natgillin/translations-raw huggingface dataset:
Blandt de co-inficerede patienter stoppede 3% i efavirenz-gruppen og 2% i kontrolgruppen på grund af leversygdom (se pkt.
Among co-infected patients, 3% of those treated with efavirenz and 2% in the control arm discontinued because of liverdisorders (see section 4.4).
Patienterne bør monitoreres mhp.
Patients should be monitored for seizure control.
Der er indberettet psykiatriske bivirkninger hos patienter, der er behandlet med efavirenz.
Psychiatric adverse reactions have been reported in patients treated with efavirenz.
Hyppigheden af tilbagevendende udslæt efter skift fra behandling med nevirapin til efavirenz, varierer fra 13 til 18% (primært baseret på retrospektive kohortedata fra publiceret litteratur), hvilket svarer til hyppigheden hos patienter, der er blevet behandlet med efavirenz i kliniske undersøgelser (se pkt.
Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18%, comparable to the rate observed in patients treated with efavirenz in clinical studies.
Carcinogenitetsundersøgelser på hanmus samt han- og hunrotter var negative.
Carcinogenicity studies in male mice, male and female rats were negative.
Der er rapporteret let til moderat udslæt i kliniske studier med efavirenz, og dette forsvinder sædvanligvis ved fortsat behandling.
Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Pakninger med 30 x 1 eller multipakning med 90 (3 pakninger med 30 x 1) filmovertrukne tabletter i perforeret enkeltdosisblister af aluminium/PVC.
Packs of 30 x 1 or multipacks of 90 (3 packs of 30 x 1) film-coated tablets in aluminium/PVC perforated unit dose blisters.
SUSTIVA 200 mg hårde kapsler fås i beholdere med 90 kapsler og i pakninger, der indeholder 42 x 1 kapsler i aluminium/PVC perforerede enkeltdosisblister.
What SUSTIVA looks like and contents of the pack SUSTIVA 200 mg hard capsules are supplied in bottles of 90 capsules and in packs containing 42 x 1 capsules in aluminium/PVC perforated unit dose blisters.
Nogle få af de tilfælde af leversvigt, der er indberettet efter markedsføring, forekom hos patienter uden leversygdom i anamnesen eller andre påviselige risikofaktorer (se pkt.
A few of the postmarketing reports of hepatic failure occurred in patients with no pre-existing hepatic disease or other identifiable risk factors (see section 4.8).
SUSTIVA er indiceret til antiviral kombinationsbehandling af humant immundefektvirus -1 (hiv-1) inficerede voksne, unge og børn fra 3 måneder og opefter, som vejer mindst 3,5 kg. SUSTIVA er ikke tilstrækkeligt undersøgt hos patienter med fremskreden hiv-sygdom, det vil sige patienter med CD4 tal < 50 celler/mm3, eller efter svigtende effekt af proteasehæmmerregimer (PI).
SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm
Der er set ikkevedvarende krampeanfald hos nogle aber, der fik efavirenz i ≥ 1 år, ved doser der gav plasma AUCværdier 4-13 gange højere end dem, der er set hos mennesker ved anbefalet dosis (se pkt.
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
3,5 til < 5
3.5 to < 5
Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Studie AI266922 var et ikke-blindet studie til evaluering af SUSTIVAs farmakokinetik, sikkerhed, tolerabilitet og antivirale aktivitet i kombination med didanosin og emtricitabin hos antiretroviralnaive og -erfarne pædiatriske patienter.
Study AI266922 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in antiretroviral-naive and -experienced paediatric patients.
Der er rapporteret om tilfælde af osteonekrose hos patienter, der har fremskreden hiv-sygdom og/eller hos patienter som befinder sig i langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Tabel 2: Interaktion mellem efavirenz og andre lægemidler hos voksne Lægemidler i henhold til terapeutisk område (dosis)
Table 2: Interactions between efavirenz and other medicinal products in adults
Efavirenz er kontraindiceret ved samtidig anvendelse af lægemidler (der kan medføre forlænget QTcinterval og torsade de pointes) såsom: antiarytmika klasse IA og III, neuroleptika og antidepressiva, visse antibiotika inklusive lægemidler fra følgende klasser: makrolider, fluoroquinoloner, imidazol og triazol antimykotika, visse non-sederende antihistaminer (terfenadin, astemizol), cisaprid, flecainid, visse malariamidler og methadon (se pkt.
Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and 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).
Boceprevirs plasmakoncentration faldt, når det blev administreret sammen med efavirenz.
Plasma trough concentrations of boceprevir were decreased when administered with efavirenz.
EFV + IDV 206
ZDV + 3TC EFV + IDV 206 IDV +
Disse lægemidler omfatter: - antiarytmika klasse IA og III - neuroleptika, antidepressiva - visse antibiotika inklusive lægemidler fra følgende klasser: makrolider, fluoroquinoloner,
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
- antiarytmika klasse IA og III - neuroleptika, antidepressiva - visse antibiotika inklusive lægemidler fra følgende klasser: makrolider, fluoroquinoloner,
- antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
< 500 kopier/ml
< 500 copies/ml
Tabel 3: Effektresultater for undersøgelserne ACTG 364 og 020
Table 3: Efficacy results for studies ACTG 364 and 020
Tabel 4: Effektresultater for undersøgelserne ACTG 364 og 020
Table 4: Efficacy results for studies ACTG 364 and 020
S.E.M., Standard afvigelse på middelværdi --- Ikke udført
d S.E.M., standard error of the mean.
tre 100 mg kapsler
three 100 mg capsules
Tag ikke SUSTIVA: hvis De er allergisk over for efavirenz eller et af de øvrige indholdsstoffer i SUSTIVA (angivet i punkt 6).
Do not take SUSTIVA if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Den biliære hyperplasi svandt ved seponering.
The biliary hyperplasia regressed upon cessation of dosing.
Patienter med kronisk hepatitis B eller C, som får antiretroviral kombinationsbehandling, har øget risiko for alvorlige og potentielt fatale leverbivirkninger.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Taget sammen med rifampicin kan øgning af efavirenzdosis til 800 mg dagligt hos voksne, der vejer 50 kg eller derover, give samme eksponering som en daglig dosis på 600 mg taget uden rifampicin.
When taken with rifampicin in patients weighing 50 kg or greater, increasing efavirenz daily dose to 800 mg may provide exposure similar to a daily dose of 600 mg when taken without rifampicin.
SUSTIVA kan nedsætte eller øge mængden af krampemedicin i blodet.
SUSTIVA can reduce or increase the amount of anticonvulsant in your blood.
Lægemidler med indvirkning på hjerterytmen: - Lægemidler til behandling af problemer med hjerterytmen: fx flecainid eller metoprolol.
Medicines that impact heart rhythm: - Medicines used to treat heart rhythm problems: such as flecainide or metoprolol.
AUC: ↑ 21% Cmin: ↑ 17% Cmax: ↑ 15% (CYP3A4-hæmning)
AUC: ↑ 21% Cmin: ↑ 17% Cmax: ↑ 15% (CYP3A4 inhibition)
Tabel 5: Efavirenz' forudsagte farmakokinetik ved steady rate (kapsler/kapselpulver) hos hivinficerede pædiatriske patienter
Table 5: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients
NRTIer og NNRTIer NRTIer/efavirenz
NRTIs and NNRTIs NRTIs/Efavirenz
Efavirenzbehandling kan genoptages hos patienter, der afbryder behandlingen på grund af udslæt.
Efavirenz can be reinitiated in patients interrupting therapy because of rash.
maraviroc kombinationstabletten, der indeholder efavirenz, emtricitabin og tenofovir, må ikke tages sammen med SUSTIVA medmindre Deres læge anbefaler det, da Atripla indeholder efavirenz, der er det aktive stof i SUSTIVA.
maraviroc the combination tablet containing efavirenz, emtricitabine, and tenofovir should not be taken with SUSTIVA unless recommended by your doctor since it contains efavirenz, the active ingredient of SUSTIVA.
Efavirenz filmovertrukne tabletter er ikke egent til børn, som vejer mindre end 40 kg.
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg.
Samtidig administration af velpatasvir/sofosbuvir/voxilap revir med efavirenz anbefales ikke, da det kan medføre fald i koncentrationerne af velpatasvir og voxilaprevir.
Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended, as it may decrease concentrations of velpatasvir and voxilaprevir.
< 400 kopier/ml
< 400 copies/ml
Spørg Deres læge eller på apoteket om råd.
Contact your doctor or pharmacist for advice.
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 249,6 mg lactose (i form af monohydrat).
Each film-coated tablet contains 249.6 mg of lactose (as monohydrate).
Methadon/efavirenz (stabil vedligeholdelse, 35-100 mg én gang dagligt/600 mg én gang dagligt)
Methadone/Efavirenz (stable maintenance, 35-100 mg once daily/600 mg once daily)
Studie PACTG 382 var et ikke-blindet studie til evaluering af SUSTIVAs farmakokinetik, sikkerhed, tolerabilitet og antivirale aktivitet i kombination med en nelfinavir og en NRTI hos antiretroviral-naive og NRTI-erfarne pædiatriske patienter.
Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with nelfinavir and an NRTI in antiretroviral-naive and NRTI-experienced paediatric patients.
Mørkegule, præget med "SUSTIVA" på skallen og "200 mg" på hætten.
Dark yellow, printed with "SUSTIVA" on the body and "200 mg" on the cap.
Agitstion, amnesi, ataksi, unormal koordination, kramper, abnorm tankevirksomhed, tremor
uncommon agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal,* tremor†
Patienterne bør monitoreres omhyggeligt for dosisrelaterede bivirkninger, især symptomer fra nervesystemet (se pkt.
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Cmin: ↓ 12% (↓ 24 til ↑ 1) (CYP3A4-induktion)
Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction)
Ved ordinering af medicin til brug sammen med efavirenz, bør lægen rådføre sig med det pågældende produktresumé.
When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics.
AUC: ↓ 17% Cmax: ↔ (CYP3A4-induktion)
AUC: ↓ 17% Cmax: ↔ (CYP3A4 induction)
< 50 kopier/ml
< 50 copies/ml
Se ordineringsoplysningerne for glecaprevir/pibrentasvir for yderligere information.
Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Det gennemsnitlige CD4 celletal ved baseline var 341 celler/mm3 og gennemsnitlig hiv-RNA niveau var 60.250 kopier/ml.
The mean baseline CD4 cell count was 341 cells/mm3 and the mean baseline HIV-RNA level was 60,250 copies/ml.
Tabel 1: Interaktion mellem efavirenz og andre lægemidler hos voksne Lægemidler i henhold til terapeutisk område (dosis)
Table 1: Interactions between efavirenz and other medicinal products in adults
Ved brug af ITT-analyse var andelen af patienter med hiv-RNA <400 kopier/ml og <50 kopier/ml ved uge 48 henholdsvis 57% (58/102) og 43% (44/102).
Using an ITT analysis, the overall proportion of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (58/102) and 43% (44/102), respectively.
Øvrigeindholdsstoffer i tabletkernen: Croscarmellosenatrium, mikrokrystallinsk cellulose, natriumlaurilsulfat, hydroxypropylcellulose, lactosemonohydrat og magnesiumstearat.
The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, and magnesium stearate.
Kvinder i den fertile alder skal have foretaget graviditetstest, før behandling med efavirenz initieres (se pkt.
Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz.
LÆGEMIDLETS NAVN SUSTIVA 600 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT SUSTIVA 600 mg film-coated tablets
Hvis patienten allerede tager perikon, skal dette seponeres og de virale niveauer og evt. efavirenzkoncentrationen kontrolleres.
If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Misdannelser er set hos fostre fra efavirenzbehandlede aber (se pkt.
Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Ved brug af ITT-analyse var andelen af patienter med hiv-RNA <400 kopier/ml og <50 kopier/ml ved uge 48 henholdsvis 57% (21/37) og 46% (17/37).
Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (21/37) and 46% (17/37), respectively.
Ethinylestradiol + norgestimat/efavirenz (0,035 mg + 0,25 mg én gang dagligt/600 mg én gang dagligt)
Ethinyloestradiol + Norgestimate/ Efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
Artemether/lumefantrin/efavirenz (20/120 mg tablet, 6 doser af 4 tabletter hver over 3 dage/600 mg en gang dagligt)
Artemether/lumefantrine/ Efavirenz (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Filmovertrækket indeholder: Hypromellose (E464), titandioxid (E171), macrogol 400, gul jernoxid (E172) og carnaubavoks.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172) and carnauba wax.
Hos nogle patienter med fremskreden hivinfektion (aids), som tidligere har haft en infektion, som kun forekommer under særlige betingelser (opportunistisk infektion), kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-hiv behandlingen er startet.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Tilstande med forhøjet lipid skal behandles som klinisk indiceret.
Lipid disorders should be managed as clinically appropriate.
I Table 2 ses effektresultaterne for Undersøgelse 006, for en undergruppe af 614 patienter, som havde været inkluderet i mindst 48 uger.
006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 2.
Dosisjustering af atorvastatin kan være påkrævet (se SPC for atorvastatin).
Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Blandt co-inficerede patienter i undersøgelse 006 steg ASAT mere end fem gange ULN hos 13% af de patienter, der fik efavirenz, og hos 7% af patienterne i kontrolgruppen, og ALAT steg mere end fem gange ULN hos henholdsvis 20% og 7%.
Among co-infected patients in study 006, elevations in AST to greater than five times ULN developed in 13% of efavirenz-treated patients and in 7% of control, and elevations in ALT to greater than five times ULN developed in 20% and 7%, respectively.
I et forsøg om smagspræference hos voksne, fik
In a taste preference study in adults, SUSTIVA mixed with grape jelly received the best rating.
Ingen klinisk signifikant farmakokinetisk forandring.
No clinically significant pharmacokinetic change.
Ingen klinisk signifikant farmakokinetisk interaktion.
No clinically significant pharmacokinetic interaction.
Samtidig administration af simeprevir og efavirenz resulterede i signifikant nedsat plasma-simeprevir som følge af CYP3A-induktion forårsaget af efavirenz, hvilket kan resultere i et tab af terapeutisk effekt af simeprevir.
Concomitant administration of simeprevir with efavirenz resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir.
Samtidig brug af Ginkgo biloba frarådes (se pkt.
Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Efavirenz' sikkerhed og virkning hos børn under 3 måneder, eller børn der vejer under 3,5 kg, er ikke klarlagt.
The safety and efficacy of efavirenz in children below the age of 3 months or weighing less than 3.5 kg have not been established.
- hvis De tidligere har haft krampeanfald, eller hvis De får medicin mod krampeanfald, for eksempel carbamazepin, phenobarbital og phenytoin.
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.
Det reproduktive system og mammae Ikke almindelig
Reproductive system and breast disorders uncommon gynaecomastia
celler/mm3 (S.E.M.
cells/mm (S.E.M.
Efavirenz kan forårsage svimmelhed, nedsat koncentrationsevne og/ellerdøsighed.
Efavirenz may cause dizziness, impaired concentration, and/or somnolence.
Posaconazol/efavirenz --/400 mg én gang dagligt
Posaconazole/Efavirenz --/400 mg once daily
Samtidig administration af simeprevir og efavirenz frarådes.
Co-administration of simeprevir with efavirenz is not recommended.
SUSTIVA 600 mg filmovertrukne tabletter fås i flasker med 30 tabletter.
What SUSTIVA looks like and contents of the pack SUSTIVA 600 mg film-coated tablets are supplied in bottles of 30 tablets.
Ved brug af ITT-analyse var andelen af patienter med hiv-RNA <400 kopier/ml og <50 kopier/ml ved uge 48 henholdsvis 77% (33/43) og 70% (30/43).
Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxil, bør ikke administreres samtidigt medmindre det er nødvendigt for dosisjustering (fx ved samtidig behandling med rifampicin).
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil is not recommended unless needed for dose adjustment (for example, with rifampicin).
< 400 kopier/ml (95% C.I.
< 400 copies/ml (95% C.I.
Andre makrolidantibiotika (fx erythromycin)/efavirenz
Other macrolide antibiotics (e.g.,erythromycin)/Efavirenz
Tabel 4: Efavirenz' forudsagte farmakokinetik ved steady rate (kapsler/kapselpulver) hos hivinficerede pædiatriske patienter
Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients Body Weight
De skal straks informere Deres læge for at få den nødvendige behandling, hvis De bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Det skal De vide, før De begynder at tage SUSTIVA Tag ikke SUSTIVA: hvis De er allergisk over for efavirenz eller et af de øvrige indholdsstoffer i Sustiva (angivet i punkt 6)Sustiva.
What you need to know before you take SUSTIVA Do not take SUSTIVA if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
< 50 kopier/ml (95% C.I.
< 50 copies/ml (95% C.I.
Ved baseline var det mediane plasma hiv-RNA 4,8 log10-kopier/ml, median-CD4+ celletal var 367 celler/mm3, og median-CD4+ procent var 18%.
At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Se ordineringsoplysningerne for sofosbuvir/velpatasvir for yderligere information.
Refer to the prescribing information for sofosbuvir/velpatasvir for more information.
Filmovertrukne tabletter
PHARMACEUTICAL FORM Film-coated tablet
SUSTIVA er ikke tilstrækkeligt undersøgt hos patienter med fremskreden hiv-sygdom, det vil sige patienter med CD4 tal < 50 celler/mm
SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
755 celler/mm3 , og median-CD4+ procent var 30%.
CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Velpatasvir/sofosbuvir/voxilaprev ir
Velpatasvir/ sofosbuvir/ voxilaprevir
Studie PACTG 1021 var et ikke-blindet studie til evaluering af SUSTIVAs farmakokinetik, sikkerhed, tolerabilitet og antivirale aktivitet i kombination med didanosin og emtricitabin hos antiretroviralnaive pædiatriske patienter.
Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
AUC: ↑ 17% (↑ 6 til ↑ 29)** Cmax: ↔** *sammenlignet med 200 mg alene to gange dagligt **sammenlignet med 600 mg alene én gang dagligt (kompetitiv hæmning af oxidativ metabolisme)
*compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (competitive inhibition of oxidative metabolism)
Malariamidler
Antimalarials
4.3 og 5.2) og bør ikke gives til patienter med moderat leverinsufficiens, da data er utilstrækkelige til at afgøre, om dosisjustering er nødvendig.
Efavirenz is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2) and not recommended in patients with moderate hepatic impairment because of insufficient data to determine whether dose adjustment is necessary.
Plasmakoncentrationen for phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP-isoenzymer, kan eventuelt falde eller stige, når disse administreres samtidigt med efavirenz.
There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when coadministered with efavirenz.
Effektresultater for undersøgelserne ACTG 364 og 020 kan ses i tabel 4.
Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Denne kombination bør anvendes med forsigtighed.
The combination was generally well tolerated.
Ved baseline var det mediane plasma-hiv-RNA 5,88 log10-kopier/ml, median-CD4+ celletal var 1.144 celler/mm3, og median-CD4+ procent var 25%.
At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.