natgillin/translations-raw huggingface dataset:
AUC: ↓ 58% (↓ 39 til ↓ 68) Cmax: ↓ 51% (↓ 32 til ↓ 58) Totalt aktive HMG Co- A reduktasehæmmere:
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total HMG Co-A reductase inhibitors:
AUC: ↓ 60% (↓ 52 til ↓ 68) Cmax: ↓ 62% (↓ 55 til ↓ 78) (CYP3A4- induktion) Samtidig administration af efavirenz og atorvastatin, pravastatin eller simvastatin påvirkede ikke efivarenz 'AUC - eller Cmax- værdier.
AUC: ↓ 60% (↓ 54 to ↓ 74) Cmax: ↓ 70% (↓ 58 to ↓ 85) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
71
62
72 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Graviditet bør undgås hos kvinder, der er i behandling med efavirenz.
63 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Det anbefales, at HIV- smittede kvinder, for ar undgå overførsel af HIV, ikke ammer deres børn under nogen omstændigheder.
It is recommended that HIV infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
Langtidssikkerhedsprofilen for regimer, der indeholder efavirenz, blev evalueret i en kontrolleret undersøgelse (006), hvor patienter behandledes med enten efavirenz + zidovudin + lamivudin (n = 412, medianvarighed 180 uger), efavirenz + indinavir (n = 415, medianvarighed 102 uger) eller indinavir + zidovudin + lamivudin (n = 401, medianvarighed 76 uger).
The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
73 udslættet inden for 1 måned ved fortsat behandling med efavirenz.
In most patients rash resolves with continuing therapy with efavirenz within one month.
Erfaring med efavirenz hos patienter, som er ophørt med andre antiretrovirale lægemidler af NNRTI- gruppen, er begrænset.
64 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Nervesystemet Almindelig
65 Nervous system disorders common
75 subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtakkumulering (tyrenakke).
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
4. 4).
66 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Der sås forhøjelser af aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) til mere end 5 gange den øvre grænse for normalområdet hos 3% af 1. 008 patienter, der blev behandlet med 600 mg efavirenz (5- 8% efter langtidsbehandling i Undersøgelse 006).
Liver enzymes: elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5 - 8% after long-term treatment in study 006).
Lignende forhøjelser blev set hos patienter, der blev behandlet med kontrolregimer (5% efter langtids - behandling).
Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
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).
Hos børn var bivirkningerne generelt de samme som hos voksne patienter.
67 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
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 symptoms of moderate intensity, predominantly dizziness.
Behandling af overdosis med efavirenz bør bestå i almindelige, støttende foranstaltninger inklusiv 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.
Der blev også observeret substitutioner på RT - positionerne 98, 100, 101, 108, 138, 188, 190 eller 225 blev også observeret, men med lavere frekvenser og ofte kun i kombination med K103N.
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Mønstret for aminosyresubstitutioner i RT, der er
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.
77 forbundet med resistens over for efavirenz, var uafhængigt af de andre antivirale medikamenter, der anvendtes i kombination med efavirenz.
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.
Krydsresistens:
68 the K103N substitution.
Virale isolater indhentet fra PBMCer fra patienter, der var inkluderet i kliniske efavirenzundersøgelser, som viste tegn på behandlingssvigt (reboundfænomen af virus i blodet) blev vurderet med henblik på følsomhed over for NNRTI’ ere.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
I Tabel 3 ses effektresultater for Undersøgelse 006, for en undergruppe af 614 patienter, som havde været inkluderet i mindst 48 uger.
Efficacy results for study 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 3.
78 Tabel 3:
Table 3:
Respons hyppigheder (NC Plasma HIV- RNA
Responder rates (NC = Fa) Plasma HIV-RNA
F ** a)
Plasma HIV-RNA
% (95% C. I. ** c)%
(95
celler/ mm3 (S. E. M. ** d)
cells/ mm3 (S. E. M. d)
Behandlingsregimer ** b Undersøgelse ACTG 364 48 uger
Study ACTG 364 48 weeks
NC = F, Noncompleter = Failure b EFT, 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.
79 procentdel af patienter med plasma HIV- RNA < 400 koPI' er/ ml efter 48 uger var 60% (95%, C. I.
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ ml at 48 weeks was 60% (95%, C. I.
5. 2 Farmakokinetiske egenskaber
70 5.2 Pharmacokinetic properties
Tiden indtil peak plasmakoncentrationer (3 - 5 timer) ændredes ikke efter multiple doseringer, og steady- state plasmakoncentrationerne blev nået på 6 - 7 dage.
Time to peak plasma concentrations (3 - 5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 - 7 days.
Hos 35 patienter, der fik efavirenz 600 mg 1 gang dagligt var det 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.
Køn, race, ældre:
71 Gender, race, elderly:
Kapselskal Gelatine Natriumlaurilsulfat Gul jernoxid (E172) Siliciumdioxid (E551)
Capsule shell Gelatine Sodium laurilsulfate Yellow iron oxide (E172) Silicon dioxide (E551)
81 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 3 Opbevaringstid
72 6.3 Shelf life
For beholderen:
For bottles:
For blister:
3 years For blisters:
HDPE- beholdere med børnesikret polypropylenlåg.
HDPE bottles with a child-resistant polypropylene closure.
Pakninger med 42 x 1 hårde kapsler i aluminiumperforeret enkeltdosis blister.
Packs of 42 x 1 hard capsules in aluminium perforated unit dose blisters.
EU/ 1/ 99/ 111/ 003 – HDPE- beholder EU/ 1/ 99/ 111/ 004 – blister
EU/ 1/ 99/ 111/ 003 - bottle EU/ 1/ 99/ 111/ 004 - blister
28. maj 1999 Dato for fornyelse af tilladelsen:
Date of latest renewal:
28. maj 2004
28 May 2004.
STOCRIN 30 mg/ ml oral opløsning
STOCRIN 30 mg/ ml oral solution
STOCRIN oral opløsning er indiceret til antiviral kombinationsbehandling af humant immundefekt virus- 1 (HIV- 1) - inficerede voksne, unge og børn fra 3 år og opefter, som ikke er i stand til at synke de hårde kapsler eller de filmovertrukne tabletter.
STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the hard capsules or the film-coated tablets.
5. 2).
STOCRIN oral solution may be taken with or without food (see section 5.2).
4. 8).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
4. 5) er 24 ml oralt 1 gang dagligt.
Adults: the recommended dosage of STOCRIN in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 24 ml orally, once daily.
Den anbefalede dosis af STOCRIN oral opløsning i kombination med en PI' er og/ eller NRTI’ ere til patienter i alderen 3 - 17 år er beskrevet i tabel 1.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN oral solution in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
STOCRIN hårde kapsler eller filmovertrukne tabletter må kun gives til børn, der med sikkerhed er i stand til at synke kapsler eller tabletter.
STOCRIN hard capsules or film-coated tablets must only be administered to children who are able to reliably swallow capsules or tablets.
5. 1 og 5. 2).
74 STOCRIN 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).
83 Tabel 1 Pædiatrisk dosis til indgivelse 1 gang daglig.
Table 1 Paediatric dose to be administered once daily
Legemsvægt
Body Weight kg
STOCRIN oral opløsning (30 mg/ ml)
STOCRIN oral solution (30 mg/ ml) Dose (ml)
Dosis (ml)
Children
Børn 3 - < 5 år
3 - < 5 years
og børn over 5 år
Adults and children aged 5 years or more
15 til < 20 20 til < 25
13 to < 15 15 to < 20 20 to < 25
25 til < 32, 5 32, 5 til < 40 ≥ 40
25 to < 32.5 32.5 to < 40 ≥ 40
4. 4).
Renalimpairment: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
Overfølsomhed over for det aktive indholdsstof eller et af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
75 4.4 Special warnings and precautions for use
Som med alle andre non- nukleosid reverse transkriptasehæmmere
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat, bør ikke administreres samtidigt.
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
Der er rapporteret mildt til moderat udslæt i kliniske undersøgelser med efavirenz, og dette forsvinder sædvanligvisved fortsat behandling.
Rash: mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Patienter, som seponerede behandling med andre NNRTI’ ere på grund af udslæt, kan have højere risiko for at udvikle udslæt under behandling med efavirenz.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Der er set krampeanfald hos patienter i efavirenzbehandling, disse patienter havde sædvanligvis krampeanfald i anamnesen.
76 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
85 hovedsageligt metaboliseres i leveren, som fx phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmaniveauer.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumoni fremkaldt af pneumocystis jiroveci (tidligere kendt som pneumocystis).
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Farmakokinetikken af efavirenz er ikke undersøgt hos patienter med nyreinsufficiens; mindre end 1% af en efavirenzdosis udskilles imidlertid uomdannet i urinen, og
77 Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Antallet af ældre patienter, der er vurderet i kliniske undersøgelser, er ikke tilstrækkeligt til at afgøre, om de responderer anderledes end yngre patienter.
Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
Det tyder på, at efavirenz farmakokinetikken kan være anderledes hos meget små børn.
Evidence exists indicating that efavirenz may have altered pharmacokinetics in very young children.
87 Tabel 2:
Table 2:
AUC: ↔ * (↓ 9% til ↑ 10%) Cmax: ↑ 17% * (↑ (8% til ↑ 27%) Cmin: ↓ 42% * (↓ 31% til ↓ 51%)
AUC: ↔ * (↓ 9% to ↑ 10%) Cmax: ↑ 17%* (↑ 8% to ↑ 27%) Cmin: ↓ 42%* (↓ 31% to ↓ 51%)
Hvis samtidig administration af atazanavir og et NNRTI er nødvendig, bør det overvejes at øge dosis for både atazanavir og ritonavir til henholdsvis 400 mg og 200 mg sammen med efavirenz med tæt klinisk monitorering.
If the co-administration of atazanavir with an NNRTI is required, an increase in
Dette fald i atazanavirs Cmin kan have negativ indflydelse på effekten af atazanavir. ** Baseret på historisk sammenligning.
This decrease in atazanavir Cmin might negatively
Lignende fund forventes med den godkendte darunavir/ ritonavir 600/ 100 mg
Similar findings are expected with the approved darunavir/ ritonavir
Indinavir/ efavirenz (800 mg q8h/ 200 mg én gang dagligt)
Indinavir/ Efavirenz (800 mg q8h/ 200 mg once daily)
AUC: ↓ 31% (↓ 8 til ↓ 47) Cmin: ↓ 40% Der sås en lignende reduktion i indinavireksponering, når indinavir 1. 000 mg q8h blev givet sammen med efavirenz 600 mg dagligt.
AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40% A similar reduction in indinavir exposures was observed when indinavir 1.000 mg q8h was given with efavirenz 600 mg daily.
(CYP3A4 - induktion) Efavirenz:
(CYP3A4 induction)
Dosisjustering er ikke nødvendig for efavirenz, når det gives sammen med indinavir eller indinavir/ ritonavir.
No dosage adjustment is necessary for efavirenz when given with indinavir or indinavir/ ritonavir.
Se også ritonavir nedenfor.
79 Medicinal product by therapeutic
Indinavir/ ritonavir/ efavirenz (800 mg to gange dagligt/ 100 mg to gange dagligt/ 600 mg én gang dagligt)
Recommendation concerning
Indinavir:
areas (dose)
89
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Lægemidler i henhold til
co-administration with efavirenz
Indvirkning på
Indinavir/ ritonavir/ Efavirenz
Anbefaling vedrørende
Indinavir:
terapeutisk område (dosis)
(800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
lægemiddelkoncentrationen, gennemsnitlig ændring (%) i AUC, Cmax, Cmin med konfidensintervaller hvis muligta (mekanisme)
In HIV-1 infected patients (n = 6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
samtidig administration med efavirenz
See also ritonavir row below.
Sammen med efavirenz bør en øgning af dosis for lopinavir/ ritonavir blød kapsel
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/ ~6.5 ml
eller oral opløsning på 33% overvejes (4 kapsler/ ~ 6, 5 ml to gange dagligt i stedet for 3
Caution is warranted since this dosage adjustment might be
kapsler/ 5 ml to gange dagligt).
insufficient in some patients.
(500/ 125 mg to gange dagligt/ 600 mg én gang dagligt)
The dosage of lopinavir/ ritonavir tablets should be increased to 500/ 125 mg
Lopinavirkoncentrationer:
(500/ 125 mg twice daily/ 600 mg once daily)
utilstrækkelig hos nogle patienter.
twice daily when co-administered with efavirenz 600 mg once daily.
Nelfinavir/ efavirenz (750 q8h/ 600 mg én gang dagligt)
Nelfinavir/ Efavirenz (750 mg q8h/ 600 mg once daily)
Lægemidler i henhold til
80 Medicinal product by therapeutic
Raltegravir/ efavirenz (400 mg enkeltdoser / -)
Raltegravir/ Efavirenz (400 mg single dose/ -)
Lægemidler i henhold til
81 Medicinal product by therapeutic
NRTIer/ efavirenz
NRTIs and NNRTIs NRTIs/ Efavirenz
92
Rifabutin:
Lægemidler i henhold til
82 Medicinal product by therapeutic
Antimykobakterielle lægemidler Rifabutin/ efavirenz (300 mg én gang dagligt/ 600 mg én gang dagligt)
Rifampicin/ Efavirenz (600 mg once daily/ 600 mg once daily) Antifungals
Rifabutin:
Efavirenz:
Lægemidler i henhold til
83 Medicinal product by therapeutic
Når efavirenz administreres sammen med voriconazol, bør vedligeholdelsesdosis for voriconazol øges til 400 mg to gange dagligt, og efavirenz- dosis skal reduceres med 50%, dvs.
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i. e., to 300 mg once daily.
Ketoconazol og andre imidazol - antimykotika ANTACIDA
Ketoconazole and other imidazole antifungals ACID REDUCING AGENTS
Aluminiumhydroxid - magnesiumhydroxid- simeticon antacida/ efavirenz (30 ml enkeltdosis/ 400 mg enkeltdosis) Famotidin/ efavirenz (40 mg enkeltdosis/ 400 mg enkeltdosis ANXIOLYTIKA
Aluminium hydroxide-magnesium hydroxide-simethicone antacid/ Efavirenz (30 mL single dose/ 400 mg single dose) Famotidine/ Efavirenz (40 mg single dose/ 400 mg single dose) ANTIANXIETY AGENTS
Hverken aluminium / magnesiumhydroxidantacida eller famotidin ændrede absorptionen af efavirenz.
Neither aluminium/ magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Lorazepam/ efavirenz (2 enkeltdoser/ 600 mg én gang dagligt)
Lorazepam/ Efavirenz (2 mg single dose/ 600 mg once daily)
Lægemidler i henhold til
84 Medicinal product by therapeutic
ANTIKONVULSIVA Carbamazepin/ efavirenz (400 mg én gang dagligt/ 600 mg én gang dagligt)
ANTICONVULSANTS Carbamazepine/ Efavirenz (400 mg once daily/ 600 mg once daily)
Når efavirenz administreres sammen med et antikonvulsivum, som er et substrat for CYP450- isoenzymer, bør regelmæssig monitorering af antikonvulsiva- koncentrationen foretages.
When efavirenz is co-administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
95
No dosage adjustment is necessary for efavirenz.
Lægemidler i henhold til
85 Medicinal product by therapeutic
Paroxetin/ efavirenz (20 mg én gang dagligt/ 600 mg én gang dagligt)
Paroxetine/ Efavirenz (20 mg once daily/ 600 mg once daily)
Fluoxetin/ efavirenz ANTIHISTAMINER
Fluoxetine/ Efavirenz ANTIHISTAMINES
Da fluoxetin har samme metaboliske profil som paroxetin, dvs. stærk CYP2D6- hæmmende virkning, forventes samme mangel på interaktion for fluoxetin.
Since fluoxetine shares a similar metabolic profile with paroxetine, i. e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Cetirizin/ efavirenz (10 enkeltdoser/ 600 mg én gang dagligt)
Cetirizine/ Efavirenz (10 mg single dose/ 600 mg once daily) CARDIOVASCULAR AGENTS Calcium Channel Blockers
AUC: ↔ Cmax: ↓ 24% (↓ 18 til ↓ 30) Disse ændringer anses ikke for at være klinisk signifikante.
AUC: ↔ Cmax: ↓ 24% (↓ 18 to ↓ 30) These changes are not considered clinically significant.
samtidig administration med efavirenz
Diltiazem/ Efavirenz (240 mg once daily/ 600 mg once daily)
AUC: ↓ 75% (↓ 59 til ↓ 84) Cmax: ↓ 64% (↓ 57 til ↓ 69) Cmin: ↓ 62% (↓ 44 til ↓ 75) N- monodesmethyl diltiazem:
AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75) N-monodesmethyl diltiazem:
AUC: ↑ 11% (↑ 5 til ↑ 18) Cmax: ↑ 16% (↑ 6 til ↑ 26) Cmin: ↑ 13% (↑ 1 til ↑ 26) (CYP3A4- induktion) Stigningen i efavirenz 'farmakokinetiske parametre anses ikke for at være klinisk signifikant.
AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Verapamil, felodipin, nifedipin og nicardipin LIPIDSÆNKENDE LÆGEMIDLER HMG Co- A reduktasehæmmere
Verapamil, Felodipine, Nifedipine and Nicardipine
Dosisjustering er ikke nødvendig for efavirenz.
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Atorvastatin/ efavirenz (10 mg én gang dagligt/ 600 mg én gang dagligt)
co-administration with efavirenz
samtidig administration med efavirenz
Pravastatin/ Efavirenz (40 mg once daily/ 600 mg once daily)
Rosuvastatin/ efavirenz ORALE KONTRACEPTIVA
Rosuvastatin/ Efavirenz HORMONAL CONTRACEPTIVES
Ethinylestradiol/ efavirenz (50 µg enkeltdosis/ 400 mg én gang dagligt)
Ethinyloestradiol/ Efavirenz (50 µg single dose/ 400 mg once daily)
AUC: ↔ Cmax: ↔ (ukendt mekanisme) Klinisk signifikans af virkningen på ethinylestradiols AUC er ikke kendt.
AUC: ↔ Cmax: ↔ (mechanism unknown) The clinical significance of the effect on ethinyloestradiol AUC is not known.
Kun ethinylestradiolkomponenten
Only the ethinyloestradiol component of oral contraceptives has been studied.
Eventuel interaktion mellem efavirenz og orale antikonceptionsmidler er ikke fuldt beskrevet.
The potential interaction of efavirenz with oral contraceptives has not been fully characterised.
4. 6).
A reliable method of barrier contraception must be used in addition to oral contraceptives (see section 4.6).
Lægemidler i henhold til
87 Medicinal product by therapeutic
IMMUNOSUPPRESSIVA Immunosuppressiva metaboliseres via CYP3A4 (fx cyclosporin, tac - rolimus, sirolimus) / efavirenz OPIOIDER
IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (e. g., cyclosporine, tacrolimus, sirolimus)/ Efavirenz OPIOIDS
99 4. 6 Graviditet og amning
4.6 Pregnancy and lactation