FrancophonIA/ELRC3.0 huggingface dataset:
English: PEGylated proteins have the potential to elicit an immune response.
Croatian: Pegilirani proteini imaju potencijal izazivanja imunološkog odgovora.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes, ATC code: A16AB19
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, enzimi, ATK oznaka: A16AB19
English: The vascular inflammation observed in these studies was reversible upon cessation of treatment.
Croatian: Vaskularna upala zabilježena u tim ispitivanjima bila je reverzibilna po prestanku liječenja.
English: Figure F Inject at least 5 cm apart
Croatian: Slika F Injicirajte s razmakom od najmanje 5 cm
English: • gauze pad or cotton ball
Croatian: • jastučić gaze ili pamučni tupfer
English: Step 1: Collect supplies:
Croatian: Korak 1: Pripremite pribor:
English: If you see drops of blood at the injection site, press a sterile cotton ball or gauze over the injection site and hold for about 10 seconds.
Croatian: Ako vidite kapljice krvi na mjestu injiciranja, pritisnite sterilnu pamučnu vatu ili gazu na mjesto injiciranja i držite 10 sekundi.
English: Dose was not changed for 23 (96%) episodes and dose was reduced for 1 (4%) episode.
Croatian: Za 23 (96%) epizode doza nije promijenjena, a za 1 (4%) epizodu doza je smanjena.
English: Losing control of urine or stools
Croatian: Gubitak kontrole mokrenja ili stolice
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.
Croatian: Prije primjene lijeka Palynziq, recite liječniku ako ne možete ili ne želite koristiti uređaj za injekciju adrenalina za liječenje teških alergijskih reakcija na lijek Palynziq.
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).
Croatian: Početnu(e) primjenu(e) treba provesti pod nadzorom zdravstvenog radnika, a bolesnike treba pažljivo pratiti najmanje 60 minuta nakon svake od tih početnih injekcija (vidjeti dijelove 4.4 i 4.8).
English: All of these injection site reactions resolved.
Croatian: Sve te reakcije na mjestu primjene injekcije su se povukle.
English: • train the patient and assess patient competency on proper self-administration of this medicinal product.
Croatian: • obučiti bolesnika i procijeniti sposobnost bolesnika za pravilnu samoprimjenu ovog lijeka.
English: If you use more Palynziq than you should, tell your doctor.
Croatian: Ako primijenite više lijeka Palynziq nego što ste trebali, obratite se svom liječniku.
English: People who have PKU have high levels of phenylalanine and this can lead to serious health problems.
Croatian: U osoba koje imaju PKU, razine fenilalanina visoke su što može dovesti do ozbiljnih zdravstvenih problema.
English: AFTER THE INJECTION
Croatian: NAKON INJICIRANJA
English: No data are available in paediatric patients less than 16 years of age.
Croatian: Nema dostupnih podataka o primjeni u pedijatrijskih bolesnika u dobi mlađoj od 16 godina.
English: - if you have a severe allergy to pegvaliase or any other ingredients of this medicine, or another medicine that contains polyethylene glycol (PEG) (listed in section 6).
Croatian: - ako imate tešku alergiju na pegvaliazu ili neki drugi sastojak ovog lijeka ili na drugi lijek koji sadrži polietilenglikol (PEG) (naveden u dijelu 6).
English: • Never pull back on the plunger.
Croatian: • Nikada nemojte povlačiti klip.
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.
Croatian: Preporučena mjesta injiciranja na tijelu su: prednji srednji dio bedara i donji dio abdomena osim područja 5 cm oko pupka.
English: Read this Instructions for use before you start using the Palynziq pre-filled syringe and each time you get a new prescription.
Croatian: Pročitajte ove upute za uporabu prije početka primjene napunjene štrcaljke lijeka Panynziq i svaki put kad ponovno dobijete lijek.
English: 12 weeks to 24 weeks2
Croatian: 12 tjedana do 24 tjedna2
English: Rates decreased over time as the immune response matured (see Description of selected adverse reactions section).
Croatian: Stope su se tijekom vremena smanjivale kako je imunološki odgovor sazrijevao (vidjeti dio Opis odabranih nuspojava).
English: Step 16: If your health care provider tells you to use more than one syringe for your dose, repeat Steps 4 to 15 listed above for each syringe that you use.
Croatian: Korak 16: Ako Vam je liječnik rekao da za propisanu dozu primijenite više od jedne štrcaljke, ponovite gore navedene korake od 4 do 15 za svaku štrcaljku koju primjenjujete.
English: Protein intake from intact food (g) N
Croatian: Unos proteina cjelovitom neprocesiranom hranom (g) N
English: Patients previously treated with sapropterin were required to discontinue treatment at least 14 days prior to first dose of Palynziq.
Croatian: Bolesnici prethodno liječeni sapropterinom morali su prekinuti liječenje najmanje 14 dana prije prve doze lijeka Palynziq.
English: • Physician educational material • Patient information pack
Croatian: • Obrazovni materijal za liječnike • Informativni paket za bolesnike
English: Severe arthralgia (severe pain limiting self-care activities of daily living) was experienced in 14 (5%) patients.
Croatian: Teška artralgija (jaka bol koja ograničava aktivnosti svakodnevnog života) javila se u 14 (5%) bolesnika.
English: See Step 6 for choosing an injection site.
Croatian: Pogledajte korak 6 za odabir mjesta injiciranja.
English: Arthralgia and other joint related signs and symptoms
Croatian: Artralgija i drugi znakovi i simptomi vezani uz zglobove
English: The arterial inflammation observed in these studies involved small arteries and arterioles in a wide range of organs and tissues and in subcutaneous injection sites.
Croatian: Arterijska upala zabilježena u tim ispitivanjima obuhvaćala je male arterije i arteriole u velikom broju organa i tkiva, kao i na mjestima primjene supkutane injekcije.
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)
Croatian: Obratite se svom liječniku odmah ako imate sljedeće: - Vrstu alergijske reakcije koja se zove serumska bolest koja uključuje kombinaciju vrućice (visoka temperatura), osipa, bolova u mišićima i zglobovima (Često - može se javiti u manje od 1 na 10 osoba)
English: Necrobiosis lipoidica diabeticorum was treated with steroid injections and complicated by Pseudomonas infection.
Croatian: Necrobiosis lipoidica diabeticorum liječena je injekcijama steroida, a komplicirala ju je infekcija prouzročena bakterijom Pseudomonas.
English: Palynziq can cause severe allergic reactions that may be life-threatening and these can happen any time after a Palynziq injection.
Croatian: Palynziq može uzrokovati teške alergijske reakcije koje mogu biti opasne po život i koje se mogu dogoditi u bilo kojem trenutku nakon injekcije lijeka Palynziq.
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).
Croatian: Korak 12: Brzim pokretom potpuno ubodite iglu u nabor kože pod kutom od 45 do 90 stupnjeva (pogledajte Sliku L).
English: More pressure may be needed to inject all the medicine for the 10 mg and 20 mg strengths.
Croatian: Veći pritisak može biti potreban za injiciranje cjelokupnog sadržaja štrcaljke za jačine od 10 mg i 20 mg.
English: Long-term extension period
Croatian: Razdoblje dugotrajnog nastavka
English: 2 Reflects number of patients who reached time point (Month 12/Month 18/Month 24/Month 36) of treatment at the time of the data cut-off and had a scheduled phenylalanine assessment for that time point.
Croatian: 2 Odražava broj bolesnika koji je postigao vremensku točku (12. mjesec/18. mjesec/24. mjesec/36. mjesec) liječenja u vrijeme prestanka prikupljanja podataka i imao je planiranu kontrolu fenilalanina za tu vremensku točku.
English: In clinical studies, anti-PAL, anti-PEG and anti-pegvaliase have been identified as IgG and IgM mainly.
Croatian: U kliničkim ispitivanjima, anti-PAL, anti-PEG i anti-pegvaliaza protutijela identificirana su uglavnom kao IgG i IgM.
English: Prescribing physician should continue or consider resuming use of premedication.
Croatian: Liječnik koji propisuje lijek treba nastaviti ili razmotriti daljnju primjenu premedikacije.
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).
Croatian: ADHD-RS IV podskala nepažnje u rasponu je od 0 do 27, veći rezultat ukazuje na veći stupanj poremećaja, a rezultat ispod 9 ukazuje da je bolesnik asimptomatičan (tj. ima rezultat u normativnom rasponu).
English: One patient reported soft tissue infection associated with mesenteric panniculitis, which resulted in treatment discontinuation.
Croatian: Jedan bolesnik prijavio je infekciju mekog tkiva povezanu s mezenteričnim panikulitisom, što je rezultiralo prekidom liječenja.
English: During dose escalation from 20 mg/day to 40 mg/day and 40 mg/day to 60 mg/day, a greater dose proportional increase in exposure was observed.
Croatian: Tijekom povećavanja doze sa 20 mg/dan na 40 mg/dan i sa 40 mg/dan na 60 mg/dan, primijećeno je povećanje izloženosti veće nego proporcionalno povećanju doze.
English: Patients should be instructed to carry adrenaline injection device with them at all times during Palynziq treatment.
Croatian: Bolesnike treba uputiti da sa sobom nose uređaj za injekciju adrenalina sve vrijeme tijekom liječenja lijekom Palynziq.
English: Injecting cold Palynziq can be uncomfortable.
Croatian: Injiciranje hladnog lijeka Palynziq može biti neugodno.
English: The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Croatian: Srednja vrijednost (standardna devijacija) vremena od prve doze pegvaliaze do pojave reakcije bila je 372 (384) dana.
English: Arteritis was attributed to the immune-mediated response associated with chronic administration of foreign protein to the animals.
Croatian: Arteritis je pripisan imunološki posredovanom odgovoru povezanom s kroničnom primjenom stranog proteina u životinja.
English: Management of hypersensitivity reactions should be based on the severity of the reaction; in clinical trials, this has included dose adjustment, treatment interruption, additional antihistamines, antipyretics, and/or corticosteroids.
Croatian: Liječenje reakcija preosjetljivosti treba temeljiti na težini reakcije; u kliničkim ispitivanjima to je obuhvaćalo prilagodbu doze, prekid liječenja, dodatne antihistaminike, antipiretike i/ili kortikosteroide.
English: Step 8: Clean the chosen site with an alcohol pad.
Croatian: Korak 8: Očistite mjesto injiciranja jastučićem natopljenim alkoholom.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Croatian: Za liječenje nuspojava vidjeti dijelove 4.4 i 4.8.
English: • is able to recognise the signs and symptoms of an acute systemic hypersensitivity reaction,
Croatian: • može prepoznati znakove i simptome akutne sistemske reakcije preosjetljivosti,
English: Decreased plasma phenylalanine and reduced body weight gain was reversible after cessation of treatment.
Croatian: Smanjenje fenilalanina u plazmi i smanjenje porasta tjelesne težine bili su reverzibilni nakon prestanka liječenja.
English: Do not use this medicine after the expiry date which is stated on the syringe label, tray cover, and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici štrcaljke, pokrovu podloška i kutiji iza oznake „EXP”.
English: Antibody titres were stable with long-term treatment and dose increases were not associated with increased antibody titres.
Croatian: Titri protutijela bili su stabilni uz dugotrajno liječenje, a povećanja doze nisu bila povezana s povišenim titrima protutijela.
English: The MAH shall ensure that in each Member State where Palynziq is marketed, all healthcare professionals and patients, carers and observers who are expected to prescribe, use or oversee the administration of Palynziq have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet u svakoj zemlji članici u kojoj je Palynziq na tržištu osigurat će svim zdravstvenim radnicima i bolesnicima, njegovateljima i promatračima od kojih se očekuje propisivanje, upotreba ili nadgledanje primjene lijeka Palynziq, da imaju pristup ili dobiju sljedeće obrazovne pakete:
English: It is not known if Palynziq is safe and effective in children and adolescents less than 16 years of age with PKU and therefore should not be used in people aged less than 16 years.
Croatian: Nije poznato je li lijek Palynziq siguran i učinkovit u djece i adolescenata s PKU u dobi mlađoj od 16 godina te ga stoga ne treba primjenjivati u osoba mlađih od 16 godina.
English: • Your healthcare provider will give you the Palynziq injection until you (or a caregiver) can do it yourself.
Croatian: • Vaš će Vam zdravstveni radnik davati injekciju lijeka Palynziq sve dok Vi (ili Vaš njegovatelj) to ne možete uraditi sami.
English: The injection sites should be at least 5 centimetres away from each other.
Croatian: Mjesta injiciranja trebaju biti najmanje 5 centimetara međusobno udaljena.
English: The PEG molecule is expected to be primarily eliminated by renal filtration.
Croatian: Očekuje se da će se PEG molekula primarno eliminirati bubrežnom filtracijom.
English: • Your doctor will show you how and when to use the adrenaline injection device.
Croatian: • Liječnik će Vam pokazati kako i kada primijeniti uređaj za injekciju adrenalina.
English: The most clinically significant hypersensitivity reactions include acute systemic hypersensitivity reaction (6%), angioedema (7%), and serum sickness (2%) (see sections 4.3 and 4.4).
Croatian: Klinički najznačajnije reakcije preosjetljivosti uključuju akutnu sistemsku reakciju preosjetljivosti (6%), angioedem (7%) i serumsku bolest (2%) (vidjeti dijelove 4.3 i 4.4).
English: Analysis of pegvaliase concentration data from clinical trials indicated that body weight, gender and age did not have a notable effect on pegvaliase pharmacokinetics.
Croatian: Analiza podataka iz kliničkih ispitivanja o koncentraciji pegvaliaze pokazala je kako tjelesna težina, spol i dob nisu imali značajan učinak na farmakokinetiku pegvaliaze.
English: If your dose requires more than one syringe, repeat Steps 4 to 15 immediately for each syringe you use.
Croatian: Ako je za Vašu dozu potrebno više od jedne štrcaljke, odmah ponovite korake od 4 do 15 za svaku štrcaljku koju primjenjujete.
English: Palynziq may also increase hypersensitivity to other PEGylated injectable medicinal products (see Effect of Palynziq on other PEGylated injectable medicinal products).
Croatian: Palynziq također može povećati rizik od preosjetljivosti na druge pegilirane injekcijske lijekove (vidjeti Učinak lijeka Palynziq na druge pegilirane injekcijske lijekove).
English: Choose an injection site that is at least 5 centimetres away from the injection site(s) you used the day before.
Croatian: Odaberite mjesto injiciranja koje je najmanje 5 centimetara udaljeno od mjesta u koje ste lijek injicirali dan prije.
English: • Do not touch the plunger head while inserting the needle into the skin.
Croatian: • Nemojte dodirivati glavu klipa tijekom uvođenja igle u kožu.
English: You and your doctor will decide the best way for you to manage your blood phenylalanine levels.
Croatian: Vi i Vaš liječnik ćete odlučiti koji je za Vas najbolji način kontroliranja razina fenilalanina u krvi.
English: What Palynziq contains - The active substance is pegvaliase.
Croatian: Što Palynziq sadrži - Djelatna tvar je pegvaliaza.
English: * Anabaena variabilis rAvPAL produced by recombinant DNA technology in Escherichia coli.
Croatian: * rAvPAL iz Anabaena variabilis proizvedena tehnologijom rekombinantne DNK u bakteriji Escherichia coli.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Palynziq u jednoj ili više podskupina pedijatrijske populacije za liječenje hiperfenilalaninemije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: See section 4 for details on what to do based on your symptoms.
Croatian: Za detalje o tome što učiniti na temelju Vaših simptoma, pogledajte dio 4.
English: What Palynziq is and what it is used for What you need to know before you use Palynziq How to use Palynziq
Croatian: Što je Palynziq i za što se koristi Što morate znati prije nego počnete primjenjivati Palynziq Kako primjenjivati Palynziq
English: It is not known if Palynziq has an effect on fertility.
Croatian: Nije poznato utječe li Palynziq na plodnost.
English: Acute systemic hypersensitivity reactions require treatment with adrenaline and immediate medical care.
Croatian: Za akutne sistemske reakcije preosjetljivosti potrebno je liječenje adrenalinom i hitna medicinska skrb.
English: Of the 100 patients who discontinued treatment, 40 patients discontinued due to an adverse event, 29 patients discontinued due to patient decision, 10 patients discontinued due to physician decision, and 21 patients discontinued to other reasons (e.g. lost to follow-up, pregnancy, or protocol deviation).
Croatian: Od 100 bolesnika koji su prekinuli liječenje, 40 bolesnika prekinulo je liječenje zbog štetnog događaja, 29 bolesnika prekinulo je liječenje na temelju svoje odluke, 10 bolesnika prekinulo je liječenje na temelju odluke liječnika, a 21 bolesnik prekinuo je liječenje iz drugih razloga (npr. izgubljeni iz praćenja, trudnoća, odstupanje od protokola).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane po redoslijedu opadanja ozbiljnosti.
English: Pegvaliase is primarily cleared by immune-mediated mechanisms following repeat dosing.
Croatian: Pegvaliaza se primarno eliminira imunološki posredovanim mehanizmima nakon ponovljenog doziranja.
English: As a consequence, these patients were more likely to develop hypophenylalaninaemia.
Croatian: Kao posljedica toga, u tih bolesnika bilo je vjerojatnije da će doći do hipofenilalaninemije.
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
Croatian: • „Upute za uporabu” (dio 7 ove upute) pokazuju Vam: o kako pripremiti i injicirati lijek Palynziq i o kako pravilno baciti štrcaljke nakon primjene lijeka Palynziq
English: Currently available data on patients aged 16 up to 18 years are described in section 4.8 and 5.1.
Croatian: Trenutno dostupni podaci za bolesnike u dobi od 16 do 18 godina opisani su u dijelovima 4.8 i 5.1. Doziranje u ovih bolesnika isto je kao i u odraslih.
English: - Sudden severe allergic reactions: (Common - may affect up to 1 in 10 people).
Croatian: - Iznenadne teške alergijske reakcije: (Često - mogu se javiti u manje od 1 na 10 osoba).
English: • can call for emergency medical support and administer adrenaline, if warranted.
Croatian: • može pozvati hitnu medicinsku pomoć i dati injekciju adrenalina, ako je to opravdano.
English: Animal studies suggest that women may have difficulty becoming pregnant if their phenylalanine levels are abnormally low.
Croatian: Ispitivanja u životinja pokazala su da žene mogu imati poteškoća zatrudniti ako su im razine fenilalanina u krvi neuobičajeno niske.
English: The liquid should look clear and colourless to pale yellow.
Croatian: Tekućina treba biti bistra, bezbojna do blijedo žuta.
English: Do not divide your daily dose throughout the day.
Croatian: Nemojte podijeliti dozu na manje doze tijekom dana.
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.
Croatian: U vrijeme prestanka prikupljanja podataka, 188 od 261 bolesnika liječeno je najmanje godinu dana, 4 bolesnika završila su liječenje, a 69 bolesnika prekinulo je liječenje u prvoj godini.
English: Available toxicological data in animals have shown excretion of pegvaliase in milk.
Croatian: Dostupni toksikološki podaci u životinja pokazuju da se pegvaliaza izlučuje u mlijeko.
English: Date removed from refrigeration: _____/_____/______ Peel here
Croatian: Datum vađenja iz hladnjaka: _____/_____/______ Odlijepiti ovdje
English: In clinical trials, a direct correlation between pegvaliase plasma exposure and blood phenylalanine reduction was observed.
Croatian: U kliničkim ispitivanjima, zamijećena je izravna korelacija između izloženosti pegvaliazi u plazmi i smanjenja fenilalanina u krvi.
English: The impact of anti-PEG antibodies on the clinical effects of other PEG-containing medicinal products is unknown.
Croatian: Utjecaj anti-PEG protutijela na kliničke učinke drugih lijekova koji sadrže PEG nije poznat.
English: A PK/PD analysis using the Phase III data demonstrated an inverse pegvaliase exposure-phenylalanine response relationship, which could be influenced by dietary phenylalanine intake.
Croatian: Analiza PK/PD koristeći podatke iz faze III pokazala je inverzni odnos izloženosti pegvaliazi i odgovora fenilalanina, na što je mogao utjecati unos fenilalanina prehranom.
English: The safety and efficacy of Palynziq in paediatric patients from birth to less than 16 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Palynziq u djece u dobi od rođenja do manje od 16 godina nisu još ustanovljene.
English: In clinical trials, the majority of patients experienced injection site reactions (93%), arthralgia (85%), and hypersensitivity reactions (75%).
Croatian: U kliničkim ispitivanjima, većina bolesnika imala je reakcije na mjestu primjene injekcije (93%), artralgiju (85%) te reakcije preosjetljivosti (75%).
English: Supplies you will need for your Palynziq Injection:
Croatian: Pribor koji će Vam trebati za injekciju lijeka Palynziq:
English: The 2.5 mg syringe has a white plunger.
Croatian: Štrcaljka od 2,5 mg ima bijeli klip.
English: • Palynziq pre-filled syringes come in 3 different strengths: 2.5 mg, 10 mg, and 20 mg.
Croatian: • Palynziq napunjene štrcaljke dostupne su u 3 različite jačine: 2,5 mg, 10 mg i 20 mg.
English: Step 6: Choose your injection site.
Croatian: Korak 6: Odaberite mjesto injiciranja.
English: Your healthcare provider will tell you which syringe, or combination of syringes, to use.
Croatian: Vaš će Vam zdravstveni radnik reći koju štrcaljku, ili koju kombinaciju štrcaljki primijeniti.
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.
Croatian: Štetni reproduktivni i razvojni učinci pegvaliaze u štakora i kunića bili su ovisni o dozi i uključivali smanjenu stopu implantacije, manju veličinu legla, smanjenu težinu fetusa i povećane alteracije fetusa.
English: Persistent arthralgia (lasting at least 6 months) occurred in 19 (7%) patients with a total of 24 episodes.
Croatian: Perzistirajuća artralgija (koja je trajala duže od 6 mjeseci) javila se u 19 (7%) bolesnika s ukupno 24 epizode.
English: Presence of antibody titres were not predictive of hypersensitivity reactions.
Croatian: Prisutnost titara protutijela nije bila pokazatelj pojave reakcija preosjetljivosti.