FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
English: 20 ml Glass
Danish: 20 ml Glas
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN HVAD ANGÅR UDLEVERING OG BRUG
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN HVAD ANGÅR UDLEVERING OG BRUG
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml & 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 & EU/2/96/001/008 only)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 50 ml og 100 ml hætteglas-etiketter (kun EU/2/96/001/004, EU/2/96/001/005, EU/2/96/001/007 & EU/2/96/001/008)
English: Special precautions for storage
Danish: 6.4 Særlige opbevaringsforhold
English: Active substances: - F4ab (K88ab) fimbrial adhesin
Danish: F4ab (K88ab) fimbrie adhæsin
English: 50 ml Glass
Danish: 50 ml Glas
English: (E508) All food-producing species
Danish: (E508) Alle fødevareproducerende dyrearter Kaliumdihydrogenphosphatc (E340i) Alle fødevareproducerende dyrearter Natriumchloridd
English: (E339ii) All food-producing species
Danish: Dinatriumhydrogenphosphate (E339ii) Alle fødevareproducerende dyrearter Polysorbat 80f
English: PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses)
Danish: PAKNINGSSTØRRELSE 20 ml (10 doser)
English: NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/96/001/005
Danish: MAKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/96/001/005
English: NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/96/001/003
Danish: MAKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/96/001/003
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of two ml: - F4ab (K88ab) fimbrial adhesin
Danish: Aktive stoffer - F4ab (K88ab) fimbrie adhæsin ≥ 9,0 log2 Ab titer1 - F4ac (K88ac) fimbrie adhæsin ≥ 5,4 log2 Ab titer1 - F5 (K99) fimbrie adhæsin
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: 4.4 Special warnings and precautions
Danish: Særlige advarsler og forholdsregler
English: Haldol Decanoate and associated names (such as Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, and Serenase Depot) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Sweden and United Kingdom, and in Iceland and Norway.
Danish: Haldol Decanoate og relaterede navne (som f.eks. Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat og Serenase Depot) markedsføres i Østrig, Belgien, Cypern, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Holland, Portugal, Sverige og Storbritannien samt Island og Norge.
English: The companies that market these medicines include Janssen-Cilag Ltd and associated companies.
Danish: De virksomheder, der markedsfører disse lægemidler, er Janssen-Cilag og tilknyttede virksomheder.
English: Low doses are recommended for elderly patients unless they have already been receiving higher doses of haloperidol and have not had unacceptable side effects.
Danish: Lave doser anbefales hos ældre patienter, medmindre de allerede har fået høje doser af haloperidol og ikke har haft uacceptable bivirkninger.
English: The European Commission issued a decision on this opinion on 28/04/2017.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 28.
English: Haldol Decanoate is authorised in the EU via national procedures.
Danish: Haldol Decanoate blev godkendt i EU via nationale procedurer.
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol Decanoate.
Danish: Den 23. februar 2017 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Haldol Decanoate.
English: Why was Haldol Decanoate reviewed?
Danish: Hvorfor blev Haldol Decanoate undersøgt?
English: In particular, Haldol Decanoate must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Danish: Navnlig må Haldol Decanoate ikke anvendes hos patienter med hjertesygdomme som f.eks. visse forstyrrelser af hjerterytmen, hjertesvigt og nyligt hjerteanfald og hos patienter med undertrykkelse af centralnervesystemet (nedsat hjerneaktivitet, som gør vejrtrækningen og hjerterytmen langsommere samt nedsætter bevidstheden).
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol Decanoate and associated names in the EU.
Danish: Den 18. juni 2014 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Haldol Decanoate og relaterede navne i EU.
English: What is Haldol Decanoate?
Danish: Hvad er Haldol Decanoate?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol Decanoate in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Haldol Decanoate i Den Europæiske Union (EU).
English: Haldol Decanoate is an antipsychotic medicine used for schizophrenia and schizoaffective disorder (schizophrenia with mood disorders), which are mental disorders that affect how the person thinks, feels or behaves.
Danish: Haldol Decanoate er et antipsykotisk lægemiddel til behandling af skizofreni og skizoaffektiv lidelse (skizofreni med humørforstyrrelser), der er hjernesygdomme, som påvirker den måde, som en person tænker, føler eller opfører sig på.
English: The CHMP agreed to harmonisation of Haldol Decanoate's contra-indications.
Danish: CHMP vedtog at harmonisere kontraindikationerne for Haldol Decanoate.
English: The CHMP agreed that Haldol Decanoate injection can be used for the continuing treatment of schizophrenia and schizoaffective disorder in adults who have been on a stable dose of haloperidol by mouth.
Danish: CHMP konkluderede, at Haldol Decanoate som injektionsvæske kan anvendes til fortsat behandling af skizofreni og skizoaffektiv lidelse hos voksne, der har været på en stabil dosis af haloperidol taget gennem munden.
English: Haldol Decanoate is given by injection into the muscle usually every 4 weeks, to patients who have been taking haloperidol by mouth.
Danish: Haldol Decanoate indgives ved injektion i en muskel, typisk hver 4. uge, hos patienter, der har taget haloperidol gennem munden.
English: The SmPC recommends caution in patients who have a high level of the hormone prolactin and in those who have tumours that are worsened by prolactin.
Danish: I produktresuméet anbefales det at udvise forsigtighed hos patienter med en høj koncentration af hormonet prolaktin og hos patienter med tumorer, der forværres på grund af prolaktin.
English: The CHMP harmonised the SmPC to include information on when Haldol Decanoate's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Danish: CHMP harmoniserede også dette punkt i produktresuméet med oplysninger om, hvornår Haldol Decanoates bivirkninger på bevægelsesevnen kan forekomme, om mortaliteten hos ældre og om indvirkningen på hjertet og hjernen.
English: The CHMP has harmonised the guidance on calculating the dose of Haldol Decanoate based on the patient's dose of haloperidol by mouth.
Danish: CHMP harmoniserede vejledningen vedrørende beregningen af dosen af Haloperidol Decanoate på grundlag af patientens dosis af haloperidol taget gennem munden.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Det har medført forskelle mellem produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlet markedsføres, og dermed forskelle i den måde, som lægemidlet kan anvendes på.
English: It contains the active ingredient haloperidol decanoate.
Danish: Det indeholder det aktive stof haloperidoldecanoat.
English: It is also available in the EU as generic haloperidol decanoate.
Danish: Haldol Decanoate fås desuden i EU som generisk haloperidoldecanoat.
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol Decanoate and other medicines (section 4.5), as well as information on pregnancy, lactation and fertility (section
Danish: CHMP harmoniserede andre punkter i produktresuméet, herunder interaktioner mellem Haldol Decanoate og andre lægemidler (pkt.
English: Haldol Decanoate was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) fandt det nødvendigt at harmonisere Haldol Decanoate.
English: The four components of this comprehensive program are:
Danish: De fire komponenter i det samlede program er:
English: Other mechanisms, which have yet to be elucidated, may also be involved.
Danish: Andre mekanismer, som stadig mangler at blive klarlagt, kan også være involveret.
English: Please read the instructions carefully and follow them step by step.
Danish: Læs instruktionerne omhyggeligt og følg dem trin for trin.
English: Your doctor may gradually increase your dose.
Danish: Deres læge kan gradvist øge Deres dosis.
English: These levels are considerably higher than levels achieved with therapeutic doses.
Danish: Disse niveauer er væsentlig højere end dem, der opnås med terapeutiske doser.
English: This needs only to be done the first time that the bottle is opened.
Danish: Det er kun nødvendigt at gøre dette første gang, flasken åbnes.
English: Date for first authorisation: 13 October 2005 Date of latest renewal: 08 September 2015
Danish: Dato for første markedsføringstilladelse: 13. oktober 2005 Dato for seneste fornyelse: 08. september 2015
English: Most data derives from the illicit use of GHB.
Danish: De fleste data stammer fra ulovlig brug af GHB.
English: Not known (cannot be estimated from the available data):
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data):
English: Children and adolescents Do not give this medicine to children and adolescents.
Danish: Børn og unge Giv ikke dette lægemiddel til børn og unge.
English: Patients with major depression.
Danish: Patienter med major depression.
English: To date no other relevant epidemiological data are available.
Danish: Der er ikke andre relevante epidemiologiske data tilgængelige.
English: It is not always possible to reliably estimate the frequency of their incidence in the population to be treated.
Danish: Det er ikke altid muligt at estimere en pålidelig frekvens af deres forekomst i den befolkning, der skal behandles.
English: Abuse potential and dependence
Danish: Misbrugspotentiale og afhængighed
English: You should take the labelled medicine bottle with you, even if it is empty.
Danish: De bør tage medicinflasken med etiket med, også selvom den er tom.
English: The adaptor can then be left in the bottle for all subsequent uses
Danish: Derefter kan adapteren efterlades i flasken til efterfølgende brug.
English: No active metabolites have been identified.
Danish: Ingen aktive metabolitter er identificeret.
English: Take Xyrem orally two times each night.
Danish: Tag Xyrem oralt (gennem munden) to gange hver nat.
English: * The CGI-c data were analysed by defining responders as those patients who were very much improved or much improved.
Danish: * CGI-c data blev analyseret således, at responderende patienter blev defineret som de patienter, der fik det rigtig meget bedre eller meget bedre.
English: Carton and bottle
Danish: Karton og flaske
English: • topiramate (used for treatment of epilepsy)
Danish: • topiramat (anvendes til behandling af epilepsi)
English: The rat and dog exposures at the NOEL were lower (~50%) than that in humans.
Danish: Eksponeringen i rotter og hunde ved NOEL var lavere (~50 %) end hos mennesker.
English: Therefore, it is best to take Xyrem at set times two-three hours after a meal.
Danish: Derfor er det bedst at tage Xyrem på bestemte tidspunkter 2-3 timer efter et måltid.
English: If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects.
Danish: Hvis De er ældre, vil Deres læge nøje overvåge Deres tilstand for at kontrollere, om Xyrem har de ønskede virkninger.
English: Median attacks/week
Danish: Median af anfald/uge
English: The risk of taking Xyrem during pregnancy is unknown, and, therefore, the use of Xyrem in pregnant women or women trying to become pregnant is not recommended.
Danish: Risikoen ved at tage Xyrem under graviditet kendes ikke, og derfor kan anvendelse af Xyrem ikke anbefales til gravide kvinder eller kvinder, som forsøger at blive gravide.
English: Single doses greater than 4.5 g have not been studied.
Danish: Enkeltdoser over 4,5 g har ikke været undersøgt.
English: A minimum of one to two weeks is recommended between dose increments.
Danish: Det anbefales, at der minimum går 1 til 2 uger mellem hver øgning af dosis.
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Danish: Allée de la Recherche 60 B-1070 Bruxelles Belgien
English: Xyrem has a well-known abuse potential.
Danish: Xyrem har et velkendt misbrugspotentiale.
English: Xyrem with food, drink and alcohol You must not drink alcohol while taking Xyrem, as its effects can be increased.
Danish: Brug af Xyrem sammen med mad, drikke og alkohol De må ikke drikke alkohol, mens De tager Xyrem, da dets virkninger kan blive forøget.
English: Placebo 3.0 g/day 6.0 g/day 9.0 g/day
Danish: Placebo 3,0 g/dag 6,0 g/dag 9,0 g/dag
English: Responders* N (%)
Danish: Responderende patienter* N (%)
English: On average, less than 5% of unchanged medicinal product appears in human urine within 6 to 8 hours after dosing.
Danish: I gennemsnit forekommer mindre end 5 % uændret lægemiddel i human urin inden for 6 til 8 timer efter dosering.
English: The association of these developmental effects with maternal toxicity could not be established.
Danish: Sammenhæng mellem disse udviklingseffekter og maternal toksicitet kunne ikke fastslås.
English: It is unclear if some or all of these episodes correspond to true somnambulism (a parasomnia occurring during non-REM sleep) or to any other specific medical disorder.
Danish: Det er uklart, om nogle eller alle disse episoder svarer til egentlig somnabulisme (en parasomni, der opstår under non-REM-søvn) eller til en anden specifik medicinsk lidelse.
English: After first opening: 40 days
Danish: Efter anbrud: 40 dage.
English: It is eliminated mainly by metabolism with a half-life of 0.5 to 1 hour.
Danish: Det udskilles hovedsageligt ved metabolisme med en halveringstid på 0,5 - 1 time.
English: Median attacks/two weeks
Danish: Median af anfald/to uger
English: Cheyne-Stokes respiration and apnoea have been observed.
Danish: Cheyne-Stokes respiration og apnø er set.
English: The risk of injury or self-harm should be borne in mind in any patient with sleepwalking.
Danish: Risikoen for skade eller selvpåført skade bør tages i betragtning hos enhver patient, som går i søvne.
English: Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvensinddeling: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 og < 1/10); Ikke almindelig (≥ 1/1.000 og < 1/100); Sjælden (≥ 1/10.000 og < 1/1.000); Meget sjælden (< 1/10.000); Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There have been very few women who have taken Xyrem sometime during their pregnancy and a few of them had spontaneous abortions.
Danish: Et meget lille antal kvinder har taget Xyrem på et tidspunkt i løbet af deres graviditet, og få af dem aborterede spontant.
English: An increasing depth of coma has been observed at higher doses.
Danish: Tiltagende dybde af koma er observeret ved højere doser.
English: Rinse out the syringe with water.
Danish: Skyl sprøjten med vand.
English: If you forget to take the first dose, take it as soon as you remember and then continue as before.
Danish: Hvis De glemmer at tage den første dosis, skal De tage den, så snart De kommer i tanker om det, og derefter fortsætte som før.
English: Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level.
Danish: Enkeltdoser på 4,5 g bør ikke gives, med mindre patienten tidligere er titreret til dette dosisniveau.
English: Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature.
Danish: Selv om disse bivirkninger ikke er almindelige, er de, hvis de alligevel forekommer, sædvanligvis af let til moderat grad.
English: Whether this affected respiration during the night is unknown.
Danish: Hvorvidt dette påvirkede respirationen om natten, er ikke kendt.
English: • medicines that increase central nervous system activity and antidepressants
Danish: • medicin, som øger centralnervesystemets aktivitet, og medicin mod depression
English: You should continue to take Xyrem for as long as instructed by your doctor.
Danish: De bør fortsætte med at tage Xyrem i så lang tid, som Deres læge har foreskrevet.
English: The following instructions explain how to prepare Xyrem.
Danish: Følgende instruktioner forklarer, hvordan Xyrem gøres klar.
English: Your doctor will ask if you have ever abused any drugs before you start taking Xyrem and whilst you are using the medicine
Danish: Deres læge vil spørge Dem, om De nogensinde har misbrugt nogen form for medicin, før De begynder at tage Xyrem og så længe, De tager Xyrem.
English: It may harm them,
Danish: Sådan skal De tage Xyrem
English: Also tell your doctor or pharmacist if your are taking any of the following types of medicines:
Danish: Fortæl det også til lægen eller på apoteket, hvis De tager nogen af følgende typer medicin:
English: Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma.
Danish: Patienter har udvist varierende grad af nedsat bevidsthed, som kan skifte hurtigt mellem en konfus, agiteret kampberedt tilstand med ataksi og koma.
English: The most commonly reported adverse reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients.
Danish: De hyppigst rapporterede bivirkninger er svimmelhed, kvalme og hovedpine, som optræder hos 10 % til 20 % af patienterne.
English: Trial 4 was designed specifically to evaluate the continued efficacy of sodium oxybate after long-term use.
Danish: Studie 4 var specifikt designet til vurdering af den fortsatte virkning af natriumoxybat efter langtidsbrug.
English: Bradycardia has been responsive to atropine intravenous administration.
Danish: Bradycardi har responderet på intravenøs administration af atropin.
English: Change from Baseline Compared to Placebo (p-value)
Danish: Afvigelse fra baseline sammenlignet med placebo (p-værdi)
English: If this occurs, they should be evaluated fully, and appropriate intervention considered on an individual basis.
Danish: Hvis dette sker, bør patienten evalueres grundigt, og passende intervention bør overvejes på individuel basis.
English: Food decreases the amount of Xyrem that is absorbed by your body.
Danish: Mad nedsætter den mængde Xyrem, som optages i kroppen.
English: Secondary Efficacy Duration Active treatment and Dose (g/d)
Danish: Varighed Aktiv behandling og dosering (g/d)
English: • Benzodiazepines
Danish: • Benzodiazepiner
English: Drug discrimination studies show that GHB produces a unique discriminative stimulus that in some respects is similar to that of alcohol, morphine and certain GABA-mimetic medicinal products.
Danish: Lægemiddeldiskriminationsstudier viser, at GHB forårsager en unik diskriminativ stimulus, som i visse henseender ligner den, som findes i alkohol, morfin og visse GABA-lignende lægemidler.
English: Sodium oxybate undergoes significant presystemic (hepatic first-pass) metabolism.
Danish: Natriumoxybat undergår signifikant præsystemisk (hepatisk first-pass) metabolisme.
English: If you miss the second dose, skip that dose and do not take Xyrem again until the next night.
Danish: Hvis De glemmer den anden dosis, så spring denne dosis over, og tag ikke Xyrem igen før næste aften.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders.
Danish: Behandlingen bør påbegyndes og fortsættes under vejledning af en læge med erfaring i behandling af søvnforstyrrelser.
English: Sodium oxybate is absorbed rapidly following oral administration with an absolute bioavailability of about 88 %.
Danish: Natriumoxybat absorberes hurtigt efter oral administration med en absolut biotilgængelighed på omkring 88 %.
English: Myoclonus and tonic-clonic seizures have been reported.
Danish: Myoklonus og tonisk-kloniske anfald har været rapporteret.
English: Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of spontaneous abortions.
Danish: Data fra anvendelse af natriumoxybat hos et begrænset antal gravide kvinder, som blev eksponeret i 1. trimester, tyder på en mulig øget risiko for spontan abort.
English: At sodium oxybate concentrations ranging from 3 to 300 µg/mL, less than 1% is bound to plasma proteins.
Danish: Ved natriumoxybatplasmakoncentrationer fra 3 til 300 g/ml er mindre end 1 % bundet til plasmaproteiner.
English: You may need to set an alarm clock to make sure you wake up to take the second dose.
Danish: Det kan være nødvendigt at stille vækkeuret, så De er sikker på at vågne, når De skal tage den anden dosis.
English: There is insufficient evidence to recommend the use of naloxone in the treatment of overdose with GHB.
Danish: Der er utilstrækkelig evidens til at anbefale brug af naloxon til behandling af en overdosis med GHB.
English: In each trial, the daily dose was divided into two equal doses.
Danish: I hvert studie blev den daglige dosis fordelt på to lige store doser.
English: Respiratory and CNS depression
Danish: Respirationsdepression og CNS-depression
English: You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may affect you if you have had high blood pressure, heart or kidney problems in the past.
Danish: De skal holde øje med, hvor meget salt De indtager, da Xyrem indeholder natrium (findes i bordsalt), som kan påvirke Dem, hvis De tidligere har haft forhøjet blodtryk eller problemer med hjertet eller nyrerne.
English: Additionally, patient response and tolerability should be carefully monitored and dose should be adapted accordingly.
Danish: Derudover bør patientens respons og tolerabilitet nøje monitoreres og dosis tilpasses i overenstemmelse hermed.
English: Clinical Global Impressions of Change (CGI-c) Dose Group [g/d (n)]
Danish: Clinical Global Impressions of Change (CGI-c) Dosisgruppe [g/d (n)]
English: In Trial 4, the response was numerically similar for patients treated with doses of 6 to 9 g/day, but there was no effect seen in patients treated with doses less than 6 g/day.
Danish: I studie 4 var svaret numerisk tilsvarende for patienter behandlet med doser på 6 til 9 g/dag, men ingen effekt observeredes hos patienter behandlet med lavere doser end 6 g/dag.