataset:
English: In MTX-controlled studies, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 0.6% compared to 0.4% in the MTX group.
Slovenian: V študijah, nadzorovanih z MTX, je bila pogostnost resnih okužb v 12/14 tednih v skupini, ki je prejemala monoterapijo s 15 mg upadacitiniba, 0,6 % in v skupini z MTX 0,4 %.
English: e nominal p≤0.001 upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison
Slovenian: e p z nadzorovano multipliciteto ≤ 0,001 za primerjavo upadacitiniba s placebom ali MTX.
English: CPK elevations > 5 x upper limit of normal (ULN) were reported in 1.0% and 0.3% of patients over 12/14 weeks in the upadacitinib 15 mg and placebo groups, respectively.
Slovenian: O zvišanju CPK na > 5-krat nad zgornjo normalno mejo (ZNM) so v obdobju 12/14 tednov poročali pri 1,0 % bolnikov, ki so prejemali
English: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, posaconazole, voriconazole, and clarithromycin).
Slovenian: Sočasna uporaba z zaviralci CYP3A4 Med sočasno uporabo z močnimi zaviralci CYP3A4 (kot so npr. ketokonazol, itrakonazol,
English: • Upadacitinib 15 mg
Slovenian: • 15 mg upadacitiniba
English: • Risk of MACE o Language on the increased risk of MACE in RA patients and the need to consider typical CV risk factors (e.g., hypertension, hyperlipidaemia) when treating RA patients o Language on the risk of MACE during treatment with upadacitinib o Language on the risk of hyperlipidaemia during upadacitinib therapy o Details on monitoring of lipid levels and management of elevated lipid levels per clinical guidelines
Slovenian: • Tveganje za pomembne neželene srčno-žilne dogodke (MACE) o informacije o povečanem tveganju za nastanek srčno-žilnih bolezni pri bolnikih z revmatoidnim artritisom in o potrebi po upoštevanju tipičnih srčno-žilnih dejavnikov tveganja (npr. hipertenzija, hiperlipidemija) pri bolnikih z revmatoidnim artritisom,
English: How to store RINVOQ
Slovenian: Shranjevanje zdravila RINVOQ
English: Treatment should be temporarily interrupted if drug-induced liver injury is suspected
Slovenian: Zdravljenje je treba prekiniti, če se AŠL zmanjša na
English: o Language on the risk of VTE during treatment with upadacitinib o Language on need for discontinuation of upadacitinib, evaluation, and appropriate treatment for VTE if clinical features of deep venous thrombosis or pulmonary embolism develop
Slovenian: • Tveganje za vensko tromboembolijo (VTE) o primeri dejavnikov tveganja, ki pri bolniku lahko povečajo tveganje za VTE in je zato pri teh bolnikih potrebna previdnost pri uporabi upadacitiniba, o informacije o tveganju za VTE med zdravljenjem z upadacitinibom, o informacije o potrebnem prenehanju uporabe upadacitiniba, ovrednotenju in ustreznem zdravljenju VTE, če se razvijejo klinični znaki globoke venske tromboze ali pljučne embolije.
English: Fertility
Slovenian: Manitol
English: - Keep this leaflet.
Slovenian: Pogoltnite jih cele.
English: In methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group.
Slovenian: V študijah, nadzorovanih z metotreksatom (MTX), je bila pogostnost okužb v 12/14 tednih v skupini, ki je prejemala monoterapijo s 15 mg upadacitiniba, 19,5 % in v skupini z
English: AbbVie Logistics B.V Zuiderzeelaan 53
Slovenian: AbbVie Logistics B.V.
English: Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.
Slovenian: Pri bolnikih s hudo (Child-Pugh C) okvaro jeter upadacitinib ni raziskan.
English: • Guide for healthcare professionals
Slovenian: • Vodnik za zdravstvene delavce • Opozorilno kartico za bolnika
English: You will need blood tests before you start taking RINVOQ, or while you are taking it.
Slovenian: Pred začetkom jemanja zdravila RINVOQ ali med jemanjem tega zdravila boste morali opraviti preiskave krvi.
English: d No progression defined as mTSS change ≤ 0
Slovenian: d Brez napredovanja je opredeljeno kot sprememba mTSS ≤ 0. e Nominalna p ≤ 0,001 za primerjavo upadacitiniba s placebom ali MTX.
English: In the studies SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-COMPARE, treatment with upadacitinib 15 mg resulted in a significantly greater improvement in the mean duration of morning joint stiffness compared to placebo or MTX.
Slovenian: 15 mg upadacitiniba doseglo značilno večje izboljšanje povprečnega trajanja jutranje okorelosti sklepov kot placebo ali MTX.
English: • Language to advise patients and their HCPs about the risk of live vaccinations when given during upadacitinib therapy o Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
Slovenian: Informacije za bolnike in zdravstvene delavce glede tveganja pri uporabi živih cepiv, če so ta uporabljena med zdravljenjem z upadacitinibom.
English: Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified.
Slovenian: V kliničnih študijah so upadacitinib uporabili do odmerkov, ki so bili glede na dnevno AUC enakovredni uporabi 60 mg s podaljšanim sproščanjem enkrat na dan. Neželeni učinki so bili primerljivi s tistimi pri manjših odmerkih in specifičnih toksičnih učinkov niso ugotovili.
English: Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection.
Slovenian: Če se pojavi kakšna resna ali oportunistična okužba, je potrebno zdravljenje z upadacitinibom prekiniti.
English: • Instructions on where to report AEs
Slovenian: • Navodila glede poročanja neželenih učinkov.
English: Malignancy
Slovenian: Smukec
English: • Low disease activity (DAS28-CRP) vs adalimumab
Slovenian: • Nizka aktivnost bolezni (DAS28-CRP) v prim.
English: Adverse reactions System Organ Class
Slovenian: Odziv telesnega delovanja in zdravstveni izidi
English: In a clinical study, coadministration of upadacitinib after multiple doses of rifampicin (strong CYP3A inducer) resulted in approximately 50% and 60% decreases in upadacitinib Cmax and AUC, respectively.
Slovenian: CYP3A) zmanjšala Cmax upadacitiniba za 50 % in njegovo AUC za 60 %.
English: The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis.
Slovenian: Bolniki z revmatoidnim artritisom imajo večje tveganje za maligne bolezni, vključno z limfomi.
English: Patients should be monitored for changes in disease activity if upadacitinib is co-administered with strong CYP3A4 inducers.
Slovenian: Če je upadacitinib uporabljen sočasno z močnimi induktorji CYP3A4, je treba bolnike spremljati glede sprememb aktivnosti bolezni.
English: • Primary endpoint: clinical remission
Slovenian: Preglednica 3: Povzetek kliničnih preskušanj
English: NMSCs have been reported in patients treated with upadacitinib.
Slovenian: Pri bolnikih, zdravljenih z upadacitinibom, so poročali o nemelanomskih rakih kože.
English: Combination with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, and biologic DMARDs or other Janus kinase (JAK) inhibitors has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.
Slovenian: Janusove kinaze (JAK); takšna uporaba ni priporočljiva, saj tveganja za aditivno imunosupresijo ni mogoče izključiti.
English: • A reminder to use contraception, that upadacitinib is contraindicated during pregnancy, and to notify their HCPs if they become pregnant while taking upadacitinib o Description of signs/symptoms of deep venous thrombosis or pulmonary embolism which the patient needs to be aware of, so that they can seek attention from an HCP.
Slovenian: o Opis znakov/simptomov globoke venske tromboze ali pljučne embolije, na katere mora biti pozoren bolnik, da lahko poišče pomoč zdravnika.
English: In MTX-controlled studies, there were no cases of opportunistic infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group and 0.2% in the MTX group.
Slovenian: 15 mg upadacitiniba, oportunističnih okužb ni bilo, v skupini z MTX pa je bila njihova pogostnost 0,2 %.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: • povečanje telesne mase Občasni (pojavijo se lahko pri največ 1 od 100 oseb)
English: Metabolism
Slovenian: Pljučnica
English: 1 vial + 1 pre-filled syringe powder: 450 IU; solvent: 0.75 ml (600 IU/ml)
Slovenian: 1 viala + 1 napolnjena injekcijska brizga prašek: 450 i.e. vehikel: 0,75 ml (600 i.e./ml)
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Slovenian: Velikost pakiranja prašek: viala (steklo); vehikel: viala (steklo)
English: Packaging
Slovenian: Vsebina
English: Invented name Strength
Slovenian: Številka EU Zaščiteno ime Jakost
English: There is more evidence to come about the medicine, which the company is required to provide.
Slovenian: To pomeni, da se pričakujejo dodatni dokazi o zdravilu, ki jih mora zagotoviti podjetje.
English: Lorviqua is available as tablets (25 and 100 mg) and the recommended dose is 100 mg once a day.
Slovenian: Zdravilo Lorviqua je na voljo v obliki tablet (25 mg in 100 mg), priporočeni odmerek pa je 100 mg enkrat na dan.
English: The European Medicines Agency therefore decided that Lorviqua's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Lorviqua večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Lorviqua?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lorviqua?
English: If certain side effects develop the doctor may reduce the dose or interrupt treatment temporarily.
Slovenian: Če se pojavijo določeni neželeni učinki, lahko zdravnik zmanjša odmerek ali zdravljenje začasno prekine.
English: As for all medicines, data on the use of Lorviqua are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lorviqua stalno spremljajo.
English: In this study Lorviqua was not compared with any other treatment or placebo (a dummy treatment).
Slovenian: V tej študiji zdravila Lorviqua niso primerjali z nobenim drugim zdravilom ali placebom (zdravilom brez učinkovine).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lorviqua have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lorviqua upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Slovenian: Odziv na zdravljenje so ocenjevali s slikanjem telesa in standardiziranimi merili za ocenitev čvrstih tumorjev; popoln odziv je pri tem pomenil, da bolnik nima nikakršnih preostalih znakov raka.
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance.
Slovenian: Genske okvare, ki vplivajo na anaplastično limfomsko kinazo (ALK-pozitivno stanje), je treba predhodno potrditi.
English: The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), oedema (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), problems with thinking, learning and memory, tiredness, weight gain and effects on mood.
Slovenian: Najpogostejši neželeni učinki zdravila Lorviqua (ki lahko prizadenejo več kot 1 osebo od 5) so hiperholesterolemija (visoke ravni holesterola v krvi), hipertrigliceridemija (visoke ravni trigliceridov, vrsta maščobe, v krvi), edem (kopičenje tekočine), periferna nevropatija (poškodbe živcev v rokah in stopalih), težave z razmišljanjem, učenjem in spominom, utrujenost, zvečanje telesne mase in učinki na razpoloženje.
English: Why is Lorviqua authorised in the EU?
Slovenian: Zakaj je zdravilo Lorviqua odobreno v EU?
English: An overview of Lorviqua and why it is authorised in the EU
Slovenian: Pregled zdravila Lorviqua in zakaj je odobreno v EU
English: Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Lorviqua, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019 Further information on Lorviqua can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Lorviqua.
Slovenian: Nadaljnje informacije o zdravilu Lorviqua so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Lorviqua.
English: Lorviqua has been given ‘conditional authorisation'.
Slovenian: Zdravilo Lorviqua je pridobilo „pogojno dovoljenje za promet“.
English: Depending on which previous treatment the patients had received, around 67% and 52% of patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced.
Slovenian: Glede na predhodno zdravljenje, ki so ga bolniki prejemali, približno 67 % oziroma 52 % bolnikov, zdravljenih z zdravilom Lorviqua, ni imelo znakov raka v možganih ali pa so se znaki raka zmanjšali.
English: Other information about Lorviqua
Slovenian: Druge informacije o zdravilu Lorviqua
English: Treatment with Lorviqua should be started and supervised by a doctor who is experienced in using cancer medicines.
Slovenian: Zdravljenje z zdravilom Lorviqua lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: For more information about using Lorviqua, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Lorviqua glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Lorviqua and what is it used for?
Slovenian: Kaj je zdravilo Lorviqua in za kaj se uporablja?
English: Lorviqua must not be used together with medicines known as ‘strong CYP3A4/5 inducers' because the combined medicines could have an effect on the liver.
Slovenian: Zdravilo Lorviqua se ne sme jemati skupaj z zdravili, znanimi kot močni zaviralci CYP3A4, ker bi lahko sočasna uporaba teh dveh zdravil učinkovala na jetra.
English: What benefits of Lorviqua have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lorviqua izkazalo v študijah?
English: What are the risks associated with Lorviqua?
Slovenian: Kakšna tveganja so povezana z zdravilom Lorviqua?
English: Lorviqua was also effective when the cancer had spread to the brain.
Slovenian: Zdravilo Lorviqua je bilo učinkovito tudi, kadar se je rak razširil na možgane.
English: Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to the medicine.
Slovenian: Pri približno 43 % bolnikih, ki so bili predhodno zdravljeni z alektinibom ali ceritinibom, so zdravniki menili, da so se popolnoma ali delno odzvali na zdravilo.
English: Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib.
Slovenian: Ker je zdravilo Lorviqua pridobilo pogojno dovoljenje na promet, bo podjetje, ki trži to zdravilo, izvedlo študijo pri bolnikih, katerih bolezen se je poslabšala po zdravljenju z alektinibom ali ceritinibom.
English: The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor.
Slovenian: Učinkovina v zdravilu Lorviqua, lorlatinib, je zaviralec tirozin-kinaze.
English: What information is still awaited for Lorviqua?
Slovenian: Katere informacije o zdravilu Lorviqua še pričakujemo?
English: ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them.
Slovenian: Anaplastična limfomska kinaza spada v skupino encimov, imenovanih receptorji tirozin-kinaze, ki sodelujejo pri rasti celic in razvoju novih krvnih žil, ki te celice oskrbujejo.
English: It works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer cells.
Slovenian: Deluje tako, da zavira delovanje anaplastične limfomske kinaze, s čimer zmanjšuje rast in širjenje rakavih celic.
English: Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Slovenian: Zdravilo Lorviqua je zdravilo za zdravljenje odraslih bolnikov z nedrobnoceličnim pljučnim rakom (NSCLC), kadar je bolezen napredovala in je ALK-pozitivna, kar pomeni, da imajo rakave celice določene spremembe, ki vplivajo na gen, odgovoren za beljakovino, imenovano ALK (anaplastično limfomsko kinazo).
English: For the full list of side effects and restrictions with Lorviqua, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lorviqua glejte navodilo za uporabo.
English: Out of patients who had been previously treated with crizotinib and another ALK tyrosine kinase inhibitor, around 40% had a complete or partial response to the medicine.
Slovenian: Pri bolnikih, ki so bili predhodno zdravljeni s krizotinibom in drugim ALK-zaviralcem tirozin-kinaze, je imelo približno 40 % popoln ali delni odziv na zdravilo.
English: Lorviqua contains the active substance lorlatinib.
Slovenian: Zdravilo Lorviqua vsebuje učinkovino lorlatinib.
English: Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.
Slovenian: Zdravilo Lorviqua se uporablja samostojno, kadar se je bolezen poslabšala kljub zdravljenju z drugimi zdravili iz istega razreda, znanimi kot ALK-zaviralci tirozin-kinaze, vključno z alektinibom, ceritinibom in krizotinibom.
English: Lorviqua was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK tyrosine kinase inhibitor.
Slovenian: Zdravilo Lorviqua je bilo učinkovito pri zdravljenju ALK-pozitivnega nedrobnoceličnega pljučnega raka v eni glavni študiji, ki je vključevala 139 bolnikov, katerih bolezen se je poslabšala kljub zdravljenju bodisi z alektinibom ali ceritinibom bodisi s krizotinibom in drugim ALK-zaviralcem tirozin-kinaze.
English: In patients with ‘ALK-positive' NSCLC, an abnormal form of ALK is produced that causes the cancer cells to divide and grow in an uncontrolled fashion.
Slovenian: Pri bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom nastaja nenormalna oblika anaplastične limfomske kinaze, ki povzroča nenadzorovano delitev in rast rakavih celic.
English: Lorviqua was also effective against cancer that had spread to the brain.
Slovenian: Učinkovito je bilo tudi za zdravljenje raka, ki se je razširil na možgane.
English: How does Lorviqua work?
Slovenian: Kako zdravilo Lorviqua deluje?
English: In addition, the company will provide the results of an ongoing study comparing Lorviqua with crizotinib in patients with ALK-positive NSCLC who have not been treated before.
Slovenian: Poleg tega bo zagotovilo rezultate o potekajoči študiji, v kateri zdravilo Lorviqua primerjajo s krizotinibom pri še nezdravljenih bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom.
English: How is Lorviqua used?
Slovenian: Kako se zdravilo Lorviqua uporablja?
English: Very few other treatments are available for patients after ALK tyrosine kinase inhibitors have failed or for those whose cancer has spread to the brain, and the side effects with Lorviqua are manageable.
Slovenian: Za bolnike, pri katerih zdravljenje z ALK-zaviralci tirozin-kinaze ni bilo uspešno ali se je rak razširil na možgane, je na voljo zelo malo drugih oblik zdravljenja, neželeni učinki zdravila Lorviqua pa so obvladljivi.
English: Lorviqua is effective at treating ALK-positive NSCLC that has worsened despite treatment with other ALK tyrosine kinase inhibitors.
Slovenian: Zdravilo Lorviqua je bilo učinkovito pri zdravljenju ALK-pozitivnega nedrobnoceličnega pljučnega raka, ki se je poslabšal kljub zdravljenju z drugimi ALK-zaviralci tirozin-kinaze.
English: Lorviqua can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Lorviqua je le na recept.
English: Treatment may be stopped altogether if the patient develops severe side effects.
Slovenian: Če se pri bolniku pojavijo resni neželeni učinki, se lahko zdravljenje trajno ukine.
English: Pack size blister (PA/Alu/PVC/Alu)
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja peroralna uporaba pretisni omot (PA/Alu/PVC/Alu)
English: 224 (4 x 56) capsules
Slovenian: 224 (4 x 56) kapsule peroralna uporaba plastenka HDPE 240 kapsul
English: Doc.
Slovenian: Error!
English: Ref.: EMEA/711149/2009 EMEA/H/C/219
Slovenian: EMEA/703051/2009 EMEA/H/C/219
English: As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 6 July 2004.
Slovenian: Ker je družba predložila dodatne zahtevane podatke, so bile „izjemne okoliščine“ razveljavljene 6. julija 2004.
English: In contrast, untreated newborns usually die within the first year of life.
Slovenian: Nasprotno pa nezdravljeni novorojenčki navadno umrejo v prvem letu življenja.
English: Early diagnosis and immediate treatment are important to reduce the risk of disability.
Slovenian: Zgodnja diagnoza in takojšnje zdravljenje sta pomembna za zmanjšanje tveganja invalidnosti.
English: The marketing authorisation was renewed on 8 December 2004 and on 8 December 2009.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 8. decembra 2004 in 8. decembra 2009.
English: It is available as white oval tablets (500 mg) and as granules (940 mg/g).
Slovenian: Na voljo je v obliki belih ovalnih tablet (500 mg) in zrnc (940 mg/g).
English: Other information about Ammonaps:
Slovenian: Druge informacije o zdravilu Ammonaps:
English: The survival rate was higher in patients who had developed the disease later in life.
Slovenian: Stopnja preživetja je bila višja pri bolnikih, pri katerih se je bolezen razvila kasneje v življenju.
English: The marketing authorisation holder is Swedish Orphan International AB.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Swedish Orphan International AB.
English: • ‘early-onset' disease in babies who show a complete lack of one or more of these enzymes within the first month of life;
Slovenian: • pri zgodnji bolezni pri dojenčkih, ki izkazujejo popolno pomanjkanje enega ali več teh encimov v prvem mesecu življenja;
English: The tablets are for adults and children, and the granules are used in babies and in patients who cannot swallow tablets.
Slovenian: Tablete so namenjene odraslim in otrokom, zrnca pa dojenčkom in bolnikom, ki tablet ne morejo pogoltniti.
English: The main measure of effectiveness was survival, but the study also looked at the number of hyperammonaemic episodes (periods of very high blood ammonia levels), cognitive development (development of the ability to think, learn and remember), growth, and blood ammonia and glutamine levels.
Slovenian: Glavno merilo učinkovitosti je bilo preživetje, vendar pa je študija proučevala tudi število hiperamoniemičnih dogodkov (obdobij zelo visoke ravni amoniaka v krvi), kognitivni razvoj (razvoj sposobnosti mišljenja, učenja in spominjanja), rast ter ravni amoniaka in glutamina.