natgillin/translations-raw huggingface dataset:
The most common injection site reactions (occurring in at least 10% of patients) were reaction, erythema, bruising, pruritus, pain, swelling, rash, induration, and urticaria. 
Najpogostejše reakcije na mestu injiciranja (prisotne pri vsaj 10 % bolnikov) so bile reakcija, eritem, podplutba, pruritus, bolečina, oteklina, izpuščaj, induracija in urtikarija.
Dose was not changed for 23 (96%) episodes and dose was reduced for 1 (4%) episode. 
Pri 23 epizodah (96 %) odmerek ni bil spremenjen, pri 1 epizodi (4 %) pa je bil odmerek zmanjšan.
• Do not remove the needle cap until you are ready to inject. 
• Pokrovčka igle ne odstranite, dokler niste pripravljeni na injiciranje.
PEGylated proteins have the potential to elicit an immune response. 
Pri pegiliranih beljakovinah obstaja možnost, da sprožijo imunski odziv.
• Your doctor will tell you how long to continue taking medicines such as paracetamol, fexofenadine, and/or ranitidine before you take Palynziq. 
• Zdravnik vam bo povedal, kako dolgo morate še jemati zdravila, kot so paracetamol, feksofenadin in/ali ranitidin, preden vzamete zdravilo Palynziq.
• Your doctor will prescribe medicines for you to take before your Palynziq injection, such as paracetamol, fexofenadine, and/or ranitidine. 
• Zdravnik vam bo predpisal zdravila, ki jih morate vzeti pred injekcijo zdravila Palynziq, kot so paracetamol, feksofenadin in/ali ranitidin.
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. 
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.
Treatment difference in LS mean change (95% CI) 
Razlika pri zdravljenjih pri povprečni spremembi LS (95-odstotni IZ) P-vrednost2
If you stop taking Palynziq treatment, your blood phenylalanine levels are likely to increase. 
Če ste prenehali jemati zdravilo Palynziq, se bo vaša raven fenilalanina v krvi verjetno zvišala.
• 44% of patients, 62% of patients, and 66% of patients reached blood phenylalanine level 
• 44 % bolnikov, 62 % bolnikov in 66 % bolnikov doseglo raven fenilalanina v krvi, ki je znašala
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. 
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.
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). 
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).
Figure 1: Mean (SE) phenylalanine levels over time 
Slika 1: Povprečne (SE) ravni fenilalanina glede na čas
- Sudden severe allergic reactions: (Common - may affect up to 1 in 10 people). 
- nenadne hude alergijske reakcije (pogoste - pojavijo se lahko pri največ 1 od 10 bolnikov).
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. 
Priporočeni mesti injiciranja na telesu sta: sredina sprednjega dela stegen in spodnji del trebuha z izjemo območja 5 cm okoli popka.
Before initiating treatment, blood phenylalanine level must be obtained. 
Pred začetkom zdravljenja je treba pridobiti raven fenilalanina v krvi.
Palynziq may also increase hypersensitivity to other PEGylated injectable medicinal products (see Effect of Palynziq on other PEGylated injectable medicinal products). 
Zdravilo Palynziq lahko prav tako poveča preobčutljivost na druga pegilirana zdravila za injiciranje (glejte Vpliv zdravila Palynziq na druga pegilirana zdravila za injiciranje).
It is unknown whether pegvaliase is excreted in human milk. 
Ni znano, ali se pegvaliaza izloča v materino mleko.
Reactions were managed by administration of adrenaline (10/16 patients; 11/25 episodes), corticosteroids, antihistamines, and/or oxygen under emergency medical care. 
Reakcije so bile obravnavane z uporabo adrenalina (10/16 bolnikov; 11/25 epizod), kortikosteroidov, antihistaminikov in/ali kisika v okviru nujne medicinske pomoči.
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). 
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).
The solution should not be used if discoloured or cloudy or if visible particles are present. 
Raztopina se ne sme uporabiti, če je razbarvana ali motna ali so v njej prisotni vidni delci.
If you inject Palynziq with another injectable medicine that contains PEG, such as PEGylated medroxyprogesterone acetate, you may have an allergic reaction. 
Če zdravilo Palynziq vbrizgate z drugim zdravilom za vbrizgavanje, ki vsebuje PEG (kot je pegiliran medroksiprogesteron acetat), lahko pride do alergijske reakcije.
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. 
Študija 301 je nezaslepljena, randomizirana (1 : 1), multicentrična študija bolnikov s PKU za ocenjevanje varnosti in prenašanja samoapliciranega zdravila Palynziq pri režimu odmerjanja za indukcijo/titracijo/vzdrževalno zdravljenje.
• A healthcare provider will monitor you for at least 1 hour after you get Palynziq for signs and symptoms of an allergic reaction. 
• Zdravstveni delavec bo vaše stanje spremljal vsaj 1 uro po uporabi zdravila Palynziq, če bi prišlo do znakov in simptomov alergijske reakcije.
Additional findings in rabbits included increased abortions, foetal malformations and embryo/foetal lethality. 
Dodatne ugotovitve pri zajcih so vključevale večje število splavov, malformacije ploda in večjo smrtnost zarodka/ploda.
2 Hypersensitivity reactions cover a group of terms, including acute systemic hypersensitivity reactions, and can manifest as a range of symptoms including angioedema, serum sickness, rash, and urticaria. 
2 Preobčutljivostne reakcije zajemajo skupino izrazov, vključno z akutnimi sistemskimi preobčutljivostnimi reakcijami, ter se lahko izrazijo v obliki različnih simptomov, kot so angioedem, serumska bolezen, izpuščaj in urtikarija.
* Anabaena variabilis rAvPAL produced by recombinant DNA technology in Escherichia coli. 
* rAvPAL iz bakterije Anabaena variabilis, pridobljen s tehnologijo rekombinantne DNK v sevu Escherichia coli.
A total of 164 previously-treated Palynziq patients (152 patients from Study 301, and 12 patients from other Palynziq trials) continued treatment for up to 13 weeks. 
Skupno 164 bolnikov, ki so se predhodno zdravili z zdravilom Palynziq (152 bolnikov iz študije 301 in 12 bolnikov iz drugih preskušanj z zdravilom Palynziq), je zdravljenje nadaljevalo do 13 tednov.
Of the 5 serum sickness episodes where time to onset was evaluable, 1 episode occurred within 1 hour of injection and 4 episodes occurred between 24 hours and up to 5 days following injection. 
Od 5 epizod serumske bolezni, pri katerih je bilo mogoče oceniti čas do nastopa, se je 1 epizoda pojavila v 1 uri od injiciranja, 4 epizode pa so se pojavile med 24 urami in 5 dnevi od injiciranja.
Patients should be monitored every 2 weeks until blood phenylalanine levels are within a clinically acceptable range (see section 4.4, Hypophenylalaninaemia). 
Bolnike je treba spremljati vsaka 2 tedna, dokler ravni fenilalanina v krvi niso v klinično sprejemljivem razponu (glejte poglavje 4.4 Hipofenilalaninemija).
Twelve patients (11 patients from Study 301) aged 16 up to 18 years received Palynziq treatment. 
Dvanajst bolnikov (11 bolnikov iz študije 301), starih od 16 do 18 let, se je zdravilo z zdravilom Palynziq.
As a consequence, these patients were more likely to develop hypophenylalaninaemia. 
Zato je bil razvoj hipofenilalaninemije pri teh bolnikih verjetnejši.
• Your doctor will continue to check your blood phenylalanine levels during treatment and may adjust your dose of Palynziq or ask you to change your diet. 
• Zdravnik vam bo med zdravljenjem preverjal raven fenilalanina v krvi in vam morda prilagodil odmerek zdravila Palynziq ali naročil, da spremenite dieto.
• Your doctor will then slowly increase your dose and/or how often you inject Palynziq. 
• Zdravnik vam bo nato počasi povečeval odmerek in/ali pogostnost vbrizgavanja zdravila Palynziq.
Therefore, a reduction in pegvaliase dose should be considered in patients experiencing hypophenylalaninaemia despite appropriate levels of protein intake (see section 4.2). 
Zato bi bilo treba o zmanjšanju odmerka pegvaliaze razmisliti pri bolnikih, ki imajo hipofenilalaninemijo kljub ustreznim ravnem vnosa beljakovin (glejte poglavje 4.2).
PREPARING FOR INJECTION 
PRIPRAVA NA INJEKCIJO
Time to response (achieving blood phenylalanine levels ≤ 600 micromol/l) varies among patients. 
Čas do odziva (vzpostavitev ravni fenilalanina v krvi ≤ 600 mikromolov/l) se med bolniki razlikuje.
Patients who developed hypophenylalaninaemia during the studies were advised to increase their protein intake from intact foods and/or reduce Palynziq dose. 
Bolnikom, pri katerih se je med študijami razvila hipofenilalaninemija, se je svetovalo povečanje vnosa beljakovin iz nepredelane hrane in/ali zmanjšanje odmerka zdravila Palynziq.
Do not use a Palynziq syringe more than once. 
Injekcijske brizge z zdravilom Palynziq ne uporabite več kot enkrat.
Of the 261 patients in Study 301, 11 patients were aged between 16 and 18 years at enrolment. 
Od 261 bolnikov v študiji 301 je bilo 11 bolnikov ob vključitvi v študijo starih med 16 in 18 let.
The purpose of the PEGylation of rAvPAL is to reduce immune recognition of the rAvPAL bacterial protein, and increase the half-life. 
Namen pegilacije beljakovine rAvPAL je zmanjšanje imunskega prepoznavanja bakterijske beljakovine rAvPAL in povečanje razpolovnega časa.
Allergic reactions occur very commonly (may affect more than 1 in 10 people) and range in severity. 
Alergijske reakcije se pojavijo zelo pogosto (pojavijo se lahko pri več kot 1 od 10 bolnikov) in se razlikujejo glede na resnost.
• If you need more than 1 injection for your daily dose, the injection sites should be at least 5 centimetres away from each other (see Figures E and F). 
• Če za dnevni odmerek potrebujete več kot 1 injekcijo, morajo biti mesta vbrizgavanja med seboj oddaljena vsaj 5 centimetrov (glejte sliki E in F).
Treatment with Palynziq should be directed by physicians experienced in the management of PKU. 
Zdravljenje z zdravilom Palynziq mora voditi zdravnik z izkušnjami pri obravnavi PKU.
Of the 9 angioedema episodes where time to onset was evaluable, 5 episodes occurred within 24 hours of injection, 4 episodes occurred between 24 hours and up to 29 days of injection. 
Od 9 epizod angioedema, pri katerih je bilo mogoče oceniti čas do nastopa, se je 5 epizod pojavilo v 24 urah od injiciranja, 4 epizode pa so se pojavile med 24 urami in 29 dnevi od injiciranja.
• Palynziq pre-filled syringes come in 3 different strengths: 2.5 mg, 10 mg, and 20 mg. 
• Zdravilo Palynziq je v napolnjenih injekcijskih brizgah na voljo v 3 različnih jakostih: 2,5 mg, 10 mg in 20 mg.
You may see a drop of liquid on the tip of the needle. 
Na konici igle lahko vidite kapljico tekočine.
Three injection site reactions consistent with granulomatous skin lesions were reported (each reaction occurring in one patient): granulomatous dermatitis (occurred 15 months after Palynziq treatment and lasted 16 days), xanthogranuloma (occurred 12 months after Palynziq treatment and lasted 21 months), and necrobiosis lipoidica diabeticorum (occurred 9 months after Palynziq treatment and lasted 9 months). 
Poročali so o treh reakcijah na mestu injiciranja z znaki granulomatozne kožne lezije (vsaka reakcija se je pojavila pri enem bolniku): granulomatoznem dermatitisu (pojavil se je 15 mesecev po zdravljenju z zdravilom Palynziq in trajal 16 dni), ksantogranulomu (pojavil se je 12 mesecev po zdravljenju z zdravilom Palynziq in trajal 21 mesecev) in lipoidni diabetični nekrobiozi (pojavila se je 9 mesecev po zdravljenju z zdravilom Palynziq in trajala 9 mesecev).
All episodes resolved without sequelae (see Immunogenicity section). 
Vse epizode so se odpravile brez posledic (glejte poglavje Imunogenost).
Palynziq is given as an injection under the skin (subcutaneous injection). 
Zdravilo Palynziq se daje kot podkožna injekcija (subkutana injekcija).
Blood phenylalanine1 
Fenilalanin v krvi1
Following cellular uptake, the metabolism of phenylalanine ammonia lyase (PAL) is expected to occur via catabolic pathways and be degraded into small peptides and amino acids; the PEG molecule is metabolically stable and expected to be separated from PAL protein and primarily eliminated by renal filtration. 
Po vnosu v celice se pričakuje, da se fenilalanin amoniakliaza (PAL) metabolizira prek katabolnih poti ter se razgradi v majhne peptide in aminokisline; molekula PEG je metabolno stabilna ter naj bi se ločila od beljakovine PAL in primarno izločila s filtracijo v ledvicah.
In Palynziq clinical trials, the majority of patients developed anti-PEG IgM and IgG antibodies after treatment with Palynziq (see section 4.8). 
V kliničnih preskušanjih zdravila Palynziq so se pri večini bolnikov po zdravljenju z zdravilom Palynziq razvila protitelesa proti PEG razredov IgM in IgG (glejte poglavje 4.8).
1 Blood phenylalanine level prior to initiating treatment with Palynziq. 
1 Raven fenilalanina v krvi pred začetkom zdravljenja z zdravilom Palynziq.
10 mg once a week 10 mg twice a week 10 mg four times a week 10 mg daily 
10 mg enkrat tedensko 10 mg dvakrat tedensko 10 mg štirikrat tedensko 10 mg dnevno zelen bat
Ten out of the 16 patients who experienced an acute systemic hypersensitivity reaction were rechallenged and 4 patients had at least one recurrence. 
Deset od 16 bolnikov, pri katerih je prišlo do akutne sistemske preobčutljivostne reakcije, je znova prejelo zdravilo in pri 4 bolnikih je prišlo do vsaj ene ponovitve.
These reactions were consistent with a Type III immune-complex mediated hypersensitivity mechanism and were most frequent in the early phases of treatment (during the induction and titration periods) when the early immune response was dominated by PEG IgM, PEG IgG and PAL IgM responses and C3/C4 levels were at their lowest. 
Te reakcije so imele znake mehanizma preobčutljivosti tipa III, posredovanega z imunskimi kompleksi, in so bile najpogostejše v zgodnjih fazah zdravljenja (med indukcijo in titracijo), ko so v zgodnjem imunskem odzivu prevladovali odzivi protiteles IgM proti PEG, IgG proti PEG in IgM proti PAL, ravni faktorja C3/C4 pa so bile najnižje.
Patients in the 20 mg once daily randomised arm reached their maintenance dose at a median time of 10 weeks (range: 9 to 29 weeks) and patients in the 40 mg once daily arm reached their maintenance dose at a median time of 11 weeks (range: 10 to 33 weeks). 
Bolniki v randomizirani skupini z 20 mg enkrat na dan so svoj vzdrževalni odmerek dosegli pri mediani časa 10 tednov (razpon: 9 do 29 tednov), bolniki v skupini s 40 mg enkrat na dan pa so svoj vzdrževalni odmerek dosegli pri mediani časa 11 tednov (razpon: od 10 do 33 tednov).
In clinical trials, serum sickness was reported in 7 out of 285 (2%) patients. 
V kliničnih preskušanjih so o serumski bolezni poročali pri 7 od 285 (2 %) bolnikov.
Your healthcare provider will tell you which syringe, or combination of syringes, to use. 
Zdravstveni delavec vam bo povedal, katero injekcijsko brizgo oziroma kombinacijo injekcijskih brizg morate uporabiti.
• Do not remove the needle cap until you are ready to inject Palynziq. 
• Pokrovčka igle ne odstranite, dokler niste pripravljeni na injekcijo zdravila Palynziq.
Symptoms of mood (confusion, fatigue, depression, tension-anxiety, vigour, and anger domains) were evaluated using the Profile of Mood States (POMS) tool that has been modified to be specific to PKU (PKU-POMS). 
Simptomi v povezavi z razpoloženjem (povezani z zmedenostjo, utrujenostjo, depresijo, napetostjo/tesnobo, zavzetostjo in jezo) so se ocenili s profilom razpoloženjskih stanj („Profile of Mood States“ - POMS), ki je bil posebej prilagojen za PKU (PKU-POMS).
1 Post-baseline phenylalanine values were mapped to the closest monthly visit (i.e. within a 1-month window). 
1 Vrednosti fenilalanina, pridobljene po izhodiščni vrednosti, so bile pripisane najbližjemu obisku v enem mesecu (tj. v obdobju 1 meseca).
• 54% of patients, 69% of patients, and 72% of patients reached blood phenylalanine level 
• 54 % bolnikov, 69 % bolnikov in 72 % bolnikov doseglo raven fenilalanina v krvi, ki je znašala
Pegvaliase induced anti-PEG IgM and IgG responses were detected in the majority of patients (98%) and titres peaked at 1 to 3 months after treatment initiation and then returned to baseline levels in most patients by 6 to 9 months after treatment initiation (see section 4.5). 
Odzivi protiteles proti PEG razredov IgM in IgG, ki jih je inducirala pegvaliaza, so bili zaznani pri večini bolnikov (98 %), pri čemer so titri dosegli največjo vrednost od 1 do 3 mesece po začetku zdravljenja, nato pa so se pri večini bolnikov vrnili na izhodiščne vrednosti od 6 do 9 mesecev po začetku zdravljenja (glejte poglavje 4.5).
Based on animal studies, hypophenylalaninaemia in pregnant women with PKU treated with Palynziq may be associated with adverse foetal outcomes (see sections 4.6 and 5.3). 
Na podlagi študij na živalih je lahko hipofenilalaninemija pri nosečnicah s PKU, ki se zdravijo z zdravilom Palynziq, povezana z neželenimi posledicami za plod (glejte poglavji 4.6 in 5.3).
Effect of Palynziq on other PEGylated injectable medicinal products 
Vpliv zdravila Palynziq na druga pegilirana zdravila za injiciranje
• The goal is to reach a daily dose that lowers your blood phenylalanine levels to within the target range of 120 to 600 micromol/l and does not cause too many side effects. 
• Cilj je doseči dnevni odmerek, ki vam bo raven fenilalanina v krvi znižal na ciljni razpon 120600 mikromolov/l in vam ne bo povzročil preveč neželenih učinkov.
Mean (SD) for apparent volume of distribution (Vz/F) at steady state following 20 mg and 40 mg doses was 26.4 L (64.8 L) and 22.2 L (19.7 L) respectively. 
Povprečje (SD) navideznega volumna porazdelitve (Vz/F) pri stanju dinamičnega ravnovesja po odmerku 20 mg in 40 mg je znašalo 26,4 l (64,8 l) in 22,2 l (19,7 l), v tem zaporedju.
Use a new pre-filled syringe for your injection. 
Za injekcijo uporabite novo napolnjeno injekcijsko brizgo.
1 patient did not complete the RDT due to adverse event transitioned to the long-term extension period and the remaining 4 patients who did not complete phenylalanine assessment within the window for Week 8 (Day 43 to 56). 
1 bolnik zaradi neželenega dogodka ni zaključil obdobja RDT in je prešel na zdravljenje v dolgotrajnem podaljšanem obdobju, za preostale 4 bolnike pa se ni pridobila ocena fenilalanina v obdobju 8. tedna (43. do 56. dan).
Uncontrolled blood phenylalanine levels (hyperphenylalaninaemia) before and during pregnancy are associated with increased risk for miscarriage, major birth defects (including microcephaly and major cardiac malformations), intrauterine foetal growth retardation and future intellectual disability with low IQ. 
Neuravnane ravni fenilalanina v krvi (hiperfenilalaninemija) pred in med nosečnostjo so povezane s povečanim tveganjem za spontani splav, hudimi prirojenimi okvarami (vključno z mikrocefalijo in hudimi srčnimi napakami), intrauterinim zastojem rasti ploda in poznejšo umsko prizadetostjo z nizkim IQ.
The pre-filled syringe includes an automatic needle guard. 
Napolnjena injekcijska brizga vključuje samodejni ščitnik igle.
High sensitivity CRP levels increased6 
Preiskave zvišanje ravni CRP visoke občutljivosti6
Injection of other medicines that contain PEG while using Palynziq Palynziq includes an ingredient called polyethylene glycol (PEG). 
Vbrizgavanje drugih zdravil, ki vsebujejo PEG, med uporabo zdravila Palynziq Zdravilo Palynziq vsebuje sestavino z imenom polietilen glikol (PEG).
Step 14: Slowly move your thumb up to release the plunger allowing the needle to automatically be covered by the syringe body (see Figure N). 
14. korak: Palec počasi dvignite in s tem sprostite bat, da bo telo injekcijske brizge samodejno prekrilo iglo (glejte sliko N).
After injection, the needle automatically retracts into the needle guard safely covering the needle. 
Po injiciranju se igla samodejno uvleče v ščitnik igle, ki jo varno prekrije.
It is normal to see an air bubble. 
Prisotnost zračnih mehurčkov je normalna.
Patients and the observer should be instructed to recognise the signs and symptoms of acute systemic hypersensitivity reactions, in the proper emergency use of the adrenaline injection device, and the requirement to seek immediate medical care. 
Bolnike in opazovalca je treba poučiti o znakih in simptomih akutnih sistemskih preobčutljivostnih reakcij, ustrezni uporabi pripomočka za injiciranje adrenalina v nujnih primerih ter o tem, da je treba poiskati takojšnjo medicinsko pomoč.
Example of steps to reach your blood phenylalanine goal Palynziq dose and how often to take it 
Primer korakov za doseganje ciljne ravni fenilalanina v krvi Odmerek zdravila Palynziq in pogostnost jemanja
The most common cutaneous reactions (at least 5% of patients) reported were pruritus (37 patients; 13%), rash (33 patients; 12%), erythema (15 patients; 5%), and urticaria (15 patients; 5%). 
Najpogostejše kožne reakcije (vsaj 5 % bolnikov), o katerih so poročali, so bile pruritus (37 bolnikov; 13 %), izpuščaj (33 bolnikov; 12 %), eritem (15 bolnikov; 5 %) in urtikarija (15 bolnikov; 5 %).
Eligibility period 
Obdobje ocenjevanja primernosti
2 Based on the mixed model repeated measures (MMRM) method, with treatment arm, visit, and treatment arm-by-visit interaction (the time profile of blood phenylalanine changes is assessed separately for each treatment arm) as factors adjusting for baseline blood phenylalanine concentration. 
2 Glede na metodo mešanega modela ponovljene meritve (MMRM), pri čemer so skupina zdravljenja, obisk in interakcija skupina zdravljenja-obisk (časovni profil sprememb ravni fenilalanina v krvi je ocenjen ločeno za posamezno skupino zdravljenja) dejavniki prilagoditve izhodiščne koncentracije fenilalanina v krvi.
Patients with lower antibody titres for all antibody analytes including NAb had higher pegvaliase concentrations due to less immune-mediated pegvaliase clearance. 
Pri bolnikih z nižjo vrednostjo titrov protiteles za vse analite protiteles, vključno z NAb, je bila koncentracija pegvaliaze višja, in sicer zaradi manjšega očistka pegvaliaze z imunskim odzivom.
The active substance is a covalent conjugate of the protein phenylalanine ammonia lyase (rAvPAL)* with NHS-methoxypolyethylene glycol (NHS-PEG). 
Zdravilna učinkovina je kovalentni konjugat beljakovine fenilalanin amoniakliaze (rAvPAL)* z NHS-metoksipolietilen glikolom (NHS-PEG).
The underlying mechanism for acute systemic hypersensitivity reactions observed in clinical trials was non-IgE mediated Type III (immune-complex mediated) hypersensitivity (see section 4.8). 
Mehanizem akutnih sistemskih preobčutljivostnih reakcij, ki so bile opažene v kliničnih preskušanjih, je bila preobčutljivost tipa III, ki ni bila posredovana s protitelesi razreda IgE, temveč z imunskimi kompleksi (glejte poglavje 4.8).