FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, talk to your healthcare provider about your medical condition or your treatment.
Slovenian: Prav tako se glede svojega zdravstvenega stanja ali zdravljenja posvetujte z zdravstvenim delavcem.
English: Protein intake from intact food (g) N
Slovenian: Vnos beljakovin iz nepredelane hrane (g) N
English: • Do not change your protein intake unless your doctor tells you to.
Slovenian: • Vnosa beljakovin ne spreminjajte, če vam tega ne naroči zdravnik.
English: No data are available in paediatric patients less than 16 years of age.
Slovenian: Za pediatrične bolnike, mlajše od 16 let, ni na voljo podatkov.
English: If more than one syringe is needed:
Slovenian: Če potrebujete več kot eno injekcijsko brizgo:
English: • 1 alcohol pad
Slovenian: • 1 alkoholna krpica
English: The mean duration of serum sickness was 5 days and ranged from 1 to 8 days.
Slovenian: Povprečno trajanje serumske bolezni je bilo 5 dni, pri čemer je znašalo od 1 do 8 dni.
English: Angioedema can also present as one of the symptoms of an acute systemic hypersensitivity reaction.
Slovenian: Angioedem se lahko pojavi tudi kot eden od simptomov akutne sistemske preobčutljivostne reakcije.
English: These patients received the same induction/titration/maintenance regimen as patients aged 18 years and older in this study.
Slovenian: V tej študiji se je za te bolnike izvajal enak režim odmerjanja za indukcijo/titracijo/vzdrževalno zdravljenje kot za bolnike, stare 18 let in več.
English: In maintenance phase of the treatment, steady state is expected 4 to 24 weeks after maintenance dose started.
Slovenian: V fazi vzdrževalnega zdravljenja se pričakuje, da se stanje dinamičnega ravnovesja doseže 4-24 tednov po začetku dajanja vzdrževalnega odmerka.
English: Long-term extension period
Slovenian: Dolgotrajno podaljšano obdobje
English: Immune response affects clearance and time to reach steady state.
Slovenian: Imunski odziv vpliva na očistek in čas do doseženega stanja dinamičnega ravnovesja.
English: The median duration was 161 days (range: 35, 1408).
Slovenian: Mediana trajanja je bila 161 dni (razpon: 35, 1.408).
English: Linearity/nonlinearity
Slovenian: Linearnost/nelinearnost
English: The long-term clinical consequences of chronic hypophenylalaninaemia are unknown.
Slovenian: Dolgoročne klinične posledice kronične hipofenilalaninemije niso znane.
English: The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.
Slovenian: Povprečna molekulska masa znaša približno 1.000 kDa, pri čemer beljakovinski del znaša približno 248 kDa. Mehanizem delovanja
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.
Slovenian: Ni znano, ali je zdravilo Palynziq varno in učinkovito pri otrocih in mladostnikih s PKU, mlajših od 16 let, zato se ne sme uporabljati pri osebah, mlajših od 16 let.
English: Use your other hand to pinch up the skin around the injection site.
Slovenian: Z drugo roko stisnite kožo okoli mesta vbrizgavanja.
English: - Place each sealed tray on a clean, flat surface out of reach of children and pets.
Slovenian: - Posamezni zatesnjeni pladenj položite na čisto, ravno površino zunaj dosega otrok in domačih živali.
English: Check with your doctor, pharmacist or nurse about the right way to throw away the container.
Slovenian: Zdravnika, farmacevta ali medicinsko sestro vprašajte, kako lahko pravilno zavržete vsebnik.
English: Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 - 7.4.
Slovenian: Brezbarvna do bledo rumena, bistra do nekoliko opalescentna raztopina s pH 6,6-7,4.
English: Step 7: Wash your hands well with soap and water (see Figure G).
Slovenian: 7. korak: Roke si dobro umijte z milom in vodo (glejte sliko G).
English: Osmolality: 285 - 315 mOsm/kg, viscous solution
Slovenian: Osmolalnost: 285-315 mOsm/kg, viskozna raztopina
English: Step 11: Hold the body of the pre-filled syringe in 1 hand between your thumb and index finger.
Slovenian: 11. korak: Telo napolnjene injekcijske brizge držite v 1 roki, in sicer med palcem in kazalcem.
English: Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with pegvaliase.
Slovenian: Dolgotrajne študije na živalih za ocenjevanje karcinogenega potenciala oziroma študije za ocenjevanje mutagenega potenciala s pegvaliazo niso bile izvedene.
English: - Open each carton and take out the sealed tray you need for your dose.
Slovenian: - Odprite posamezno škatlo in iz nje vzemite zatesnjeni pladenj, ki ga potrebujete za svoj odmerek.
English: • Never pull back on the plunger.
Slovenian: • Nikoli ne vlecite za bat.
English: The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Slovenian: Povprečni (SD) čas od prvega odmerka pegvaliaze do nastopa kožne reakcije ,je znašal 372 (384) dni.
English: After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Slovenian: Po 6 mesecih zdravljenja z zdravilom Palynziq se lahko znova razmisli o prisotnosti opazovalca.
English: Following a single subcutaneous dose (0.01, 0.03 or 0.1 mg/kg), pegvaliase is absorbed slowly with a median tmax of 3.5 to 4 days (individual range of 2.5 to 7 days).
Slovenian: Po enkratnem subkutanem odmerku (0,01, 0,03 ali 0,1 mg/kg) se pegvaliaza absorbira počasi z mediano tmax 3,5-4 dni (posamezni razpon 2,5-7 dni).
English: • train the patient and assess patient competency on proper self-administration of this medicinal product.
Slovenian: • poučiti bolnika in oceniti njegovo sposobnost ustreznega samoinjiciranja tega zdravila;
English: • can call for emergency medical support and administer adrenaline, if warranted.
Slovenian: • lahko pokliče nujno medicinsko pomoč in aplicira adrenalin, če je potrebno.
English: Date removed from refrigeration: _____/_____/______
Slovenian: Datum, ko se je zdravilo vzelo iz hladilnika: _____/_____/______
English: Additional risk to the unborn child due to hypophenylalaninaemia is not established.
Slovenian: Druga tveganja za nerojenega otroka zaradi hipofenilalaninemije niso bila dokazana.
English: In clinical trials, doses of pegvaliase were explored up to 150 mg/day and no specific signs or symptoms were identified following these higher doses.
Slovenian: V kliničnih preskušanjih so se preskušali odmerki pegvaliaze do 150 mg/dan; po teh večjih odmerkih ni prišlo do nobenih posebnih znakov ali simptomov.
English: Due to lack of human data, Palynziq should only be administered to breast-feeding women if the potential benefit is considered to outweigh the potential risk to the infant.
Slovenian: Zaradi pomanjkanja podatkov za ljudi se sme zdravilo Palynziq dajati doječim materam le, kadar se šteje, da potencialna korist odtehta potencialno tveganje za otroka.
English: Hold the skin firmly (see Figure K).
Slovenian: Kožo dobro držite (glejte sliko K).
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.
Slovenian: Pri povečanju odmerka z 20 mg/dan na 40 mg/dan in s 40 mg/dan na 60 mg/dan je bilo opaženo več kot proporcionalno povečanje izpostavljenosti.
English: The safety and efficacy of Palynziq in paediatric patients from birth to less than 16 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Palynziq pri pediatričnih bolnikih od rojstva do starosti manj kot 16 let nista bili dokazani.
English: Anti-PAL IgG was detected in almost all patients by 4 months.
Slovenian: Protitelesa proti PAL razreda IgG so bila zaznana pri skoraj vseh bolnikih do 4. meseca.
English: If a patient does not reach a clinically relevant blood phenylalanine reduction after 18 months of treatment, continuation should be reconsidered.
Slovenian: Če se pri bolniku ne doseže klinično pomembno znižanje fenilalanina v krvi po 18 mesecih zdravljenja, je treba ponovno razmisliti o nadaljevanju zdravljenja.
English: Step 15: Treat injection site (if needed).
Slovenian: 15. korak: Oskrbite mesto vbrizgavanja (po potrebi).
English: For this study, the maintenance period was defined as at least 3 weeks dosing at randomised 20 mg or 40 mg once daily.
Slovenian: Za to študijo je bilo obdobje vzdrževalnega zdravljenja opredeljeno kot vsaj 3-tedensko dajanje randomiziranega odmerka 20 mg ali 40 mg enkrat na dan.
English: If the expiry date has passed, do not use the pre-filled syringe in that carton.
Slovenian: Če je datum izteka roka uporabnosti potekel, napolnjene injekcijske brizge v tej škatli ne uporabljajte.
English: Place the thumb of your other hand on the plunger head (see Figure L).
Slovenian: Palec druge roke položite na glavo bata (glejte sliko L).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes, ATC code: A16AB19
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi, oznaka ATC: A16AB19
English: Prior to launch of Palynziq in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Palynziq na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
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.
Slovenian: Vnetje arterij, opaženo v teh študijah, je vključevalo majhne arterije in arteriole v velikem naboru organov in tkiv ter na mestih subkutanega injiciranja.
English: Three out of 7 (1%) patients had severe serum sickness (see section 4.8).
Slovenian: Pri treh od 7 (1 %) bolnikov je šlo za hudo serumsko bolezen (glejte poglavje 4.8).
English: The vascular inflammation observed in these studies was reversible upon cessation of treatment.
Slovenian: Vnetje arterij, opaženo v teh študijah, je bilo reverzibilno po ustavitvi zdravljenja.
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).
Slovenian: - če ste hudo alergični na pegvaliazo ali katero koli drugo sestavino tega zdravila oziroma drugo zdravilo, ki vsebuje polietilen glikol (PEG) (navedeno v poglavju 6).
English: • is able to recognise the signs and symptoms of an acute systemic hypersensitivity reaction,
Slovenian: • zna prepoznati znake in simptome akutne sistemske preobčutljivostne reakcije,
English: The liquid should look clear and colourless to pale yellow.
Slovenian: Tekočina mora biti bistra in brezbarvna do bledo rumena.
English: Your doctor will tell you how long to stay at each dose.
Slovenian: Povedal vam bo, kako dolgo morate uporabljati posamezni odmerek.
English: Tell your doctor or pharmacist if you are injecting, have recently injected or might inject any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če vbrizgavate, ste pred kratkim vbrizgavali ali pa boste morda začeli vbrizgavati katero koli drugo zdravilo.
English: The impact of anti-PEG antibodies on the clinical effects of other PEG-containing medicinal products is unknown.
Slovenian: Vpliv protiteles proti PEG na klinične učinke drugih zdravil, ki vsebujejo PEG, ni znan.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, kjer se trži zdravilo Palynziq, zagotoviti, da bodo vsi zdravstveni delavci ter bolniki, skrbniki in opazovalci, za katere se pričakuje, da bodo predpisovali, uporabljali ali nadzorovali dajanje zdravila Palynziq, imeli dostop oziroma prejeli naslednji paket izobraževalnih gradiv:
English: Patients previously treated with sapropterin were required to discontinue treatment at least 14 days prior to first dose of Palynziq.
Slovenian: Bolniki, ki so se pred tem zdravili s sapropterinom, so se morali prenehati zdraviti vsaj 14 dni pred prvim odmerkom zdravila Palynziq.
English: Adverse reactions were similar in type and frequency to that of adult patients.
Slovenian: Neželeni učinki pri njih so bili glede na vrsto in pogostnost podobnim tistim, ki so se pojavili pri odraslih bolnikih.
English: No human data are available.
Slovenian: Podatki za ljudi niso na voljo.
English: - Do not warm up the pre-filled syringe in any other way.
Slovenian: - Napolnjene injekcijske brizge ne segrevajte na nikakršen drug način.
English: Severe arthralgia (severe pain limiting self-care activities of daily living) was experienced in 14 (5%) patients.
Slovenian: Huda artralgija (huda bolečina, ki omejuje vsakodnevne dejavnosti samooskrbe) se je pojavila pri 14 bolnikih (5 %).
English: Your healthcare provider will also tell you which signs and symptoms to look out for and what to do if you have a severe allergic reaction.
Slovenian: Zdravstveni delavec vam bo prav tako povedal, na katere znake in simptome morate biti pozorni in kako ukrepate v primeru hude alergijske reakcije.
English: In case of hypophenylalaninaemia during pregnancy, there is a risk of intrauterine foetal growth retardation.
Slovenian: V primeru hipofenilalaninemije med nosečnostjo obstaja tveganje za intrauterini zastoj rasti ploda.
English: 5 Complement factor C3/C4 decrease is defined changing from normal or high baseline complement value to low post-baseline complement value.
Slovenian: 5 Znižanje ravni faktorja C3/C4 komplementa je opredeljeno kot sprememba z normalne ali visoke izhodiščne vrednosti komplementa na nizko vrednost komplementa, pridobljeno po izhodiščni vrednosti.
English: Do not use this medicine after the expiry date which is stated on the syringe label, tray cover, and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na injekcijski brizgi, ovoju za pladenj in škatli poleg oznake „EXP“.
English: Acute systemic hypersensitivity reactions require treatment with adrenaline and immediate medical care.
Slovenian: Pri akutnih sistemskih preobčutljivostnih reakcijah sta potrebna zdravljenje z adrenalinom in takojšnja medicinska pomoč.
English: Hypersensitivity reactions that include symptoms such as dizziness or syncope may affect the ability to drive and use machines.
Slovenian: Preobčutljivostne reakcije, ki vključujejo simptome, kot je omotica ali sinkopa, lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: Rates decreased over time as the immune response matured (see Description of selected adverse reactions section).
Slovenian: Stopnje so se s časom zmanjševale zaradi zorenja imunskega odziva (glejte poglavje Opis izbranih neželenih učinkov).
English: - Put the carton with any remaining trays back in the refrigerator.
Slovenian: - Škatlo z morebitnimi ostalimi pladnji položite nazaj v hladilnik.
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.
Slovenian: 16. korak: Če vam zdravstveni delavec naroči, da morate za svoj odmerek uporabiti več kot eno injekcijsko brizgo, za vsako injekcijsko brizgo, ki jo uporabite, ponovite zgornje postopke v 4.-15. koraku.
English: Release the pinch of skin.
Slovenian: Popustite prijem na koži.
English: 4 Change from baseline was based on subjects with available measurements at both time points.
Slovenian: 4 Sprememba glede na izhodiščno vrednost je temeljila na preiskovancih, za katere so bile na voljo meritve za obe časovni točki.
English: Animal studies suggest that women may have difficulty becoming pregnant if their phenylalanine levels are abnormally low.
Slovenian: Študije na živalih kažejo, da lahko ženske težje zanosijo, če imajo nenormalno nizko raven fenilalanina.
English: If you have a severe allergic reaction, do not continue to use Palynziq until you have talked with the doctor who prescribes you Palynziq.
Slovenian: Če imate hudo alergijsko reakcijo, zdravila Palynziq ne uporabljajte, dokler se ne posvetujete z zdravnikom, ki vam je predpisal zdravilo Palynziq.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija v napolnjeni injekcijski brizgi, kar v bistvu pomeni „brez natrija“.
English: In the pups of these animals, systemic exposure of pegvaliase was not detected.
Slovenian: Pri mladičih teh živali ni bila zaznana sistemska izpostavljenost pegvaliazi.
English: The bioavailability is not affected by the different injection sites on the body (see section 4.2).
Slovenian: Različna mesta injiciranja na telesu ne vplivajo na biološko uporabnost (glejte poglavje 4.2).
English: Of the 261 patients who enrolled in Study 301, 152 patients continued to the eligibility period of Study 302, and 51 patients continued directly from Study 301 into the long-term extension period of Study 302.
Slovenian: Od 261 bolnikov, vključenih v študijo 301, je 152 bolnikov sodelovanje nadaljevalo v obdobju ocenjevanja primernosti študije 302, 51 bolnikov pa je bilo iz študije 301 neposredno vključenih v dolgotrajno podaljšano obdobje študije 302.
English: Do not wipe it away.
Slovenian: Ne obrišite je.
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.
Slovenian: Če na mestu vbrizgavanja opazite kapljice krvi, nanj pritisnite sterilno kroglico iz vate ali gazo ter držite približno 10 sekund.
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).
Slovenian: Od 100 bolnikov, ki so se prenehali zdraviti, se je 40 bolnikov prenehalo zdraviti zaradi neželenega dogodka, 29 bolnikov se je samih odločilo prenehati zdravljenje, 10 bolnikov je zdravljenje prekinilo zaradi odločitve zdravnika, 21 bolnikov pa zaradi drugih razlogov (npr. neodzivnost na nadaljnje spremljanje, zanositev ali odklon od protokola).
English: Patients or caregiver should be advised to rotate sites for subcutaneous injections.
Slovenian: Bolnikom ali negovalcem je treba svetovati, naj menjajo mesta za subkutano injiciranje.
English: Step 6: Choose your injection site.
Slovenian: 6. korak: Izberite mesto vbrizgavanja.
English: Five out of the 7 patients who experienced serum sickness continued treatment without a recurrence, and managed serum sickness with treatment interruption, dose reduction and/or concomitant medicinal products.
Slovenian: Pet od 7 bolnikov, pri katerih se je pojavila serumska bolezen, je nadaljevalo zdravljenje brez ponovitve, pri čemer je bila serumska bolezen pri teh bolnikih obravnavana z začasno prekinitvijo zdravljenja, zmanjšanjem odmerka in/ali sočasno uporabo zdravil.
English: • If multiple syringes are needed for a single dose, you should inject at the same time of day.
Slovenian: • Če za enkratni odmerek potrebujete več injekcijskih brizg, jih vbrizgajte ob istem času.
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.
Slovenian: Preobčutljivostne reakcije je treba obravnavati na podlagi stopnje resnosti reakcije; v kliničnih preskušanjih je to vključevalo prilagajanje odmerka, prekinitev zdravljenja, dodatne antihistaminike, antipiretike in/ali kortikosteroide.
English: Check the expiry date on the carton.
Slovenian: Na škatli preverite datum izteka roka uporabnosti.
English: A mean (SD) half-life at 20 mg and 40 mg were 47.3 hours (41.6 hours) and 60.2 hours (44.6 hours), respectively.
Slovenian: Povprečni (SD) razpolovni čas pri 20 mg in 40 mg je bil 47,3 ure (41,6 ure) in 60,2 ure (44,6 ure), v tem zaporedju.
English: It is not known if Palynziq has an effect on fertility.
Slovenian: Ni znano, ali zdravilo Palynziq vpliva na plodnost.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči stopnji resnosti.
English: 12 weeks to 24 weeks2
Slovenian: 12 tednov do 24 tednov2
English: The physician may decide, with the patient, to continue Palynziq treatment in those patients who show other beneficial effects (e.g. ability to increase protein intake from intact food or improvement of neurocognitive symptoms).
Slovenian: Zdravnik se lahko skupaj z bolnikom odloči za nadaljevanje zdravljenja z zdravilom Palynziq pri tistih bolnikih, pri katerih je mogoče opaziti druge koristne učinke (npr. možnost povečanja vnosa beljakovin iz nepredelane hrane ali izboljšanje nevrokognitivnih simptomov).
English: Available toxicological data in animals have shown excretion of pegvaliase in milk.
Slovenian: Razpoložljivi toksikološki podatki za živali so pokazali, da se pegvaliaza izloča v mleko.
English: • Do not use the pre-filled syringe if it looks damaged or used.
Slovenian: • Napolnjene injekcijske brizge ne uporabljajte, če je videti poškodovana ali uporabljena.
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).
Slovenian: Klinično najpomembnejše preobčutljivostne reakcije vključujejo akutno sistemsko preobčutljivostno reakcijo (6 %), angioedem (7 %) in serumsko bolezen (2 %) (glejte poglavji 4.3 in 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.
Slovenian: Analiza podatkov o koncentraciji pegvaliaze, pridobljenih v kliničnih preskušanjih, je pokazala, da telesna teža, spol in starost nimajo pomembnega vpliva na farmakokinetiko pegvaliaze.
English: Table 4: Efficacy results at Month 12, Month 18, Month 24 and Month 36 in Palynziq-treated patients Baseline Month 12 Month 18 Month 24 Month 36
Slovenian: Tabela 4: Rezultati učinkovitosti v 12. mesecu, 18. mesecu, 24. mesecu in 36. mesecu pri bolnikih, zdravljenih z zdravilom Palynziq
English: • Note: Do not inject multiple injections in the same spot.
Slovenian: • Opomba: Za več injekcij ne uporabite istega mesta.
English: Arteritis was attributed to the immune-mediated response associated with chronic administration of foreign protein to the animals.
Slovenian: Razlog za arteriitis je bil pripisan imunskemu odzivu, povezanemu z dolgotrajnim dajanjem tuje beljakovine živalim.
English: Decreased plasma phenylalanine and reduced body weight gain was reversible after cessation of treatment.
Slovenian: Nižja raven fenilalanina v plazmi in manjše pridobivanje telesne teže sta bila reverzibilna po ustavitvi zdravljenja.
English: Persistent arthralgia (lasting at least 6 months) occurred in 19 (7%) patients with a total of 24 episodes.
Slovenian: Do persistentne artralgije (s trajanjem vsaj 6 mesecev) je prišlo pri 19 bolnikih (7 %), in sicer do skupno 24 epizod.
English: In clinical trials, the majority of patients experienced injection site reactions (93%), arthralgia (85%), and hypersensitivity reactions (75%).
Slovenian: V kliničnih preskušanjih je pri večini bolnikov prišlo do reakcij na mestu injiciranja (93 %), artralgije (85 %) in preobčutljivostnih reakcij (75 %).
English: What Palynziq is and what it is used for
Slovenian: Kaj je zdravilo Palynziq in za kaj ga uporabljamo