natgillin/translations-raw huggingface dataset:
In clinical trials, a direct correlation between pegvaliase plasma exposure and blood phenylalanine reduction was observed.
V kliničnih preskušanjih je bila opažena neposredna korelacija med plazemsko izpostavljenostjo pegvaliazi in zmanjšanjem ravni fenilalanina v krvi.
You may cover the injection site with an adhesive bandage if needed.
Na mesto vbrizgavanja lahko po potrebi nalepite obliž.
Marketing Authorisation Holder and Manufacturer BioMarin International Limited Shanbally, Ringaskiddy
Imetnik dovoljenja za promet z zdravilom in izdelovalec BioMarin International Limited Shanbally, Ringaskiddy
Study 302 was a follow-on study (from Study 301) and included: an open label eligibility period; a double-blind, placebo-controlled randomised discontinuation trial period (RDT), and a long-term open-label extension period.
Študija 302 je bila nadaljnja študija (po študiji 301) in je vključevala nezaslepljeno obdobje ocenjevanja primernosti; dvojno slepo, s placebom kontrolirano obdobje preskušanja z randomiziranim prenehanjem dajanja zdravila (RDT) in dolgotrajno nezaslepljeno podaljšano obdobje.
The effects of Palynziq in the treatment of PKU have been demonstrated in patients with phenylketonuria in Study 301, an open-label study to initiate Palynziq treatment, and Study 302, a follow-on study for efficacy assessment.
Učinki zdravila Palynziq pri zdravljenju PKU so se pokazali pri bolnikih s fenilketonurijo v študiji 301, nezaslepljeni študiji za začetek zdravljenja z zdravilom Palynziq, in študiji 302, nadaljnji študiji za ocenjevanje učinkovitosti.
AFTER THE INJECTION
PO INJEKCIJI
• would be present with the patient during and after Palynziq administration,
• je prisotna ob bolniku med uporabo zdravila Palynziq in po njej,
Animal studies have shown maternal reproductive toxicity that was associated with decreased blood phenylalanine concentrations below normal levels (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost pri materi, ki je bila povezana s koncentracijami fenilalanina v krvi, nižjimi od normalnih ravni (glejte poglavje 5.3).
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).
12. korak: S hitrim gibom iglo v celoti vstavite v stisnjeno kožo, in sicer pod kotom 45 do 90 stopinj (glejte sliko L).
Injecting cold Palynziq can be uncomfortable.
Vbrizgavanje mrzlega zdravila Palynziq je lahko neprijetno.
The pharmacokinetics of pegvaliase exhibit high inter-patient and intra-patient variability due to the heterogeneity of the immune response in adult patients with PKU.
Farmakokinetika pegvaliaze kaže visoko inter- in intravariabilnost bolnikov, in sicer zaradi heterogenosti imunskega odziva pri odraslih bolnikih s PKU.
The mean (SD) duration of these reactions was 64 (78) days, and the maximum duration was 638 days, 5% of these reactions persisted at least 180 days, and 86% of these reactions resolved by the time of the data cut-off.
Povprečno (SD) trajanje teh reakcij je znašalo 64 (78) dni, najdaljše trajanje je znašalo 638 dni, 5 % teh reakcij je vztrajalo vsaj 180 dni, pri čemer se je 86 % teh reakcij odpravilo do datuma prenehanja zbiranja podatkov.
In clinical studies, anti-PAL, anti-PEG and anti-pegvaliase have been identified as IgG and IgM mainly.
V kliničnih študijah so bila protitelesa proti PAL, PEG in pegvaliazi večinoma prepoznana kot protitelesa razredov IgG in IgM.
Prescribing physician should continue or consider resuming use of premedication.
Zdravnik, ki je predpisal zdravilo, bi moral nadaljevati dajanje premedikacije ali razmisliti o ponovnem dajanju premedikacije.
Thus, mean dose levels also stabilized with long-term treatment with sustained therapeutic effect.
Povprečna količina odmerka se je tako pri dolgotrajnem zdravljenju stabilizirala in terapevtski učinek se je ohranil.
• The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
• Izobraževalno gradivo za zdravnika mora vsebovati: o povzetek glavnih značilnosti zdravila; o vodnik za zdravstvene delavce.
Pegvaliase plasma exposure was primarily driven by immune response to pegvaliase.
Plazemska izpostavljenost pegvaliazi je bila primarno odvisna od imunskega odziva na pegvaliazo.
Palynziq can cause severe allergic reactions that may be life-threatening and these can happen any time after a Palynziq injection.
Zdravilo Palynziq lahko povzroči hude alergijske reakcije, ki so lahko življenjsko nevarne, do njih pa lahko pride kadar koli po injekciji zdravila Palynziq.
The PEG molecule is expected to be primarily eliminated by renal filtration.
Pričakuje se, da se molekula PEG primarno izloči s filtracijo v ledvicah.
Pegvaliase is rAvPAL conjugated with linear 20 kDa NHS-PEG at a degree of substitution of 28 to 44 moles of polymer/mole of protein.
Pegvaliaza je konjugat beljakovine rAvPAL z linearnim NHS-PEG mase 20 kDa pri stopnji substitucije 28-44 molov za polimer/mol beljakovine.
4 Abdominal pain reflects the following terms: abdominal pain, abdominal pain upper and abdominal discomfort.
4 Bolečine v trebuhu zajemajo naslednje izraze: bolečine v trebuhu, bolečine v zgornjem delu trebuha in neugodje v trebuhu.
Do not divide your daily dose throughout the day.
Dnevnega odmerka si ne razdelite na več manjših odmerkov čez dan.
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).
Podlestvica za nepozornost v okviru ADHD-RS IV vsebuje vrednosti od 0 do 27, pri čemer višje vrednosti pomenijo višjo stopnjo motnje, vrednost pod 9 pa pomeni, da bolnik nima simptomov (tj. ima vrednost, ki je v normativnem razponu).
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)
Nemudoma se obrnite na zdravnika, če se pojavi: - vrsta alergijske reakcije, imenovane serumska bolezen, ki vključuje kombinacijo vročine (povišana telesna temperatura), izpuščaja ter bolečin v mišicah in sklepih (pogosta - pojavi se lahko pri največ 1 od 10 bolnikov).
Supplies you will need for your Palynziq Injection:
Pripomočki, ki jih boste potrebovali za injekcijo zdravila Palynziq:
Four out of 16 (1%; 4/285) patients experienced a total of 5 episodes of acute systemic hypersensitivity reactions that were considered severe (see sections 4.3 and 4.8).
Pri štirih od 16 (1 %; 4/285) bolnikov se je pojavilo skupno 5 epizod akutnih sistemskih preobčutljivostnih reakcij, ki so se štele za hude (glejte poglavji 4.3 in 4.8).
• Before you inject Palynziq, check each carton and syringe to make sure you have the right pre-filled syringe for your prescribed dose.
• Preden vbrizgate zdravilo Palynziq, preglejte posamezne škatle in injekcijske brizge ter se prepričajte, da imate ustrezno napolnjeno injekcijsko brizgo za predpisani odmerek.
• 1 sharps disposal or puncture resistant container
• 1 vsebnik za odlaganje ostrih predmetov ali vsebnik, odporen na vbode
Injection site reactions were reported in 266 out of 285 (93%) patients.
O reakcijah na mestu injiciranja so poročali pri 266 od 285 (93 %) bolnikov.
Keep the adrenaline injection device with you at all times.
Pripomoček za injekcijo adrenalina imejte vedno pri sebi.
All patients treated with Palynziq developed a sustained total anti-pegvaliase antibody (TAb) response with a majority of patients (91%) becoming positive by Week 4.
Pri vseh bolnikih, zdravljenih z zdravilom Palynziq, se je razvil trajen odziv skupnih protiteles proti pegvaliazi („total anti-pegvaliase antibodies“ - TAb), pri čemer so bili rezultati večine bolnikov (91 %) pozitivni do 4. tedna.
Neutralising antibodies (NAb) capable of inhibiting PAL enzyme activity were detected in a majority of patients over time with 78% of patients testing positive for NAb at one year after treatment initiation and maintaining stable NAb titres through long-term treatment.
Nevtralizacijska protitelesa („neutralising antibodies“ - NAb), ki lahko inhibirajo aktivnost encima PAL, so bila sčasoma zaznana pri večini bolnikov, pri čemer so bili pri 78 % bolnikov rezultati za NAb pozitivni eno leto po začetku zdravljenja, pri dolgotrajnem zdravljenju pa so se ohranili stabilni titri NAb.
Three of these patients experienced severe serum sickness (3/285; 1%), which resulted in treatment discontinuation (2 patients) or treatment interruption (1 patient).
Pri treh od teh bolnikov je prišlo do hude serumske bolezni (3/285; 1 %), zaradi česar so se prenehali zdraviti (2 bolnika) oziroma so zdravljenje začasno prekinili (1 bolnik).
Do not share your pre-filled syringes with anyone else.
Napolnjenih injekcijskih brizg ne delite z nikomer.
Palynziq has a minor influence on the ability to drive and use machines.
Zdravilo Palynziq ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
Škodljivi učinki pegvaliaze na razmnoževanje in razvoj podgan in zajcev so bili odvisni od odmerka in so vključevali manjšo stopnjo implantiranja, manjše leglo, manjšo težo ploda in večje spremembe pri plodu.
Exposure-effect
Vpliv izpostavljenosti
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