FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients experiencing hypophenylalaninaemia on 10 mg/day, the dose may be reduced to 5 mg/day.
Slovenian: Pri bolnikih, pri katerih se hipofenilalaninemija pojavi pri odmerku 10 mg/dan, se lahko odmerek zmanjša na 5 mg/dan.
English: Figure A below shows what the pre-filled syringe looks like before use.
Slovenian: Na spodnji sliki A je prikazano, kako je napolnjena injekcijska brizga videti pred uporabo.
English: Check the syringe label to make sure you have the correct strength for your prescribed dose.
Slovenian: Preverite nalepko na injekcijski brizgi in se prepričajte, da je jakost zdravila ustrezna za vaš predpisani odmerek.
English: Eighteen out of 21 patients who experience angioedema were re-challenged and 5 patients had at least one recurrence.
Slovenian: Osemnajst od 21 bolnikov, pri katerih je prišlo do angioedema, je znova prejelo zdravilo in pri 5 bolnikih je prišlo do vsaj ene ponovitve.
English: Antibody titres were stable with long-term treatment and dose increases were not associated with increased antibody titres.
Slovenian: Pri dolgotrajnem zdravljenju je bila vrednost titrov protiteles stabilna in povečani odmerki niso bili povezani z večjo vrednostjo titrov protiteles.
English: • Before injecting, check to make sure the needle is not damaged or bent.
Slovenian: • Pred vbrizgavanjem preglejte iglo in se prepričajte, da ni poškodovana ali ukrivljena.
English: Acute systemic hypersensitivity reactions generally occurred within the first hour after injection (88%; 22/25 episodes); however, reactions have occurred up to 24 hours after dosing.
Slovenian: Akutne sistemske preobčutljivostne reakcije so se običajno pojavile v prvi uri po injiciranju (88 %; 22/25 epizod), vendar so se reakcije pojavile tudi do 24 ur po dajanju odmerka.
English: Randomised study arm
Slovenian: Randomizirana skupina v študiji
English: Necrobiosis lipoidica diabeticorum was treated with steroid injections and complicated by Pseudomonas infection.
Slovenian: Lipoidna diabetična nekrobioza je bila zdravljena z injiciranjem steroidov, pri čemer se je zapletla zaradi okužbe z bakterijo Pseudomonas.
English: Initial administration(s) should be performed under supervision of a healthcare professional and patients should be closely observed for at least 60 minutes following each of these initial injection(s) (see sections 4.4 and 4.8).
Slovenian: Dajanje začetnega odmerka oziroma začetnih odmerkov mora potekati pod nadzorom zdravstvenega delavca, pri čemer je treba bolnike skrbno opazovati vsaj 60 minut po tem začetnem injiciranju oz. vsakem od teh začetnih injiciranj (glejte poglavji 4.4 in 4.8).
English: Phenylalanine levels over time
Slovenian: Ravni fenilalanina glede na čas
English: The injection sites should be at least 5 centimetres away from each other.
Slovenian: Mesta vbrizgavanja morajo biti med seboj oddaljena vsaj 5 centimetrov.
English: • You will start Palynziq at the lowest dose.
Slovenian: • Zdravilo Palynziq boste začeli uporabljati pri najmanjšem odmerku.
English: • Front middle of the thighs.
Slovenian: • sredina sprednjega dela stegen,
English: Dietary phenylalanine intake should remain consistent until a maintenance dose is established.
Slovenian: Vnos fenilalanina s hrano mora ostati nespremenljiv, dokler se ne vzpostavi vzdrževalni odmerek.
English: Before using Palynziq, tell your doctor if you cannot use or do not want to use an adrenaline injection device to treat a severe allergic reaction to Palynziq.
Slovenian: Pred uporabo zdravila Palynziq zdravniku povejte, če ne morete ali ne želite uporabiti pripomočka za injekcijo adrenalina za ukrepanje v primeru hude alergijske reakcije na zdravilo Palynziq.
English: One patient reported soft tissue infection associated with mesenteric panniculitis, which resulted in treatment discontinuation.
Slovenian: En bolnik je poročal o okužbi mehkega tkiva, povezani z mezenteričnim panikulitisom, zaradi česar se je prenehal zdraviti.
English: If hypophenylalaninaemia develops prior to reaching daily dosing, the dose may be reduced to the previous titration dose.
Slovenian: Če se hipofenilalaninemija razvije, preden se doseže dnevno odmerjanje, se lahko odmerek zmanjša na prejšnji titracijski odmerek.
English: Each pre-filled syringe is for single use only.
Slovenian: Posamezna napolnjena injekcijska brizga je samo za enkratno uporabo.
English: Results for PKU-POMS confusion subscale over time are shown in Table 4.
Slovenian: Rezultati glede na čas, pridobljeni s podlestvico za zmedenost PKU-POMS, so prikazani v tabeli 4.
English: At the time of the data cut-off, 188 out of the 261 patients received treatment for at least 1 year, 4 patients completed treatment, and 69 discontinued treatment in the first year.
Slovenian: Na datum prenehanja zbiranja podatkov se je 188 od 261 bolnikov zdravilo vsaj 1 leto, 4 bolniki so zaključil zdravljenje, 69 pa se jih je prenehalo zdraviti v prvem letu.
English: Your doctor will tell you if you can continue Palynziq treatment.
Slovenian: Zdravnik vam bo povedal, ali lahko nadaljujete zdravljenje z zdravilom Palynziq.
English: It is not known if Palynziq passes into breast milk or if it will affect your baby.
Slovenian: Ni znano, ali zdravilo Palynziq prehaja v materino mleko in ali lahko vpliva na otroka.
English: Of these 188 patients, 164 patients received treatment for at least 2 years, 2 patients continued treatment but had not yet reached 2 years of treatment, and 22 patients discontinued in the second year, and 9 patients discontinued after 2 years of treatment.
Slovenian: Od teh 188 bolnikov se je 164 bolnikov zdravilo vsaj 2 leti, 2 bolnika sta nadaljevala zdravljenje, vendar še nista dosegla 2 let zdravljenja, 22 bolnikov se je prenehalo zdraviti v drugem letu, 9 bolnikov pa po 2 letih zdravljenja.
English: If your healthcare provider decides that you or your caregiver can give your injections of Palynziq at home, your healthcare provider will show you or your caregiver how to inject Palynziq before you inject it for the first time.
Slovenian: Če se zdravstveni delavec odloči, da si lahko injekcije zdravila Palynziq dajete sami doma oziroma da vam jih lahko daje negovalec, bo vam ali negovalcu pokazal, kako vbrizgati zdravilo Palynziq, preden ga prvič uporabite.
English: The PKU-POMS confusion subscale (ranging from 0 to 12 points with higher scores indicating greater degree of impairment) was considered most sensitive to changes in blood phenylalanine levels.
Slovenian: Podlestvica za zmedenost PKU-POMS (z vrednostmi od 0 do 12 točk, pri čemer več točk pomeni višjo stopnjo motnje) se je štela kot najnatančnejša pri določanju sprememb ravni fenilalanina v krvi.
English: Let the skin air dry for at least 10 seconds before injecting (see Figure H).
Slovenian: Pred vbrizgavanjem počakajte vsaj 10 sekund, da se koža posuši na zraku (glejte sliko H).
English: Look at the liquid through the viewing window (see Figure D).
Slovenian: Skozi okence za ogled si oglejte tekočino (glejte sliko D).
English: Step 2: Remove Palynziq tray(s) from carton and check expiry date: - Take out the cartons needed for your dose from the refrigerator.
Slovenian: 2. korak: Enega ali več pladnjev z zdravilom Palynziq odstranite iz škatle in preverite datum izteka roka uporabnosti: - Iz hladilnika vzemite škatle, ki jih potrebujete za svoj odmerek.
English: The recommended starting dose of Palynziq is 2.5 mg administered once per week for 4 weeks.
Slovenian: Priporočeni začetni odmerek zdravila Palynziq je 2,5 mg, ki se daje enkrat na teden 4 tedne.
English: Presence of antibody titres were not predictive of hypersensitivity reactions.
Slovenian: Na podlagi prisotnosti titrov protiteles ni bilo mogoče napovedati preobčutljivostnih reakcij.
English: • The “Instructions for Use” (section 7 of this leaflet) shows you: o how to prepare and inject Palynziq and o how to throw away Palynziq syringes properly after you use them
Slovenian: • V navodilih za uporabo (poglavje 7 tega navodila) je prikazano: o kako pripravite in vbrizgate zdravilo Palynziq in o kako po uporabi ustrezno zavržete injekcijske brizge z zdravilom Palynziq.
English: Step 5: Check syringe strength and check for particles:
Slovenian: 5. korak: Preverite jakost zdravila v injekcijski brizgi in prisotnost delcev:
English: In clinical trials, a direct correlation between pegvaliase plasma exposure and blood phenylalanine reduction was observed.
Slovenian: V kliničnih preskušanjih je bila opažena neposredna korelacija med plazemsko izpostavljenostjo pegvaliazi in zmanjšanjem ravni fenilalanina v krvi.
English: You may cover the injection site with an adhesive bandage if needed.
Slovenian: Na mesto vbrizgavanja lahko po potrebi nalepite obliž.
English: Marketing Authorisation Holder and Manufacturer BioMarin International Limited Shanbally, Ringaskiddy
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec BioMarin International Limited Shanbally, Ringaskiddy
English: Study 302 was a follow-on study (from Study 301) and included: an open label eligibility period; a double-blind, placebo-controlled randomised discontinuation trial period (RDT), and a long-term open-label extension period.
Slovenian: Študija 302 je bila nadaljnja študija (po študiji 301) in je vključevala nezaslepljeno obdobje ocenjevanja primernosti; dvojno slepo, s placebom kontrolirano obdobje preskušanja z randomiziranim prenehanjem dajanja zdravila (RDT) in dolgotrajno nezaslepljeno podaljšano obdobje.
English: The effects of Palynziq in the treatment of PKU have been demonstrated in patients with phenylketonuria in Study 301, an open-label study to initiate Palynziq treatment, and Study 302, a follow-on study for efficacy assessment.
Slovenian: Učinki zdravila Palynziq pri zdravljenju PKU so se pokazali pri bolnikih s fenilketonurijo v študiji 301, nezaslepljeni študiji za začetek zdravljenja z zdravilom Palynziq, in študiji 302, nadaljnji študiji za ocenjevanje učinkovitosti.
English: AFTER THE INJECTION
Slovenian: PO INJEKCIJI
English: • would be present with the patient during and after Palynziq administration,
Slovenian: • je prisotna ob bolniku med uporabo zdravila Palynziq in po njej,
English: Animal studies have shown maternal reproductive toxicity that was associated with decreased blood phenylalanine concentrations below normal levels (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost pri materi, ki je bila povezana s koncentracijami fenilalanina v krvi, nižjimi od normalnih ravni (glejte poglavje 5.3).
English: Step 12: Use a quick motion to fully insert the needle into the pinched skin at a 45 to 90 degree angle (see Figure L).
Slovenian: 12. korak: S hitrim gibom iglo v celoti vstavite v stisnjeno kožo, in sicer pod kotom 45 do 90 stopinj (glejte sliko L).
English: Injecting cold Palynziq can be uncomfortable.
Slovenian: Vbrizgavanje mrzlega zdravila Palynziq je lahko neprijetno.
English: The pharmacokinetics of pegvaliase exhibit high inter-patient and intra-patient variability due to the heterogeneity of the immune response in adult patients with PKU.
Slovenian: Farmakokinetika pegvaliaze kaže visoko inter- in intravariabilnost bolnikov, in sicer zaradi heterogenosti imunskega odziva pri odraslih bolnikih s PKU.
English: The mean (SD) duration of these reactions was 64 (78) days, and the maximum duration was 638 days, 5% of these reactions persisted at least 180 days, and 86% of these reactions resolved by the time of the data cut-off.
Slovenian: Povprečno (SD) trajanje teh reakcij je znašalo 64 (78) dni, najdaljše trajanje je znašalo 638 dni, 5 % teh reakcij je vztrajalo vsaj 180 dni, pri čemer se je 86 % teh reakcij odpravilo do datuma prenehanja zbiranja podatkov.
English: In clinical studies, anti-PAL, anti-PEG and anti-pegvaliase have been identified as IgG and IgM mainly.
Slovenian: V kliničnih študijah so bila protitelesa proti PAL, PEG in pegvaliazi večinoma prepoznana kot protitelesa razredov IgG in IgM.
English: Prescribing physician should continue or consider resuming use of premedication.
Slovenian: Zdravnik, ki je predpisal zdravilo, bi moral nadaljevati dajanje premedikacije ali razmisliti o ponovnem dajanju premedikacije.
English: Thus, mean dose levels also stabilized with long-term treatment with sustained therapeutic effect.
Slovenian: Povprečna količina odmerka se je tako pri dolgotrajnem zdravljenju stabilizirala in terapevtski učinek se je ohranil.
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Slovenian: • Izobraževalno gradivo za zdravnika mora vsebovati: o povzetek glavnih značilnosti zdravila; o vodnik za zdravstvene delavce.
English: Pegvaliase plasma exposure was primarily driven by immune response to pegvaliase.
Slovenian: Plazemska izpostavljenost pegvaliazi je bila primarno odvisna od imunskega odziva na pegvaliazo.
English: Palynziq can cause severe allergic reactions that may be life-threatening and these can happen any time after a Palynziq injection.
Slovenian: Zdravilo Palynziq lahko povzroči hude alergijske reakcije, ki so lahko življenjsko nevarne, do njih pa lahko pride kadar koli po injekciji zdravila Palynziq.
English: The PEG molecule is expected to be primarily eliminated by renal filtration.
Slovenian: Pričakuje se, da se molekula PEG primarno izloči s filtracijo v ledvicah.
English: Pegvaliase is rAvPAL conjugated with linear 20 kDa NHS-PEG at a degree of substitution of 28 to 44 moles of polymer/mole of protein.
Slovenian: Pegvaliaza je konjugat beljakovine rAvPAL z linearnim NHS-PEG mase 20 kDa pri stopnji substitucije 28-44 molov za polimer/mol beljakovine.
English: 4 Abdominal pain reflects the following terms: abdominal pain, abdominal pain upper and abdominal discomfort.
Slovenian: 4 Bolečine v trebuhu zajemajo naslednje izraze: bolečine v trebuhu, bolečine v zgornjem delu trebuha in neugodje v trebuhu.
English: Do not divide your daily dose throughout the day.
Slovenian: Dnevnega odmerka si ne razdelite na več manjših odmerkov čez dan.
English: The ADHD-RS IV inattention subscale ranges from 0 to 27, higher scores indicate a greater degree of impairment, and a score below 9 indicates that the patient is asymptomatic (i.e. has a score that is in the normative range).
Slovenian: Podlestvica za nepozornost v okviru ADHD-RS IV vsebuje vrednosti od 0 do 27, pri čemer višje vrednosti pomenijo višjo stopnjo motnje, vrednost pod 9 pa pomeni, da bolnik nima simptomov (tj. ima vrednost, ki je v normativnem razponu).
English: Contact your doctor immediately if you have the following: - A type of allergic reaction called serum sickness which includes a combination of fever (high temperature), rash, muscle and joint aches (Common - may affect up to 1 in 10 people)
Slovenian: Nemudoma se obrnite na zdravnika, če se pojavi: - vrsta alergijske reakcije, imenovane serumska bolezen, ki vključuje kombinacijo vročine (povišana telesna temperatura), izpuščaja ter bolečin v mišicah in sklepih (pogosta - pojavi se lahko pri največ 1 od 10 bolnikov).
English: Supplies you will need for your Palynziq Injection:
Slovenian: Pripomočki, ki jih boste potrebovali za injekcijo zdravila Palynziq:
English: Four out of 16 (1%; 4/285) patients experienced a total of 5 episodes of acute systemic hypersensitivity reactions that were considered severe (see sections 4.3 and 4.8).
Slovenian: Pri štirih od 16 (1 %; 4/285) bolnikov se je pojavilo skupno 5 epizod akutnih sistemskih preobčutljivostnih reakcij, ki so se štele za hude (glejte poglavji 4.3 in 4.8).
English: • Before you inject Palynziq, check each carton and syringe to make sure you have the right pre-filled syringe for your prescribed dose.
Slovenian: • Preden vbrizgate zdravilo Palynziq, preglejte posamezne škatle in injekcijske brizge ter se prepričajte, da imate ustrezno napolnjeno injekcijsko brizgo za predpisani odmerek.
English: • 1 sharps disposal or puncture resistant container
Slovenian: • 1 vsebnik za odlaganje ostrih predmetov ali vsebnik, odporen na vbode
English: Injection site reactions were reported in 266 out of 285 (93%) patients.
Slovenian: O reakcijah na mestu injiciranja so poročali pri 266 od 285 (93 %) bolnikov.
English: Keep the adrenaline injection device with you at all times.
Slovenian: Pripomoček za injekcijo adrenalina imejte vedno pri sebi.
English: All patients treated with Palynziq developed a sustained total anti-pegvaliase antibody (TAb) response with a majority of patients (91%) becoming positive by Week 4.
Slovenian: Pri vseh bolnikih, zdravljenih z zdravilom Palynziq, se je razvil trajen odziv skupnih protiteles proti pegvaliazi („total anti-pegvaliase antibodies“ - TAb), pri čemer so bili rezultati večine bolnikov (91 %) pozitivni do 4. tedna.
English: Neutralising antibodies (NAb) capable of inhibiting PAL enzyme activity were detected in a majority of patients over time with 78% of patients testing positive for NAb at one year after treatment initiation and maintaining stable NAb titres through long-term treatment.
Slovenian: Nevtralizacijska protitelesa („neutralising antibodies“ - NAb), ki lahko inhibirajo aktivnost encima PAL, so bila sčasoma zaznana pri večini bolnikov, pri čemer so bili pri 78 % bolnikov rezultati za NAb pozitivni eno leto po začetku zdravljenja, pri dolgotrajnem zdravljenju pa so se ohranili stabilni titri NAb.
English: Three of these patients experienced severe serum sickness (3/285; 1%), which resulted in treatment discontinuation (2 patients) or treatment interruption (1 patient).
Slovenian: Pri treh od teh bolnikov je prišlo do hude serumske bolezni (3/285; 1 %), zaradi česar so se prenehali zdraviti (2 bolnika) oziroma so zdravljenje začasno prekinili (1 bolnik).
English: Do not share your pre-filled syringes with anyone else.
Slovenian: Napolnjenih injekcijskih brizg ne delite z nikomer.
English: Palynziq has a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Palynziq ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Adverse reproductive and developmental effects of pegvaliase in rats and rabbits were dose dependent and included reduced implantation rate, smaller litter size, lower foetal weights, and increased foetal alterations.
Slovenian: Škodljivi učinki pegvaliaze na razmnoževanje in razvoj podgan in zajcev so bili odvisni od odmerka in so vključevali manjšo stopnjo implantiranja, manjše leglo, manjšo težo ploda in večje spremembe pri plodu.
English: Exposure-effect
Slovenian: Vpliv izpostavljenosti
English: The most common injection site reactions (occurring in at least 10% of patients) were reaction, erythema, bruising, pruritus, pain, swelling, rash, induration, and urticaria.
Slovenian: Najpogostejše reakcije na mestu injiciranja (prisotne pri vsaj 10 % bolnikov) so bile reakcija, eritem, podplutba, pruritus, bolečina, oteklina, izpuščaj, induracija in urtikarija.
English: Dose was not changed for 23 (96%) episodes and dose was reduced for 1 (4%) episode.
Slovenian: Pri 23 epizodah (96 %) odmerek ni bil spremenjen, pri 1 epizodi (4 %) pa je bil odmerek zmanjšan.
English: • Do not remove the needle cap until you are ready to inject.
Slovenian: • Pokrovčka igle ne odstranite, dokler niste pripravljeni na injiciranje.
English: PEGylated proteins have the potential to elicit an immune response.
Slovenian: Pri pegiliranih beljakovinah obstaja možnost, da sprožijo imunski odziv.
English: • Your doctor will tell you how long to continue taking medicines such as paracetamol, fexofenadine, and/or ranitidine before you take Palynziq.
Slovenian: • Zdravnik vam bo povedal, kako dolgo morate še jemati zdravila, kot so paracetamol, feksofenadin in/ali ranitidin, preden vzamete zdravilo Palynziq.
English: • Your doctor will prescribe medicines for you to take before your Palynziq injection, such as paracetamol, fexofenadine, and/or ranitidine.
Slovenian: • Zdravnik vam bo predpisal zdravila, ki jih morate vzeti pred injekcijo zdravila Palynziq, kot so paracetamol, feksofenadin in/ali ranitidin.
English: However, due to the substantial variability in antibody titres between patients, no specific antibody titre was predictive of pegvaliase dose required to reach substantial blood phenylalanine reduction, or the development of hypophenylalaninaemia.
Slovenian: Vendar pa zaradi velike raznolikosti vrednosti titrov protiteles pri bolnikih na podlagi nikakršnega posebnega titra protiteles ni bilo mogoče napovedati, kakšen odmerek pegvaliaze je potreben za doseganje pomembnega znižanja ravni fenilalanina v krvi ali za razvoj hipofenilalaninemije.
English: Treatment difference in LS mean change (95% CI)
Slovenian: Razlika pri zdravljenjih pri povprečni spremembi LS (95-odstotni IZ) P-vrednost2
English: If you stop taking Palynziq treatment, your blood phenylalanine levels are likely to increase.
Slovenian: Če ste prenehali jemati zdravilo Palynziq, se bo vaša raven fenilalanina v krvi verjetno zvišala.
English: • 44% of patients, 62% of patients, and 66% of patients reached blood phenylalanine level
Slovenian: • 44 % bolnikov, 62 % bolnikov in 66 % bolnikov doseglo raven fenilalanina v krvi, ki je znašala
English: Of the 11 patients initially enrolled in Study 301, 3 patients reached blood phenylalanine levels ≤ 600 micromol/l by 12 months, 7 patients reached this threshold by 24 months, and 8 patients reached this threshold by 36 months.
Slovenian: Od 11 bolnikov, ki so bili prvotno vključeni v študijo 301, so 3 bolniki raven fenilalanina v krvi ≤ 600 mikromolov/l dosegli do 12. meseca, 7 bolnikov je ta prag doseglo do 24. meseca, 8 bolnikov pa do 36. meseca.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Palynziq in one or more subsets of the paediatric population for the treatment of hyperphenylalaninaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je za zdravljenje hiperfenilalaninemije začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Palynziq za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Figure 1: Mean (SE) phenylalanine levels over time
Slovenian: Slika 1: Povprečne (SE) ravni fenilalanina glede na čas
English: - Sudden severe allergic reactions: (Common - may affect up to 1 in 10 people).
Slovenian: - nenadne hude alergijske reakcije (pogoste - pojavijo se lahko pri največ 1 od 10 bolnikov).
English: The recommended injection sites on the body are: the front middle of the thighs and the lower part of the abdomen except for 5 cm directly around the navel.
Slovenian: Priporočeni mesti injiciranja na telesu sta: sredina sprednjega dela stegen in spodnji del trebuha z izjemo območja 5 cm okoli popka.
English: Before initiating treatment, blood phenylalanine level must be obtained.
Slovenian: Pred začetkom zdravljenja je treba pridobiti raven fenilalanina v krvi.
English: Palynziq may also increase hypersensitivity to other PEGylated injectable medicinal products (see Effect of Palynziq on other PEGylated injectable medicinal products).
Slovenian: Zdravilo Palynziq lahko prav tako poveča preobčutljivost na druga pegilirana zdravila za injiciranje (glejte Vpliv zdravila Palynziq na druga pegilirana zdravila za injiciranje).
English: It is unknown whether pegvaliase is excreted in human milk.
Slovenian: Ni znano, ali se pegvaliaza izloča v materino mleko.
English: Reactions were managed by administration of adrenaline (10/16 patients; 11/25 episodes), corticosteroids, antihistamines, and/or oxygen under emergency medical care.
Slovenian: Reakcije so bile obravnavane z uporabo adrenalina (10/16 bolnikov; 11/25 epizod), kortikosteroidov, antihistaminikov in/ali kisika v okviru nujne medicinske pomoči.
English: Of the 261 enrolled patients, 195 (75%) patients reached their randomised maintenance dose (103 patients in the 20 mg once daily arm, 92 patients in the 40 mg once daily arm).
Slovenian: Od 261 vključenih bolnikov jih je 195 (75 %) doseglo svoj randomizirani vzdrževalni odmerek (103 bolniki v skupini z 20 mg enkrat na dan in 92 bolnikov v skupini s 40 mg enkrat na dan).
English: The solution should not be used if discoloured or cloudy or if visible particles are present.
Slovenian: Raztopina se ne sme uporabiti, če je razbarvana ali motna ali so v njej prisotni vidni delci.