natgillin/translations-raw huggingface dataset:
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.
s vorikonazolom, dozu održavanja vorikonazola treba povisiti na 400 mg dvaput na dan, dok se doza efavirenza mora sniziti za 50%, tj. na 300 mg jedanput na dan.
It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
Preporučuje se efavirenz uzimati na prazan želudac, najbolje prije spavanja.
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.
Ispitivanje PACTG 1021 bilo je otvoreno ispitivanje za procjenu farmakokinetike, sigurnosti, podnošljivosti i antivirusnog djelovanja efavirenza u kombinaciji s didanozinom i emtricitabinom u pedijatrijskih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima.
Desacetyl diltiazem:
Dezacetil-diltiazem:
Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz.
Efavirenz može povećati ili smanjiti koncentracije u plazmi i učinke varfarina ili acenokumarola.
- unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly - suicide
U većini slučajeva radi se o bolesnicima s već postojećom bolešću jetre, ali je nekoliko slučajeva zabilježeno i u bolesnika koji nisu imali bolest jetre. - neobjašnjivi osjećaj jada, koji nije povezan s halucinacijama, ali može biti teško jasno ili razumno razmišljati - samoubojstvo
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%).
microM (29%) [srednja vrijednost ± S.D. (% C.V.)], Cmin 5,6 ± 3,2 microM (57%), a AUC 184 ± 73 microM·h (40%).
If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Ako se prekine liječenje efavirenzom, također treba razmotriti prekid liječenja drugim antiretrovirusnim lijekovima radi sprječavanja nastanka rezistentnog virusa
AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90)
AUC: ↓ 83% (↓ 79 do ↓ 87) Cmax: ↓ 80% (↓ 77 do ↓ 83) Cmin: ↓ 86% (↓ 80 do ↓ 90)
Itraconazole:
Itrakonazol:
ACID-REDUCING AGENTS Aluminium hydroxidemagnesium hydroxidesimethicone antacid/efavirenz (30 ml single dose/400 mg single dose)
Aluminijev hidroksid-magnezijev hidroksid-simetikon antacid/efavirenz (30 ml jednostruka doza /400 mg jednostruka doza)
- Warfarin or acenocoumarol (medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
- Varfarin ili acenokumarol (lijek koji se koristi za smanjivanje zgrušavanja krvi): liječnik će
imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone.
antimikotike koji sadrže imidazol i triazol, pojedine antihistaminike koji nemaju sedativno djelovanje (terfenadin, astemizol), cisaprid, flekainid, pojedine antimalarike i metadon (vidjeti dio 4.3).
Pregnancy, breast-feeding and fertility Women should not get pregnant during treatment with Efavirenz Teva and for 12 weeks thereafter.
Žene ne smiju zatrudnjeti tijekom liječenja i 12 tjedana nakon završetka liječenja Efavirenzom Teva.
Grapefruit juice should be avoided when taking Efavirenz Teva.
Za vrijeme uzimanja lijeka Efavirenz Teva treba izbjegavati sok od grejpa.
Medicinal product by therapeutic areas (dose)
Lijekovi po terapijskim područjima
Famotidine/efavirenz (40 mg single dose/400 mg single dose)
Famotidin/efavirenz (40 mg jednostruka doza /400 mg
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.
Ispitivanje AI266922 bilo je otvoreno ispitivanje za procjenu farmakokinetike, sigurnosti, podnošljivosti i antivirusnog djelovanja efavirenza u kombinaciji s didanozinom i emtricitabinom u pedijatrijskih bolesnika koji prethodno nisu bili liječeni i onih koji su već liječeni antiretrovirusnim lijekovima.
LIPID-LOWERING MEDICINAL PRODUCTS HMG CoA Reductase Inhibitors Atorvastatin/efavirenz (10 mg once daily/600 mg once daily)
HIPOLIPEMICI Inhibitori HMG Co-A reduktaze Atorvastatin/efavirenz (10 mg jedanput na dan/600 mg jedanput na dan)
Efavirenz induced foetal resorptions in rats.
Kod štakora je efavirenz inducirao resorpciju fetusa.
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.
Ispitivanje PACTG 382 bilo je otvoreno ispitivanje za procjenu farmakokinetike, sigurnosti, podnošljivosti i antivirusnog djelovanja efavirenza u kombinaciji s nelfinavirom i NRTI-ma u pedijatrijskih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i u onih koji su već liječeni NRTI-ma.
voriconazole.
vorikonazol.
Tests may show: - increased liver enzymes in the blood - increased triglycerides (fatty acids) in the blood
- svrbež - umor - osjećaj tjeskobe, depresivno raspoloženje Pretrage mogu pokazati: - povišene razine jetrenih enzima u krvi - povišene razine triglicerida (masnih kiselina) u krvi
ANTICOAGULANTS Warfarin/efavirenz Acenocoumarol/efavirenz
Varfarin/efavirenz Acenokumarol/efavirenz
Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
CYP3A4 pa je potreban oprez sa supstratima CYP3A4 uskog terapijskog indeksa (vidjeti dio 4.3).
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.
U pet od tih izolata rezistentnih na NNRTI ustanovljena je zamjena K103N ili zamjena valina izoleucinom na mjestu 108 (V108I) u reverznoj transkriptazi.
Table 2: Efficacy results for study 006 Treatment regimen d n
Tablica 2: Rezultati djelotvornosti iz ispitivanja 006 Terapijski protokol d n Stope bolesnika s odgovorom (NC = F a) HIV-RNK u plazmi
Hepatitis C antivirals Boceprevir/efavirenz (800 mg 3 times daily/600 mg
Antivirusni lijekovi za hepatitis C Boceprevir/efavirenz (800 mg 3 puta na dan /600 mg jedanput na dan)
Common Abdominal pain, diarrhoea, nausea, vomiting Uncommon Pancreatitis
Poremećaji probavnog sustava često bolovi u abdomenu, proljev, mučnina, povraćanje manje često pankreatitis
AUC12: ↓ 45% (↓ 38 to ↓ 51) Cmax: ↓ 51% (↓ 37 to ↓ 62)
AUC12: ↓ 45% (↓ 38 do ↓ 51) Cmax: ↓ 51% (↓ 37 do ↓ 62)
No data are available to make a dose recommendation.
Nisu provedena ispitivanja interakcija Nema dostupnih podataka da bi se mogla dati preporuka za dozu.
Voriconazole:
Vorikonazol:
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.
artemeter/lumefantrin: Efavirenz Teva može smanjiti koncentraciju artemetera/lumefantrina u krvi.
Skin rash was considered treatment-related in 18% of patients treated with efavirenz.
Smatra se da je u 18% bolesnika osip bio povezan s primjenom efavirenza.
Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Liječenje efavirenzom mora se prekinuti u bolesnika u kojih se razvije jaki osip s mjehurima, deskvamacijom,
Telaprevir/efavirenz (1,125 mg q8h/600 mg once daily)
Telaprevir/efavirenz (1.125 mg q8h/600 mg jedanput na dan)
triazole antifungal agents certain antimalarial treatments methadone (used to treat opiate addiction)
o lijekove za liječenje gljivičnih infekcija koji sadrže triazol o pojedine lijekove za liječenje malarije o metadon (za liječenje ovisnosti o opijatima).
Liver disease
Oštećenje jetre
Velpatasvir/sofosbuvir/voxilap revir
velpatasvir/sofosbuvir/voksilaprevir ↓velpatasvir
CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/efavirenz (240 mg once daily/600 mg once daily)
Blokatori kalcijevih kanala Diltiazem/efavirenz (240 mg jedanput na dan/600 mg jedanput na dan)
Plasma HIV-RNA
HIV-1 virusa.
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.
Višestruko pakiranje (paket) sa 90 filmom obloženih tableta (3 pakovanja sa 30 x 1 filmom obloženom tabletom) u bijelim, neprozirnim, PVC/PVdC-aluminijskim ili aluminij-aluminijskim perforiranim blisterima djeljivim na jedinične doze.
Clarithromycin/efavirenz (500 mg q12h/400 mg once daily)
Klaritromicin/efavirenz (500 mg q12h/400 mg jedanput na dan)
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58)
AUC: ↓ 58% (↓ 39 do ↓ 68) Cmax: ↓ 51% (↓ 32 do ↓ 58)
90 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium perforated unit-dose blisters.
90 x 1 filmom obloženih tableta u bijelim, neprozirnim PVC/PVdC-aluminijskim perforiranim blisterima djeljivim na jedinične doze.
Cmax: ↑ 11% (↑ 6 to ↑ 16)
Cmax: ↑ 11% (↑ 6 do ↑ 16) Cmin: ↔
Indinavir/efavirenz (800 mg q8h/200 mg once daily)
Indinavir/efavirenz (800 mg q8h/200 mg jedanput na dan)
AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58)
AUC: ↓ 39% (↓ 21 do ↓ 53) Cmax: ↓ 37% (↓ 20 do ↓ 51) Cmin: ↓ 44% (↓ 27 do ↓ 58)
Dose adjustment of buprenorphine or efavirenz may not be necessary when co-administered.
Pri istodobnoj primjeni možda neće biti potrebna prilagodba doze buprenorfina ili efavirenza.
Triacetin 3
PRILOG III.
Atovaquone and proguanil hydrochloride/efavirenz (250/100 mg single dose/600 mg once daily)
Atovakvon i progvanilklorid/efavirenz (250/100 mg jednostruka doza/600 mg jedanput na dan)
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Čini se da je rizik od pojave ozbiljnih psihijatrijskih poremećaja veći u bolesnika s psihijatrijskim poremećajima u anamnezi.
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.
Višestruko pakiranje (kutija) sa 90 filmom obloženih tableta (3 pakovanja sa 30 x 1 filmom obloženom tabletom) u bijelim, neprozirnim, PVC/PVdC-aluminijskim ili aluminij-aluminijskim perforiranim blisterima djeljivim na jedinične doze.
AUC: ↓ 75% (↓ 62 to ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
AUC: ↓ 75% (↓ 62 do ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
30 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
30 x 1 filmom obložena tableta u bijelim, neprozirnim, PVC/PVdC-aluminijskim ili aluminijaluminijskim perforiranim blisterima djeljivim na jedinične doze.
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.
Prilikom odabira protokola koji uključuje i efavirenz i indinavir, potrebno je uzeti u obzir opsežnost opaženih farmakokinetičkih interakcija iako nije utvrđen klinički značaj sniženih koncentracija indinavira.
These
Ovu
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
AUC: ↓ 60% (↓ 52 do ↓ 68) Cmax: ↓ 62% (↓ 55 do ↓ 78)
Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Atazanavir/ritonavir/efavirenz (400 mg jedanput na dan /200 mg jedanput na dan /600 mg jedanput na dan, sve uzimati uz hranu)
Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients
Tablica 4: Predviđena farmakokinetika u stanju dinamičke ravnoteže efavirenza
Norepinephrine and dopamine reuptake inhibitor Bupropion/efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Inhibitor ponovne pohrane norepinefrina i dopamina Bupropion/efavirenz [150 mg jednostruka doza
- Efavirenz Teva is for oral use.
- Efavirenz Teva uzima se kroz usta.
Dihydroartemisinin:
o midazolam ili triazolam (primjenjuju se za uspavljivanje)
efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Kod primjene efavirenza s niskom dozom ritonavira, mora se uzeti u obzir mogućnost povećane incidencije štetnih događaja povezanih s efavirenzom, zbog moguće farmakodinamičke interakcije.
ANTIHISTAMINES Cetirizine/efavirenz (10 mg single dose/600 mg once daily)
ANTIHISTAMINICI Cetirizin/efavirenz (10 mg jednostruka doza/600 mg jedanput na dan)
↓velpatasvir ↓voxilaprevir
↓voksilaprevir
Concomitant administration of velpatasvir/sofosbuvir/voxilaprevir with efavirenz is not recommended (see section 4.5).
Istodobna primjena velpatasvira/sofosbuvira/voksilaprevira s efavirenzom se ne preporučuje (vidjeti dio 4.5).
(CYP3A induction by efavirenz)
(CYP3A indukcija efavirenzom)
AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
AUC: ↓ 64% (↓ 62 do ↓ 67) Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85)
Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
Simeprevir/efavirenz (150 mg jedanput na dan /600 mg jedanput na dan)
Recommendation concerning co-administration with efavirenz immunosuppressants are not anticipated to affect exposure of efavirenz.
Ne očekuje se da će ovi imunosupresivi utjecati na izloženost efavirenzu.
Uncommon (affects 1 to 10 users in 1,000)
Manje često (javljaju se u 1 do 10 na 1000 korisnika)
Effects on drug levels Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea
Cmax, Cmin uz intervale pouzdanosti ako su dostupni a
(CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
(indukcija CYP3A4) Osip se javio u 46% nezaraženih
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Other formulations are available for these patients.
Efavirenz filmom obložene tablete nisu primjerene za djecu tjelesne težine manje od 40 kg.
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.
AST-a više od pet puta iznad gornje granice normale zabilježen je u 13% bolesnika koji su primali efavirenz i u 7% u kontrolnoj skupini, a porast ALT-a više od pet puta iznad gornje granice normale zabilježen je u 20% bolesnika na efavirenzu i u 7% bolesnika u kontrolnoj skupini.
Also listed in italics are adverse reactions observed post-marketing in association with efavirenz-containing antiretroviral treatment regimens.
Također su navedene nuspojave (otisnute kurzivom) zabilježene nakon stavljanja lijeka u promet u vezi s antiretrovirusnim protokolima koji uključuju efavirenz.
Efavirenz Teva contains lactose
Efavirenz Teva sadrži laktozu
Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
U kliničkim ispitivanjima efavirenza prijavljen je blagi do umjereni osip koji se obično povukao u nastavku liječenja.
Lopinavir/ritonavir soft capsules or oral solution/ efavirenz
Lopinavir/ritonavir meke kapsule ili oralna otopina / efavirenz
- Once you start taking Efavirenz Teva, look out for: signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
o znakove omaglice, poteškoće sa spavanjem, pospanost, poteškoće s koncentracijom ili neuobičajene snove.
(CYP3A4 induction)
(indukcija CYP3A4)
EU/1/11/742/004 (bundle multi-pack - blister PVC/PVDC/alu) EU/1/11/742/009 (bundle multi-pack - blister alu/alu)
EU/1/11/742/004 (višestruko pakiranje u paketu - blister PVC/PVDC/alu EU/1/11/742/009 (višestruko pakiranje u paketu - blister alu/alu)
Stevens-Johnson syndrome) - yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver - breast enlargement in males - angry behaviour, mood being affected, seeing or hearing things that are not really there
- žuta boja kože ili bjeloočnica, svrbež ili bolovi u trbuhu (želucu) prouzročeni upalom jetre - povećanje dojki u muškaraca
AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
AUC: ↓ 75% (↓ 59 do ↓ 84) Cmax: ↓ 64% (↓ 57 do ↓ 69) Cmin: ↓ 62% (↓ 44 do ↓ 75)
Carbamazepine may make Efavirenz Teva less likely to work.
Karbamazepin može smanjiti djelotvornost Efavirenza Teva.
AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
AUC: ↓ 26% (↓ 15 do ↓ 36) Cmax: ↓ 20% (↓ 11 do ↓ 28) Cmin: ↓ 32% (↓ 15 do ↓ 46)
EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
EU/1/11/742/005 (višestruko pakovanje u kutiji - blister PVC/PVDC/alu) EU/1/11/742/010 (višestruko pakovanje u kutiji - blister alu/alu)
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
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA PAKETU ZA VIŠESTRUKA PAKIRANJA SA 90 (3 PAKOVANJA SA 30 x 1 FILMOM OBLOŽENIH TABLETA) - S PLAVIM OKVIROM
Mean change from baseline-CD4 cell count
Srednja vrijednost promjena u odnosu na početni broj CD4
Plasma trough concentrations of boceprevir were decreased when
Koncentracije boceprevira u plazmi smanjene su u slučaju istovremene primjene efavirenza.
Recommendation concerning co-administration with efavirenz
Preporuke vezano za istodobnu primjenu s efavirenzom
Efavirenz Teva may reduce the amount of itraconazole in your blood.
Efavirenz Teva može smanjiti koncentraciju itrakonazola u krvi. posakonazol.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA VIŠESTRUKA PAKIRANJA SA 90 (3 PAKOVANJA SA 30 x 1 FILMOM OBLOŽENIH TABLETA) - S PLAVIM OKVIROM
Saquinavir/ritonavir/efavirenz
Sakvinavir/ritonavir/efavirenz
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)
o astemizol ili terfenadin (za liječenje simptoma alergije) o bepridil (za liječenje bolesti srca)
N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
AUC: ↓ 37% (↓ 17 do ↓ 52) Cmax: ↓ 28% (↓ 7 do ↓ 44) Cmin: ↓ 37% (↓ 17 do ↓ 52)
Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended (see section 4.5).
Ne preporučuje se istodobna primjena glekaprevira/pibrentasvira s efavirenzom (vidjeti dio 4.5).
Medicines used to treat depression such as imipramine, amitriptyline or clomipramine Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
antibiotici, uključujući sljedeće tipove: makrolidi, fluorokinoloni ili imidazol.
Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Azitromicin/efavirenz (600 mg jednostruka doza/400 mg jedanput na dan)
Recommendation concerning co-administration with efavirenz gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Preporuke vezano za istodobnu primjenu s efavirenzom došlo do kompeticije za iste metaboličke enzime i putove eliminacije
Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
Rifampicin/efavirenz (600 mg jedanput na dan /600 mg jedanput na dan)
Symptoms including, but not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Sljedeći su simptomi, ali ne samo oni, često zabilježene nuspojave u kliničkim ispitivanjima u bolesnika koji su uzimali efavirenz u dozi od 600 mg na dan: omaglica, nesanica, pospanost,
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)
*u usporedbi sa 200 mg dvaput na dan u monoterapiji ** u usporedbi sa 600 mg jedanput na dan u monoterapiji (Kompetitivna inhibicija oksidativnog metabolizma)
Dose adjustments of diltiazem should be guided by clinical response (refer to the Summary of Product Characteristics for diltiazem).
Pri prilagodbi doze diltiazema treba se voditi kliničkim odgovorom
PARTICULARS TO APPEAR ON THE OUTER CARTON COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS)WITHOUT BLUE BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SASTAVNI DIO VIŠESTRUKOG PAKIRANJA SA 90 (3 PAKIRANJA SA 30 x 1 FILMOM OBLOŽENIH TABLETA) - BEZ PLAVOG OKVIRA
Ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) Midazolam or triazolam (used to help you sleep)
o cisaprid (za liječenje žgaravice) o ergot alkaloide (primjerice ergotamin, dihidroergotamin, ergonovin i metilergonovin)
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%.
Medijan porasta broja CD4+ stanica od početne vrijednosti do 48. tjedna liječenja iznosio je 238 stanica/mm3, a medijan porasta postotka CD4+
AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
AUC: ↓ 18% (↓ 8 do ↓ 27) Cmax: ↓ 14% (↓ 3 do ↓ 24) Cmin: ↓ 25% (↓ 14 do ↓ 34)%
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).
pojedine antibiotike koji uključuju neke lijekove sljedećih skupina: makrolide, fluorokinolone te antimikotike koji sadrže imidazol i triazol, pojedine antihistaminike koji nemaju sedativno djelovanje (terfenadin, astemizol), cisaprid, flekainid, pojedine antimalarike, metadon.
Efavirenz Teva can reduce the amount of statins in your blood.
Efavirenz Teva može smanjiti koncentraciju statina u krvi.
Antimycobacterials Rifabutin/efavirenz (300 mg once daily/600 mg once daily)
Antimikobakterijski lijekovi Rifabutin/efavirenz (300 mg jedanput na dan/600 mg jedanput na dan)
↓elbasvir ↓grazoprevir
↓elbasvir ↓grazoprevir ↔efavirenz
Cmin: ↓ 44% Efavirenz:
Cmin: ↓ 91% (↓ 88 do ↓ 92) efavirenz:
Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Može se očekivati smanjena izloženost imunosupresivima (indukcija
In a single-dose study, half-life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
U ispitivanju jednokratne doze lijeka, u jednog bolesnika s teškim oštećenjem jetre (Child-Pugh stadij
Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
Fosamprenavir/ritonavir/ efavirenz (700 mg dvaput na dan/100 mg dvaput na dan /600 mg jedanput na dan)
Mean change from baseline-CD4 cell count Cells/mm3 (S.E.M.
stanica Stanica/mm3 (S.E.M. c)
Magnesium stearate
Jetrene nuspojave