FrancophonIA/ELRC3.0 huggingface dataset:
English: In paediatric patients with a successful tropism test, dual mixed/CXCR4-tropic virus was detected in around 40% of screening samples (8/27, 30% in 2-6 year-olds, 31/81, 38% in 6-12 year-olds and 41/90, 46% in 12-18 year-olds), underscoring the importance of tropism testing also in the paediatric population.
Danish: Hos pædiatriske patienter med succesrig tropismetest blev der set dual mixed/CXCR4-tropismevirus hos ca. 40 % af screeningsprøverne (8/27, 30 % hos 2-6-årige, 31/81, 38 % hos 6-12-årige og 41/90, 46 % hos 12-18-årige), hvilket understreger vigtigheden af tropismetest også i den pædiatriske population.
English: Maraviroc was the major component present in urine (mean of 8% dose) and faeces (mean of 25% dose).
Danish: Maraviroc var den væsentligste komponent i urin (gennemsnit på 8 % dosis) og i fæces (gennemsnit på 25 % dosis).
English: Failure with CXCR4-using virus
Danish: Behandlingssvigt med CXCR4-using virus
English: Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc.
Danish: Derudover viste samtidig administration af maraviroc og tenofovir (substrat for renal elimination) og co-trimoxazol (der indeholder trimethoprim, som er en renal kationtransporthæmmer), ingen virkning på farmakokinetikken af maraviroc.
English: Therefore, maraviroc tablets and oral solution can be taken with or without food at the recommended doses in adults, adolescents and children aged 2 years and older and weighing at least 10 kg (see section 4.2).
Danish: Maraviroc tabletter og oral opløsning kan derfor indtages sammen med eller uden føde ved de anbefalede doser hos voksne, unge og børn i alderen 2 år og derover, som vejer mindst 10 kg (se pkt.
English: A relatively small number of individuals receiving maraviroc-containing therapy have failed with phenotypic resistance (i.e. the ability to use drug-bound CCR5 with MPI <95%).
Danish: Et forholdsvis lille antal individer, der fik maraviroc-holdig behandling, har ikke opnået fænotypisk resistens (dvs. evnen til at anvende lægemiddelbundet CCR5 med MPI < 95 %).
English: If a patient is hypersensitive to peanut or soya, CELSENTRI should not be used.
Danish: Patienter, der er overfølsomme over for jordnødder (peanuts) eller soja, må ikke behandles med Celsentri.
English: Refer to the Package Leaflets of these other medicines for guidance on how to take them.
Danish: Se indlægssedlen for denne anden medicin for vejledning i, hvordan den skal tages.
English: Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Danish: Filmovertræk: polyvinylalkohol, titandioxid (E171), macrogol 3350, talcum, sojalecithin, indigocarmin (E132).
English: In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia.
Danish: In vitro- og in vivo-studier viser, at maraviroc har et potentiale for at øge QTc-intervallet ved supraterapeutiske doser uden tegn på arytmi.
English: Median peak maraviroc plasma concentrations are attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
Danish: Maravirocs mediane plasmakoncentration nås 2 timer (0,5-4 timer) efter en enkeltdosis på 300 mg kommerciel tablet administreret til raske frivillige forsøgspersoner.
English: The pack contains an oral applicator and a bottle adapter.
Danish: Pakningen indeholder en oral doseringssprøjte og en flaske adaptor.
English: The CYP3A5 allelic frequency depends on ethnicity: the majority of Caucasians (~90%) are poor metabolisers of CYP3A5 substrates (i.e., subjects with no copy of functional CYP3A5 alleles) while approximately 40% of African-Americans and 70% of Sub-Saharan Africans are extensive metabolisers (i.e., subjects with two copies of functional CYP3A5 alleles).
Danish: CYP3A5-allelfrekvensen er afhængig af etnicitet: flertallet af kaukasiere (~ 90 %) er dårlige metabolisatorer af CYP3A5-substrater (dvs. personer uden nogen kopi af funktionelle CYP3A5-alleler), mens ca. 40 % af afro-amerikanere og 70 % af subsahariske afrikanere er ekstensive metabolisatorer af CYP3A5-substrater (dvs. individer med to kopier af funktionelle CYP3A5-alleler).
English: Therefore, despite differences in CYP3A5 genotype prevalence by race, the effect of CYP3A5 genotype on maraviroc exposure is not considered clinically significant and no maraviroc dose adjustment according to CYP3A5 genotype, race or ethnicity is needed.
Danish: Trods forskelle i forekomsten af CYP3A5-genotyper mellem racer, anses effekten af CYP3A5-genotype på eksponering for maraviroc ikke at være klinisk signifikant og dosisjustering af maraviroc i henhold til CYP3A5-genotype, race eller etnicitet er ikke nødvendig.
English: DRUG ABUSE Methadone
Danish: MEDICINMISBRUG Methadon
English: Remove and wash the applicator thoroughly in clean water once you have finished using it. Let it dry completely before you use it again.
Danish: Tag doseringssprøjten af og vask den grundigt i rent vand, når du er færdig med at bruge den.
English: HIV-1 variants with reduced susceptibility to maraviroc have been selected in vitro, following serial passage of two CCR5-tropic viruses (0 laboratory strains, 2 clinical isolates).
Danish: Hiv 1-varianter med nedsat følsomhed over for maraviroc er udvalgt in vitro efter seriepassage af to CCR5-tropisme virus (0 laboratoriestammer, 2 kliniske isolater).
English: Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2)
Danish: Tabel 7: Andel af patienter, som opnåede < 50 kopier/ml ved uge 48 i henhold til undergrupper (puljede studier MOTIVATE 1 og MOTIVATE 2)
English: Write the date the oral solution should be discarded on the carton in the space provided.
Danish: Angiv den dato, hvorpå den orale opløsning skal bortskaffes, på den beregnede plads på kartonen.
English: Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low.
Danish: Baseret på in vitro og kliniske data er potentialet for, at maraviroc påvirker farmakokinetikken af samtidigt administrerede lægemidler, lav.
English: This analysis indicated that CXCR4-using virus emerged from a pre-existing CXCR4-using reservoir not detected at baseline, rather than from mutation of CCR5-tropic virus present at baseline.
Danish: Denne analyse tyder på, at CXCR4-using virus opstår fra et præ-eksisterende CXCR4-using reservoir, som ikke blev påvist ved baseline, snarere end fra en mutation af CCR5-tropisme virus, som var til stede ved baseline.
English: In the pivotal studies of treatment-experienced patients coronary heart disease events were more common in patients treated with maraviroc than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up).
Danish: I de pivotale studier med behandlingserfarne patienter var tilfælde af koronar hjertesygdom hyppigere hos patienter, der fik maraviroc, end hos patienter, der fik placebo (11 i en opfølgningsperiode på 609 patientår sammenlignet med 0 i en opfølgningsperiode på 111 patientår).
English: Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, and necrosis).
Danish: Gentagne dosistoksicitetsstudier hos rotter identificerede leveren som primært målorgan for toksicitet (stigning i transaminaser, galdegang-hyperplasi og nekrose).
English: The pack also includes a thermoplastic elastomeric press in bottle adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with mL graduations) and a polyethylene plunger.
Danish: Pakningen indeholder også en termoplastisk elastomeradapter til at trykke ned i flaskehalsen samt en 10 ml oral doseringssprøjte bestående af en polypropylentromle (med mlgraduering) og et polyethylenstempel.
English: Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the maximum recommended dose of 300 mg twice daily.
Danish: Der er set forlænget QT-interval hos hunde og aber ved plasmakoncentrationer, der er henholdsvis 6 gange og 12 gange højere end dem, der er set hos mennesker ved den maksimalt anbefalede dosis på 300 mg 2 gange daglig.
English: The Long Term Safety/Selected Endpoints (LTS/SE) included death, AIDS-defining events, hepatic failure, Myocardial infarction/cardiac ischaemia, malignancies, rhabdomyolysis and other serious infectious events with maraviroc treatment.
Danish: De langsigtede sikkerheds-/ valgte endepunkter (The Long Term Safety/Selected Endpoints (LTS/SE)) omfattede død, AIDS-definerende hændelser, leversvigt, myokardieinfarkt/ hjerteiskæmi, maligniteter, rabdomyolyse og andre alvorlige infektionshændelser ved behandling med maraviroc.
English: Paediatric patients (children younger than 2 years of age or weighing less than 10 kg) The safety and efficacy of CELSENTRI in children younger than 2 years of age or weighing less than 10 kg has not been established (see section 5.2).
Danish: Pædiatriske patienter (børn under 2 år eller som vejer under 10 kg) Sikkerhed og virkning af Celsentri hos børn under 2 år eller som vejer under 10 kg er ikke fastlagt (se pkt.
English: More patients treated with maraviroc discontinued due to lack of efficacy (43 vs.15) and among patients with lack of efficacy, the proportion acquiring NRTI resistance (mainly lamivudine) was higher in the maraviroc arm.
Danish: Flere patienter behandlet med maraviroc seponerede behandlingen pga. manglende effekt (43 mod 15), og blandt patienter med manglende effekt var andelen, der udviklede NRTI-resistens (fortrinsvis lamivudin) højere i maraviroc-armen.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD FRA HERAF
English: Overall, the mechanisms of resistance to maraviroc observed in this treatment-experienced paediatric population were similar to those observed in adult populations.
Danish: Samlet set var modstandsmekanismerne over for maraviroc, som blev observeret i denne behandlingserfarne pædiatriske population, de samme som blev observeret i den voksne population.
English: Talk to your doctor immediately.
Danish: Tal straks med lægen.
English: ANTIVIRALS Anti-HBV Pegylated interferon
Danish: ANTIVIRALE Anti-HBV Pegyleret interferon
English: Indigo carmine aluminium lake (E132)
Danish: Indigocarmin (E132)
English: Significant reductions in amprenavir Cmin observed may result in virological failure in patients
Danish: Signifikant nedsat Cmin er observeret for amprenavir, hvilket kan medføre virologisk svigt hos nogle patienter.
English: CELSENTRI oral solution is supplied in a carton containing a high density polyethylene bottle, with a child resistant cap.
Danish: Celsentri oral opløsning leveres i en karton indeholdende en high density polyethylenflaske med børnesikret låg.
English: Maraviroc did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats up to 1000 mg/kg.
Danish: Maraviroc forringer ikke parringen eller fertiliteten hos han- eller hunrotter, og det påvirker ikke spermen hos rotter, der er behandlet med doser op til 1.000 mg/kg.
English: The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied.
Danish: Maravirocs effekt på digoxin ved en dosis på 600 mg 2 gange daglig er ikke undersøgt.
English: • antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)
Danish: • antibiotika (clarithromycin, telithromycin, rifampicin, rifabutin)
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Der er rapporteret tilfælde af osteonekrose især hos patienter med bekræftede risikofaktorer, avanceret hiv-sygdom eller langtidsbehandling med antiretroviral kombinationsbehandling (CART).
English: Percentage of patients with HIV-1 RNA <50 copies/mL
Danish: Procentdel af patienter med hiv 1-RNA < 50 kopier/ml
English: The bottle contains 230 ml of maraviroc solution (20 mg/ml).
Danish: Flasken indeholder 230 ml maravirocopløsning (20 mg/ml).
English: Pharmacokinetic Enhancers Cobicistat
Danish: ANTIINFEKTIVA Antiretrovirale Farmakokinetiske fremmere Cobicistat
English: Check with your doctor if you think this applies to you or your child.
Danish: Spørg lægen, hvis du tror, at dette gælder for dig eller dit barn.
English: In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2).
Danish: In vitro studier har vist, at maraviroc ved klinisk relevante koncentrationer ikke hæmmer nogen af de vigtige renale reabsorptionsmekanismer (OAT1, OAT3, OCT2, OCTN1 og OCTN2).
English: Hence, in the selection of a treatment regimen, it should be assumed that viruses forming part of the previously undetected CXCR4 -using population (i.e. minor viral population) harbours the same resistance pattern as the CCR5-tropic population.
Danish: Ved selektering af behandlingsregimer bør det derfor antages, at virus, som er en del af den hidtil ikke-detekterede del af CXCR4-using populationen (dvs. lav viralpopulation), har samme resistensmønster som CCR5-tropisme population.
English: After intravenous administration (30 mg), the half-life of maraviroc was 13.2 h, 22% of the dose was excreted unchanged in the urine and the values of total clearance and renal clearance were 44.0 L/h and 10.17 L/h respectively.
Danish: Efter en intravenøs administration (30 mg) var maravirocs halveringstid 13,2 timer, 22 % af dosis blev udskilt uændret i urinen, total-clearance var 44,0 l/time og renal clearance var 10,17 l/time.
English: Caution should be used when administering maraviroc in patients on concomitant medicinal products known to lower blood pressure.
Danish: Der skal udvises forsigtighed, når maraviroc administreres til patienter, der samtidig er i behandling med lægemidler, som sænker blodtrykket.
English: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090
Danish: Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, Tyskland.
English: Abdominal pain, flatulence, nausea common
Danish: Abdominalsmerte, flatulens, kvalme Almindelig
English: The primary objective assessed the incidence of Grade 3 and 4 ALT abnormalities (>5x upper limit of normal (ULN) if baseline ALT ≤ ULN; or >3.5x baseline if baseline ALT > ULN) at Week 48.
Danish: Det primære mål var at evaluere forekomsten af ALAT grad 3- og 4-anormaliteter (> 5 x den øvre normale grænseværdi, hvis baseline-ALAT ≤ den øvre normale grænseværdi; eller > 3,5 x baseline, hvis baseline-ALAT > den øvre normale grænseværdi) ved uge 48.
English: Maraviroc belongs to a group of medicines called CCR5 antagonists.
Danish: Maraviroc tilhører en gruppe lægemidler, der kaldes CCR5-antagonister.
English: • feeling weak or lack of energy, anaemia (seen in blood test result)
Danish: • følelse af svaghed eller manglende energi, blodmangel (set i blodprøver)
English: Fewer patients discontinued maraviroc due to adverse events (15 vs. 49).
Danish: Færre patienter seponerede behandlingen med maraviroc pga. bivirkninger (15 mod 49).
English: Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc (<100% maximal percentage inhibition (MPI)).
Danish: Koncentrationsresponskurver for maraviroc-resistent virus er fænotypisk karakteriseret ved kurver, der ikke når 100 % hæmning ved analyser, når der anvendes fortyndingsserier af maraviroc (< 100 % af den maksimale procent-hæmning (MPI)).
English: Studies in Adult Patients Co-infected with Hepatitis B and/or Hepatitis C virus
Danish: Studier med Voksne Patienter med Samtidig Infektion med Hepatitis B- og/eller C-virus
English: CELSENTRI must be taken in combination with other medicines to treat HIV.
Danish: Celsentri skal tages sammen med anden medicin til at behandle hiv.
English: Stevens-Johnson syndrome / Toxic epidermal necrolysis rare / not known
Danish: Stevens-Johnsons syndrom/ toksisk epidermal nekrolyse
English: Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine.
Danish: Da maraviroc er moderat proteinbundet, kan dialyse med fordel fjerne maraviroc fra kroppen.
English: Medicines containing St. John's Wort (Hypericum perforatum) are likely to prevent CELSENTRI
Danish: Medicin, der indeholder perikon (Hypericum perforatum) vil sandsynligvis forhindre Celsentri i at virke korrekt.
English: In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics.
Danish: Desuden viser samtidig anvendelse af maraviroc og lamivudin/zidovudin ingen virkning af maraviroc på farmakokinetikken af lamivudin (primært renalt udskilt) eller af zidovudin (non-P450 metabolisme og renal clearance).
English: • feeling very tired
Danish: • udtalt træthed
English: CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults, adolescents and children of 2 years and older, and weighing at least 10 kg.
Danish: Celsentri anvendes til at behandle human immundefekt virus type-1 (hiv 1) hos voksne, unge og børn i alderen 2 år og derover, som vejer mindst 10 kg.
English: ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
Danish: ANTIKONVULSIVA Carbamazepin, phenobarbital, phenytoin
English: Table 4 shows the incidence ≥1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values.
Danish: Tabel 4 viser hyppigheden ≥ 1 % af grad 3-4 anormaliteter (ACTG-kriterier) baseret på den maksimale grænse i laboratorieværdier uden hensyn til baseline-værdier.
English: These may affect 1 to 10 in 100 people:
Danish: Kan forekomme hos 1 til 10 ud af 100 personer:
English: Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and mouse bone marrow micronucleus.
Danish: Maraviroc er ikke mutagent eller genotoksisk i en række in vitro- og in vivo-studier, herunder bakteriel revers-mutationstest, kromosomafvigelser i humane lymfocytter og muse-knoglemarv-micronucleus.
English: Cases of hepatotoxicity and hepatic failure with allergic features have been reported in association with maraviroc.
Danish: Tilfælde af levertoksicitet og leversvigt med allergilignende karakteristika er blevet rapporteret i forbindelse med maraviroc.
English: Population PK studies suggest that a dose adjustment of maraviroc is not required.
Danish: Farmakokinetiske populationsanalyser tyder på at dosisjustering af maraviroc ikke er nødvendig.
English: CELSENTRI contains soya lecithin.
Danish: Celsentri indeholder sojalecithin.
English: Tropism
Danish: Tropisme
English: Virologic escape from maraviroc can occur via 2 routes: the emergence of pre-existing virus which can use CXCR4 as its entry co-receptor (CXCR4-using virus) or the selection of virus that continues to use exclusively drug-bound CCR5 (CCR5-tropic virus).
Danish: Udvikling af viral resistens for maraviroc kan ske via to veje: fremkomst af præ-eksisterende virus, som anvender CXCR4 som deres co-receptor (CXCR4-using virus), eller selektering af virus, der fortsætter med udelukkende at bruge lægemiddelbundet CCR5 (CCR5-tropisme virus).
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hiv-inficerede patienter med svær immundefekt, kan der ved initiering af antiretroviral kombinationsbehandling (CART), opstå en inflammatorisk reaktion til asymptomatisk eller residual opportunistisk infektion.
English: Concomitant use of CELSENTRI and rifampicin + efavirenz is not recommended.
Danish: Samtidig administration af Celsentri og rifampicin + efavirenz kan ikke tilrådes.
English: The recommended dose of CELSENTRI is either 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg (30 ml) twice daily, depending on other medicines that you are taking at the same time.
Danish: Den anbefalede dosis Celsentri er enten 150 mg (7,5 ml), 300 mg (15 ml) eller 600 mg (30 ml) to gange dagligt, afhængig af anden medicin, du tager samtidig.
English: In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
Danish: In vitro-studier tyder på, at CYP3A4 er et vigtigt enzym for maravirocs metabolisme.
English: Serious side effects - get medical help immediately Serious allergic or skin reactions
Danish: Alvorlige bivirkninger - søg straks lægehjælp
English: The pharmacokinetics in other races has not been evaluated.
Danish: Farmakokinetikken i andre racer er ikke undersøgt.
English: Thus, CELSENTRI dose should be modified in line with the recommendation for co-administration with respective PI/ritonavir combination (see ‘Protease Inhibitors').
Danish: Derfor skal Celsentridosis justeres i henhold til anbefalingerne for samtidig administration med de respektive PI/ritonavir kombinationer (se Proteasehæmmere').
English: Alanine aminotransferase increased, aspartate aminotransferase increased common
Danish: Stigning i alaninaminotransferase, stigning i aspartataminotransferase
English: In mice, no statistically significant increase in the incidence of tumours was reported at systemic exposures from 7 to 39-times the human exposure (unbound AUC 0-24h measurement) at a dose of 300 mg twice daily.
Danish: Hos mus ses ingen statistisk signifikant stigning i hyppigheden af tumorer ved en systemisk eksponering fra 7-39 gange den humane eksponering (ubundet AUC0-24 timers måling) ved en dosis på 300 mg 2 gange daglig.
English: Discontinuation of maraviroc should be strongly considered in any patient with signs or symptoms of acute hepatitis, in particular if drug-related hypersensitivity is suspected or with increased liver transaminases combined with rash or other systemic symptoms of potential hypersensitivity (e.g. pruritic rash, eosinophilia or elevated IgE).
Danish: Seponering af maraviroc skal alvorligt overvejes hos patienter, der viser tegn og symptomer på akut hepatitis, især ved mistænkt lægemiddelrelateret overfølsomhed eller ved stigning i leveraminotransferaser kombineret med udslæt eller systemiske symptomer på mulig overfølsomhed (f.eks. kløende udslæt, eosinofili eller forhøjet IgE).
English: ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Danish: United Kingdom ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: Maraviroc should also be used with caution in patients with severe renal insufficiency and in patients who have risk factors for, or have a history of postural hypotension.
Danish: Maraviroc bør også anvendes med forsigtighed hos patienter med alvorligt nedsat nyrefunktion og hos patienter med risikofaktorer for ortostatisk hypotension eller med ortostatisk hypotension i anamnesen.
English: a Refer to Table 1 for maraviroc paediatric dosing recommendations when co-administered with antiretroviral therapy and other medicinal products.
Danish: a Se tabel 1 for dosisanbefalinger for maraviroc til pædiatriske patienter ved samtidig administration af antiretroviral behandling og andre lægemidler.
English: The highest dose administered in clinical studies was 1,200 mg.
Danish: 1.200 mg var den højeste dosis, som blev givet i kliniske studier.
English: Tell your doctor if you (or your child) are taking any of these medicines.
Danish: Fortæl det til lægen, hvis du (eller dit barn) tager nogle af disse lægemidler.