natgillin/translations-raw huggingface dataset:
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).
Of the 164 patients that entered the eligibility period of Study 302, 86 patients met the eligibility criterion (achieved at least 20% mean blood phenylalanine reduction from pre-treatment baseline at their randomised dose within 13 weeks) and continued to the RDT, 12 patients discontinued treatment, and 57 patients did not enter the RDT and continued Palynziq treatment in the long-term extension period of Study 302, where they were allowed to increase dose.
Od 164 bolnikov, ki so bili vključeni v obdobje ocenjevanja primernosti študije 302, je 86 bolnikov izpolnjevalo merilo primernosti (doseženo vsaj 20-odstotno znižanje povprečne ravni fenilalanina v krvi glede na izhodiščno vrednost pred zdravljenjem pri randomiziranem odmerku v 13 tednih) in so bili vključeni v obdobje preskušanja z randomiziranim prenehanjem dajanja zdravila (RDT), 12 bolnikov se je prenehalo zdraviti, 57 bolnikov pa ni bilo vključenih v obdobje RDT in je nadaljevalo zdravljenje z zdravilom Palynziq v dolgotrajnem podaljšanem obdobju študije 302, v katerem je bilo mogoče povečati odmerek.
The contribution of maternal phenylalanine depletion to the incidence of embryo-foetal developmental effects was not evaluated.
Vpliv znižanja ravni fenilalanina pri materi na incidenco učinkov na razvoj zarodka/ploda se ni ocenjeval.
All 16 patients who experienced acute systemic hypersensitivity reactions tested negative for pegvaliase-specific IgE at or near the time of the acute systemic hypersensitivity reactions episode.
Vseh 16 bolnikov, pri katerih so se pojavile akutne sistemske preobčutljivostne reakcije, je imelo negativne rezultate za protitelesa razreda IgE, specifična za pegvaliazo, v času, ko je prišlo do epizode akutne sistemske preobčutljivostne reakcije.
Patients should be instructed to carry adrenaline injection device with them at all times during Palynziq treatment.
Bolnikom je treba naročiti, naj imajo med zdravljenjem z zdravilom Palynziq pripomoček za injiciranje adrenalina vedno pri sebi.
Arthralgia episodes were managed with concomitant medicinal products (e.g., nonsteroidal anti-inflammatory drugs, glucocorticoids, and/or antipyretic), dose reduction (4% of episodes), treatment interruption (4% of episodes), or treatment withdrawal (0.6% of episodes), and 97% of arthralgia episodes resolved by the time of the data cut-off.
Epizode artralgije so bile obravnavane s sočasno uporabo zdravil (npr. nesteroidnimi protivnetnimi zdravili, glukokortikoidi in/ali antipiretiki), zmanjšanjem odmerka (4 % epizod), prekinitvijo zdravljenja (4 % epizod) ali trajno prekinitvijo zdravljenja (0,6 % epizod), pri čemer se je 97 % epizod artralgije odpravilo do datuma prenehanja zbiranja podatkov.
• The patient information pack should contain: o The patient information leaflet o The guide for patients and trained observers o The patient alert card
• Komplet z informacijami za bolnika mora vsebovati: o navodilo za uporabo; o vodnik za bolnike in usposobljene opazovalce; o opozorilno kartico za bolnika.
1 ml pre-filled syringe made of Type I borosilicate glass, equipped with a stainless steel 26 gauge needle, needle safety device, polypropylene plunger rod, and chlorobutyl rubber syringe stopper with fluoropolymer coating.
1-mililitrska napolnjena injekcijska brizga iz borosilikatnega stekla tipa I, opremljena z iglo 26 G iz nerjavnega jekla, ščitnikom igle, batom iz polipropilena in zamaška injekcijske brizge iz klorobutilne gume s prevleko iz fluoropolimera.
Acute systemic hypersensitivity reactions were managed by administration of adrenaline (44%; 11/25 episodes), corticosteroids (56%; 14/25 episodes), antihistamines (56%; 14/25 episodes), and/or oxygen (8%; 2/25 episodes).
Akutne sistemske preobčutljivostne reakcije so bile obravnavane z uporabo adrenalina (44 %; 11/25 epizod), kortikosteroidov (56 %; 14/25 epizod), antihistaminikov (56 %; 14/25 epizod) in/ali kisika (8 %; 2/25 epizod).
Refer to the adrenaline product information for complete information.
Za celotne informacije glejte informacije o adrenalinu.
- The other ingredients are trometamol, trometamol hydrochloride, sodium chloride (see section 2 for further information), trans-cinnamic acid, water for injections.
- Druge sestavine so trometamol, trometamol hidroklorid, natrijev klorid (za več informacij glejte poglavje 2), trans-cinamična kislina, voda za injekcije.
These findings occurred in the presence of maternal toxicity (decreased body weights, decreased ovarian weights, and decreased food consumption) and were associated with markedly decreased maternal blood phenylalanine below normal levels in non-PKU animals.
Do teh ugotovitev je prišlo v primeru toksičnosti pri materi (manjša telesna teža, manjša teža jajčnikov, manj zaužite hrane), povezane pa so bile z ravnjo fenilalanina v krvi matere, ki je bila znatno pod normalno ravnjo, in sicer pri živalih brez PKU.
EU/1/19/1362/001 1 x 2.5 mg pre-filled syringe EU/1/19/1362/002 1 x 10 mg pre-filled syringe EU/1/19/1362/003 1 x 20 mg pre-filled syringe EU/1/19/1362/004 10 x 20 mg pre-filled syringes
EU/1/19/1362/001 1 x 2,5-miligramska napolnjena injekcijska brizga EU/1/19/1362/002 1 x 10-miligramska napolnjena injekcijska brizga EU/1/19/1362/003 1 x 20-miligramska napolnjena injekcijska brizga EU/1/19/1362/004 10 x 20-miligramskih napolnjenih injekcijskih brizg
The mean duration of arthralgia was 15 days and ranged 1 day to 936 days; 78% of arthralgia episodes had a duration of less than 14 days, and 1% of arthralgia episodes persisted at least 180 days.
Povprečno trajanje artralgije je bilo 15 dni, pri čemer je znašalo od 1 do 936 dni; 78 % epizod artralgije je trajalo manj kot 14 dni in 1 % epizod artralgije je vztrajal vsaj 180 dni.
Severe systemic hypersensitivity reaction or recurrence of a mild to moderate acute systemic hypersensitivity reaction to pegvaliase, any of the excipients listed in section 6.1, or another PEGylated medicinal product (see section 4.4).
Huda sistemska preobčutljivostna reakcija ali ponovitev blage do zmerne akutne sistemske preobčutljivostne reakcije na pegvaliazo, katero koli pomožno snov, navedeno v poglavju 6.1, ali drugo pegilirano zdravilo (glejte poglavje 4.4).
You and your doctor will decide the best way for you to manage your blood phenylalanine levels.
Z zdravnikom se bosta skupaj odločila, kateri je za vas najboljši način za uravnavanje ravni fenilalanina v krvi.
• This medicine comes in pre-filled syringes with 3 different strengths (2.5 mg-white plunger, 10 mg-green plunger, or 20 mg-blue plunger).
• To zdravilo je v 3 različnih jakostih na voljo v napolnjenih injekcijskih brizgah (2,5-miligramska z belim batom, 10-miligramska z zelenim batom ali 20-miligramska z modrim batom).
Take out the required number of cartons needed for your dose from the refrigerator.
Iz hladilnika vzemite toliko škatel, kot jih potrebujete za svoj odmerek.
Patients who develop hypophenylalaninaemia should be monitored every 2 weeks until blood phenylalanine level is within a clinically acceptable range.
Bolnike, pri katerih se razvije hipofenilalaninemija, je treba spremljati vsaka 2 tedna, dokler raven fenilalanina v krvi ni v klinično sprejemljivem razponu.
The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation.
Jakost označuje količino dela fenilalanin amoniakliaze (rAvPAL) pegvaliaze brez upoštevanja pegilacije.
Mean (SD) Median n=172
Povprečje (SD) Mediana n = 172
Because antibodies bind to the PEG portion of pegvaliase, there may be potential for binding with other PEGylated therapeutics and increased hypersensitivity to other PEGylated injectables.
Protitelesa se vežejo na del PEG pegvaliaze, zato lahko obstaja možnost za vezavo z drugimi pegiliranimi zdravili in povečano preobčutljivost na druga pegilirana zdravila za injiciranje.
• Your doctor will need to check your blood phenylalanine monthly to see if this medicine is working for you.
• Zdravnik vam bo raven fenilalanina v krvi moral preveriti vsak mesec, da bo ugotovil, ali zdravilo deluje.
The automatic needle guard is composed of a polycarbonate transparent needle guard and a stainless steel spring inside the needle guard.
Samodejni ščitnik igle je sestavljen iz prosojnega ščitnika igle iz polikarbonata in vzmeti iz nerjavnega jekla, ki je v notranjosti ščitnika igle.
Symptoms of allergic reaction can include skin rash, itching, swelling of head or face, itchy or runny eyes, cough, and wheezing.
Simptomi alergijske reakcije lahko vključujejo kožni izpuščaj, srbenje, otekanje glave ali obraza, srbeče oči ali izcedek iz oči, kašelj in piskanje v pljučih.
For at least the first 6 months of treatment when the patient is self-injecting (i.e. when administration is not under healthcare professional supervision), an observer must be present during and for at least 60 minutes after each administration.
Vsaj prvih 6 mesecev zdravljenja, ko si bolnik zdravilo injicira sam (tj. ko uporaba zdravila ne poteka pod nadzorom zdravstvenega delavca), mora biti pri vsakem injiciranju in vsaj 60 minut po njem prisoten opazovalec.
Date removed from refrigeration: _____/_____/______ Peel here
Datum, ko se je zdravilo vzelo iz hladilnika: _____/_____/______ Odlepite tukaj
There are no or limited amount of data from the use of Palynziq in pregnant women.
Podatkov o uporabi zdravila Palynziq pri nosečnicah ni oziroma so omejeni.
If your blood phenylalanine levels are too low, your doctor may ask you to change your diet and/or will lower your dose of Palynziq.
Če boste imeli prenizko raven fenilalanina v krvi, vam bo zdravnik lahko naročil, da spremenite dieto, in/ali zmanjšal odmerek zdravila Palynziq.
See section 4 for details on what to do based on your symptoms.
Za podrobnosti o ukrepanju glede na simptome glejte poglavje 4.
o Your doctor will train them on the signs and symptoms of a severe allergic reaction and how to give an injection of adrenaline.
o Vaš zdravnik bo to osebo poučil o tem, kako prepoznati znake in simptome hude alergijske reakcije ter kako vam dati injekcijo adrenalina.
• Your doctor will also prescribe adrenaline injection device to use for any severe allergic reactions.
• Zdravnik vam bo predpisal tudi pripomoček za injekcijo adrenalina, ki ga uporabite v primeru kakršne koli hude alergijske reakcije.
Instructions for the preparation and administration of Palynziq are given in the package leaflet.
Navodila za pripravo in dajanje zdravila Palynziq so navedena v navodilu za uporabo.
• Lower part of the abdomen except for the 5 centimetre area around the belly button (navel).
• spodnji del trebuha z izjemo območja 5 centimetrov okoli popka.
At baseline, 149 (57%) patients were receiving part of their total protein intake from medical food and 41 out of 261 (16%) patients were on a phenylalanine-restricted diet (defined as receiving greater than 75% of total protein intake from medical food).
V izhodišču je 149 (57 %) bolnikov del svojega skupnega vnosa beljakovin prejemalo z živili za posebne zdravstvene namene, 41 od 261 (16 %) bolnikov pa je bilo na dieti z omejenim vnosom fenilalanina (kar pomeni, da so več kot 75 % skupnega vnosa beljakovin prejeli z živili za posebne zdravstvene namene).
1 week2
1 teden2
3 Post-baseline ADHD-inattention/PKU-POMS confusion values were mapped to the closest 3-month visit (i.e. within a 3-month window).
³ Vrednosti za nepozornost v okviru ADHD/zmedenost po PKU/POMS, pridobljene po izhodiščni vrednosti, so bile pripisane najbližjemu obisku v 3 mesecih (tj. v obdobju 3 mesecev).
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.
Analiza farmakokinetike/farmakodinamike, opravljena s podatki iz faze III, je pokazala obratni odnos med izpostavljenostjo pegvaliazi in odzivom pri fenilalaninu, na katerega je morda vplival vnos fenilalanina s hrano.
Patients continued Palynziq treatment in the long-term open-label extension period and dose was adjusted (5, 10, 20, 40 and 60 mg/day) by the physician to achieve further blood phenylalanine reductions and maintain previously achieved phenylalanine levels.
Bolniki so zdravljenje z zdravilom Palynziq nadaljevali v dolgotrajnem nezaslepljenem podaljšanem obdobju, zdravnik pa jim je prilagodil odmerek (5, 10, 20, 40 in 60 mg/dan), da bi se doseglo nadaljnje znižanje ravni fenilalanina v krvi in vzdrževale predhodno dosežene ravni fenilalanina.
What you need to know before you use Palynziq
Kaj morate vedeti, preden boste uporabili zdravilo Palynziq
During early treatment (less than 6 months after Palynziq administration) when immune-mediated clearance was high, and doses were low, patients with higher antibody titres achieved less blood phenylalanine reduction.
V zgodnjem obdobju zdravljenja (manj kot 6 mesecev po dajanju zdravila Palynziq), ko je bil očistek z imunskim odzivom velik, odmerki pa majhni, so bolniki z višjo vrednostjo titrov protiteles dosegli manjše znižanje ravni fenilalanina v krvi.
If a caregiver is giving the injection, the top of the buttocks and the back of the upper arms may also be used (see Figure E).
Če vam injekcijo daje negovalec, sta primerni mesti tudi zgornji del zadnjice in hrbtni del nadlakti (glejte sliko E).
Acute systemic hypersensitivity reactions
Akutne sistemske preobčutljivostne reakcije
Hold the middle of the pre-filled syringe body and take out the pre-filled syringe from the tray (see Figure C).
Primite srednji del telesa napolnjene injekcijske brizge in jo vzemite s pladnja (glejte sliko C).
Palynziq is not recommended during pregnancy, unless the clinical condition of the woman requires treatment with pegvaliase and alternative strategies to control phenylalanine levels have been exhausted.
Zdravilo Palynziq se ne priporoča med nosečnostjo, razen če je zaradi kliničnega stanja nosečnice potrebno zdravljenje s pegvaliazo in so bile druge strategije uravnavanja ravni fenilalanina izčrpane.
If hypophenylalaninaemia develops once daily dosing is reached, the dose may be reduced by at least 10 mg decrements to achieve and maintain blood phenylalanine levels in the clinically acceptable range.
Če se hipofenilalaninemija razvije, ko se doseže dnevno odmerjanje, se lahko odmerek zmanjšuje po vsaj 10 mg, s čimer se dosežejo ravni fenilalanina v krvi v klinično sprejemljivem razponu in se tam vzdržujejo.