FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein.
Danish: Docetaxel Teva er et koncentrat og en solvens, der blandes til en opløsning til infusion (dråbetilførsel) i en vene.
English: Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.
Danish: Behandling med Docetaxel Teva bør kun finde sted på en specialafdeling for kemoterapi (lægemidler mod kræft) under tilsyn af en læge med speciale i kemoterapi mod kræft.
English: Why has Docetaxel Teva been approved?
Danish: Hvorfor blev Docetaxel Teva godkendt?
English: The Committee recommended that Docetaxel Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Docetaxel Teva.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Danish: Docetaxel Teva anvendes sammen med cisplatin og 5-fluorouracil (andre lægemidler mod kræft).
English: Docetaxel Teva is an anticancer medicine.
Danish: Docetaxel Teva er et lægemiddel mod kræft.
English: What is Docetaxel Teva?
Danish: Hvad er Docetaxel Teva?
English: How has Docetaxel Teva been studied?
Danish: Hvordan blev Docetaxel Teva undersøgt?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion.
Danish: Dagen før infusionen med Docetaxel Teva gives patienten endvidere dexamethason (et antiinflammatorisk lægemiddel).
English: How is Docetaxel Teva used?
Danish: Hvordan anvendes Docetaxel Teva?
English: What is Docetaxel Teva used for?
Danish: Hvad anvendes Docetaxel Teva til?
English: How does Docetaxel Teva work?
Danish: Hvordan virker Docetaxel Teva?
English: • If you are over 65.
Danish: • Hvis De er over 65 år.
English: No antagonism was observed for any of these combinations.
Danish: Ingen antagonisme blev observeret for nogle af disse kombinationer.
English: Date of first authorisation: 24 May 2013 Date of latest renewal: 19 April 2018
Danish: Dato for første markedsføringstilladelse: 24. maj 2013 Dato for seneste fornyelse: 19. april 2018
English: Pregnant women should not take Stribild.
Danish: Gravide kvinder bør ikke tage Stribild.
English: Black/African American Asian
Danish: Sort/afroamerikaner Asiatisk
English: 3 These are drugs within class where similar interactions could be predicted.
Danish: 3 Disse er lægemidler i samme klasse, hvor lignende interaktioner kunne forudsiges.
English: Stribild reduces the amount of HIV in your body.
Danish: Stribild nedsætter mængden af hiv i Deres krop.
English: These are mentioned above under the heading “Do not take Stribild - If you are taking one of these medicines”.
Danish: Disse lægemidler er nævnt under overskriften ”Tag ikke Stribild - Hvis De tager et af disse lægemidler”
English: BMD Z-scores were not adjusted for height and weight.
Danish: BMD Z-scorer blev ikke justeret for højde og vægt.
English: • other allergic reactions
Danish: • andre allergiske reaktioner
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af de følgende bivirkninger er ikke kendt (hyppigheden kan ikke vurderes ud fra forhåndenværende data).
English: • Use effective contraception while taking Stribild.
Danish: • Anvend effektiv prævention, mens De tager Stribild.
English: b Week 144 window is between Day 967 and 1,050 (inclusive).
Danish: b Uge 144-vindue er fra dag 967 til 1.050 (inklusive).
English: ATC code: J05AR09
Danish: ATC-kode: J05AR09
English: Table 1: Interactions between the individual components of Stribild and other medicinal products
Danish: Tabel 1: Interaktion mellem Stribilds individuelle komponenter og andre lægemidler
English: 1 When data available from drug interaction studies.
Danish: 1 Når data er tilgængelige fra lægemiddelinteraktionsstudier.
English: • Tell your doctor immediately if you become pregnant, think you may be pregnant or are planning to have a baby.
Danish: • Fortæl det straks til lægen, hvis De bliver gravid, har mistanke om, at De er gravid eller planlægger at blive gravid.
English: Your doctor will carefully consider whether to treat you with Stribild.
Danish: Lægen vil omhyggeligt overveje, om De skal behandles med Stribild.
English: Insufficient safety data are available for children below 12 years of age.
Danish: Der foreligger utilstrækkelige sikkerhedsdata for børn under 12 år.
English: INR should continue to be monitored during the first weeks following ceasing treatment with Stribild.
Danish: INR bør stadig overvåges i løbet af de første uger efter behandlingen med Stribild stoppes.
English: It is especially important to talk to your doctor if you are taking any of the following:
Danish: Det er især vigtigt at tale med lægen, hvis De tager noget af det følgende:
English: It is recommended that digoxin levels be monitored when digoxin is combined with Stribild.
Danish: Det anbefales at overvåge digoxinniveauerne, når digoxin kombineres med Stribild.
English: No human data on the effect of Stribild on fertility are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af Stribild på fertilitet.
English: Stopping Stribild can seriously affect your response to future treatment.
Danish: Stribild, kan det i alvorlig grad påvirke Deres reaktion på fremtidig behandling.
English: a Patients were stratified by baseline HIV-1 RNA in both studies.
Danish: a Patienter blev stratificeret ved baseline hiv 1-rna i begge studier.
English: As a result, the amounts of Stribild or other medicines in your blood may be affected.
Danish: Som et resultat heraf kan mængden af Stribild eller anden medicin i Deres blod påvirkes.
English: Do not give this medicine to children under 12 years of age.
Danish: Denne medicin må ikke gives til børn under 12 år.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Stribild in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af Stribild til gravide kvinder.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Stribild or by other medicines that you are taking at the same time, or by the HIV disease itself.
Danish: Når hiv-infektion behandles, er det ikke altid muligt at afgøre, om nogle af de uønskede virkninger er forårsaget af Stribild eller af anden medicin, som De tager samtidigt, eller af selve hiv-sygdommen.
English: allergic reaction1
Danish: allergiske reaktioner1
English: What Stribild is and what it is used for Stribild contains four active substances:
Danish: Virkning og anvendelse Stribild indeholder fire aktive stoffer:
English: Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation.
Danish: Der anbefales derfor en tværfaglig tilgang for at sikre, at benefit/risk-forholdet ved behandlingen bliver afvejet på fyldestgørende vis fra sag til sag for at fastlægge den hensigtsmæssige monitorering under behandlingen (inklusive beslutning om seponering af behandlingen) og overveje behovet for tilskud.
English: There is no specific antidote for overdose with Stribild.
Danish: Der er ingen specifik antidot for overdosering med Stribild.
English: If this is unavoidable, your doctor will monitor your kidney function more frequently.
Danish: Hvis dette ikke kan undgås, vil Deres læge overvåge Deres nyrefunktion hyppigere.
English: Reductions in BMD have been reported in paediatric patients.
Danish: Der er rapporteret om reduktioner i BMD hos pædiatriske patienter.
English: Once you start taking Stribild, look out for:
Danish: Når De begynder med at tage Stribild, skal De holde øje med:
English: d Includes patients who discontinued due to adverse event or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Danish: d Omfatter patienter, som afbrød behandlingen som følge af en adverse event eller død på et tidspunkt fra dag 1 og i løbet af tidsvinduet, hvis dette ikke resulterede i virologiske data om behandlingen i løbet af det specificerede tidsvindue.
English: Missing data during window but on study drug a Week 48 window is between Day 309 and 378 (inclusive).
Danish: Manglende data i tidsvinduet, men får studiemedicin a Uge 48-vindue er fra dag 309 til 378 (inklusive).
English: 2 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: 2 Anæmi var almindelig og misfarvning af huden (øget pigmentering) meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.
English: It is recommended to separate Stribild and antacid administration by at least 4 hours.
Danish: Det anbefales at separere administrationen af Stribild og antacida med mindst 4 timer.
English: Eighteen of these 20 patients maintained virologic suppression through 48 weeks.
Danish: 18 ud af disse 20 patienter opretholdt virologisk suppression til og med 48 uger.
English: e Includes subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
Danish: e Omfatter personer, som afbrød behandlingen af andre årsager end en adverse event, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
English: For patients with ClCr < 60 mL/min, alternative antibacterials should be considered.
Danish: For patienter med ClCr < 60 ml/min bør alternative antibakterielle midler overvejes.
English: The interactions described are based on studies conducted with the components of Stribild as individual agents and/or in combination, or are potential drug interactions that may occur with Stribild.
Danish: De beskrevne interaktioner er baseret på studier udført med Stribild-komponenterne som individuelle stoffer og/eller i kombination, eller de er mulige lægemiddelinteraktioner, der kan forekomme med Stribild.
English: You must remain under the care of your doctor while taking Stribild.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Stribild.
English: Stribild is not to be given with other antiretroviral medicinal products.
Danish: Stribild må ikke gives sammen med andre antiretrovirale lægemidler.
English: Your doctor will also order blood tests during treatment to monitor your kidneys.
Danish: Deres læge vil også bestille blodprøver under behandlingen for at overvåge Deres nyrer.
English: Tenofovir disoproxil may cause a reduction in BMD.
Danish: Tenofovirdisoproxil kan forårsage en reduktion i BMD.
English: If you have HIV infection and hepatitis B, it is especially important not to stop your Stribild treatment without talking to your doctor first.
Danish: Hvis De har hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Stribild uden først at konsultere Deres læge.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: Stribild has limited data in patients over the age of 65 years.
Danish: Stribild har begrænsede data hos patienter over 65 år.
English: Other medicines and Stribild There are some medicines that should never be taken with Stribild.
Danish: Brug af anden medicin sammen med Stribild Der er nogle lægemidler, der aldrig bør tages sammen med Stribild.
English: An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Stribild.
Danish: En vurdering af forholdet mellem fordele og risici anbefales for at berettige anvendelsen af voriconazol sammen med Stribild.
English: Lactic acidosis occurs more often in women - particularly if they are overweight and in people with liver disease.
Danish: Laktatacidose forekommer hyppigere hos kvinder - især hvis de er overvægtige og hos personer med leversygdom.
English: However increased postimplantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Danish: Der blev imidlertid observeret øget postimplantationstab og nedsat fødselsvægt hos rotter, forbundet med signifikante reduktioner i moderens kropsvægt ved 125 mg/kg/dag.
English: No additional proximal renal tubular dysfunction cases were reported from Week 48 to Week 144.
Danish: Ingen yderligere tilfælde med dysfunktion af de proksimale renale tubuli blev rapporteret fra uge 48 til uge 144.
English: See also under Co-administration of other medicinal products below.
Danish: Se også afsnittet Samtidig administration af andre lægemidler nedenfor.
English: While taking Stribild you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Stribild, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: Stribild has no or negligible influence on the ability to drive and use machines.
Danish: Stribild påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: However, patients should be informed that dizziness, fatigue and insomnia have been reported during treatment with Stribild.
Danish: Patienter bør dog informeres om, at svimmelhed, træthed og insomni er blevet indberettet under behandling med Stribild.
English: Interactions between the components of Stribild and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem Stribild-komponenterne og mulige samtidigt administrerede lægemidler ses i tabel 1 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“).
English: Talk to your doctor before taking Stribild:
Danish: Kontakt lægen, før De tager Stribild:
English: Stribild should be taken orally, once daily with food (see section 5.2).
Danish: Stribild skal tages oralt, én gang dagligt, sammen med mad (se pkt.
English: Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Stribild.
Danish: Start med den lavest mulige dosis atorvastatin under nøje monitorering ved samtisig administration af Stribild.
English: No dose adjustment of buprenorphine/naloxone is required.
Danish: Ingen dosisjustering af buprenorphin/naloxon er nødvendig.
English: If Stribild is stopped for any reason, speak to your doctor before you restart taking Stribild tablets.
Danish: Hvis Stribild stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Stribild tabletter.
English: No virologic data at Week 48 or 144 window Discontinued study drug due to AE or deathd
Danish: Ingen virologiske data ved uge 48eller uge 144vinduet Seponerede studiemedicin som følge af AE (adverse event) eller dødd
English: It is also important to tell your doctor if you are taking any of the following types of medicines:
Danish: Det er også vigtigt at fortælle det til lægen, hvis De tager nogle af de følger former for lægemidler:
English: rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin
Danish: rosuvastatin, atorvastatin, pravastatin, fluvastatin og pitavastatin
English: • changes to your urine
Danish: • ændringer i urinen
English: 4 Study conducted using Stribild.
Danish: 4 Studiet blev udført med Stribild.
English: If you have hepatitis B infection liver problems may become worse after you stop taking Stribild.
Danish: Hvis De har en hepatitis B-infektion, kan leverproblemerne blive værre, efter De holder op med at tage Stribild.
English: hepatic steatosis1, hepatitis1
Danish: steatosis hepatis1, hepatitis1
English: • low white blood cell count (which can make you more prone to infection)
Danish: • lavt antal af hvide blodlegemer (som kan gøre Dem mere modtagelig for infektion)
English: EU/1/13/830/001 30 film-coated tablets EU/1/13/830/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/13/830/001 30 filmovertrukne tabletter EU/1/13/830/002 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English: Stribild can cause dizziness, tiredness or insomnia.
Danish: Stribild kan forårsage svimmelhed, træthed eller søvnløshed.
English: Mean age, years (range)
Danish: Gennemsnitsalder, år (interval)
English: Stribild [Outer packaging only]
Danish: Stribild [kun på den ydre emballage]
English: Mean age was 15 years (range, 12−17), 70% were male, 68% black, 28% Asian.
Danish: Gennemsnitsalderen var 15 år (interval 12-17), 70 % var drenge, 68 % sorte, 28 % asiatere.
English: As the effect of cationic complexation of elvitegravir cannot be excluded when Stribild is co-administered with multivitamin supplements, it is recommended to separate Stribild and multivitamin supplements dosing by at least 4 hours.
Danish: Da virkningen af kationisk kompleksation af elvitegravir ikke kan udelukkes, når Stribild administreres sammen med multivitamin-tilskud, anbefales det at separere administrationen af Stribild og multivitamin-tilskud med mindst 4 timer.
English: Before starting treatment, your doctor will order blood tests to assess your kidney function.
Danish: Før De påbegynder behandlingen, vil Deres læge bestille blodprøver for at bedømme Deres nyrefunktion.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Stribild.
Danish: Nøje overvågning af patienten og dosisjustering af metformin anbefales for patienter, som tager Stribild.
English: • increased sugar, fatty acids (triglycerides), bilirubin in your blood
Danish: • forhøjet indhold af sukker, fedtsyrer (triglycerider), bilirubin i blodet
English: If you are older than this and are prescribed Stribild, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og får ordineret Stribild, vil Deres læge overvåge Dem nøje.
English: The MAH must agree the content and format of the medical educational pack with the national competent authority in each Member State prior to its distribution in their territory.
Danish: Indehaveren af markedsføringstilladelsen skal nå til enighed med den kompetente myndighed i hvert medlemsland om indholdet og formatet af den medicinske uddannelsespakke, før den uddeles i deres territorium.
English: Two of the four subjects had renal impairment (i.e. estimated creatinine clearance less than 70 mL/min) at baseline.
Danish: 2 af de 4 personer havde nedsat nyrefunktion (dvs. estimeret kreatininclearance på under 70 ml/min) ved baseline.
English: Patients receiving Stribild or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Patienter, der får Stribild eller anden antiretroviral behandling, kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer ved hiv-infektion og bør derfor holdes under fortsat tæt klinisk observation af læger med erfaring i behandling af patienter med hiv-associerede sygdomme.
English: • If you stopped treatment with any medicine containing tenofovir disoproxil on the advice of your doctor following problems with your kidney function.
Danish: • Hvis De stoppede behandling med lægemidler indeholdende tenofovirdisoproxil efter rådgivning fra Deres læge efter problemer med Deres nyrefunktion.
English: Interaction not studied with any of the components of Stribild.
Danish: Interaktion er ikke undersøgt med nogen af Stribilds komponenter.
English: Tenofovir disoproxil had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of a CYP1A1/2 substrate was observed.
Danish: Tenofovirdisoproxil havde ingen virkning på nogen af CYP450-isoformerne, undtagen på CYP1A1/2, hvor en lille (6 %), men statistisk signifikant reduktion i metabolismen af et CYP1A1/2-substrat blev observeret.
English: Most patients who developed resistance substitutions to elvitegravir developed resistance substitutions to both emtricitabine and elvitegravir.
Danish: De fleste patienter, der udviklede resistenssubstitutioner mod elvitegravir, udviklede resistenssubstitutioner over for både emtricitabin og elvitegravir.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~ 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~ 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thiolandelen til at danne 3'-sulfoxid-diastereomere (~ 9 % af dosen) og forbindelse med glucuronsyre til at danne 2'-O-glucuronid (~ 4 % af dosen).
English: Adults and adolescents aged 12 years and older weighing at least 35 kg: One tablet, once daily with food.
Danish: Voksne og unge i alderen 12 år og derover, som vejer mindst 35 kg: Én tablet én gang dagligt sammen med mad.
English: Studies with Stribild
Danish: Studier med Stribild
English: Stribild is a single tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults.
Danish: Stribild er et behandlingsregime med en enkelt tablet til behandling af infektion med humant immundefekt virus (hiv) hos voksne.
English: Exposures of cobicistat and emtricitabine in paediatric patients aged 12 to <18 years were similar to exposures achieved in adults.
Danish: Eksponeringen for cobicistat og emtricitabin hos pædiatriske patienter i alderen 12 til < 18 år var den samme som den eksponering, der opnås hos voksne.
English: Aromatic and aliphatic hydroxylation or glucuronidation metabolites are present in very low levels, display considerably lower anti-HIV activity and do not contribute to the overall antiviral activity of elvitegravir.
Danish: Metabolitter fra aromatisk og alifatisk hydroxylering og glukuronidation er kun til stede i meget lave niveauer, og udviser betragteligt lavere anti-hiv-aktivitet og bidrager ikke til den samlede antivirale aktivitet af elvitegravir.
English: Stribild has not been studied in patients over 65 years of age.
Danish: Stribild er ikke undersøgt hos patienter over 65 år.
English: That a multidisciplinary approach is recommended for the management of adolescent patients.
Danish: At der anbefales en tværfaglig tilgang ved behandling af unge patienter.
English: Before initiating treatment with Stribild
Danish: Før påbegyndelse af behandling med Stribild
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 De bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed, der begynder i hænder og fødder og bevæger sig op mod kroppens torso, hjertebanken, rysten eller hyperaktivitet, skal De straks informere lægen for at få den nødvendige behandling.
English: The transporters that cobicistat inhibits include P-gp, BCRP, OATP1B1 and OATP1B3.
Danish: De transportstoffer, som cobicistat hæmmer, omfatter P-gp, BCRP, OATP1B1 og OATP1B3.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions.
Danish: Samtidig administration af tenofovirdisoproxil og didanosin anbefales ikke, da det resulterer i en stigning i systemisk eksponering over for didanosin på 40-60 %, hvilket kan øge risikoen for didanosinrelaterede bivirkninger.