FrancophonIA/ELRC3.0 huggingface dataset:
English: A limited increase in total lopinavir concentrations of approximately 30% has been observed which is not expected to be of clinical relevance (see section 4.2).
Danish: En begrænset stigning i total lopinavir koncentrationer på omkring 30 %, som ikke forventes at have klinisk relevans, blev observeret.
English: • Once daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
Danish: • Det frarådes at administrere lopinavir/ritonavir en gang dagligt til gravide kvinder på grund af manglende farmakokinetiske og klinisk data.
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3.
Danish: QTcF-intervallet blev evalueret i et randomiseret, placebo og aktiv (moxifloxacin 400 mg en gang daglig) kontrolleret overkrydsnings-studie hos 39 raske voksne, med 10 målinger over 12 timer på dag 3.
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion, som tidligere har haft opportunistisk infektion, kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-hiv-behandlingen er startet.
English: The adequate dosing may be achieved with the two available strengths of lopinavir/ritonavir tablets: 100/25 mg and 200/50 mg.*
Danish: En passende dosis kan opnås med de to tilgængelige styrker af lopinavir/ritonavir-tabletter: 100/25 mg og 200/50 mg.*
English: Tablet contents:
Danish: Tabletten indeholder:
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Længden af antiretroviral kombinationsbehandling, brug af kortikosteroider, indtagelse af alkohol, svær immunsuppression (nedsat aktivitet i immunsystemet), højere legemsmasseindeks (BMI) m.m. kan være nogle af de risikofaktorer, der er, for at udvikle denne sygdom.
English: It may be difficult to tell which side effects have been caused by lopinavir/ritonavir and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.
Danish: Det kan være vanskeligt at skelne mellem bivirkninger, der er forårsaget af lopinavir/ritonavir, og bivirkninger, der kan opstå pga. andre lægemidler, som du tager samtidig, eller som skyldes komplikationer forbundet med hiv-infektionen.
English: − elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
Danish: − elbasvir/grazoprevir (bruges til at behandle kronisk hepatitis C-virus [HCV]);
English: Recommended number of 100/25 mg tablets twice-daily
Danish: Anbefalet antal 100/25 mg tabletter to gange dagligt
English: Anticoagulants Warfarin
Danish: Anti-koagulantia Warfarin
English: As compared to the BID regimen, the once-daily dosing is associated with a reduction in the Cmin/Ctrough values of approximately 50%.
Danish: Sammenlignet med regimet med to daglige administrationer er dosering en gang dagligt forbundet med en reduktion i Cmin/Cdal-værdierne på cirka 50 %.
English: It is unknown whether the combination of Lopinavir/Ritonavir Mylan causes a similar increase in trazodone exposure.
Danish: Det vides ikke, om kombinationen af Lopinavir/Ritonavir Mylan forårsager lignende stigning i trazodon-eksposition.
English: For patients with renal impairment (CrCL < 30 ml/min) dose reduction of clarithromycin should be considered (see section 4.4).
Danish: Til patienter med nyreinsufficiens (kreatinin-clearence < 30 ml/min) bør nedsættelse af clarithromycindosis overvejes (se pkt.
English: A 14C-lopinavir study in humans showed that 89% of the plasma radioactivity after a single 400/100 mg lopinavir/ritonavir dose was due to parent active substance.
Danish: En afprøvning i mennesker med 14C-lopinavir har vist at 89 % af plasmaradioaktiviteten efter en enkelt 400/100 mg lopinavir/ritonavir-dosis skyldes den aktive modersubstans.
English: Very common: may affect more than 1 in 10 people.
Danish: Meget almindelige: kan påvirke flere end 1 ud af 10 personer diarré; kvalme øvre luftvejsinfektion.
English: For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions).
Danish: For patienter, der har afsluttet titreringsfasen og som er på en stabil daglig dosis venetoclax, skal have venetoclax-dosis reduceret med mindst 75 %, når det anvendes sammen med stærke CYP3A-hæmmere (se produktresuméet for venetoclax for doseringsanvisninger).
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of lopinavir/ritonavir (i.e. 400/100 mg twice daily).
Danish: Medmindre andet er anført, er studierne, som er nærmere beskrevet nedenfor, udført med den anbefalede dosis af lopinavir/ritonavir (dvs. 400/100 mg to gange daglig).
English: If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring.
Danish: Hvis anvendelse af atorvastatin findes strengt nødvendig, bør den lavest mulige dosis gives med omhyggelig overvågning af sikkerheden.
English: Lopinavir/ritonavir does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
Danish: Lopinavir/ritonavir hæmmer ikke CYP2C6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 eller CYP1A2 i klinisk relevante koncentrationer (se pkt.
English: If Lopinavir/Ritonavir Mylan is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Lopinavir/Ritonavir Mylan administreres sammen med parenteral midazolam, bør det ske på en intensiv plejeenhed (ICU) eller lignende, der sikrer nøje klinisk overvågning og passende medicinsk håndtering, i tilfælde af respirationsdepression og/eller langvarig sedation.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Danish: 4.4) En dosisreduktion af glukokortikoid bør overvejes med nøje overvågning af lokale og systemiske virkninger eller et skift til et glukokortikoid, som ikke er et substrat for CYP3A4 (f.eks. beclomethason).
English: HCV protease inhibitors Boceprevir 800 mg three times daily
Danish: HCV-proteasehæmmere Boceprevir 800 mg tre gange daglig
English: Based on known metabolic profiles, clinically significant interactions are not expected between Lopinavir/Ritonavir Mylan and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Danish: På grundlag af kendte metaboliske profiler forventes der ikke klinisk signifikante interaktioner mellem Lopinavir/Ritonavir Mylan og dapson, trimethoprim/sulfamethoxazol, azithromycin eller fluconazol.
English: A series of blood samples were collected pre-dose and at intervals over the course of 12 hours in trimester 2 and trimester 3, at birth, and 4-6 weeks postpartum (in women who continued treatment postdelivery) for pharmacokinetic analysis of total and unbound levels of plasma lopinavir concentrations.
Danish: Der blev taget en række blodprøver før dosering og med intervaller i løbet af 12 timer i 2. og 3. trimester, ved fødslen, og 4-6 uger efter fødslen (hos kvinder som fortsatte behandlingen efter fødslen) til farmakokinetisk analyse af koncentrationen af total og ubundet lopinavir i plasma.
English: Sixty-one patients completed the study (35 patients received the recommended 400/100 mg twice daily dose throughout the study).
Danish: Enogtres patienter gennemførte studiet (35 patienter fik den anbefalede dosis på 400/100 mg to gange dagligt under hele studieforløbet).
English: Hydroxypropylcellulose Talc
Danish: Hydroxypropylcellulose
English: The following table contains dosing guidelines for lopinavir/ritonavir tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Danish: Følgende tabel indeholder doseringsvejledning for lopinavir/ritonavir-tabletter baseret på BSA, når de anvendes til børn i kombination med efavirenz eller nevirapin.
English: Uncommon Tinnitus, vertigo
Danish: Tinnitus, vertigo
English: The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the
Danish: De gennemsnitlige ændringer i PR-interval fra baseline strækker sig fra 11,6 ms til 24,4 ms i et interval på 12 timer efter dosen.
English: Sustained virological response to lopinavir/ritonavir (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Danish: Et længerevarende virologisk respons over for lopinavir/ritonavir (i kombination med nukleosid/nukleotid revers transkriptasehæmmere) er ligeledes observeret i et mindre fase II-studie (M97-720) efter 360 ugers behandling.
English: Paediatric dosing guidelines without concomitant efavirenz or nevirapine* Weight (kg)
Danish: Pædiatrisk doseringsvejledning uden samtidig efavirenz eller nevirapin* Vægt (kg)
English: Patients were administered emtricitabine 200 mg once daily and tenofovir DF 300 mg once daily.
Danish: Patienterne fik emtricitabin 200 mg en gang dagligt og tenofovir DF 300 mg en gang dagligt.
English: Initiation of digoxin in patients already taking Lopinavir/Ritonavir Mylan is likely to result in lower than expected increases of digoxin concentrations.
Danish: Indledning af digoxin-behandling til patienter, som allerede tager Lopinavir/Ritonavir Mylan, vil sandsynligvis resultere i lavere stigninger digoxin-koncentrationer end forventet.
English: Lopinavir/ritonavir tablets have also shown less pharmacokinetic variability under all meal conditions compared to lopinavir/ritonavir soft capsules.
Danish: Lopinavir/ritonavir tabletter har også udvist mindre farmakokinetisk variation i forbindelse med et måltid sammenlignet med lopinavir/ritonavir bløde kapsler.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Danish: I denne gruppe var følgende mutationer i hiv-protease forbundet med nedsat følsomhed overfor lopinavir in vitro: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V,
English: Mean age of patients enrolled was 39 years (range: 19 to 71); 75% were Caucasian, and 78% were male.
Danish: Gennemsnitsalderen for de deltagende patienter var 39 år (interval: 19 til 71); 75 % var kaukasere og 78 % var mænd.
English: − Symptoms of dizziness, lightheadedness, fainting or sensation of abnormal heartbeats.
Danish: Symptomer på svimmelhed, uklarhed, besvimelse eller fornemmelse af unormal hjerterytme.
English: Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Danish: Samtidig administration med andre hiv-proteasehæmmere (PIs) I henhold til gældende behandlingsvejledninger anbefales samtidig behandling med to proteasehæmmere generelt ikke.
English: The adult dose of lopinavir/ritonavir tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the dosing guideline tables below.
Danish: Dosis til voksne af lopinavir/ritonavir-tabletter (400/100 mg to gange daglig) kan anvendes til børn på 40 kg eller derover eller med en legemsoverflade (BSA)* større end 1,4 m2. Til børn som vejer mindre end 40 kg eller med en legemsoverflade (BSA) på mellem 0,5 og 1,4 m2, og som er i stand til at synke tabletter, henvises der til nedenstående skema med doseringsretningslinjer.
English: Long-term carcinogenicity studies of lopinavir/ritonavir in mice revealed a nongenotoxic, mitogenic induction of liver tumours, generally considered to have little relevance to human risk.
Danish: Langtids karcinogenicitetsstudier af lopinavir/ritonavir i mus viste en ikke genotoksisk, mitogen induktion af levertumorer, som generelt menes at have lille relevans for mennesker.
English: In the QD group, no patient demonstrated lopinavir resistance, and in the BID group, 1 patient who had significant protease inhibitor resistance at baseline demonstrated additional lopinavir resistance on study.
Danish: I gruppen med en daglig administration viste ingen af patienterne lopinavir-resistens, og i gruppen med to daglige administrationer viste 1 patient, som havde signifikant proteasehæmmer-resistens ved baseline, yderligere lopinavir-resistens i studiet.
English: Children were eligible when they were aged <18 years, ≥15 kg in weight, receiving cART that included lopinavir/ritonavir, HIV-1 ribonucleic acid (RNA) <50 copies/ml for at least 24 weeks and able to swallow tablets.
Danish: Børnene kunne inkluderes, når de var < 18 år, vejede ≥ 15 kg, fik cART, der omfattede lopinavir/ritonavir, havde hiv-1-ribonukleinsyre (RNA) < 50 kopier/ml i mindst 24 uger og var i stand til at synke tabletter.
English: Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Danish: Højere tenofovir-koncentrationer kan forstærke tenofovirassocierede bivirkninger, herunder nyrelidelser.
English: Mean age of patients enrolled was 41 years (range: 21 to 73); 51% were Caucasian and 66% were male.
Danish: Gennemsnitsalderen for de deltagende patienter var 41 år (interval: 21 til 73); 51 % var kaukasere og 66 % var mænd.
English: The mean steady-state trough concentration prior to the morning dose was 5.5 ± 5.4 μg/ml.
Danish: Den gennemsnitlige steady-state dalkoncentration forud for morgendosen var 5,5 ± 5,4 µg/ml.
English: − Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition.
Danish: Kvalme, opkastning og mavesmerter, da en stor stigning i mængden af triglycerider (fedtstoffer i blodet) anses for at være en risikofaktor for pankreatitis (betændelse i bugspytkirtlen), og disse symptomer kan tyde på denne sygdom.
English: During in vitro studies, cloned human cardiac potassium channels (HERG) were inhibited by 30% at the highest concentrations of lopinavir/ritonavir tested, corresponding to a lopinavir exposure 7-fold total and 15-fold free peak plasma levels achieved in humans at the maximum recommended therapeutic dose.
Danish: I in vitro studier blev klonede humane kardiale kalium kanaler (HERG) inhiberet 30 % af de højeste testede koncentrationer af lopinavir/ritonavir, svarende til en lopinavir eksponering på 7 gange det totale og 15 gange det frie peak plasma niveau, som opnås i mennesker ved de maksimalt anbefalede doser.
English: Lopinavir/ritonavir may cause changes in your heart rhythm and the electrical activity of your heart.
Danish: lopinavir/ritonavir kan forårsage ændringer i din hjerterytme og i den elektriske aktivitet i hjertet.
English: Lopinavir/ritonavir should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
Danish: Lopinavir/ritonavir må ikke tages sammen med lægemidler, hvis clearance er stærkt afhængige af CYP3A og for hvilke forhøjede plasmakoncentrationer er forbundet med alvorlige og/eller livstruende tilfælde.
English: Plasma concentrations of lopinavir were measured over four 12-hour periods during second trimester (20-24 weeks gestation), third trimester before dose increase (30 weeks gestation), third trimester after dose increase (32 weeks gestation), and at 8 weeks post-partum.
Danish: Plasmakoncentrationen af lopinavir blev målt over fire 12-timers perioder i løbet af det andet trimester (gestationsuge 20-24), tredje trimester inden dosisøgning (gestationsuge 30), tredje trimester efter dosisøgning (gestationsuge 32) og 8 uger efter fødslen.
English: - Lopinavir/ritonavir is prescribed for use in combination with other antiviral medicines.
Danish: Lopinavir/ritonavir ordineres til brug i kombination med andre antivirale lægemidler.
English: Patients should be monitored closely for a decreased VPA effect when Lopinavir/Ritonavir Mylan and valproic acid or valproate are given concomitantly.
Danish: Patienterne bør monitoreres tæt for nedsat VPA-effekt, når Lopinavir/Ritonavir Mylan og valproinsyre eller valproat gives samtidig.
English: The two regimens resulted in exposures on Day 3 which were approximately 1.5 and 3-fold higher than those observed with recommended oncedaily or twicedaily LPV/r doses at steady state.
Danish: Ved steady state resulterede de to regimer i ekspositioner på dag 3, som var tilnærmelsesvis 1,5 og 3-gange højere end dem, som blev set med den anbefalede LPV/r dosis en gang daglig eller to gange daglig.
English: In the QD group, 6/75 (8%) patients demonstrated new primary protease inhibitor mutations (codons 30, 32, 48, 50, 82, 84, 90), as did 12/77 (16%) patients in the BID group.
Danish: I gruppen med en daglig administration viste 6/75 (8 %) patienter nye primære proteasehæmmermutationer (codon 30, 32, 48, 50, 82, 84, 90), ligesom 12/77 (16 %) patienter i gruppen med to daglige administrationer.
English: In rats, embryofoetotoxicity (pregnancy loss, decreased foetal viability, decreased foetal body weights, increased frequency of skeletal variations) and postnatal developmental toxicity (decreased survival of pups) was observed at maternally toxic dosages.
Danish: Embryoføtotoksisitet (spontan abort, nedsat føtal levedygtighed, nedsat føtal kropsvægt, øget frekvens af skeletforandringer) og postnatal udviklingstoksicitet (nedsat overlevelse af afkom) var observeret i rotter ved maternelt toksiske doser.
English: If this coadministration is judged unavoidable, increased dose of Lopinavir/Ritonavir Mylan at 400 mg/400 mg twice daily may be administered with rifampicin under close safety and therapeutic drug monitoring.
Danish: Hvis den samtidige administration vurderes at være uundgåelig, kan en øget dosis af Lopinavir/Ritonavir Mylan på 400 mg/400 mg to gange daglig administreres med rifampicin under nøje sikkerheds-og terapeutisklægemiddelovervågning.
English: Patients who exhibit these signs or symptoms should be evaluated and lopinavir/ritonavir therapy should be suspended if a diagnosis of pancreatitis is made (see section 4.8).
Danish: Patienter, der har disse tegn eller symptomer, bør vurderes, og lopinavir/ritonavirbehandling bør seponeres, hvis diagnosen pankreatitis stilles (se pkt.
English: − If you take sildenafil or tadalafil and lopinavir/ritonavir together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours.
Danish: Hvis du tager sildenafil eller tadalafil og lopinavir/ritonavir sammen, kan du risikere at få bivirkninger såsom lavt blodtryk, besvimelse, synsændringer og rejsning af penis, der varer mere end 4 timer.
English: HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during lopinavir/ritonavir therapy.
Danish: Hiv-1 blev inkuberet in vitro med lopinavir alene og med lopinavir plus ritonavir i koncentrationer, der svarer til de forskellige plasmakoncentrationer, der ses under behandling med lopinavir/ritonavir.
English: Alpha1 adrenoreceptor antagonist Alfuzosin
Danish: Alfa1-antagonist Alfuzosin
English: Ritonavir has been shown to induce metabolic enzymes, resulting in the induction of its own metabolism, and likely the induction of lopinavir metabolism.
Danish: Det er vist, at ritonavir inducerer metaboliske enzymer, som forårsager induktion af dens egen metabolisme, og sandsynligvis induktion af lopinavir metabolisme.
English: Outcomes at Week 48: Study M98-863 Lopinavir/ritonavir (N=326)
Danish: Resultater ved uge 48: Studie M98-863 Lopinavir/ritonavir (N = 326)
English: The effects of lopinavir/ritonavir (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4+ T-cell counts) have been investigated in controlled studies of lopinavir/ritonavir of 48 to 360 weeks duration.
Danish: Lopinavir/ritonavirs virkning (i kombination med andre antiretrovirale stoffer) på biologiske markører (plasma-hiv-RNA-niveauer og CD4+ T-celletælling) er blevet vurderet i kontrollerede studier med lopinavir/ritonavir af 48 uger til 360 ugers varighed.
English: Anxiety Uncommon Abnormal dreams, libido decreased
Danish: Abnorme drømme, nedsat libido
English: Particular caution must be used when prescribing lopinavir/ritonavir and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin.
Danish: Særlig forsigtighed skal udvises ved ordinering af lopinavir/ritonavir og lægemidler med kendt forlængende virkning på QT-intervaller såsom: chlorpheniramin, quinidin, erthromycin, clarithromycin.
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7, 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
Danish: Middeltallet for EC50 for lopinavir mod isolater med 0- 3, 4-5, 6-7 og 8-10 mutationer i de aminosyre codons, der er beskrevet ovenfor, var henholdsvis 0,8, 2,7, 13,5 og 44,0 gange højere end EC50 mod vildtype hiv.
English: Lopinavir/ritonavir should be prescribed by physicians who are experienced in the treatment of HIV infection.
Danish: Lopinavir/ritonavir bør ordineres af en læge, der har erfaring med behandling af hiv-infektioner.
English: For plastic containers, use within 120 days after first opening.
Danish: I tilfælde af plastbeholdere skal indholdet anvendes inden for 120 dage efter anbrud.
English: * The tablets must not be chewed, broken or crushed.
Danish: * Tabletterne må ikke tygges, deles eller knuses.
English: Through 360 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 19 of 28 patients with confirmed HIV RNA above 400 copies/ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Danish: Gennem 360 ugers behandling blev der udført en succesfuld genotype-analyse af virale isolater hos 19 ud af 28 patienter med bekræftet hiv-RNA over 400 kopier/ml og ingen primære eller aktiv sitemutationer i protease (aminosyrer i positionerne 8, 30, 32, 46, 47, 48, 50, 82, 84 og 90) eller proteasehæmmer-fænotyperesistens blev vist.
English: Hypromellose Titanium dioxide (E171) Macrogol
Danish: Titandioxid (E171)
English: The effective (peak to trough) half-life of lopinavir over a 12 hour dosing interval averaged 5 - 6 hours, and the apparent oral clearance (CL/F) of lopinavir is 6 to 7 l /h.
Danish: Lopinavirs effektive halveringstid (fra maksimum til minimum) over et doseringsinterval på 12 timer er i gennemsnit 5-6 timer, og lopinavirs tilsyneladende orale clearance (CL/F) er 6 til 7 l/t.
English: − Breast-feeding mothers should not take lopinavir/ritonavir unless specifically directed by the doctor.
Danish: Ammende kvinder må ikke tage lopinavir/ritonavir uden lægens specifikke anvisning.