FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Danish: De alvorligste er anført først: meget almindelig (> 1/10); almindelig (> 1/100 til < 1/10); ikke almindelig (>1/1.000 til < 1/100); sjælden (> 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The time to maximum concentration (Tmax) remained constant at approximately 4 hours with increasing dose.
Danish: Tiden til maksimumkoncentration (Tmax) forblev konstant på ca. 4 timer ved øget dosering.
English: These interactions are noted in the medicinal product interaction tables below.
Danish: Disse interaktioner er opført i lægemiddelinteraktionstabellen nedenfor.
English: Ritonavir Mylan should be taken every day to help control your HIV, no matter how much better you feel.
Danish: Du skal tage Ritonavir Mylan hver dag for at det kan medvirke til at kontrollere din hiv-infektion, uanset hvor meget bedre tilpas du føler dig.
English: In this instance, close clinical monitoring is warranted.
Danish: Tæt klinisk overvågning er berettiget.
English: if you have severe liver disease.
Danish: hvis du har en alvorlig leversygdom.
English: Some people had other illnesses or were taking other medicines.
Danish: Nogle patienter havde andre sygdomme og tog anden medicin.
English: There may be additional information in those leaflets about situations when ritonavir should be avoided.
Danish: Der kan være yderligere oplysninger i disse indlægssedler om situationer, hvor ritonavir bør undgås.
English: Talk to your doctor or pharmacist if you need five or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Danish: Tal med lægen eller apotekspersonalet, hvis du har brug for fem eller flere tabletter dagligt i en længere periode, især hvis du har fået at vide, at du skal følge en saltfattig (natriumfattig) diæt.
English: Patients with chronic diarrhoea or malabsorption
Danish: Patienter med kronisk diarré eller malabsorption
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Danish: Dato for første markedsføringstilladelse: 10 November 2017
English: Tissue distribution studies with
Danish: Vævsdistributionsstudier med
English: However, the AUC of the M-2 metabolite was approximately 3% of the AUC of parent compound.
Danish: AUC for M-2 metabolitten var imidlertid ca. 3 % af moderstoffets AUC.
English: • low blood pressure and feeling faint when getting up
Danish: • lavt blodtryk og svimmelhed, når man rejser sig
English: S-Warfarin R-Warfarin
Danish: Warfarin S-Warfarin R-Warfarin
English: This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 4,4 % af det anbefalede maksimale daglige indtag af natrium for en voksen.
English: A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester.
Danish: Et stort antal gravide kvinder (6.100 levendefødsler) var eksponeret for ritonavir under graviditet; 2.800 levendefødsler var eksponeret i det første trimester.
English: These data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.
Danish: Disse data indikerer ingen øget forekomst af medfødte misdannelser sammenlignet med forekomsten i populationsbaserede overvågningssystemer af medfødte misdannelser.
English: Response was similar in both dosing regimens and across patient age.
Danish: Der var stort set samme respons for begge dosisregimer og på tværs af patientaldre.
English: Ritonavir did not appear to increase the chance of developing birth defects compared to the general population.
Danish: Ritonavir synes ikke at øge risikoen for medfødte misdannelser sammenlignet med den generelle befolkning.
English: Events noted as having frequency not known were identified via post-marketing surveillance.
Danish: Bivirkninger, der er registreret med ikke kendt hyppighed, blev identificeret i forbindelse med overvågning efter markedsføring.
English: Your doctor may wish to reduce the steroid dose or monitor your side effects more closely.
Danish: Din læge vil muligvis reducere steroiddosen eller følge dine bivirkninger nøje.
English: Effects on the electrocardiogram
Danish: Effekt på elektrokardiogram
English: This is why you should tell your doctor if you are taking any medicines, including those you have bought yourself or herbal products, but it is especially important to mention these:
Danish: Det er grunden til, at du skal informere din læge, hvis du tager nogen form for lægemidler, herunder dem, du selv har købt, eller naturlægemidler, men det er især vigtigt, at du nævner følgende:
English: It is recommended that a condom or other non-hormonal method of contraception is used instead.
Danish: Det anbefales derfor i stedet at anvende kondom eller en anden ikke-hormonel præventionsform.
English: • damage to the nerves that can cause weakness and pain
Danish: • nerveskade, som kan give svaghed og smerte
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune sygdomme (en tilstand, der skyldes, at immunsystemet angriber sundt kropsvæv) også opstå efter, at du er begyndt at tage medicin til behandling af din hiv-infektion.
English: There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability have not been determined.
Danish: Der findes ingen parenteral formulering af ritonavir, og derfor er omfanget af absorption og den absolutte biotilgængelighed ikke målt.
English: Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Danish: Reduktion af ritonavirs antiretrovirale aktivitet er primært knyttet til proteasemutationerne V82A/F/T/S og I84V.
English: This increase is likely due to ritonavir and a more pronounced effect may be observed during prolonged co-administration.
Danish: Stigningen skyldes sandsynligvis ritonavir, og en mere udtalt effekt kan observeres under langvarig samtidig administration.
English: Your doctor will advise you on the dosage to be taken.
Danish: Din læge vil vejlede dig om den dosis, du skal tage.
English: When you travel or need to stay in the hospital, make sure you have enough Ritonavir Mylan to last until you can get a new supply.
Danish: Når du er på rejse eller skal indlægges på hospitalet, skal du sørge for at have tilstrækkeligt med Ritonavir Mylan, indtil du kan få en ny forsyning.
English: If this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations.
Danish: Hvis en sådan co-administration vurderes at være uundgåelig, henvises der til abemaciclib SmPC for anbefalinger om dosisjustering.
English: • thirst (dehydration)
Danish: • tørst (dehydrering)
English: Ritonavir was the first protease inhibitor (approved in 1996) for which efficacy was proven in a study with clinical endpoints.
Danish: Ritonavir var den første proteasehæmmer (godkendt i 1996), hvis virkning blev påvist i et studie med kliniske effektmål.
English: There is a large amount of information on the use of ritonavir (the active ingredient in Ritonavir Mylan) during pregnancy.
Danish: Der findes en stor mængde oplysninger om brugen af ritonavir (det aktive stof i Ritonavir Mylan) under graviditet.
English: Maximum PR interval was 252 msec and no second or third degree heart block was observed (see section 4.4).
Danish: Det maksimale PR-interval var 252 msek, og der blev ikke observeret nogen 2. eller 3.grads hjerteblokade (se pkt.
English: • low levels of blood platelets
Danish: • lavt antal blodplader i blodet
English: 4.1 Therapeutic indications
Danish: 4.1 Terapeutiske Indikationer
English: The AUC of the metabolite prednisolone increased by 37 and 28% after 4 and 14 days ritonavir, respectively.
Danish: AUC for metabolitten prednisolon steg med 37 og 28 % efter henholdsvis 4 og 14 dage med ritonavir.
English: You may need additional medicine to help your blood clot (factor VIII), in order to control any bleeding.
Danish: Du kan få brug for yderligere medicin til at hjælpe dit blod med at koagulere (faktor VIII) og kontrollere en eventuel blødning.
English: This should be particularly taken into account for those on a low sodium diet.
Danish: Der skal især tages højde for dette hos patienter, som er på saltfattig diæt.
English: These are listed earlier in section 2, under ‘Do not take Ritonavir Mylan'.
Danish: Disse lægemidler er anført tidligere under punkt 2 i afsnittet ‘Tag ikke Ritonavir Mylan'.
English: To avoid transmitting the infection, mothers with HIV must not breast-feed their babies.
Danish: For at undgå overførsel af hiv til spædbarnet må hiv-smittede mødre ikke amme deres børn.
English: Even if you feel better, do not stop taking Ritonavir Mylan without talking to your doctor.
Danish: Selv om du føler dig bedre tilpas, må du ikke holde op med at tage Ritonavir Mylan uden først at have talt med din læge.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C bør de relevante produktinformationer for disse lægemidler konsulteres.
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: Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending ritonavir treatment.
Danish: Thyreoideastimulerende hormon (TSH) bør monitoreres hos patienter, som behandles med levothyroxin i minimum den første måned efter start og/eller ophør af ritonavirbehandling.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværret leversygdom hos disse patienter, bør det derfor overvejes enten at afbryde eller seponere behandlingen.
English: Treatment of overdose with ritonavir should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med ritonavir bør bestå af generelle forholdsregler såsom overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Danish: En kausal relation formodes, men virkningsmekanismen ikke er blevet klarlagt.
English: * Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose) of ritonavir but a full dose of ritonavir must not be taken together with these two medicines.
Danish: * Din læge kan beslutte, at du kan tage rifabutin og/eller voriconazol sammen med en boosterdosis (lavere dosis) af ritonavir, men du må ikke tage en fuld dosis ritonavir sammen med disse to lægemidler.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV-infected patients.
Danish: Den officielle vejledning vedrørende den hensigtsmæssige behandling af tuberkulose hos hivinficerede patienter bør tages i betragtning.
English: Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Danish: Fortæl din læge, hvis du tager tadalafil mod pulmonal arteriel hypertension.
English: Hypromellose Titanium dioxide (E171) Macrogols
Danish: Filmovertræk Hypromellose Titandioxid (E171) Macrogoler
English: • abnormally heavy periods
Danish: • unormalt kraftige menstruationer
English: • if Ritonavir Mylan 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 Ritonavir Mylan bruges til at booste virkningen af visse andre anti-hiv-lægemidler, er den sædvanlige dosis til voksne 1-2 tabletter en eller to gange dagligt.
English: Always keep enough Ritonavir Mylan on hand so you don't run out.
Danish: Sørg altid for at have tilstrækkeligt med Ritonavir Mylan på lager, så du ikke løber tør.
English: The maximum daily dose of this product is equivalent to 53% of the WHO recommended maximum daily intake for sodium.
Danish: Den maksimale daglige dosis af dette produkt svarer til 53 % af WHO's anbefalede maksimale daglige indtag af natrium.
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Danish: Der er rapporteret sager efter markedsføring, som indikerer en potentiel interaktion mellem produkter indeholdende ritonavir og levothyroxin.
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune sygdomme kan opstå flere måneder efter, at du er påbegyndt behandlingen.
English: Ritonavir penetrates minimally into the brain.
Danish: Ritonavir trænger minimalt igennem til hjernen.
English: Dose adjustment should be considered based on the patient's clinical response to methadone therapy.
Danish: Dosisjustering bør overvejes på baggrund af patientens kliniske respons på methadonbehandlingen.
English: The effect of ritonavir on rifampicin is not known.
Danish: Ritonavirs virkning på rifampicin kendes ikke.
English: The following adverse reactions of moderate to severe intensity with possible or probable relationship to ritonavir have been reported.
Danish: Følgende bivirkninger af moderat til svær grad med en mulig eller sandsynlig relation til ritonavir er blevet rapporteret.
English: No subject experienced an increase in QTcF of ≥ 60 msec from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 msec.
Danish: Ingen af forsøgspersonerne oplevede en stigning i QTcF på  60 msek fra baseline eller et QTcF-interval, som oversteg den potentielt kliniske relevante grænse på 500 msek.
English: Clozapine, pimozide
Danish: Clozapin, pimozid
English: Some patients taking a number of antiretroviral medicines may develop this disease.
Danish: Nogle patienter, som tager flere antiretrovirale lægemidler samtidigt, kan udvikle denne sygdom.
English: The isopropylthiazole oxidation metabolite (M-2) is the major metabolite and has antiviral activity similar to that of parent compound.
Danish: Isopropylthiazol oxidationsmetabolitten (M-2) er den vigtigste metabolit og har en antiviral aktivitet, der ligner moderstoffets.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, når du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral behandling.
English: • increase in triglycerides
Danish: • forhøjede triglycerider
English: Upon multiple dosing, ritonavir accumulation is slightly less than predicted from a single dose due to a time and dose-related increase in apparent clearance (Cl/F).
Danish: Ved flergangsdosering er ritonavir-akkumuleringen en smule mindre end forventet ud fra en enkelt dosis på grund af en tids- og dosisafhængig øgning i den tilsyneladende clearance (Cl/F).
English: The protein binding of ritonavir in human plasma is approximately 98 - 99% and is constant over the concentration range of 1.0 - 100 μg/ml.
Danish: Ritonavirs binding til humane plasmaproteiner er ca. 98-99 % og er konstant inden for koncentrationsområdet 1,0 - 100 g/ml.
English: Based on comparison to historical data, the pharmacokinetics of delavirdine did not appear to be affected by ritonavir.
Danish: På baggrund af en sammenligning med historiske data synes delavirdins farmakokinetik ikke at være påvirket af ritonavir.
English: Some patients taking ritonavir may experience changes in the electrocardiogram (ECG).
Danish: Nogle patienter, som tager ritonavir kan opleve ændringer i elektrokardiogram (ekg).
English: The mechanism of this interaction is not clear, but may be the result of transporter inhibition.
Danish: Mekanismen bag denne interaktion er ikke klarlagt men kan være resultatet af transporterhæmning.
English: Erythromycin, itraconazole
Danish: Erythromycin, itraconazol
English: This medicinal product contains 87.75 mg sodium per tablet, equivalent to 4.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 87,75 mg natrium pr. tablet, svarende til 4,4 % af WHO's anbefalede maksimale daglige indtag på 2 g natrium for en voksen.
English: This medicine contains 87.75 mg of sodium in each tablet.
Danish: Denne medicin indeholder 87,75 mg natrium i hver tablet.
English: Long term carcinogenicity studies of ritonavir in mice and rats revealed tumourigenic potential specific for these species, but are regarded as of no relevance for humans.
Danish: Langtidsundersøgelser af karcinogenicitet i mus og rotter har vist et tumorgent potentiale hos disse arter, som ikke anses at være relevant for mennesker.
English: Weight and metabolic parameters:
Danish: Vægt og metaboliske parametre
English: Paediatric populations The safety profile of ritonavir in children 2 years of age and older is similar to that seen in adults.
Danish: Pædiatrisk population Ritonavirs sikkerhedsprofil hos børn i alderen 2 år og ældre svarer til den, der ses hos voksne.
English: If you have any further questions about Ritonavir Mylan (ritonavir) or the other medicines prescribed, please ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål om Ritonavir Mylan (ritonavir) eller den anden ordinerede medicin, skal du spørge din læge eller apotekspersonalet.
English: It is believed that this happens because the body's immune response improves and helps the body to fight these infections.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som således hjælper kroppen med at bekæmpe infektionerne.
English: No clinically significant differences in AUC or Cmax were noted between males and females.
Danish: Der blev ikke konstateret nogen klinisk betydningsfuld forskel i AUC eller Cmax mellem mænd og kvinder.
English: The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients.
Danish: Stigninger i buprenorphins og dens aktive metabolits plasmaniveauer førte ikke til klinisk signifikante farmakodynamiske ændringer hos en gruppe af opioid-tolerante patienter.
English: • a tingling sensation or numbness in the hands, feet or around the lips and mouth
Danish: • en prikkende eller sovende fornemmelse i hænder, fødder eller omkring læberne og munden
English: Ritonavir can be used during pregnancy if clinically needed.
Danish: Anvendelsen af ritonavir kan overvejes under graviditet, hvis det er klinisk indiceret.
English: Renal clearance averaged less than 0.1 l/h and was relatively constant throughout the dosage range.
Danish: Den renale clearance udgjorde i gennemsnit mindre end 0,1 l/t og var relativt konstant i doseringsintervallet.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may be required over a longer period.
Danish: Endvidere kan det i tilfælde af behandlingsophør med glukokortikoider være nødvendigt, at nedtrapning sker gradvist over en længere periode.
English: There are medicines that may not mix with ritonavir because their effects could increase or decrease when taken together.
Danish: Der er lægemidler, som helst ikke skal blandes med ritonavir, fordi deres virkning kan øges eller nedsættes, når de tages sammen.
English: Cmax (μg/ml) Ctrough (μg/ml) 0.08 ± 0.04 0.22
Danish: Cmax (g/ml) Ctrough (g/ml) 0,08  0.04
English: • inflammation of the liver and yellowing of skin or whites of the eyes
Danish: • inflammation i leveren og gulfarvning af huden eller det hvide i øjnene
English: Due to the risk of severe hepatotoxicity, saquinavir/ritonavir should not be given together with rifampicin.
Danish: På grund af risikoen for alvorlig levertoksicitet, bør saquinavir/ritonavir ikke gives sammen med rifampicin.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jiroveci pneumoni.
English: The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.
Danish: Stigningen i AUC og Cmax afhænger af tidspunktet for administration af ritonavir.
English: A case of renal failure with eosinophilia has been reported.
Danish: Et tilfælde af nyresvigt med eosinofili er rapporteret.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: Hvis du bemærker symptomer på infektion eller andre symptomer såsom muskelsvaghed, svaghed som starter i hænder og fødder og bevæger sig op gennem kroppen, hjertebanken, rysten eller hyperaktivitet, skal du omgående kontakte din læge for at få den nødvendige behandling.
English: Animal studies as well as in vitro experiments with human hepatic microsomes indicated that ritonavir primarily underwent oxidative metabolism.
Danish: Dyrestudier samt in vitro-studie med humane hepatiske mikrosomer har vist, at ritonavir hovedsagelig metaboliseres oxidativt.
English: Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn't know they had had them.
Danish: Hos nogle patienter med fremskreden hiv-infektion (AIDS), som påbegynder anti-hiv-behandling, kan der forekomme symptomer på infektioner, som de har haft på et tidligere tidspunkt, og som de måske ikke engang var klar over, at de havde haft.
English: The signs of toxicity observed in animals (mice and rats) included decreased activity, ataxia, dyspnoea and tremors.
Danish: Tegn på toksicitet, der blev observeret hos dyr (mus og rotter), omfattede nedsat aktivitet, ataksi, dyspnø og tremor.
English: Ritonavir-resistant isolates of HIV-1 have been selected in vitro and isolated from patients treated with therapeutic doses of ritonavir.
Danish: Ritonavir-resistente isolater af hiv-1 blev selekteret in vitro og isoleret fra patienter i behandling med terapeutiske doser af ritonavir.
English: • feeling weak/tired
Danish: • en følelse af svaghed/træthed
English: Stevens Johnson syndrome, toxic epidermal necrolysis (TEN)
Danish: Stevens-Johnsons syndrom, toksisk epidermal nekrolyse (TEN)
English: The dose and/or frequency of use of these medicines may need to be reduced to avoid hypotension and prolonged erection.
Danish: Det kan være nødvendigt at nedsætte dosis og/eller hyppigheden af brugen af disse lægemidler for at undgå lavt blodtryk og forlænget erektion.
English: Microsomal triglyceride transfer protein (MTTP) inhibitor
Danish: Mikrosomal triglyceridtransfersproteininhibitor (MTTP)
English: Dizziness is a known undesirable effect that should be taken into account when driving or using machinery.
Danish: Svimmelhed er en kendt bivirkning, som der skal tages hensyn til, når man kører bil eller motorcykel eller anvender maskiner.
English: After first opening, use within 100 days.
Danish: Skal anvendes inden for 100 dage efter første åbning.