FrancophonIA/ELRC3.0 huggingface dataset:
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 resulterer i forhøjede plasmakoncentrationer af det andet lægemiddel, hvilket kan øge eller forlænge dets terapeutiske effekt eller effekten af bivirkninger.
English: • if Norvir is used to boost the effects of other anti-HIV medicines, the typical dose for adults is 1 or 2 sachets once or twice daily.
Danish: • Hvis Norvir bruges til at booste virkningen af andre anti-hiv-lægemidler, er den typiske dosis til voksne 1 eller 2 breve én eller to gange dagligt.
English: Beige/pale yellow to yellow powder.
Danish: Pulver til oral opløsning Beige/lys gul til gult pulver
English: − antiretroviral medicines including HIV-protease inhibitors (amprenavir, atazanavir, darunavir,
Danish: − antiretrovirale lægemidler, herunder hiv-proteasehæmmere (amprenavir, atazanavir, darunavir,
English: Common Hypertension, hypotension including orthostatic hypotension, peripheral coldness
Danish: Hypertension, hypotension inklusive ortostatisk hypotension, perifer kuldefølelse
English: − antibiotics (e.g. erythromycin, clarithromycin);
Danish: − antibiotika (f.eks. erythromycin, clarithromycin);
English: If a side effect is preventing you from taking Norvir, tell your doctor straight away.
Danish: Hvis en bivirkning forhindrer dig i at tage Norvir, skal du straks kontakte lægen.
English: How do I take the correct dose of Norvir powder for oral suspension mixed with liquid?
Danish: Hvordan udmåler jeg den korrekte dosis af Norvir pulver til oral suspension blandet med væske?
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 på raske frivillige forsøgspersoner (se pkt.
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 i ikke-fastende hiv-positive voksne frivillige forsøgspersoner.
English: Check prescription for number of sachets or call your doctor or pharmacist.
Danish: Kontrollèr antallet af ordinerede breve eller spørg din læge eller apotekspersonalet.
English: Other medicines and Norvir
Danish: Brug af anden medicin sammen med Norvir
English: Clozapine, pimozide Increased plasma concentrations of clozapine and pimozide.
Danish: Clozapin, pimozid Forhøjede plasmakoncentrationer af clozapin og pimozid.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Norvir, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
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 i terapeutiske eller lave doser, da ritonavir sandsynligvis vil nedsætte virkningen og ændre den uterine blødningsprofil ved indgift sammen med antikonceptionsmidler, som indeholder estradiol.
English: Lovastatin, simvastatin Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section
Danish: Lovastatin, simvastatin Forhøjede plasmakoncentrationer af lovastatin og simvastatin; Derved forøges risikoen for myopati inklusiv rhabdomyolysis (se pkt.
English: Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection.
Danish: Denne hæmning af hiv-proteasen bevirker at enzymet bliver ude af stand til at danne gag-pol polyproteinprecursor hvorved der dannes hiv-partikler med umoden morfologi, der er ude af stand til at starte en ny omgang infektion.
English: − sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by injection;
Danish: − sovepiller (f.eks. alprazolam, zolpidem) og endvidere midazolam indgivet med injektion;
English: − avanafil or vardenafil (used to treat erectile dysfunction); − colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Norvir);
Danish: − avanafil eller vardenafil (brugt til behandling af rejsningsbesvær); − colchicin (bruges til behandling af urinsyregigt) hvis du har problemer med nyre og/eller lever (se sektionen vedrørende Brug af anden medicin sammen med Norvir);
English: The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects.
Danish: Anvendelse af følgende lægemidler er kontraindiceret, når de anvendes sammen med ritonavir og, medmindre andet er angivet, er kontraindikationen baseret på ritonavirs evne til at hæmme metabolismen af det samtidigt indgivne lægemiddel, hvilket medfører øget eksponering over for det samtidigt indgivne lægemiddel samt risiko for klinisk signifikante bivirkninger.
English: Ritonavir pharmacokinetic parameters have not been studied in patients with renal impairment.
Danish: Ritonavirs farmakokinetiske parametre er ikke undersøgt hos patienter med svækket nyrefunktion.
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 bosentans maksimum steady state koncentration (Cmax) og arealet under kurven (AUC).
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 forøget blødning, herunder spontane hudhæmatomer og hæmartrose hos patienter med hæmofili type A og B, som er behandlet med proteasehæmmere.
English: To calculate the volume to be administered (in ml) for intermediate body surface areas not included in the above table, the body surface area should be multiplied by a factor of: 25 for a dose of 250 mg/m²; 30 for 300 mg/m²; and 35 for 350 mg/m².
Danish: For at beregne den nødvendige dosis (i ml) skal kroppens overflade ganges med: 25 for doser på 250 mg/ m2, med 30 for doser på 300 mg/ m2, og med 35 for 350 mg/ m2.
English: c. Pull the plunger down.
Danish: c. Træk stemplet ned.
English: Based on interaction studies with the ritonavir boosted protease inhibitors (lopinavir/ritonavir, atazanavir), concurrent administration of omeprazole or ranitidine does not significantly modify ritonavir efficacy as a pharmacokinetic enhancer despite a slight change of exposure (about 6 - 18%).
Danish: Baseret på interaktionsstudier med ritonavir boostet proteasehæmmere (lopinavir/ritonavir, atazanavir) ændrer samtidig administration af omeprazol eller ranitidin ikke signifikant ritonavirs effekt som farmakokinetisk forstærker, selv om der er en mindre ændring af eksponering (omkring 6 - 18%).
English: Endothelin antagonists
Danish: Endotelin-antagonister
English: It is important that Norvir tablets are swallowed whole and not chewed, broken or crushed.
Danish: Det er vigtigt, at Norvir-tabletter synkes hele og ikke tygges, deles eller knuses.
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 store terapeutiske område bør det ikke være nødvendigt at foretage nogen nedsættelse af dosis for patienter med normal nyrefunktion.
English: − products containing St John's wort (Hypericum perforatum) as this may stop Norvir from working properly.
Danish: − præparater, der indeholder perikon (Hypericum perforatum), da dette kan forhindre Norvir i at virke på den rette måde.
English: Ritonavir is not a cure for HIV-1 infection or AIDS.
Danish: Ritonavir helbreder hverken hiv-1-infektion eller AIDS.
English: − Diabetes, as there have been reports of worsening of or the development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
Danish: − sukkersyge (diabetes), da der har været rapporteret om forværring eller udvikling af diabetes (diabetes mellitus) hos nogle patienter i behandling med proteasehæmmere.
English: Haloperidol, risperidone, thioridazine
Danish: Haloperidol, risperidon, thioridazin
English: d. Wash and dry the area used to mix the medicine.
Danish: d. Vask og aftør området, hvor medicinen er tilberedt.
English: Co-administration of abemaciclib and Norvir should be avoided.
Danish: Samtidig administration af abemaciclib og Norvir bør undgås.
English: − Diarrhoea or vomiting that is not improving (persistent), as this may reduce how well the medicines you are taking work.
Danish: − Diarré eller opkastning, der ikke bliver bedre (som er vedvarende), da dette kan mindske virkningen af de lægemidler, du tager.
English: − astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);
Danish: − astemizol eller terfenadin (lægemidler, der ofte anvendes til behandling af overfølsomhedssymptomer, og som måske kan fås uden recept);
English: Sulfamethoxazole was co-administered with trimethoprim.
Danish: Sulfamethoxazol blev indgivet sammen med trimethoprim.
English: Concentrations of colchicine are expected to increase when coadministered with ritonavir.
Danish: Koncentrationen af colchicin forventes at stige ved indgift sammen med ritonavir.
English: Serum levels of ritonavir may be affected by select co-administered medicinal products (e.g. delavirdine, efavirenz, phenytoin and rifampicin).
Danish: Serumniveauerne af ritonavir kan påvirkes ved samtidig administration af udvalgte lægemidler (f.eks. delavirdin, efavirenz, phenytoin og rifampicin).
English: − clorazepate, diazepam, estazolam, flurazepam, triazolam or oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety);
Danish: − clorazepat, diazepam, estazolam, flurazepam, triazolam eller oral (taget gennem munden) midazolam (bruges til at hjælpe dig med at sove og/eller mod angst);
English: Ritonavir has a high affinity for several cytochrome P450 (CYP) isoforms and may inhibit oxidation with the following ranked order: CYP3A4 > CYP2D6.
Danish: Ritonavir har stor affinitet til flere cytokrom P450 (CYP)-isoformer, angivet i aftagende rækkefølge, og kan hæmme oxidation: CYP3A4 > CYP2D6.
English: Ritonavir concentrations obtained after 350 to 400 mg/m² twice daily in paediatric patients were comparable to those obtained in adults receiving 600 mg (approximately 330 mg/m²) twice daily.
Danish: De opnåede koncentrationer af ritonavir efter 350 til 400 mg/m² to gange dagligt hos pædiatriske patienter var sammenlignelige med de koncentrationer, der blev opnået hos voksne, som fik 600 mg (ca. 330 mg/m²) to gange dagligt.
English: In general, as mutations associated with ritonavir resistance accumulate, susceptibility to select other PIs may decrease due to cross-resistance.
Danish: Som udgangspunkt, akkumuleres mutationer associeret med resistens over for ritonavir og muligheden for at vælge andre proteasehæmmere falde på grund af krydsresistens.
English: The prescribed dose of Norvir powder for oral suspension can be administered via a feeding tube after being mixed with water as detailed in section 6.6.
Danish: Den anbefalede dosis af Norvir pulver til oral suspension kan administreres gennem ernæringssonde efter blanding med vand som bekrevet i detaljer i pkt.
English: − Hepatitis B or C and are being treated with a combination of antiretroviral agents, as you are at a greater risk of a severe and potentially life threatening reaction because of the effect on the liver.
Danish: − hepatitis B eller C og er i behandling med en kombination af antiretrovirale lægemidler, da du i så fald er i større risiko for at få en alvorlig og muligvis livstruende reaktion på grund af indvirkningen på leveren.
English: Thereby, increasing the risk of extreme sedation and respiratory depression from these agents.
Danish: Derved forøges risikoen for alvorlige sedation og respirationsdepression forårsaget af disse midler.
English: − Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as serious liver damage can occur when taken with Norvir.
Danish: − Rifampicin og saquinavir (anvendes i behandlingen af henholdsvis tuberkulose og hiv), da der kan forekomme alvorlig leverskade, når de tages sammen med Norvir.
English: How do I take the correct dose of Norvir powder for oral suspension mixed with food (full sachet)?
Danish: Hvordan udmåler jeg den korrekte dosis af Norvir pulver til oral suspension blandet med mad (helt brev)?
English: Very common Dysgeusia, oral and peripheral paraesthesia, headache, dizziness, peripheral neuropathy
Danish: Meget almindelig Dysgeusi, oral og perifer paræstesi, hovedpine, svimmelhed, perifer neuropati
English: − voriconazole (used to treat fungal infections)*;
Danish: − voriconazol (anvendes til behandling af svampeinfektioner)*;
English: Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia.
Danish: Forhøjede plasmakoncentrationer af ergotaminderivater, som medfører akut toksikologisk ergotisme, herunder vasospasmer og iskæmi.
English: The enzyme-modulating effect of ritonavir may be dose dependent.
Danish: Den enzymforstærkende effekt af ritonavir kan være dosisafhængig.
English: Caution should be exercised in administering afatinib with Norvir (refer to the afatinib SmPC).
Danish: Der skal udvises forsigtighed ved administration af afatinib sammen med Norvir (se produktreuméet for afatinib).
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/µl) uden forudgående antiretroviral behandling, medførte ritonavir sammen med zidovudin eller alene nedsat viralbelastning i plasma og forøget CD4 tal.
English: − fusidic acid (used to treat bacterial infections);
Danish: − fusidinsyre (bruges til behandling af bakterielle infektioner);
English: Although rifampicin may induce metabolism of ritonavir, limited data indicate that when high doses of ritonavir (600 mg twice daily) is co-administered with rifampicin, the additional inducing effect of rifampicin (next to that of ritonavir itself) is small and may have no clinical relevant effect on ritonavir levels in high-dose ritonavir therapy.
Danish: Selvom rifampicin kan inducerer ritonavirs metabolisme, tyder begrænsede data på, at rifampicins øgede inducerende effekt (ved siden af ritonavirs egen) er lille og ikke har nogen klinisk relevant effekt på ritonavir-niveauer i højdosis enkeltstof-behandling.
English: Norvir should be started at 250 mg/m² and increased at 2 to 3 day intervals by 50 mg/m² twice daily.
Danish: Norvir bør påbegyndes med 250 mg/m2 og øges efter 2 til 3 dages interval med 50 mg/m2 to gange dagligt.
English: Ritonavir effects on Non-antiretroviral Co-administered Medicinal Products
Danish: Ritonavirs virkning på samtidigt indgift af ikke-antiretrovirale lægemidler
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 4.1.
English: For details on preparation and administration of the Norvir powder for oral suspension, see section 6.6.
Danish: For detaljer vedrørende tilberedning og administration af Norvir pulver til oral suspension, se pkt.
English: Uncommon Increased neutrophils
Danish: Ikke almindelig Forhøjet antal neutrofile celler
English: − alfuzosin (used to treat enlarged prostate gland);
Danish: − alfuzosin (bruges mod forstørret prostata);
English: Amphetamine
Danish: Amphetamin
English: The bitter aftertaste of Norvir powder for oral suspension may be lessened if peanut butter, hazelnut chocolate spread, or black currant syrup are taken immediately after dose administration.
Danish: Den bitre eftersmag af Norvir pulver til oral suspension kan mindskes, hvis jordnøddesmør (peanut butter), chokoladesmørepålæg med hasselnød eller solbærsaft indtages straks efter administration af dosis.
English: In patients who are already taking digoxin when ritonavir is introduced, the digoxin dose should be reduced to one-half of the patients' normal dose and patients need to be followed more closely than usual for several weeks after initiating co-administration of ritonavir and digoxin.
Danish: For patienter, som allerede tager digoxin, når behandling med ritonavir påbegyndes, bør digoxindosen reduceres til halvdelen af patientens normale dosis, og patienterne bør følges nøjere end normalt i adskillige uger efter påbegyndelse af samtidig indgift af ritonavir og digoxin.
English: In intent to treat analyses, 50% and 57% of patients in the 350 and 450 mg/m2 dose groups, respectively, achieved reduction in plasma HIV-1 RNA to ≤ 400 copies/ml at Week 48.
Danish: I intention-to-treat opnåede henholdsvis 50% og 57% af patienterne i dosisgrupperne 350 og 450 mg/m2 reduktion i plasma-hiv-1 RNA til ≤ 400 kopier/ml ved uge 48.
English: (For caution on parenterally administered midazolam, see section 4.5.
Danish: (For advarsler vedrørende parenteral administreret midazolam, se pkt.
English: Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of ritonavir and potential loss of virologic response.
Danish: Apalutamid er en moderat til stærk CYP3A4-inducer og dette kan føre til nedsat eksponering for ritonavir og potentielt give et fald i virologisk respons.
English: Silica, colloidal anhydrous Polysorbate 80
Danish: Kolloid silica, vandfri Polysorbat 80
English: Norvir powder for oral suspension has a lingering aftertaste.
Danish: Norvir pulver til oral suspension har en længerevarende eftersmag.
English: Pethidine, piroxicam, propoxyphne
Danish: Pethidin, piroxicam, propoxyphen
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 forsøgspersoner (500 mg to gange dagligt) og forsøgspersoner med mild til moderat nedsat leverfunktion (Child-Pugh klasse A og B, 400 mg to gange dagligt) var eksponeringen af ritonavir efter normalisering af dosis ikke signifikant forskellig for de to grupper.
English: − dihydroergotamine, ergotamine (used to treat migraine headache);
Danish: − dihydroergotamin, ergotamin (bruges mod migræne);
English: Rationale Concomitant medicinal product levels increased or decreased α1-Adrenoreceptor Antagonist
Danish: Lægemiddelklasse Lægemiddel i klassen Rationale Forhøjet eller nedsat koncentration af samtidigt indgivet lægemiddel α1-adrenerge antagonister
English: b. Remove the plunger from the syringe.
Danish: b. Tag stemplet ud af sprøjten.
English: − Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone) as Norvir 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 Norvir kan øge niveauerne af disse lægemidler i blodet, hvilket kan føre til Cushings syndrom (udvikling af ‘måneansigt') og nedsætte produktionen af hormonet kortisol.
English: Interactions between ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below.
Danish: Interaktioner mellem ritonavir og proteasehæmmere, antiretrovirale stoffer som ikke er proteasehæmmere og andre non-antiretrovirale lægemidler er opført i listen nedenfor.
English: ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
Danish: ibrutinib, nilotinib,venetoclax, vincristin, vinblastin);
English: Norvir powder for oral suspension should be taken with food.
Danish: Norvir pulver til oral suspension skal tages sammen med mad.
English: Pethidine Norpethidine metabolite
Danish: Pethidin Norpethidin metabolit
English: If a side effect is preventing you from taking Norvir as directed, tell your doctor straight away.
Danish: Hvis en bivirkning forhindrer dig i at tage Norvir efter anvisningerne, skal du straks kontakte lægen.
English: Very common 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: Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions.
Danish: Potente CYP3A4-hæmmere som f.eks. proteasehæmmere kan øge bedaquilin-eksponeringen, hvilket potentielt kan øge risikoen for bedaquilin-relaterede bivirkninger.
English: Concomitant administration of Norvir and quetiapine is contraindicated as it may increase quetiapine-related toxicity (see section 4.3).
Danish: Samtidig administration af Norvir og quetiapin er kontraindiceret, idet quetiapin-relateret toksicitet kan øges (se pkt.
English: Saquinavir4 ↑ 15-fold ↑ 5-fold Ritonavir
Danish: Saquinavir4 ↑ 15 gange ↑ 5 gange Ritonavir
English: Increased plasma concentrations of alfuzosin which may lead to severe hypotension (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af alfuzosin, som kan medfører alvorlig hypotension (se pkt.
English: Norvir film-coated tablets should be swallowed whole and not chewed, broken or crushed.
Danish: Norvir filmovertrukne tabletter skal synkes hele og ikke tygges, deles eller knuses.
English: Nevirapine Ritonavir Co-administration of ritonavir with nevirapine does not lead to clinically relevant changes in the pharmacokinetics of either nevirapine or ritonavir.
Danish: Nevirapin ↔ Ritonavir Samtidig indgift af ritonavir og nevirapin fører ikke til klinisk relevante ændringer i hverken nevirapins eller ritonavirs farmakokinetik.
English: Ritonavir inhibits CYP3A-mediated metabolism of ketoconazole.
Danish: Ritonavir hæmmer den CYP3A-medierede metabolisering af ketoconazol.
English: − The tablet coating is composed of: hypromellose, titanium dioxide, macrogols, hydroxypropyl cellulose, talc, colloidal anhydrous silica, polysorbate 80.
Danish: − tabletovertræk indeholder: hypromellose; titandioxid; macrogoler; hydroxypropylcellulose; talcum; silica kolloid vandfri; polysorbat 80.