FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance is certolizumab pegol.
Danish: Cimzia indeholder - Aktivt stof: certolizumab pegol.
English: However, do not inject in an area where the skin is reddened, bruised, or hard.
Danish: Du må imidlertid ikke injicere på steder, hvor huden er rød, bekadigeteller er hård.
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
Danish: Efter startdosis er den anbefalede vedligeholdelsesdosis til voksne med aksial spondyloartritis 200 mg Cimzia hver 2. uge eller 400 mg Cimzia hver 4. uge.
English: The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Danish: Kanylebeskyttelsen er af styrenbutadiengummi, der indeholder et derivat af naturlig gummilatex (se pkt.
English: What Cimzia is and what it is used for What you need to know before you use Cimzia How Cimzia will be given Possible side effects
Danish: Det skal du vide, før du begynder at bruge Cimzia Sådan skal du bruge Cimzia Bivirkninger
English: • coughing
Danish: • kramper
English: • breast disorders
Danish: • brystlidelser
English: Treatment regimen week 0 to 16 Cimzia 400 mg + MTX at week 0, 2 and 4, followed by
Danish: Tabel 7 ACR-respons i det kliniske studie DoseFlex ved uge 34 Behandlingsregime uge 0 til 16 Cimzia 400 mg + MTX ved uge 0, 2 and 4, efterfulgt af Cimzia 200 mg + MTX hver 2. uge
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia pre-filled syringe.
Danish: Der er til dato ikke blevet fundet antigent latexprotein i den aftagelige kanylehætte til den fyldte sprøjte med Cimzia.
English: • formation of stones in the gall bladder
Danish: • stendannelse i galdeblæren
English: Cimzia 200 mg + MTX N = 528 Mean (SD)
Danish: Cimzia 200 mg + MTX N = 528 Gennemsnit (SD)
English: 3: Needle guard activation clips
Danish: 1: Kanylehætte 2: Stempelhoved 3: Aktiveringsclips til kanylebeskyttelse
English: Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Danish: Multipakning indeholdende 6 (3 pakninger a 2) fyldte sprøjter og 6 (3 pakninger a 2) alkoholservietter.
English: • The starting dose for adults with plaque psoriasis is 400 mg every 2 weeks given at weeks 0, 2 and 4.
Danish: • Startdosistil voksne med plaque psoriasis er 400 mg hver 2. uge givet i uge 0, 2 og 4.
English: Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Danish: Multipakning indeholdende 10 (5 pakninger a 2) fyldte sprøjter og 10 (5 pakninger a 2) alkoholservietter.
English: Patients were treated with a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either 200 mg of Cimzia every 2 weeks or 400 mg of Cimzia every 4 weeks or placebo.
Danish: Patienterne blev behandlet med en støddosis på 400 mg Cimzia ved uge 0, 2 og 4 (i begge behandlingsarme) eller placebo efterfulgt af enten 200 mg Cimzia hver 2. uge eller 400 mg Cimzia hver 4. uge eller placebo.
English: Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Cimzia.
Danish: Cimzia kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i mindre grad. Svimmelhed (herunder følelsen af, at rummet drejer rundt, sløret syn eller træthed) kan forekomme, efter du har taget Cimzia.
English: Syringe
Danish: Hjerte
English: • psoriatic arthritis
Danish: • psoriasisartritis
English: Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus.
Danish: Dyrestudier viste ikke evidens for nedsat fertilitet eller fosterskade ved brug af anti-rotte-TNF-α fra gnavere.
English: Medication body
Danish: Medicininformationschip
English: On/Off Button
Danish: Tænd/sluk-knap
English: Patients received a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either Cimzia 200 mg every 2 weeks or 400 mg every 4 weeks or placebo every 2 weeks.
Danish: Patienterne fik en støddosis på 400 mg Cimzia ved uge 0, 2 og 4 (i begge behandlingsarme) eller placebo efterfulgt af enten 200 mg Cimzia hver 2. uge eller 400 mg Cimzia hver 4. uge eller placebo hver 2. uge.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: ACR 50 Week 24 Week 52
Danish: ACR50 Uge 24 Uge 52
English: *p<0.01, Cimzia vs placebo **p<0.001, Cimzia vs placebo ***p<0.001(nominal), Cimzia vs placebo
Danish: Hos personer med psoriasis på mindst 3% af legemesoverfladen (BSA) ved baseline *p< 0,01, Cimzia vs. placebo **p< 0,001, Cimzia vs. placebo ***p< 0,001(nominel), Cimzia vs. placebo
English: • The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4.
Danish: • Startdosis til voksne med reumatoid artritis er 400 mg ved uge 0, 2 og 4.
English: Patients should be tested for HBV infection before initiating treatment with Cimzia.
Danish: Før behandling med Cimzia påbegyndes, skal patienten testes for HBV-infektion.
English: Cimzia 200 mg + MTX every 2 weeks N=70
Danish: Cimzia 200 mg + MTX hver 2. uge N=70
English: • Do not shake the syringe.
Danish: • Ryst ikke sprøjten.
English: Rare odynophagia, hypermotility
Danish: Sjælden interstitiel lungesygdom, pneumonitis
English: • Do not remove the cap until you are ready to inject.
Danish: - Tag ikke kanylehætten af, før du er klar til at injicere.
English: - Repeat the injection process starting at Step 2.
Danish: - Meddelelsen ”Du har 1 injektion tilbage.” vises på skærmen - Gentag injektionsproceduren startende fra trin 2.
English: Clinical
Danish: Kirurgi
English: • If you need to have a second injection as prescribed by your doctor:
Danish: • Hvis den dosis din læge har ordineret kræver, at du indgiver endnu en injektion:
English: dizziness, tremor
Danish: Nyrer og urinveje
English: • cardiac arrhythmia
Danish: • hævede lymfekirtler
English: ACR 20 Week 24 Week 52
Danish: ACR20 Uge 24 Uge 52
English: Non-radiographic axial spondyloarthritis (nr-axSpA) The efficacy and safety of Cimzia were assessed in a 52 weeks multicenter, randomized, double-blind, placebo-controlled study (AS0006) in 317 patients ≥18 years of age with adult-onset axial spondyloarthritis and back pain for at least 12 months.
Danish: Cimzias virkning og sikkerhed blev undersøgt i et 52-ugers multicenter, randomiseret, dobbeltblindet, placebokontrolleret studie (AS0006) hos 317 patienter ≥ 18 år med spondyloartritis med debut i voksenalderen og rygsmerter af mindst 12 måneders varighed.
English: Do not use the pre-filled pen if the solution is discoloured, cloudy or if you can see particles in it.
Danish: - Brug ikke den fyldte pen, hvis opløsningen er misfarvet, uklar eller hvis du kan se partikler i den. - Der kan være luftbobler.
English: • stomach problems including abdominal fluid collection, ulcers (including oral ulcers),
Danish: • maveproblemer, herunder væskeansamling i maven, sår (herunder sår i munden), perforering,
English: • two pre-filled syringes of solution, and
Danish: • To fyldte sprøjter med opløsning og
English: - TUBERCULOSIS (TB) cases have been reported in patients treated with Cimzia, your doctor will check you for signs and symptoms of tuberculosis before starting Cimzia.
Danish: - Der er blevet indberettet tilfælde af TUBERKULOSE (TB) hos patienter, som blev behandlet med Cimzia.
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).
Danish: Cimzia kan påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre grad. Svimmelhed (inklusive vertigo, synsforstyrrelser og træthed) kan forekomme efter administrering af Cimzia (se pkt.
English: Multipack containing 6 (3 packs of 2) dose-dispenser cartridge and 6 (3 packs of 2) alcohol wipes.
Danish: Multipakning indeholdende 6 (3 pakninger a 2) kassetter til dosisdispenser og 6 (3 pakninger a 2) alkoholservietter.
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is 200 mg every 2 weeks.
Danish: Efter startdosis er den anbefalede vedligeholdelsesdosis til voksne med reumatoid artritis 200 mg Cimzia hver 2. uge.
English: Multipack containing 10 (5 packs of 2) dose-dispenser cartridge and 10 (5 packs of 2) alcohol wipes.
Danish: Multipakning indeholdende 10 (5 pakninger a 2) kassetter til dosisdispenser og 10 (5 pakninger a 2) alkoholservietter.
English: Excluding non-melanoma of the skin, 121 malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4,049 patients were treated, representing 9,277 patient-years.
Danish: I Cimzia RA kliniske studier, hvor i alt 4.049 patienter blev behandlet, svarende til 9.277 patientår, blev der, med undtagelse af non-melanomer i huden, observeret 121 maligniteter, inklusive 5 tilfælde af lymfomer.
English: Cimzia-treated patients reported significant improvements in tiredness (fatigue) as reported by the BASDAI-fatigue item and in health-related quality of life as measured by the ankylosing spondylitis QoL (ASQoL) and the SF-36 Physical and Mental Component Summaries and all domain scores as compared to placebo.
Danish: Fysisk funktionsrespons og helbredsrelaterede resultater I det kliniske studie AS001 rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, hvilket blev vurderet ved BASFI, og i smerter, hvilket blev vurderet ved Total og Nocturel Back Pain NRS skala, sammenlignet med placebo.Patienter behandlet med Cimzia rapporterede signifikante forbedringer i træthed (fatigue), hvilket blev rapporteret ved BASDAI-fatigue-indeks, og i helbredsorienteret livskvalitet, hvilket blev vurderet ved ankyloserende spondylitis QoL (ASQol) og SF-36 Physical and Mental Component Summaries samt scorer for alle områder, sammenlignet med placebo.
English: • Look at the expiry date on the syringe and pack.
Danish: • Se på udløbsdatoen på sprøjten og pakningen.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8) as instructed by your physician.
Danish: • Dette efterfølges af en vedligeholdelsesdosis på 200 mg hver 2. uge (fra uge 6) eller 400 mg hver
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE/PEN/DOSE-DISPENSER CARTRIDGE LABEL
Danish: ETIKET TIL SPRØJTE/PEN/KASSETTE TIL DOSISDISPENSER
English: Cimzia 200 mg solution for injection in dose-dispenser cartridge certolizumab pegol
Danish: Cimzia 200 mg injektionsvæske, opløsning i kassette til dosisdispenser certolizumab pegol
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Solution for injection in pre-filled syringe 2 single-use pre-filled syringes 2 alcohol wipes
Danish: Injektionsvæske, opløsning i fyldt sprøjte 2 fyldte engangssprøjter 2 alkoholservietter
English: There is no need to replace the cap. • After injection, immediately throw away the used pen(s) in a special container as instructed by your doctor, nurse or pharmacist.
Danish: • Efter injektion, skal den/de brugte pen(ne) straks bortskaffes i en særlig beholder, som angivet af din læge, sygeplejerske eller apotekspersonalet.
English: After proper training in injection technique, patients may self-inject using the pre-filled syringe if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Hvis lægen vurderer, det er hensigtsmæssigt, kan patienten selv injicere den fyldte sprøjte med Cimzia efter passende oplæring i injektionsteknik og med lægelig opfølgning efter behov.
English: INSTRUCTIONS FOR USE FOR THE CIMZIA INJECTION BY MEANS OF PRE-FILLED PEN
Danish: BRUGERVEJLEDNING TIL CIMZIA INJEKTION MED KASSETTE TIL DOSISDISPENSER
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 6 (3 x 2) single-use AutoClicks pre-filled pens and 6 (3 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i en fyldt pen (AutoClicks) Multipakning: 6 (3 x 2) AutoClicks fyldte engangspenne og 6 (3 x 2) alkoholservietter
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 10 (5 x 2) single-use AutoClicks pre-filled pens and 10 (5 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i en fyldt pen (AutoClicks) Multipakning: 10 (5 x 2) AutoClicks fyldte engangspenne og 10 (5 x 2) alkoholservietter
English: What Cimzia looks like and contents of the pack Cimzia is provided as a solution for injection in a ready to use pre-filled syringe.
Danish: Cimzia leveres som en injektionsvæske, opløsning i en fyldt sprøjte, der er klar til brug.
English: ACR 70 Week 24 Week 52
Danish: ACR70 Uge 24 Uge 52
English: Cimzia(a)200 mg Q2W
Danish: Cimzia 200 mg Q2W
English: Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Danish: Injektionsvæske, opløsning i kassette til dosisdispenser 2 engangskassetter til dosisdispenser 2 alkoholservietter
English: The needle shield inside the removable cap of the CIMZIA pre-filled pen contains a derivative of natural rubber latex (see section 6.5).
Danish: Kanylebeskyttelsen inden i den aftagelige kanylehætte på den fyldte pen med Cimzia indeholder et naturlig gummilatex derivat (se pkt.
English: Do not use Cimzia after the expiry date which is stated on the pack and medication after EXP.
Danish: Brug ikke Cimzia efter den udløbsdato, der står på pakningen og medicinen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: ◦ One or two AutoClicks pre-filled pen(s), depending on your prescribed dose ◦ One or two alcohol wipe(s)
Danish: • Tag følgende ting fra Cimzia-pakningen og læg dem på et rent, jævnt underlag: - En eller to fyldt(e) AutoClicks pen(ne), afhængigt af hvilken dosis du har fået ordineret - En eller to alkoholserviet(ter)
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) 2 single-use AutoClicks pre-filled pens 2 alcohol wipes
Danish: Injektionsvæske, opløsning i en fyldt pen (AutoClicks) 2 AutoClicks fyldte engangspenne 2 alkoholservietter
English: • The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
Danish: • Startdosistil voksne med aksial spondyloartritis er 400 mg givet ved uge 0, 2 og 4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 dose-dispenser cartridges and 2 alcohol wipes)
Danish: Ydre karton (for pakninger med 2 kassetter til dosisdispenser og 2 alkoholservietter)
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 6 (3 x 2) single-use dose-dispenser cartridges and 6 (3 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i kassette til dosisdispenser Multipakning: 6 (3 x 2) engangskassetter til dosisdispenser og 6 (3 x 2) alkoholservietter
English: Solution for injection in a pre-filled pen (AutoClicks) 2 AutoClicks pre-filled pens 2 alcohol wipes
Danish: Injektionsvæske, opløsning i en fyldt pen (AutoClicks) 2 AutoClicks fyldte penne
English: NN:
Danish: (d)
English: The needle shield inside the removable cap of the CIMZIA dose-dispenser cartridge contains a derivative of natural rubber latex (see section 6.5).
Danish: Kanylebeskyttelsen inden i den aftagelige kanylehætte på kasetten til dosisdispenser med Cimzia indeholder et naturlig gummilatex derivat (se pkt.
English: • Allow the AutoClicks pre filled pen(s) to reach room temperature.
Danish: • Lad den fyldte pen opnå stuetemperatur.
English: The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex (see section 6.5).
Danish: Kanylebeskyttelsen inden i den aftagelige kanylehætte på den fyldte sprøjte med Cimzia indeholder et naturlig gummilatex derivat (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe Multipack: 10 (5 x 2) single-use pre-filled syringes and 10 (5 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i fyldt sprøjte Multipakning: 10 (5 x 2) fyldte engangssprøjter og 10 (5 x 2) alkoholservietter
English: Do not use this medicine after the expiry date which is stated on the pack and pen after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og pennen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Do not use this medicine after the expiry date which is stated on the pack and dose-dispenser cartridge after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og kassetten til dosisdispenser efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe Multipack: 6 (3 x 2) single-use pre-filled syringes and 6 (3 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i fyldt sprøjte Multipakning: 6 (3 x 2) fyldte engangssprøjter og 6 (3 x 2) alkoholservietter
English: Each pre-filled pen contains 200 mg of certolizumab pegol in one ml.
Danish: En fyldt pen indeholder 200 mg certolizumab pegol i én ml.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 10 (5 x 2) single-use dose-dispenser cartridge and 10 (5 x 2) alcohol wipes
Danish: Injektionsvæske, opløsning i kassette til dosisdispenser Multipakning: 10 (5 x 2) engangskassetter til dosisdispenser og 10 (5 x 2) alkoholservietter
English: Intermediate carton within Multipack of 6 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Danish: Indre karton i multipakning med 6 (til 2 kassetter til dosisdispenser og 2 alkoholservietter) (uden blå boks)
English: • Look at the expiry date on the pack and dose tray.
Danish: • Se på udløbsdatoen på pakningen og dosispakningen.
English: ACR20 Week 12 Week 24 ACR50 Week 12 Week 24
Danish: ACR20 Uge 12 Uge 24
English: Do not use if the solution is discoloured, cloudy or if you can see particles in it. You may see air bubbles - this is normal.
Danish: - Brug ikke opløsningen, hvis den er misfarvet, uklar eller hvis du kan se partikler i den. - Der kan være luftbobler.
English: Do not use Cimzia after the expiry date which is stated on the pack and pre-filled pen after EXP.
Danish: Brug ikke Cimzia efter den udløbsdato, der står på pakningen og den fyldte pen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - If you have any further questions, please ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in dose-dispenser cartridge
Danish: Cimzia 200 mg injektionsvæske, opløsning i kassette til dosisdispenser
English: What Cimzia is and what it is used for What you need to know before you use Cimzia How to use Cimzia
Danish: Det skal du vide, før du begynder at bruge Cimzia Sådan indgives Cimzia
English: Each dose-dispenser cartridge contains 200 mg of certolizumab pegol in one ml.
Danish: En kassette til dosisdispenser indeholder 200 mg certolizumab pegol i én ml.
English: Tell your doctor IMMEDIATELY if you notice any of the following side effects: • severe rash, hives or other signs of allergic reaction (urticaria)
Danish: Fortæl det til lægen før behandlingen med Cimzia, hvis noget af nedenstående gælder for dig: Allergiske reaktioner - Hvis du oplever ALLERGISKE REAKTIONER, såsom trykken i brystet, hiven efter vejret,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 6 (3 packs of 2 dose-dispenser cartridges and 2 alcohol wipes) (with bluebox)
Danish: Karton Multipakning med 6 (3 pakninger a 2 kassetter til dosisdispenser og 2 alkoholservietter) (med Blå Boks)
English: - As the injection is being given, keep holding ava firmly against your skin.
Danish: - Hold ava tæt ned mod huden under injektionen.
English: Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.
Danish: Hver fyldt sprøjte indeholder 200 mg certolizumab pegol i én ml.
English: Do not use this medicine after the expiry date which is stated on the pack and syringe after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og sprøjten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled pen
Danish: Cimzia 200 mg injektionsvæske, opløsning i fyldt pen
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 6 (3 packs of 2 pre-filled pens and 2 alcohol wipes) (with bluebox)
Danish: Karton Multipakning med 6 (3 pakninger a 2 fyldte penne og 2 alkoholservietter) (med Blå Boks)
English: Statistically significantly greater ACR 20 and ACR 50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo.
Danish: Uge 1 og Uge 2 i begge kliniske studier sammenlignet med placebo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 10 (5 packs of 2 pre-filled pens and 2 alcohol wipes) (with bluebox)
Danish: Karton Multipakning med 10 (5 pakninger a 2 fyldte penne og 2 alkoholservietter) (med Blå Boks)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled pens and 2 alcohol wipes)
Danish: Ydre karton (for pakninger med 2 fyldte penne og 2 alkoholservietter)
English: Do not use Cimzia after the expiry date which is stated on the pack and syringe after EXP.
Danish: Brug ikke Cimzia efter den udløbsdato, der står på pakningen og sprøjten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Cimzia 200 mg solution for injection in pre-filled syringe certolizumab pegol
Danish: Cimzia 200 mg injektionsvæske, opløsning i fyldt sprøjte certolizumab pegol
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled syringe
Danish: Cimzia 200 mg injektionsvæske, opløsning i fyldt sprøjte
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 6 (for 2 pre-filled pens and 2 alcohol wipes) (without blue box)
Danish: Indre karton i multipakning med 6 (til 2 fyldte penne og 2 alkoholservietter) (uden Blå Boks)
English: ASAS 40 Week 12
Danish: Uge 12 Uge 24
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes and 2 alcohol wipes)
Danish: Ydre karton (for pakninger med 2 fyldte sprøjter og 2 alkoholservietter)
English: Cimziaa 200 mg every 2 weeks N=159
Danish: 200 mg hver 2. uge N=90
English: Cimzia 200 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard certolizumab pegol
Danish: Cimzia 200 mg injektionsvæske, opløsning i fyldt pen Fyldt sprøjte med kanylebeskyttelse certolizumab pegol
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is 200 mg every 2 weeks.
Danish: Efter startdosis er den anbefalede vedligeholdelsesdosis til voksne med psoriasisartritis 200 mg Cimzia hver 2. uge.
English: Cimzia 200 mg solution for injection in pre-filled pen certolizumab pegol
Danish: Cimzia 200 mg injektionsvæske, opløsning i fyldt pen certolizumab pegol
English: Pack size of 2 pre-filled pens and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled pens and 6 (3 packs of 2) alcohol wipes, a multipack of 10 (5 packs of 2) pre-filled pens and 10 (5 packs of 2) alcohol wipes
Danish: Pakning a 2 fyldte penne og 2 alkoholservietter, multipakning indeholdende 6 (3 pakninger a 2) fyldte penne og 6 (3 pakninger a 2) alkoholservietter, multipakning indeholdende 10 (5 pakninger a 2) fyldte penne og 10 (5 pakninger a 2) alkoholservietter.
English: a) Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Week 0, 2, 4. b) PGA 5 category scale.
Danish: Cimzia administreret hver 2. uge efter en forudgående støddosis på 400 mg ved uge 0, 2 og 4 * p<0,001