FrancophonIA/ELRC3.0 huggingface dataset:
English: The following medicines are not recommended: - fluticasone (used to treat asthma) - atorvastatin (used to lower blood cholesterol) - salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD) - bosentan (used to treat pulmonary artery hypertension) - halofantrine or lumefantrine (used to treat malaria) - tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence)) - boceprevir and telaprevir (used to treat hepatitis C) - cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).
Danish: Det frarådes at anvende følgende medicin: - fluticason (medicin mod astma) - atorvastatin (kolesterolsænkende medicin) - salmeterol (medicin mod astma - vedligeholdelsesbehandling, forebyggende mod astmalignende anfald ved kronisk obstruktiv lungesygdom (KOL) - bosentan (medicin mod forhøjet blodtryk i lungernes blodkarsystem) - halofantrin eller lumefantrin (anvendes til behandling af malaria) - tolterodin (anvendes til behandling af overaktiv blære (herunder symptomer som hyppig vandladning, vandladningstrang eller ufrivillig vandladning))
English: Compared to the capsules, tipranavir exposure is higher when administering the same dose as oral solution.
Danish: Absorptionen af tipranavir er mindre fra kapsler end når den samme dosis gives, som oral opløsning.
English: The following medicines are not recommended: - fluticasone (used to treat asthma) - atorvastatin (used to lower blood cholesterol) - salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD)
Danish: Det frarådes at anvende følgende medicin: - fluticason (medicin mod astma) - atorvastatin (kolesterolsænkende medicin) - salmeterol (medicin mod astma - vedligeholdelsesbehandling, forebyggende mod astmalignende anfald ved kronisk obstruktiv lungesygdom (KOL) - bosentan (medicin mod forhøjet blodtryk i lungernes blodkarsystem) - halofantrin eller lumefantrin (anvendes til behandling af malaria)
English: Generally, it is not recommended to take Aptivus, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT).
Danish: Generelt frarådes det at tage Aptivus og ritonavir sammen med p-piller eller kvindelige kønshormoner.
English: An increase in gastric pH that may result from H2-receptor antagonist therapy is not expected to have an impact on tipranavir plasma concentrations.
Danish: Det anses ikke for betydende for tipranavir plasmakoncentrationen, at pH-værdien i maven øges grundet behandling med H2receptor antagonister.
English: The clinical relevance of this reduction in amprenavir concentrations has not been established.
Danish: Den kliniske relevans ved reduktionen af amprenavirkoncentrationen er ikke fastlagt.
English: Steady-state tipranavir/r Midazolam Cmax ↑ 3.7 fold Midazolam AUC ↑ 9.8 fold
Danish: Midazolam Cmax ↑ 3,7 gange Midazolam AUC ↑ 9,8 gange
English: Muscle disorders
Danish: Muskelsygdomme
English: Concomitant use of salmeterol and Aptivus, co-administered with low dose ritonavir, is not recommended (see section 4.5).
Danish: Salmeterol Samtidig administration af salmeterol og Aptivus plus lavdosis ritonavir anbefales ikke (se pkt.
English: Both of these factors may contribute to an increased risk of adverse reactions (type, frequency and/or severity).
Danish: Kompositionen af kapslerne adskiller sig fra den orale opløsning ved at have et bemærkelsesværdigt højt indhold af vitamin E. Disse faktorer kan forårsage en øget risiko for bivirkninger (type, hyppighed og/eller alvorlighed).
English: The clinical relevance of this reduction in lopinavir concentrations has not been established.
Danish: Den kliniske relevans ved reduktionen af loponavirkoncentrationen er ikke fastlagt.
English: These medicines are used to treat anxiety or sleep disorders - ergot derivatives (used to treat headaches) - astemizole or terfenadine (used to treat allergies or hay fever) - simvastatin or lovastatin (used to lower blood cholesterol) - amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart disorders) - metoprolol (used to treat heart failure) - alfuzosin and sildenafil (when used to treat a rare blood vessel disorder characterized by increased pressure in the pulmonary artery) - colchicine (when used to treat gout flares in patients with kidney or liver disease).
Danish: - hvis du i øjeblikket tager nedenstående medicin: - rifampicin (medicin mod tuberkulose) - cisaprid (medicin mod maveproblemer) - pimozid eller sertindol (medicin mod skizofreni) - quetiapin (medicin mod skizofreni, bipolar lidelse (manio-depressiv lidelse) og depression) - lurasidon (medicin mod skizofreni) - triazolam eller midazolam som tabletter (medicin mod mod angst eller søvnforstyrrelser) - sekalealkaloider (medicin mod hovedpine) - astemizol eller terfenadin (medicin mod allergi eller høfeber) - simvastin eller lovastatin (medicin mod forhøjet kolesteroltal) - amioradon, bepridil, flecainid, propafenon eller quinidin (medicin mod hjertesygdomme) - metoprolol (medicin til behandling af hjertesvigt) - alfuzosin (medicin til behandling af forstørret prostata inden operation) - sildenafil (medicin til behandling af en sjælden karsygdom kendetegnet ved forhøjet blodtryk i de kar, der fører blodet fra hjertet til lungerne) - colchicin (ved behandling af urinsyregigt hos patienter med nyre- eller leversygdom).
English: Liver impairment
Danish: Nedsat nyrefunktion
English: You should inform your child's doctor as soon as possible if you notice your child has the signs or symptoms of hepatitis: - fever - malaise (feeling generally unwell) - nausea (upset stomach) - vomiting - abdominal pain
Danish: Får dit barn nogle af nedenstående tegn eller symptomer på hepatitis, skal du hurtigst muligt kontakte din læge: - feber - utilpashed - kvalme - opkastning - smerte i maveregionen - træthed - gulsot (gulfarvning af huden og i øjnene).
English: The combined use of Aptivus with ritonavir with either omeprazole, esomeprazole or with other proton pump inhibitors is not recommended (see section 4.5).
Danish: Omeprazol og andre protonpumpehæmmere Kombinationen af Aptivus med ritonavir med enten omeprazol, esomeprazol eller andre protonpumpehæmmere kan ikke anbefales (se pkt.
English: Examples include: - rifabutin and clarithromycin (antibiotics) - theophylline (used to treat asthma) - desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for smoking cessation) - midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help you sleep - rosuvastatin or pravastatin (used to lower blood cholesterol) - colchicine (used to treat gout flares with normal kidney and liver function).
Danish: Dosis af nedenstående medicin kan blive forøget eller nedsat af din læge, når du er i behandling med Aptivus: - rifabutin og clarithromycin (antibiotika) - theophyllin (medicin mod astma) - desipramin, trazodon og bupropion (medicin mod depression; bupropion anvendes også som rygeafvæningsmiddel) - midazolam (givet som injektion); midazolam er en beroligende medicin mod uro og afhjælper søvnløshed - rosuvastatin eller pravastatin (anvendes til at sænke kolesterol i blodet) - colchicin (til behandling af urinsyregigt hos patiener med normal nyre- og leverfunktion).
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with astemizole or terfenadine is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Danish: Samtidig brug af Aptivus plus lavdosis ritonavir med astemizol eller terfenadin er kontraindiceret på grund af risiko for alvorlige og/eller livstruende bivirkninger (se pkt.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with cisapride is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Danish: Samtidig brug af Aptivus plus lavdosis ritonavir med cisaprid er kontraindiceret på grund af risiko for alvorlige og/eller livstruende bivirkninger (se pkt.
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of lopinavir is strongly encouraged (see section
Danish: Hvis kombinationen alligevel anses for nødvendig, anbefales det kraftigt at monitorere plasmakoncentrationerne for lopinavir (se pkt.
English: Before starting treatment, your doctor will have taken blood samples to test the resistance of your HIV.
Danish: Din læge tager derfor blodprøver, før behandlingen startes for at teste, om hiv i dit blod er resistent, og at Aptivus er egnet til behandling af dig.
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of amprenavir is strongly encouraged (see section
Danish: Hvis kombinationen alligevel anses for nødvendig, anbefales det kraftigt at monitorere plasmakoncentrationerne for amprenavir (se pkt.
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: Du skal straks informere din læge for at få den nødvendige behandling hvis du bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
English: Examples include: - rifabutin and clarithromycin (antibiotics) - theophylline (used to treat asthma) - desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for smoking cessation) - midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help your child sleep - rosuvastatin or pravastatin (used to lower blood cholesterol) - colchicine (used to treat gout flares with normal kidney and liver function).
Danish: Dosis af nedenstående medicin kan blive forøget eller nedsat af lægen, når dit barn er i behandling med Aptivus: - rifabutin og clarithromycin (antibiotika) - theophyllin (medicin mod astma) - desipramin, trazodon og bupropion (medicin mod depression; bupropion anvendes også som rygeafvæningsmiddel) - midazolam (givet som injektion); midazolam er en beroligende medicin mod uro og afhjælper søvnløshed - rosuvastatin eller pravastatin (anvendes til at sænke kolesterol i blodet) - colchicin (til behandling af urinsyregigt hos patiener med normal nyre- og leverfunktion).
English: Co-administration of tipranavir and low dose ritonavir with PDE5 inhibitors is expected to substantially increase PDE5 concentrations and may result in an increase in PDE5 inhibitorassociated adverse events including hypotension, visual changes and priapism.
Danish: Dette kan resultere i øget forekomst af bivirkninger relateret til PDE5hæmmere, herunder hypotension, synsændringer og priapisme.
English: Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (see sections 4.3, 4.4 and 5.2).
Danish: Aptivus er kontraindiceret til patienter med moderat eller svær leverinsufficiens (Child-Pugh B eller C) (se pkt.
English: Tipranavir is contraindicated in moderate or severe hepatic impairment (see sections 4.2 and 4.3).
Danish: Tipranavir er kontraindiceret ved moderat eller svær leverinsufficiens (se pkt.
English: Compared to the capsules, tipranavir exposure is higher when administering the same dose as oral solution (see section 5.2).
Danish: Tipranavir koncentrationen er højere efter indtagelse af Aptivus oral opløsning end efter indtagelse af samme dosis fra Aptivus kapsler (se pkt.
English: In in vitro studies, tipranavir was found to inhibit platelet aggregation when using human platelets (see section 4.4) and thromboxane A2 binding in an in vitro cell model at levels consistent with exposure observed in patients receiving Aptivus with ritonavir.
Danish: 4.4) og thromboxan A2-binding ved niveauer, der var konsistente med den eksponering, der er set hos patienter i behandling med Aptivus med ritonavir blev det observeret, at tipranavir hæmmer blodplade-aggregationen.
English: Package leaflet: Information for the user Aptivus 250 mg soft capsules tipranavir
Danish: Aptivus 250 mg bløde kapsler tipranavir
English: These factors lead to the conclusion that the benefits outweigh the risks of Aptivus oral solution only in children between 2 and 12 years of age without any other therapeutic option (see section 4.1).
Danish: Desuden, kan korrekt dosisjustering ikke opnås med kapselformuleringen hos patienter med en kropsoverflade på mindre end 1.33 m2. Herudfra konkluderes, at fordele ved brug af Aptivus oral opløsning hos børn 2-12 år opvejer de ricisi ved behandling, når ikke andre behandlingsmuligheder er tilstede (se pkt.
English: HIV-positive, paediatric patients, aged 2 through 18 years, were studied in a randomized, open-label, multicenter study (trial 1182.14).
Danish: I studie 1182.14, et åbent, randomiseret, multicenter studie blev hiv-positive, pædiatriske patienter i alderen fra 2 til 18 år undersøgt.
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 child's doctor immediately to seek necessary treatment.
Danish: Du skal straks informere dit barns læge for at få den nødvendige behandling, hvis du hos dit barn bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
English: When coadministered with ritonavir at the recommended dosage (see section 4.2) there is a net inhibition of P450 CYP3A.
Danish: 4.2) er der en netto hæmning af P450 CYP3A.
English: These belong to a class of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: - abacavir og zidovudin tilhører begge typen af hiv-medicin, der kaldes nukleosid reverstranskriptase-hæmmere (NRTI).
English: - If you have any further questions, please ask your doctor or your pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with triazolam is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Danish: Samtidig brug af Aptivus plus lavdosis ritonavir med triazolam er kontraindiceret på grund af risiko for alvorlige og/eller livstruende bivirkninger (se pkt.
English: Valaciclovir and Aptivus with low dose of ritonavir may be coadministered without dose adjustment.
Danish: Valaciclovir kan administreres uden dosisjustering samtidig med Aptivus plus lavdosis ritonavir.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase halofantrine and lumefantrine concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosisritonavir øger koncentrationerne af halofantrin og lumefantrin.
English: Clarithromycin 500 mg BID
Danish: Rifabutin 150 mg x 1
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase astemizole and terfenadine concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationerne af astemizol og terfenadin.
English: Taking Aptivus, with atazanavir, may cause the blood levels of Aptivus and ritonavir to increase a lot.
Danish: Plasmakoncentrationen af Aptivus og ritonavir stiger markant, når Aptivus og ritonavir tages med atazanavir.
English: A significant decrease in plasma concentrations of atazanavir and a marked increase of tipranavir and ritonavir concentrations was observed when Aptivus, associated with low dose ritonavir, was coadministered with atazanavir (see section 4.5).
Danish: Da Aptivus sammen med lavdosis ritonavir co-administreredes med atazanavir fandtes der et signifikant fald af atazanavirplasmakoncentrationen og en markant stigning af tipranavir- og ritonavirkoncentration (se pkt.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen inden du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Antispasmodic Tolterodine No interaction study performed
Danish: Spasmolytika Tolterodin Der er ikke udført interaktionsstudier.
English: General disorders and administration site conditions common fatigue uncommon pyrexia, influenza like illness, malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig træthed
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase tolterodine concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger koncentrationen af tolterodin.
English: In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3).
Danish: I rotter forøgedes blødningsrisikoen, når tipranavir og vitamin E administreres samtidig (se pkt.
English: If you miss a dose of Aptivus or ritonavir by more than 5 hours, wait and then take the next dose of Aptivus and ritonavir at the regularly scheduled time.
Danish: Overskrides doseringstidspunktet med mere end 5 timer, skal du vente med at tage en dosis til det næste planlagte doseringstidspunkt for Aptivus og ritonavir.
English: If a dose is missed by more than 5 hours, the patient should be instructed to wait and then to take the next dose of tipranavir and ritonavir at the regularly scheduled time.
Danish: Overskrides doseringstidspunktet med mere end 5 timer, bør patienten informeres om at vente til det næste planlagte doseringstidspunkt for Aptivus og ritonavir.
English: You should therefore carefully read the Package Leaflets of ritonavir and your other antiretroviral medicines.
Danish: Det er derfor vigtigt, at du også har kendskab til disse lægemidler, og du bør læse indlægssedlerne for både ritonavir og for de andre antiretrovirale midler, som du får.
English: Adults and adolescents (from 12 - 18 years of age) The recommended dose of Aptivus is 500 mg, co-administered with 200 mg ritonavir (low dose ritonavir), twice daily (see section 4.4 for precautionary measures in adolescents).
Danish: Den anbefalede dosis af Aptivus er 500 mg plus 200 mg ritonavir (lavdosis ritonavir) to gange dagligt (se pkt.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set, og kan forekomme i forbindelse med immunreaktiveringssyndrom.
English: Combination with Aptivus, coadministered with low dose ritonavir, is not recommended (see section 4.4)
Danish: En kombination af disse med Aptivus og lavdosis ritonavir anbefales ikke (se pkt.
English: What Aptivus is and what it is used for What you need to know before your child takes Aptivus How to take Aptivus
Danish: Det skal du vide, før dit barn begynder at tage Aptivus Sådan skal dit barn tage Aptivus Bivirkninger
English: could be expected.
Danish: Dette kan være dødeligt.
English: Protease inhibitors
Danish: Proteasehæmmere
English: In Phase III RESIST trials, the frequency of transaminase elevations was significantly increased in the tipranavir with ritonavir arm compared to the comparator arm. Close monitoring is therefore needed in patients treated with Aptivus, co-administered with low dose ritonavir (see section
Danish: I fase III RESIST-studierne var frekvensen af forhøjet aminotransferase signifikant forøget i tipranavir med ritonavir-gruppen sammenlignet med komparatorgruppen.
English: Zidovudine 300 mg BID (TPV/r 750/100 mg BID)
Danish: Zidovudin 300 mg x 2 (TPV/r 750/100 mg x 2)
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with atazanavir/ritonavir is not recommended.
Danish: Atazanavir/ritonavir anbefales ikke samtidig med Aptivus givet med lavdosis ritonavir.
English: In patients with normal renal and hepatic function, a reduction in colchicine dosage or an interruption of colchicine treatment is recommended in co-administration (see section 4.5).
Danish: Nedsat dosis af colchicin eller afbrydelse af colchicinbehandlingen anbefales ved samtidig administration af colchicin og Aptivus hos patienter med normal nyre- og leverfunktion (se pkt.
English: Pravastatin No interaction study performed
Danish: Pravastatin Der er ikke udført interaktionsstudier.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase triazolam concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationen af triazolam.
English: Emtricitabine No interaction study performed
Danish: Emtricitabin Der er ikke udført interaktionsstudier.
English: P-gp activity is significantly inhibited after the first dose,
Danish: Efter første dosis er P-gp-aktiviteten signifikant hæmmet, men der fantes en svag induktion ved steady state.
English: Pyrexia
Danish: Rilpivirin
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with saquinavir/ritonavir is not recommended.
Danish: Saquinavir/ritonavir anbefales ikke samtidig med Aptivus givet med lavdosis ritonavir.
English: Inhibition of CYP 3A4 and CYP 2D6 by tipranavir/r
Danish: Tipranavir/r hæmmer CYP3A4 og CYP2D6.
English: If your child misses a dose of Aptivus or ritonavir by more than 5 hours, wait and then give the next dose of Aptivus and ritonavir at the regularly scheduled time.
Danish: Overskrides doseringstidspunktet med mere end 5 timer, bør dit barn vente med at tage en dosis til det næste planlagte doseringstidspunkt for Aptivus og ritonavir.
English: Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1
Danish: Boehringer Ingelheim, Unipessoal, Lda Tel: +351 21 313 53 00
English: Herbal preparations containing St. John's wort must not be combined with Aptivus, co-administered with low dose ritonavir.
Danish: Naturlægemidler indeholdende perikon må ikke anvendes samtidig med Aptivus og lavdosis ritonavir.
English: recommended when coadministered with Aptivus/ritonavir.
Danish: Når Aptivus/ritonavir administreres
English: - Protease Inhibitors (PIs): Taking Aptivus may cause large decreases in the blood levels of other HIV protease inhibitors.
Danish: - proteasehæmmere (PI): Aptivus sænker i høj grad plasmakoncentrationen af hiv-proteasehæmmerne amprenavir, atazanavir, lopinavir og saquinavir.
English: At the age of 12 years, children treated with Aptivus should be switched from the oral solution to the capsules.
Danish: Dit barn skal blive ved med at tage Aptivus, lige så længe, som lægen anbefaler det. Ved 12 år bør børn i behandling med Aptivus oral opløsning skiftes over til Aptivus kapsler.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase cisapride concentrations.
Danish: Teoretisk forventes det, at tipranvir plus lavdosis ritonavir øger koncentrationen af bosentan.
English: active.
Danish: Aptivus.
English: Your child's doctor will only prescribe them abacavir and zidovudine if they are unable to take other NRTIs.
Danish: Dit barn vil kun få ordineret abacavir og zidovudin, hvis det ikke kan tåle andre NRTI-midler - didanosin: Hvis dit barn er i behandling med didanosin depottabletter, skal disse tages mindst 2
English: low dose ritonavir (this helps Aptivus to reach a high enough level in your blood) other HIV medicines.
Danish: - Lavdosis ritonavir (kombinationen er nødvendig, for at sikre optimal virkning af Aptivus i kroppen).
English: In case of acute crisis, it is recommended that the tablets are taken before meals.'
Danish: Ved akut krise anbefales det, at tabletterne tages før måltiderne."