FrancophonIA/ELRC3.0 huggingface dataset:
English: Outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Danish: Pakning med 1 tabletbeholder med 30 filmovertrukne tabletter og pakning med 90 (3 tabletbeholdere med hver 30) filmovertrukne tabletter.
English: How to take Emtricitabine/Tenofovir disoproxil Zentiva • Always take this medicine exactly as your doctor has told you.
Danish: Sådan skal du tage Emtricitabine/Tenofovir disoproxil Zentiva • Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • That Emtricitabine/Tenofovir disoproxil Zentiva is not recommended for use in paediatric patients with renal impairment
Danish: • At Emtricitabin/Tenofovirdisoproxil Zentiva frarådes til pædiatriske patienter med nedsat nyrefunktion
English: • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver,
Danish: • gulfarvning af hud eller øjne, kløe eller mavesmerter på grund af leverbetændelse
English: • That use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: • At det bør undgås at anvende Emtricitabin/Tenofovirdisoproxil Zentiva samtidig med eller efter nylig brug af nefrotoksiske lægemidler.
English: Emtricitabine/Tenofovir disoproxil Zentiva contains sodium
Danish: Emtricitabine/Tenofovir disoproxil Zentiva indeholder natrium
English: The effectiveness of Emtricitabine/Tenofovir disoproxil Zentiva in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood (see section 5.1).
Danish: Der er en stærk korrelation mellem Emtricitabine/Tenofovir disoproxil Zentiva-behandlingens effektivitet med hensyn til at reducere risikoen for at få HIV 1 og adhærens påvist ved målbare lægemiddelniveauer i blodet (se pkt.
English: Emtricitabine/ tenofovir disoproxil (n = 1251)
Danish: Emtricitabin/ tenofovirdisoproxil (n = 1.251)
English: Therefore the use of Emtricitabine/Tenofovir disoproxil Zentiva may be considered during pregnancy, if necessary.
Danish: Hvis det er indiceret, kan anvendelse af Emtricitabine/Tenofovir disoproxil Zentiva derfor overvejes under graviditet.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan opstå hos flere end 1 ud af 10 personer):
English: HIV-1 RNA < 400 copies/ml (TLOVR)
Danish: HIV-1-rna < 400 kopier/ml (TLOVR) p-værdi % forskel (95% CI)
English: In the Partners PrEP clinical study, no HIV 1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 during the study.
Danish: I det kliniske Partners PrEP-studie blev der ikke registreret HIV 1-varianter, som eksprimerede K65R, K70E, M184V eller M184I på tidspunktet for serokonvertering, blandt forsøgspersoner, der blev inficeret med HIV 1 i løbet af studiet.
English: Lopinavir/ritonavir/emtricitabine Interaction not studied.
Danish: Lopinavir/Ritonavir/Emtricitabin Interaktion er ikke undersøgt.
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: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng·h/ml in subjects with normal renal function, to 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng·h/ml, in subjects with mild, moderate and severe renal impairment, respectively.
Danish: Den gennemsnitlige (% variationskoefficient) tenofovireksponering steg fra 2.185 (12%) ng·t/ml hos forsøgspersoner med normal nyrefunktion til 3.064 (30%) ng·t/ml, 6.009 (42%) ng·t/ml og 15.985 (45%) ng·t/ml hos forsøgspersoner med henholdsvis let, moderat og svært nedsat nyrefunktion.
English: Renal management in HIV-1 infected patients
Danish: Håndtering af nedsat nyrefunktion hos HIV 1-inficerede patienter:
English: Use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Danish: Brug af Emtricitabine/Tenofovir disoproxil Zentiva bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel.
English: Drug Detected
Danish: Lægemiddel detekteret
English: What Emtricitabine/Tenofovir disoproxil Zentiva is and what it is used for Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine and tenofovir disoproxil.
Danish: Virkning og anvendelse Emtricitabine/Tenofovir disoproxil Zentiva indeholder to aktive stoffer, emtricitabin og tenofovirdisoproxil.
English: Lamivudine/ zidovudine/ efavirenz
Danish: Lamivudin+ zidovudin+ efavirenz
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R mutation.
Danish: Tenofovirdisoproxil bør undgås hos tidligere antiretroviralbehandlede patienter med HIV 1 med stammer, som har K65R-mutationer.
English: If a dose of Emtricitabine/Tenofovir disoproxil Zentiva is missed within 12 hours of the time it is usually taken, Emtricitabine/Tenofovir disoproxil Zentiva should be taken as soon as possible and the normal dosing schedule should be resumed.
Danish: Hvis en patient glemmer at tage en dosis Emtricitabine/Tenofovir disoproxil Zentiva i 12 timer efter tidspunktet, hvor dosen normalt skulle tages, skal patienten tage Emtricitabine/Tenofovir disoproxil Zentiva sammen med mad så snart som muligt og derefter fortsætte i henhold til den normale doseringsplan.
English: If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Zentiva a second dose should not be taken.
Danish: Hvis patienten kaster op mere end 1 time efter at have taget Emtricitabine/Tenofovir disoproxil Zentiva, må patienten ikke tage en ny dosis.
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Danish: Sikkerheden af tenofovirdisoproxil ved administration sammen med ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir, velpatasvir/voxilaprevir og en farmakokinetisk forstærker er ikke klarlagt.
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving Emtricitabine/Tenofovir disoproxil Zentiva (see sections 4.2, 4.4 and 5.2).
Danish: Da tenofovirdisoproxil kan forårsage nyretoksicitet, anbefales tæt monitorering af nefrotoksicitet hos alle voksne med nedsat nyrefunktion, som behandles med Emtricitabine/Tenofovir disoproxil Zentiva (se pkt.
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg / 245 mg film-coated tablets
Danish: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg / 245 mg filmovertrukne tabletter
English: • Reminder of the key safety information regarding the use of Emtricitabine/Tenofovir disoproxil
Danish: • Påmindelse om de vigtigste sikkerhedsoplysninger omkring brugen af Emtricitabine/Tenofovir disoproxil Zentiva til PrEP hos voksne og unge
English: Emtricitabine/Tenofovir disoproxil Zentiva 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: Emtricitabine/Tenofovir disoproxil Zentiva bør ikke administreres samtidig med andre lægemidler, som indeholder emtricitabin, tenofovirdisoproxil, tenofoviralafenamid eller andre cytidinanaloger, såsom lamivudin (se pkt.
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Zentiva therapy
Danish: • At pædiatriske patienters nyrefunktion skal vurderes, før Emtricitabin/Tenofovirdisoproxil Zentiva behandling påbegyndes (nyrefunktion ved baseline)
English: Therefore Emtricitabine/Tenofovir disoproxil Zentiva should not be used during breast-feeding.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva bør derfor ikke anvendes under amning.
English: NARCOTIC ANALGESICS Methadone/tenofovir disoproxil
Danish: NARKOTISKE ANALGETIKA Methadon/Tenofovirdisoproxil
English: • Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: • Du må ikke amme, mens du er i behandling med Emtricitabine/Tenofovir disoproxil
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan opstå hos op til 1 ud af 1.000 personer):
English: Cmax: ↓ 24% (↓ 35 to ↓ 11) Cmin: ↔
Danish: Cmax: ↓ 24% (↓ 35 til ↓ 11)
English: • Emtricitabine/Tenofovir disoproxil Zentiva is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg,
Danish: • Emtricitabine/Tenofovir disoproxil Zentiva bruges også til at nedsætte risikoen for at få HIV 1-infektion hos voksne og unge i alderen 12 år til under 18 år, som vejer mindst 35 kg, når det bruges dagligt og sammen med udøvelse af sikker sex: Se punkt 2 for en liste over de forholdsregler, der skal tages, for ikke at få HIV-infektion.
English: Norgestimate:
Danish: Almindelig:
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: Warnings and precautions While taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV:
Danish: Advarsler og forsigtighedsregler Hvis du tager Emtricitabine/Tenofovir disoproxil Zentiva for at nedsætte risikoen for at få HIV:
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly (see section 4.4).
Danish: Adefovirdipivoxil og Emtricitabine/Tenofovir disoproxil Zentiva må ikke administreres samtidigt (se pkt.
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Danish: Der er rapporteret om mitokondriel dysfunktion hos HIVnegative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller postnatalt.
English: HIV/HBV or HCV co-infected patients
Danish: Patienter, som både er inficerede med HIV/HBV eller HCV:
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Danish: AUC: ↓ 4% (↓ 15 til ↑ 8) Cmax: ↑ 102% (↓ 96 til ↑ 108)
English: Asian
Danish: Asiater
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Danish: AUC: ↓ 11% (↓ 14 til ↓ 7) Cmax: ↓ 7% (↓ 13 til ↓ 0)
English: AUC: ↑ 45% Cmax: ↑ 60% Cmin: ↔
Danish: AUC: ↑ 45% Cmax: ↑ 60%
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12)
Danish: AUC: ↓ 3% (↓ 8% til ↑ 15) Cmax: ↓ 24% (↓ 44 til ↓ 12)
English: Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva er også indiceret til behandling af HIV 1-inficerede unge med NRTI-resistens eller -toksicitet, der udelukker brug af førstevalgspræparater (se pkt.
English: Co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4).
Danish: Samtidig administration af Emtricitabine/Tenofovir disoproxil Zentiva og didanosin kan ikke anbefales (se pkt.
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Danish: Elimination Emtricitabin udskilles primært gennem nyrerne med komplet genfinding af dosis opnået i urinen (ca.
English: Protease inhibitors Atazanavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Danish: ANTIINFEKTIVA Antiretrovirale lægemidler Proteasehæmmere Atazanavir/Ritonavir/ Tenofovirdisoproxil (300 mg q.d./100 mg q.d./ 245 mg q.d.)
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 Zentiva, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
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 Zentiva 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 Emtricitabine/Tenofovir disoproxil Zentiva som profylakse før eksponering, skal nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
English: Recommendation concerning co-administration with Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Danish: samtidig administration af Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabin 200 mg, tenofovirdisoproxil 245 mg)
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets Emtricitabine/tenofovir disoproxil
Danish: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg filmovertrukne tabletter Emtricitabin/tenofovirdisoproxil
English: Darunavir/ritonavir/emtricitabine Interaction not studied.
Danish: Darunavir/Ritonavir/Emtricitabin Interaktion er ikke undersøgt.
English: • Just taking Emtricitabine/Tenofovir disoproxil Zentiva may not stop you getting HIV.
Danish: • Det er ikke nødvendigvis nok at tage Emtricitabine/Tenofovir disoproxil Zentiva for at undgå at få HIV.
English: Use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel (se pkt.
English: Before taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV:
Danish: Inden du tager Emtricitabine/Tenofovir disoproxil Zentiva for at nedsætte risikoen for 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 Zentiva, renal function should be reevaluated 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 Emtricitabine/Tenofovir disoproxil Zentiva, bør nyrefunktionen revurderes inden for en uge, herunder måling af blodglucose, blodkalium og uringlucose (se pkt.
English: Do not miss any doses of Emtricitabine/Tenofovir disoproxil Zentiva, or stop taking it.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva-doser over eller holde op med at tage det.
English: Tenofovir: AUC: ↑ 81% (↑ 68 to ↑ 94)
Danish: Tenofovir: AUC: ↑ 6% (↓ 1 til ↑ 13)
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: The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV is:
Danish: Den anbefalede dosis af Emtricitabine/Tenofovir disoproxil Zentiva til at nedsætte risikoen for at få HIV er:
English: ANTI-INFECTIVES Antiretrovirals
Danish: ANTIINFEKTIVA
English: HIV-1 RNA < 50 copies/ml (TLOVR)
Danish: HIV -1-rna < 50 kopier/ml (TLOVR) p-værdi % forskel (95% CI)
English: Common dizziness headache
Danish: svimmelhed hovedpine
English: Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Danish: Profylakse før eksponering (Pre-exposure prophylaxis, PrEP) Emtricitabine/Tenofovir disoproxil Zentiva er i kombination med god praksis for sikker sex indiceret som profylakse før eksponering for at mindske risikoen for seksuelt erhvervet HIV 1-infektion hos meget udsatte voksne og unge (se pkt.
English: Nervous system disorders Very common headache dizziness
Danish: Nervesystemet Meget almindelig:
English: Emtricitabine/ tenofovir disoproxil/ efavirenz*
Danish: Emtricitabin+ tenofovirdisoproxil+ efavirenz*
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva frarådes hos personer under 18 år med nedsat nyrefunktion (se pkt.
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 (see section 4.5).
Danish: Samtidig administration af tenofovirdisoproxil og didanosin Samtidig administration anbefales ikke, da det resulterer i en stigning på 40-60% i den systemiske eksponering for didanosin, hvilket kan øge risikoen for didanosinrelaterede bivirkninger (se pkt.
English: While taking Emtricitabine/Tenofovir disoproxil Zentiva to treat HIV or to reduce the risk of getting HIV:
Danish: Hvis du tager Emtricitabine/Tenofovirdisoproxil Zentiva for at behandle HIV eller nedsætte risikoen for at få HIV:
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly (see section 4.4).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva må ikke administreres samtidigt (se pkt.
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Danish: AUC: ↓ 1% (↓ 8 til ↑ 6) Cmax: ↑ 7% (↓ 6 til ↑ 22)
English: Efavirenz/tenofovir disoproxil
Danish: Efavirenz/Tenofovirdisoproxil
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
Danish: AUC: ↓ 4% (↓ 7 til ↓ 1) Cmax: ↓ 4% (↓ 9 til ↑ 2)
English: FTC/tenofovir disoproxil groupa
Danish: FTC/tenofovirdisoproxilgruppea
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Danish: AUC: ↓ 2% (↓ 5 til ↑ 0) Cmax: ↓ 1% (↓ 7 til ↑ 6)
English: Administration every 48 hours is recommended based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section
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: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: Det er vigtigt, at du husker at tage alle doser Emtricitabine/Tenofovir disoproxil Zentiva.
English: • Children commonly experienced low red blood cell count (anaemia).
Danish: • Hos børn er det almindeligt at opleve et lavt antal røde blodlegemer (anæmi) Dette kan forårsage, at barnet blivet træt eller stakåndet
English: Consideration should be given to interrupting use of Emtricitabine/Tenofovir disoproxil Zentiva 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 brugen af Emtricitabine/Tenofovir disoproxil Zentiva hos personer, hvor kreatininclearance er faldet til < 60 ml/min- eller serumphosphat til < 1,0 mg/dl (0,32 mmol/), ligesom det bør overvejes at afbryde behandlingen i tilfælde af progredierende fald i nyrefunktionen, når ingen anden årsag er blevet identificeret.
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1)
Danish: AUC: ↑ 26% (↑ 20 til ↑ 32) Cmax: ↓ 5% (↓ 11 til ↑ 1) Cmin: IB
English: Uncommon rhabdomyolysis1, muscular weakness1
Danish: rabdomyolyse1, muskelsvækkelse1
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, før den beskyttende virkning opnås.
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Danish: AUC: ↑ 5% (↓ 2 til ↑ 13) Cmax: ↑ 5% (↓ 3 til ↑ 14) Cmin: IB
English: Contents of the pack and other information What Emtricitabine/Tenofovir disoproxil Zentiva contains
Danish: Pakningsstørrelser og yderligere oplysninger Emtricitabine/Tenofovir disoproxil Zentiva indeholder:
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Danish: AUC: ↑ 4% (↓ 3 til ↑ 11) Cmax: ↑ 3% (↓ 3 til ↑ 9) Cmin: IB
English: Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice, and drink immediately.
Danish: Hvis du har problemer med at synke, kan du knuse tabletten med spidsen af en ske og opløse den i ca. 100 ml (et halvt glas) vand, appelsinjuice eller druesaft.
English: 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: Possible serious side effects:
Danish: Alvorlige bivirkninger
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: • 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 Zentiva ved indikationen Profylakse før eksponering (PrEP)”
English: Indigo carmine aluminum lake (E 132)
Danish: Indigotin (E132)
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
Danish: AUC: ↓ 5% (↓ 9 til ↓ 1) Cmax: ↓ 11% (↓ 17 til ↓ 5) Cmin: IB
English: HIV-1 infection
Danish: Hiv 1-infektion:
English: Emtricitabine/ tenofovir disoproxil/ efavirenz
Danish: Emtricitabin+ tenofovirdisoproxil + efavirenz
English: • If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Zentiva treatment
Danish: • Hvis nyreabnormiteter mistænkes eller påvises, bør der tages kontakt til en nefrolog med henblik på at overveje at afbryde behandlingen
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan opstå hos op til 1 ud af 100 personer):
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan opstå hos op til 1 ud af 10 personer):
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 1-inficerede patienter med renale risikofaktorer.
English: Lamivudine/tenofovir disoproxil
Danish: Lamivudin/Tenofovirdisoproxil
English: Ribavirin/tenofovir disoproxil
Danish: Ribavirin/Tenofovirdisoproxil
English: • decreases in potassium in the blood,
Danish: • fald i blodets indhold af kalium