natgillin/translations-raw huggingface dataset:
Emtricitabin/tenofovirdisoproxil bør ikke indgives samtidig med andre lægemidler, som indholder emtricitabin, tenofovirdisoproxil, tenofoviralafenamid eller andre cytidinanaloger, såsom lamivudin (se pkt. 
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).
AUC: ↓ 27% (↓ 35 til ↓ 18) Cmax: ↓ 37% (↓ 48 til ↓ 25) 
AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Cmax: ↑ 47% (↑ 37 til ↑ 58) Cmin: ↑ 47% (↑ 38 til ↑ 57) 
Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
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. 
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).
Cmin: ↑ 45% (↑ 27 til ↑ 64) 
Cmin: ↑ 45% (↑ 27 to ↑ 64)
• 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. 
• 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.
• At pædiatriske patienters nyrefunktion skal vurderes, før Emtricitabine/Tenofovir disoproxil Mylan-behandling påbegyndes (nyrefunktion ved baseline) 
• That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Mylan therapy
Leversygdom 
asthenia
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. 
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).
Norgestimat/Ethinylestradiol/ Tenofovirdisoproxil 
ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol /Tenofovir disoproxil
Tenofovirdisoproxil 245 mg+emtricitabin/tenofovirdisoproxil 
Tenofovir disoproxil 245 mg)+Emtricitabine/tenofovir disoproxil
Emtricitabin/tenofovirdisoproxil bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel (se pkt. 
Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Didanosin: Samtidig indgivelse af emtricitabin/tenofovirdisoproxil og didanosin anbefales ikke (se pkt. 
Didanosine: The co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Lamivudin og emtricitabin/tenofovirdisoproxil må ikke administreres samtidigt (se pkt. 
Lamivudine and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Emtricitabin+ tenofovirdisoproxil+efavirenz 
Emtricitabine+ tenofovir disoproxil +efavirenz
Cmax: ↑ 42% (↑ 27 til ↑ 57) Cmin: ↔ 
Cmax: ↑ 42% (↑ 27 to ↑ 57) Cmin: ↔
AUC: ↓ 25% (↓ 42 til ↓ 3) Cmax: ↓ 28% (↓ 50 til ↑ 5) Cmin: ↓ 26% (↓ 46 til ↑ 10) 
AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Adefovirdipivoxil og emtricitabin/tenofovirdisoproxil må ikke administreres samtidigt (se pkt. 
Adefovir dipivoxil and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 90 (3 tabletbeholdere à 30) filmovertrukne tabletter 5. 
Multipack: 90 (3 bottle packs of 30) film-coated tablets
Profylakse før eksponering 
Pre-exposure prophylaxis
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. 
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).
• Give oplysninger om, hvordan Emtricitabine/Tenofovir disoproxil Mylan tages 
• Provides information on how to take Emtricitabine/Tenofovir Mylan
AUC: ↓ 34% (↓ 41 til ↓ 25) Cmax: ↓ 34% (↓ 41 til ↑ 25) Cmin: ↓ 34% (↓ 43 til ↑ 24) 
AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
AUC: ↑ 32% (↑ 25 til ↑ 38) Cmax: ↔ 
AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Hvis patienten kaster op mere end 1 time efter at have taget Emtricitabine/Tenofovir disoproxil Mylan, må patienten ikke tage en ny dosis. 
If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan a second dose should not be taken.
smerter, asteni 
pain, asthenia
AUC: ↓ 4% (↓ 9 til ↑ 0) Cmax: ↓ 6% (↓ 13 til ↑ 0) Cmin: ↓ 2% (↓ 9 til ↑ 6) 
AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
AUC: ↑ 96% (↑ 74 til ↑ 121) Cmax: ↑ 68% (↑ 54 til ↑ 84) Cmin: ↑ 118% (↑ 91 til ↑ 150) 
AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150)
Cmax: ↑ 25% (↑ 8 til ↑ 45) Cmin: ↔ 
Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg filmovertrukne tabletter Emtricitabin/tenofovirdisoproxil 
Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Cmin: ↑ 48% (↑ 34 til ↑ 63) 
Cmin: ↑ 48% (↑ 34 to ↑ 63)
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. 
Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice and drink immediately.
• Det er ikke nødvendigvis nok at tage Emtricitabine/Tenofovir disoproxil Mylan for at undgå at få HIV. 
• Just taking this Emtricitabine/Tenofovir disoproxil Mylan may not stop you getting HIV.
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. 
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).
Darunavir/ritonavir/ tenofovirdisoproxil (300 mg q.d./100 mg q.d./245 mg q.d.) 
Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Sådan skal De tage Emtricitabine/Tenofovir disoproxil Mylan 4. 
How to take Emtricitabine/Tenofovir disoproxil Mylan 4.
Serokonverteringer / Na Forekomst pr. 100 personår (95% CI) Relativ Risikoreduktion (95% CI) 
Incidence per 100 person-years (95% CI) 1.99 (1.49, 2.62) Relative Risk Reduction (95% CI)
• De skal være HIV-negativ, inden De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan for at reducere risikoen for at få HIV. 
• You must be HIV negative before you start to take this medicine to reduce the risk of getting HIV.
Cmin: ↑ 42% (↑ 37 til ↑ 49) 
Cmin: ↑ 42% (↑ 37 to ↑ 49)
Norgestimat: 
Norgestimate:
Lactosemonohydrat 
Lactose monohydrate Hypromellose
Det er vigtigt, at De husker at tage alle doser Emtricitabine/Tenofovir disoproxil Mylan. 
It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Mylan .
Tabel 8: Studiepopulation fra studie CO−US−104−0380 (Partners PrEP) 
Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 200 mg emtricitabin og 245 mg tenofovirdisoproxil (svarende til 300 mg tenofovirdisoproxilmaleat). 
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).
• nattesved 
• tiredness
Samtidig indgivelse af emtricitabin/tenofovirdisoproxil og didanosin kan ikke anbefales (se pkt. 
Co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Det skal De vide, før De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan 
What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan
AUC: ↑ 6% (↓ 1 til ↑ 13) Cmax: ↑ 13% (↑ 1 til ↑ 27) Cmin: IB 
AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27) Cmin: NC
Undervisningsbrochure om HIV og nyrefunktion hos pædiatriske patienter: 
HIV paediatric renal educational brochure:
AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: IB 
AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: NC
Hvis De tager Emtricitabine/Tenofovir disoproxil Mylan for at behandle HIV eller reducere risikoen for at få HIV: 
While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV:
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. 
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).
Tenofovirdisoproxil 245 mg (n = 1.584) 
245 mg (n = 1584)
AUC: ↓ 4% (↓ 15 til ↑ 8) Cmax: ↑ 102% (↓ 96 til ↑ 108) Cmin: IB 
AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108) Cmin: NC
Efavirenz/Tenofovirdisoproxil 
Efavirenz/Tenofovir disoproxil
AUC: ↓ 3% (↓ 8% til ↑ 15) Cmax: ↓ 24% (↓ 44 til ↓ 12) Cmin: IB 
AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Emtricitabine/Tenofovir disoproxil Mylan for at nedsætte risikoen for at få HIV-infektion 
Emtricitabine/Tenofovir Mylan to Reduce the Risk of getting Human Immunodeficiency Virus
Cmin: ↑ 42% (↑ 34 til ↑ 49) 
Cmin: ↑ 42% (↑ 34 to ↑ 49)
AUC: ↑ 81% (↑ 68 til ↑ 94) Cmax: ↑ 77% (↑ 53 til ↑ 104) Cmin: ↑ 121% (↑ 100 til ↑ 143) 
AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to
FTC/tenofovirdisoproxilgruppea 
FTC/tenofovir disoproxil Groupa
• led- eller muskelsmerter 
• joint or muscle aches
ORALE KONTRACEPTIVA 
Antiretrovirals
• PrEP-undervisningsbrochure til ordinerende læger med titlen ”Vigtige sikkerhedsoplysninger til ordinerende læger om Emtricitabine/Tenofovir disoproxil Mylan ved indikationen Profylakse før eksponering (PrEP)” 
• PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
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 %). 
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).
Den anbefalede dosis af Emtricitabine/Tenofovir disoproxil Mylan til at nedsætte risikoen for at få HIV er: 
The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV is:
AUC: ↑ 65% (↑ 59 til ↑ 71) Cmax: ↑ 61% (↑ 51 til ↑ 72) Cmin: ↑ 115% (↑ 105 til ↑ 126) 
AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to
AUC: ↓ 11% (↓ 14 til ↓ 7) Cmax: ↓ 7% (↓ 13 til ↓ 0) Cmin: IB 
AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0) Cmin: NC
AUC: ↑ 4% (↓ 3 til ↑ 11) Cmax: ↑ 3% (↓ 3 til ↑ 9) Cmin: IB 
AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9) Cmin: NC
McDermott Laboratories Limited under forretningsnavnet Gerard Laboratories under forretningsnavnet Mylan Dublin 
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
AUC: ↑ 98% (↑ 77 til ↑ 123) Cmax: ↑ 79% (↑ 56 til ↑ 104) Cmin: ↑ 163% (↑ 137 til ↑ 197) 
AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑
AUC: ↑ 50% (↑ 42 til ↑ 59) Cmax: ↑ 64% (↑ 54 til ↑ 74) Cmin: ↑ 59% (↑ 49 til ↑ 70) 
AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Emtricitabine/Tenofovir disoproxil Mylan indeholder 
What Emtricitabine/Tenofovir disoproxil Mylan contains
• PrEP-huskekort 
• PrEP reminder card
• fald i blodets indhold af kalium 
• decreases in potassium in the blood
AUC: ↓ 4% (↓ 32 til ↑ 34) Cmax: ↓ 5% (↓ 27 til ↑ 24) Cmin: IB 
AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
AUC: ↓ 5% (↓ 9 til ↓ 1) Cmax: ↓ 11% (↓ 17 til ↓ 5) Cmin: IB 
AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5) Cmin: NC
AUC: ↑ 5% (↓ 2 til ↑ 13) Cmax: ↑ 5% (↓ 3 til ↑ 14) Cmin: IB 
AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
AUC: ↑ 39% (↑ 33 til ↑ 44) Cmax: ↑ 55% (↑ 45 til ↑ 66) Cmin: ↑ 52% (↑ 45 til ↑ 59) 
AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, 
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.
Emtricitabin/tenofovirdisoproxils farmakokinetik er ikke undersøgt hos forsøgspersoner med nedsat leverfunktion. 
The pharmacokinetics of emtricitabine/tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Den forøgede tenofovireksponering kan øge risikoen for bivirkninger af tenofovir, herunder renale lidelser. 
The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Inden De tager Emtricitabine/Tenofovir disoproxil Mylan for at nedsætte risikoen for at få HIV: 
Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
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. 
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).
AUC: ↑ 40% (↑ 34 til ↑ 46) Cmax: ↑ 44% (↑ 33 til ↑ 55) Cmin: ↑ 84% (↑ 76 til ↑ 92) 
AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
• Aktive stoffer: Emtricitabin og tenofovirdisoproxil. 
• The active substances are emtricitabine and tenofovir disoproxil.
Deutschland Mylan dura GmbH Tel: + 49-(0) 6172 888 01 
Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800
Hver filmovertrukken tablet indeholder 200 mg emtricitabin og 245 mg tenofovi disoproxil (svarende til 300 mg tenofovirdisoproxilmaleat). 
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Brug af anden medicin sammen med Emtricitabine/Tenofovir disoproxil Mylan 
Other medicines and Emtricitabine/Tenofovir disoproxil Mylan
AUC: ↓ 4% (↓ 7 til ↓ 1) Cmax: ↓ 4% (↓ 9 til ↑ 2) Cmin: IB 
AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC
Serokonverteringer / Nb 14 / 404 
Seroconversions / Na
AUC: ↓ 7% (↓ 13 til ↓ 1) Cmax: ↓ 11% (↓ 20 til ↑ 1) Cmin: IB 
AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
AUC: ↓ 2% (↓ 5 til ↑ 0) Cmax: ↓ 1% (↓ 7 til ↑ 6) Cmin: IB 
AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
• svaghedsfølelse 
• feeling weak
Tacrolimus/Tenofovirdisoproxil/Emtri -citabin 
Tacrolimus/Tenofovir disoproxil /Emtricitabine
Samtidig behandling med tenofovirdisoproxil og en boosted proteasehæmmer skal evalueres omhyggeligt hos HIV 1inficerede patienter med renale risikofaktorer. 
In HIV-1 infected patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
AUC: ↑ 40% (↑ 34 til ↑ 45) Cmax: ↑ 46% (↑ 39 til ↑ 54) Cmin: ↑ 70% (↑ 61 til ↑ 79) 
AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Lamivudin/Tenofovirdisoproxil 
Lamivudine/Tenofovir disoproxil
AUC: ↓ 1% (↓ 8 til ↑ 6) Cmax: ↑ 7% (↓ 6 til ↑ 22) Cmin: IB 
AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Sikkerheden af tenofovirdisoproxil sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt. 
The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Ribavirin/Tenofovirdisoproxil 
Ribavirin/Tenofovir disoproxil
Tenofovirdisoproxil 
Tenofovir disoproxil
Knogleproblemer (giver somme tider anledning til brud) kan også forekomme på grund af skader på tubulære celler i nyrerne (se punkt 4, Bivirkninger). 
• Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells
INFORMATION I BRAILLESKRIFT Emtricitabine/Tenofovir disoproxil Mylan [kun på den ydre emballage] 
Emtricitabine/Tenofovir disoproxil Mylan [To appear on outer carton only]
NARKOTISKE ANALGETIKA 
lactic acidosis
AUC: ↓ 9% (↓ 16 til ↓ 1) Cmax: ↓ 7% (↓ 22 til ↑ 11) Cmin: IB 
AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovirdisoproxil, herunder nyrerelaterede bivirkninger. 
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Det vides ikke, hvor lang tid der går efter start af emtricitabin/tenofovirdisoproxil-behandling, før den beskyttende virkning opnås. 
The time to onset of protection after commencing emtricitabine/tenofovir disoproxil is unknown.
UDLØBSDATO EXP: 
Open date:
Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt. 
The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
udslæt 
Excipients
• At der bør søges råd hos en endokrinolog og/eller en nefrolog, hvis knogleabnormiteter mistænkes eller påvises hos pædiatriske patienter 
• That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
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. 
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.
Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir/voxil aprevir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt. 
The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Hvis der ikke er andre alternativer, skal kombinationen anvendes med forsigtighed med hyppig monitorering af nyrefunkionen, (se pkt. 
The combination should be used with caution with frequent renal monitoring, if other alternatives are not available (see section 4.4).
samtidig administration af emtricitabin/tenofovirdisoproxil (emtricitabin 200 mg, tenofovirdisoproxil 245 mg) 
Recommendation concerning co-administration with emtricitabine/tenofovir disoproxil (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
• muskelsvaghed 
• joint stiffness
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret at forekomme i forbindelse med immunreaktivering. 
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.
anæmi2 
anaemia2
Bivirkninger 
Bone effects
Hvis De tager Emtricitabine/Tenofovir disoproxil Mylan for at nedsætte risikoen for at få HIV: 
While taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Blandet/andet 
ANNEX II
Opbevaring af Emtricitabine/Tenofovir disoproxil Mylan 
How to store Emtricitabine/Tenofovir disoproxil Mylan
• mavesmerter på grund af betændelse i bugspytkirtlen 
• pain in the abdomen (tummy) caused by inflammation of the pancreas
Det er vigtigt, at De ikke holder op med at tage emtricitabin/tenofovirdisoproxil uden først at tale med Deres læge. 
It is important not to stop taking emtricitabine/tenofovir disoproxil without talking to your doctor: see section 3, Do not stop taking
Emtricitabine/Tenofovir disoproxil Mylan kan kun hjælpe med at nedsætte Deres risiko for at få HIV, før De bliver smittet. 
This medicine can only help reduce your risk of getting HIV before you are infected.
+ Efavirenz/Emtricitabin/ Tenofovirdisoproxil (600 mg/200 mg/245 mg q.d.) 
+ Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Emtricitabin/tenofovirdisoproxil 
Placebo Emtricitabine/tenofovir disoproxil
Sådan skal De tage Emtricitabine/Tenofovir disoproxil Mylan 
How to take Emtricitabine/Tenofovir disoproxil Mylan
Emtricitabin/tenofovirdisoproxil (200 mg/245 mg q.d.) 
Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Triacetin 
NRTIs
Knogler, led, muskler og bindevæv: 
Musculoskeletal and connective tissue disorders:
+ Emtricitabin/Tenofovirdisoproxil (200 mg/245 mg q.d.) 
+ Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
• diarré, opkastning, kvalme 
• diarrhoea, being sick (vomiting), feeling sick (nausea)
Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir/voxil aprevir og darunavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger. 
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Tenofovirdisoproxilgruppea 
Tenofovir disoproxil Groupa
Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, ledipasvir/sofosbuvir og atazanavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger. 
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.