FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are trometamol, trometamol hydrochloride, sodium chloride (see section 2 for further information), trans-cinnamic acid, water for injections.
Slovenian: - Druge sestavine so trometamol, trometamol hidroklorid, natrijev klorid (za več informacij glejte poglavje 2), trans-cinamična kislina, voda za injekcije.
English: 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.
Slovenian: 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.
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
Slovenian: 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
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: You and your doctor will decide the best way for you to manage your blood phenylalanine levels.
Slovenian: Z zdravnikom se bosta skupaj odločila, kateri je za vas najboljši način za uravnavanje ravni fenilalanina v krvi.
English: • 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).
Slovenian: • 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).
English: Take out the required number of cartons needed for your dose from the refrigerator.
Slovenian: Iz hladilnika vzemite toliko škatel, kot jih potrebujete za svoj odmerek.
English: Patients who develop hypophenylalaninaemia should be monitored every 2 weeks until blood phenylalanine level is within a clinically acceptable range.
Slovenian: Bolnike, pri katerih se razvije hipofenilalaninemija, je treba spremljati vsaka 2 tedna, dokler raven fenilalanina v krvi ni v klinično sprejemljivem razponu.
English: The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation.
Slovenian: Jakost označuje količino dela fenilalanin amoniakliaze (rAvPAL) pegvaliaze brez upoštevanja pegilacije.
English: Mean (SD) Median n=172
Slovenian: Povprečje (SD) Mediana n = 172
English: 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.
Slovenian: 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.
English: • Your doctor will need to check your blood phenylalanine monthly to see if this medicine is working for you.
Slovenian: • Zdravnik vam bo raven fenilalanina v krvi moral preveriti vsak mesec, da bo ugotovil, ali zdravilo deluje.
English: The automatic needle guard is composed of a polycarbonate transparent needle guard and a stainless steel spring inside the needle guard.
Slovenian: Samodejni ščitnik igle je sestavljen iz prosojnega ščitnika igle iz polikarbonata in vzmeti iz nerjavnega jekla, ki je v notranjosti ščitnika igle.
English: Symptoms of allergic reaction can include skin rash, itching, swelling of head or face, itchy or runny eyes, cough, and wheezing.
Slovenian: Simptomi alergijske reakcije lahko vključujejo kožni izpuščaj, srbenje, otekanje glave ali obraza, srbeče oči ali izcedek iz oči, kašelj in piskanje v pljučih.
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.
Slovenian: 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.
English: Date removed from refrigeration: _____/_____/______ Peel here
Slovenian: Datum, ko se je zdravilo vzelo iz hladilnika: _____/_____/______ Odlepite tukaj
English: There are no or limited amount of data from the use of Palynziq in pregnant women.
Slovenian: Podatkov o uporabi zdravila Palynziq pri nosečnicah ni oziroma so omejeni.
English: 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.
Slovenian: Če boste imeli prenizko raven fenilalanina v krvi, vam bo zdravnik lahko naročil, da spremenite dieto, in/ali zmanjšal odmerek zdravila Palynziq.
English: See section 4 for details on what to do based on your symptoms.
Slovenian: Za podrobnosti o ukrepanju glede na simptome glejte poglavje 4.
English: o Your doctor will train them on the signs and symptoms of a severe allergic reaction and how to give an injection of adrenaline.
Slovenian: o Vaš zdravnik bo to osebo poučil o tem, kako prepoznati znake in simptome hude alergijske reakcije ter kako vam dati injekcijo adrenalina.
English: • Your doctor will also prescribe adrenaline injection device to use for any severe allergic reactions.
Slovenian: • Zdravnik vam bo predpisal tudi pripomoček za injekcijo adrenalina, ki ga uporabite v primeru kakršne koli hude alergijske reakcije.
English: Instructions for the preparation and administration of Palynziq are given in the package leaflet.
Slovenian: Navodila za pripravo in dajanje zdravila Palynziq so navedena v navodilu za uporabo.
English: • Lower part of the abdomen except for the 5 centimetre area around the belly button (navel).
Slovenian: • spodnji del trebuha z izjemo območja 5 centimetrov okoli popka.
English: 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).
Slovenian: 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).
English: 1 week2
Slovenian: 1 teden2
English: 3 Post-baseline ADHD-inattention/PKU-POMS confusion values were mapped to the closest 3-month visit (i.e. within a 3-month window).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What you need to know before you use Palynziq
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Palynziq
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.
Slovenian: 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.
English: 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).
Slovenian: Če vam injekcijo daje negovalec, sta primerni mesti tudi zgornji del zadnjice in hrbtni del nadlakti (glejte sliko E).
English: Acute systemic hypersensitivity reactions
Slovenian: Akutne sistemske preobčutljivostne reakcije
English: Hold the middle of the pre-filled syringe body and take out the pre-filled syringe from the tray (see Figure C).
Slovenian: Primite srednji del telesa napolnjene injekcijske brizge in jo vzemite s pladnja (glejte sliko C).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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.
Slovenian: Pri štirih od 16 (1 %; 4/285) bolnikov se je pojavilo skupno 5 epizod akutnih sistemskih preobčutljivostnih reakcij, ki so se štele za hude na podlagi prisotnosti: cianoze ali nasičenosti s kisikom (SpO2) ≤ 92 %, hipotenzije (sistolični krvni tlak, nižji od 90 mmHg pri odraslih) ali sinkope.
English: It will take time to find the dose that works best to lower your blood phenylalanine levels.
Slovenian: Nekaj časa bo trajalo, preden bo ugotovil, kateri odmerek je najboljši za znižanje vaše ravni fenilalanina v krvi.
English: Table 2 provides adverse reactions in patients treated with Palynziq.
Slovenian: V tabeli 2 so prikazani neželeni učinki pri bolnikih, zdravljenih z zdravilom Palynziq.
English: • Do not touch the plunger head while inserting the needle into the skin.
Slovenian: • Med vstavljanjem igle v kožo se ne dotikajte glave bata.
English: Hypersensitivity reactions decreased over time in maintenance as the incidence of these antibodies decreased, and C3/C4 returned towards baseline.
Slovenian: Pogostnost preobčutljivostnih reakcij se je s časom zmanjšala v fazi vzdrževalnega zdravljenja z zmanjšanjem incidence teh protiteles, ravni faktorja C3/C4 pa so se vrnile na vrednosti blizu izhodiščne.
English: Step 13: Use your thumb to push in the plunger slowly and steadily as far as it will go to inject all the medicine (see Figure M).
Slovenian: 13. korak: S palcem počasi in enakomerno potiskajte bat, dokler ne vbrizgate celotnega zdravila (glejte sliko M).
English: Results for ADHD inattention subscale over time are shown in Table 4.
Slovenian: Rezultati glede na čas, pridobljeni s podlestvico za nepozornost v okviru ADHD, so prikazani v tabeli 4.
English: At high pegvaliase Ctrough concentrations ≥ 10,000 ng/ml, the majority of the blood phenylalanine levels (97%) are ≤ 30 micromol/l, even when dietary phenylalanine intake is high.
Slovenian: Pri visokih koncentracijah pegvaliaze Ctrough, ki znašajo ≥ 10.000 ng/ml, ravni fenilalanina v krvi pri večini bolnikov (97 %) znašajo ≤ 30 mikromolov/l, tudi ko je vnos fenilalanina s hrano visok.
English: Your doctor will tell you how to manage your allergic reactions based on the severity of the reaction, and will prescribe you additional medicines to manage the reaction.
Slovenian: Zdravnik vam bo povedal, kako v primeru alergijske reakcije ukrepate glede na njeno resnost, in vam predpisal dodatna zdravila za obvladovanje reakcije.
English: All serum sickness reactions resolved without sequelae.
Slovenian: Vse reakcije s serumsko boleznijo so se odpravile brez posledic.
English: Select the correct Palynziq pre-filled syringe(s) for your dose: When you receive your Palynziq pre-filled syringe(s), check that the name “Palynziq” appears on the carton(s).
Slovenian: Izberite eno ali več ustreznih napolnjenih injekcijskih brizg z zdravilom Palynziq za svoj odmerek: Ko prejmete eno ali več napolnjenih injekcijskih brizg z zdravilom Palynziq, preverite, ali je na škatli oziroma škatlah navedeno ime „Palynziq“.
English: Put your used needles and syringes in a sharps disposal or puncture-resistant container right away after use.
Slovenian: Uporabljene igle in injekcijske brizge takoj po uporabi zavrzite v vsebnik za odlaganje ostrih predmetov ali vsebnik, odporen na vbode.
English: Doses should not be divided over the course of the day
Slovenian: Odmerek se ne sme razdeliti na več manjših odmerkov čez dan.
English: Your healthcare provider will tell you which syringe, or a combination of syringes, to use and will show you (or a caregiver) how to inject Palynziq.
Slovenian: Zdravstveni delavec vam bo povedal, katero injekcijsko brizgo oziroma kombinacijo injekcijskih brizg morate uporabiti, in vam pokazal, kako vbrizgate zdravilo Palynziq (oziroma bo to povedal in pokazal negovalcu).
English: Once stored outside of refrigeration, the product must not be returned to the refrigerator.
Slovenian: Ko se izdelek hrani zunaj hladilnika, se vanj ne sme vrniti.
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).
Slovenian: V primeru hudih sistemskih preobčutljivostnih reakcij ali ponovitve blage do zmerne akutne sistemske preobčutljivostne reakcije morajo bolniki poiskati takojšno medicinsko pomoč in trajno prenehati zdravljenje z zdravilom Palynziq (glejte poglavje 4.3).
English: The most common hypersensitivity reactions (occurring in at least 10% of patients) were rash, urticaria, and hypersensitivity.
Slovenian: Najpogostejše preobčutljivostne reakcije (ki so se pojavile pri vsaj 10 % bolnikov) so bile izpuščaj, urtikarija in preobčutlijvost.
English: Other reactions reported included skin exfoliation, generalised rash, erythematous rash, maculo-papular rash, and pruritic rash.
Slovenian: Druge reakcije, o katerih so poročali, so vključevale luščenje kože, generalizirani izpuščaj, eritematozni izpuščaj, makulopapulozni izpuščaj in pruritični izpuščaj.
English: After removal from the refrigerator, the product must not be returned to the refrigerator.
Slovenian: Ko se izdelek vzame iz hladilnika, se vanj ne sme vrniti.
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.
Slovenian: Pri enem od dveh bolnikov je prišlo do preobčutljivostne reakcije na 15. dan po enkratnem odmerku zdravila Palynziq v 15 minutah po prejemu medroksiprogesteron acetata in pozneje do akutne sistemske preobčutljivostne reakcije na 89. dan v 30 minutah po naslednjem odmerku suspenzije medroksiprogesteron acetata za injiciranje.
English: Your doctor will check your blood phenylalanine levels every 2 weeks until your blood phenylalanine levels return to normal.
Slovenian: Zdravnik vam bo na vsaka 2 tedna preverjal raven fenilalanina v krvi, dokler se ne bo vrnila na normalno.
English: • Do not inject into moles, scars, birthmarks, bruises, rashes, or areas where the skin is hard, tender, red, damaged, burned, inflamed, or tattooed.
Slovenian: • Ne vbrizgavajte v pigmentna znamenja, brazgotine, materina znamenja, podplutbe, izpuščaje ali območja, kjer je koža trda, občutljiva, pordela, poškodovana, opečena, vneta ali tetovirana.
English: No clinical studies have been conducted to evaluate the effect of renal or hepatic impairment on the pharmacokinetics of pegvaliase.
Slovenian: Klinične študije za ocenjevanje vpliva okvare ledvic ali jeter na farmakokinetiko pegvaliaze niso bile izvedene.
English: Can be stored outside the refrigerator (below 25°C) for a single period up to 30 days.
Slovenian: Zunaj hladilnika (pri temperaturi do 25 °C) se lahko hrani samo enkrat za največ 30 dni.
English: All persistent arthralgia episodes resolved without sequelae.
Slovenian: Vse epizode persistentne artralgije so se odpravile brez posledic.
English: Do not use this medicine if the pre-filled syringe is damaged or you notice the solution is discoloured, cloudy, or if you can see particles.
Slovenian: Zdravila ne uporabljajte, če je napolnjena injekcijska brizga poškodovana ali če opazite, da je raztopina obarvana, motna ali vsebuje delce.
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).
Slovenian: Po koncu zorenja zgodnjega imunskega odziva (več kot 6 mesecev po aplikaciji zdravila Palynziq) in prilagoditvi odmerka za vzdrževanje uravnane ravni fenilalanina v krvi pri dolgotrajnem zdravljenju so se povprečne ravni fenilalanina v krvi še naprej nižale pri bolnikih, ki so nadaljevali zdravljenje (glejte poglavje 5.1).
English: Step 9: Hold the body of the pre-filled syringe with one hand with the needle facing away from you (see Figure I).
Slovenian: 9. korak: Telo napolnjene injekcijske brizge držite z eno roko, pri čemer naj bo igla obrnjena stran od vas (glejte sliko I).
English: Due to the potential for an acute systemic hypersensitivity reaction, premedication prior to each dose is required during induction and titration (see section 4.2, Method of administration).
Slovenian: Zaradi možnosti akutne sistemske preobčutljivostne reakcije je pred vsakim odmerkom med fazo indukcije in titracije potrebna premedikacija (glejte poglavje 4.2 Način uporabe).
English: 16 weeks2
Slovenian: 16 tednov2
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).
Slovenian: 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 (glejte poglavje 4.2 Način uporabe).
English: ≤ 600 micromol/l by 12 months, 24 months, and 36 months, respectively;
Slovenian: ≤ 600 mikromolov/l, in sicer do 12. meseca, 24. meseca in 36. meseca (v tem zaporedju);
English: All of these injection site reactions resolved.
Slovenian: Vse omenjene reakcije na mestu injiciranja so se odpravile.
English: No differences were observed in inattention and mood between patients randomised to placebo versus those randomised to Palynziq during this 8-week duration.
Slovenian: V teh 8 tednih ni bilo opaženih razlik glede nepozornosti ali razpoloženja med bolniki, randomiziranimi na prejemanje placeba, in bolniki, randomiziranimi na prejemanje zdravila Palynziq.
English: 4 weeks2
Slovenian: 4 tedni2
English: • Physician educational material • Patient information pack
Slovenian: • izobraževalno gradivo za zdravnika; • komplet z informacijami za bolnika.
English: In clinical trials, 16 out of 285 (6%) patients experienced 25 acute systemic hypersensitivity reactions of any severity.
Slovenian: V kliničnih preskušanjih se je pri 16 od 285 (6 %) bolnikov pojavilo 25 akutnih sistemskih preobčutljivostnih reakcij različnih stopenj resnosti.
English: Read this Instructions for use before you start using the Palynziq pre-filled syringe and each time you get a new prescription.
Slovenian: Preden začnete uporabljati napolnjeno injekcijsko brizgo z zdravilom Palynziq in vsakič, ko dobite nov recept, preberite ta navodila za uporabo.
English: For storage instructions, refer to section 5 “How to store Palynziq” of this leaflet.
Slovenian: Za navodila o shranjevanju glejte poglavje 5 „Shranjevanje zdravila Palynziq“ v tem navodilu.
English: What Palynziq is and what it is used for What you need to know before you use Palynziq How to use Palynziq
Slovenian: Kaj je zdravilo Palynziq in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Palynziq Kako uporabljati zdravilo Palynziq Možni neželeni učinki
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).
Slovenian: Bolniki, zdravljeni z zdravilom Palynziq, so po 8 tednih lahko vzdrževali znižano raven fenilalanina v krvi v primerjavi z bolniki, ki so prejemali placebo in katerih raven fenilalanina v krvi se je po tem obdobju vrnila na izhodiščno vrednost pred zdravljenjem (p < 0,0001, glejte tabelo 3).
English: The maintenance dose is individualised to achieve patient's blood phenylalanine control (i.e., a phenylalanine level between 120 to 600 micromol/l) taking into account patient tolerability to Palynziq and dietary protein intake (see Table 1).
Slovenian: Vzdrževalni odmerek je prilagojen posameznemu bolniku, s čimer se uravna njegova raven fenilalanina v krvi (tj. raven fenilalanina od 120 do 600 mikromolov/l), pri čemer se upošteva bolnikovo prenašanje zdravila Palynziq in vnos beljakovin s hrano (glejte tabelo 1).
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).
Slovenian: V kliničnih preskušanjih je pri 16 od 285 (6 %) bolnikov prišlo do 25 akutnih sistemskih preobčutljivostnih reakcij različnih stopenj resnosti na podlagi akutnega nastopa sprememb na koži in/ali mukoznem tkivu ter vsaj poslabšanja respiratorne funkcije ali znižanega krvnega tlaka (ali povezanih simptomov disfunkcije ciljnega organa).