FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the potential for an acute systemic hypersensitivity reaction, premedication prior to each dose is required during induction and titration (time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose; see section 4.8).
Danish: På grund af potentialet for en akut systemisk overfølsomhedsreaktion er præmedicinering nødvendig før hver dosis under induktion og titrering (tid før opnåelse af et fenylalaninniveau i blodet på mindre end 600 mikromol/l på en stabil dosis; se pkt.
English: (20 mg/day or 40 mg/day): 4 patients did not complete the RDT due to adverse events (1 patient discontinued treatment and 3 patients transitioned to the long-term extension period) and the remaining 5 patients who did not complete phenylalanine assessment within the window for Week 8 (Day 43 to 56).
Danish: ³ 9 patienter fra Palynziq-behandlingsarmene (20 mg/dag eller 40 mg/dag) blev udelukket fra analysen i uge 8: 4 patienter fuldførte ikke RDT på grund af bivirkninger (1 patient stoppede med behandlingen, og 3 patienter overgik til den langsigtede forlængelsesperiode), og de resterende 5 patienter fuldførte ikke fenylalaninvurderingen inden for vinduet for uge 8 (dag 43 til 56).
English: Hypersensitivity reaction2
Danish: Overfølsomhedsreaktion2
English: In patients with baseline ADHD inattention scores > 9 (suggesting symptoms of inattention at baseline), mean reduction in ADHD inattention score from baseline (suggesting improvement) was above the MCID estimated for adults with ADHD at Month 12 (n=80; a reduction of 7.8), Month 18 (n=78; a reduction of 8.9), Month 24 (n=76; a reduction of 9.6) and Month 36 (n=45; a reduction of 10.6).
Danish: Hos patienter med en score for ADHD-uopmærksomhed > 9 ved baseline (som tyder på uopmærksomhedssymptomer ved baseline) var middelreduktionen i scoren for ADHD-uopmærksomhed fra baseline (der tyder på forbedring) over MCID estimeret for voksne med ADHD ved måned 12 (n = 80, en reduktion på 7,8), måned 18 (n = 78, en reduktion på 8,9), måned 24 (n = 76, en reduktion på 9,6) og måned 36 (n = 45, en reduktion på 10,6).
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).
Danish: I kliniske forsøg oplevede 16 ud af 285 (6 %) patienter 25 akutte systemiske overfølsomhedsreaktioner af forskellig sværhedsgrad baseret på akut frembrud af manifestationer i hud- og/eller slimhindevæv og som minimum enten åndedrætsbesvær eller nedsat blodtryk (eller relaterede symptomer på dysfunktion i målorgan).
English: Step 10: Pull the needle cap straight off the needle (see Figure J).
Danish: Trin 10: Træk kanylehætten lige af kanylen (se figur J).
English: Mean change from baseline PKU-POMS confusion subscale (suggesting improvement) was above MCID (defined as a reduction of at least 1) at Month 12 (n=130; a reduction of 1.6), Month 18 (n=123; a reduction of 2), Month 24 (n=117; a reduction of 2.2) and Month 36 (n=51; a reduction of
Danish: Middelændringen fra baseline på PKU-POMS-delskalaen for forvirring (der tyder på forbedring) lå over MCID (defineret som en reduktion på mindst 1) ved måned 12 (n = 130, en reduktion på 1,6), måned 18 (n = 123, en reduktion på 2), måned 24 (n = 117, en reduktion på 2,2) og måned 36 (n = 51, en reduktion på 2,2).
English: If you forget to use Palynziq
Danish: Hvis du har glemt at bruge Palynziq
English: Eligibility period
Danish: Inklusionsperiode
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.
Danish: (måned 12/måned 18/måned 24/måned 36) i behandlingen på tidspunktet for data cut-off og fik foretaget en planlagt fenylalaninvurdering for dette tidspunkt.
English: All 11 patients had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline.
Danish: Alle 11 patienter havde utilstrækkelig kontrol af fenylalanin i blodet (fenylalaninniveau i blodet over 600 mikromol/l) ved baseline.
English: 4 weeks2
Danish: 4 uger2
English: If a patient has a confirmed phenylalanine level below 30 micromol/l, dietary protein intake should be increased to appropriate levels, and then, if needed, the dose of Palynziq should be reduced (see section 4.2).
Danish: Hvis en patient har et bekræftet fenylalaninniveau i blodet på mindre end 30 mikromol/l, bør indtaget af protein i kosten øges til et passende niveau, og, om nødvendigt, bør Palynziq-dosis derefter reduceres (se pkt.
English: Hold the middle of the pre-filled syringe body and take out the pre-filled syringe from the tray (see Figure C).
Danish: Tag fat om den fyldte injektionssprøjte midtpå, og tag den ud af bakken (se figur C).
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).
Danish: På grund af muligheden for en akut systemisk overfølsomhedsreaktion er præmedicinering påkrævet før hver dosis under induktion og titrering (se pkt.
English: Patients should be monitored every 2 weeks until blood phenylalanine levels are within a clinically acceptable range (see section 4.4, Hypophenylalaninaemia).
Danish: Patienterne bør kontrolleres hver anden uge, indtil fenylalaninniveauet i blodet ligger inden for et klinisk acceptabelt område (se pkt.
English: Hypersensitivity reactions occurred as early as the first dose and can occur at any time during treatment.
Danish: Overfølsomhedsreaktioner forekom allerede ved den første dosis og kan forekomme når som helst under behandlingen.
English: Throw the needle cap away in a sharps disposal or puncture-resistant container.
Danish: Kassér kanylehætten i en kanylebeholder eller en punktérfast beholder.
English: Management of hypersensitivity reactions should be based on the severity of the reaction; in clinical trials, this has included dose adjustment, treatment interruption, additional antihistamines, antipyretics, and/or corticosteroids.
Danish: I kliniske forsøg har dette omfattet dosisjustering, afbrydelse af behandlingen, yderligere antihistaminer, antipyretika og/eller kortikosteroider.
English: - joint stiffness - joint swelling - muscle stiffness - skin rash with small bumps - blistering or peeling of the outer layer of the skin
Danish: Almindelig: forekommer hos op til 1 ud af 10 personer - ledstivhed - ledhævelse - muskelstivhed - hududslæt med små buler - blæredannelse eller afskalning af det yderste lag af huden
English: Other reactions reported included skin exfoliation, generalised rash, erythematous rash, maculo-papular rash, and pruritic rash.
Danish: Andre reaktioner, der blev rapporteret, omfattede hudeksfoliation, generaliseret udslæt, erytematøst udslæt, makulopapuløst udslæt og pruritisk udslæt.
English: Mean reduction (suggesting improvement) from baseline ADHD-RS inattention was above the minimally clinically important difference (MCID) for adults with ADHD (defined as a reduction of at least 5.2) at Month 18 (n=168; a reduction of 5.3), Month 24 (n=160; a reduction of 5.9) and Month 36 (n=92; a reduction of 6.7).
Danish: Middelreduktionen (der tyder på forbedring) for ADHD-RS-uopmærksomhed fra baseline lå over den minimale klinisk relevante forskel (MCID) for voksne med ADHD (defineret som en reduktion på mindst 5,2) ved måned 18 (n = 168, en reduktion på 5,3), måned 24 (n = 160, en reduktion på 5,9) og måned 36 (n = 92, en reduktion på 6,7).
English: The mean duration of hypersensitivity reactions was 7 days, and ranged less than 1 day to 227 days; 89% of hypersensitivity reactions had a duration of less than 14 days, 0.4% of hypersensitivity reactions persisted at least 180 days, and 99% of hypersensitivity reactions resolved by the time of the data cut-off.
Danish: 89 % af overfølsomhedsreaktionerne varede i mindre end 14 dage, 0,4 % af overfølsomhedsreaktionerne varede i mindst 180 dage, og 99 % af overfølsomhedsreaktionerne var forsvundet på tidspunktet for data cut-off.
English: In clinical trials, 241 out of 285 (85%) patients experienced episodes consistent with arthralgia (including back pain, musculoskeletal pain, pain in extremity, and neck pain).
Danish: Artralgi og andre ledrelaterede tegn og symptomer I kliniske forsøg oplevede 241 ud af 285 (85 %) patienter episoder svarende til artralgi (herunder rygsmerter, muskuloskeletale smerter, smerter i ekstremiteter og nakkesmerter).
English: (2 injections of 20 mg pre-filled syringe)1
Danish: (2 injektioner af 20 mg fyldt injektionssprøjte)1
English: • 1 alcohol pad
Danish: • 1 spritserviet
English: Excipients: trometamol, trometamol hydrochloride, sodium chloride, trans-cinnamic acid, water for injections.
Danish: Hjælpestoffer: trometamol, trometamolhydrochlorid, natriumchlorid, trans-kanelsyre, vand til injektionsvæsker.
English: The risk of cutaneous reactions lasting at least 14 days occurring is 1.5-fold higher in induction/titration phase compared to maintenance phase.
Danish: Risikoen for forekomst af kutane reaktioner med en varighed på mindst 14 dage er 1,5 gange højere i induktions-/titreringsfasen sammenlignet med vedligeholdelsesfasen.
English: Placebo 40 mg once daily4
Danish: Placebo 40 mg én gang dagligt4
English: 2.5 mg once a week 2.5 mg two times a week
Danish: 2,5 mg én gang ugentligt 2,5 mg to gange ugentligt
English: Hypophenylalaninaemia occurred during titration and maintenance phase, as early as 51 days and up 1405 days into Palynziq treatment (median: 393 days from Palynziq treatment initiation).
Danish: Hypofenylalaninæmi forekom i titrerings- og vedligeholdelsesfasen allerede fra 51 dage og op til 1.405 dage inde i Palynziq-behandlingen (median: 393 dage fra initiering af Palynziq-behandling).
English: Persistent arthralgia occurred as early as 6 days and up to 1526 days into Palynziq treatment (median: 554 days from Palynziq treatment initiation).
Danish: Vedvarende artralgi forekom allerede 6 dage og op til 1.526 dage inde i behandlingen med Palynziq (median: 554 dage fra start af behandling med Palynziq).
English: 6 Reflects high sensitivity CRP (hsCRP) levels above upper limit of normal (greater than 0.287 mg/dl) over a 6 month period.
Danish: 6 Dækker over niveauer af ekstra følsom CRP (hsCRP) over den øvre grænse for normalniveauet
English: Serum sickness occurred as early as 10 days and up to 232 days into Palynziq treatment (median: 13 days from Palynziq treatment initiation).
Danish: Serumsygdom forekom allerede 10 dage og op til 232 dage inde i behandlingen med Palynziq (median: 13 dage fra start af behandling med Palynziq).
English: Placebo 20 mg once daily4
Danish: Placebo 20 mg én gang dagligt4
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.
Danish: • Brug ikke den fyldte injektionssprøjte, hvis væsken er uklar eller misfarvet, eller der er klumper eller partikler i den.
English: Dosing regimens Induction
Danish: Doseringsregimer
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.
Danish: 78 % af artralgiepisoderne havde en varighed på mindre end 14 dage, og 1 % of artralgiepisoderne fortsatte i mindst 180 dage.
English: Pre-filled syringe 20 mg (blue plunger): Each 20 mg carton contains 1 or 10 pre-filled syringes.
Danish: Fyldt injektionssprøjte 20 mg (blåt stempel): Hver 20 mg-pakning indeholder 1 eller 10 fyldte injektionssprøjter.
English: The risk of an acute systemic hypersensitivity reaction occurring is 7-fold higher in induction/titration phase compared to maintenance phase.
Danish: Risikoen for forekomst af en akut systemisk overfølsomhedsreaktion er 7 gange højere i induktions-/titreringsfasen sammenlignet med vedligeholdelsesfasen.
English: • Before injecting, check to make sure the needle is not damaged or bent.
Danish: • Sørg for at kontrollere, at kanylen ikke er beskadiget eller bøjet, inden du injicerer.
English: Blood phenylalanine levels that are too low
Danish: For lavt niveau af fenylalanin i blodet
English: Your doctor will check your blood phenylalanine levels monthly.
Danish: Lægen vil kontrollere fenylalaninniveauet i blodet en gang om måneden.
English: Mean (SD) Median n=154
Danish: Median n = 154
English: 1 If blood phenylalanine levels are below 30 micromol/l, dietary protein intake should be increased to appropriate levels, and then, if needed, the dose of Palynziq should be reduced (see section 4.4, Hypophenylalaninaemia).
Danish: 1 Hvis fenylalaninniveauet i blodet ligger under 30 mikromol/l, bør indtaget af protein i kosten øges til et passende niveau, og, om nødvendigt, bør Palynziq-dosis derefter reduceres (se pkt.
English: Hypophenylalaninaemia
Danish: Hypofenylalaninæmi
English: The pre-filled syringe includes an automatic needle guard.
Danish: Den fyldte injektionssprøjte har automatisk kanyleafskærmning.
English: The risk of serum sickness occurring is greater than 2-fold higher in induction/titration phase compared to maintenance phase.
Danish: Risikoen for forekomst af serumsygdom er mere end 2 gange højere i induktions-/titreringsfasen sammenlignet med vedligeholdelsesfasen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 2.5 MG CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 2,5 MG ÆSKE
English: In patients experiencing hypophenylalaninaemia despite appropriate levels of protein intake, dose reductions are expected to be most effective in managing hypophenylalaninaemia (see section 5.2, Exposure-effect).
Danish: Hos patienter, der oplever hypofenylalaninæmi på trods af et passende proteinindtag, forventes dosisreduktioner at være mest effektive til styring af hypofenylalaninæmi (se pkt.
English: Acute systemic hypersensitivity reaction3
Danish: Akut systemisk overfølsomhedsreaktion³
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.
Danish: Palynziq injektionsvæske, opløsning (injektionsvæske) er en klar til let opaliserende, farveløs til svagt gul opløsning.
English: 2.5 mg pre-filled syringe:
Danish: 2,5 mg fyldt injektionssprøjte:
English: 4 Five patients were excluded from the Week 8 analysis from the placebo arms (20 mg/day or
Danish: 4 5 patienter fra placeboarmene (20 mg/dag eller 40 mg/dag) blev udelukket fra analysen i uge 8:
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).
Danish: Kutane reaktioner med en varighed på mindst 14 dage forekom hyppigst i induktions- og titreringsfasen (31 % af patienterne, 137 episoder i løbet af middelbehandlingsvarigheden på 12 måneder) og faldt i vedligeholdelsesfasen (38 % af patienterne, 129 episoder i løbet af middelbehandlingsvarigheden på 28 måneder).
English: 10 mg four times a week
Danish: 10 mg fire gange ugentligt
English: All episodes resolved without sequelae.
Danish: Alle episoder ophørte uden følgevirkninger.
English: Palynziq 2.5 mg
Danish: INFORMATION I BRAILLESKRIFT Palynziq 2,5 mg
English: Angioedema occurred as early as 4 days and up to 1222 days into Palynziq treatment (median: 91 days from Palynziq treatment initiation).
Danish: Angioødem forekom allerede 4 dage og op til 1.222 dage inde i behandlingen med Palynziq (median: 91 dage fra start af behandling med Palynziq).
English: 3 The maintenance dose is individualised to achieve blood phenylalanine levels between 120 to 600 micromol/l.
Danish: ³ Vedligeholdelsesdosis tilpasses den enkelte patient for at opnå et fenylalaninniveau i blodet mellem 120 og 600 mikromol/l.
English: The injection sites should be at least 5 centimetres away from each other.
Danish: Der skal være mindst 5 centimeter mellem injektionsstederne.
English: Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml solution.
Danish: Hver 20 mg fyldt injektionssprøjte indeholder 20 mg pegvaliase i 1 ml opløsning.
English: The risk of angioedema occurring is 4.5-fold higher in induction/titration phase compared to maintenance phase.
Danish: Risikoen for forekomst af angioødem er 4,5 gange højere i induktions-/titreringsfasen sammenlignet med vedligeholdelsesfasen.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Danish: 4.4 og 4.8).
English: Neutralising antibodies (NAb) capable of inhibiting PAL enzyme activity were detected in a majority of patients over time with 78% of patients testing positive for NAb at one year after treatment initiation and maintaining stable NAb titres through long-term treatment.
Danish: 78 % af patienterne blev testet positive for NAb et år efter behandlingsstart og opretholdt stabile NAb-titre gennem langtidsbehandling.
English: If you stop taking Palynziq
Danish: Hvis du holder op med at bruge Palynziq
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 20 MG CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 20 MG ÆSKE
English: Mean (SD) change from baseline was 20 (323) micromol/l at Month 12 (n=9), -460 (685) micromol/l at Month 24 (n=5), and -783 (406) micromol/l at Month 36 (n=5).
Danish: −460 (685) mikromol/l ved måned 24 (n = 5) og −783 (406) mikromol/l ved måned 36 (n = 5).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 2.5 MG TRAY COVER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP 2,5 MG BAKKELÅG
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).
Danish: Reaktioner på injektionsstedet forekom hyppigst i induktions- og titreringsfasen (90 % af patienterne, 3.899 episoder i løbet af middelbehandlingsvarigheden på 12 måneder) og faldt i vedligeholdelsesfasen (64 % af patienterne, 1.110 episoder i løbet af middelbehandlingsvarigheden på 28 måneder).
English: • Use each Palynziq pre-filled syringe once only.
Danish: • Brug kun hver enkelt fyldt injektionssprøjte én gang.
English: Severe arthralgia (severe pain limiting self-care activities of daily living) was experienced in 14 (5%) patients.
Danish: 14 (5 %) patienter oplevede svær artralgi (svære smerter, der begrænsede dagligdags egenomsorg).
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
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1362/003 1 x 20 mg fyldt injektionssprøjte EU/1/19/1362/004 10 x 20 mg fyldte injektionssprøjter
English: 60 mg daily (3 consecutive injections of 20 mg pre-filled syringe)4
Danish: 60 mg dagligt (3 injektioner af 20 mg fyldt injektionssprøjte i træk)4
English: Following cellular uptake, the metabolism of phenylalanine ammonia lyase (PAL) is expected to occur via catabolic pathways and be degraded into small peptides and amino acids; the PEG molecule is metabolically stable and expected to be separated from PAL protein and primarily eliminated by renal filtration.
Danish: Efter optagelse i cellerne forventes fenylalaninammoniaklyases (PAL) metabolisme at ske via kataboliske processer og at blive nedbrudt i små peptider og aminosyrer.
English: • Do not hold the pre-filled syringe by the plunger or plunger head while taking the needle cap off.
Danish: • Hold ikke fast i den fyldte injektionssprøjtes stempel eller stempelhoved, når du tager kanylehætten af.
English: 2.5 mg once weekly
Danish: 2,5 mg én gang ugentligt
English: PREPARING FOR INJECTION
Danish: SÅDAN GØR DU KLAR TIL INJEKTION
English: The mean (SD) duration of these reactions was 64 (78) days, and the maximum duration was 638 days, 5% of these reactions persisted at least 180 days, and 86% of these reactions resolved by the time of the data cut-off.
Danish: 5 % af reaktionerne varede i mindst 180 dage, og 86 % af disse reaktioner var forsvundet på tidspunktet for data cut-off.
English: 20 mg daily
Danish: 20 mg dagligt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 10 MG CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 10 MG ÆSKE
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).
Danish: Overfølsomhedsreaktioner forekom hyppigst i induktions- og titreringsfasen (65 % af patienterne, 921 episoder i løbet af middelbehandlingsvarigheden på 12 måneder) og faldt i vedligeholdelsesfasen (58 % af patienterne, 491 episoder i løbet af middelbehandlingsvarigheden på 28 måneder).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 20 MG TRAY COVER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP 20 MG BAKKELÅG
English: Palynziq 20 mg solution for injection in pre-filled syringe pegvaliase
Danish: Palynziq 20 mg injektionsvæske, opløsning i fyldt injektionssprøjte pegvaliase
English: Losing control of urine or stools
Danish: Fornemmelse af svimmelhed eller besvimelse Tab af kontrol med urin eller afføring Hurtige hjerteslag
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).
Danish: Artralgi forekom hyppigst i induktions- og titreringsfasen (78 % af patienterne, 1.264 episoder i løbet af middelbehandlingsvarigheden på 12 måneder) og faldt i vedligeholdelsesfasen (62 % af patienterne, 612 episoder i løbet af middelbehandlingsvarigheden på 28 måneder).
English: • The guide for patients and trained observers shall contain the following key messages: o Description of the signs and symptoms of severe allergic reactions o Information on the action to be taken by the patient and/or trained observer in the event of the occurrence of a severe allergic reaction o Description of the risk minimisation measures necessary to minimise the risk of severe allergic reactions, in particular: Premedication requirements Requirement to carry adrenaline injection device at all times Requirement for trained observer for at least the first 6 months of treatment o The need to contact the prescriber in the event of a severe allergic reaction prior to continuing treatment o The importance of carrying the patient alert card
Danish: • Vejledningen til patienter og uddannede observatører skal indeholde følgende nøglebudskaber: o Beskrivelse af tegn og symptomer på svære allergiske reaktioner o Information om de aktiviteter, patienten og/eller den uddannede observatør skal udføre i tilfælde af en svær allergisk reaktion o Beskrivelse af de risikominimeringsforanstaltninger, der er nødvendige for at minimere risikoen for svære allergiske reaktioner, især:
English: • 44% of patients, 62% of patients, and 66% of patients reached blood phenylalanine level
Danish: • 44 % af patienterne, 62 % af patienterne og 66 % af patienterne nåede et fenylalaninniveau i blodet ≤ 360 mikromol/l ved henholdsvis 12 måneder, 24 måneder og 36 måneder.
English: 40 mg daily
Danish: 40 mg dagligt
English: Pre-filled syringe 2.5 mg (white plunger): Each 2.5 mg carton contains 1 pre-filled syringe.
Danish: Fyldt injektionssprøjte 2,5 mg (hvidt stempel): Hver 2,5 mg-pakning indeholder 1 fyldt injektionssprøjte.
English: • Do not remove the needle cap from your pre-filled syringe.
Danish: • Fjern ikke kanylehætten fra den fyldte injektionssprøjte.
English: Other medicines and Palynziq
Danish: Brug af anden medicin sammen med Palynziq
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 2.5 MG PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 2,5 MG FYLDT INJEKTIONSSPRØJTE