FrancophonIA/ELRC3.0 huggingface dataset:
English: 40 mg daily (2 consecutive injections of 20 mg pre-filled syringe)4
Slovenian: 40 mg dnevno (2 zaporedni injiciranji z 20-miligramsko napolnjeno injekcijsko brizgo)4
English: All 11 patients had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline.
Slovenian: Vseh 11 bolnikov je imelo v izhodišču neustrezno uravnan fenilalanin v krvi (ravni fenilalanina v krvi, višje od 600 mikromolov/l).
English: Your doctor will train and instruct you and someone helping you on when and how to use adrenaline.
Slovenian: Zdravnik bo vas in še nekoga, ki vam bo pomagal, poučil o tem, kdaj se uporabi adrenalin in kako, ter vaju naučil postopka.
English: Complement factor C3 decreased5
Slovenian: zelo pogosti zelo pogosti znižanje ravni faktorja C4 komplementa5
English: Each tray contains 1 syringe.
Slovenian: Ena škatla vsebuje 1 napolnjeno injekcijsko brizgo.
English: LS mean change from Study 302 RDT baseline to Week 8 (95% CI)
Slovenian: Povprečna sprememba LS v 8. tednu glede na izhodiščno vrednost za obdobje RDT študije 302 (95-odstotni IZ)
English: Placebo 40 mg once daily4
Slovenian: 40 mg placeba enkrat na dan4
English: 2 Reflects number of patients who reached time point (Month 12/Month 18/Month 24/Month 36) of treatment at the time of the data cut-off and had a scheduled phenylalanine assessment for that time point.
Slovenian: 2 Pomeni število bolnikov, ki so na datum prenehanja zbiranja podatkov dosegli časovno točko v zdravljenju (12. mesec/18.
English: 2.5 mg pre-filled syringe:
Slovenian: 2,5-miligramska napolnjena injekcijska brizga:
English: If more than one injection is needed for a single dose, each injection site should be at least 5 cm away from another injection site.
Slovenian: Če je za enkratni odmerek potrebno več kot eno injiciranje, morajo biti posamezna mesta injiciranja med seboj oddaljena vsaj 5 cm.
English: Placebo 20 mg once daily4
Slovenian: 20 mg placeba enkrat na dan4
English: Cutaneous reactions lasting at least 14 days were most frequent during induction and titration phase (31% of patients; 137 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (38% of patients; 129 episodes over mean treatment duration of 28 months).
Slovenian: Kožne reakcije, ki so trajale vsaj 14 dni, so bile najpogostejše v fazi indukcije in titracije (31 % bolnikov; 137 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njihova pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (38 % bolnikov; 129 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
English: Angioedema occurred as early as 4 days and up to 1222 days into Palynziq treatment (median: 91 days from Palynziq treatment initiation).
Slovenian: Angioedem se je pojavil med 4. in 1.222. dnem zdravljenja z zdravilom Palynziq (mediana: 91 dni od začetka zdravljenja z zdravilom Palynziq).
English: The risk of an acute systemic hypersensitivity reaction occurring is 7-fold higher in induction/titration phase compared to maintenance phase.
Slovenian: Tveganje za pojav akutne sistemske preobčutljivostne reakcije je 7-krat večje v fazi indukcije/titracije kot v fazi vzdrževalnega zdravljenja.
English: • Do not flick or try to push the bubble out.
Slovenian: • Zračnih mehurčkov ne poskušajte odstraniti s frcanjem ali potiskanjem.
English: Palynziq 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Palynziq 20 mg
English: All episodes resolved without sequelae.
Slovenian: Vse epizode so se odpravile brez posledic.
English: 3 The maintenance dose is individualised to achieve blood phenylalanine levels between 120 to 600 micromol/l.
Slovenian: ³ Vzdrževalni odmerek se prilagodi posameznemu bolniku, da se doseže raven fenilalanina v krvi med 120 in 600 mikromoli/l.
English: Special populations Paediatric population
Slovenian: Posebne populacije bolnikov
English: Maternal blood phenylalanine levels must be strictly controlled between 120 and 360 micromol/l both before and during pregnancy.
Slovenian: Pred in med nosečnostjo je treba ravni fenilalanina v krvi pri materi strogo uravnavati tako, da se doseže raven med 120 in 360 mikromolov/l.
English: During maintenance, premedication may be considered for subsequent injections based on patient tolerability to Palynziq.
Slovenian: Med fazo vzdrževalnega zdravljenja se lahko razmislio premedikaciji pri naknadnih injiciranjih skladno z bolnikovim prenašanjem zdravila Palynziq.
English: 2.5 mg once a week 2.5 mg two times a week
Slovenian: 2,5 mg enkrat tedensko 2,5 mg dvakrat tedensko bel bat
English: Palynziq 20 mg solution for injection in pre-filled syringe pegvaliase
Slovenian: Palynziq 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegvaliaza
English: Of 253 patients who had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline in Study 301:
Slovenian: Od 253 bolnikov, ki so imeli v študiji 301 v izhodišču neustrezno uravnan fenilalanin v krvi (ravni fenilalanina v krvi, višje od 600 mikromolov/l), je:
English: How to use Palynziq
Slovenian: Kako uporabljati zdravilo Palynziq
English: Injection site reactions were most frequent during induction and titration phase (90% of patients; 3899 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (64% of patients; 1110 episodes over mean treatment duration of 28 months).
Slovenian: Reakcije na mestu injiciranja so bile najpogostejše v fazi indukcije in titracije (90 % bolnikov; 3.899 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njihova pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (64 % bolnikov; 1.110 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
English: What Palynziq looks like and contents of the pack Palynziq solution for injection (injection) is a clear to slightly opalescent, colourless to pale yellow solution.
Slovenian: Raztopina za injiciranje Palynziq (injekcija) je bistra do nekoliko opalescentna, brezbarvna do bledo rumena raztopina.
English: • Do not use the pre-filled syringe if the liquid is cloudy, discoloured, or has lumps or particles in it. Use a new pre-filled syringe for your injection.
Slovenian: • Napolnjene injekcijske brizge ne uporabljajte, če je tekočina motna, obarvana ali vsebuje grudice oziroma delce.
English: Record the date removed from refrigeration on the unopened product tray.
Slovenian: Na neodprt pladenj za izdelek zabeležite datum, ko se je zdravilo vzelo iz hladilnika.
English: Palynziq 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Palynziq 10 mg
English: 20 mg daily
Slovenian: 20 mg dnevno
English: 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: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM 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: 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.
Slovenian: V toksikoloških študijah, ki so trajale 4 in 39 tednov ter so vključevale ponavljajoče se odmerke, sta bili pri javanskih makakih incidenca in stopnja resnosti vnetja arterij pri klinično pomembni izpostavljenosti odvisni od odmerka in opaženi pri velikem naboru organov in tkiv.
English: Step 4: Remove syringe from tray: Peel the cover from the tray.
Slovenian: 4. korak: Injekcijsko brizgo vzemite s pladnja: S pladnja odlepite ovoj.
English: Choose an injection site that is at least 5 centimetres away from the injection site(s) you used the day before.
Slovenian: Izberite mesto vbrizgavanja, ki je vsaj 5 centimetrov oddaljeno od mest vbrizgavanja, v katere ste injekcijo dali prejšnji dan. Mesto je lahko na istem ali drugem delu telesa (glejte sliki E in F).
English: 10 mg four times a week
Slovenian: 10 mg štirikrat tedensko
English: Arthralgia was most frequent during induction and titration phase (78% of patients; 1264 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (62% of patients; 612 episodes over mean treatment duration of 28 months).
Slovenian: Artralgija je bila najpogostejša v fazi indukcije in titracije (78 % bolnikov; 1.264 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njena pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (62 % bolnikov; 612 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
English: 40 mg daily
Slovenian: 40 mg dnevno
English: PKU-POMS confusion3 subscale (self-rated)
Slovenian: Podlestvica za zmedenost PKU-POMS³ (samoocena) N
English: Pre-filled syringe 20 mg (blue plunger): Each 20 mg carton contains 1 or 10 pre-filled syringes.
Slovenian: 20-miligramska napolnjena injekcijska brizga (moder bat): Ena škatla z 20 mg zdravila vsebuje 1 ali 10 napolnjenih injekcijskih brizg.
English: • Your doctor will show you how and when to use the adrenaline injection device.
Slovenian: • Zdravnik vam bo pokazal, kako se uporabi pripomoček za injekcijo adrenalina, in vam povedal, kdaj ga uporabite.
English: Hypersensitivity reactions were most frequent during induction and titration phase (65% of patients; 921 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (58% of patients; 491 episodes over mean treatment duration of 28 months).
Slovenian: Preobčutljivostne reakcije so bile najpogostejše v fazi indukcije in titracije (65 % bolnikov; 921 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njihova pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (58 % bolnikov; 491 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
English: • Stop injecting Palynziq if any of the following symptoms occur.
Slovenian: • Če pride do katerega koli od naslednjih simptomov, prenehajte vbrizgavati zdravilo Palynziq:
English: 4 If multiple injections are needed for a single dose, injections should be administered at the same time of day and injection sites should be at least 5 cm away from each other.
Slovenian: 1 Če za dnevni odmerek potrebujete več kot eno injekcijo, morate vse injekcije dobiti ob istem času, pri čemer morajo biti mesta vbrizgavanja med seboj oddaljena vsaj 5 centimetrov.
English: Angioedema was most frequent during induction and titration phase (6% of patients; 27 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (3% of patients; 10 episodes over mean treatment duration of 28 months).
Slovenian: Angioedem je bil najpogostejši v fazi indukcije in titracije (6 % bolnikov; 27 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njegova pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (3 % bolnikov; 10 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
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.
Slovenian: Zdravilo Palynziq se lahko po potrebi hrani zunaj hladilnika (pri temperaturi do 25 °C) samo enkrat za največ 30 dni, pri čemer mora biti zatesnjeno na pladnju in zaščiteno pred viri toplote.
English: See Step 6 for choosing an injection site.
Slovenian: Za informacije o izbiri mesta vbrizgavanja glejte 6. korak.
English: NAME OF THE MEDICINAL PRODUCT Palynziq 2.5 mg solution for injection in pre-filled syringe Palynziq 10 mg solution for injection in pre-filled syringe Palynziq 20 mg solution for injection in pre-filled syringe
Slovenian: Palynziq 2,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Palynziq 10 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Palynziq 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Acute systemic hypersensitivity reactions were most frequent during induction and titration phase (5% of patients; 19 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (2% of patients; 6 episodes over mean treatment duration of 28 months).
Slovenian: Akutne sistemske preobčutljivostne reakcije so bile najpogostejše v fazi indukcije in titracije (5 % bolnikov; 19 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njihova pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (2 % bolnikov; 6 epizod pri povprečnem trajanju zdravljenja 28 mesecev).
English: Palynziq 2.5 mg solution for injection in pre-filled syringe Palynziq 10 mg solution for injection in pre-filled syringe Palynziq 20 mg solution for injection in pre-filled syringe pegvaliase
Slovenian: Palynziq 2,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Palynziq 10 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Palynziq 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegvaliaza (pegvaliasum)
English: 10 mg twice weekly
Slovenian: 10 mg dvakrat tedensko
English: In the peri/postnatal study, pegvaliase decreased pup weight, litter size, and survival of offspring during lactation, and delayed sexual maturation of offspring when administered daily in rats at 20 mg/kg subcutaneously.
Slovenian: Pri subkutanem dnevnem dajanju 20 mg/kg pegvaliaze v študiji v peri-/postnatalnem obdobju pri podganah je zaradi pegvaliaze prišlo do zmanjšanja teže mladičev, velikosti legla in možnosti preživetja mladičev med laktacijo ter poznejše spolne zrelosti mladičev.
English: Ask your healthcare provider if you have any questions.
Slovenian: Če imate kakršna koli vprašanja, se posvetujte z zdravstvenim delavcem.
English: Mean blood phenylalanine levels reduced from 1233 micromol/l at baseline to 565 micromol/l at Month 12 (n=164) and 345 micromol/l at Month 24 (n=90), and these reductions in mean blood phenylalanine levels were maintained through Month 36 (341 micromol/l; n=48) (see Table 4 and Figure 1).
Slovenian: Povprečne ravni fenilalanina v krvi so se znižale z izhodiščne vrednosti 1.233 mikromolov/l na 565 mikromolov/l (12. mesec; n = 164) in 345 mikromolov/l (24. mesec; n = 90).
English: 10 mg once weekly
Slovenian: 10 mg enkrat tedensko
English: Prior to first dose of Palynziq, the patient should be trained on the signs and symptoms of an acute systemic hypersensitivity reaction and to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device (auto-injector or pre-filled syringe/pen).
Slovenian: Pred prvim odmerkom zdravila Palynziq je treba bolnika poučiti o znakih in simptomih akutne sistemske preobčutljivostne reakcije ter o tem, da mora v primeru reakcije poiskati takojšnjo medicinsko pomoč.
English: The risk of angioedema occurring is 4.5-fold higher in induction/titration phase compared to maintenance phase.
Slovenian: Tveganje za pojav angioedema je 4,5-krat večje v fazi indukcije/titracije kot v fazi vzdrževalnega zdravljenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 2.5 MG CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 2,5 MG ZDRAVILA
English: More pressure may be needed to inject all the medicine for the 10 mg and 20 mg strengths.
Slovenian: Pri jakostih zdravila 10 mg in 20 mg boste morda morali uporabiti večji pritisk, da boste vbrizgali celotno z
English: Mean (SD) Median n=80
Slovenian: Mediana n = 80
English: Serum sickness was most frequent during induction and titration phase (2% of patients; 6 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (0.6% of patients; 1 episode over mean treatment duration of 28 months).
Slovenian: Serumska bolezen je bila najpogostejša v fazi indukcije in titracije (2 % bolnikov; 6 epizod pri povprečnem trajanju zdravljenja 12 mesecev), njena pogostnost pa se je zmanjšala v fazi vzdrževalnega zdravljenja (0,6 % bolnikov; 1 epizoda pri povprečnem trajanju zdravljenja 28 mesecev).
English: 10 mg daily
Slovenian: 10 mg dnevno
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva okorelost sklepov pogosti pogosti
English: Pre-filled syringe 2.5 mg (white plunger): Each 2.5 mg carton contains 1 pre-filled syringe.
Slovenian: 2,5-miligramska napolnjena injekcijska brizga (bel bat): Ena škatla z 2,5 mg zdravila vsebuje 1 napolnjeno injekcijsko brizgo.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 2.5 mg injection pegvaliase
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Palynziq 2,5 mg injekcija pegvaliaza s.c.
English: The risk of a hypersensitivity reaction occurring is 2.6-fold higher in induction/titration phase compared to maintenance phase.
Slovenian: Tveganje za pojav preobčutljivostne reakcije je 2,6-krat večje v fazi indukcije/titracije kot v fazi vzdrževalnega zdravljenja.
English: Pre-filled syringe 10 mg (green plunger): Each 10 mg carton contains 1 pre-filled syringe.
Slovenian: 10-miligramska napolnjena injekcijska brizga (zelen bat): Ena škatla z 10 mg zdravila vsebuje 1 napolnjeno injekcijsko brizgo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 20 MG CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 20 MG ZDRAVILA
English: Time needed to lower your blood phenylalanine levels Your doctor will start you on Palynziq at a low dose and will increase your dose slowly.
Slovenian: Zdravnik bo zdravljenje z zdravilom Palynziq začel z majhnim odmerkom, ki ga bo počasi povečeval.
English: Pegvaliase is primarily cleared by immune-mediated mechanisms following repeat dosing.
Slovenian: Po ponavljajočem odmerjanju se pegvaliaza primarno izčisti z imunskimi mehanizmi.
English: The risk of injection site reactions occurring is 4.9-fold higher in induction/titration phase compared to maintenance phase.
Slovenian: Tveganje za pojav reakcij na mestu injiciranja je 4,9-krat večje v fazi indukcije/titracije kot v fazi vzdrževalnega zdravljenja.
English: Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml solution.
Slovenian: Ena 20-miligramska napolnjena injekcijska brizga vsebuje 20 mg pegvaliaze v 1 ml raztopine.
English: It is very important to keep your phenylalanine levels under control before and during pregnancy.
Slovenian: Izjemno pomembno je, da imate pred nosečnostjo in po njej uravnano raven fenilalanina.
English: Dose-dependent reductions in body weight gain attributed to decreased plasma phenylalanine levels to below normal levels in normal animals (monkeys, rats and rabbits) was observed in single and repeat dose toxicology studies as well as developmental and reproductive toxicity studies with pegvaliase.
Slovenian: Toksikološke študije z enkratnim in ponavljajočim se odmerkom in toksikološke študije o razvoju in razmnoževanju, ki so vključevale pegvaliazo, so pokazale, da je bilo pri normalnih živalih (opicah, podganah in zajcih) odvisno od odmerka manjše pridobivanje telesne teže, ki je bilo pripisano padcu ravni fenilalanina v plazmi na raven, nižjo od normalne.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 10 mg injection pegvaliase
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Palynziq 10 mg injekcija pegvaliaza s.c.
English: Change from baseline protein intake (n)4
Slovenian: Sprememba glede na izhodiščno vrednost vnosa beljakovin (n)4 Povprečje (SD)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 20 mg injection pegvaliase
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Palynziq 20 mg injekcija pegvaliaza s.c.
English: Mean (SD) Median n=130
Slovenian: Mediana n = 130
English: Each 10 mg pre-filled syringe contains 10 mg pegvaliase in 0.5 ml solution.
Slovenian: Ena 10-miligramska napolnjena injekcijska brizga vsebuje 10 mg pegvaliaze v 0,5 ml raztopine.
English: Inject Palynziq
Slovenian: Vbrizgavanje zdravila Palynziq
English: Treat injection site
Slovenian: Raztopina za injiciranje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 10 MG CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 10 MG ZDRAVILA
English: Palynziq contains the active substance pegvaliase, an enzyme that can break down a substance called phenylalanine in the body.
Slovenian: To je encim, ki lahko razgradi snov z imenom fenilalanin, ki je v telesu.
English: The risk of arthralgia occurring is 2.9-fold higher in induction/titration phase compared to maintenance phase.
Slovenian: Tveganje za pojav artralgije je 2,9-krat večje v fazi indukcije/titracije kot v fazi vzdrževalnega zdravljenja.
English: Trometamol hydrochloride Sodium chloride trans-cinnamic acid Water for injections
Slovenian: Natrijev klorid trans-cinamična kislina
English: Each 2.5 mg pre-filled syringe contains 2.5 mg pegvaliase in 0.5 ml solution.
Slovenian: Ena 2,5-miligramska napolnjena injekcijska brizga vsebuje 2,5 mg pegvaliaze v 0,5 ml raztopine.
English: Talk to your healthcare provider if you have any questions about how to inject Palynziq the right way.
Slovenian: Če imate kakršna koli vprašanja glede pravilnega načina vbrizgavanja zdravila Palynziq, se posvetujte z zdravstvenim delavcem.
English: Talk to your doctor before stopping Palynziq treatment.
Slovenian: Pred prenehanjem zdravljenja z zdravilom Palynziq se posvetujte z zdravnikom.
English: - joint stiffness - joint swelling - muscle stiffness - skin rash with small bumps - blistering or peeling of the outer layer of the skin
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - okorelost sklepov, - otekanje sklepov, - okorelost mišic, - kožni izpuščaj z majhnimi izboklinami, - mehurjasti izpuščaji ali luščenje zunanje plasti kože.
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.
Slovenian: • Vsaj prvih 6 mesecev zdravljenja z zdravilom Palynziq mora biti nekdo z vami, ko si vbrizgate zdravilo Palynziq.
English: • Do not remove the needle cap from your pre-filled syringe.
Slovenian: • Z napolnjene injekcijske brizge ne odstranite pokrovčka igle.
English: You may have blood phenylalanine levels that are too low when using Palynziq.
Slovenian: Med uporabo zdravila Palynziq boste morda imeli prenizke ravni fenilalanina v krvi.
English: Talk to your healthcare provider about the best way to feed your baby if you use Palynziq.
Slovenian: Če uporabljate zdravilo Palynziq, se glede najboljšega načina hranjenja otroka posvetujte z zdravstvenim delavcem.
English: EU/1/19/1362/001 2.5 mg pre-filled syringe
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/19/1362/001 2,5-miligramska napolnjena injekcijska brizga
English: • Do not hold the pre-filled syringe by the plunger or plunger head while taking the needle cap off.
Slovenian: • Ko odstranjujete pokrovček igle, napolnjene injekcijske brizge ne držite za bat ali glavo bata.
English: 2.5 mg twice weekly
Slovenian: 2,5 mg dvakrat tedensko
English: • Do not use the pre-filled syringe if it has been dropped.
Slovenian: • Če vam je napolnjena injekcijska brizga padla, je ne uporabljajte.
English: The vacuolation observed in these studies was not associated with any organ related toxicities as determined by clinical chemistry/urinalysis and histopathological analysis.
Slovenian: Klinična kemijska analiza/analiza urina in histopatološka preiskava sta pokazali, da vakuolizacija, opažena v teh študijah, ni povezana z nikakršno toksičnostjo v zvezi z organi.
English: • train the observer to recognise signs and symptoms of an acute systemic hypersensitivity reaction and to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device (auto-injector or pre-filled syringe/pen).
Slovenian: • poučiti opazovalca o znakih in simptomih akutne sistemske preobčutljivostne reakcije ter o tem, da mora v primeru reakcije poiskati takojšnjo medicinsko pomoč.
English: Maintenance
Slovenian: Vzdrževalno zdravljenje
English: Syringe colour
Slovenian: Barva injekcijske brizge
English: Talk to your doctor, pharmacist, or nurse before using Palynziq.
Slovenian: Pred začetkom uporabe zdravila Palynziq se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Joint stiffness
Slovenian: Hipofenilalaninemija