FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the potential for an acute systemic hypersensitivity reaction, premedication prior to each dose is required during induction and titration (see section 4.2, Method of administration).
Croatian: S obzirom na mogućnost akutne sistemske reakcije preosjetljivosti, tijekom indukcije i titracije potrebna je premedikacija prije svake doze (vidjeti dio 4.2, Način primjene).
English: Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase enzyme that converts phenylalanine to ammonia and trans-cinnamic acid that are primarily eliminated by liver metabolism.
Croatian: Pegvaliaza je pegilirani rekombinantni enzim fenilalanin-amonij-lijaza koji pretvara fenilalanin u amonijak i trans-cimetnu kiselinu koji se primarno eliminiraju metabolizmom u jetri.
English: High sensitivity CRP levels increased6
Croatian: Pretrage povišene koncentracije CRP-a visoke osjetljivosti6
English: If your blood phenylalanine levels are too low, your doctor may ask you to change your diet and/or will lower your dose of Palynziq.
Croatian: Ako su Vam razine fenilalanina u krvi preniske, liječnik Vam može savjetovati da promijenite prehranu i/ili smanjite dozu lijeka Palynziq.
English: In a single dose study of Palynziq in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension containing PEG experienced hypersensitivity reactions.
Croatian: U ispitivanju primjene jedne doze lijeka Palynziq u odraslih bolesnika s PKU, dva bolesnika koji su istodobno primali injekcije suspenzije medroksiprogesteronacetata koja je sadržavala PEG, imali su reakcije preosjetljivosti.
English: At treatment initiation, 253 (97%) patients had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) and 8 patients had blood phenylalanine levels less than or equal to 600 micromol/l.
Croatian: Na početku liječenja, 253 (97%) bolesnika imalo je neadekvatnu kontrolu fenilalanina u krvi (koncentracije fenilalanina u krvi iznad 600 mikromola/l), a 8 bolesnika imalo je koncentraciju fenilalanina u krvi manju ili jednaku 600 mikromola/l.
English: o Your doctor will train them on the signs and symptoms of a severe allergic reaction and how to give an injection of adrenaline.
Croatian: o Tu će osobu Vaš liječnik obučiti kako prepoznati znakove i simptome teške alergijske reakcije i kako dati injekciju adrenalina.
English: The second patient experienced a hypersensitivity reaction on day 40 after a single Palynziq dose within 10 minutes following medroxyprogesterone acetate injectable suspension.
Croatian: Drugi bolesnik imao je reakciju preosjetljivosti 40. dan nakon pojedinačne doze lijeka Palynziq unutar 10 minuta nakon primjene suspenzije medroksiprogesteronacetata za injekciju.
English: Time to response (achieving blood phenylalanine levels ≤ 600 micromol/l) varies among patients.
Croatian: Vrijeme do postizanja odgovora (postizanja razine fenilalanina u krvi ≤ 600 mikromola/l) varira od bolesnika do bolesnika.
English: Patients who developed hypophenylalaninaemia during the studies were advised to increase their protein intake from intact foods and/or reduce Palynziq dose.
Croatian: Bolesnici u kojih se tijekom ispitivanja javila hipofenilalaninemija upućeni su da povećaju unos proteina kroz cjelovitu neprocesiranu hranu i/ili smanje dozu lijeka Palynziq.
English: The mean duration of injection site reaction was 9 days, and ranged 1 day to 970 days; 91% of injection site reactions had a duration of less than 14 days, 0.8% of injection site reactions persisted at least 180 days, and 99% of injection site reactions resolved by the time of the data cut-off.
Croatian: Srednja vrijednost vremena trajanja reakcije na mjestu primjene injekcije bila je 9 dana, u rasponu od 1 dana do 970 dana; 91% reakcija na mjestu primjene injekcije trajalo je manje od 14 dana, 0,8% reakcija na mjestu primjene injekcije nastavilo se najmanje 180 dana, a 99% reakcija na mjestu primjene injekcije povuklo se do prestanka prikupljanja podataka.
English: Your doctor will train and instruct you and someone helping you on when and how to use adrenaline.
Croatian: Vaš liječnik će Vas i nekoga tko Vam pomaže obučiti i uputiti kada i kako primijeniti adrenalin.
English: Refer to the adrenaline product information for complete information.
Croatian: Za potpune informacije pogledajte informacije o lijeku za adrenalin.
English: Severe systemic hypersensitivity reaction or recurrence of a mild to moderate acute systemic hypersensitivity reaction to pegvaliase, any of the excipients listed in section 6.1, or another PEGylated medicinal product (see section 4.4).
Croatian: Teška sistemska reakcija preosjetljivosti ili ponavljajuća blaga do umjerena akutna sistemska reakcija preosjetljivosti na pegvaliazu, na neku od pomoćnih tvari navedenih u dijelu 6.1 ili na drugi pegilirani lijek (vidjeti dio 4.4).
English: Angioedema was managed with dose reduction (3 episodes; 8%), treatment interruption (5 episodes; 14%), treatment withdrawal (3 episodes; 8%), and/or concomitant medicinal products.
Croatian: Angioedem je liječen smanjenjem doze (3 epizode; 8%), privremenim prekidom liječenja (5 epizoda; 14%), trajnom obustavom liječenja (3 epizode; 8%) i/ili popratnim lijekovima.
English: All persistent arthralgia episodes resolved without sequelae.
Croatian: Sve epizode perzistirajuće artralgije povukle su se bez trajnih posljedica.
English: Palynziq reduces the levels of phenylalanine in the blood of patients who have PKU whose blood phenylalanine levels cannot be kept below 600 micromol/l by other means such as by diet.
Croatian: Palynziq smanjuje razine fenilalanina u krvi u bolesnika s PKU u kojih se razine fenilalanina u krvi ne mogu održati ispod 600 mikromola/l na druge načine poput prehrane.
English: Exposure-effect
Croatian: Izloženost - učinak
English: Your doctor will train you and someone helping you on when and how to use adrenaline.
Croatian: Liječnik će Vas i nekoga tko Vam pomaže obučiti kada i kako primijeniti adrenalin.
English: Step 4: Remove syringe from tray: Peel the cover from the tray.
Croatian: Korak 4: Izvadite štrcaljku iz podloška: Odlijepite pokrov s podloška.
English: The injection site should be checked for redness, swelling, or tenderness.
Croatian: Potrebno je provjeriti na mjestu injiciranja pojavu crvenila, oticanja ili osjetljivosti.
English: In patients experiencing hypophenylalaninaemia despite appropriate levels of protein intake, dose reductions are expected to be most effective in managing hypophenylalaninaemia (see section 5.2, Exposure-effect).
Croatian: U bolesnika koji imaju hipofenilalaninemiju unatoč odgovarajućim razinama unosa proteina, očekuje se da će smanjenje doze biti najučinkovitije u liječenju hipofenilalaninemije (vidjeti dio 5.2, Izloženost - učinak).
English: Instructions for the preparation and administration of Palynziq are given in the package leaflet.
Croatian: Upute za pripremu i primjenu lijeka Palynziq navedene su u uputi o lijeku.
English: Change from baseline protein intake (n)4
Croatian: Promjena od početne vrijednosti unosa proteina (n)4
English: To manage hypophenylalaninaemia, dietary protein intake should be increased to appropriate levels, and then, if needed, the dose of Palynziq should be reduced.
Croatian: Za liječenje hipofenilalaninemije potrebno je povećati unos proteina hranom na odgovarajuću razinu, a potom, ako je potrebno, smanjiti dozu lijeka Palynziq.
English: Hypophenylalaninaemia occurred during titration and maintenance phase, as early as 51 days and up 1405 days into Palynziq treatment (median: 393 days from Palynziq treatment initiation).
Croatian: Hipofenilalaninemija se javila tijekom titracije i faze održavanja, već od 51. dana pa sve do 1405. dana liječenja lijekom Palynziq (medijan: 393 dana od početka liječenja lijekom Palynziq).
English: Prior to first dose of Palynziq, the patient should be trained on the signs and symptoms of an acute systemic hypersensitivity reaction and to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device (auto-injector or pre-filled syringe/pen).
Croatian: Prije prve doze lijeka Palynziq, bolesnika treba obučiti o znakovima i simptomima akutne sistemske reakcije preosjetljivosti te uputiti da zatraži hitnu medicinsku skrb ako dođe do reakcije i kako pravilno primijeniti uređaj za injekciju adrenalina (autoinjektor ili napunjenu štrcaljku/brizgalicu).
English: Common 1 Induction and titration phase reflects the time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose.
Croatian: 1 Faza indukcije i titracije odražava vrijeme prije postizanja razine fenilalanina u krvi manje od 600 mikromola/l na stabilnoj dozi.
English: In patients experiencing hypophenylalaninaemia despite appropriate levels of protein intake, dose reductions are expected to be most effective in managing hypophenylalaninaemia.
Croatian: U bolesnika s hipofenilalaninemijom unatoč odgovarajućim razinama unosa proteina, očekuje se da će smanjenje doze biti najučinkovitije u liječenju hipofenilalaninemije.
English: Before initiating treatment, blood phenylalanine level must be obtained.
Croatian: Prije započinjanja liječenja, potrebno je utvrditi razinu fenilalanina u krvi.
English: Placebo 40 mg once daily4
Croatian: Placebo 40 mg jednom dnevno4
English: Other reactions reported included skin exfoliation, generalised rash, erythematous rash, maculo-papular rash, and pruritic rash.
Croatian: Ostale zabilježene reakcije uključuju ljuštenje kože, generalizirani osip, eritematozni osip, makulopapularni osip i pruritički osip.
English: Table 3: LS Mean change from RDT baseline in blood phenylalanine concentration (micromol/l) at RDT Week 8 in patients with PKU (Study 302)
Croatian: Tablica 3: Srednja vrijednost dobivena metodom najmanjih kvadrata (LS) promjene od RDT početne vrijednosti koncentracije fenilalanina u krvi (mikromol/l) u 8. tjednu RDT u bolesnika s PKU (Ispitivanje 302)
English: Do not use this medicine if the pre-filled syringe is damaged or you notice the solution is discoloured, cloudy, or if you can see particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako je napunjena štrcaljka oštećena ili ako primijetite da je otopina promijenila boju, mutna ili sadrži čestice.
English: Throw the needle cap away in a sharps disposal or puncture-resistant container.
Croatian: Bacite kapicu igle u neprobojan spremnik za odlaganje oštrih predmeta.
English: Not all subjects had a baseline ADHD inattention score and POMS confusion score taken at the start of the study.
Croatian: Nije svim ispitanicima na početku liječenja ocijenjena ADHD nepažnja i POMS konfuzija.
English: Median change from baseline was -634 micromol/l at Month 12, -965 micromol/l at Month 24, and -913 micromol/l at Month 36.
Croatian: Medijan promjene u odnosu na početnu vrijednost bio je −634 mikromola/l u 12. mjesecu, −965 mikromola/l u 24. mjesecu i −913 mikromola/l u 36. mjesecu.
English: The solution should not be used if discoloured or cloudy or if visible particles are present.
Croatian: Otopina se ne smije upotrijebiti ako je promijenila boju ili je zamućena ili ako sadrži vidljive čestice.
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, that the patient is using Palynziq and severe allergic reactions have been associated with this product o Signs or symptoms of the severe allergic reactions and action to be taken in the event of such a reaction o The importance of carrying an adrenaline injection device and the patient alert card at all times o Emergency contact details for the patient and contact details of the prescriber
Croatian: • Kartica upozorenja za bolesnika treba sadržavati sljedeće ključne poruke: o Poruku upozorenja za zdravstvene radnike koji liječe bolesnika u bilo kojem trenutku da bolesnik koristi Palynziq te da su s ovim proizvodom povezane teške alergijske reakcije o Znakove i simptome teških alergijskih reakcija i mjera koje treba poduzeti u slučaju da dođe do takvih reakcija o Važnost da se uza se sve vrijeme nosi uređaj za injekciju adrenalina i kartica upozorenja za bolesnika o Detalje o bolesnikovom kontaktu u slučaju hitnosti i kontaktne detalje liječnika koji propisuje lijek
English: Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase (rAvPAL), derived from the cyanobacterium Anabaena variablis expressed in Escherichia coli.
Croatian: Pegvaliaza je pegilirani rekombinantni enzim fenilalanin-amonij-lijaza (rAvPAL), dobiven iz cijanobakterije Anabaena variabilis i eksprimiran u bakteriji Escherichia coli.
English: If you stop taking Palynziq
Croatian: Ako prestanete primjenjivati Palynziq
English: Palynziq is a clear to slightly opalescent, colourless to pale yellow solution.
Croatian: Palynziq je bistra do blago opalescentna, bezbojna do blijedo žuta otopina.
English: Study 301 an open-label randomised (1:1), multi-centre study of patients with PKU to assess the safety and tolerability of self-administered Palynziq in an induction/titration/maintenance dose regimen.
Croatian: Ispitivanje 301: Početak liječenja (indukcija i titracija) Ispitivanje 301 bilo je otvoreno randomizirano (1:1), multicentrično ispitivanje bolesnika s PKU za ocjenu sigurnosti i podnošljivosti samoprimijenjenog lijeka Palynziq u režimu doze za indukciju/titraciju/održavanje.
English: See section 6.3 for additional information on storage outside the refrigerator (below 25°C).
Croatian: Dodatne informacije o čuvanju izvan hladnjaka (ispod 25°C) vidjeti u dijelu 6.3.
English: Blue plunger
Croatian: Plavi klip
English: Each tray contains 1 syringe.
Croatian: Jedan podložak sadrži 1 napunjenu štrcaljku.
English: • The guide for patients and trained observers shall contain the following key messages: o Description of the signs and symptoms of severe allergic reactions o Information on the action to be taken by the patient and/or trained observer in the event of the occurrence of a severe allergic reaction o Description of the risk minimisation measures necessary to minimise the risk of severe allergic reactions, in particular: Premedication requirements Requirement to carry adrenaline injection device at all times Requirement for trained observer for at least the first 6 months of treatment o The need to contact the prescriber in the event of a severe allergic reaction prior to continuing treatment o The importance of carrying the patient alert card
Croatian: • Vodič za bolesnike i obučene promatrače treba sadržavati sljedeće ključne poruke: o Opis znakova i simptoma teških alergijskih reakcija o Informacije o mjerama koje bolesnik i/ili obučeni promatrač treba poduzeti u slučaju pojave teške alergijske reakcije o Opis mjera minimizacije rizika potrebnih za smanjivanje rizika od teških alergijskih reakcija na najmanju moguću mjeru, posebice: potreba premedikacije potreba da se uza se sve vrijeme nosi uređaj za injekciju adrenalina potreba za obučenim promatračem tijekom najmanje prvih 6 mjeseci liječenja o Potreba za kontaktiranjem liječnika koji propisuje lijek prije nastavka liječenja u slučaju pojave teške alergijske reakcije o Važnost nošenja kartice upozorenja za bolesnika
English: The dose should be escalated gradually based on tolerability to the daily maintenance dose required to achieve blood phenylalanine level of 120 to 600 micromol/l according to Table 1.
Croatian: Dozu treba postupno povećavati na temelju podnošljivosti do dnevne doze održavanja potrebne za postizanje razine fenilalanina u krvi u vrijednosti od 120 do 600 mikromola/l prema Tablici 1.
English: • Lower part of the abdomen except for the 5 centimetre area around the belly button (navel).
Croatian: • Donji dio trbuha osim područja 5 cm oko pupka.
English: Injection site reactions occurred as early as the first dose and can occur at any time during treatment.
Croatian: Reakcije na mjestu primjene injekcije javljale su se već pri prvoj dozi i mogu se pojaviti u bilo kojem trenutku tijekom liječenja.
English: • Do not twist the needle cap during removal.
Croatian: • Nemojte uvrtati kapicu igle tijekom skidanja.
English: Mean (SD) Median n=154
Croatian: Medijan n=154
English: During titration and maintenance of Palynziq treatment, patients may develop blood phenylalanine levels below 30 micromol/l.
Croatian: Tijekom titracije i terapije održavanja lijekom Palynziq, razina fenilalanina u krvi bolesnika može pasti ispod 30 mikromola/l.
English: Dose1 administered subcutaneously
Croatian: Doza1 primijenjena supkutano
English: All episodes resolved without sequelae (see Immunogenicity section).
Croatian: Sve reakcije povukle su se bez trajnih posljedica (vidjeti dio Imunogenost).
English: No human data are available.
Croatian: Nema dostupnih podataka o primjeni u ljudi.
English: 1 If blood phenylalanine levels are below 30 micromol/l, dietary protein intake should be increased to appropriate levels, and then, if needed, the dose of Palynziq should be reduced (see section 4.4, Hypophenylalaninaemia).
Croatian: 1 Ako je razina fenilalanina u krvi niža od 30 mikromola/l, potrebno je povećati unos proteina hranom na odgovarajuću razinu, a potom, ako je potrebno, smanjiti dozu lijeka Palynziq (vidjeti dio 4.4, Hipofenilalaninemija).
English: Mean blood phenylalanine levels reduced from 1233 micromol/l at baseline to 565 micromol/l at Month 12 (n=164) and 345 micromol/l at Month 24 (n=90), and these reductions in mean blood phenylalanine levels were maintained through Month 36 (341 micromol/l; n=48) (see Table 4 and Figure 1).
Croatian: Srednje vrijednosti razina fenilalanina u krvi smanjene su sa početne vrijednosti od 1233 mikromola/l na 565 mikromola/l u 12. mjesecu (n=164) i 345 mikromola/l u 24. mjesecu (n=90); ova smanjenja srednjih vrijednosti razina fenilalanina u krvi održavana su do 36. mjeseca (341 mikromola/l; n=48)
English: Readministration for the first dose must be done under supervision of a healthcare professional with the ability to manage acute systemic hypersensitivity reactions.
Croatian: Ponovna primjena prve doze mora se obaviti pod nadzorom zdravstvenog radnika koji zna kako postupati u slučaju akutne sistemske reakcije preosjetljivosti.
English: Hold the middle of the pre-filled syringe body and take out the pre-filled syringe from the tray (see Figure C).
Croatian: Izvadite napunjenu štrcaljku iz podloška držeći je za srednji dio tijela (pogledajte Sliku C).
English: All serum sickness reactions resolved without sequelae.
Croatian: Sve reakcije serumske bolesti povukle su se bez trajnih posljedica.
English: The mean duration of hypersensitivity reactions was 7 days, and ranged less than 1 day to 227 days; 89% of hypersensitivity reactions had a duration of less than 14 days, 0.4% of hypersensitivity reactions persisted at least 180 days, and 99% of hypersensitivity reactions resolved by the time of the data cut-off.
Croatian: Srednja vrijednost trajanja reakcije preosjetljivosti bila je 7 dana, u rasponu od manje od 1 dana do 227 dana; 89% reakcija preosjetljivosti trajalo je manje od 14 dana, 0,4% reakcija preosjetljivosti nastavilo se najmanje 180 dana, a 99% reakcija preosjetljivosti nestalo je do prestanka prikupljanja podataka.
English: Feeling dizzy or fainting
Croatian: Osjećaj omaglice ili nesvjestice
English: Your doctor will check your blood phenylalanine levels monthly.
Croatian: Vaš liječnik će Vam provjeravati razinu fenilalanina u krvi jedanput mjesečno.
English: During maintenance, premedication may be reconsidered for subsequent injections based on patient tolerability to Palynziq.
Croatian: Tijekom održavanja, može se ponovno razmotriti premedikacija za kasnije injekcije na temelju bolesnikove podnošljivosti lijeka Palynziq.
English: 3 Refer to Description of selected adverse reactions section.
Croatian: ³ Pogledajte dio Opis odabranih nuspojava.
English: Step 3: Allow Palynziq tray(s) to sit at room temperature for 30 minutes before opening: Let the sealed tray(s) sit at room temperature for at least 30 minutes.
Croatian: Korak 3: Ostavite podložak(ške) s lijekom Palynziq na sobnoj temperaturi 30 minuta prije otvaranja:
English: • train the observer to recognise signs and symptoms of an acute systemic hypersensitivity reaction and to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device (auto-injector or pre-filled syringe/pen).
Croatian: • obučiti promatrača kako prepoznati znakove i simptome akutne sistemske reakcije preosjetljivosti i hitno zatražiti medicinsku pomoć ako dođe do reakcije te kako pravilno primijeniti uređaj za injekciju adrenalina (autoinjektor ili napunjenu štrcaljku/brizgalicu).
English: During maintenance, premedication may be considered for subsequent injections based on patient tolerability to Palynziq.
Croatian: Tijekom održavanja, može se razmotriti premedikacija za kasnije injekcije na temelju bolesnikove podnošljivosti lijeka Palynziq.
English: - Put the carton with any remaining trays back in the refrigerator.
Croatian: - Ako je u kutiji ostao neotvoren podložak, vratite kutiju natrag u hladnjak.
English: Of 253 patients who had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline in Study 301:
Croatian: Od 253 bolesnika koji su imali neadekvatnu kontrolu fenilalanina u krvi (koncentracije fenilalanina u krvi iznad 600 mikromola/l) na početku Ispitivanja 301:
English: Hypersensitivity reactions were managed with dose reduction (3% of episodes), treatment interruption (5% of episodes), treatment withdrawal (2% of episodes), and/or concomitant medicinal products.
Croatian: Reakcije preosjetljivosti liječene su smanjenjem doze (3% epizoda), privremenim prekidom liječenja (5% epizoda), trajnom obustavom liječenja (2% epizoda) i/ili popratnim lijekovima.
English: Arthralgia occurred as early as the first dose and can occur at any time during treatment.
Croatian: Artralgija se javljala već pri prvoj dozi i može se pojaviti u bilo kojem trenutku tijekom liječenja.
English: Mean (SD) change from baseline was 20 (323) micromol/l at Month 12 (n=9), -460 (685) micromol/l at Month 24 (n=5), and -783 (406) micromol/l at Month 36 (n=5).
Croatian: Srednja vrijednost (standardna devijacija) promjene u odnosu na početnu vrijednost bila je 20 (323) mikromola/l u 12. mjesecu (n=9), −460 (685) mikromola/l u 24. mjesecu (n=5) i −783 (406) mikromola/l u 36. mjesecu (n=5).
English: • Do not remove the needle cap from your pre-filled syringe.
Croatian: • Nemojte skidati kapicu igle s napunjene štrcaljke.
English: Patients continued Palynziq treatment in the long-term open-label extension period and dose was adjusted (5, 10, 20, 40 and 60 mg/day) by the physician to achieve further blood phenylalanine reductions and maintain previously achieved phenylalanine levels.
Croatian: Liječnik je prilagodio dozu (5, 10, 20, 40 i 60 mg/dan) radi postizanja daljnjeg smanjenja fenilalanina u krvi i održavanja prethodno postignutih razina fenilalanina.
English: Abdominal pain2,4
Croatian: vrlo često vrlo često abdominalna bol2,4
English: 2.5 mg once a week 2.5 mg two times a week
Croatian: 2,5 mg jedanput tjedno 2,5 mg dvaput tjedno
English: Upon readministration, the first dose must be administered with premedication under the supervision of a healthcare professional with the ability to manage acute systemic hypersensitivity reactions.
Croatian: Nakon ponovne primjene, prva doza mora se primijeniti s premedikacijom pod nadzorom zdravstvenog radnika koji zna kako postupati u slučaju akutne sistemske reakcije preosjetljivosti.
English: An analysis of ADHD inattention and PKU-POMS confusion subscales by change in blood phenylalanine from baseline quartiles showed that patients with the largest phenylalanine reductions experienced the greatest improvements in ADHD inattention and PKU-POMS confusion subscales.
Croatian: Utjecaj smanjenja fenilalanina u krvi na ADHD nepažnju i PKU-POMS konfuziju Analizom podskala ADHD nepažnje i PKU-POMS konfuzije prema promjeni koncentracija fenilalanina u krvi od početnih kvartila pokazalo se da su bolesnici s najvećim smanjenjima fenilalanina u krvi imali najveće poboljšanje u podskalama ADHD nepažnje i PKU-POMS konfuzije.