FrancophonIA/ELRC3.0 huggingface dataset:
English: Three pack sizes are available for Norvir tablets:
Danish: Der findes tre pakningsstørrelser af Norvir-tabletter:
English: • you cannot move the plunger
Danish: • du ikke kan bevæge stemplet
English: If you realise you have taken more Norvir than you were supposed to, contact your doctor or the Accident and Emergency Department of your nearest hospital straight away.
Danish: Hvis du bliver klar over, at du har taget mere Norvir, end du skulle, skal du straks kontakte din læge eller skadestuen på det nærmeste hospital.
English: Stevens Johnson syndrome, toxic epidermal necrolysis (TEN)
Danish: Stevens Johnson Syndrom, toksisk epidermal nekrolyse (TEN)
English: Norvir is a protease inhibitor used to control HIV infection.
Danish: Norvir er en proteasehæmmer, som anvendes til at kontrollere hiv-infektion.
English: − lurasidone (used to treat depression);
Danish: − lurasidon (bruges til behandling af depression);
English: − anxiety medicine, buspirone;
Danish: − lægemidler mod angst, buspiron;
English: For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions).
Danish: For patienter, der har afsluttet optitreringsfasen og har en stabil dagligt dosis venetoclax, skal venetoclax-dosis reduceres med mindst 75%, når det anvendes sammen med stærke CYP3A-hæmmere (se venetoclax-SmPC for doseringsanvisninger).
English: In contrast to long-term administration of ritonavir, there was no significant interaction with bupropion after short-term administration of low doses of ritonavir (200 mg twice daily for 2 days), suggesting reductions in bupropion concentrations may have onset several days after initiation of ritonavir co-administration.
Danish: I modsætning til lang tids administration af ritonavir, var der ingen signifikant interaktion med bupropion efter kort tids administration af lave doser af ritonavir (200 mg to gange dagligt i 2 dage), hvilket tyder på reduktion af bupropion koncentrationer kan begynde adskillige dage efter initiering af samtidig administration af ritonavir.
English: Tissue distribution studies with 14C-labelled ritonavir in rats showed the liver, adrenals, pancreas, kidneys and thyroid to have the highest concentrations of ritonavir.
Danish: Vævsdistributionsstudier med 14C-mærket ritonavir i rotter har vist, at lever, binyrer, pankreas, nyrer og thyreoidea indeholdt den højeste koncentration af ritonavir.
English: Saquinavir4 ↑ 17-fold ND
Danish: Saquinavir4 ↑ 17-gange ND
English: Be careful not to spill the liquid outside of the mixing cup.
Danish: Pas på ikke at spilde væske ved siden af blande-koppen.
English: • Discard any mixture remaining in the mixing cup.
Danish: • Kassér al blanding som er tilbage i blande-koppen.
English: If trazodone is coadministered with ritonavir, the combination should be used with caution, initiating trazodone at the lowest dosage and monitoring for clinical response and tolerability.
Danish: Hvis trazodon anvendes samtidig med ritonavir, bør kombinationen gives med forsigtighed, således at behandling med trazodon initieres med laveste dosis og med overvågning af klinisk respons og tolerabilitet.
English: If you forget to take Norvir
Danish: Hvis du har glemt at tage Norvir
English: For selected medicinal products (e.g. alprazolam) the inhibitory effects of ritonavir on CYP3A4 may decrease over time.
Danish: For udvalgte lægemidler (f.eks. alprazolam) kan den hæmmende effekt af ritonavir på CYP3A4 falde med tiden.
English: − clozapine, pimozide, (used to treat abnormal thoughts or feelings);
Danish: − clozapin, pimozid, (bruges mod unormale tanker eller følelser);
English: The effects of ritonavir (alone or combined with other antiretroviral agents) on biological markers of disease activity such as CD4 cell count and viral RNA were evaluated in several studies involving HIV-1 infected patients.
Danish: Ritonavirs virkning (alene eller sammen med andre antiretrovirale stoffer) på biologiske markører på sygdomsaktivitet, f.eks. CD4 celletælling og viralt RNA, blev vurderet i flere studier, hvori der indgik hiv-1 smittede patienter.
English: For older children it may be feasible to substitute tablets for the maintenance dose of the powder for oral suspension.
Danish: Til ældre børn er det muligt at udskifte den perorale vedligeholdelsesdosis af pulver til oral suspension med tabletter.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid denne medicin nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Norvir powder for oral suspension should be stored below 30°C.
Danish: Norvir pulver til oral opløsning skal opbevares under 30 °C.
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
Danish: QTcF-intervallet blev evalueret i et randomiseret, placebo og aktiv (moxifloxacin 400 mg en gang dagligt) kontrolleret overkrydsnings-studie hos 45 raske voksne, med 10 målinger over 12 timer på dag 3.
English: Refer to the ceritinib SmPC for dosage adjustment recommendations.
Danish: Se produktreuméet for ceritinib vedrørende anbefalinger for dosisjustering.
English: Mix the powder and liquid a.Tightly screw on the lid and keep shaking the mixing cup hard for at least 90 seconds until all the lumps have gone.
Danish: Bland pulver og væske a.Skru låget stramt på og ryst blande-koppen kraftigt i mindst 90 sekunder, indtil alle klumper er væk.
English: The relatively high frequency of diarrhoea during treatment with ritonavir may compromise the absorption and efficacy (due to decreased compliance) of ritonavir or other concurrent medicinal products.
Danish: Den relativt hyppige forekomst af diarré under ritonavirbehandling kan hæmme optagelsen og virkningen (på grund af nedsat compliance) af ritonavir eller andre lægemidler, der indtages samtidig.
English: − neratinib (used to treat breast cancer);
Danish: − neratinib (bruges til at behandle brystkræft);
English: Ritonavir film-coated tablets are administered orally and should be ingested with food (see section
Danish: Ritonavir filmovertrukne tabletter indgives oralt og bør indtages sammen med et måltid (se pkt.
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 opløselighedsegenskaberne og muligheden for transintestinal elimination foreslås det at behandling i forbindelse med overdosering bør omfatte maveudskyldning og indgift af aktivt kul.
English: - If you have any other health concerns, discuss these with your doctor as soon as you can.
Danish: − hvis du har nogen andre bekymringer med hensyn til helbredet, bør du drøfte dem med din læge så hurtigt som muligt.
English: Like all medicines, Norvir can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • The oral dosing syringe and mixing cup should be dry prior to use.
Danish: • Den orale doseringssprøjte og blande-kop skal være tør inden brug.
English: Patients should not remain on 300 mg twice daily for more than 3 days.
Danish: Patienter bør ikke givesen dosis på 300 mg to gange dagligt i mere end 3 dage.
English: Amprenavir2 ↑ 64% ↑ 5 fold
Danish: Amprenavir2 ↑ 64 % ↑ 5 gange
English: Patients who exhibit these signs or symptoms should be evaluated and Norvir therapy should be discontinued if a diagnosis of pancreatitis is made (see section 4.8).
Danish: Patienter med disse tegn eller symptomer bør vurderes, og behandlingen med Norvir bør seponeres, hvis diagnosen pankreatit stilles (se pkt.
English: Measure the dose a. Check the prescription label on the carton for the dose in ml.
Danish: Afmåling af dosis a. Kontrollér dosis i ml på ordinationsetiketten på kartonen.
English: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).
Danish: Ritonavir er indiceret sammen med andre antiretrovirale stoffer til behandling af hiv-1 -inficerede patienter (voksne og børn, der er 2 år og ældre).
English: For some products, contraindications may be more relevant when ritonavir is used as an antiretroviral agent than when ritonavir is used as a pharmacokinetic enhancer (e.g. rifabutin and voriconazole):
Danish: For nogle produkter, kan kontraindikationer være mere relevante, når ritonavir anvendes som et antiretroviralt stof end når ritonavir anvendes som farmakokinetisk forstærker (f.eks. rifabutin og voriconazol):
English: Patients receiving Ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Danish: Patienter, der får ritonavir eller anden antiretroviral behandling, kan fortsat udvikle opportunistiske infektioner og andre komplikationer af hiv-1-infektion.
English: Before mixing dose of Norvir, collect the following supplies: (see Figure 1).
Danish: Før blanding af en dosis Norvir, findes følgende ting frem: (se figur 1).
English: − amphetamine or amphetamine derivatives;
Danish: − amphetamin eller derivater heraf
English: Norvir can cause dizziness.
Danish: Norvir kan medføre svimmelhed.
English: 30 sachets of powder for oral suspension Carton also contains 1 mixing cup and 2 oral dosing syringes
Danish: 30 breve med pulver til oral suspension Kartonen indeholder også 1 blande-kop og 2 orale doseringssprøjter
English: Serious persistent vomiting and/or diarrhoea associated with ritonavir use might also compromise renal function.
Danish: Alvorlig vedvarende opkastning og/eller diarré i forbindelse med ritonavir kan også påvirke nyrefunktionen.
English: The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (e.g. digoxin and fexofenadine-see table “Ritonavir effects on non-antiretroviral medicinal products” below).
Danish: Den hæmmende effekt af ritonavir ( med eller uden proteasehæmmere) på P-gp aktiviteten kan falde med tiden (f.eks. digoxin og fexofenadin - se tabel ”Ritonavir virkning på ikke-antiretrovirale lægemidler” nedenfor).
English: The Day 3 ritonavir exposure was approximately 1.5 fold higher than that observed with the 600 mg twice daily dose at steady state.
Danish: Eksposition af ritonavir dag 3 var tilnærmelsesvis 1,5 gange højere end den, som blev set med dosen 600 mg to gange dagligt ved steady state.
English: Co-administration of voriconazole and ritonavir dosed as a pharmacokinetic enhancer should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Danish: Samtidig anvendelse af voriconazol og ritonavir doseret som en farmakokinetisk forstærker bør undgås, medmindre en vurdering af benefit/risk-forholdet for patienten berettiger brugen af voriconazol.
English: Caution should be exercised in administering ceritinib with Norvir.
Danish: Der skal udvises forsigtighed ved administration af ceritinib sammen med Norvir.
English: Norvir tablets are supplied in white high density polyethylene (HDPE) bottles closed with polypropylene caps.
Danish: Norvir-tabletter udleveres i hvide polyethylen (HDPE) beholdere med polypropylenlåg.
English: Check the prescription label on the carton or call your doctor or pharmacist if you are not sure.
Danish: Kontrollèr etiketten på kartonen eller spørg din læge eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Concomitant use of ritonavir with apalutamide is not recommended.
Danish: Samtidig brug af ritonavir med apalutamid anbefales ikke.
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 et antiretroviralt stof.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL PACKAGING UNITS NORVIR POWDER FOR ORAL SUSPENSION - Sachet Label Text
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER NORVIR PULVER TIL ORAL SUSPENSION - Brev etikettekst
English: HCV Direct Acting Antiviral
Danish: HCV, Direkte virkende antivirale midler
English: These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.
Danish: Disse data refererer overvejende til eksposition, hvor ritonavir blev anvendt i kombinationsbehandling og ikke i terapeutiske ritonavir doser men i lavere doser som farmakokinetisk forstærker af andre PI-er.
English: under ‘Do not take Norvir'.
Danish: ‘Tag ikke Norvir' ovenfor).
English: Common Insomnia, anxiety, confusion, disturbance in attention, syncope, seizure
Danish: Søvnløshed, angst, konfusion, opmærksomhedsforstyrrelser, synkope, krampeanfald
English: Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking Norvir.
Danish: Abnorm leverfunktionstest, leverbetændelse (hepatitis) og sjældent gulsot er blevet rapporteret hos patienter, der tog Norvir.
English: Ritonavir concentrations in this study were highly variable and somewhat lower than those obtained in adults receiving 600 mg (approximately 330 mg/m²) twice daily.
Danish: De opnåede koncentrationer af ritonavir i dette studie var meget variable og noget lavere end de koncentrationer, der blev opnået hos voksne, som fik 600 mg (ca. 330 mg/m²) to gange dagligt.
English: − asthma medicine, theophylline, salmeterol;
Danish: − lægemidler mod astma, theophyllin, salmeterol;
English: − atovaquone, a medicine used to treat a certain type of pneumonia and malaria;
Danish: − atovaquon, der er et lægemiddel, som anvendes til behandling af en specifik type lungebetændelse og malaria;
English: Ritonavir is recommended for children 2 years of age and older.
Danish: Ritonavir anbefales til børn på 2 år og derover.
English: Norvir powder for oral suspension is administered orally, poured on soft food (apple sauce or vanilla pudding) or mixed with liquid (water, chocolate milk, or infant formula).
Danish: Norvir pulver til oral suspension er til indtagelse peroralt, hældes på blød mad (æblemos eller vanille budding) eller blandet med væske (vand, kakaomælk eller modermælkerstatning).
English: c. Hand wash the syringe, plunger, and mixing cup and lid in warm water and dish soap.
Danish: c. Vask sprøjten, stemplet og blande-koppen i varmt postevand og opvaskemiddel.
English: d. Tap the syringe again to break up the bubbles so they are all at the tip (see Figure 9).
Danish: d. Bank på sprøjten igen for at bryde boblerne, så de alle er i spidsen (se figur 9).
English: Common Increased amylase, decreased free and total thyroxine
Danish: Forhøjet amylase, nedsat fri og totalthyroxin
English: Saquinavir/ritonavir should not be given together with rifampicin, due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three medicines are given together (see section 4.5).
Danish: Saquinavir/ritonavir bør ikke gives sammen med rifampicin på grund af risikoen for alvorlig levertoxicitet (viser sig ved forhøjede leveraminotransferaser), hvis de tre lægemidler gives sammen (se afsnit 4.5).
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 rhabdomyolyse, er kombinationen af disse lægemidler med ritovanir kontraindiceret (se pkt.
English: Norvir can pass into breast milk.
Danish: Norvir kan udskilles i brystmælken hos mennesker.
English: Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200mg once daily could be considered.
Danish: Kun når atazanavir med ritonavir administreres sammen med efavirenz, kan en dosisøgning af ritonavir til 200 mg en gang dagligt overvejes.
English: Across dose groups, ritonavir oral clearance (CL/F/m2) declined with age with median values of 9.0 L/h/m2 in children less than 3 months of age, 7.8 L/h/m2 in children between 3 and 6 months of age and 4.4 L/h/m2 in children between 6 and 24 months of age.
Danish: På tværs af dosisgrupper var oral clearance (CL/F/m2) af ritonavir faldt med alder med middelværdier på 9,0 l/t/m2 hos børn på under 3 måneder, 7,8 l/t/m2 hos børn på mellem 3 og 6 måneder og 4,4 l/t/m2 hos børn på mellem 6 og 24 måneder.
English: • if Norvir is used to boost the effects of certain other anti-HIV medicines the typical dose for adults is 1 to 2 tablets once or twice daily.
Danish: • Hvis Norvir bruges til at booste virkningen af visse andre anti-hiv-lægemidler, er den typiske dosis til voksne 1-2 tabletter én eller to gange dagligt.
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: Hvis du oplever uforklarlige eller fortsatte smerter eller ømhed i musklerne, 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: Paediatric dosage guidelines for Norvir powder for oral suspension (prepared as 100 mg/10 ml)*†
Danish: Pædiatrisk doseringsvejledning for Norvir pulver til oral suspension (tilberedt som 100 mg/ml)
English: Co-administration of tipranavir with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation including some fatalities.
Danish: Samtidig administratiuon af tipranavir og 200 mg ritonavir er blevet associeret med rapporterede tilfælde af klinisk hepatit og hepatisk dekompensation, herunder dødsfald.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug Oral anvendelse.
English: No interaction study is available with ritonavir only.
Danish: Der er ingen tilgængelige interaktionsstudier alene med ritonavir.
English: In patients who are already taking ritonavir when digoxin is introduced, digoxin should be introduced more gradually than usual.
Danish: For patienter, der allerede tager ritonavir, når behandling med digoxin påbegyndes, bør digoxin introduceres mere gradvist end normalt.
English: − simvastatin, lovastatin (used to lower blood cholesterol);
Danish: − simvastatin, lovastatin (bruges til at sænke kolesterol i blodet);
English: So it is important that you carefully read the side effects section of the leaflets that are provided with these other medicines.
Danish: Det er vigtigt at læse afsnittet om bivirkninger omhyggeligt i de indlægssedler, der er vedlagt de andre lægemidler.
English: − Kidney (renal) disease, since your doctor may need to check the dose of your other medicines (such as protease inhibitors).
Danish: − nyresygdom, da det kan være nødvendigt for din læge at tjekke dosis af den anden medicin (såsom proteasehæmmere).
English: Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis (see section 4.4).
Danish: Patienter med avanceret hiv-sygdom kan have en risiko for forhøjede triglycerid værdier og pankreatit (se afsnit 4.4).
English: Hydroxypropyl cellulose Talc
Danish: Hydroxypropylcellulose Talcum
English: b. Slowly push the plunger to give all of the dose (see Figure 11).
Danish: b. Skub langsomt stemplet i bund for at indgive hele dosis (se figur 11).
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/µl viste et fald i dødeligheden og AIDS definerende begivenheder.
English: HCV Protease Inhibitor
Danish: HCV-proteasehæmmer
English: Before mixing a dose of Norvir, collect the items shown in Figure 1.
Danish: Før blanding af en dosis Norvir, findes følgende ting frem vist på figur 1.
English: This medicinal product does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav vedrørende temperaturer for for dette lægemiddel.
English: Astemizole, terfenadine Increased plasma concentrations of astemizole and terfenadine.
Danish: Astemizol, terfenadin Forhøjede plasmakoncentrationer af astemizol og terfanadin.
English: Common Hepatitis (including increased AST, ALT, GGT), blood bilirubin increased (including jaundice)
Danish: Hepatitis (inklusive øget AST, ALT, GGT), øget bilirubin i blodet (inklusive gulsot)
English: Contents of the pack and other information What Norvir contains
Danish: Pakningsstørrelser og yderligere oplysninger Norvir indeholder:
English: In addition to the interactions listed above, as ritonavir is highly protein bound, the possibility of increased therapeutic and toxic effects due to protein binding displacement of concomitant medicinal products should be considered.
Danish: Ud over de ovenfor anførte interaktioner bør der, da ritonavir i høj grad er proteinbundet, tages højde for en mulig øget terapeutisk virkning og toksisk virkning på grund af ændret proteinbinding af samtidigt indgivne lægemidler.
English: Dose alteration of sulfamethoxazole/trimethoprim during concomitant ritonavir therapy should not be necessary.
Danish: Dosisændring af sulfamethoxazol/trimethoprim under samtidig behandling med ritonavir skulle ikke være nødvendig.
English: Hepatic transaminase elevations exceeding five times the upper limit or normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretrovirals.
Danish: Stigning i hepatiske aminotransferaser udover 5 gange den øvre normalgrænse, klinisk hepatit og gulsot er set hos patienter som fik Norvir alene eller i kombination med andre retrovirale medikamenter.
English: Smoke cessation
Danish: Rygeophør
English: Store in the original bottle in order to protect from moisture.
Danish: Opbevares i den original flaske for at beskytte mod fugt.
English: − Trazodone (a medicine for depression) as, unwanted effects like nausea, dizziness, low blood pressure and fainting can occur when taken with Norvir.
Danish: − Trazodon (et lægemiddel mod depression), da uønskede bivirkninger såsom kvalme, svimmelhed, lavt blodtryk og besvimelse kan forekomme, når det tages sammen med Norvir.
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 en farmakokinetisk forstærker.
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 centralstimulende virkning.
English: − anti-tuberculosis medicine (bedaquiline and delamanid);
Danish: − lægemiddel mod tuberkulose (bedaquilin og delamanid);
English: One patient in clinical trials took ritonavir 1500 mg/day for two days and reported paraesthesia, which resolved after the dose was decreased.
Danish: I et klinisk studie tog en patient ritonavir i en dosis på 1500 mg/dag i to dage og meldte om paræstesi, der svandt efter at dosis blev sat ned.