FrancophonIA/ELRC3.0 huggingface dataset:
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Danish: Der skal anvendes en pålidelig kontraceptiv barrieremetode sammen med hormonkontraceptiva (se pkt.
English: Since efavirenz/emtricitabine/tenofovir disoproxil is a combination product and the dosing interval of the individual components cannot be altered, treatment with efavirenz/emtricitabine/tenofovir disoproxil must be interrupted in patients with confirmed creatinine clearance < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Danish: Da efavirenz/emtricitabin/tenofovirdisoproxil er et kombinationsprodukt, og dosisintervallet for de enkelte komponenter ikke kan justeres, skal behandling med efavirenz/emtricitabin/tenofovirdisoproxil seponeres hos patienter med bekræftet kreatininclearance < 50 ml/min eller fald i serumfosfat til < 1,0 mg/dl (0,32 mmol/l).
English: Patients with mild liver disease (Child-Pugh-Turcotte (CPT), Class A) may be treated with the normal recommended dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (see sections 4.3, 4.4 and 5.2).
Danish: Patienter med let leversygdom (Child-Pugh-Turcotte (CPT), klasse A) kan behandles med den dosis, der normalt anbefales for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (se pkt.
English: - if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
Danish: - Hvis De tidligere har haft kramper (krampeanfald), eller hvis De får krampestillende behandling med f.eks. carbamazepin, phenobarbital og phenytoin.
English: Reference: single dose of a 600 mg efavirenz tablet, 200 mg emtricitabine capsule and 300 mg tenofovir disoproxil tablet taken under fasted conditions.
Danish: Reference: Enkeltdosis 600 mg efavirenz-tablet, 200 mg emtricitabin-kapsel og 300 mg tenofovirdisoproxiltablet taget under faste.
English: - if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Danish: - Hvis De tager anden medicin, som indeholder efavirenz, emtricitabin, tenofovirdisoproxil, tenofoviralafenamid, lamivudin eller adefovirdipivoxil.
English: Multipack: 90 (3 packs of 30) film-coated tablets.
Danish: Multipakning: 90 filmovertrukne tabletter (3 pakker med 30).
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir disoproxil.
Danish: K65R-mutationen kan desuden selekteres ved hjælp af abacavir eller didanosin og forårsager nedsat følsomhed over for disse stoffer samt lamivudin, emtricitabin og tenofovirdisoproxil.
English: You do not need to take another tablet if you were sick more than 1 hour after taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: De behøver ikke tage en ny tablet, hvis De kastede op mere end en time efter, De tog Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Prior NNRTI-based regimen (N=104)
Danish: Tidligere NNRTIbaseret behandling (N=104)
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Danish: - Medicin til behandling af hepatitis C-virusinfektion: boceprevir, elbasvir/grazoprevir simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
English: patients with HIV-1 RNA < 50 copies/ml
Danish: Patienter med hiv-1-rna < 50 kopier/ml PVR (KM) 94,5%
English: If you had a rash while taking another NNRTI, you may be at higher risk of getting a rash with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: Hvis De har haft udslæt, mens De tog en anden NNRTI, kan der være større risiko for, at De får udslæt med Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: The mean (%CV) tenofovir exposure increased from 2,185 ng•h/ml (12%) in patients with normal renal function, to 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) and 15,985 ng•h/ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Danish: Gennemsnitlig (%CV) tenofovir-eksponering øgedes fra 2.185 ng·t/ml (12%) hos patienter med normal nyrefunktion til henholdsvis 3.064 ng·t/ml (30%), 6.009 ng·t/ml (42%) og 15.985 ng·t/ml (45%) hos patienter med let, moderat og svært nedsat nyrefunktion.
English: Don't stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan without talking to your doctor.
Danish: Hold ikke op med at tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan uden at tale med Deres læge.
English: [To appear on outer carton only]
Danish: [Kun på den ydre emballage]
English: Efavirenz/emtricitabine/tenofovir disoproxil (N=203) n/N (%)
Danish: Efavirenz/emtricitabin/tenofovi rdisoproxil (N=203) n/N (%)
English: Liver enzyme monitoring should be considered for all patients independent of pre-existing hepatic dysfunction or other risk factors.
Danish: Monitorering af leverenzymer skal overvejes hos alle patienter, uanset om der er leverdysfunktion eller andre risikofaktorer i anamnesen.
English: Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz (see sections 4.3 and 4.4).
Danish: Patienterne skal monitoreres omhyggeligt for bivirkninger, især symptomer fra nervesystemet, der er relateret til efavirenz (se pkt.
English: Concomitant administration with efavirenz/emtricitabine/tenofovir disoproxil should be avoided due to the risk for QTc prolongation (see section 4.3).
Danish: Samtidig administration med Efavirenz/Emtricitabine/Tenofovi r disoproxil Mylan bør undgås pga. risikoen for QTc-forlængelse (se pkt.
English: Latvija Mylan Healthcare SIATel: +371 676 055 80
Danish: Mylan Healthcare SIA Tel: +371 676 055 80
English: Efavirenz, one of the active components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, may remain in your blood for a time after therapy is stopped.
Danish: Efavirenz, som er et af de aktive stoffer i Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, kan blive i blodet i et stykke tid efter, at behandlingen er stoppet.
English: Nervous system symptoms: Nervous system symptoms are common with efavirenz, one of the components of efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Symptomer fra nervesystemet: Symptomer fra nervesystemet er almindelige med efavirenz, et af de aktive stoffer i efavirenz/emtricitabin/tenofovirdisoproxil.
English: Your doctor may consider giving you the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan separately if you are having problems or need your dose adjusted.
Danish: Lægen kan overveje at give Dem de aktive stoffer i Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan hver for sig, hvis De har problemer, eller det er nødvendigt at justere Deres dosis.
English: Efavirenz/emtricitabine/tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R, M184V/I or K103N mutation (see sections 4.1 and 5.1).
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil skal undgås til patienter inficeret med hiv-1, som har K65R-, M184V/I- eller K103N-mutationer (se pkt.
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, antivirale lægemidler til behandling af hiv-infektioner, kombinationer.
English: Efavirenz/emtricitabine/tenofovir disoproxil is not recommended for patients who have had a lifethreatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking an NNRTI.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil må ikke anvendes til patienter, som har haft en livstruende hudreaktion (f.eks. Stevens-Johnsons syndrom) under NNRTI-behandling.
English: If you have severe liver disease, do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (see earlier in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).
Danish: Hvis De har en alvorlig leversygdom, må De ikke tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (se ovenfor punkt 2, Tag ikke Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).
English: AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36% (UGT1A1 induction)
Danish: AUC: ↓ 36% C12t: ↓ 21% Cmax: ↓ 36% (UGT1A1-induktion)
English: The mean (%CV) emtricitabine exposure increased from 12 µg•h/ml (25%) in subjects with normal renal function to 20 µg•h/ml (6%), 25 µg•h/ml (23%) and 34 µg•h/ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Danish: Gennemsnitlig (%CV) emtricitabin-eksponering øgedes fra 12 µg·t/ml (25%) hos patienter med normal nyrefunktion til henholdsvis 20 µg·t/ml (6%), 25 µg·t/ml (23%) og 34 µg·t/ml (6%) hos patienter med let, moderat og svært nedsat nyrefunktion.
English: Concomitant administration of simeprevir with efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil, resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir.
Danish: Samtidig administration af simeprevir og efavirenz, et aktivt stof i efavirenz/emtricitabin/tenofovirdi soproxil, resulterede i signifikant nedsat plasmakoncentration af simeprevir på grund af efavirenzforårsaget CYP3A-induktion, som kan resultere i manglende terapeutisk virkning af simeprevir.
English: Tenofovir disoproxil (n=45)
Danish: Tenofovirdisoproxil (N=45)
English: When the two strata were analysed separately, response rates in the stratum with prior PI-treatment were numerically lower for patients switched to efavirenz/emtricitabine/tenofovir disoproxil [92.4% versus 94.0% for the PVR (sensitivity analysis) for efavirenz/emtricitabine/tenofovir disoproxil and SBR patients respectively; a difference (95%CI) of -1.6% (-10.0%, 6.7%).
Danish: Når de to strata blev analyseret separat, var responsraterne i det stratum med tidligere proteasehæmmer-behandling numerisk lavere for de patienter, der skiftede til efavirenz/emtricitabin/tenofovirdisoproxil [92,4% versus 94,0% for PVR (sensitivitetsanalyse) for henholdsvis efavirenz/emtricitabin/tenofovirdisoproxil- og SBR-patienter (SBR, stayed on their baseline regimen); en forskel (95% CI) på -1,6% (-10,0%; 6,7%).
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz + lamivudine/zidovudine group among all patients.
Danish: K70E TAM'er2 * p-værdi < 0,05, Fishers eksakte test, som sammenligner efavirenz + emtricitabin + tenofovirdisoproxilgruppen med efavirenz + lamivudin/zidovudin-gruppen blandt alle patienter.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).
Danish: - Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tages normalt ikke sammen med anden medicin, som kan skade Deres nyrer (se Brug af anden medicin sammen med Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).
English: Atazanavir/ritonavir: Insufficient data are available to make a dosing recommendation for atazanavir/ritonavir in combination with efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Atazanavir/ritonavir: Der er ikke tilstrækkelig dokumentation til en doseringsanbefaling for atazanavir/ritonavir i kombination med efavirenz/emtricitabin/tenofovirdisoproxil.
English: Efavirenz/emtricitabine/tenofovir disoproxil must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil skal seponeres hos patienter, der udvikler svært udslæt ledsaget af blæredannelse, afskalning, mucosapåvirkning eller feber.
English: Cmax: ↓ 45% (CYP3A4 or P gp inductioneffect on elbasvir)
Danish: Cmax: ↓ 45 % (CYP3A4 eller P-gp-induktionvirkning på elbasvir)
English: Symptoms of your hepatitis may become worse after discontinuation of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: Symptomerne på Deres hepatitis kan blive værre, efter De er holdt med at tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Danish: Behandlingen må ikke seponeres hos patienter med fremskreden leversygdom eller levercirrose, da forværringen af hepatitis efter behandlingsophør kan føre til hepatisk dekompensation.
English: AUC12h: ↓ 45% (↓ 38 to ↓ 51) Cmax: ↓ 51% (↓ 37 to ↓ 62) Efavirenz concentrations not measured, no effect is expected.
Danish: AUC12t: ↓ 45% (↓ 38 til ↓ 51) Cmax: ↓ 51% (↓ 37 til ↓ 62) Koncentrationen af efavirenz er ikke målt, ingen virkning forventes.
English: As a result, the amounts of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan or other medicines in your blood may be affected.
Danish: Dette kan betyde, at mængden af Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan eller anden medicin i blodet kan blive påvirket.
English: Also, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Danish: De bør heller ikke tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan sammen med anden medicin, der indeholder efavirenz (medmindre Deres læge anbefaler det), emtricitabin, tenofovirdisoproxil, tenofoviralafenamid, lamivudin eller adefovirdipivoxil.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan kan påvirke virkningen af anden medicin, herunder naturlægemidler med Ginkgo biloba-ekstrakt (tempeltræ-ekstrakt).
English: If efavirenz/emtricitabine/tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis efavirenz/emtricitabin/tenofovirdisoproxil administreres sammen med et NSAID, skal nyrefunktionen monitoreres på tilstrækkelig vis.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should not be taken with any of these medicines.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan må ikke tages sammen med nogen af disse lægemidler.
English: - if you are currently taking any of the following medicines (see also “Other Medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan”): - astemizole or terfenadine (used to treat hay fever or other allergies) - bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - elbasvir/grazoprevir (used to treat hepatitis C) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches) - midazolam or triazolam (used to help you sleep) - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - St. John's wort (Hypericum perforatum) (a herbal preparation used for depression and anxiety) - voriconazole (used to treat fungal infections) - flecainide, metoprolol (used to treat irregular heart beat) - certain antibiotics (macrolides, fluoroquinolones, imidazole) - triazole antifungal agents - certain antimalarial agents - methadone (used to treat opiate addiction)
Danish: - hvis De i øjeblikket tager et eller flere af følgende lægemidler(se også “Brug af anden medicin sammen med Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan”): - astemizol eller terfenadin (mod høfeber eller andre allergier) - bepridil (mod hjertesygdom) - cisaprid (mod halsbrand) - Elbasvir/grazoprevir (medicin til behandling af hepatitis C) - ergotalkaloider (f.eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin) (mod migræne og klyngehovedpine) - midazolam eller triazolam (sovemedicin) - pimozid, imipramin, amitriptylin eller clomipramin (mod visse sindstilstande) - Perikon (Hypericum perforatum) (naturlægemiddel mod depression og angst) - voriconazol (mod svampeinfektioner) - - flecainid, metoprolol (mod uregelmæssigt hjerteslag) - - visse antibiotika (makrolider, fluorokinoloner, imidazol) - - triazol-svampemidler - - visse midler mod malaria - - methadon (medicin til behandling af stofmisbrug)
English: AUC: ↑ 34% (↑ 18 to ↑ 53) Cmax: ↑ 49% (↑ 32 to ↑ 69) Efavirenz:
Danish: AUC: ↑ 34% (↑ 18 til ↑ 53) Cmax: ↑ 49% (↑ 32 til ↑ 69) Efavirenz:
English: When efavirenz/emtricitabine/tenofovir disoproxil is taken with rifampicin in patients weighing 50 kg or greater, an additional 200 mg/day (800 mg total) of efavirenz may provide exposure similar to a daily efavirenz dose of 600 mg when taken without rifampicin.
Danish: Når efavirenz/emtricitabin/tenofovirdi soproxil tages sammen med rifampicin hos patienter, der vejer 50 kg eller derover, kan yderligere 200 mg/dag (800 mg i alt) efavirenz give samme eksponering som en daglig dosis efavirenz på 600 mg, når dosen tages uden rifampicin.
English: AUC: ↔*/** (↓ 10% to ↑ 26%) Cmax: ↔*/** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49) (CYP3A4 induction).
Danish: AUC: ↔*/ ** (↓ 10% til ↑ 26%) Cmax: ↔*/ ** (↓ 5% til ↑ 26%) Cmin: ↑ 12%*/ ** (↓ 16 til ↑ 49) (CYP3A4-induktion).
English: Carbamazepine can reduce the amount of efavirenz, one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, in your blood.
Danish: Carbamazepin kan nedsætte mængden af efavirenz, der er et af de aktive stoffer i Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, i blodet.
English: In a 144-week open-label randomised clinical study (GS-01-934) antiretroviral treatment-naïve HIV-1 infected patients received either a once-daily regimen of efavirenz, emtricitabine and tenofovir disoproxil or a fixed combination of lamivudine and zidovudine administered twice daily and efavirenz once daily (please refer to the Summary of Product Characteristics for this medicine).
Danish: I et 144-ugers åbent, randomiseret, klinisk studie (GS-01-934), hvor antiretroviralt-behandlingsnaive hiv-1-inficerede patienter enten fik et efavirenz-regimen en gang dagligt, emtricitabin og tenofovirdisoproxil eller en fast kombination af lamivudin og zidovudin, som blev givet to gange dagligt og efavirenz en gang dagligt (se produktresuméet for dette lægemiddel).
English: Cmax: ↓ 87% (CYP3A4 or P gp inductioneffect on grazoprevir)
Danish: Cmax: ↓ 87 % (CYP3A4 eller P-gp-induktionvirkning på grazoprevir)
English: They may occur more frequently when efavirenz/emtricitabine/tenofovir disoproxil is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Danish: De kan forekomme hyppigere, hvis efavirenz/emtricitabin/tenofovirdisoproxil indtages sammen med et måltid, muligvis pga. øget plasmakoncentration for efavirenz (se pkt.
English: If a patient misses a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan within 12 hours of the time it is usually taken, the patient should take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan as soon as possible and resume the normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan i mindre end 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: Dosage adjustment of lopinavir/ritonavir is necessary when given with efavirenz.
Danish: Dosisjustering af lopinavir/ritonavir er nødvendig ved administration sammen med efavirenz.
English: Artemether/Lumefantrine/Emtricitabine Interaction not studied.
Danish: Artemether/lumefantrin/emtricitabin Interaktion ikke undersøgt.
English: Metabolism and nutrition disorders: Very common hypophosphataemia2
Danish: Metabolisme og ernæring: Meget almindelig
English: General disorders and administration site conditions: Very common asthenia
Danish: Generelle symptomer og forstyrrelser ved applikationssted: Meget almindelig
English: The daily dose of rifabutin should be increased by 50% when given with Efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Den daglige dosis rifabutin skal øges med 50%, når dosen gives sammen med efavirenz/emtricitabin/tenofovirdi soproxil.
English: The use of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan in children and adolescents has not been studied.
Danish: Brug af efavirenz/emtricitabin/tenofovirdisoproxil Mylan til børn og unge er ikke blevet undersøgt.
English: Co-administration of efavirenz with atazanavir/ritonavir is not recommended.
Danish: Samtidig administration af efavirenz sammen med atazanavir/ritonavir frarådes.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan must be taken every day.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan skal tages hver dag.
English: QT Prolonging Drugs: efavirenz/emtricitabine/tenofovir disoproxil is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes, such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Danish: QT-forlængende lægemidler: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan er kontraindiceret ved samtidig brug af lægemidler, som vides at forlænge QTc-intervallet og kan føre til Torsade de Pointes, f.eks. antiarytmika af klasse IA og III, neuroleptika og antidepressiva, visse antibiotika, herunder nogle stoffer af følgende klasser: makrolider, fluorokinoloner, imidazol- og triazolantimykotika, visse non-sederende antihistaminer (terfenadin, astemizol), cisaprid, flecainid, visse antimalariamidler og methadon (sepkt.
English: No human data on the effect of efavirenz/emtricitabine/tenofovir disoproxil are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af efavirenz/emtricitabin/tenofovirdisoproxil.
English: Co-administration with voriconazole.
Danish: 4.5).Samtidig administration med voriconazol.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
Danish: Cmax: ↑ 11% (↑ 6 til ↑ 16) Cmin: ↔ (CYP3A4-induktion)
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with efavirenz/emtricitabine/tenofovir disoproxil and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Danish: Desuden skal nyrefunktionen (kreatininclearance og serumfosfat) monitoreres efter to til fire ugers behandling, efter tre måneders behandling og derefter hver tredje til sjette måned hos patienter uden renale risikofaktorer.
English: LIST OF EXCIPIENTS Also contains: sodium metabisulfite and lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: natriummetabisulfit og laktosemonohydrat.
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with ritonavir boosted saquinavir.
Danish: Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxil blev administreret sammen med ritonavir-boostet saquinavir.
English: Buprenorphine/naloxone/Emtricitabine Interaction not studied.
Danish: Buprenorphin/naloxon/emtricitabin Interaktion ikke undersøgt.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukken tablet.