FrancophonIA/ELRC3.0 huggingface dataset:
English: Using aseptic technique, reconstitute each vial of canakinumab at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle.
Danish: Rekonstituér hvert canakinumabhætteglas under aseptiske forhold ved stuetemperatur (typisk 15°C til 25°C) ved langsomt at injicere 1 ml vand til injektionsvæsker med en 1 ml sprøjte og en 18 G x 2 tommer (50 mm) kanyle.
English: Slowly pull the syringe plunger up to the correct mark (amount to be given as per healthcare provider's instructions), filling the syringe with Ilaris solution.
Danish: Træk langsomt sprøjtestemplet op til det rigtige mærke (mængden skal svare til lægens instrukser), så sprøjten fyldes med Ilaris-opløsning.
English: If the child responds well enough to this, treatment may be continued with a dose of 8 mg/kg every 8 weeks.
Danish: Hvis barnet reagerer godt på denne dosis, kan behandlingen fortsættes med en dosis på 8 mg/kg hver 8. uge.
English: No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment.
Danish: Langtidsbehandling havde ingen indflydelse på bivirkningernes type eller frekvens.
English: 3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below
Danish: 4De fleste repræsenterede forbigående antydning til 1+ positiv urinprotein ved urinsticks.
English: What you need to know before you use Ilaris
Danish: Det skal du vide, før du begynder at tage Ilaris
English: • 150 mg for patients with body weight > 40 kg
Danish: • 150 mg til patienter med legemsvægt >40 kg
English: Ilaris is injected every 8 weeks as a single dose.
Danish: Ilaris indsprøjtes hver 8. uge som en enkelt dosis.
English: Table 3 Tabulated summary of efficacy in Phase III trial, pivotal, randomised, placebocontrolled treatment period (Part II)
Danish: Tabel 3 Opsummering af effekt i fase III-studiets pivotale, randomiserede, placebokontrollerede behandlingsperiode (del II)
English: Ilaris is used in adults, adolescents and children to treat active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older if other treatments have not worked well enough.
Danish: Ilaris anvendes til voksne, unge og børn til behandling af aktiv Stills sygdom, herunder Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA) hos patienter på 2 år og derover, som ikke har haft tilstrækkelig virkning af anden behandling.
English: The solution should be colourless or may have a slight brownish-yellow tint.
Danish: Opløsningen skal være farveløs eller kan have et svagt brun-gult skær.
English: Musculoskeletal pain Back pain
Danish: Almindelig Muskuloskeletale smerter
English: For CAPS, TRAPS, HIDS/MKD, FMF and Still's disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.
Danish: Ved CAPS, TRAPS, HIDS/MKD, FMF og Stills sygdom bør behandlingen indledes og superviseres af en speciallæge, der har erfaring med diagnosticering og behandling af den relevante sygdom.
English: The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous administration of 150 mg canakinumab every 8 weeks.
Danish: Den forventede akkumuleringsratio var 1,3 gange efter 6 måneders subkutan administration af 150 mg canakinumab hver 8. uge.
English: Ilaris is indicated for the treatment of active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
Danish: Ilaris er indiceret til behandling af aktiv Stills sygdom, herunder Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA) hos patienter på 2 år og ældre, der har reageret utilstrækkeligt på tidligere behandling med non-steroide antiinflammatoriske stoffer (NSAID) og systemiske kortikosteroider.
English: 150 mg or 2 mg/kg
Danish: 150 mg eller 2 mg/kg
English: Study G2305
Danish: Studie G2305
English: Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
Danish: Hyperimmunglobulin D-syndrom (HIDS)/mevalonatkinasemangel (MKD) Ilaris er indiceret til behandling af hyperimmunglobulin D-syndrom (HIDS)/mevalonat-kinase-mangel (MKD).
English: - Tumour necrosis factor receptor associated periodic syndrome (TRAPS) - Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD) - Familial Mediterranean fever (FMF): Ilaris is used to treat FMF.
Danish: - Tumornekrosefaktor-receptor-associeret periodisk syndrom (TRAPS) - Hyperimmunglobulin D-syndrom (HIDS) også kendt som mevalonat-kinase-mangel (MKD) - Familiær middelhavsfeber (FMF): Ilaris anvendes til behandling af FMF.
English: If you forget to use Ilaris
Danish: Hvis du har glemt at tage Ilaris
English: Patients on urate lowering therapy (ULT)
Danish: Patienter i urat-sænkende behandling (ULT)
English: Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Danish: Injektionsvæsken må ikke anvendes, hvis den indeholder tydeligt synlige partikler, er uklar eller er tydeligt brun.
English: Maintenance dose: 150 mg every 4 weeks
Danish: Vedligeholdelsesdosis: 150 mg hver 4. uge
English: Your doctor will discuss with you the potential risks of taking Ilaris before breast-feeding.
Danish: Din læge vil tale med dig om de mulige risici, der er ved at tage Ilaris, før du begynder at amme.
English: The recommended dose of Ilaris for patients with Still's disease (AOSD or SJIA) with body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg).
Danish: Den anbefalede dosis Ilaris til patienter med Stills sygdom (AOSD eller SJIA), der vejer 7,5 kg eller derover, er 4 mg/kg (op til højst 300 mg).
English: • Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological,
Danish: Neonatalt multisystemisk inflammatorisk sygdom (NOMID)/kronisk infantilt neurologisk hudog ledsyndrom (CINCA),
English: The expected accumulation ratio was 1.1-fold following subcutaneous administration of 150 mg canakinumab every 12 weeks.
Danish: Den forventede akkumulationsratio var 1,1 gange efter subkutan administration af 150 mg canakinumab hver 12. uge.
English: All patients should be instructed to seek medical advice if signs or symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy.
Danish: Alle patienter skal informeres om at søge læge, hvis tegn eller symptomer, der tyder på tuberkulose (fx vedvarende hoste, vægttab, let feber) opstår under behandling med canakinumab.
English: What Ilaris is used for Ilaris is used for treatment of the following inflammatory diseases: - Periodic fever syndromes:
Danish: Ilaris anvendes til behandling af følgende inflammatoriske sygdomme (betændelseslignende tilstande): - Periodiske febersyndromer:
English: Upper abdominal pain.
Danish: Smerter i den øvre del af abdomen
English: • 150 mg for patients who weigh more than 40 kg
Danish: • 150 mg til patienter, som vejer over 40 kg
English: For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Danish: Canakinumab skal administreres så hurtigt som muligt efter frembrud af et urinsyregigt-anfald for at få maksimal virkning.
English: Hold the syringe at a 90-degree angle and in a single, smooth motion, push the needle straight down completely into the skin.
Danish: Hold sprøjten vinkelret på huden, og skub med en enkelt, jævn bevægelse kanylen lige ned og helt ind i huden.
English: Not included in the pack one vial (or ampoule) of sterile water for injections (“water”) (at room temperature) one 1.0 ml syringe one 18 G x 2 inch (50 mm) needle for reconstituting the powder (“transfer needle”) one 27 G x 0.5 inch (13 mm) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials (sharps container)
Danish: Pakningen indeholder ikke et hætteglas (eller ampul) med sterilt vand til injektionsvæsker (”vand”) (opbevares ved stuetemperatur) en 1,0 ml sprøjte en 18 G x 2 tommer (50 mm) kanyle til opløsning af pulveret (”overførselskanyle”) en 27 G x 0,5 tommer (13 mm) kanyle til indsprøjtning (”indsprøjtningskanyle”) spritservietter rene, tørre bomuldsservietter et hæfteplaster en passende affaldsbeholder til brugte kanyler, sprøjte og hætteglas (kanyleboks)
English: Bioavailability in SJIA patients has not been determined independently.
Danish: Biotilgængeligheden er ikke blevet bestemt specifikt hos SJIA-patienter.
English: If you do not respond well enough to the second dose, a third dose of Ilaris at 300 mg or 4 mg/kg may be given.
Danish: Hvis du ikke reagerer godt nok på den anden dosis, kan en tredje dosis Ilaris på 300 mg eller 4 mg/kg gives.
English: The active substance is canakinumab.
Danish: Ilaris indeholder Aktivt stof: canakinumab.
English: - Still's disease including adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) - Gouty arthritis
Danish: Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA)
English: Laboratory abnormalities in TRAPS, HIDS/MKD and FMF patients Neutrophils
Danish: Laboratorieabnormiteter hos TRAPS-, HIDS/MKD- og FMF-patienter Neutrofiler
English: What Ilaris looks like and contents of the pack Ilaris is supplied as a powder for solution for injection (150 mg in a 6 ml glass vial).
Danish: Udseende og pakningsstørrelser - Ilaris leveres som et pulver til injektionsvæske, opløsning (150 mg i et 6 ml hætteglas).
English: CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA): You should continue using Ilaris for as long as the doctor tells you.
Danish: CAPS, TRAPS, HIDS/MKD, FMF eller Stills sygdom (AOSD eller SJIA): Du skal fortsætte med at tage Ilaris, så længe lægen fortæller dig, at du skal.
English: Mean exposure in a typical gouty arthritis patient (93 kg) after a single subcutaneous 150 mg dose (Cmax: 10.8 µg/ml and AUCinf: 495 µg*d/ml) was lower than in a typical 70 kg CAPS patient (15.9 µg/ml and 708 µg*d/ml).
Danish: Den gennemsnitlige eksponerning hos en typisk urinsyregigtpatient (93 kg) efter en enkel subkutan 150 mg dosis (Cmax: 10,8 µg/ml og AUCinf: 495 µg*dag/ml) var lavere end hos en typisk 70 kg CAPS-patient (15,9 µg/ml og 708 µg*dag/ml).
English: - Any unused medicine must be discarded after the dose has been injected.
Danish: Eventuelle medicinrester skal kasseres efter, at lægemidlet er blevet indsprøjtet.
English: Slowly pull the syringe plunger up to the correct mark (amount to be given), filling the syringe with Ilaris solution.
Danish: Træk langsomt sprøjtestemplet op til det rigtige mærke (den mængde, der skal gives), så sprøjten fyldes med Ilaris-injektionsvæske.
English: Set the syringe aside.
Danish: Læg sprøjten til side.
English: There were 102 TRAPS, HIDS/MKD and FMF patients (2-17 years of age) who received canakinumab in a 16-week study.
Danish: 102 patienter med TRAPS, HIDS/MKD eller FMF (i alderen 2-17 år) fik canakinumab i et studie af 16 ugers varighed.
English: If not used immediately, the solution should be stored in the refrigerator (2°C - 8°C) and used within 24 hours.
Danish: Hvis injektionsvæsken ikke anvendes straks, skal den opbevares i køleskab (2 C - 8 C) og anvendes indenfor 24 timer.
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) The recommended starting dose of Ilaris is: - Adults and children aged 2 years or more
Danish: Tumornekrosefaktor-receptor-associerede periodiske syndromer (TRAPS), hyperimmunglobulin Dsyndrom (HIDS)/mevalonat-kinase-mangel (MKD) og familiær middelhavsfeber (FMF) Den anbefalede startdosis er: Voksne og børn på 2 år og derover
English: Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in children aged 2 to < 4 years were similar to those in patients 4 years of age and older.
Danish: Baseret på en populationsfarmakokinetisk modelleringsanalyse var canakinumabs farmakokinetik hos børn i alderen 2 til <4 år lig den hos patienter i alderen 4 år og ældre.
English: Avoid touching the needles and the tops of the vials.
Danish: Undgå at berøre kanylerne og toppen af hætteglassene.
English: Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall population.
Danish: Overordnet var der ingen klinisk relevant forskel mellem sikkerheds- og tolerabilitetsprofilen for canakinumab hos pædiatriske patienter sammenlignet med den samlede population.
English: Turn the vial and syringe upside down and bring to eye level.
Danish: Vend hætteglas og sprøjte på hovedet, og hold dem op i øjenhøjde.
English: Efficacy and safety of canakinumab in young adult SJIA patients aged 16 to 20 years were consistent with the efficacy and safety observed for patients less than 16 years of age.
Danish: Effekten og sikkerheden af canakinumab hos unge SJIA-patienter i alderen 16 til 20 år var i overensstemmelse med effekten og sikkerheden observeret hos patienter under 16 år.
English: If you see bubbles in the syringe, remove bubbles as instructed by your healthcare professional or pharmacist.
Danish: Hvis du kan se bobler i sprøjten, skal du fjerne boblerne som anvist af lægen, sygeplejersken eller apoteket.
English: • Neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurological, cutaneous, articular syndrome (CINCA),
Danish: • Systemisk inflammatorisk sygdom med neonatal debut (NOMID) også kaldet kronisk infantil neurologisk hud- og ledsyndrom (CINCA),
English: Remove the caps from the Ilaris and water vials.
Danish: Fjern hætten fra hætteglasset med Ilaris og hætteglasset med vand.
English: It is colourless to slightly brownish-yellow.
Danish: Den er farveløs til svagt brunlig-gul.
English: Mixing Ilaris
Danish: Blanding af Ilaris
English: - Part III: Patients who completed 16 weeks of treatment and were classified as responders were re-randomised into a 24-week, double-blind withdrawal period during which they received canakinumab 150 mg (2 mg/kg for patients ≤ 40 kg) s.c. or placebo every 8 weeks.
Danish: - Del III: Patienter, der gennemførte 16 ugers behandling og blev klassificeret som respondenter, blev randomiseret igen til en dobbeltblind seponeringsperiode på 24 uger, hvor de fik canakinumab 150 mg (2 mg/kg for patienter ≤40 kg) s.c. eller placebo hver 8. uge.
English: Choose an injection site on the upper thigh, abdomen, upper arm or buttocks.
Danish: Vælg et indsprøjtningssted på det øverste af låret, maven, overarmen eller balden.
English: • Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD),
Danish: • Hyperimmunglobulin D-syndrom (HIDS)/mevalonatkinase-mangel (MKD),
English: If you have CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA) and have forgotten to inject a dose of Ilaris, inject the next dose as soon as you remember.
Danish: Hvis du har CAPS, TRAPS, HIDS/MKD, FMF eller Stills sygdom (AOSD eller SJIA) og har glemt at indsprøjte en dosis Ilaris, skal du tage den næste indsprøjtning, så snart du kommer i tanke om det.
English: After proper training in the correct injection technique, patients or their caregivers may inject Ilaris if the physician determines that it is appropriate and with medical follow-up as necessary (see section 6.6).
Danish: Efter grundig undervisning i korrekt injektionsteknik kan patienter eller deres plejeperson injicere Ilaris, hvis det efter lægens afgørelse er hensigtsmæssigt.
English: TRAPS, HIDS/MKD and FMF
Danish: TRAPS, HIDS/MKD og FMF
English: Treatment of CAPS, TRAPS, HIDS/MKD, FMF and Still's disease (AOSD and SJIA) Canakinumab should not be initiated or continued in patients during an active infection requiring medical intervention.
Danish: Behandling af CAPS, TRAPS, HIDS/MKD, FMF og Stills sygdom (AOSD og SJIA) canakinumab-behandling bør ikke indledes eller fortsættes hos patienter med en aktiv, behandlingskrævende infektion.
English: CAPS, TRAPS, HIDS/MKD and FMF
Danish: CAPS, TRAPS, HIDS/MKD og FMF
English: If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) every 4 weeks should be maintained.
Danish: Hvis der efterfølgende opnås fuldt behandlingsrespons, bør det intensiverede doseringsregime på 300 mg (eller 4 mg/kg for patienter, der vejer ≤40 kg) hver 4. uge opretholdes.
English: • Respiratory infections such as chest infection, flu, sore throat, runny nose, blocked nose, sneezing, feeling of pressure or pain in the cheeks or forehead with or without fever (pneumonia, bronchitis, influenza, sinusitis, rhinitis, pharyngitis, tonsilitis, nasopharyngitis, upper respiratory tract infection).
Danish: • Luftvejsinfektioner, som fx infektion i brystkassen, influenza, ondt i halsen, løbende næse, stoppet næse, nysen, følelse af trykken eller smerte i kinderne eller panden med eller uden feber (lungebetændelse, bronkitis, influenza, bihulebetændelse, snue, halsbetændelse, næse- og svælgkatar, infektion i de øvre luftveje).
English: Other medicines and Ilaris
Danish: Brug af anden medicin sammen med Ilaris
English: Table 2 Tabulated summary of efficacy in Phase III trial, pivotal placebo-controlled withdrawal period (Part II)
Danish: Tabel 2 Opsummering af effekt i fase III-studiets pivotale placebo-kontrollerede seponerings-periode (del II)
English: Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection)
Danish: Luftvejsinfektioner (herunder pneumoni, bronkitis, influenza, virusinfektion, sinusitis, rhinitis, faryngitis, tonsillitis, nasofaryngitis, infektion i øvre luftveje) Øreinfektion Cellulitis Gastroenteritis Urinvejsinfektion Almindelig Vulvovaginal candidiasis Nervesystemet Almindelig Svimmelhed/vertigo Mave-tarm-kanalen Meget almindelig
English: The solution should be free of visible particles and clear to opalescent.
Danish: Opløsningen skal være fri for synlige partikler og klar til opaliserende.
English: All indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis
Danish: Alle indikationer: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, urinsyregigt
English: If a satisfactory clinical response has not been achieved 7 days after this increased dose, a third dose of canakinumab at 300 mg or 4 mg/kg can be considered.
Danish: Hvis et tilfredsstillende klinisk respons ikke er opnået 7 dage efter denne øgede dosis, kan en tredje dosis canakinumab på 300 mg eller 4 mg/kg overvejes.
English: The recommended dose of Ilaris for adult gouty arthritis patients is 150 mg given as a single dose at the time of a gouty arthritis attack.
Danish: Den anbefalede dosis af Ilaris til voksne gigtpatienter er 150 mg givet som en enkelt dosis på det tidspunkt, hvor du har et anfald af urinsyregigt.
English: The solution is clear to opalescent and colourless to slightly brownish yellow.
Danish: Opløsningen er klar til opaliserende og farveløs til svagt brunlig-gul.
English: • Tumour necrosis factor receptor associated periodic syndrome (TRAPS),
Danish: • Tumornekrosefaktor-receptor-associeret periodisk syndrom (TRAPS),
English: Ilaris blocks the activity of IL-1 beta, which may improve the signs and symptoms of Still's disease.
Danish: Ilaris blokkerer aktiviteten af IL-1 beta, hvilket kan lindre symptomerne på Stills sygdom.
English: Your healthcare provider will instruct you on the right amount for you.
Danish: Lægen, sygeplejersken eller apoteket vil fortælle dig, hvilken mængde der er den rigtige for dig.
English: Allow to stand for about 15 minutes at room temperature to get a clear to opalescent solution.
Danish: Lad hætteglasset stå i omkring 15 minutter ved stuetemperatur, indtil opløsningen er klar til opaliserende.
English: Avoid injecting into a vein.
Danish: Undgå at give indsprøjtningen i en blodåre.
English: Carefully remove the transfer needle from the vial and recap the needle as instructed by your healthcare provider or pharmacist.
Danish: Fjern forsigtigt overførselskanylen fra hætteglasset, og sæt hætten på kanylen igen som anvist af lægen, sygeplejersken eller apoteket.
English: Laboratory abnormalities in SJIA patients
Danish: Laboratorieanomalier hos SJIA-patienter
English: Canakinumab should be used as an on-demand therapy to treat gouty arthritis attacks.
Danish: Canakinumab bør anvendes som behovsbehandling af urinsyregigt-anfald.
English: Opportunistic infections have been reported in patients treated with canakinumab (see section 4.4).
Danish: Opportunistiske infektioner er blevet rapporteret hos patienter, der blev behandlet med canakinumab (se pkt.
English: - The solution should be used immediately after first piercing the vial stopper to prepare the injection.
Danish: Injektionsvæsken skal anvendes straks efter perforering af gummihætten for klargøring af injektionen.
English: It blocks the activity of a substance called interleukin-1 beta (IL-1 beta) in the body, which is present at increased levels in inflammatory diseases.
Danish: Det blokerer aktiviteten af et stof i kroppen, der kaldes interleukin-1 beta (IL-1 beta).
English: If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 8 weeks should be maintained.
Danish: Hvis fuldt behandlingsrespons efterfølgende opnås, bør det intensiverede dosisregime på 300 mg eller 4 mg/kg hver 8. uge opretholdes.
English: Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the solution subcutaneously.
Danish: Når det nødvendige volumen er udtaget, sættes hætten tilbage på kanylen, udtrækningskanylen fjernes fra sprøjten, og en 27 G x 0,5 tomme kanyle (eller lignende tilgængelig) fastgøres.
English: Solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium).
Danish: Injektionsvæske i et hætteglas (type I-glas) med prop (lamineret chlorbutylgummi) og flip-off-låg (aluminium).
English: If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks
Danish: Hvis fuldt behandlingsrespons efter 7 dage, vedligeholdelsesdosis: 600 mg eller 8 mg/kg hver 8. uge
English: The safety profile in AOSD patients is expected to be similar to SJIA patients based on literature reports.
Danish: Baseret på litteraturrapporter forventes sikkerhedsprofilen hos AOSD-patienter at være magen til sikkerhedsprofilen hos SJIA-patienter.
English: Instructions for use of Ilaris powder for solution for injection
Danish: Brugervejledning til Ilaris pulver til injektionsvæske, opløsning
English: Open the wrappers containing the syringe and the withdrawal needle.
Danish: Åbn pakningerne, der indeholder injektionssprøjten og udtrækningskanylen.
English: UNIT PACK CARTON
Danish: KARTON FOR ENHEDSPAKNING
English: Predicted canakinumab steady state exposures at a dose level of 4 mg/kg (maximum 300 mg) in patients over the age of 20 years were comparable to those in SJIA patients younger than 20 years of age.
Danish: Ved et dosisniveau på 4 mg/kg (maksimalt 300 mg) var de forventede canakinumabeksponeringer ved steady state hos patienter over 20 år sammenlignelige med eksponeringerne hos SJIA-patienter under 20 år.
English: Bioavailability in gouty arthritis patients has not been determined independently.
Danish: Biotilgængeligheden er ikke blevet bestemt selvstændigt hos urinsyregigtpatienter.