FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of a tuberculosis infection occur during or after therapy with Cimzia.
Danish: Patienter bør informeres om, at de skal søge lægelig rådgivning, hvis der opstår tegn/symptomer (f.eks. vedvarende hoste, svækket almentilstand/vægttab, let feber, apati), som tyder på tuberkuloseinfektion, under eller efter behandling med Cimzia.
English: ACR 20 p-value*
Danish: ACR20 p-værdi*
English: Adverse reactions of the haematologic system, including medically significant cytopaenia (e.g. leukopaenia, pancytopaenia, thrombocytopaenia) have been reported with Cimzia (see section 4.8).
Danish: Der er rapporteret hæmatologiske bivirkninger, inklusive medicinsk signifikant cytopeni (f.eks. leukopeni, pancytopeni, trombocytopeni), ved behandling med Cimzia (se pkt.
English: • oral disorders including pain on swallowing
Danish: • orale forstyrrelser, såsom smerter ved synkning
English: Erosion Score
Danish: Erosionscore
English: Patients receiving concomitant NSAIDs and conventional DMARDs were 72.6% and 70.2% respectively.
Danish: 72,6% af patienterne fik samtidig NSAID, og 70,2% af patienterne fik samtidig konventionelle DMARDs.
English: • Remove the needle cap from the needle by pulling off in a straight line.
Danish: • Fjern kanylehætten fra nålen ved at trække den lige af.
English: Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Danish: Der er ikke tilstrækkelige data om antiviral profylakse mod HBV-reaktivering hos patienter, der er HBV-bærere, i forbindelse med behandling med en TNF-antagonist.
English: • Do not re-use the syringe or re-cap the needle.
Danish: • Genbrug ikke sprøjten og sæt ikke hætten tilbage på nålen.
English: Utilization and dose adjustment of standard of care medication (SC) (e.g., NSAIDs, DMARDs, corticosteroids, analgesics) were permitted at any time.
Danish: NSAID, DMARD, kortikosteroider, analgetika) var tilladt til enhver tid.
English: Cimzia is used to treat active psoriatic arthritis.
Danish: Cimzia anvendes til behandling af aktiv psoriasisartritis.
English: • blood disorders
Danish: • blodsygdomme
English: Of the 135 patients randomised to Cimzia 400 mg every 4 weeks, 89, 62 and 41 patients had an ACR 20/50/70 response, respectively.
Danish: Ud af de 135 patienter, som var randomiseret til 400 mg Cimzia hver 4. uge, havde henholdsvis 89, 62 og 41 patienter et ACR20/50/70-respons.
English: You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:
Danish: Du bør IKKE bruge Cimzia, hvis du bruger følgende medicin til behandling af reumatoid artritis: - anakinra - abatacept
English: Key efficacy outcomes from the AS001 clinical trial are shown in Table -8.
Danish: Vigtige effektresultater fra det kliniske studie AS001 er vist i tabel 8.
English: Results are from the randomized set.Treatment Difference: Cimzia 200 mg-placebo, Cimzia 400 mgplacebo (and corresponding 95% CI and p-value) are estimated using a standard two-sided Wald asymptotic standard errors test. Non-responder Imputation (NRI) is used for patients who escaped therapy or had missing data.
Danish: Behandlingsforskel: Cimzia 200 mg vs. placebo, Cimzia 400 mg vs. placebo (og svarende til 95% CI og p-værdi) er estimeret ved brug af en standard to-sidet Wald asymptotisk standardafvigelsestest.
English: • Gently grasp the cleaned area of skin with one hand and hold firmly.
Danish: • Klem forsigtigt med én hånd om det rensede hudområde og hold fast.
English: Week 12 Week 24 ASAS40(c,d)
Danish: Uge 12 Uge 24 ASAS40
English: Uncommo asthma and related symptoms, pleural effusion and symptoms, respiratory tract congestion and inflammation, cough
Danish: Ikke almindelig astma og lignende symptomer, pleural effusion og symptomer, kongestion og inflammation i luftvejene, hoste
English: In C-EARLY, Cimzia+MTX-treated patients reported significant improvements at Week 52 compared to placebo+MTX in pain as assessed by the Patient Assessment of Arthritis Pain (PAAP) - 48,5 vs44,0 (least square mean) (p<0.05).
Danish: I C-EARLY rapporterede patienter behandlet med Cimzia+MTX signifikante forbedringer i smerter ved uge 52, vurderet ved Patient Assessment of Arthritis Pain (PAAP) - 48,5 vs. - 44,0 (gennemsnit beregnet ved mindste kvadraters metode) (p< 0,05), sammenlignet med patienter, som fik placebo+MTX.
English: At Week 52, patients treated with Cimzia showed a clinical meaningful improvement in the MASES compared to placebo (LS mean change from baseline -2.4 ; -0.2 respectively).
Danish: Ved uge 52 viste patienter behandlet med Cimzia en klinisk meningsfuld forbedring i MASES sammenlignet med placebo (LS (mindste kvadrat) gennemsnitlig ændring fra baseline henholdsvis -2,4 og -0,2).
English: Key efficacy outcomes from the PsA001 clinical trial are shown in Table 10.
Danish: Vigtige effektresultater fra det kliniske studie PsA001 er vist i tabel 10.
English: Creatine phosphokinase elevations
Danish: Forhøjet indhold af kreatininfosfokinase
English: Similar results were achieved in both the ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations.
Danish: Der blev opnået samme resultater i subpopulationen med ankyloserende spondylitis og i subpopulationen med non-radiografisk aksial spondyloartritis.
English: • flu-like symptoms, chills, altered temperature perception, night sweats, flushing
Danish: • influenza-lignende symptomer, kuldegysninger, ændret temperaturopfattelse, nattesved, rødmen
English: There are limited data on the use of Cimzia in patients who have experienced a severe hypersensitivity reaction towards another TNF-antagonist; in these patients caution is needed.
Danish: Der er begrænset dokumentation omhandlende brug af Cimzia hos patienter, som tidligere har haft en alvorlig overfølsomhedsreaktion over for en anden TNF-antagonist.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 11.5%.
Danish: Den samlede procentdel af patienter, som var antistof-positive med en vedvarende nedsat lægemiddelkoncentration i plasma, blev estimeret til at være 11,5%.
English: Cimzia is provided as a solution for injection in a ready to use pre-filled pen (AutoClicks).
Danish: Cimzia leveres som en injektionsvæske, opløsning i en fyldt pen (AutoClicks).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY BACKING TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: Consequently, Cimzia can be used during breastfeeding.
Danish: Som en konsekvens heraf, kan Cimzia anvendes under amning.
English: At week 12 significant inhibition of inflammatory signs in both sacroiliac joints and the spine was observed in the Cimzia-treated patients (all dose group), in the overall axial spondyloarthritis population as well as in the sub-populations of ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Danish: Der blev observeret signifikant hæmning af inflammatoriske tegn både i sacroiliacaleddene og i rygsøjlen ved uge 12 hos patienter behandlet med Cimzia (begge dosisgrupper) i den samlede aksiale spondyloartritis-population samt i subpopulationerne med ankyloserende spondylitis og non-radiografisk aksial spondyloartritis.
English: Cimzia was studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiopraphic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period.
Danish: Cimzia blev undersøgt i op til 4 år hos 325 patienter med aktiv aksial spondyloartritis (inklusive ankyloserende spondylitis og non-radiografisk aksial spondyloartritis) i det kliniske studie AS001, hvilket omfatter en 24-ugers placebokontrollet fase efterfulgt af 24 uger med blindede doser, og en 156-ugers åben (open label) behandlingsperiode.
English: - Only remove the needle cap when you are ready to inject.
Danish: - Tag først nålehætten af når du er klar til at injicere.
English: Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
Danish: Detaljeret vejledning til tilberedning og administrering af Cimzia i en fyldt sprøjte er givet i indlægssedlen.
English: In the overall population, the percentage of ASAS20 responders was clinically relevant and significantly higher for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit from Week 1 through Week 24 (p≤0.001 at each visit).
Danish: I den totale population var procentdelen af ASAS20-respondenter klinisk relevant og signifikant højere i de grupper, som fik 200 mg Cimzia hver 2. uge eller 400 mg Cimzia hver 4. uge, sammenlignet med placebo-gruppen ved hvert besøg fra uge 1 til uge 24 (p≤ 0,001 ved hver besøg).
English: Suitable sites for injection would include the thigh or abdomen.
Danish: Egnede injektionssteder inkluderer låret eller maven.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9.1%.
Danish: Den samlede procentdel af patienter, som var antistof-positive, og som havde vedvarende nedsat lægemiddelkoncentration i plasma, blev estimeret til at være 9,1 %.
English: The key results of the CIMPACT trial are presented in Table 12.
Danish: Hovedresultaterne af CIMPACT-studiet er vist i tabel 12.
English: - If the seal(s) is missing or broken - do not use and contact your pharmacist.
Danish: - Hvis forseglingen mangler eller er brudt - anvend ikke Cimzia, kontakt apotekspersonalet.
English: ASAS20(b,c)
Danish: (b,c)
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 1.03 per patient-year for all Cimzia-treated patients and 0.92 per patient-year for placebotreated patients.
Danish: Incidensraten af nye infektionstilfælde i placebokontrollerede kliniske studier med reumatoid artritis var 1,03 pr. patientår for alle patienter, som fik Cimzia, og 0,92 pr. patientår for alle patienter, som fik placebo.
English: Please read the instructions at the end of this leaflet on how to inject Cimzia.
Danish: Læs venligst vejledningen om hvordan Cimzia injiceres i slutningen af denne indlægsseddel.
English: Cimzia solution for injection in a dose-dispenser cartridge (also referred to as “medication”) is intended for single-use in conjunction with the electromechanical injection device called ava.
Danish: Vejledning til selvinjektion af CimziaCimzia injektionsvæske, opløsning i en kassette til dosisdispenser (også kaldet ”medicin”) er til engangsanvendelse sammen med den elektromekaniske injektionsanordning, kaldet ava.
English: • Look at the expiry date on the medication and pack.
Danish: • Se på udløbsdatoen på medicinen og pakningen.
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Danish: BRUGERVEJLEDNING TIL CIMZIA INJEKTION MED FYLDT SPRØJTE Efter passende oplæring, kan injektionen gives af dig selv eller af en anden person, f.eks. et familiemedlem eller en ven.
English: • axial spondyloarthritis (including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
Danish: • aksial spondyloartritis (herunder ankyloserende spondylitis og aksial spondyloartritis uden tegn på ankyloserende spondylitis ved røntgen),
English: Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Danish: Det er vist, at Cimzia i kombination med MTX reducerer udviklingen af ledskader, målt ved røntgen, og forbedrer den fysiske funktion.
English: • After injection, immediately throw away the used syringe(s) in a special container as instructed by your doctor, nurse or pharmacist.
Danish: • Efter injektion, skal den/de brugte sprøjte(r) straks bortskaffes i en særlig beholder, som angivet af din læge, sygeplejerske eller apotekspersonalet.
English: The percentage of ACR 20 responders was clinically relevant for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit after baseline through Week 24 (nominal p≤0.001 at each visit).
Danish: Procentdelen af ACR20-respondenter var klinisk signifikant for behandlingsgrupperne, som fik hhv. 200 mg Cimzia hver 2. uge og 400 mg Cimzia hver 4. uge, sammenlignet med placebogruppen, ved alle besøg efter baseline frem til uge 24 (nominel p≤ 0,001 ved hvert besøg).
English: Uncommo menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
Danish: Ikke almindelig forstyrrelser i menstruationscyklus og livmoderblødning (inklusive amenorré), brystlidelser
English: One ml pre-filled pen (AutoClicks) containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Danish: Én ml fyldt pen (AutoClicks) indeholder en fyldt sprøjte (type I glas) med en stempelprop (brombutylgummi) indeholdende 200 mg certolizumab pegol.
English: Certolizumab pegol does not cross-react with rodent TNF.
Danish: Certolizumab pegol krydsreagerer ikke med gnaverTNF.
English: • Do not re-use the syringe.
Danish: • Genbrug ikke sprøjten.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • inflammation of the blood vessels
Danish: • betændelse i blodårerne
English: • skin disorders such as new onset or worsening of psoriasis, inflammation of the skin (such as eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries
Danish: • hudsygdomme såsom nyopstået eller forværring af psoriasis, betændelse i huden (såsom eksem), sygdomme i svedkirtlerne, sår, lysfølsomhed, acne, hårtab, misfarvning, negleløsning,
English: Cimzia 200 mg + MTX every 2 weeks
Danish: Cimzia 200 mg + MTX hver 2. uge
English: Keep the dose-dispenser cartridge in the outer carton in order to protect from light.
Danish: Opbevar kassetten til dosisdispenser i den ydre karton for at beskytte mod lys.
English: In AS001 clinical trial, at Week 12 ASAS20 responses were achieved by 58% of patients receiving Cimzia 200 mg every 2 weeks and 64% of patients receiving Cimzia 400 mg every 4 weeks as compared to 38% of patients receiving placebo (p<0.01).
Danish: I det kliniske studie AS001 opnåede 58% af patienterne, som fik 200 mg Cimzia hver 2. uge, og 64% af patienterne, som fik 400 mg Cimzia hver 4. uge, ASAS20-respons sammenlignet med 38% af patienterne, som fik placebo (p< 0,01).
English: NA = not available *p≤0.05, Cimzia vs placebo **p<0.001, Cimzia vs placebo
Danish: NA = Ikke tilgængelig *p≤ 0,05, Cimzia vs. placebo **p< 0,001, Cimzia vs. placebo
English: The total content (1 ml) of the dose-dispenser cartridge should be administered using the electromechanical injection device ava for a subcutaneous injection only.
Danish: Hele indholdet (1 ml) i kassetten til dosisdispenser bør udelukkende administreres som subkutan injektion ved brug af den elektromekaniske anordning ava.
English: In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of 0 or 1 (Cimzia 400 mg every 2 weeks, 45.5% and 50.6% respectively; Cimzia 200 mg every 2 weeks, 47.4% and 46.2% respectively, versus placebo, 5.9% and 8.2% respectively).
Danish: Endvidere blev Cimzia-behandlingen i uge 16 associeret med en større andel af patienter, der opnåede en DLQI-score på 0 eller 1 (Cimzia 400 mg hver 2. uge, henholdsvis 45,5 % og 50,6 %; Cimzia 200 mg hver 2. uge, henholdsvis 47,4 % og 46,2 %, versus placebo, henholdsvis 5,9 % og 8,2 %).
English: Below is a diagram of the pre-filled syringe with needle guard.
Danish: Nedenfor ses en figur, som viser den fyldte sprøjte med kanylebeskyttelse.
English: Scroll wheel (to adjust the speed of injection)
Danish: Rullehjul (til justering af injektionshastigheden) 6.
English: Physical function response and health-related outcomes In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
Danish: Fysisk funktionsrespons og helbredsrelaterede resultater I det kliniske studie PsA001 rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, vurderet ved Health Assessment Questionnaire - Disability Index (HAQ-DI), i smerter, vurderet ved PAAP, og i træthed (fatigue), som beskrevet i Fatigue Assessment Scale (FAS), sammenlignet med placebo.
English: Incubation of monocytes with Cimzia resulted in a dose-dependent inhibition of lipopolysaccharide (LPS)-induced TNFα and IL1β production in human monocytes.
Danish: Det er vist, at Cimzia neutraliserer membranrelateret og opløselig human TNF-α på dosisafhængig vis. Inkubation af monocyter med Cimzia resulterede i en dosisafhængig hæmning af lipopolysakkarid (LPS)-induceret TNF-α og IL-1β produktion i humane monocytter.
English: The pre-filled pens may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Danish: De fyldte penne kan opbevares ved rumtemperatur (op til 25 °C) i en enkelt periode på maksimalt 10 dage beskyttet mod lys.
English: The pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Danish: De fyldte sprøjter kan opbevares ved rumtemperatur (op til 25 °C) i en enkelt periode på maksimalt 10 dage beskyttet mod lys.
English: • respiratory disorders and inflammation (including asthma, shortness of breath, cough, blocked sinuses, pleurisy, or difficulty breathing)
Danish: • sygdomme og betændelse i luftvejene (herunder astma, åndenød, hoste, stoppede bihuler,
English: • After injection, immediately throw away the used cartridge(s) in a special container as instructed by your doctor, nurse or pharmacist.
Danish: • Efter injektion, skal den/de brugte kassette(r) straks bortskaffes i en særlig beholder, som angivet af din læge, sygeplejerske eller apotekspersonalet.
English: The dosedispenser cartridge is to be used with the electromechanical injection device ava.
Danish: Kassetten til dosisdispenser skal anvendes sammen med den elektromekaniske injektionsanordning ava.
English: The efficacy and safety of Cimzia were assessed in a multicentre, randomised, double-blind, placebo controlled clinical trial (PsA001) in 409 patients ≥ 18 years of age with adult-onset active psoriatic arthritis for at least 6 months as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Danish: Cimzias sikkerhed og virkning blev undersøgt i et multicenter, randomiseret, dobbeltblindt, placebokontrolleret studie (PsA001) hos 409 patienter ≥ 18 år med aktiv psoriasisartritis med debut i voksenalderen og af mindst 6 måneders varighed, som defineret i Klassifikationskriterierne for Psoriasisartritis (CASPAR).
English: The dose-dispenser cartridges may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Danish: Kassetter til dosisdispenser kan opbevares ved rumtemperatur (op til 25 °C) i en enkelt periode på maksimalt 10 dage beskyttet mod lys.
English: Rare cholelithiasis Common rash Uncommo alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail and nail bed disorders
Danish: Almindelig Udslæt Ikke almindelig alopeci, nyopstået eller forværring afpsoriasis (herunder palmoplantar pustuløs psoriasis) og lignende tilstande, dermatitis og eksem, lidelser i svedkirtlerne, sår på huden, fotosensitivitet, akne, misfarvning af huden, tør hud, lidelser i negle og neglelejet
English: • Look at the expiry date on the pre-filled pen and pack.
Danish: • Se på udløbsdatoen på den fyldte pen og pakningen.
English: Only the highest titers were associated with reduced certolizumab pegol plasma levels, however, no impact on efficacy was observed.
Danish: Kun de højeste titre var forbundet med reduceret plasmaniveau af certolizumab pegol.
English: Patients were randomized to receive placebo, or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4), or Cimzia 400 mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 12.
Danish: Patienterne blev randomiseret til at få placebo eller Cimzia 200 mg hver 2. uge (efter en støddosis af Cimzia 400 mg i uge 0, 2 og 4) eller Cimzia 400 mg hver 2. uge op til uge 16, eller etanercept 50 mg to gange om ugen op til uge 12.
English: Of the 138 patients randomised to Cimzia 200 mg every 2 weeks, 92, 68 and 48 had an ACR 20/50/70 response, at Week 48 respectively.
Danish: Ud af de 138 patienter, som var randomiseret til 200 mg Cimzia hver 2. uge, havde henholdsvis 92, 68 og 48 patienter et ACR20/50/70-respons ved uge 48.
English: The efficacy and safety of Cimzia were assessed in one multicenter, randomized, double-blind, placebo-controlled trial (AS001) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months as defined by the Assessment of Spondyloarthritis International Society (ASAS) Classification Criteria for axial spondyloarthritis.
Danish: Cimzias sikkerhed og virkning blev undersøgt i et randomiseret, dobbeltblindt, placebokontrolleret multicenterstudie (AS001) hos 325 patienter ≥ 18 år med aktiv aksial spondyloartritis med debut i voksenalderen og af mindst 3 måneders varighed, som defineret af Assessment of Spondyloartritis International Society (ASAS) klassifikationskriterier for aksial spondyloartritis.
English: perforation, distension, inflammation heartburn, upset, dry mouth
Danish: oppustethed, betændelse, halsbrand, mavebesvær, mundtørhed
English: Read the instructions below carefully - this explains how to inject Cimzia by means of a dosedispenser cartridge.
Danish: Læs brugervejledningen grundigt - den forklarer hvordan Cimzia skal injiceres med kassette til dosisdispenser.
English: • Remove the prefilled syringe from the dose tray by grasping the syringe body as shown in
Danish: • Tag den fyldte sprøjte ud af dosispakningen ud ved at gribe om sprøjtens cylinder som vist på Figur 2.
English: • If something is not clear - please ask your doctor or pharmacist.
Danish: • Hvis der er noget du er i tvivl om, skal du spørge lægen eller apotekspersonalet.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks, or 400 mg every 2 weeks as instructed by your physician.
Danish: • Dette efterfølges af en vedligeholdelsesdosis på 200 mg hver 2. uge eller 400 mg hver 2. uge som anvist af lægen.
English: Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy.
Danish: Antistofdannelsen var forbundet med nedsat lægemiddelkoncentration i plasma og nedsat effekt hos nogle patienter.
English: Cimzia is contraindicated in moderate or severe heart failure (see section 4.3).
Danish: Cimzia er kontraindiceret ved moderat til alvorligt hjertesvigt (se pkt.