FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 7: Efficacy and adherence in study CO-US-104-0288 (iPrEx, matched case-control analysis)
Danish: Tabel 7: Effekt og adhærens i studie CO−US−104−0288 (iPrEx, matchet case-kontrolanalyse)
English: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
Danish: AUC: ↑ 40% (↑ 31 til ↑ 50) Cmax: ↔
English: Bottle pack: use within 90 days after first opening
Danish: Tabletbeholder: Skal anvendes inden for 90 dage efter anbrud.
English: AUC: ↓ 28% (↓ 34 to ↓ 20) Cmax: ↓ 38% (↓ 46 to ↓ 29)
Danish: AUC: ↓ 28% (↓ 34 til ↓ 20) Cmax: ↓ 38% (↓ 46 til ↓ 29)
English: No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: • Provides information on how to store Emtricitabine/Tenofovir Mylan.
Danish: • Give oplysninger om, hvordan Emtricitabine/Tenofovir disoproxil Mylan opbevares.
English: Tel: + 39 02 612 46921
Danish: Mylan S.p.A Tel: + 39 02 612 46921
English: Cmin: ↑ 29% (↑ 15 to ↑ 44)
Danish: Cmin: ↑ 29% (↑ 15 til ↑ 44)
English: • fatty liver
Danish: • fedtlever
English: Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).
Danish: Emtricitabine/Tenofovir disoproxil Mylan er også indiceret til behandling af HIV 1-inficerede unge med NRTI-resistens eller -toksicitet, der udelukker brug af førstevalgspræparater (se pkt.
English: No data are available to make dose recommendations (see sections 4.2 and 4.4).
Danish: Der foreligger ingen data, og der kan ikke gives nogen anbefalinger vedrørende dosering (se pkt.
English: Emtricitabine:
Danish: Emtricitabin:
English: Lopinavir/Ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d/245 mg q.d.)
Danish: Lopinavir/Ritonavir/ Tenofovirdisoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
English: Cmin: ↑ 63% (↑ 45 to ↑ 84)
Danish: Cmin: ↑ 63% (↑ 45 til ↑ 84)
English: Adefovir dipivoxil:
Danish: Adefovirdipivoxil:
English: Cmax: ↑ 55% (↑ 43 to ↑ 68) Cmin: ↑ 39% (↑ 31 to ↑ 48)
Danish: Cmax: ↑ 55% (↑ 43 til ↑ 68) Cmin: ↑ 39% (↑ 31 til ↑ 48)
English: Table 9: Efficacy in study CO-US-104-0380 (Partners PrEP)
Danish: Tabel 9: Effekt i studie CO-US-104-0380 (Partners PrEP)
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose
Danish: Emtricitabine/Tenofovir disoproxil Mylan indeholder lactose
English: Emtricitabine/tenofovir disoproxil should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Danish: Emtricitabin/tenofovirdisoproxil bør ikke indgives samtidig med andre lægemidler, som indholder emtricitabin, tenofovirdisoproxil, tenofoviralafenamid eller andre cytidinanaloger, såsom lamivudin (se pkt.
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Danish: AUC: ↓ 27% (↓ 35 til ↓ 18) Cmax: ↓ 37% (↓ 48 til ↓ 25)
English: Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
Danish: Cmax: ↑ 47% (↑ 37 til ↑ 58) Cmin: ↑ 47% (↑ 38 til ↑ 57)
English: Individuals with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving emtricitabine/tenofovir disoproxil (see sections 4.2, 4.4 and 5.2).
Danish: Personer med nedsat nyrefunktion: Da tenofovirdisoproxil kan forårsage nefrotoksicitet, anbefales tæt monitorering af nyrefunktionen hos alle voksne med nedsat nyrefunktion, som får emtricitabin/tenofovirdisoproxil (se pkt.
English: Cmin: ↑ 45% (↑ 27 to ↑ 64)
Danish: Cmin: ↑ 45% (↑ 27 til ↑ 64)
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Danish: • At nyrefunktionen revurderes inden for en uge, hvis serumphosphat bekræftes at være <3,0 mg/dl (0,96 mmol/l) hos enhver pædiatrisk patient, der får tenofovirdisoproxil.
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Mylan therapy
Danish: • At pædiatriske patienters nyrefunktion skal vurderes, før Emtricitabine/Tenofovir disoproxil Mylan-behandling påbegyndes (nyrefunktion ved baseline)
English: asthenia
Danish: Leversygdom
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Danish: Hvis serumphosphat er < 1,5 mg/dl (0,48 mmol/l) eller kreatininclearance reduceret til < 60 ml/min hos en person, der får emtricitabin/tenofovirdisoproxil som profylakse før eksponering, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol /Tenofovir disoproxil
Danish: Norgestimat/Ethinylestradiol/ Tenofovirdisoproxil
English: Tenofovir disoproxil 245 mg)+Emtricitabine/tenofovir disoproxil
Danish: Tenofovirdisoproxil 245 mg+emtricitabin/tenofovirdisoproxil
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Danish: Emtricitabin/tenofovirdisoproxil bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel (se pkt.
English: Didanosine: The co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Danish: Didanosin: Samtidig indgivelse af emtricitabin/tenofovirdisoproxil og didanosin anbefales ikke (se pkt.
English: Lamivudine and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Danish: Lamivudin og emtricitabin/tenofovirdisoproxil må ikke administreres samtidigt (se pkt.
English: Emtricitabine+ tenofovir disoproxil +efavirenz
Danish: Emtricitabin+ tenofovirdisoproxil+efavirenz
English: Cmax: ↑ 42% (↑ 27 to ↑ 57) Cmin: ↔
Danish: Cmax: ↑ 42% (↑ 27 til ↑ 57) Cmin: ↔
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Danish: AUC: ↓ 25% (↓ 42 til ↓ 3) Cmax: ↓ 28% (↓ 50 til ↑ 5) Cmin: ↓ 26% (↓ 46 til ↑ 10)
English: Adefovir dipivoxil and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Danish: Adefovirdipivoxil og emtricitabin/tenofovirdisoproxil må ikke administreres samtidigt (se pkt.
English: Multipack: 90 (3 bottle packs of 30) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 90 (3 tabletbeholdere à 30) filmovertrukne tabletter 5.
English: Pre-exposure prophylaxis
Danish: Profylakse før eksponering
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Emtricitabine/tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Danish: Hvis serumphosphat bekræftes at være < 3,0 mg/dl (0,96 mmol/l) hos en pædiatrisk patient, der får Emtricitabine/Tenofovir disoproxil Mylan, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
English: • Provides information on how to take Emtricitabine/Tenofovir Mylan
Danish: • Give oplysninger om, hvordan Emtricitabine/Tenofovir disoproxil Mylan tages
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Danish: AUC: ↓ 34% (↓ 41 til ↓ 25) Cmax: ↓ 34% (↓ 41 til ↑ 25) Cmin: ↓ 34% (↓ 43 til ↑ 24)
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Danish: AUC: ↑ 32% (↑ 25 til ↑ 38) Cmax: ↔
English: If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan a second dose should not be taken.
Danish: Hvis patienten kaster op mere end 1 time efter at have taget Emtricitabine/Tenofovir disoproxil Mylan, må patienten ikke tage en ny dosis.
English: pain, asthenia
Danish: smerter, asteni
English: AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
Danish: AUC: ↓ 4% (↓ 9 til ↑ 0) Cmax: ↓ 6% (↓ 13 til ↑ 0) Cmin: ↓ 2% (↓ 9 til ↑ 6)
English: AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150)
Danish: AUC: ↑ 96% (↑ 74 til ↑ 121) Cmax: ↑ 68% (↑ 54 til ↑ 84) Cmin: ↑ 118% (↑ 91 til ↑ 150)
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Danish: Cmax: ↑ 25% (↑ 8 til ↑ 45) Cmin: ↔
English: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Danish: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg filmovertrukne tabletter Emtricitabin/tenofovirdisoproxil
English: Cmin: ↑ 48% (↑ 34 to ↑ 63)
Danish: Cmin: ↑ 48% (↑ 34 til ↑ 63)
English: Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice and drink immediately.
Danish: Hvis De har problemer med at synke, kan De knuse tabletten med spidsen af en ske og opløse den i ca. 100 ml (et halvt glas) vand, appelsinjuice eller druesaft.
English: • Just taking this Emtricitabine/Tenofovir disoproxil Mylan may not stop you getting HIV.
Danish: • Det er ikke nødvendigvis nok at tage Emtricitabine/Tenofovir disoproxil Mylan for at undgå at få HIV.
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving, emtricitabine/tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Danish: Hvis serumphosphat er < 1,5 mg/dl (0,48 mmol/l), eller kreatininclearance er reduceret til < 50 ml/min hos patienter, der får emtricitabin/tenofovirdisoproxil, bør nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Danish: Darunavir/ritonavir/ tenofovirdisoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: How to take Emtricitabine/Tenofovir disoproxil Mylan 4.
Danish: Sådan skal De tage Emtricitabine/Tenofovir disoproxil Mylan 4.
English: Incidence per 100 person-years (95% CI) 1.99 (1.49, 2.62) Relative Risk Reduction (95% CI)
Danish: Serokonverteringer / Na Forekomst pr. 100 personår (95% CI) Relativ Risikoreduktion (95% CI)
English: • You must be HIV negative before you start to take this medicine to reduce the risk of getting HIV.
Danish: • De skal være HIV-negativ, inden De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan for at reducere risikoen for at få HIV.
English: Cmin: ↑ 42% (↑ 37 to ↑ 49)
Danish: Cmin: ↑ 42% (↑ 37 til ↑ 49)
English: Norgestimate:
Danish: Norgestimat:
English: Lactose monohydrate Hypromellose
Danish: Lactosemonohydrat
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Mylan .
Danish: Det er vigtigt, at De husker at tage alle doser Emtricitabine/Tenofovir disoproxil Mylan.
English: Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
Danish: Tabel 8: Studiepopulation fra studie CO−US−104−0380 (Partners PrEP)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 200 mg emtricitabin og 245 mg tenofovirdisoproxil (svarende til 300 mg tenofovirdisoproxilmaleat).
English: • tiredness
Danish: • nattesved
English: Co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Danish: Samtidig indgivelse af emtricitabin/tenofovirdisoproxil og didanosin kan ikke anbefales (se pkt.
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan
Danish: Det skal De vide, før De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27) Cmin: NC
Danish: AUC: ↑ 6% (↓ 1 til ↑ 13) Cmax: ↑ 13% (↑ 1 til ↑ 27) Cmin: IB
English: HIV paediatric renal educational brochure:
Danish: Undervisningsbrochure om HIV og nyrefunktion hos pædiatriske patienter:
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: NC
Danish: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: IB
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV:
Danish: Hvis De tager Emtricitabine/Tenofovir disoproxil Mylan for at behandle HIV eller reducere risikoen for at få HIV:
English: Administration every 48 hours is recommended based on modelling of singledose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4).
Danish: Ud fra modellering af farmakokinetiske data for enkeltdosis af emtricitabin og tenofovirdisoproxil hos ikke-HIVinficerede forsøgspersoner med varierende grader af nedsat nyrefunktion anbefales det at administrere hver 48. time (se pkt.
English: 245 mg (n = 1584)
Danish: Tenofovirdisoproxil 245 mg (n = 1.584)
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108) Cmin: NC
Danish: AUC: ↓ 4% (↓ 15 til ↑ 8) Cmax: ↑ 102% (↓ 96 til ↑ 108) Cmin: IB
English: Efavirenz/Tenofovir disoproxil
Danish: Efavirenz/Tenofovirdisoproxil
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Danish: AUC: ↓ 3% (↓ 8% til ↑ 15) Cmax: ↓ 24% (↓ 44 til ↓ 12) Cmin: IB
English: Emtricitabine/Tenofovir Mylan to Reduce the Risk of getting Human Immunodeficiency Virus
Danish: Emtricitabine/Tenofovir disoproxil Mylan for at nedsætte risikoen for at få HIV-infektion
English: Cmin: ↑ 42% (↑ 34 to ↑ 49)
Danish: Cmin: ↑ 42% (↑ 34 til ↑ 49)
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to
Danish: AUC: ↑ 81% (↑ 68 til ↑ 94) Cmax: ↑ 77% (↑ 53 til ↑ 104) Cmin: ↑ 121% (↑ 100 til ↑ 143)
English: FTC/tenofovir disoproxil Groupa
Danish: FTC/tenofovirdisoproxilgruppea
English: • joint or muscle aches
Danish: • led- eller muskelsmerter
English: Antiretrovirals
Danish: ORALE KONTRACEPTIVA
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Danish: • PrEP-undervisningsbrochure til ordinerende læger med titlen ”Vigtige sikkerhedsoplysninger til ordinerende læger om Emtricitabine/Tenofovir disoproxil Mylan ved indikationen Profylakse før eksponering (PrEP)”
English: HIV-1 infection: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Danish: 5.1) var de hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til emtricitabin og/eller tenofovirdisoproxil, kvalme (12 %) og diarré (7 %).
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV is:
Danish: Den anbefalede dosis af Emtricitabine/Tenofovir disoproxil Mylan til at nedsætte risikoen for at få HIV er:
English: AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to
Danish: AUC: ↑ 65% (↑ 59 til ↑ 71) Cmax: ↑ 61% (↑ 51 til ↑ 72) Cmin: ↑ 115% (↑ 105 til ↑ 126)
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0) Cmin: NC
Danish: AUC: ↓ 11% (↓ 14 til ↓ 7) Cmax: ↓ 7% (↓ 13 til ↓ 0) Cmin: IB
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9) Cmin: NC
Danish: AUC: ↑ 4% (↓ 3 til ↑ 11) Cmax: ↑ 3% (↓ 3 til ↑ 9) Cmin: IB
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Danish: McDermott Laboratories Limited under forretningsnavnet Gerard Laboratories under forretningsnavnet Mylan Dublin
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑
Danish: AUC: ↑ 98% (↑ 77 til ↑ 123) Cmax: ↑ 79% (↑ 56 til ↑ 104) Cmin: ↑ 163% (↑ 137 til ↑ 197)
English: AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Danish: AUC: ↑ 50% (↑ 42 til ↑ 59) Cmax: ↑ 64% (↑ 54 til ↑ 74) Cmin: ↑ 59% (↑ 49 til ↑ 70)
English: What Emtricitabine/Tenofovir disoproxil Mylan contains
Danish: Emtricitabine/Tenofovir disoproxil Mylan indeholder
English: • PrEP reminder card
Danish: • PrEP-huskekort
English: • decreases in potassium in the blood
Danish: • fald i blodets indhold af kalium
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Danish: AUC: ↓ 4% (↓ 32 til ↑ 34) Cmax: ↓ 5% (↓ 27 til ↑ 24) Cmin: IB
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5) Cmin: NC
Danish: AUC: ↓ 5% (↓ 9 til ↓ 1) Cmax: ↓ 11% (↓ 17 til ↓ 5) Cmin: IB
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Danish: AUC: ↑ 5% (↓ 2 til ↑ 13) Cmax: ↑ 5% (↓ 3 til ↑ 14) Cmin: IB
English: AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
Danish: AUC: ↑ 39% (↑ 33 til ↑ 44) Cmax: ↑ 55% (↑ 45 til ↑ 66) Cmin: ↑ 52% (↑ 45 til ↑ 59)
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression,
English: The pharmacokinetics of emtricitabine/tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Danish: Emtricitabin/tenofovirdisoproxils farmakokinetik er ikke undersøgt hos forsøgspersoner med nedsat leverfunktion.
English: The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Danish: Den forøgede tenofovireksponering kan øge risikoen for bivirkninger af tenofovir, herunder renale lidelser.
English: Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Danish: Inden De tager Emtricitabine/Tenofovir disoproxil Mylan for at nedsætte risikoen for at få HIV:
English: Consideration should be given to interrupting use of with emtricitabine/tenofovir disoproxil in individuals with creatinine clearance decreased to < 60 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Danish: Det bør overvejes at afbryde behandlingen med emtricitabin/tenofovirdisoproxil hos personer, hvor kreatininclearance er faldet til < 60 ml/min eller serumphosphat til < 1,0 mg/dl (0,32 mmol/l), ligesom det bør overvejes at afbryde behandlingen i tilfælde af progredierende fald i nyrefunktion en, når ingen anden årsag er blevet identificeret.
English: AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
Danish: AUC: ↑ 40% (↑ 34 til ↑ 46) Cmax: ↑ 44% (↑ 33 til ↑ 55) Cmin: ↑ 84% (↑ 76 til ↑ 92)
English: • The active substances are emtricitabine and tenofovir disoproxil.
Danish: • Aktive stoffer: Emtricitabin og tenofovirdisoproxil.
English: Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800
Danish: Deutschland Mylan dura GmbH Tel: + 49-(0) 6172 888 01
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Danish: Hver filmovertrukken tablet indeholder 200 mg emtricitabin og 245 mg tenofovi disoproxil (svarende til 300 mg tenofovirdisoproxilmaleat).
English: Other medicines and Emtricitabine/Tenofovir disoproxil Mylan
Danish: Brug af anden medicin sammen med Emtricitabine/Tenofovir disoproxil Mylan
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC
Danish: AUC: ↓ 4% (↓ 7 til ↓ 1) Cmax: ↓ 4% (↓ 9 til ↑ 2) Cmin: IB
English: Seroconversions / Na
Danish: Serokonverteringer / Nb 14 / 404
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
Danish: AUC: ↓ 7% (↓ 13 til ↓ 1) Cmax: ↓ 11% (↓ 20 til ↑ 1) Cmin: IB
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
Danish: AUC: ↓ 2% (↓ 5 til ↑ 0) Cmax: ↓ 1% (↓ 7 til ↑ 6) Cmin: IB
English: • feeling weak
Danish: • svaghedsfølelse
English: Tacrolimus/Tenofovir disoproxil /Emtricitabine
Danish: Tacrolimus/Tenofovirdisoproxil/Emtri -citabin
English: In HIV-1 infected patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Danish: Samtidig behandling med tenofovirdisoproxil og en boosted proteasehæmmer skal evalueres omhyggeligt hos HIV 1inficerede patienter med renale risikofaktorer.
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Danish: AUC: ↑ 40% (↑ 34 til ↑ 45) Cmax: ↑ 46% (↑ 39 til ↑ 54) Cmin: ↑ 70% (↑ 61 til ↑ 79)
English: Lamivudine/Tenofovir disoproxil
Danish: Lamivudin/Tenofovirdisoproxil
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Danish: AUC: ↓ 1% (↓ 8 til ↑ 6) Cmax: ↑ 7% (↓ 6 til ↑ 22) Cmin: IB
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: Ribavirin/Tenofovir disoproxil
Danish: Ribavirin/Tenofovirdisoproxil
English: Tenofovir disoproxil
Danish: Tenofovirdisoproxil
English: • Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells
Danish: Knogleproblemer (giver somme tider anledning til brud) kan også forekomme på grund af skader på tubulære celler i nyrerne (se punkt 4, Bivirkninger).
English: Emtricitabine/Tenofovir disoproxil Mylan [To appear on outer carton only]
Danish: INFORMATION I BRAILLESKRIFT Emtricitabine/Tenofovir disoproxil Mylan [kun på den ydre emballage]
English: lactic acidosis
Danish: NARKOTISKE ANALGETIKA
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Danish: AUC: ↓ 9% (↓ 16 til ↓ 1) Cmax: ↓ 7% (↓ 22 til ↑ 11) Cmin: IB
English: The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Danish: Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: The time to onset of protection after commencing emtricitabine/tenofovir disoproxil is unknown.
Danish: Det vides ikke, hvor lang tid der går efter start af emtricitabin/tenofovirdisoproxil-behandling, før den beskyttende virkning opnås.
English: Open date:
Danish: UDLØBSDATO EXP:
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: Excipients
Danish: udslæt
English: • That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Danish: • At der bør søges råd hos en endokrinolog og/eller en nefrolog, hvis knogleabnormiteter mistænkes eller påvises hos pædiatriske patienter
English: In study GS US 104 0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Danish: Disse patienter blev randomiseret til enten at erstatte stavudin eller zidovudin med tenofovirdisoproxil (n = 48) eller fortsætte med deres oprindelige regime (n = 49) i 48 uger.