natgillin/translations-raw huggingface dataset:
Hos 35 patienter, der fik efavirenz 600 mg 1 gang daglig var det gennemsnitlige steady-state Cmax 12,9 ± 3,7 mikroM (29%) [gennemsnit ± S.D. (% C.V.
In 35 patients receiving efavirenz 600 mg once daily, steady-state Cmax was 12.9 ± 3.7 microM (29%) [mean ± S.D. (% C.V.)], steady-state Cmin was 5.6 ± 3.2 microM (57%), and AUC was 184 ± 73 microM·h (40%).
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)
Lægen vil kontrollere dit kolesterol i blodet og måske ændre din statindosis.
Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
* Ved sammenligning med atazanavir 300 mg/ritonavir 100 mg én gang dagligt om aftenen uden efavirenz.
(CYP3A4 induction) * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
AUC: ↔ Cmax: ↑ 11% (↑ 3 til ↑19)
AUC: ↔ Cmax: ↑ 11% (↑ 3 to ↑19)
Studie AI266922 var et ikke-blindet studie til evaluering af efavirenz' 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 efavirenz in combination with didanosine and emtricitabine in antiretroviral-naive and -experienced paediatric patients.
Hvis du har glemt at tage Efavirenz Teva
If you forget to take Efavirenz Teva
NRTIer og NNRTIer NRTIer/efavirenz
NRTIs and NNRTIs NRTIs/efavirenz
Studie PACTG 382 var et ikke-blindet studie til evaluering af efavirenz' 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 efavirenz in combination with nelfinavir and an NRTI in antiretroviral-naive and NRTI-experienced paediatric patients.
"↑", fald som "↓", ingen ændring som "↔" og én gang hver 8. eller 12. time som "q8h" eller "q12h").
Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “q8h” or “q12h”).
AUC: ↓ 31% (↓ 8 til ↓47) Cmin: ↓ 40%
AUC: ↓ 31% (↓ 8 to ↓47) Cmin: ↓ 40%
Anbefaling vedrørende samtidig administration med efavirenz phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP450-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 co-administered with efavirenz.
Samtidig administration af glecaprevir/pibrentasvir med efavirenz kan medføre signikant fald i plasmakoncentrationerne af glecaprevir og pibrentasvir og medføre nedsat terapeutisk effekt.
Concomitant administration of glecaprevir/pibrentasvir with efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect.
boceprevir koncentrationerne er ikke direkte vurderet.
The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
AUC: ↓ 52% (↓ 33 til ↓ 66) Cmax: ↓ 45% (↓ 25 til ↓ 59) (CYP3A4-induktion)
AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
AUC: ↓ 36% (↓ 32 til ↓ 40) Cmax: ↓ 21% (↓ 15 til ↓ 26) Cmin: ↓ 47% (↓ 41 til ↓ 53) (fald i carbamazepinkoncentrationen: CYP3A4-induktion; fald i efvirenzkoncentrationen: CYP3A4- og
AUC: ↓ 36% (↓ 32 to ↓ 40) Cmax: ↓ 21% (↓ 15 to ↓ 26) Cmin: ↓ 47% (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction)
Efavirenz Teva kan mindske mængden af posaconazol i blodet.
Efavirenz Teva may reduce the amount of posaconazole in your blood.
Efavirenz Teva kan nedsætte mængden af statiner i blodet.
Efavirenz Teva can reduce the amount of statins in your blood.
Efavirenz Teva kan mindske mængden af itraconazol i blodet.
Efavirenz Teva may reduce the amount of itraconazole in your blood.
Se ordineringsoplysningerne for velpatasvir/sofosbuvir/voxilapr evir for yderligere information.
Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information.
Data er ikke tilgængelige mhp doseringsanbefaling.
No data are available to make a dose recommendation.
artemether/lumefantrin: Efavirenz Teva kan nedsætte mængden af artemether/lumefantrin i blodet.
artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in your blood atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.
AUC: ↑ 21% (↑ 10 til ↑ 34) Cmax: ↑ 14% (↑ 4 til ↑ 26) Cmin: ↑ 25% (↑ 7 til ↑ 46) b
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46)
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,
Posaconazol/efavirenz (--/400 mg én gang dagligt)
Posaconazole/efavirenz (--/400 mg once daily)
Naturlægemidler som indeholder Prikbladet perikum (Hypericum perforatum) må ikke indtages samtidigt med indtagelse af efavirenz på grund af risiko for reduktion i plasmakoncentrationer samt reduceret klinisk effekt af efavirenz (se pkt.
Herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 til ↓ 52) Cmax: ↓ 28% (↓ 7 til ↓ 44) Cmin: ↓ 37% (↓ 17 til ↓ 52)
N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Ved brug af ITTanalyse 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.
Famotidin/efavirenz (40 mg enkeltdosis/400 mg enkeltdosis)
Famotidine/efavirenz (40 mg single dose/400 mg single dose)
Lactosemonohydrat 6cP (HPMC 2910) Titaniumdioxid
Hypromellose 6cP (HPMC 2910) Lactose monohydrate Titanium dioxide Macrogol/PEG 3350
Den øgede efavirenz-koncentration observeret efter administration af efavirenz sammen med mad kan medføre en øgede frekvens af bivirkninger (se pkt.
The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Intergrasehæmmer af genoverførelse Raltegravir/efavirenz (400 mg enkeltdosis/ -)
Integrase strand transfer inhibitor Raltegravir/efavirenz (400 mg single dose/ -)
Multipack (bundt) med 90 filmovertrukne tabletter (3 pakninger à 30 x 1 filmovertrukket tablet) i hvide gennemsigtige PVC/PVdC-aluminium eller aluminium-aluminium perforerede enkeltdosisblisterpakninger.
Multipack (bundle) containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet) in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
AUC: ↑ 20% (↑ 8 til ↑ 34) Cmax: ↑ 21% (↑ 10 til ↑ 33)
AUC: ↑ 20% (↑ 8 to ↑ 34) Cmax: ↑ 21% (↑ 10 to ↑ 33)
CCR5-antagonist Maraviroc/efavirenz (100 mg to gange dagligt/600 mg én gang dagligt)
CCR5 antagonist Maraviroc/efavirenz (100 mg twice daily/600 mg once daily)
Tilstande med forhøjet lipid skal behandles som klinisk indiceret.
Lipid disorders should be managed as clinically appropriate
Aluminiumhydroxidmagnesiu mhydroxid-simeticon antacida/efavirenz (30 ml enkeltdosis/400 mg enkeltdosis)
ACID-REDUCING AGENTS Aluminium hydroxidemagnesium hydroxidesimethicone antacid/efavirenz (30 ml single dose/400 mg single dose)
Tabel 3: Effektresultater for undersøgelserne ACTG 364 og 020
Table 3: Efficacy results for studies ACTG 364 and 020 Responder rates (NC = Fa) Plasma HIV-RNA
Atovaquon og proguanil hydrochlorid/efavirenz (250/100 mg enkeltdosis/600 mg én gang dagligt)
Atovaquone and proguanil hydrochloride/efavirenz (250/100 mg single dose/600 mg once daily)
Lopinavir/ritonavir bløde kapsler eller oral opløsning/efavirenz
Lopinavir/ritonavir soft capsules or oral solution/ efavirenz
Studie PACTG 1021 var et ikke-blindet studie til evaluering af efavirenz' 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 efavirenz in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
AUC: ↓ 71% (↓ 67 til ↓ 74) Cmax: ↓ 51% (↓ 46 til ↓ 56) Cmin: ↓ 91% (↓ 88 til ↓ 92)
AUC: ↓71% (↓67 to ↓74) Cmax: ↓51% (↓46 to ↓56) Cmin: ↓91% (↓88 to ↓92)
Samtidig administration af glecaprevir pibrentasvir med efavirenz anbefales ikke.
Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended.
Dette skyldes perikons induktion af lægemiddelmetaboliserende enzymer og/eller transportproteiner.
Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug-metabolising enzymes and/or transport proteins by St. John's wort.
Affektlabilitet, aggression, konfusion, eufori, hallucinationer, mani, paranoia, psykose†, suicidalforsøg, suicidaltanker, katatoni*
paranoia, psychosis†, suicide attempt, suicide ideation, catatonia*
Multipack (æske) med 90 filmovertrukne tabletter (3 pakninger à 30 x 1 filmovertrukket tablet) i hvide gennemsigtige PVC/PVdC-aluminium eller aluminium-aluminium perforerede enkeltdosisblisterpakninger.
Multipack (carton) containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet) in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Almindelig Pruritus Ikke almindelig
Common Pruritus
Lægen vil måske give dig en anden medicin mod krampeanfald.
Your doctor may give you a different anticonvulsant.
Kontrolregime
Method of administration
hvis du samtidigt tager et eller flere af følgende lægemidler (se også ”Brug af anden medicin sammen med Efavirenz Teva”): astemizol eller terfenadin (mod symptomer på allergi) bepridil (mod hjertesygdom) cisaprid (mod halsbrand) sekalealkaloider (f.eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin) (mod migræne og klyngehovedpine)
If you are currently taking any of the following medicines (see also “Other medicines and Efavirenz Teva): Astemizole or terfenadine (used to treat allergy symptoms) Bepridil (used to treat heart disease) Cisapride (used to treat heartburn)
Samtidig anvendelse af Ginkgo biloba frarådes (se pkt.
Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Proteasehæmmer: Elbasvir/grazoprevir
Protease inhibitor : Elbasvir/grazoprevir
Middel Cmax for efavirenz hos forsøgspersoner med genotype CYP2B6 *6/*6 efter administration af en daglig dosis på 600 mg i 14 dage var
The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype.
Disse immunsuppressiva forventes ikke at påvirke efavirenz' eksponering.
Recommendation concerning co-administration with efavirenz immunosuppressants are not anticipated to affect exposure of efavirenz.
- Leversvigt, som i nogle tilfælde kan føre til død eller levertransplantation, er forekommet sammen med efavirenz.
- itchy rash caused by a reaction to sunlight - liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Ved baseline var det mediane plasma hiv-RNA 4,57 log10-kopier/ml, median-CD4+ celletal var 755 celler/mm3, og median-CD4+ procent var 30%.
At baseline, median plasma HIV-1 RNA was 4.57 log10 copies/mL, median CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
AUC12: ↓ 45% (↓ 38 til ↓ 51) Cmax: ↓ 51% (↓ 37 til ↓ 62)
AUC12: ↓ 45% (↓ 38 to ↓ 51) Cmax: ↓ 51% (↓ 37 to ↓ 62)
Clarithromycin/efavirenz (500 mg q12h/400 mg én gang dagligt)
Clarithromycin/efavirenz (500 mg q12h/400 mg once daily)
(V108I) i RT. 3 af de testede efavirenz-behandlingssvigtisolater forblev følsomme over for efavirenz ved cellekultur og var også følsomme over for nevirapin og delavirdin.
Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Efavirenz Teva kan nedsætte eller øge mængden af krampemedicin i blodet.
Efavirenz Teva can reduce or increase the amount of anticonvulsant in your blood.
30 x 1 filmovertrukket tablet i hvide gennemsigtige PVC/PVdC-aluminium eller aluminiumaluminium perforeret enkeltdosis-blisterpakninger.
30 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Når din Efavirenz Teva er ved at slippe op, skal du hente mere hos din læge eller på apoteket.
If you stop taking Efavirenz Teva When your Efavirenz Teva supply starts to run low, get more from your doctor or pharmacist.
Der kan forventes nedsat eksponering for etonogestrel (CYP3A4-induktion).
Implant: Etonogestrel/efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Må ikke tages sammenen med Efavirenz Teva, medmindre din læge anbefaler det, da dette indeholder efavirenz, der er det aktive stof i Efavirenz Teva.
maraviroc - the combination tablet containing efavirenz, emtricitabine, and tenofovir should not be taken with Efavirenz Teva unless recommended by your doctor since it contains efavirenz, the active ingredient of Efavirenz Teva.
Buprenorphin/naloxon/efavire nz
Buprenorphine/naloxone/ efavirenz
Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/200 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE BUNDT-ETIKET TIL MULTIPACKS À 90 (3 PAKNINGER À 30 X 1 FILMOVERTRUKKET TABLET) - MED BLUE BOX
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BUNDLE LABEL FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLET) - WITH THE BLUE BOX
90 x 1 filmovertrukket tablet i hvide gennemsigtige PVC/PVdC-aluminium perforeret enkeltdosisblisterpakninger.
90 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium perforated unit-dose blisters.
Se nedenfor samt pkt.
See below and section 5.3.
perikon (Hypericum perforatum) (et naturlægemiddel mod depression og angst) flecainid, metoprolol (til behandling af uregelmæssig hjerterytme) visse antibiotika (makrolider, fluoroquinoloner, imidazol)
Pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPACK-KOMPONENT À 90 (3 PAKNINGER À 30 x 1 FILMOVERTRUKNE TABLETTER) - UDEN BLUE BOX
PARTICULARS TO APPEAR ON THE OUTER CARTON COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS)WITHOUT BLUE BOX
Samtidigt administration 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 metaboliseringen.
Co-administration 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 adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
EU/1/11/742/005 (multi-pack-æske - blister PVC/PVDC/alu) EU/1/11/742/010 (multi-pack-æske - blister alu/alu)
EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
Indinavir/efavirenz (800 mg q8h/200 mg én gang dagligt)
Indinavir/efavirenz (800 mg q8h/200 mg once daily)
Når efavirenz gives sammen med ritonavir i lav dosis, bør muligheden for stigning i incidensen af efavirenzassocierede bivirkninger overvejes på grund af eventuel farmakodynamisk interaktion.
When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of
Phenytoin, phenobarbital og andre antikonvulsiva, som er
Phenytoin, phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 238 celler/mm3, og den mediane stigning i CD4+ procent var 13%.
The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in CD4+ percentage was 13%.
Disse er nævnt under Tag ikke Efavirenz Teva i begyndelsen af pkt.
Efavirenz Teva", at the start of Section 2.
Lægen vil måske overveje at give dig et andet lægemiddel mod krampeanfald.
Your doctor may need to consider giving you a different anticonvulsant.
Telaprevir/efivarenz (1.125 mg q8h/600 mg én gang daglig)
Telaprevir/efavirenz (1,125 mg q8h/600 mg once daily)
4.3 og 4.4).
(see section 4.3).
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Samtidig administration af velpatasvir/sofosbuvir/voxilaprevir med efavirenz anbefales ikke (se pkt.
Concomitant administration of velpatasvir/sofosbuvir/voxilaprevir with efavirenz is not recommended (see section 4.5).
Nelfinavir/efavirenz (750 mg q8h/600 mg én gang dagligt)
Nelfinavir/efavirenz (750 mg q8h/600 mg once daily)
AUC: ↓ 75% (↓ 59 til ↓ 84) Cmax: ↓ 64% (↓ 57 til ↓ 69) Cmin: ↓ 62% (↓ 44 til ↓ 75)
AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Almene symptomer og reaktioner på administrationsstedet Almindelig Træthed *,†,‡ Se pkt.
General disorders and administration site conditions Common Fatigue *,†, ‡ See section c. Description of selected adverse reactions for more details.
Azithromycin/efavirenz (600 mg enkeltdosis/400 mg én gang dagligt)
Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Simeprevir/efavirenz (150 mg en gang dagligt/600 mg en gang dagligt)
Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
Akut hepatitis
Hepatic failure
Sådan skal du tage Efavirenz Teva
How to take Efavirenz Teva
Agitation, amnesi, ataksi, unormal koordination, kramper, abnorm tankevirksomhed*, tremor†
Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Lorazepam/efavirenz (2 mg enkeltdoser/600 mg én gang dagligt)
ANTIANXIETY AGENTS Lorazepam/efavirenz (2 mg single dose/600 mg once daily)
ANTI-INFEKTIVA Lægemidler mod hiv
ANTI-INFECTIVES
Dosisjustering af atorvastatin kan være påkrævet (se SPC for
Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Cmax: ↓ 15% (CYP3A4-induktion) Efavirenz:
(CYP3A4 induction) Efavirenz:
Cmax morgen: ↑ 24% (↑ 12 til Cmax aften: ↔
Morning Cmax: ↑ 24% (↑ 12 to ↑ 38)
Der er dog også blevet observeret hæmning in vitro, og nettoeffekten ved samtidig administration af substrater for disse enzymer er ikke klarlagt (se pkt.
Efavirenz may be an inducer of CYP2C19 and CYP2C9; however inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Cmin morgen: ↑ 42% (↑ 9 til ↑ 86) b Cmin aften: ↑ 24% (↑ 3 til ↑ 50) b
Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b
De fleste tilfælde af udslæt forsvinder dog uden ændring af din behandling med Efavirenz Teva.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Efavirenz Teva.
Voriconazol/efavirenz (400 mg to gange dagligt/300 mg én gang dagligt)
Voriconazole/efavirenz (400 mg twice daily/300 mg once daily)
EFV + NRTI'ere 65 58 (46, 70) NFV + NRTI'ere 66 30 (19, 42) Undersøgelse 020
EFV + NRTIs NFV + NRTIs Study 020
Fosamprenavir/ritonavir/efavir enz (700 mg to gange dagligt/100 mg to gange dagligt/600 mg én gang dagligt)
Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
(3,6%), svimmelhed (8,5%), hovedpine (5,7%), døsighed (2,0%)*
Delusion ‡, neurosis ‡, completed suicide‡,* Nervous system disorders Common Cerebellar co-ordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)* Uncommon Agitation, amnesia, ataxia, co-ordination abnormal, convulsions, thinking abnormal*, tremor†
Forsigtighed tilrådes, når efavirenz og artemether/lumefantrin-tabletter tages samtidigt, da fald i koncentrationen af artemether, dihydroartemisinin eller lumefantrin kan resultere i nedsat effekt mod malaria.
Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when efavirenz and artemether/lumefantrine tablets are coadministered.
Indinavir/ritonavir/efavirenz (800 mg to gange dagligt/100 mg to gange dagligt/600 mg én gang dagligt)
Indinavir/ritonavir/efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Darunavir/ritonavir/efavirenz
Saquinavir/ritonavir/efavirenz
Cmax: ↔** * sammenlignet med 200 mg alene to gange dagligt
AUC: ↑ 17% (↑ 6 to ↑ 29) ** Cmax: ↔** *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (Competitive inhibition of oxidative metabolism)
Cetirizin/efavirenz (10 mg enkeltdoser/600 mg én gang dagligt)
ANTIHISTAMINES Cetirizine/efavirenz (10 mg single dose/600 mg once daily)
Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 215 celler/mm3, og den mediane stigning i CD4+ procent var 6%.
CD4+ count at 48 weeks was 215 cells/mm3 and the median increase in CD4+ percentage was 6%.
Proteasehæmmere (PIer) Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/100 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Fluconazol/efavirenz (200 mg én gang dagligt/400 mg én gang dagligt)
Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
Rifampicin/efavirenz (600 mg én gang dagligt/600 mg én gang dagligt)
Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
Ritonavir/efavirenz (500 mg to gange dagligt/600 mg én gang dagligt)
Ritonavir/efavirenz (500 mg twice daily/600 mg once daily)
AUC: ↓ 18% (↓ 8 til ↓ 27) Cmax: ↓ 14% (↓ 3 til ↓ 24) Cmin: ↓ 25% (↓ 14 til ↓ 34)
AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
Hud og subkutane væv Meget almindelig
Skin and subcutaneous tissue disorders Very common Rash (11.6%)*
Cmax: ↑ 23% (↓ 1 til ↑ 53) *
AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) *