FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients or caregiver should be advised to rotate sites for subcutaneous injections.
Croatian: Bolesnike i njegovatelje treba savjetovati da mijenjaju mjesta primjene supkutanih injekcija.
English: Adverse reactions were similar in type and frequency to that of adult patients.
Croatian: Nuspojave su bile slične po vrsti i učestalosti onima u odraslih bolesnika.
English: Can be stored outside the refrigerator (below 25°C) for a single period up to 30 days.
Croatian: Može se čuvati izvan hladnjaka (ispod 25°C) u jednokratnom razdoblju do 30 dana.
English: Your doctor will prescribe an adrenaline injection device to use for a severe allergic reaction.
Croatian: Vaš liječnik će Vam propisati uređaj za injekciju adrenalina za primjenu kod teške alergijske reakcije.
English: In the double-blind, placebo-controlled RDT, patients were randomised in a 2:1 ratio to either continue their randomised dosing (20 mg/day or 40 mg/day) or receive matching placebo for 8 weeks.
Croatian: U dvostruko slijepom, placebom kontroliranom RDT, bolesnici su randomizirani u omjeru 2:1 za nastavak primjene randomizirane doze (20 mg/dan ili 40 mg/dan) ili za primjenu odgovarajućeg placeba tijekom 8 tjedana.
English: - The other ingredients are trometamol, trometamol hydrochloride, sodium chloride (see section 2 for further information), trans-cinnamic acid, water for injections.
Croatian: - Drugi sastojci su trometamol, trometamolklorid, natrijev klorid (za daljnje informacije pogledajte dio 2), trans-cimetna kiselina, voda za injekcije.
English: Palynziq contains the active substance pegvaliase, an enzyme that can break down a substance called phenylalanine in the body.
Croatian: Palynziq sadrži djelatnu tvar pegvaliazu, enzim koji u tijelu može razgraditi tvar koja se zove fenilalanin.
English: In cynomolgus monkeys, the incidence and severity of arterial inflammation was dose dependent and observed in a wide range of organs and tissues at clinically relevant exposures in the 4- and 39-week repeat-dose toxicology studies.
Croatian: U cynomolgus (makaki) majmuna, incidencija i težina arterijske upale ovisile su o dozi i zabilježene su u velikom broju organa i tkiva pri klinički značajnim izloženostima u toksikološkim ispitivanjima ponovljenih doza u trajanju od 4 i 39 tjedana.
English: After removal from the refrigerator, the product must not be returned to the refrigerator.
Croatian: Nakon vađenja iz hladnjaka, lijek se ne smije više vraćati u hladnjak.
English: For storage instructions, refer to section 5 “How to store Palynziq” of this leaflet.
Croatian: Za upute o čuvanju pogledajte dio 5 „Kako čuvati Palynziq” u ovim uputama.
English: Hives (like an itchy, bumpy skin rash) that spreads quickly Flushing
Croatian: Koprivnjača (kao osip koji svrbi, s kvržicama na koži) koja se brzo širi
English: In clinical trials, 213 out of 285 (75%) patients experienced hypersensitivity reactions.
Croatian: U kliničkim ispitivanjima, 213 od 285 (75%) bolesnika imalo je reakcije preosjetljivosti.
English: What you need to know before you use Palynziq
Croatian: Što morate znati prije nego počnete primjenjivati Palynziq
English: In clinical trials, 16 out of 285 (6%) patients experienced 25 acute systemic hypersensitivity reactions of any severity.
Croatian: U kliničkim ispitivanjima, 16 od 285 (6%) bolesnika imalo je 25 akutnih sistemskih reakcija preosjetljivosti neke težine.
English: For at least the first 6 months of treatment, someone must be with you when you are self-injecting
Croatian: Tijekom najmanje prvih 6 mjeseci liječenja, netko mora biti uz Vas dok si dajete injekciju lijeka Palynziq.
English: Once stored outside of refrigeration, the product must not be returned to the refrigerator.
Croatian: Nakon čuvanja izvan hladnjaka, lijek se ne smije više vraćati u hladnjak.
English: Adverse reaction(s) Induction/Titration1 Maintenance
Croatian: Indukcija/Titracija1 Održavanje
English: • Your doctor will need to check your blood phenylalanine monthly to see if this medicine is working for you.
Croatian: • Vaš liječnik će Vam provjeravati razinu fenilalanina u krvi jedanput mjesečno kako bi provjerio djeluje li ovaj lijek za Vas.
English: Take out the required number of cartons needed for your dose from the refrigerator.
Croatian: Uzmite iz hladnjaka onoliko kutija koliko je potrebno za dozu koja Vam je propisana.
English: The most common hypersensitivity reactions (occurring in at least 10% of patients) were rash, urticaria, and hypersensitivity.
Croatian: Najčešće reakcije preosjetljivosti (javile su se u najmanje 10% bolesnika) bile su osip, urtikarija i preosjetljivost.
English: No differences were observed in inattention and mood between patients randomised to placebo versus those randomised to Palynziq during this 8-week duration.
Croatian: Tijekom ovih 8 tjedana nisu zabilježene razlike u nepažnji i raspoloženju među bolesnicima randomiziranim za primanje placeba u usporedbi s onima koji su primali lijek Palynziq.
English: Blood phenylalanine1
Croatian: Fenilalanin u krvi1
English: If needed, you may store Palynziq in its sealed tray outside the refrigerator (below 25°C) for up to a single period of 30 days away from sources of heat.
Croatian: Ako je potrebno, Palynziq možete čuvati u zatvorenom podlošku izvan hladnjaka (ispod 25°C) tijekom jednokratnog razdoblja do 30 dana dalje od izvora topline.
English: Use a new pre-filled syringe for your injection.
Croatian: Za svoju injekciju uzmite novu napunjenu štrcaljku.
English: Your doctor will check your blood phenylalanine levels every 2 weeks until your blood phenylalanine levels return to normal.
Croatian: Liječnik će Vam provjeravati razine fenilalanina u krvi svaka 2 tjedna dok se razine vrate u granice normale.
English: Swelling of the face, eyes, lips, mouth, throat, tongue, hands and/or feet Trouble breathing or wheezing
Croatian: Oticanje lica, očiju, usana, usta, grla, jezika, dlanova i/ili stopala Poteškoće s disanjem ili piskanje u plućima Stezanje u grlu ili osjećaj gušenja
English: Four out of 16 (1%; 4/285) patients experienced a total of 5 episodes of acute systemic hypersensitivity reactions considered severe based on the presence of: cyanosis or oxygen saturation (SpO2) less than or equal to 92%, hypotension (systolic blood pressure below 90 mm Hg in adults) or syncope.
Croatian: Četiri od 16 (1%; 4/285) bolesnika imalo je ukupno 5 epizoda akutne sistemske reakcije preosjetljivosti koje su se smatrale teškima na temelju prisutnosti: cijanoze ili zasićenja kisikom (SpO2) ≤ 92%, hipotenzije (sistolički krvni tlak ispod 90 mmHg u odraslih) ili sinkope.
English: ≤ 600 micromol/l by 12 months, 24 months, and 36 months, respectively;
Croatian: ≤ 600 mikromola/l do 12. mjeseca, 24. mjeseca odnosno 36. mjeseca;
English: Table 2: Adverse reactions in patients treated with Palynziq System organ class
Croatian: Tablica 2: Nuspojave u bolesnika liječenih lijekom Palynziq Klasifikacija organskih sustava
English: If hypophenylalaninaemia develops prior to reaching daily dosing, the dose may be reduced to the previous titration dose.
Croatian: Ako se hipofenilalaninemija javi prije postizanja dnevnog doziranja, doza lijeka Palynziq može se smanjiti na prethodnu dozu titracije.
English: 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.
Croatian: Od 164 bolesnika koja su bila uključena u razdoblje podobnosti Ispitivanja 302, 86 bolesnika zadovoljilo je kriterij podobnosti (unutar 13 tjedana je pri svojoj randomiziranoj dozi postiglo najmanje 20% srednje vrijednosti smanjenja koncentracije fenilalanina u krvi u odnosu na početne vrijednosti prije liječenja) i nastavilo je u RDT, 12 bolesnika prekinulo je liječenje, a 57 bolesnika nije ušlo u RDT već je nastavilo liječenje lijekom Palynziq u razdoblju dugotrajnog nastavka Ispitivanja 302, gdje im je bilo dopušteno povećati dozu.
English: Symptoms of allergic reaction can include skin rash, itching, swelling of head or face, itchy or runny eyes, cough, and wheezing.
Croatian: Simptomi alergijske reakcije mogu uključiti kožni osip, svrbež, oticanje glave ili lica, svrbež u očima ili suzne oči, kašalj i piskanje u plućima.
English: o Swelling of the face, eyes, lips, mouth, throat, tongue, hands and/or feet o Trouble breathing or wheezing o Throat tightness or a choking feeling o Trouble swallowing or speaking o Feeling dizzy or fainting o Losing control of urine or stools o Rapid heartbeat o Hives (like an itchy, bumpy skin rash) that spreads quickly o Flushing o Severe stomach cramps or pain, vomiting, or diarrhoea
Croatian: o Oticanje lica, očiju, usana, usta, grla, jezika, dlanova i/ili stopala o Poteškoće s disanjem ili piskanje u plućima o Stezanje u grlu ili osjećaj gušenja o Poteškoće s gutanjem ili govorom o Osjećaj omaglice ili nesvjestice o Gubitak kontrole mokrenja ili stolice o Ubrzan rad srca o Koprivnjača (kao osip koji svrbi, s kvržicama na koži) koja se brzo širi o Naleti crvenila o Teški grčevi ili bol u trbuhu, povraćanje ili proljev
English: Step 10: Pull the needle cap straight off the needle (see Figure J).
Croatian: Korak 10: Povucite kapicu igle ravno sa igle (pogledajte Sliku J).
English: 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 (see section 4.2, Method of administration).
Croatian: Najmanje prvih 6 mjeseci liječenja, kad bolesnik sam sebi daje injekcije (tj. kad primjena nije pod nadzorom zdravstvenog radnika), promatrač mora biti prisutan tijekom svake primjene i najmanje 60 minuta nakon svake primjene (vidjeti dio 4.2, Način primjene).
English: • For at least the first 6 months of Palynziq treatment, you must have someone with you when you self-inject Palynziq, and for at least 1 hour after your injection to watch for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of adrenaline and call for emergency medical help.
Croatian: • Tijekom najmanje prvih 6 mjeseci liječenja lijekom Palynziq, dok si dajete injekciju lijeka Palynziq morate imati drugu osobu sa sobom koja će ostati najmanje 1 sat nakon injekcije i pratiti zbog moguće pojave znakova i simptoma teške alergijske reakcije te Vam, ako je potrebno, dati injekciju adrenalina i pozvati hitnu medicinsku službu.
English: Figure 1: Mean (SE) phenylalanine levels over time
Croatian: Slika 1: Srednja vrijednost (standardna pogreška) razine fenilalanina tijekom vremena
English: Palynziq contains sodium
Croatian: Palynziq sadrži natrij
English: - decrease in complement factors C3 and C4 proteins (which are parts of your immune system) in blood test - allergic reaction - too low levels of phenylalanine in blood tests - headache - skin rash - stomach pain - feeling sick, also called nausea - vomiting - hives (raised itchy rash on the skin) - itchiness - thinning or loss of hair - cough - increase in c-reactive protein (CRP) in blood test (CRP is a protein that indicates that you have inflammation) - swollen glands in the neck, armpit or groin - skin redness - muscle pain
Croatian: Palynziq - bol u zglobovima - smanjenje proteina komponenti C3 i C4 komplementa (koji su dijelovi vašeg imunološkog sustava) u krvnim pretragama - alergijska reakcija - preniske razine fenilalanina u krvnim pretragama - glavobolja - kožni osip - bol u trbuhu - mučnina - povraćanje - koprivnjača (osip koji svrbi, s uzdignućima na koži) - svrbež - stanjivanje ili gubitak kose - kašalj - povećanje c-reaktivnog proteina (CRP) u krvnim pretragama (CRP je protein koji ukazuje na upalu) - oticanje žlijezda u vratu, pazuhu i preponama - crvenilo kože - bol u mišićima
English: • Do not inject into moles, scars, birthmarks, bruises, rashes, or areas where the skin is hard, tender, red, damaged, burned, inflamed, or tattooed.
Croatian: • Nemojte injicirati u madeže, ožiljke, urođene promjene kože, modrice, kožni osip ili područja gdje je koža tvrda, osjetljiva, crvena, oštećena, opečena, upaljena ili tetovirana.
English: For severe systemic hypersensitivity reactions or recurrence of a mild to moderate acute systemic hypersensitivity reaction, patients should seek immediate medical care and Palynziq should be permanently discontinued (see section 4.3).
Croatian: Za teške sistemske reakcije preosjetljivosti ili ponavljajuće blage do umjerene akutne sistemske reakcije preosjetljivosti, bolesnici trebaju odmah potražiti medicinsku pomoć, a primjenu lijeka Palynziq treba odmah trajno prekinuti (vidjeti dio 4.3).
English: • Your doctor will then slowly increase your dose and/or how often you inject Palynziq.
Croatian: • Liječnik će Vam zatim polako povećavati dozu i/ili učestalost injiciranja lijeka Palynziq.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za jednokratnu uporabu.
English: In clinical trials, 21 out of 285 (7%) patients experienced 37 episodes of mild to moderate episodes of angioedema (symptoms include one or more of the following: pharyngeal oedema, swollen tongue, lip swelling, mouth swelling, eyelid oedema and face oedema) occurring independent of acute systemic hypersensitivity reactions.
Croatian: U kliničkim ispitivanjima, u 21 od 285 bolesnika (7%) bilo je 37 epizoda blagog do umjerenog angioedema (simptomi uključuju jedno ili više od sljedećeg: edem ždrijela, otečen jezik, oticanje usana, oticanje usta, edem kapaka i edem lica) koji se javio neovisno od akutne sistemske reakcije preosjetljivosti.
English: Anti-phenylalanine ammonia lyase (PAL) IgM was detected in all patients with a majority of treated patients (98%) becoming positive by 2 months.
Croatian: U svih bolesnika otkriven je anti-fenilalanin-amonij-lijaza (PAL) IgM s većinom liječenih bolesnika (98%) pozitivnom do 2. mjeseca.
English: Palynziq should not be injected into moles, scars, birthmarks, bruises, rashes, or areas where the skin is hard, tender, red, damaged, burned, inflamed, or tattooed.
Croatian: Palynziq se ne smije injicirati u madeže, ožiljke, urođene promjene kože, modrice, kožni osip ili područja gdje je koža tvrda, osjetljiva, crvena, oštećena, opečena, upaljena ili tetovirana.
English: In clinical trials, 125 out of 285 (44%) patients developed a total of 237 episodes of hypophenylalaninaemia (blood phenylalanine levels below 30 micromol/l on two consecutive measurements).
Croatian: U kliničkim ispitivanjima, 125 od 285 (44%) bolesnika imalo je ukupno 237 epizoda hipofenilalaninemije (razina fenilalanina u krvi ispod 30 mikromola/l pri dva uzastopna mjerenja).
English: Patients with higher antibody titres required higher doses to overcome clearance and achieve blood phenylalanine reduction.
Croatian: Za bolesnike s povišenim titrima protutijela bile su potrebne veće doze kako bi prevladali klirens i postigli smanjenje fenilalanina u krvi.
English: It is unknown whether pegvaliase is excreted in human milk.
Croatian: Nije poznato izlučuje li se pegvaliaza u majčino mlijeko.
English: LS mean change from Study 302 RDT baseline to Week 8 (95% CI)
Croatian: LS srednja vrijednost promjene od početne vrijednosti u RDT Ispitivanja 302 do 8. tjedna (95% CI)
English: Talk to your doctor before stopping Palynziq treatment.
Croatian: Obratite se svom liječniku prije nego prestanete primjenjivati lijek Palynziq.
English: Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Croatian: Palynziq je indiciran za liječenje bolesnika s fenilketonurijom (PKU) u dobi od 16 godina i starijih koji imaju neadekvatnu kontrolu fenilalanina u krvi (razine fenilalanina u krvi veće od 600 mikromola/l) unatoč prethodnom liječenju dostupnim opcijama liječenja.
English: Following maturation of the early immune response (more than 6 months after Palynziq administration), and dose adjustment for managing blood phenylalanine control in long-term treatment, mean blood phenylalanine levels continued to decrease in patients who continued treatment (see section 5.1).
Croatian: Nakon sazrijevanja ranog imunološkog odgovora (više od 6 mjeseci nakon primjene lijeka Palynziq) i prilagodbe doze radi kontrole koncentracije fenilalanina u krvi tijekom dugotrajnog liječenja, srednje vrijednosti razine fenilalanina u krvi nastavile su se smanjivati u bolesnika koji su nastavili liječenje (vidjeti dio 5.1).
English: 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
Croatian: EU/1/19/1362/001 1 napunjena štrcaljka od 2,5 mg EU/1/19/1362/002 1 napunjena štrcaljka od 10 mg EU/1/19/1362/003 1 napunjena štrcaljka od 20 mg EU/1/19/1362/004 10 napunjenih štrcaljki od 20 mg
English: ≤ 360 micromol/l by 12 months, 24 months, and 36 months, respectively.
Croatian: ≤ 360 mikromola/l do 12. mjeseca, 24. mjeseca odnosno 36. mjeseca.
English: The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation.
Croatian: Jačina pokazuje količinu fenilalanin-amonij-lijaza (rAvPAL) dijela pegvaliaze ne uzimajući u obzir pegilaciju.
English: Palynziq-treated patients were able to maintain their blood phenylalanine reductions compared to the placebo patients whose blood phenylalanine levels returned to their pre-treatment baseline levels after 8 weeks (p < 0.0001, see Table 3).
Croatian: Bolesnici liječeni lijekom Palynziq održavali su smanjenje koncentracije fenilalanina u krvi u usporedbi s bolesnicima koji su primali placebo u kojih se koncentracija fenilalanina u krvi nakon 8 tjedana vratila na vrijednosti koje su imali prije početka liječenja (p < 0,0001, vidjeti Tablicu 3).
English: In clinical trials, 16 out of 285 (6%) patients experienced 25 acute systemic hypersensitivity reactions of any severity based on acute onset of skin and/or mucosal tissue manifestations and at least either respiratory compromise or reduced blood pressure (or associated symptoms of end-organ dysfunction).
Croatian: U kliničkim ispitivanjima, 16 od 285 (6%) bolesnika imalo je 25 akutnih sistemskih reakcija preosjetljivosti neke težine na temelju akutnih manifestacija na koži i/ili mukoznom tkivu uz najmanje još slabljenje dišnih funkcija ili snižen krvni tlak (ili povezane simptome krajnje disfunkcije organa).
English: Palynziq may be stored in its sealed tray outside the refrigerator (below 25°C) for a single period up to 30 days with protection from sources of heat.
Croatian: Palynziq se može čuvati u zatvorenom podlošku izvan hladnjaka (ispod 25°C) u jednokratnom razdoblju do 30 dana zaštićen od izvora topline.
English: • Use adrenaline injection device as instructed by your doctor and seek urgent medical assistance.
Croatian: • Uređaj za injekciju adrenalina koristite prema uputama liječnika i potražite hitnu medicinsku skrb.
English: One of the two patients experienced a hypersensitivity reaction on day 15 after a single Palynziq dose within 15 minutes following medroxyprogesterone acetate, and subsequently experienced an acute systemic hypersensitivity reaction on day 89 within 30 minutes after the next dose of medroxyprogesterone acetate injectable suspension.
Croatian: Jedan od ta dva bolesnika imao je reakciju preosjetljivosti 15. dan nakon pojedinačne doze lijeka Palynziq unutar 15 minuta nakon primjene medroksiprogesteronacetata, a potom je 89. dan imao akutnu sistemsku reakciju preosjetljivosti unutar 30 minuta nakon primanja sljedeće doze suspenzije medroksiprogesteronacetata za injekciju.
English: 1 week2
Croatian: 1 tjedan2
English: 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.
Croatian: Bolesnika i promatrača treba uputiti kako prepoznati znakove i simptome akutnih sistemskih reakcija preosjetljivosti, kako pravilno primijeniti uređaj za injekciju adrenalina u hitnom slučaju te kako je potrebno zatražiti hitnu medicinsku skrb.
English: • 1 alcohol pad
Croatian: • 1 jastučić natopljen alkoholom
English: 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.
Croatian: Nekontrolirane razine fenilalanina u krvi (hiperfenilalaninemija) prije i tijekom trudnoće povezane su s povećanim rizikom od pobačaja, teških urođenih mana (uključujući mikrocefaliju i teške srčane malformacije), intrauterinog zastoja rasta fetusa te budućeg intelektualnog invaliditeta s niskim IQ. U slučaju hipofenilalaninemije tijekom trudnoće postoji rizik od intrauterinog zastoja rasta fetusa.
English: In clinical trials, adverse reaction rates were highest in induction and titration phases (time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose) coinciding with the period when titres of IgM and anti-PEG antibodies were highest.
Croatian: U kliničkim ispitivanjima, stope nuspojava bile su najveće u fazama indukcije i titracije (vrijeme do postizanja razine fenilalanina u krvi manje od 600 mikromola/l na stabilnoj dozi) što se podudaralo s razdobljem u kojem su titri IgM i anti-PEG protutijela bili najveći.
English: Patients who develop hypophenylalaninaemia should be monitored every 2 weeks until blood phenylalanine level is within a clinically acceptable range.
Croatian: Bolesnike u kojih se javila hipofenilalaninemija potrebno je pratiti svaka 2 tjedna dok razina fenilalanina u krvi ne bude unutar klinički prihvatljivog raspona.
English: 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.
Croatian: Tijekom ranog razdoblja liječenja (manje od 6 mjeseci nakon primjene lijeka Palynziq) dok je imunološki posredovan klirens bio visok, a doze niske, bolesnici s povišenim tritrima protutijela postigli su manje smanjenje fenilalanina u krvi.
English: At lower plasma pegvaliase Ctrough concentrations < 10,000 ng/ml, patients with higher dietary phenylalanine intake tend to have higher blood phenylalanine levels compared to patients with the same Ctrough concentration and lower dietary phenylalanine intake, suggesting saturation of the enzyme (i.e. rAvPAL).
Croatian: Pri nižim Ctrough koncentracijama pegvaliaze u plazmi (< 10 000 ng/ml), bolesnici s većim unosom fenilalanina prehranom obično imaju veće razine fenilalanina u krvi u usporedbi s bolesnicima s istom Ctrough koncentracijom i manjim unosom fenilalanina prehranom, što sugerira zasićenje enzima (tj. rAvPAL).
English: Mean anti-PAL (IgM and IgG) titres peaked 3 to 6 months post treatment initiation and were relatively stable through long-term treatment (greater than 1 year after pegvaliase initiation).
Croatian: Srednje vrijednosti anti-PAL (IgM i IgG) titara bile su najveće od 3 do 6 mjeseci nakon početka liječenja i ostale su relativno stabilne tijekom dugotrajnog liječenja (više od 1 godine nakon početka liječenja pegvaliazom).
English: Use adrenaline injection device as instructed by your doctor and seek urgent medical assistance.
Croatian: Uređaj za injekciju adrenalina koristite prema uputama liječnika i potražite hitnu medicinsku skrb.