natgillin/translations-raw huggingface dataset:
Dosisjustering af atorvastatin kan være påkrævet (se SPC for atorvastatin).
Dosage adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Dosisjustering af pravastatin kan være påkrævet (se SPC for pravastatin).
Dosage adjustment of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
administration med efavirenz
Simvastatin/ Efavirenz (40 mg once daily/ 600 mg once daily)
Dosisjustering af simvastatin kan være påkrævet (se SPC for simvastatin).
Dosage adjustment of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
ORALE KONTRACEPTIVA Ethinylestradiol/ efavirenz (50 µg enkeltdosis/ 400 mg én gang dagligt) IMMUNOSUPPRESSIVA
HORMONAL CONTRACEPTIVES Ethinyloestradiol/ Efavirenz (50 µg single dose/ 400 mg once daily) IMMUNOSUPPRESSANTS
Kun ethinylestradiolkomponenten i orale kontraceptiva er blevet undersøgt.
Only the ethinyloestradiol component of oral contraceptives has been studied.
Immunosuppressiva metaboliseres via CYP3A4 (fx cyclosporin, tacrolimus, sirolimus) / efavirenz OPIOIDER
Immunosuppressants metabolized by CYP3A4 (eg, cyclosporine, tacrolimus, sirolimus)/ Efavirenz OPIOIDS
Nedsat eksponering af det immunosuppressive lægemiddel kan forventes (CYP3A4 - induktion).
Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Buprenorphin/ naloxon/ efavirenz a
Buprenorphine/ naloxone/ Efavirenz a
90% konfidensinterval med mindre andet er angivet. b 95% konfidensinterval.
90% confidence intervals unless otherwise noted. b 95% confidence intervals.
Mængden af data vedrørende anvendelse af efavirenz til gravide kvinder er begrænset.
15 Pregnancy: there are limited amount of data from the use of efavirenz in pregnant women.
16 Patienterne skal instrueres i at undgå potentielt farlige opgaver som fx at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
4. 4).
The administration of SUSTIVA with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Udslættene er for det meste milde til moderate, makulopapuløse huderuptioner, der optræder inden for de første 2 uger efter påbegyndelsen af efavirenz- behandling.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
For kontrollerede undersøgelser med 1. 008 patienter, der blev behandlet med regimer, der indeholder efavirenz i gennemsnitligt 1, 6 år og 635 patienter behandlet med kontrolregimer i gennemsnitligt 1, 3 år, er hyppigheden af specifikke, alvorlige psykiatriske bivirkninger beskrevet i detaljer nedenfor:
16 average of 1.6 years and 635 patients treated with control regimens for an average of 1.3 years, the frequency of specific serious psychiatric events are detailed hereafter:
Patienter med psykiatriske lidelser i anamnesen synes at have større risiko for disse alvorlige, psykiatriske bivirkninger, hvor hyppigheden af hvert af de ovenstående tilfælde varierer fra 0, 3% for maniske reaktioner til 2, 0% for både svær depression og suicidaltanker.
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Der har, ligeledes efter markedsføring været indberetninger om selvmord, vrangforestillinger og psykotisk opførsel.
There have also been post-marketing reports of death by suicide, delusions and psychosis-like behaviour.
Svimmelhed, søvnløshed, somnolens, nedsat koncentrationsevne og unormal drømmeaktivitet.
Nervous system symptoms: in clinical controlled trials, frequently reported adverse reactions in patients receiving 600 mg efavirenz with other antiretroviral agents included, but were not limited to: dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
I en klinisk undersøgelse varierede den månedlige prevalens af symptomer af mindst moderat sværhedsgrad fra nervesystemet mellem uge 4 og 48, mellem 5 - 9% hos patienter i behandligsregimer med efavirenz og mellem 3 - 5% hos patienterne, som fik kontrolbehandling.
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
Moderate eller mere alvorlige bivirkninger, hvor der mindst er en mulig forbindelse til behandlingsregimet (baseret på investigator tilskrivning), som er rapporteret i kliniske undersøgelser for efavirenz i anbefalede doser i kombinationsbehandling (n = 1. 008) er anført nedenfor.
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
18 Hud og subkutane væv Meget almindelig
Skin and subcutaneous tissue disorders
Udslæt
very common
Unormale laboratorieprøver:
18 Laboratory test abnormalities:
Der sås forhøjelser af gamma- glutamyltransferase (GGT) til mere end fem gange ULN hos 4% af alle patienter, der blev behandlet med 600 mg efavirenz og hos 1, 5- 2% af de patienter, der blev behandlet med kontrolregimerne (7% af de efavirenzbehandlede patienter og 3% patienter i kontrolgruppen efter langtidsbehandling).
Elevations of gamma-glutamyltransferase (GGT) to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5-2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment).
Isolerede forhøjelser af GGT hos patienter, som får, efavirenz kan give enzyminduktion.
Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction.
19 I langtidsdata fra undersøgelse 006 var 137 patienter i regimer, der indeholder efavirenz (median behandlingsvarighed 68 uger) og 84 patienter i kontrolregimer (median behandlingsvarighed 56 uger) seropositive ved screening for hepatitis B (surface antigen positive) og/ eller C (hepatitis C antistof positive).
In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/ or C (hepatitis C antibody positive).
Blandt disse co- inficerede patienter udvikledes der forhøjelser af ASAT på mere end fem gange ULN hos 13% af patienterne i efavirenz - gruppen og hos 7% af patienterne i kontrolgruppen, samt forhøjelser af ALAT på mere end fem gange ULN hos 20% af patienterne i efavirenz- gruppen og hos 7% af patienterne i kontrolgruppen.
Among these co-infected patients, elevations in AST to greater than five times ULN developed in 13% of patients in the efavirenz arms and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed in 20% of patients in the efavirenz arms and 7% of the patients in the control arm.
21 – 31%, 23 – 34% og 23 – 49%).
In clinical trials of various efavirenz-containing regimens in treatment naive patients, total cholesterol, HDL-cholesterol, and triglycerides increased over 48 weeks of treatment (21 - 31%, 23 - 34%, and 23 - 49%, respectively).
I en undersøgelse, der omfattede 57 børn oplevede 3, 5% symptomer fra nervesystemet af moderat intensitet, fortrinsvis svimmelhed.
In the study of 57 children, 3.5% of patients experienced nervous system
Behandling af overdosis med efavirenz bør bestå i almindelige, støttende foranstaltninger inklusive monitorering af objektive symptomer og observation af patientens kliniske tilstand.
Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient’ s clinical status.
20 Administration af aktivt kul kan anvendes for at understøtte fjernelse af ikke- absorberet efavirenz.
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
J05AG03
J05AG03
Den frie koncentration af efavirenz, der er nødvendig for 90 - 95% hæmning af vildtype - eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0, 46 til 6, 8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag - / monocytkulturer.
Antiviral activity: the free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.
Mønstret for aminosyresubstitutioner i RT, der er forbundet med resistens over for efavirenz var uafhængigt af de andre antivirale medikamenter, der anvendtes i kombination med efavirenz.
The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medications used in combination with efavirenz.
Ved cellekultur viste krydsresistensprofiler for efavirenz, nevirapin og delavirdin, at K103N- substitutionen giver tab af følsomhed over for alle tre NNRTI´ere.
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Man fandt, at 5 af disse NNRTI- resistente isolater havde K103N - eller en valin- til- isoleucin- substitution på position 108 (V108I) i RT.
20 isoleucine substitution at position 108 (V108I) in RT.
21 Farmakodynamisk effekt:
Pharmacodynamic effects:
1 års varighed med efavirenz i kombination med NRTI´ere og/ eller PI´ere har vist en reduktion i mængden af virus i blodet til under detektionsgrænsen i assayet og stigning i CD4 lymfocytter hos antiretroviral behandlingsnaive og NRTI- behandlede HIV- inficerede patienter.
Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/ or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV-infected patients.
I disse undersøgelser var efavirenzdosis 600 mg en gang dagligt; indinavirdosis på 1. 000 mg hver 8. time blev anvendt i kombination med efavirenz og 800 mg hver 8. time blev anvendt uden efavirenz.
In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
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.
I analysen af responsraten (non- completer lig med failure analysen [NC = F]), blev patienter, der udgik af studiet tidligt uanset grund, patienter som manglede en HIV- RNA måling, som enten var forudgået eller blev efterfulgt af en måling over assaygrænsen, formodet at have HIV- RNA over 50 eller over 400 kopier/ ml på de manglende tidspunkter.
In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ ml at the missing time points.
Middelændring fra
Mean change from baseline-CD4 cell count
Behandlings - regimed
Treatme
N
nt n
48% 41%, 55%)
48% (41%, 55%)
NC = F, non- completer = failure b C. I., konfidensinterval. c S. E. M.
NC = F, noncompleter = failure. b C. I., confidence interval. c S. E. M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Standard afvigelse på middelværdi d EFV, efavirenz; ZDV, zidovudin, 3TC, lamivudin; IDV, indinavir.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV+IDV, 196 patients with EFV+ZDV+3TC and 127 patients with IDV+ZDV+3TC, respectively),
Langtidsresultater efter 168 uger i Undersøgelse 006 (160 patienter fuldførte undersøgelsen med EFV+IDV, 196 med EFV+ZDV+3TC og 127 patienter med IDV+ZDV+3TC) tyder på varigt respons med hensyn til mængden af patienter med HIV RNA < 400 kopier/ ml, HIV RNA < 50 kopier/ ml og med hensyn til middelændring fra baseline af CD4 celletal.
21 suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ ml, HIV RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Lægen kunne skifte patienternes NRTI regime ved indgangen til studiet.
Physicians were allowed to change their patient’ s NRTI regimen upon entry into the study.
baseline- CD4 celletal
Study Number/ Treatment Regimensb
EFV + NFV + NRTI´ere EFV + NRTI´ere NFV + NRTI´ere
EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
EFV + IDV + NRTI´ere IDV + NRTI´ere a NC = F, noncompleter = failure b
EFV + IDV + NRTIs IDV + NRTIs
EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nucleoside reverse transkriptasehæmmer; NFV, nelfinavir c C. I., konfidensinterval for antal patienter med respons d S. E. M., Standard afvigelse på middelværdi --- Ikke udført
NC = F, noncompleter = failure. b EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir. c C. I., confidence interval for proportion of patients in response. d S. E. M., standard error of the mean. ---, not performed.
ACTG 382 er en igangværende ukontrolleret undersøgelse af 57 NRTI - erfarne, pædiatriske patienter (3 - 16 år), som beskriver farmakokinetik, antiviral aktivitet og sikkerhed af efavirenz i kombination med nelfinavir (20- 30 mg/ kg indgivet 3 gange om dagen) og et eller flere NRTI´ere.
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
De højeste efavirenz- plasmakoncentrationer på 1, 6 - 9, 1 μM blev nået senest 5 timer efter orale enkeltdoser på 100 - 1. 600 mg, der blev indgivet til ikke- inficerede frivillige.
Absorption: peak efavirenz plasma concentrations of 1.6 - 9.1 μ M were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Hos 35 patienter, der fik efavirenz 600 mg 1 gang dagligt var gennemsnitlige steady- state Cmax 12, 9 ± 3, 7 μM (29%) [gennemsnit ± S. D.
In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μ M (29%) [mean ± S. D.
4. 4).
22 Effect of food: the bioavailability of a single 600 mg dose of efavirenz hard capsules in uninfected volunteers was increased 22% and 17%, respectively, when given with a meal of high fat or normal composition, relative to the bioavailability of a 600 mg dose given under fasted conditions (see section 4.4).
Biotilgængeligheden af indholdet i hårde kapsler i blandinger med føde som bindemidler: hos sunde voksne undersøgelsespersoner, opfylder efavirenz AUC' s kriterier for AUC- biotilgængeligheden for lægemiddel i intakte kapsler, ved indgivelse i form af tre (3) 200 mg hårde kapsler blandet med to (2) tsk. af et bestemt fødebindemiddel (æblemost, marmelade, yoghurt eller modermælkserstatning) på fastende mave.
Bioavailability of hard capsule contents mixed with food vehicles: in healthy adult subjects, the efavirenz AUC when administered as the contents of three 200 mg hard capsules mixed with 2 teaspoons of certain food vehicles (applesauce, grape jelly, yogurt or infant formula) met bioequivalency criteria for the AUC of the intact capsule formulation administered under fasted conditions.
Efavirenz har en forholdsvis lang halveringstid på mindst 52 timer efter enkeltdoser og 40 - 55 timer efter multiple doser.
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 - 55 hours after multiple doses.
Der er set misdannelser hos 3 ud af 20 fostre/ nyfødte fra efavirenzbehandlede cynomolgusaber, der fik indgivet en dosis der resulterede i efavirenzkoncentrationer i plasma lig dem set hos mennesker.
Malformations were observed in 3 of 20 foetuses/ newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz
Der er set ikke -
Biliary fibrosis has been observed in rats.
Selvom carcinogenicitetspotentialet hos mennesker ikke er kendt, antyder disse data, at efavirenz 'kliniske fordele opvejer den mulige carcinogenicitet hos mennesker.
While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Kapselkerne Natriumlaurilsulfat Lactosemonohydrat Magnesiumstearat, Natriumstivelsesglycollat
Capsule core Sodium laurilsulfate Lactose monohydrate Magnesium stearate Sodium starch glycolate
Prægeblæk Cochenillecarminsyre (E120) Indigocarmin (E132) Titandioxid (E171).
Printing ink Cochineal carminic acid (E120) Indigo carmine (E132) Titanium dioxide (E171)
6. 5 Emballagetype og pakningsstørrelser
24 6.5 Nature and content of container
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH Storbritannien
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH United Kingdom
EU/ 1/ 99/ 110/ 001 – HDPE- beholder
EU/ 1/ 99/ 110/ 001 - bottle
28. maj 1999 Dato for seneste fornyelse af tilladelsen:
28 May 1999 Date of latest renewal:
Hårde kapsler Hvide, præget med "SUSTIVA" på skallen og "100 mg" på hætten.
White, printed with "SUSTIVA" on the body and "100 mg" on the cap.
SUSTIVA hårde kapsler må kun gives til børn, der med sikkerhed er i stand til at synke hårde kapsler.
SUSTIVA hard capsules must only be administered to children who are able to reliably swallow hard capsules.
5. 1 og 5. 2).
26 SUSTIVA is not recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
Tabel 1 Pædiatrisk dosis til indgivelse én gang daglig *.
Table 1 Paediatric dose to be administered once daily*
Legemsvægt Kg 13 til < 15 15 til < 20 20 til < 25 25 til < 32, 5 32, 5 < 40 ≥ 40
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
Efavirenz må ikke gives samtidigt med terfenadin, astemizol, cisaprid, midazolam, triazolam, primozid, bepridil eller ergotalkaloider (fx ergotamin, dihydroergotamin, ergonovin og methylergonovin) da konkurrence om CYP3A4 fra efavirenz kan resultere i hæmning af
27 Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
28 metaboliseringen.
Herbal preparations containing St.
Patienterne bør rådes til straks at kontakte deres læge, hvis de oplever symptomer såsom svær depression, psykose eller selvmordstanker, med henblik på vurdering af, om symptomerne er relaterede til brugen af efavirenz, og hvis dette er tilfældet, for at beslutte hvorvidt risici ved fortsat behandling overstiger fordelene (se pkt.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor
4. 8).
28 immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
Patienter med
Efavirenz is contraindicated in patients with severe hepatic impairment (see
30 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.
Patienter med sjældne, arvelige sygdomme som galactose- inteolerance, Lapp lactasemangel eller glucose/ galactose malabsorptionssyndrom bør ikke tage dette lægemiddel.
Lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
31 Hvis muligt vises 90% eller 95% konfidensinterval i parentes.
If available, 90% or 95% confidence intervals are shown in parentheses.
Tabel 2:
30 Table 2:
Hvis samtidig administration af atazanavir og et NNRTI er nødvendig, bør det overvejes at øge dosis for både atazanavir og ritonavir til henholdsvis
If the co- administration of atazanavir with an NNRTI is required, an increase in the dose of both
Atazanavir/ ritonavir/ efavirenz (400 mg én gang dagligt/ 200 mg én gang dagligt/ 600 mg én gang dagligt, alle
Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 200 mg once daily/ 600 mg once daily, all administered with food)
AUC: ↔ * / ** (↓ 10% til ↑ 26%)
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir. ** based on historical comparison
400 mg og 200 mg sammen med efavirenz med tæt klinisk monitorering.
atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
32 Lægemidler i henhold til terapeutisk
Medicinal product by
33 Lægemidler i henhold til terapeutisk
Medicinal product by
Raltegravir/ efavirenz (400 mg enkeltdosis / -) NRTIer og NNRTIer
Raltegravir/ Efavirenz (400 mg single dose/ -) NRTIs and NNRTIs
34 Lægemidler i henhold til terapeutisk
NRTIs/ Efavirenz
NRTIer/ efavirenz
Medicinal product by
35 Lægemidler i henhold til terapeutisk
Medicinal product by
36 Lægemidler i henhold til terapeutisk
Medicinal product by
område
therapeutic areas (dose)
lægemiddelkoncentrationen,
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Lægemidler i henhold til terapeutisk område (dosis) ANTIDEPRESSIVA
Medicinal product by
Indvirkning på lægemiddelkoncentrationen, gennemsnitlig ændring (%) i AUC, Cmax, Cmin med konfidensintervaller hvis muligta (mekanisme)
Effects on drug levels
Anbefaling vedrørende samtidig administration med efavirenz
Recommendation concerning
Selektive serotonin genoptagelseshæmmere
therapeutic areas (dose)
(SSRIer)
co-administration with efavirenz
Sertralin/ efavirenz (50 mg én gang dagligt/ 600 mg én gang dagligt)
ANTIDEPRESSANTS Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/ Efavirenz (50 mg once daily/ 600 mg once daily)
38 Lægemidler i henhold til terapeutisk
Medicinal product by
gennemsnitlig ændring (%) i AUC, Cmax, Cmin med konfidensintervaller hvis muligta (mekanisme)
concentrations of the calcium channel blocker.
Interaktion er ikke undersøgt.
calcium channel blocker).
ORALE KONTRACEPTIVA
38
39 Lægemidler i henhold til terapeutisk
Medicinal product by
Ethinylestradiol/ efavirenz (50 µg enkeltdosis/ 400 mg én gang dagligt) IMMUNOSUPPRESSIVA
HORMONAL CONTRACEPTIVES Ethinyloestradiol/ Efavirenz (50 µg single dose/ 400 mg once daily) IMMUNOSUPPRESSANTS
Det anbefales at tage passende kontraceptive forholdsregler i 12 uger efter 40 ophørt behandling med efavirenz, da efavirenz har en lang halveringstid.
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.