FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of pharmacokinetic studies in patients with stable severe hepatic impairment (Child Pugh Grade C) without decompensation, caution should be exercised when ritonavir is used as a pharmacokinetic enhancer as increased levels of the co-administered PI may occur.
Danish: Da der ikke er gennemført farmakokinetiske studier på patienter med stabil alvorligt nedsat leverfunktion (Child-Pugh klasse C) uden dekompensation, bør der udvises forsigtighed, når ritovanir anvendes som en farmakokinetisk forstærker, da forhøjede niveauer af den proteasehæmmer, der gives sammen med ritonavir, kan forekomme.
English: The safety and efficacy of Norvir in children aged below 2 years has not been established.
Danish: Norvirs sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: − quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
Danish: − quetiapin (bruges til behandling af skizofreni, bipolær lidelse (manio-depressiv lidelse)
English: After you have finished a. Place the empty sachet and any left over medicine from the mixing cup into a rubbish bag.
Danish: Når du har afsluttet a. Smid det tomme brev og overskydende medicin i blande-koppen ud.
English: Induction of CYP1A2 and CYP2C9 lead to decreased levels of Rwarfarin while little pharmacokinetic effect is noted on S- warfarin when co-administered with ritonavir.
Danish: Induktion af CYP1A2 og CYP2C9 giver lavere koncentrationer af R-warfarin, mens der kun er registreret en lille farmakokinetisk virkning i forbindelse med S-warfarin ved samtidig indgift med ritonavir.
English: Common Decreased white blood cells, decreased haemoglobin, decreased neutrophils, increased eosinophils, thrombocytopenia
Danish: Nedsat antal leukocytter, nedsat hæmoglobin, nedsat antal neutrofile celler, forhøjet antal eosinofile celler, trombocytopeni
English: − 1 bottle of 30 tablets
Danish: − 1 beholder med 30 tabletter
English: In an open label trial completed in 1998 in HIV infected, clinically stable children there was a significant difference (p = 0.03) in the detectable RNA levels in favour of a triple regimen (ritonavir, zidovudine and lamivudine) following 48 weeks treatment.
Danish: I et åbent studie afsluttet i 1998 med hiv-smittede, klinisk stabile børn ses en signifikant forskel (p=0,03) i de påviselige RNA-niveauer efter en 48 ugers triple-behandling (ritonavir + zidovudine + lamivudine).
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 delamanidmetabolitten, hvilket er sat i forbindelse med QTc-forlængelse.
English: Delavirdine 400 q8h
Danish: Delavirdin 400 mg hver 8. time
English: Animal studies do not indicate harmful effects of ritonavir on fertility (see section 5.3).
Danish: Dyrestudier indikerer ikke, at ritonavir har skadelige virkninger på fertiliteten (se pkt.
English: − lomitapide (used to lower blood cholesterol);
Danish: − lomitapid (bruges til at sænke kolesterol i blodet);
English: If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Danish: Hvis behandling med en HMG-CoA-reductasehæmmer er indiceret, anbefales pravastatin eller fluvastatin.
English: Administration of a single 100 mg dose of Norvir tablet with a moderate fat meal (857 kcal, 31% calories from fat) or a high fat meal (907 kcal, 52% calories from fat) was associated with a mean decrease of 20-23% in ritonavir AUC and Cmax.
Danish: Administration af en enkelt 100 mg Norvir-tablet med et moderat fedt måltid (857 kcal, 31% kalorier fra fedt) eller et fedtrigt måltid (907 kcal, 52% kalorier fra fedt) blev sat i forbindelse med et gennemsnitlig fald på 20-23% i ritonavir AUC og Cmax.
English: c. Slowly pull the plunger back to the 10 ml mark - try not to pull any bubbles into the syringe (see Figure 8).
Danish: b. Anbring sprøjtens spids i bunden af blande-koppen c. Træk langsomt stemplet tilbage til 10 ml mærket - forsøg ikke at trække nogen bobler ind i sprøjten (se figur 8).
English: The degree of enhancement is related to the metabolic pathway of the co-administered protease inhibitor and the impact of the co-administered protease inhibitor on the metabolism of ritonavir.
Danish: Graden af den forstærkende virkning er relateret til den metaboliske pathway for den samtidigt indgivne proteasehæmmer og dennes indvirkning på ritonavirs metabolisme.
English: Norvir should be started at 250 mg/m² and increased at 2 to 3 day intervals by 50 mg/m² twice daily (please refer to the Norvir 100 mg powder for oral suspension Summary of Product Characteristics).
Danish: Norvir bør påbegyndes med 250 mg/m2 og øges med 2 til 3 dages mellemrum med 50 mg/m2 to gange dagligt (der henvises til produktresume for Norvir 100 mg pulver til oral suspension).
English: Maximal inhibition of metabolism of the co-administered protease inhibitor is generally achieved with ritonavir doses of 100 mg daily to 200 mg twice daily, and is dependent on the co-administered protease inhibitor.
Danish: Maksimal hæmning af den samtidigt indgivne proteasehæmmers metabolisme opnås generelt med doser af ritonavir på mellem 100 mg dagligt og 200 mg to gange dagligt og afhænger af den samtidigt indgivne proteasehæmmer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING NORVIR FILM-COATED TABLETS - Multipack containing 90 (3 bottles of 30) film-coated tablets with blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE NORVIR FILMOVERTRUKNE TABLETTER Multipakning som indeholder 90 (3 beholdere a 30) filmovertrukne tabletter med blue box
English: However, clinical trials revealed no evidence of medicinal product-induced ocular changes in humans.
Danish: Kliniske undersøgelser viste imidlertid ingen klinisk betydningsfulde øjenforandringer hos mennesker på grund af medikamentet.
English: b. Point the syringe into the mixing cup and slowly push the plunger to the correct ml for the dose (see Figure 10).
Danish: b. Anbring sprøjten i blande-koppen og skub langsomt stemplet nøjagtigt til ml for dosen (se figur 10).
English: Regular blood tests may be required to check your liver is working properly.
Danish: Det kan være nødvendigt at kontrollere din leverfunktion ved regelmæssige blodprøver.
English: • if your doctor prescribes a full dose, adults may be started on a dose of 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 6 tablets twice daily (totaling 1,200mg per day).
Danish: • Hvis din læge ordinerer en fuld dosis, kan voksne patienter begynde med en dosis på 3 tabletter om morgenen og 3 tabletter 12 timer senere, hvilket gradvist øges i en periode på højst 14 dage til den fulde dosis på 6 tabletter to gange dagligt (totalt 1.200 mg pr. dag).
English: Very common Pruritus, rash (including erythematous and maculopapular)
Danish: Meget almindelig Pruritus, udslæt (inklusive erytematøst og makulopapuløst)
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 kreatininclearance på 30 til 60 ml/min.
English: b. Check for any lumps of powder.
Danish: b. Kontrollér pulveret for eventuelle klumper.
English: • if your doctor prescribes a full dose, adults may be started on a dose of 3 sachets in the morning and 3 sachets 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 6 sachets twice daily.
Danish: • Hvis din læge ordinerer en fuld dosis, kan voksne patienter begynde med en dosis på 3 breve om morgenen og 3 breve 12 timer senere, hvilket gradvist øges i en periode på højst 14 dage til den fulde dosis på 6 breve to gange dagligt.
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 et antiretroviralt stof til patienter med inkompenseret leversygdom.
English: 200 q8h ↑ 77%
Danish: 200 mg hver 8. time ↑ 77%
English: Rare reports of 2nd or 3rd degree atrioventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving medicinal products known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving ritonavir.
Danish: Der rapporteret om sjældne tilfælde af 2. eller 3. grads atroventrikulær blok i forbindelse med lopinavir/ritonavir-behandling hos patienter med underliggende strukturel hjertesygdom og eksisterende overledningsforstyrrelser samt hos patienter, der får lægemidler, der er kendt for at forlænge PR-intervallet (sådan som verapamil eller atazanavir).
English: - Erectile dysfunction, as the medicines used to treat erectile dysfunction can cause hypotension and prolonged erection.
Danish: − rejsningsbesvær, da medicin, der bruges mod dette, kan forårsage hypotension og forlænget erektion.
English: SPECIAL STORAGE CONDITIONS Store in the original bottle in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale beholder for at beskytte mod fugt.
English: All thyroid changes were reversible upon discontinuation of ritonavir.
Danish: Alle thyreoideaforandringer var reversible efter ophør med indtagelse af medikamentet.
English: In a study completed in 2000, 76 HIV-1 infected children aged 6 months to 12 years who were protease inhibitor naive and naive to lamivudine and/or stavudine received ritonavir 350 or 450 mg/m2 every 12 hours co-administered with lamivudine and stavudine.
Danish: I et studie afsluttet i 2000 fik 76 hiv-1 inficerede børn i alderen fra 6 måneder til 12 år, som var proteasehæmmer-naive og naive overfor lamivudin og/eller stavudin, ritonavir 350 eller 450 mg/m2 hver 12. time indgivet sammen med lamivudin og stavudin.
English: 438 mg (43.8 ml) twice daily
Danish: 438 mg (43,8 ml) to gange dagligt
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Danish: Den inducerende effekt kan bestå i mindst 2 uger efter seponeringen af behandlingen med perikon (se afsnit 4.3).
English: Do not use Norvir powder for oral suspension after the expiry date on the sachet and carton.
Danish: Brug ikke Norvir pulver til oral suspension efter den udløbsdato, der står på flasken.
English: − If Norvir is taken in combination with other antiretroviral medicines, it is important that you also carefully read the leaflets that are provided with these other medicines.
Danish: − Hvis Norvir tages i kombination med anden antiretroviral medicin, er det vigtigt, at du også omhyggeligt læser de indlægssedler, som følger med den anden medicin.
English: − 1 bottle of 60 tablets
Danish: − 1 beholder med 60 tabletter
English: In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations.
Danish: In vitro og in vivo undersøgelser har vist, at ritonavir i betydelig grad hæmmer CYP3A- og CYP2D6medierede biotransformationer.
English: Common Hypersensitivity, including urticaria and face oedema.
Danish: Overfølsomhed inklusive urticaria og ansigtsødem
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 dagligt dosering hos ART-erfarne patienter.
English: Serum concentrations of ibrutinib may be increased due to CYP3A inhibition by ritonavir, resulting in increased risk for toxicity including risk of tumor lysis syndrome.
Danish: Serumkoncentrationen af ibrutinib kan øges på grund af ritonavirs hæmning af CYP3A, hvilket resulterer i øget risiko for toksicitet inklusiv risiko for tumorlysesyndrom.
English: You must not take Norvir with sildenafil if you suffer from pulmonary arterial hypertension (see also section 2.
Danish: Du må ikke tage Norvir, hvis du tager sildenafil mod forhøjet tryk i lungernes blodkar (pulmonal hypertension) (se også punkt 2.
English: nortriptyline, paroxetine, sertraline, trazodone);
Danish: nortriptylin, paroxetin, sertralin, trazodon);
English: Serum concentrations may be increased when co-administered with ritonavir which may increase the risk of toxicity, including the risk of serious adverse events such as QT interval prolongation.
Danish: Serumkoncentrationen kan øges ved samtidig administration med ritonavir, hvilket kan øge risikoen for toksicitet inklusive risikoen for alvorlige bivirkninger, såsom forlænget QT-interval.
English: Increased risk of tumor lysis syndrome at the dose initiation and during the dose-titration phase (see section 4.5).
Danish: Øget risiko for tumorlysesyndrom ved dosisinitiering og under dosistitreringsfasen (se pkt.
English: − ranolazine (used to treat chronic chest pain [angina]);
Danish: − ranolazin (bruges til behandling af kronisk smerte i brystet [angina]);
English: − Hormonal contraceptives containing ethinyl oestradiol as Norvir may reduce the effectiveness of these medicines.
Danish: − Hormonelle præventionsmidler, som indeholder ethinylestradiol, da Norvir kan mindske disse lægemidlers virkning.
English: Recommendations regarding use of ritonavir dosed as a pharmacokinetic enhancer with rifabutin are noted in section 4.5.
Danish: Anbefalinger vedrørende anvendelse af ritonavir doseret som en farmakokinetisk forstærker i kombination med rifabutin er angivet i pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, herunder lægemidler uden recept.
English: Common Increased urination, renal impairment (e.g. oliguria, elevated creatinine)
Danish: Øget vandladning, nedsat nyrefunktion (f.eks. oliguri, forhøjet kreatinin)
English: Ritonavir steady-state pharmacokinetic parameters were evaluated in HIV infected children less than 2 years of age receiving doses ranging from 350 to 450 mg/m² twice daily.
Danish: Ritonavirs steady-state farmakokinetiske parametre blev undersøgt hos hiv-inficerede børn under 2 år, som fik doser fra 350 til 450 mg/m² to gange dagligt.
English: Didanosine As ritonavir is recommended to be taken with food and didanosine should be taken on an empty stomach, dosing should be separated by 2.5 h. Dose alterations should not be necessary.
Danish: Da det anbefales, at ritonavir indtages sammen med et måltid, og didanosin bør indtages på tom mave, bør intervallet mellem doseringerne være 2,5 time.
English: The Summary of Product Characteristics of the co-administered protease inhibitor should be consulted for specific recommendations.
Danish: Produktresuméet for den samtidigt indgivne proteasehæmmer bør konsulteres med hensyn til konkrete anbefalinger.
English: Give the medicine to the patient a. Place the syringe tip against the inside of the patient's cheek.
Danish: Trin 10. Såden gives medicinen til patienten a. Anbring sprøjtens spids mod indersiden af patientens kind.
English: Dasatinib, nilotinib, vincristine, vinblastine Serum concentrations may be increased when co-administered with ritonavir resulting in the potential for increased incidence of adverse events.
Danish: Dasatinib, nilotinib, vincristin, vinblastin Ved samtidig administration med ritonavir kan serumkoncentrationerne øges, hvilket resulterer i en potentiel øget forekomst af bivirkninger.
English: − immune system (e.g. cyclosporine, tacrolimus, everolimus);
Danish: − lægemidler med indvirkning på immunsystemet (f.eks. ciclosporin, tacrolimus, everolimus);
English: c. Slowly pull the plunger back to the 10 ml mark on the syringe (see Figure 2).
Danish: c. Træk langsomt stemplet op til mærket ved 10 ml på sprøjten (se figur 2).
English: − epilepsy medicines (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
Danish: − lægemidler mod epilepsi (f.eks. carbamazepin, divalproex, lamotrigin, phenytoin);
English: Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases.
Danish: Ritonavir oralt aktivt, peptidomimetisk stof, der hæmmer hiv-1 og hiv-2 aspartyl protease.
English: Store below 30°C.
Danish: Opbevares ved temparaturer under 30°C.
English: b. Slowly push the plunger up until the top of the plunger is at 9.4 ml - this will remove any bubbles from the syringe (see Figure 4).
Danish: Afmåling af væsken a. Hold sprøjten pegende op. b. Pres langsomt stemplet opad indtil toppen af stemplet er ved 9,4 ml - det vil fjerne eventuelle bobler fra sprøjten (se figur 4).
English: Amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline
Danish: Amitriptylin, fluoxetin, imipramin, nortriptylin, paroxetin, sertralin
English: Developmental toxicity observed in rats (embryolethality, decreased foetal body weight and ossification delays and visceral changes, including delayed testicular descent) occurred mainly at a maternally toxic dosage.
Danish: Toksisk påvirkning af rotters udvikling (fosterdødelighed, nedsat fostervægt, forsinket knogledannelse og ændringer i de indre organer, herunder forsinket testis retention) fandtes hovedsaglig ved en maternelt toksisk dosis.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate (DF) in clinical practice (see section 4.8).
Danish: Der er rapporteret om nyresvigt, nedsat nyrefunktion, forhøjet kreatinin, hypofosfatæmi og påvirkning af proksimale tubuli (inklusive Fanconi syndrom) ved klinisk brug af tenofovirdisoproxilfumarat (DF) (se pkt.
English: Empty the syringe a. Slowly push the plunger to empty the liquid from the syringe into the mixing cup (see Figure
Danish: Tømning af sprøjten a. Pres langsomt på stemplet for at tømme væsken fra sprøjten ned i blande-koppen (se figur 5).
English: Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Samtidig indgift af ritonavir doseret som et antiretroviralt stof eller som en farmakokinetisk forstærker og disse glukokortikoider anbefales derfor ikke, medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider (se pkt.
English: Fosamprenavir 700 q12h
Danish: Fosamprenavir 700 mg hver 12. time
English: The co-administration of riociguat with Norvir is not recommended (see section 4.4 and refer to riociguat SmPC).
Danish: Samtidig administration af riociguat og Norvir anbefales ikke (se pkt.4.4 og produktresuméet for riociguat).
English: − antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g.
Danish: − antivirale midler som bruges til at behandle kronisk hepatitis C-virus-infektion hos voksne
English: Administration with a high fat meal (917 kcal, 60% calories from fat) was associated with a mean decrease of 32 and 49% in ritonavir AUCinf and Cmax respectively, relative to fasting conditions.
Danish: Administration med et meget fedtrigt måltid (917 kcal, 60% kalorier fra fedt) var forbundet med et gennemsnitlig fald på henholdsvis 32 og 49% i ritonavirs AUCinf og Cmax, forbundet med en fastende tilstand.
English: A higher frequency of adverse reactions (e.g., dizziness, nausea, paraesthesia) and laboratory abnormalities (elevated liver enzymes) have been observed when efavirenz is co-administered with ritonavir dosed as an antiretroviral agent.
Danish: En højere frekvens af bivirkninger (f.eks. svimmelhed, kvalme, paræstesi) og unormale laboratorieværdier (forhøjede leverenzymer) er observeret ved samtidig indgift af efavirenz og ritonavir doseret som et antiretroviralt stof.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING NORVIR POWDER FOR ORAL SUSPENSION - Carton containing 30 sachets each containing 100mg ritonavir
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE NORVIR PULVER TIL ORAL SUSPENSION - - Karton indeholdende 30 breve, som hver indeholder 100 mg ritonavir
English: You must not take Norvir with colchicine if you have kidney and/or liver problems (see also ‘Do not take Norvir' above).
Danish: Du må ikke tage Norvir sammen med colchicin, hvis du har problemer med nyre og/eller lever (se også
English: Raltegravir Co-adminsitration of ritonavir and raltegravir results in a minor reduction in raltegravir levels Zidovudine 200 q8h
Danish: Raltegravir Samtidig administration af ritonavir og raltegravir resulterer i en mindre reduktion i raltegravirkoncentrationen Zidovudin 200 mg hver 8. time
English: Due to reductions in ethinyl estradiol concentrations, barrier or other non-hormonal methods of contraception should be considered with concomitant ritonavir use when dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Danish: På grund af nedsættelse af ethinylestradiolkoncentrationerne bør barrieremetoder eller andre ikke-hormonelle antikonceptionsmidler overvejes ved samtidig anvendelse af ritonavir doseret som et antiretroviralt stof eller som en farmakokinetisk forstærker.
English: Norvir 100 mg powder for oral suspension
Danish: Norvir 100 mg pulver til oral suspension
English: Ritonavir steady-state pharmacokinetic parameters were evaluated in HIV infected children above 2 years of age receiving doses ranging from 250 mg/m² twice daily to 400 mg/m² twice daily.
Danish: Ritonavirs steady-state farmakokinetiske parametre er blevet undersøgt hos hiv-inficerede børn over 2 år, som fik doser fra 250 mg/m² to gange dagligt til 400 mg/m² to gange dagligt.
English: Co-administration of ibrutinib and ritonavir should be avoided.
Danish: Samtidig administration af ibrutinib og ritonavir bør undgås.
English: − Norvir is not a cure for HIV infection or AIDS.
Danish: − Norvir helbreder ikke hiv-infektion eller AIDS.
English: Multipack: 90 (3 bottles of 30) film-coated tablets
Danish: Multipakning: 90 tabletter (3 beholdere af 30) filmovertrukne tabletter
English: ↓ 25% ND
Danish: Zidovudin ↓ 25 % ND
English: Norvir 100 mg tablets
Danish: Norvir 100 mg tabletter
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, herunder lægemidler uden recept.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller ét eller flere af hjælpestofferne anført i pkt.
English: − Multipacks comprising 3 bottles each containing 30 film-coated tablets (90 tablets)
Danish: − Multipakning som består af 3 beholdere, som hver indeholder 30 filmovertrukne tabletter (90
English: In a study completed in 2003, 50 HIV-1 infected, protease inhibitor and lamivudine naïve children age 4 weeks to 2 years received ritonavir 350 or 450 mg/m2 every 12 hours co-administered with zidovudine 160 mg/m2 every 8 hours and lamivudine 4 mg/kg every 12 hours.
Danish: I et studie afsluttet i 2003 fik 50 hiv-1-inficerede børn i alderen 4 uger til 2 år, der ikke tidligere havde fået proteasehæmmer og lamivudin, 350 eller 450 mg/m2 ritonavir hver 12. time sammen med 160 mg/m2 zidovudin hver 8. time og 4 mg/kg lamivudin hver 12. time.