FrancophonIA/ELRC3.0 huggingface dataset:
English: Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily.
Danish: Den mindst mulige fordel ved ritonavir-medieret farmakokinetisk forstærkning opnås med doser på over 100 mg to gange dagligt.
English: Trazodone (a medicine for depression) as, unwanted effects like nausea, dizziness, low blood pressure and fainting can occur when taken with ritonavir.
Danish: Trazodon (et lægemiddel mod depression), da du kan få bivirkninger som f.eks. kvalme, svimmelhed, lavt blodtryk og besvimelse, når du tager det sammen med ritonavir.
English: Since increased concentrations of lovastatin and simvastatin may predispose patients to myopathies, including rhabdomyolysis, the combination of these medicinal products with ritonavir is contraindicated (see section 4.3).
Danish: Da øgede koncentrationer af lovastin og simvastatin kan prædisponere patienter for myopati, herunder rabdomyolyse, er kombinationen af disse lægemidler med ritovanir kontraindiceret (se pkt.
English: Dosage conversion from oral solution to tablets for children
Danish: Doseringskonvertering fra oral opløsning til tabletter hos børn Dosis af oral opløsning
English: The safety and efficacy of ritonavir in children aged below 2 years has not been established.
Danish: Ritonavirs sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: Clinical investigation in humans has revealed no clinically significant alteration in thyroid function tests.
Danish: Kliniske undersøgelser hos mennesker har ikke påvist nogen ændring af klinisk betydning i thyreoideafunktionsundersøgelser.
English: Ritonavir was noted to be extensively metabolised by the hepatic cytochrome P450 system, primarily by the CYP3A isozyme family and to a lesser extent by the CYP2D6 isoform.
Danish: Det er konstateret, at ritonavir i stor udstrækning metaboliseres af det hepatiske cytokrom P450system, især af isoenzym CYP3A4-familien og i mindre udstrækning af CYP2D6-isoformen.
English: Effect on Coadministered Medicinal Products AUC
Danish: Virkning på samtidigt indgivet lægemiddel, AUC
English: No human data on the effect of ritonavir on fertility are available.
Danish: Der foreligger ingen data om ritonavirs virkning på fertilitet.
English: In cases of co-administration of ritonavir (100 mg twice daily) and indinavir (800 mg twice daily) caution is warranted as the risk of nephrolithiasis may be increased.
Danish: I tilfælde af samtidig indgift af ritonavir (100 mg to gange dagligt) og indinavir (800 mg to gange dagligt) er der grund til forsigtighed, da risikoen for nephrolithiasis kan øges.
English: Due to the large therapeutic window of clarithromycin no dose reduction should be necessary in patients with normal renal function.
Danish: På grund af clarithromycins brede terapeutiske område bør dosisreduktion ikke være nødvendigt hos patienter med normal nyrefunktion.
English: If the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution.
Danish: Hvis fordelen opvejer risikoen, skal samtidig administration af bedaquilin med ritonavir foretages med forsigtighed.
English: Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone) as ritonavir may raise the blood levels of these medicines which may lead to Cushing's syndrome (development of a rounded face) and reduce production of the hormone cortisol.
Danish: Steroider (f.eks. dexamethason, fluticasonpropionat, prednisolon, triamcinolon), da ritonavir kan øge indholdet af disse lægemidler i blodet, hvilket kan føre til Cushings syndrom (udvikling af ‘måneansigt') og nedsætte produktionen af hormonet kortisol.
English: On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Danish: Muskelsygdomme har i sjældne tilfælde været alvorlige (rabdomyolyse).
English: Treatment should be initiated at 300 mg (3 tablets) twice daily for a period of three days and increased by 100 mg (1 tablet) twice daily increments up to 600 mg twice daily over a period of no longer than 14 days.
Danish: Behandling bør indledes med 300 mg (3 tabletter) to gange dagligt i en periode på 3 dage og øges gradvist med 100 mg (1 tablet) to gange dagligt op til 600 mg to gange dagligt over en periode på højst 14 dage.
English: The reduction of the rifabutin dose to 150 mg 3 times per week may be indicated for select PIs when co-administered with ritonavir as a pharmacokinetic enhancer.
Danish: En nedsættelse af dosis af rifabutin til 150 mg 3 gange pr. uge kan være indiceret for udvalgte proteasehæmmere, når disse indgives sammen med ritonavir som farmakokinetisk forstærker.
English: Serum levels of ritonavir may be affected by select co-administered medicinal products (e.g. delavirdine, efavirenz, phenytoin and rifampicin).
Danish: Serumkoncentrationen af ritonavir kan påvirkes ved samtidig administration af visse lægemidler (f.eks. delavirdin, efavirenz, phenytoin og rifampicin).
English: Co-administration of ritonavir and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse effects.
Danish: Samtidig administration af ritonavir og lægemidler, som hovedsagelig metaboliseres af CYP3A, kan resultere i forhøjede plasmakoncentrationer af det andet lægemiddel, hvilket kan forstærke eller forlænge dets terapeutiske virkning og bivirkninger.
English: Co-administration of bosentan and ritonavir may increase steady state bosentan maximum concentrations (Cmax) and area under the curve (AUC).
Danish: Samtidig indgift af bosentan og ritonavir kan øge den maksimale plasmakoncentration af bosentan ved steady state (Cmax) og arealet under kurven (AUC).
English: Ritonavir is likely to change the uterine bleeding profile and reduce the effectiveness of estradiol-containing contraceptives (see section 4.4).
Danish: Ritonavir vil sandsynligvis ændre den uterine blødningsprofil og nedsætte virkningen af antikonceptionsmidler, som indeholder estradiol (se pkt.
English: Ritonavir is considered high in sodium.
Danish: Ritonavir anses for at have et højt indhold af natrium.
English: Do not take Ritonavir Mylan if you are allergic to ritonavir or any of the other ingredients of this medicine (see section 6).
Danish: Tag ikke Ritonavir Mylan hvis du er allergisk over for ritonavir eller et af de øvrige indholdsstoffer i Ritonavir Mylan (angivet i punkt 6).
English: People with liver disease or hepatitis may have worsening of liver disease.
Danish: Patienter med leversygdom eller leverbetændelse kan opleve en forværring af leversygdommen.
English: Ritonavir is not a cure for HIV infection or AIDS.
Danish: Ritonavir helbreder ikke hiv-infektion eller AIDS.
English: No medicinal product interaction study has been performed for the co-administration of ritonavir with benzodiazepines.
Danish: Der er ikke udført interaktionsstudier med samtidig administration af ritonavir og benzodiazepiner.
English: The following warnings and precautions should be considered when ritonavir is used as an antiretroviral agent.
Danish: Der skal tages hensyn til følgende advarsler og forsigtighedsregler, når ritonavir anvendes som antiretroviralt lægemiddel.
English: The mean average change from baseline over 48 weeks for HIV RNA levels was -0.88 log10 in the ritonavir group versus -0.66 log10 in the ritonavir + zidovudine group versus -0.42 log10 in the zidovudine group.
Danish: Gennemsnitsændringen fra baseline i løbet af 48 uger for hiv-RNA var -0,88 log10 for ritonavirgruppen i forhold til -0,66 log10 for den gruppe, der fik ritonavir+zidovudin og sammenlignet med -0,42 log10 for zidovudingruppen.
English: Mylan Denmark ApS Tel: + 45 28 11 69 32
Danish: Mylan Denmark ApS Tlf: + 45 28 11 69 32
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Danish: Der er rapporteret øget blødning, herunder spontane hudhæmatomer og hæmartrose hos patienter med hæmofili type A og B, som er behandlet med proteasehæmmere.
English: Ritonavir is a protease inhibitor used to control HIV infection.
Danish: Ritonavir er en proteasehæmmer, som anvendes til at kontrollere hiv-infektion.
English: Ritonavir pharmacokinetic parameters have not been studied in patients with renal impairment.
Danish: Ritonavirs farmakokinetiske parametre er ikke undersøgt hos patienter med nedsat nyrefunktion.
English: The use of pethidine and ritonavir is contraindicated due to the increased concentrations of the metabolite, norpethidine, which has both analgesic and CNS stimulant activity.
Danish: Anvendelsen af pethidin sammen med ritonavir er kontraindiceret på grund af de øgede koncentrationer af metabolitten, norpethidin, som både har smertestillende og centralstimulerende virkning.
English: A controlled study completed in 1996 with ritonavir as add-on therapy in HIV-1 infected patients extensively pre-treated with nucleoside analogues and baseline CD4 cell counts ≤ 100 cells/μl showed a reduction in mortality and AIDS defining events.
Danish: Et kontrolleret studie afsluttet i 1996 med ritonavir som supplerende behandling hos hiv-1-patienter efter intensiv forudgående behandling med nukleoside analoger og CD4-celletal  100 celler/l viste et fald i dødeligheden og AIDS-definerende hændelser.
English: Adverse reactions of nausea, dizziness, hypotension and syncope have been observed in single dose interaction studies in healthy volunteers (see section 4.5).
Danish: Bivirkninger som kvalme, svimmelhed, hypotension og synkope er observeret i interaktionsstudier med enkeltdoser med raske, frivillige forsøgspersoner (se pkt.
English: Pack sizes: 30, 90, 100 and multipack containing 90 (3 bottles of 30) film-coated tablets.
Danish: Pakningstørrelser: 30, 90, 100 og multipakning, bestående af 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
English: Abdominal pain (upper and lower), nausea, diarrhoea (including severe with electrolyte imbalance), vomiting, dyspepsia
Danish: Meget almindelig Abdominalsmerter (øvre og nedre), kvalme, diarré (inklusive svær med elektrolytforstyrrelser), opkastning, dyspepsi
English: Increased fexofenadine levels may lessen over time as induction develops.
Danish: Den forhøjede fexofenadinkoncentration vil muligvis aftage med tiden efterhånden som der fremkaldes induktion.
English: Antipsychotics/ Neuroleptics
Danish: Antipsykotika/neuroleptika Lurasidon
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1242/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/17/1242/004
English: It is therefore important that you remain under the supervision of your doctor while taking Ritonavir Mylan.
Danish: Det er derfor vigtigt, at din læge følger dig nøje, mens du tager Ritonavir Mylan.
English: The pharmacokinetics of ritonavir during multiple dose regimens were studied in non-fasting HIV-infected adult volunteers.
Danish: Ritonavirs farmakokinetik ved flergangsdosering er blevet undersøgt hos ikke-fastende hiv-positive voksne frivillige forsøgspersoner.
English: Norbuprenorphine Glucuronide metabolites
Danish: Norbuprenorphin Glukuronidmetaboliter
English: ↑ 64% ↑ 5 fold
Danish: Amprenavir2 ↑ 64 % ↑ 5 gange
English: Barrier or other non-hormonal methods of contraception should be considered when administering ritonavir at therapeutic or low doses as ritonavir is likely to reduce the effect and change the uterine bleeding profile when co-administered with estradiol-containing contraceptives.
Danish: Barrieremetoder eller andre ikke-hormonelle antikonceptionsmidler bør overvejes, når ritonavir indgives ved terapeutiske eller lave doser, da ritonavir sandsynligvis vil nedsætte virkningen og ændre den uterine blødningsprofil ved indgift sammen med estradiol-holdige antikonceptionsmidler.
English: • upset stomach or indigestion
Danish: • maveproblemer eller fordøjelsesbesvær
English: Ritonavir Mylan film-coated tablets are administered orally and should be ingested with food (see section 5.2).
Danish: Ritonavir Mylan filmovertrukne tabletter administreres oralt og bør indtages sammen med et måltid (se pkt.
English: For patients with renal impairment, a clarithromycin dose reduction should be considered: for patients with creatinine clearance of 30 to 60 ml/min the dose should be reduced by 50%, for patients with creatinine clearance less than 30 ml/min the dose should be reduced by 75%.
Danish: For patienter med nedsat nyrefunktion bør en dosisnedsættelse overvejes: til patienter med en kreatinin-clearance på 30 til 60 ml/min.
English: Co-administration of delamanid with a strong inhibitor of CYP3A (ritonavir) may increase exposure to delamanid metabolite, which has been associated with QTc prolongation.
Danish: Samtidig administration af delamanid og en potent CYP3A-hæmmer (ritonavir) kan øge eksponeringen for delamanid-metabolitten, hvilket er associeret med QTc-forlængelse.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL OF MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDRE KARTON TIL MULTIPAKKE (UDEN BLÅ BOKS)
English: Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia.
Danish: Forhøjede plasmakoncentrationer af ergotderivater, som medfører akut toksisk ergotisme, herunder vasospasmer og iskæmi.
English: Ritonavir 100 mg twice daily with saquinavir 1,000 mg twice daily provides saquinavir systemic exposure over 24 hours similar to or greater than those achieved with saquinavir 1,200 mg three times daily without ritonavir.
Danish: 100 mg ritonavir to gange dagligt sammen med 1.000 mg saquinavir to gange dagligt medfører systemisk saquinavireksponering i løbet af 24 timer, som svarer til eller er større end den, der opnås med 1.200 mg saquinavir tre gange dagligt uden ritonavir.
English: Refer to the darunavir Summary of Product Characteristics for further information on once daily dosing in ART experienced patients.
Danish: Se produktresumé for darunavir for yderligere information om én gang daglig dosering hos ART-erfarne patienter.
English: HMG co-A reductase inhibitors Atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin
Danish: Statiner (HMG-CoAreduktasehæmmere) Atorvastatin, fluvastatin, lovastatin, pravstatin, rosuvastatin, simvastatin
English: Co-administration of abemaciclib and ritonavir should be avoided.
Danish: Co-administration af abemaciclib and ritonavir bør undgås.
English: The continuation of ritonavir therapy should be evaluated by viral load because of the possibility of the emergence of resistance as described under section 4.1.
Danish: Fortsat indgift af ritonavir bør vurderes med undersøgelse for virusbelastning på grund af muligheden for udvikling af resistens, som beskrevet i pkt.
English: Ritonavir Mylan can cause dizziness.
Danish: Ritonavir Mylan kan medføre svimmelhed.
English: See also section 2 What you need to know before you or your child takes Ritonavir Mylan.
Danish: Se også punkt 2 Det skal du vide, før du eller dit barn begynder at tage Ritonavir Mylan.
English: • upper or lower stomach ache
Danish: • øvre og nedre mavepine
English: Co-administration of ibrutinib and ritonavir should be avoided.
Danish: Coadministration af ibrutinib og ritonavir bør undgås.
English: Due to the solubility characteristics and possibility of transintestinal elimination, it is proposed that management of overdose could entail gastric lavage and administration of activated charcoal.
Danish: På grund af lægemidlets opløselighed og muligheden for transintestinal elimination bør behandling af overdosering omfatte maveudskylning og indgift af aktivt kul.
English: Tell your doctor if you have a heart defect or conduction defect.
Danish: Fortæl det til lægen, hvis du har en hjertefejl eller overledningsforstyrrelser i hjertet.
English: Also tell your doctor if you experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, as this may be a sign of osteonecrosis.
Danish: Du skal også fortælle det til din læge, hvis du får stivhed, ømhed og smerter i led (især hofte, knæ og skulder) samt bevægelsesbesvær, da dette kan være tegn på knoglenekrose.
English: Ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay using S. typhimurium and E. coli, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
Danish: Ritonavir er ikke fundet at være mutagent eller klastogent i en serie af in vitro og in vivo målinger, herunder Ames bakterielle tilbagemutationsmåling ved hjælp af S. typhimurium og E.coli, muselymfomtesten, musemikronukleustesten og måling af kromosomændringer i humane lymfocytter.
English: 117 Allée des Parcs, 69800 Saint-Priest, France
Danish: 117 Allée des Parcs, 69800 Saint-Priest, Frankrig
English: Some patients taking ritonavir can develop serious problems with their pancreas.
Danish: Nogle patienter, som tager ritonavir, kan få alvorlige problemer med bugspytkirtlen.
English: The other tablet ingredients are: copovidone, sorbitan laurate, colloidal anhydrous silica, sodium chloride, sodium stearyl fumarate see section 2 ‘Ritonavir Mylan contains sodium'.
Danish: Øvrige indholdsstoffer: copovidon; sorbitanlaurat; silica kolloid vandfri; natriumchlorid, natriumstearylfumarat, se punkt 2 "Ritonavir Mylan indeholder natrium".
English: Inhaled, injectable or intranasal fluticasone propionate, budesonide, triamcinolone
Danish: Inhalations-, injektions- eller intranasal fluticasonpropionat, budesonid, triamcinolon
English: For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir.
Danish: For yderligere dosisanbefalinger henvises til produktinformationen for andre proteasehæmmere godkendt til indgivelse sammen med ritonavir.
English: Doses of ritonavir less than 200 mg twice daily should not be used with tipranavir as they might alter the efficacy of the combination.
Danish: Doser af ritonavir på mindre end 200 mg to gange dagligt bør ikke anvendes sammen med tipranavir, da de kan ændre virkningen af kombinationen.
English: Concentrations of colchicine are expected to increase when co-administered with ritonavir.
Danish: Koncentrationen af colchicin forventes at stige ved samtidig administration af ritonavir.
English: Ritonavir should not be given as a pharmacokinetic enhancer or as an antiretroviral agent to patients with decompensated liver disease.
Danish: Ritonavir bør ikke gives som en farmakokinetisk forstærker eller som antiretroviralt lægemiddel til patienter med dekompenseret leversygdom.
English: Thereby, increasing the risk of extreme sedation and respiratory depression from these agents.
Danish: Derved øges risikoen for alvorlig sedation og respirationsdepression forårsaget af disse midler.
English: What Ritonavir Mylan looks like and contents of the pack Ritonavir Mylan film-coated tablets are yellow, capsule shaped and marked with ‘M163' on one side and plain on the other.
Danish: Ritonavir Mylan filmovertrukne tabletter er gule, kapselformede og præget med “M163 ” på den ene side, den anden side er uden prægning.
English: In a study completed in 1996 recruiting less advanced HIV-1 infected patients (CD4 200-500 cells/μl) without previous antiretroviral therapy, ritonavir in combination with zidovudine or alone reduced viral load in plasma and increased CD4 count.
Danish: I et studie afsluttet i 1996 med patienter med mindre fremskredet hiv-1 (CD4 200-500 celler/l) uden forudgående antiretroviral behandling, medførte ritonavir sammen med zidovudin eller alene nedsat viralbelastning i plasma og forøget CD4-tal.
English: After multiple dosing of ritonavir to healthy volunteers (500 mg twice daily) and subjects with mild to moderate hepatic impairment (Child Pugh Class A and B, 400 mg twice daily) exposure to ritonavir after dose normalisation was not significantly different between the two groups.
Danish: Efter gentagen dosering af ritonavir til raske frivillige (500 mg to gange dagligt) og patienter med let til moderat nedsat leverfunktion (400 mg to gange dagligt) var eksponeringen af ritonavir efter normalisering af dosis ikke signifikant forskellig i de to grupper.
English: Atovaquone
Danish: Atovaquon
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (see section 4.5).
Danish: Naturlægemidler, som indeholder perikon (Hypericum perforatum), på grund af risikoen for nedsatte plasmakoncentrationer og nedsat klinisk virkning af ritonavir (se pkt.
English: Concomitant use of ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig anvendelse af ritonavir og fluticason eller andre glukokortikoider, som metaboliseres af CYP3A4, anbefales ikke, medmindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
English: 200q12h ↑ 28% ↑ 9% Careful monitoring of therapeutic and adverse effects is recommended when prednisolone is concomitantly administered with ritonavir.
Danish: 200mg hver 12. time ↑ 28% ↑ 9% Nøje overvågning af den terapeutiske virkning og bivirkninger anbefales, når prednison indgives sammen med ritonavir.
English: In the event of unexplained or continual muscle pain, tenderness, weakness or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the Accident and Emergency Department of your nearest hospital.
Danish: muskelsvækkelse eller kramper, skal du holde op med at tage medicinen, kontakte din læge hurtigst muligt eller tage på skadestuen på det nærmeste hospital.
English: Recommendations regarding use of ritonavir dosed as a pharmacokinetic enhancer with rifabutin are noted in section
Danish: Anbefalinger vedrørende anvendelse af ritonavir doseret som en farmakokinetisk forstærker i kombination med rifabutin er angivet i pkt.
English: Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination.
Danish: Lavere doser af ritonavir end 200 mg to gange dagligt bør ikke anvendes, da de kan ændre virkningsprofilen for kombinationen.
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate,
Danish: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin Unit 35/36 Baldoyle Industrial Estate
English: Concomitant administration of ritonavir and quetiapine is contraindicated as it may increase quetiapine-related toxicity (see section 4.3).
Danish: Samtidig administration af ritonavir og quetiapin er kontraindiceret, idet quetiapin-relateret toksicitet kan øges (se pkt.
English: Ritonavir should be used with caution in such patients (see section 5.1).
Danish: Ritonavir bør bruges med forsigtighed til sådanne patienter (se pkt.
English: The enzyme-modulating effect of ritonavir may be dose dependent.
Danish: Ritonavirs enzymforstærkende effekt kan være dosisafhængig.
English: It is advisable to monitor renal function in patients with renal function impairment.
Danish: Det anbefales at kontrollere nyrefunktionen hos patienter med nedsat nyrefunktion.
English: The tablet coating is composed of: hypromellose, titanium dioxide (E171), macrogols, hydroxypropylcellulose, talc, iron oxide yellow (E172), colloidal anhydrous silica, polysorbate
Danish: Tabletovertræk indeholder: hypromellose; titandioxid (E171); macrogoler; hydroxypropylcellulose; talcum; jernoxid gul (E172), silica kolloid vandfri; polysorbat 80.
English: If treatment with an HMGCoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Danish: Hvis behandling med en HMG-CoA-reduktasehæmmer er indiceret, anbefales pravastatin eller fluvastatin (se pkt.