FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for diacerin containing medicinal products
Danish: Liste over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 92931 Paris La Défense Cedex FRANCE
Danish: 92931 Paris La Défense Cedex
English: Diagonal, 67-69 08019 Barcelona Spain
Danish: Diagonal, 67-69 08019 Barcelona ESPAÑA
English: IZ NOE-Sued, Strasse 7, Obj.58D/1/2.OG, 2355 Wiener Neudorf, Austria
Danish: IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria
English: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur ISLANDE
Danish: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
English: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D2º
Danish: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D-2º 1990-090 Lisboa Portugal
English: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE
Danish: 11-15 Quai de Dion Bouton 92800 Puteaux France
English: VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674, Athens
Danish: Gounari 150, Glyfada 16674, Athens Greece
English: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Danish: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers
English: ANGELINI PHARMA HELLAS Nea Kifissia 14564, Athens Greece
Danish: ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece
English: PROTON PHARMA Anonymous Pharmaceutical Company, Achaias 4 and Trizoinias, Nea Kifissia 14564
Danish: PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564 Greece
English: 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Danish: 92300 Levallois-Perret France
English: 15, boulevard Charles de Gaulle 92700 C olombes
Danish: 15, boulevard Charles de Gaulle
English: MAZART 50 mg, gélule
Danish: MAZART 50 mg, gélule 50 mg
English: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris FRANCE
Danish: SUBSTIPHARM DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE
English: BROS EPE Avgis & Gallinis 15, n. Kifissia,
Danish: Avgis & Gallinis 15, n. Kifissia, 14564
English: VERBORIL 50 mg Kapseln
Danish: VERBORIL 50 mg Kapseln 50 mg
English: ZONDAR 50 mg, gélule
Danish: ZONDAR 50 mg, gélule 50 mg
English: 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
Danish: 92700 Colombes France
English: DIACEREIN /NORMA 50 mg capsule, hard
Danish: DIACEREIN /NORMA 50 mg
English: G. Koronis Dilou 9, Peristeri, Attikis, 12134 Greece
Danish: Dilou 9, Peristeri, Attikis,
English: Children (under 18 years of age)
Danish: Børn (under 18 år)
English: Children under 18 years of age must not take Zerene.
Danish: Børn under 18 år må ikke tage Zerene.
English: Zerene will help you to sleep.
Danish: Zerene kan hjælpe Dem til at sove.
English: Date of latest renewal: 12 March 2009
Danish: Dato for seneste fornyelse: 12. marts 2009
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser markedsføres nødvendigvis.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 12 March 1999
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 12. marts 1999
English: Taking Zerene with food and drink
Danish: Brug af Zerene sammen med mad og drikkevarer:
English: Frequencies are defined as
Danish: Hyppigheden er defineret som
English: • myasthenia gravis (very weak or tired muscles)
Danish: • Hvis De har myasthenia gravis (meget svage eller trætte muskler)
English: Tell your doctor if you are or intend to become pregnant.
Danish: Fortæl Deres læge, hvis De er eller agter at blive gravid.
English: This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication.
Danish: Dette kan forværres, hvis du har sovet mindre end 7-8 timer, efter du har taget medicinen.
English: It is not recommended that you take Zerene with or immediately after eating a large meal as it may work more slowly.
Danish: Det anbefales, at De ikke tager Zerene sammen med eller umiddelbart efter et stort måltid, da den kan virke langsommere.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Zerene.
Danish: Dette kan normalt undgås, hvis De ikke er aktiv i mindst 4 timer efter indtagelse af Zerene.
English: The total daily dose of Zerene should not exceed 10 mg in any patient.
Danish: Den totale daglige dosis af Zerene må ikke overstige 10 mg hos nogen som helst patient.
English: If there is no advantage in emptying the stomach, activated charcoal should be given to reduce the absorption.
Danish: Hvis der ikke er nogen fordel ved at tømme maven, skal der gives aktivt kul for at nedsætte absorption.
English: Myasthenia gravis
Danish: Myastenia gravis
English: Flumazenil may be useful as an antidote.
Danish: Flumazenil kan være nyttig som modgift.
English: The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Danish: Behandlingens varighed bør være så kort som muligt (se 4.2), og bør ikke overstige to uger.
English: Use of Zerene is not recommended during pregnancy.
Danish: Brug af Zerene under graviditet anbefales ikke.
English: Important information about some of the ingredients of Zerene
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Zerene
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, Selvom de har de samme symptomer, som De har.
English: The sedative effect may be enhanced when the product is used in combination with alcohol.
Danish: Den beroligende virkning kan forstærkes, når produktet anvendes i forbindelse med alkohol.
English: • Never drink alcohol while you are being treated with Zerene.
Danish: • Drik aldrig alkohol mens De bliver behandlet med Zerene.
English: Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Zerene.
Danish: Resultater fra 2- og 4-ugers undersøgelser viste, at der ikke udvikledes nogen farmakologisk tolerance med nogen af Zerene-doserne.
English: • Do not use Zerene or any other sleeping medicine for longer than your doctor tells you to.
Danish: • Brug ikke Zerene eller anden sovemedicin længere end Deres læge har sagt.
English: This affects the ability to drive or use machines (see section 4.7).
Danish: Dette har indvirkning på evnen til at føre motorkøretøj eller betjene maskiner (se afsnit 4.7).
English: Zaleplon's pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Danish: Zaleplons farmakodynamiske profil viser hurtig absorption og elimination (se 5.2).
English: Zerene contains lactose.
Danish: Zerene indeholder lactose.
English: To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Zerene (see section 4.7).
Danish: For at mindske risikoen, bør patienterne ikke foretage aktiviteter, som kræver psykomotorisk koordination før 4 eller flere timer efter indtagelse af Zerene (se afsnit 4.7).
English: Special attention should be paid to respiratory or cardiovascular functions in intensive care.
Danish: Opmærksomheden skal specielt rettes mod åndedræts- og hjertekarfunktioner under intensiv behandling.
English: 6.6 Special precautions for disposal and handling No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Zerene.
Danish: Da administrationen efter måltid forsinker tiden indtil maksimal plasmakoncentration med 2 timer, skal mad ikke indtages sammen med eller lige før man tager Zerene.
English: Do not go unaccompanied to seek medical help.
Danish: Gå ikke du og søg lægehjælp uden en ledsager.
English: Zerene has major influence on the ability to drive and use machines.
Danish: Zerene har stor indflydelse på evnen til at føre motorkøretøj og betjening af maskiner.
English: In a three month study in prepubescent dogs there was significant reduction in the weight of both prostate and testes at high multiples of the maximum therapeutic dose.
Danish: I en 3-måneders undersøgelse af hunde i præpuberteten var der en signifikant reduktion af vægten af både prostata og testikler ved doser mange gange højere end den maksimale terapeutiske dosis.
English: Some can cause drowsiness and should not be taken while taking Zerene.
Danish: Nogle af disse kan forårsage døsighed og bør ikke tages samtidig med Zerene.
English: Like all medicines, Zerene can cause side effects, although not everybody gets them.
Danish: Zerene kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: A routine dosage adjustment of Zerene is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Danish: Rutinemæssig dosisjustering af Zerene betragtes ikke som nødvendig, men patienterne bør informeres om, at den sedative effekt kan forstærkes.
English: • Do not use a second dose of Zerene within a single night.
Danish: • Tag ikke 2 doser Zerene inden for samme aften.
English: Therefore, caution is advisable in co-administering cimetidine and Zerene.
Danish: Derfor tilrådes forsigtighed ved samtidig indgivelse af cimetidin og Zerene.
English: Zerene did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Danish: Zerene havde ikke indvirkning på de farmakokinetiske og farmakodynamiske profiler ved digoxin og warfarin, som er to stoffer med et snævert terapeutisk index.
English: There is limited clinical experience with the effects of an acute overdose of Zerene, and overdose levels in humans have not been determined.
Danish: Der er begrænset klinisk erfaring med virkningerne af en akut overdosering med Zerene, og overdosisniveauer hos mennesker er ikke blevet fastlagt.
English: • If your sleeplessness persists or worsens after a short course of Zerene treatment contact your doctor.
Danish: • Hvis Deres søvnløshed fortsætter eller forværres efter kort behandlingsvarighed med Zerene skal De kontakte Deres læge.
English: Always take Zerene exactly as your doctor has told you.
Danish: Tag altid Zerene nøjagtig efter lægens anvisning.
English: Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Zerene at recommended doses in humans.
Danish: Generelt tyder resultaterne af prækliniske undersøgelser ikke på nogen signifikant fare for sikkerheden ved brug af Zerene i de anbefalede doser for mennesker.
English: However, there is no clinical experience with the use of flumazenil as an antidote to a Zerene overdose.
Danish: Der er imidlertid ingen klinisk erfaring med brugen af flumazenil som modgift til en Zerene overdosis.
English: What Zerene contains
Danish: Zerene indeholder
English: The increased incidence of benign liver tumors in mice was likely an adaptive event.
Danish: Stigningen i forekomsten af benigne levertumorer hos mus var sandsynligvis et tilpasningsforhold.
English: Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Zerene 10 mg.
Danish: Søvnlatenstiden i undersøgelser af ambulante patienter faldt i op til 4 uger hos ikke-ældre patienter med Zerene 10 mg.
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see section 4.5).
Danish: Hvis søvnperioden er utilstrækkelig, vil sandsynligheden for forringet opmærksomhed være forøget (se 4.5).
English: Never drink alcohol while you are being treated with Zerene (see “Take Special care with Zerene”).
Danish: Drik aldrig alkohol mens De er er i behandling med Zerene (se “Vær særlig forsigtig med at anvende Zerene”).
English: These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Danish: Disse hændelser kan forekomme hos såvel sedativahypnotikanaive som hos sedativa-hypnotika-erfarne personer.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http://www.emea.europa.eu/.
English: Zerene can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Danish: Zerene kan indtages straks, før patienten går i seng, eller efter at patienten er gået i seng og har besvær med at falde i søvn.
English: Because zaleplon is excreted in the breast milk, Zerene should not be administered to breast-feeding mothers.
Danish: Eftersom zaleplon udskilles i modermælk, bør Zerene ikke gives til ammende mødre.
English: Keep out of the reach and sight of children.
Danish: Opbevares utilgængeligt og ude af syne for børn.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 300C
English: Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Zerene overdose.
Danish: Undersøgelse med dyr tyder på, at flumazenil er en antagonist i forhold til zaleplon og skal tages under overvejelse ved håndtering af Zerene overdosis.
English: In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Zerene.
Danish: Endvidere viste ibuprofen, som et eksempel på stoffer som ændrer nyreekskretion, ingen interaktion med Zerene.
English: Repeated oral administration of zaleplon to rats and dogs elicited increases in liver and adrenal weights; however, these increases occurred at high multiples of the maximum therapeutic dose, were reversible, were not associated with degenerative microscopic changes in liver or adrenal glands, and were consistent with effects in animals with other compounds that bind to benzodiazepine receptors.
Danish: Gentagen oral indgivelse af zaleplon til rotter og hunde fremkaldte lever- og binyrevægtstigning; men disse stigninger, som skete ved doser mange gange højere end de maksimale terapeutiske doser, var reversible, var ikke forbundet med degenerative mikroskopiske ændringer i lever- eller binyrer, og virkningen på dyr var i overensstemmelse med andre stoffer som bindes til benzodiazepinreceptorerne.
English: In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Zerene.
Danish: Disse egenskaber, i kombination med de undertype-selektive receptorbindende egenskaber med høj selektivitet og lav affinitet til benzodiazepin type I receptoren, er ansvarlige for Zerenes overordnede egenskaber.
English: When Zerene is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Danish: Hvis Zerene tages sammen med anden medicin, som påvirker hjernen, kan denne kombination få Dem til føle Dem mere døsig end ellers.
English: Following overdose with oral benzodiazepine or benzodiazepine-like agents, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious.
Danish: Efter overdosis ved oral indtagelse af benzodiazepiner eller benzodiazepin-lignende midler, bør der fremprovokeres opkastning (indenfor en time), hvis patienten er ved bevidsthed, eller der skal foretages gastrisk skylning med beskyttelse af luftvejene, hvis patienten er bevidstløs.
English: If the medicinal product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Danish: Hvis produktet ordineres til en kvinde med potentiale for at blive gravid, bør hun advares om at kontakte sin læge med henblik på behandlingsophør, hvis hun har til hensigt at blive gravid eller har mistanke om, at hun er gravid.
English: Zerene's efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
Danish: Zerenes virkning er påvist både undersøgelser i søvnlaboratorier, hvor der benyttedes objektive polysomnografiske (PSG) mål for søvnen, og i undersøgelser med ambulante patienter, hvor man brugte patientspørgeskemaer til at vurdere søvnen.
English: Common (≥1/100 to <1/10)
Danish: Almindelig ( 1/100 til <1/10)
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Zerene 5 mg. For severe hepatic impairment see section 4.3.
Danish: Eftersom clearance er reduceret, bør patienter med mild til moderat leverinsufficiens behandles med Zerene 5 mg. Ved alvorlig nedsat leverfunktion se afsnit 4.3.
English: Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.
Danish: Selvom adfærd som kørsel i medicinpåvirket tilstand kan forekomme alene ved et sedativum-hypnotikum ved terapeutiske doser, synes brugen af alkohol og andre centralnervesystem (CNS)-depressiva sammen med sedativa-hypnotika at øge risikoen for sådan adfærd.
English: Very common (≥1/10)
Danish: Meget almindelig ( 1/10)
English: In elderly patients, sleep latency was often significantly decreased with Zerene 5 mg and was consistently decreased with Zerene 10 mg compared with placebo in 2-week studies.
Danish: Hos ældre patienter faldt søvnlatenstiden ofte signifikant med Zerene 5 mg og faldt konsekvent med Zerene 10 mg sammenlignet med 2-ugers undersøgelser med placebo.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt inden De begynder at tage medicinen - Gem indlægsseddlen.
English: In Zerene studies using objective PSG measures, Zerene 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
Danish: I undersøgelser med Zerene, hvor man brugte objektive PSG mål, var Zerene 10 mg overlegen i forhold til placebo til at reducere søvnlatenstiden og øge varigheden af søvnen i løbet af første halvdel af natten.
English: Zerene may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Danish: Zerene kan gøre dig døsig, give dig koncentrationsbesvær eller svække din hukommelse eller dine muskler.
English: • hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene
Danish: • Hvis De er overfølsom (allergisk) over for zaleplon eller nogle af de andre indholdsstoffer i
English: Zerene is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Danish: Zerene er ikke indiceret til at behandle patienter med alvorligt nedsat nyrefunktion, da der ikke foreligger tilstrækkelige studier med disse patienter.
English: Treatment should be as short as possible with a maximum duration of two weeks.
Danish: Behandlingen bør være så kortvarig som mulig, med to uger som maksimum.
English: Paediatric patients Zerene is contraindicated in children (see section 4.3).
Danish: Børn: Zerene er kontraindiceret til børn (se afsnit 4.3)
English: • sleep apnoea syndrome (stopping breathing for short periods while asleep)
Danish: • Hvis De lider af søvnapnøsyndrom (under søvn holder op med at trække vejret i korte perioder)
English: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Danish: Frekvensen af bivirkninger som er angivet nedenfor inddeles i følgende kategorier: Meget almindelige bivirkninger (det sker hos flere end l ud af 10 patienter) Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 1.000 patienter) Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 10.000 patienter) Meget sjældne bivirkninger (det sker hos færre end 1 ud af 10.000 patienter) Bivirkninger, hvor hyppigheden ikke er kendt
English: Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Danish: Zerene tilhører en gruppe stoffer, som kaldes benzodiazepin-lignende lægemidler, som består af produkter med narkotiske virkninger.
English: If affected do not drive or operate machinery.
Danish: Hvis du er påvirket, skal du ikke føre motorkøretøjer eller betjene maskiner.
English: Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Danish: Benzodiazepiner og benzodiazepin-lignende midler er ikke indiceret til behandling af patienter med alvorlig leverinsufficiens, eftersom de kan fremskynde encefalopati (se 4.2).
English: Also contains: lactose monohydrate See leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: lactosemonohydrat Se indlægsseddel for mere information
English: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines.
Danish: Den beroligende virkning, hukommelsestab, forringet koncentration og forringet muskelfunktion kan have en uønsket indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Chromaturia (blue-green urine discolouration) has been reported with zaleplon overdose.
Danish: Kromaturi (blågrøn misfarvning af urinen) er set ved overdosis af zaleplon.
English: Do not use Zerene after the expiry date which is stated on the carton after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken.
English: S-170 09 Solna
Danish: 170 09 Solna
English: No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Zerene pharmacokinetics is not altered in such patients.
Danish: Der kræves ingen justering af dosering hos patienter med mild til moderat nyreinsufficiens, eftersom Zerenes farmakokinetik ikke ændres hos sådanne patienter.
English: Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Danish: Behandling med Zerene er indiceret til at fremkalde søvn hos patienter, som lider af søvnløshed og har svært ved at falde i søvn.
English: Co-administration of Zerene together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Danish: Samtidig indgivelse af Zerene og CYP3A4 fremmere som f.eks. rifampicin, carbamazepin og phenobarbiton kan resultere i en reduktion af zaleplons virkning.
English: Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors.
Danish: Oral indgivelse af zaleplon til mus i 65 til 104 på hinanden følgende uger i høje doser (≥100 mg/kg/dag) fremkaldte en statistisk signifikant stigning i benigne men ikke maligne levertumorer.