FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo, darunavir resistance-associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) in HIV-1 protease were derived from clinical trial data of ART-experienced patients, all of whom were protease inhibitor experienced.
Danish: Darunavir-resistensassocierede mutationer in vivo (V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V og L89V) i hiv-1-protease blev udledt fra data fra kliniske studier af ART-erfarne patienter, som alle var proteasehæmmererfarne.
English: Concomitant use of everolimus or irinotecan and Symtuza is not recommended.
Danish: Samtidig brug af everolimus eller irinotecan og Symtuza frarådes.
English: common pruritus, urticaria uncommon angioedema rare drug reaction with eosinophilia and systemic symptoms a, Stevens-Johnson syndrome not known toxic epidermal necrolysis a, acute generalised exanthematous pustulosis
Danish: almindelig pruritus, urticaria ikke almindelig angioødem sjælden eosinofili og systemiske symptomer som reaktion på lægemidlet a, Stevens-Johnsons syndrom ikke kendt toksisk epidermal nekrolyse a, akut generaliseret eksantematøs pustulose
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale-coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Danish: De kan omfatte gulfarvning af huden og det hvide i øjnene, mørk (tefarvet) urin, bleg afføring (tarmbevægelser), kvalme, opkastning, appetitløshed eller smerter, jag eller smerter og ubehag i højre side af kroppen under ribbenene.
English: Symtuza must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting.
Danish: Symtuza må ikke tages sammen med et andet antiviralt lægemiddel, der indeholder en forstærker, eller et andet antiviralt lægemiddel, der kræver forstærkning.
English: Dabigatran, ticagrelor to help stop the clumping of platelets in the treatment of patients with a history of a heart attack
Danish: Dabigatran, ticagrelor som hjælp til at standse sammenklumpning af blodplader hos patienter, der tidligere har haft et hjerteanfald
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Danish: Lægemiddelinduceret hepatitis (f.eks. akut hepatitis, cytolytisk hepatitis) er blevet rapporteret efter anvendelse af darunavir/ritonavir.
English: The median terminal elimination half-life of tenofovir alafenamide was 0.3 hours when administered as Symtuza.
Danish: Tenofoviralafenamids mediane eliminationshalveringstid var 0,3 timer, når det blev administreret som Symtuza.
English: Clinical monitoring is recommended when co-administering Symtuza with these sedatives/hypnotics and a lower dose of the sedative/hypnotic should be considered.
Danish: Klinisk monitorering anbefales ved co-administration af Symtuza og disse sedativa/hypnotika, og det bør overvejes at give en lavere dosis af disse sedativa/hypnotika.
English: Symtuza may decrease boceprevir plasma concentrations.
Danish: Symtuza kan nedsætte plasmakoncentrationen af boceprevir.
English: • abnormal blood test results such as some tests for your pancreas.
Danish: • unormale resultater af blodprøver såsom nogle test af din bugspytkirtel.
English: If these anti-depressants are to be used with Symtuza clinical monitoring is recommended and a dose adjustment of the anti-depressant may be needed.
Danish: Hvis disse antidepressiva skal anvendes sammen med Symtuza, anbefales klinisk monitorering, og det kan være nødvendigt at justere dosis af det pågældende antidepressivum.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Symtuza.
Danish: Omhyggelig monitorering af patienten og justering af metformindosis anbefales, hvis patienten får Symtuza.
English: White, high density polyethylene (HDPE) bottle with a silica gel desiccant (contained in a separate sachet or canister) fitted with polypropylene (PP) child resistant closure with induction seal.
Danish: Hvid beholder af polyethylen med høj densitet (HDPE) med et silicagel-tørremiddel (i et separat pose eller en separat beholder), med et børnesikret låg af polypropylen (PP) med induktionsforsegling.
English: It is not known whether the co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g. febuxostat) would increase systemic exposure to tenofovir.
Danish: Det vides ikke, om co-administration af tenofoviralafenamid og xanthinoxidasehæmmere (f.eks. febuxostat) vil øge den systemiske eksponering for tenofovir.
English: • darunavir, an anti-HIV medicine known as a protease inhibitor
Danish: • darunavir, et hiv-lægemiddel, der kaldes en proteasehæmmer
English: Limited information is available in this population, and, therefore, Symtuza should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Danish: Der foreligger kun begrænsede oplysninger om denne population, og Symtuza skal derfor anvendes med forsigtighed hos patienter over 65 år (se pkt.
English: Concentrations of voriconazole may increase or decrease when co-administered with DRV/COBI.
Danish: Koncentrationen af voriconazol kan øges eller nedsættes ved co-administration med DRV/COBI.
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil in concentrating tenofovir in peripheral blood mononuclear cells (PBMC) (including lymphocytes and other HIV target cells) and macrophages.
Danish: Tenofoviralafenamid er permeabelt i cellerne, og som følge af en øget plasmastabilitet og intracellulær aktivering via hydrolyse af cathepsin A er tenofoviralafenamid mere effektivt end tenofovirdisoproxil til at koncentrere tenofovir i perifere mononukleære blodceller (PBMC'er) (herunder lymfocytter og andre hiv-målceller) og makrofager.
English: There are no adequate and well controlled trials with darunavir, cobicistat, emtricitabine, or tenofovir alafenamide, alone or in combination, in pregnant women.
Danish: Der er ikke udført tilstrækkelige og velkontrollerede studier med darunavir, cobicistat, emtricitabin, eller tenofoviralafenamid alene eller i kombination hos gravide kvinder.
English: Cobicistat is primarily metabolised and eliminated by the liver.
Danish: Cobicistat metaboliseres og elimineres primært i leveren.
English: Patients should be informed that dizziness may occur when treated with Symtuza (see section 4.8).
Danish: Patienten skal informeres om, at der kan forekomme svimmelhed under behandling med Symtuza (se pkt.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 15 and 40 times greater, respectively, than those expected after administration of Symtuza.
Danish: En minimal infiltration af histiocytter var til stede i øjet hos hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 15 og 40 gange større, end hvad der forventes efter administration af Symtuza.
English: Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Danish: Patienter med hæmofili skal derfor gøres opmærksomme på risikoen for øget blødningstendens.
English: Interaction
Danish: Interaktioner
English: People taking Symtuza may develop a skin rash.
Danish: Personer, der tager Symtuza, kan udvikle hududslæt.
English: There was no effect on mating or fertility in animals (see section 5.3).
Danish: Der sås ingen virkninger på parring eller fertilitet hos dyr (se pkt.
English: Latina Italy
Danish: Latina Italien
English: An open-label, Phase 2 trial (TMC114-C230) was conducted for evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Danish: Der blev udført et åbent fase 2-studie (TMC114-C230) for at evaluere darunavirs farmakokinetik, sikkerhed, tolerabilitet og virkning sammen med lavdosis ritonavir hos 12 ART-naive hiv-1-inficerede pædiatriske patienter i alderen 12 år til under 18 år, og med en vægt på mindst 40 kg.
English: Concomitant use of Symtuza may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Samtidig brug af Symtuza kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyrebarksuppression.
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was approximately 1.0 and the mean semen to plasma drug concentration ratio was approximately 4.0.
Danish: Ved maksimale plasmakoncentrationer var forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blod ca. 1,0, og forholdet mellem gennemsnitlig lægemiddelkoncentration i sæd og plasma var ca. 4,0.
English: Changes in measures of renal function
Danish: Ændringer i målinger af nyrefunktion
English: C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (approximately 86%) and faeces (approximately 14%).
Danish: C]-emtricitabin blev hele emtricitabin-dosis genfundet i urin (ca. 86 %) og i fæces (ca. 14 %).
English: Virologic Response, % HIV-1 RNA < 50 copies/mL
Danish: Virologisk respons, % Hiv-1 RNA <50 kopier/ml
English: The median terminal plasma half-life of cobicistat following administration of Symtuza is 3.6 hours.
Danish: Cobicistats mediane terminale plasmahalveringstid efter administration af Symtuza er 3,6 timer.
English: HIV-1 RNA < 50 copies/mL CD4+ percent median change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Danish: Hiv-1 RNA < 50 kopier/ml CD4+ procentvis middelændring fra baseline CD4+-celletal, gennemsnitlig ændring fra baseline ≥ 1,0 log10 fald fra baseline i plasmavirusbelastning
English: Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Danish: Tabel 8 Farmakokinetiske resultater for total-darunavir efter administration af 800/150 mg darunavir/cobicistat en gang dagligt som del af et antiretroviralt regime i andet trimester af graviditeten, tredje trimester af graviditeten og post partum Farmakokinetik for total-darunavir (Gennemsnit ± SD)
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with HIV PIs.
Danish: Der har været rapporter om øget blødningstendens, herunder spontane hudhæmatomer og hæmartrose hos patienter med type A- og B-hæmofili, der blev behandlet med hiv-PI (proteasehæmmere).
English: Lipid disorders should be managed as clinically appropriate.
Danish: Lipidforstyrrelser skal behandles som klinisk indiceret.
English: - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Danish: - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
English: Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Danish: Der har været rapporter om forhøjet kreatinkinase (CPK), myalgi, myositis og i sjældne tilfælde rabdomyolyse i forbindelse med hiv-proteasehæmmere, især i kombination med NRTI'er.
English: In case of concomitant antiviral therapy for hepatitis C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiretroviral behandling af hepatitis C henvises der desuden til det relevante produktresumé for disse lægemidler.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 mcg/mL.
Danish: Tenofovirs binding in vitro til humane plasmaproteiner er < 0,7 % og uafhængig af koncentrationen i intervallet 0,01-25 μg/ml.
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using Symtuza, interruption or discontinuation of treatment should be considered promptly (see section 5.3).
Danish: Hvis der er tegn på nyopstået eller forværret leverdysfunktion (herunder klinisk signifikant forhøjede leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørk urin, ømhed ved leveren, hepatomegali) hos patienter, der tager Symtuza, skal det omgående overvejes om behandlingen skal afbrydes midlertidigt eller helt seponeres (se pkt.
English: Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Danish: Emtricitabintriphosphat hæmmer hiv-replikationen ved optagelsen i det virale DNA, der medieres af hiv revers-transkriptase (RT), hvilket resulterer i DNA-kædeafslutning.
English: The film-coating contains polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide and yellow ferric oxide.
Danish: Filmovertrækket indeholder polyethylenglycol (macrogol), polyvinylalkohol (delvist hydrolyseret), talcum, titandioxid og jernoxid, gul.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Danish: Cobicistat metaboliseres via CYP3A- (primært) og CYP2D6- (i mindre grad) medieret oxidation og gennemgår ikke glukuronidering.
English: During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Danish: I det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) blev der rapporteret alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4 % af patienterne.
English: Based on theoretical considerations, Symtuza is expected to increase the exposure of lomitapide when coadministered.
Danish: Baseret på teoretiske overvejelser forventes Symtuza at øge eksponeringen for lomitapid ved co-administration.
English: Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Danish: Det er påvist, at behandling med 800/150 mg darunavir/cobicistat i det andet og tredje trimester fører til lav eksponering for darunavir med en reduktion i værdierne for Cmin på ca. 90 % (se pkt.
English: Based on theoretical considerations Symtuza is expected to increase concentrations of clonazepam (inhibition of CYP3A)
Danish: Baseret på teoretiske overvejelser forventes Symtuza at øge koncentrationen af clonazepam (Hæmning af CYP3A).
English: No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Danish: Dosisjustering af Symtuza er ikke er nødvendig hos patienter med en estimeret glomerulær filtrationshastighed i henhold til Cockcroft-Gault-formlen (eGFRCG) ≥ 30 ml/min.
English: Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Symtuza.
Danish: Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tenofovir, der var mindst fire gange større, end hvad der forventes efter administration af Symtuza.
English: There are no pharmacokinetic data on tenofovir alafenamide in patients with eGFRCG < 15 mL/min.
Danish: Der foreligger ingen farmakokinetiske data for tenofoviralafenamid hos patienter med eGFRCG <15 ml/min.
English: Concentrations of these medicinal products may be increased when co-administered with Symtuza resulting in the potential for increased adverse events usually associated with these medicinal products.
Danish: Koncentrationen af disse lægemidler øges muligvis ved co-administration med Symtuza og kan således muligvis resultere i en øget forekomst af de bivirkninger, som normalt er forbundet med disse lægemidler.
English: Co-administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals like clotrimazole).
Danish: Co-administration af Symtuza og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og cobicistat og medføre øgede plasmakoncentrationer af darunavir og cobicistat (f.eks. antimykotiske azoler som clotrimazol).
English: Darunavir binds primarily to plasma α1-acid glycoprotein.
Danish: Darunavir binder primært til α1-glykoproteinsyre i plasma.
English: Symtuza and antacids can be used concomitantly without dose adjustment.
Danish: Symtuza og antacida kan anvendes samtidig uden dosisjustering.
English: Based on stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and CD4+ cell count (< 200 or ≥ 200 cells/µL).
Danish: Baseret på stratumjusteret MH-test, hvor stratificeringsfaktorerne er hiv-1 RNA-niveau (≤100.000 eller > 100.000 kopier/ml) og CD4+-celletal (< 200 eller ≥200 celler/µl).
English: The 725 patients in total had a median age of 34 years (range 18-71), 88.3% were male, 83.2% White, 11.1% Black, 1.5% Asian.
Danish: De i alt 725 patienter havde en gennemsnitsalder på 34 år (interval 18-71), 88,3 % var mænd, 83,2 % hvide, 11,1 % sorte, 1,5 % asiater.
English: Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of tenofovir alafenamide and development of resistance.
Danish: Lægemidler, der inducerer P-gp-aktivitet (f.eks. rifampicin, rifabutin, carbamazepin, phenobarbital) forventes at nedsætte absorptionen af tenofoviralafenamid, hvilket fører til en nedsat plasmakoncentration af tenofoviralafenamid, hvilket kan føre til tab af terapeutisk effekt af tenofoviralafenamid og udvikling af resistens.
English: Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Danish: Tenofoviralafenamid er et substrat for OATP1B1 og OATP1B3 in vitro.
English: Phase 3 trial TMC114IFD3013 (EMERALD) evaluated the efficacy of Symtuza in virologicallysuppressed (HIV-1 RNA less than 50 copies/mL) HIV-1 infected patients.
Danish: Fase 3-studiet TMC114IFD3013 (EMERALD) evaluerede virkningen af Symtuza hos virologisk supprimerede (hiv-1 RNA under 50 kopier/ml) hiv-1-inficerede patienter.
English: Consult the Summary of Product Characteristics for darunavir for further details.
Danish: Se produktresuméet for darunavir for yderligere oplysninger.
English: In addition to the opportunistic infections, autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection, due to an improvement in the body's immune response.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion på grund af en forbedring af kroppens immunforsvar.
English: (CYP3A inhibition) Concentrations of clarithromycin may be increased upon co-administration with DRV/COBI.
Danish: (CYP3A-hæmning) Koncentrationen af clarithromycin kan øges efter co-administration med DRV/COBI.
English: No pharmacokinetic data are available for emtricitabine and tenofovir alafenamide during pregnancy.
Danish: Der findes ingen farmakokinetiske data for emtricitabin og tenofoviralafenamid under graviditet.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Danish: Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
English: The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
Danish: Det anbefalede dosisregime til voksne og unge i alderen 12 år og derover, der vejer mindst 40 kg, er én tablet, der tages én gang dagligt sammen med mad.
English: For tenofovir alafenamide, the Cmax was 1.82-fold higher in fasted condition, while the AUC was 20% lower to comparable in a fasted compared to fed condition.
Danish: For tenofoviralafenamid var Cmax 1,82 gange højere i fastende tilstand, mens AUC var 20 % lavere til sammenligning i fastende og ikke-fastende tilstand.
English: Clinical monitoring is recommended when co-administering Symtuza with perphenazine, risperidone or thioridazine.
Danish: Klinisk monitorering anbefales ved co-administration af Symtuza med perphenazin, risperidon eller thioridazin.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • cobicistat, a booster (enhancer) of darunavir
Danish: • cobicistat, der booster (forstærker) virkningen af darunavir
English: Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Danish: Co-administration sammen med den moderate CYP3A-inducer efavirenz påvirkede ikke eksponeringen af tenofoviralafenamid signifikant.
English: Reverse transcriptase
Danish: Revers transkriptase
English: The overall safety profile of Symtuza is based on data from a randomised, double-blinded, comparative Phase 2 trial, GS-US-299-0102 (N = 103 on darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), data from 2 Phase 3 trials TMC114FD2HTX3001 (AMBER, N = 362 on D/C/F/TAF) and TMC114IFD3013 (EMERALD, N = 763 on D/C/F/TAF), and on all available clinical trial and post-marketing data of its components.
Danish: Den samlede sikkerhedsprofil for Symtuza er baseret på data fra et randomiseret, dobbeltblindet, sammenlignende fase 2-studie, GS-US-299-0102 (N = 103 på darunavir/cobicistat/emtricitabin/tenofoviralafenamid [D/C/F/TAF]), data fra to fase 3-studie TMC114FD2HTX3001 (AMBER, N = 362 på D/C/F/TAF) og TMC114IFD3013 (EMERALD, N = 763 på D/C/F/TAF), og på alle tilgængelige data fra kliniske studier og efter markedsføringen af de enkelte komponenter.
English: Sildenafil to treat a heart and lung disorder called pulmonary arterial hypertension.
Danish: Sildenafil til behandling af hjerte- og lungesygdommen der kaldes pulmonal arteriel hypertension.
English: ALPHA ADRENORECEPTOR ANTAGONISTS Alfusozin
Danish: ALFA-RECEPTORANTAGONISTER Alfusozin
English: Thioridazine
Danish: Thioridazin
English: In the Phase 3 study TMC114FD2HTX3001in treatment-naïve patients, Symtuza was associated with no or smaller reductions in bone mineral density (BMD) compared DRV/COBI+F/TDF as measured by DXA analysis of hip (LS means percent change: 0.17% vs -2.69%, p < 0.001) and lumbar spine (LS means percent change: -0.68% vs -2.38%, p =0.004) after 48 weeks of treatment.
Danish: I fase 3-studiet TMC114FD2HTX3001med behandlingsnaive patienter, var Symtuza associeret med ingen eller mindre reduktion i knoglemineraldensitet (BMD) sammenlignet med kontrolgruppen (DRV/COBI+F/TDF) målt med DXA-analyse af hofte (least square means-procentændring: 0,17 % vs -2,69 %, p < 0,001) og lændehvirvelsøjlen (least square means procentændring: -0,68 % vs -2,38 %, p =0,004) efter 48 ugers behandling.
English: Ranitidine
Danish: Ranitidin