natgillin/translations-raw huggingface dataset:
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. 
Kad se odabire režim koji uključuje i efavirenz i indinavir potrebno je uzeti u obzir opsežnost opaženih farmakokinetičkih interakcija budući da nije utvrđen klinički značaj sniženih koncentracija indinavira.
INFORMATION IN BRAILLE SUSTIVA 50 mg 
16. PODACI NA BRAILLEOVOM PISMU SUSTIVA 50 mg
EFV + NFV + NRTIs 65 70 (59, 82) EFV + NRTIs 
EFV + NFV + NRTI EFV + NRTI NFV + NRTI Ispitivanje 020
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).
Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction) 
Cmax: ↓ 20% (↓ 11 do ↓ 28) Cmin: ↓ 32% (↓ 15 do ↓ 46) (indukcija CYP3A4 i CYP2B6)
NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Bristol-Myers Squibb Pharma EEIG
How to take SUSTIVA 
Kako uzimati lijek SUSTIVA
Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz. 
Prije početka liječenja efavirenzom žene reproduktivne dobi moraju napraviti test na trudnoću.
Cmin: ↓ 8% (↑ 14 to ↓ 25) Norelgestromin (active metabolite): AUC: ↓ 64% (↓ 62 to ↓ 67) 
Cmin: ↓ 8% (↑ 14 do ↓ 25) norelgestromin (aktivni metabolit):
ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg once daily/600 mg once daily) 
ANTIKONVULZIVI karbamazepin/efavirenz (400 mg jedanput na dan/600 mg jedanput na dan)
Co-administration of simeprevir with efavirenz is not recommended. 
Istodobna primjena simeprevira s efavirenzom se ne preporučuje.
- Medicines used to treat depression such as imipramine, amitriptyline or clomipramine - Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole. 
lijekovi koji utječu na srčani ritam: - lijekovi koji se koriste za liječenje problema srčanog ritma: kao što su flekainid ili metoprolol. - lijekovi koji se koriste za liječenje depresije kao što su imipramin, amitriptilin ili klomipramin. - antibiotici, uključujući sljedeće tipove: makrolidi, fluorokinoloni ili imidazol.
AUC: ↓ 36% (↓ 32 to ↓ 40) 
AUC: ↓ 36% (↓ 32 do
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks. 
Simptomi živčanog sustava obično se počinju javljati prvog ili drugog dana liječenja i uglavnom nestaju nakon 2 do 4 tjedna.
SUSTIVA 100 mg hard capsules 
SUSTIVA 100 mg tvrde kapsule
AUC: ↓ 75% (↓ 59 to ↓ 84) 
AUC: ↓ 75% (↓ 59 do
INFORMATION IN BRAILLE SUSTIVA 200 mg 
16. PODACI NA BRAILLEOVOM PISMU SUSTIVA 200 mg
The median increase from baseline in CD4+ count at 48 weeks was 215 cells/mm and the median increase in CD4+ percentage was 6%. 
Medijan porasta broja CD4+ stanica od početne vrijednosti do 48. tjedna iznosio je 215 stanica/mm3, a medijan porasta postotka CD4+ stanica iznosio je 6%.
ANNEX II 
Dublin 15
SUSTIVA 100 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules. 
SUSTIVA 100 mg tvrde kapsule mogu uzimati djeca u dobi od 3 mjeseca i starija te adolescenti tjelesne mase ne manje od 3,5 kg, koja mogu progutati kapsule.
SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules. 
SUSTIVA 50 mg tvrde kapsule mogu uzimati djeca u dobi od 3 mjeseca i starija te adolescenti tjelesne mase ne manje od 3,5 kg, koja mogu progutati kapsule.
AUC: ↓ 34% (↓ 21 to ↓ 41) 
AUC: ↓ 34% (↓ 21 do
SUSTIVA 50 mg hard capsules efavirenz 
SUSTIVA 50 mg tvrde kapsule efavirenz
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). 
S obzirom da se manje od 1% doze efavirenza izlučuje mokraćom u nepromijenjenom obliku, utjecaj oštećenja bubrega na eliminaciju efavirenza trebao bi biti minimalan (vidjeti dio 4.2).
Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays. 
Uobičajeni testovi genotoksičnosti nisu pokazali mutagene niti klastogene učinke efavirenza.
Coadministration of sofosbuvir/velpatasvir with efavirenz is not recommended (see section 4.5). 
Istodobna primjena sofosbuvira/velpatasvira s efavirenzom se ne preporučuje (vidjeti dio 4.5).
No dose adjustment is necessary for either medicinal product. 
Nije potrebno prilagođavati dozu niti jednog lijeka.
SUSTIVA can reduce the amount of statins in your blood. 
SUSTIVA može smanjiti koncentraciju statina u krvi.
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254 
Nositelj odobrenja za stavljanje lijeka u promet Bristol-Myers Squibb Pharma EEIG Plaza 254
Rifampicin/Efavirenz (600 mg once daily/600 mg once daily) 
rifampicin/efavirenz (600 mg jedanput na dan/600 mg jedanput na dan)
Psychiatric adverse reactions have been reported in patients treated with efavirenz. 
U bolesnika liječenih efavirenzom prijavljene su psihijatrijske nuspojave.
Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information. 
Za više informacija pogledati podatke o propisivanju lijekova velpatasvir/sofosbuvir/voksilaprevir.
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU TEKST NA KUTIJI I NALJEPNICI BOČICE
AUC: ↓ 37% (↓ 14 to ↓ 55) 
AUC: ↓ 37% (↓ 14 do
ANTIANXIETY AGENTS Lorazepam/Efavirenz (2 mg single dose/600 mg once daily) 
ANKSIOLITICI lorazepam/efavirenz (2 mg u jednokratnoj dozi/600 mg jedanput na dan)
Refer to the prescribing information for sofosbuvir/velpatasvir for more information. 
Za više informacija pogledati podatke o propisivanju lijekova sofosbuvir/velpatasvir.
Bottle: 30 film-coated tablets 
30 filmom obloženih tableta Blister:
Bristol-Myers Squibb GmbH & CO. KGaA Tel: +49 89 121 42-0 
KGaA Tel: +49 89 121 42-0
AUC: ↑ 11% (↑ 5 to ↑ 18) 
AUC: ↑ 34% (↑ 18 do
Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended (see section 4.5). 
Istodobna primjena glekaprevira/pibrentasvira s efavirenzom se ne preporučuje (vidjeti dio 4.5).
Each hard capsule contains 200 mg of efavirenz. 
Jedna tvrda kapsula sadrži 200 mg efavirenza.
SUSTIVA 100 mg hard capsules efavirenz 
SUSTIVA 100 mg tvrde kapsule efavirenz
Nelfinavir/Efavirenz (750 mg q8h/600 mg once daily) 
nelfinavir/efavirenz (750 mg svakih 8h/600 mg jedanput na dan)
Cmin: ↓ 35% (↓ 24 to ↓ 44) Efavirenz: 
Cmax: ↓ 20% (↓ 15 do ↓ 24) Cmin: ↓ 35% (↓ 24 do ↓ 44) efavirenz:
Each hard capsule contains 100 mg of efavirenz. 
Jedna tvrda kapsula sadrži 100 mg efavirenza.
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)
Ritonavir/Efavirenz (500 mg twice daily/600 mg once daily) 
ritonavir/efavirenz (500 mg dvaput na dan/600 mg jedanput na dan)
Cmin: ↓ 82% (↓ 79 to ↓ 85) Levonorgestrel (active metabolite): AUC: ↓ 83% (↓ 79 to ↓ 87) 
Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85) levonorgestrel (aktivni metabolit):
NAME OF THE MEDICINAL PRODUCT SUSTIVA 600 mg film-coated tablets efavirenz 
NAZIV LIJEKA SUSTIVA 600 mg filmom obložene tablete efavirenz
Ritonavir: 
atovakvon:
Cmax: ↑ 38% 
Cmax: ↑ 38% vorikonazol:
AUC: ↓ 60% (↓ 52 to ↓ 68) 
AUC: ↓ 60% (↓ 52 do
Hepatic failure 
Insuficijencija bubrega
Resistant virus emerges rapidly when efavirenz is administered as monotherapy. 
Monoterapijska primjena efavirenza brzo dovodi do nastanka rezistentnog soja virusa.
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). 
No s obzirom da se manje od 1% efavirenza izlučuje mokraćom u nepromijenjenom obliku, utjecaj oštećenja bubrega na eliminaciju efavirenza trebao bi biti minimalan (vidjeti dio 4.4).
Each hard capsule contains 50 mg of efavirenz. 
Jedna tvrda kapsula sadrži 50 mg efavirenza.
Posaconazole/Efavirenz --/400 mg once daily 
posakonazol/efavirenz --/400 mg jedanput na dan posakonazol:
Each hard capsule contains 114.0 mg of lactose (as monohydrate). 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 114 mg laktoze (u obliku hidrata).
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems. 
ako je netko od članova Vaše obitelji (roditelji, bake i djedovi, braća ili sestre) iznenada umro zbog tegoba sa srcem ili su rođeni s bolešću srca. ako Vam je liječnik rekao da imate visoke ili niske razine elektrolita u krvi, kao što su kalij ili magnezij. ako trenutno uzimate neki od sljedećih lijekova: (također vidjeti dio „Drugi lijekovi i SUSTIVA“):
Capsule shell: Gelatine, Sodium laurilsulfate, Yellow iron oxide (E172), Titanium dioxide (E171), Silicon dioxide (E551) 
Ovojnica kapsule: želatina, natrijev laurilsulfat, željezov oksid, žuti (E172), titanijev dioksid (E171), silicijev dioksid (E551)
Darunavir/ritonavir/Efavirenz (300 mg twice daily*/100 mg twice daily/600 mg once daily) 
darunavir/ritonavir/efavirenz (300 mg dvaput na dan*/100 mg dvaput na dan/600 mg jedanput na dan)
SUSTIVA 200 mg hard capsules efavirenz 
SUSTIVA 200 mg tvrde kapsule efavirenz
Bristol-Myers Squibb S.r.l. 
Bristol-Myers Squibb Pharmaceuticals Ltd.
SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime. 
Preporučuje se uzimati lijek efavirenz na prazan želudac, po mogućnosti prije spavanja.
Fluconazole/Efavirenz (200 mg once daily/400 mg once daily) 
flukonazol/efavirenz (200 mg jedanput na dan /400 mg jedanput na dan)
Cmax: ↑ 49% (↑ 32 to ↑ 69) 
Cmax: ↑ 49% (↑ 32 do ↑ 69) efavirenz:
Paroxetine/Efavirenz (20 mg once daily/600 mg once daily) 
paroksetin/efavirenz (20 mg jedanput na dan/600 mg jedanput na dan)
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, 
Navedeni lijekovi uključuju: - antiartimike skupina IA i III, - neuroleptike, antidepresive, - pojedine antibiotike koji uključuju neke tvari sljedećih klasa: makrolide, fluorokinolone te antimikotike koji sadrže imidazol i triazol, - pojedine antihistaminike koji nemaju sedativno djelovanje (terfenadin, astemizol), - cisaprid, - flekainid, - pojedine antimalarike, - metadon.
Cmin: ↓ 37% (↓ 17 to ↓ 52) Efavirenz: 
Cmax: ↓ 28% (↓ 7 do ↓ 44) Cmin: ↓ 37% (↓ 17 do ↓ 52) efavirenz:
SUSTIVA is for oral use. 
SUSTIVA se uzima kroz usta.
Simvastatin/Efavirenz (40 mg once daily/600 mg once daily) 
simvastatin/efavirenz (40 mg jedanput na dan/600 mg jedanput na dan)
Valproic acid/Efavirenz (250 mg twice daily/600 mg once daily) 
valproična kiselina/efavirenz (250 mg dvaput na dan/600 mg jedanput na dan)
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)
Voriconazole/Efavirenz (400 mg twice daily/300 mg once daily) 
vorikonazol/efavirenz (400 mg dvaput na dan/300 mg jedanput na dan)
a NC = F, noncompleter = failure. 
IDV + NRTI a NC = F, liječenje nije završeno = neuspješno.
INFORMATION IN BRAILLE SUSTIVA 100 mg 
16. PODACI NA BRAILLEOVOM PISMU SUSTIVA 100 mg
SUSTIVA may reduce the amount of posaconazole in your blood. 
SUSTIVA može smanjiti koncentraciju itrakonazola u krvi. posakonazol.
How to take SUSTIVA 4. 
3. Kako uzimati lijek SUSTIVA 4. Moguće nuspojave
Each SUSTIVA hard capsule contains 200 mg of the active substance efavirenz. 
Jedna SUSTIVA tvrda kapsula sadrži 200 mg djelatne tvari efavirenz.
Each SUSTIVA hard capsule contains 50 mg of the active substance efavirenz. 
Jedna SUSTIVA tvrda kapsula sadrži 50 mg djelatne tvari efavirenz.
The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) and silicon dioxide. 
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, žuti željezov oksid (E172), titanijev dioksid (E171) i silicijev dioksid.
Injection: 
simvastatin:
Efavirenz levels may increase on stopping St. John's wort and the dose of efavirenz may need adjusting. 
Nakon prestanka uzimanja gospine trave koncentracija efavirenza može se povećati, pa će biti potrebno prilagoditi njegovu dozu.
two 200 mg capsules one 600 mg tablet OR three 200 mg capsules *For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2. 
*Za informacije o bioraspoloživosti sadržaja kapsule pomiješanog s hranom, vidjeti dio 5.2.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 200 mg hard capsules efavirenz 
NAZIV LIJEKA SUSTIVA 200 mg tvrde kapsule efavirenz
Cmax: ↑ 50% (↑ 20 to ↑ 80) 
Cmax: ↑ 50% (↑ 20 do ↑ 80) (indukcija CYP2B6)
Serious psychiatric adverse reactions have been reported in patients treated with efavirenz. 
U bolesnika liječenih efavirenzom zabilježene su ozbiljne psihijatrijske nuspojave.
Indinavir/ritonavir/Efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily) 
indinavir/ritonavir/efavirenz (800 mg dvaput na dan/100 mg dvaput na dan/600 mg jedanput na dan)
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Kroz usta.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 50 mg hard capsules efavirenz 
NAZIV LIJEKA SUSTIVA 50 mg tvrde kapsule efavirenz
Telaprevir/Efavirenz (1,125 mg q8h/600 mg once daily) 
telaprevir/efavirenz (1125 mg svakih 8h/600 mg jedanput na dan)
Cmin: ↓ 62% (↓ 44 to ↓ 75) N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) 
AUC: ↓ 75% (↓ 59 do ↓ 84) Cmax: ↓ 64% (↓ 57 do ↓ 69) Cmin: ↓ 62% (↓ 44 do ↓ 75) N-monodezmetil diltiazem: AUC: ↓ 37% (↓ 17 do ↓ 52) Cmax: ↓ 28% (↓ 7 do ↓ 44) Cmin: ↓ 37% (↓ 17 do ↓ 52) efavirenz:
Each SUSTIVA hard capsule contains 100 mg of the active substance efavirenz. 
Jedna SUSTIVA tvrda kapsula sadrži 100 mg djelatne tvari efavirenz
Dose adjustment of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin). 
Može biti potrebno prilagođavati dozu pravastatina (vidjeti Sažetak opisa svojstava lijeka za pravastatin).
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm3, or in PI or NNRTI experienced patients. 
Nisu provedena kontrolirana ispitivanja efavirenza u bolesnika s uznapredovalom HIV bolešću, kao što su osobe s < 50 CD4 stanica/mm3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 100 mg hard capsules efavirenz 
NAZIV LIJEKA SUSTIVA 100 mg tvrde kapsule efavirenz
Printing ink: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171) 
Tinta za označavanje: boja karmin crvena (E120), indigo karmin (E132), titanijev dioksid (E171) SUSTIVA 100 mg tvrde kapsule
Azithromycin/Efavirenz (600 mg single dose/400 mg once daily) 
Antibiotici azitromicin/efavirenz (600 mg jednokratna doza/400 mg jedanput na dan)
3, or after failure of protease inhibitor (PI) containing regimens. 
3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a NC = F, noncompleter = failure. 
IDV + ZDV + 3TC a NC = F, liječenje nije završeno = terapijski neuspjeh. b C.I., interval pouzdanosti.
Cmax: ↓ 18% (↓ 59 to ↑ 12) 
AUC: ↓ 40% (↓ 26 do Cmax: ↓ 18% (↓ 59 do ↑ 12)
The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily. 
Koncentracije lopinavira: slično kao kod primjene lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan bez efavirenza lopinavir/ritonavir tableta mora se povisiti na 500/125 mg dvaput na dan kada se primjenjuju istodobno s efavirenzom u dozi od 600 mg jedanput na dan.
Liver enzyme monitoring should be considered for patients without pre-existing hepatic dysfunction or other risk factors. 
U bolesnika koji nemaju postojeće poremećaje funkcije jetre ili druge čimbenike rizika mora se razmotriti praćenje jetrenih enzima.
Cmin: ↓ 43% (↓ 18 to ↓ 60) Efavirenz: 
Cmax: ↓ 35% (↓ 12 do ↓ 52) Cmin: ↓ 43% (↓ 18 do ↓ 60) efavirenz:
Cmin: ↓ 45% (↓ 31 to ↓ 56) Efavirenz: 
Cmax: ↓ 32% (↓ 15 do ↓ 46) Cmin: ↓ 45% (↓ 31 do ↓ 56) efavirenz:
Cmin: ↓ 46% (↓ 31 to ↓ 58) Efavirenz: 
Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58) efavirenz:
Pravastatin/Efavirenz (40 mg once daily/600 mg once daily) 
pravastatin/efavirenz (40 mg jedanput na dan/600 mg jedanput na dan)
Voriconazole/Efavirenz (200 mg twice daily/400 mg once daily) 
vorikonazol/efavirenz (200 mg dvaput na dan/400 mg jedanput na dan)
Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak @merck.com 
Česká republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 msd_cr@merck.com
Medicines that impact heart rhythm: - Medicines used to treat heart rhythm problems such as flecainide or metoprolol. 
lijekovi koji utječu na srčani ritam: - lijekovi koji se koriste za liječenje problema srčanog ritma: kao što su flekainid ili metoprolol. - lijekovi koji se koriste za liječenje depresije kao što su imipramin, amitriptilin ili klomipramin. - antibiotici, uključujući sljedeće tipove: makrolidi, fluorokinoloni ili imidazol
Cmax: ↓ 76% (↓ 63 to ↓ 79) 
Cmax: ↓ 76% (↓ 63 do ↓ 79) simvastatinska kiselina:
Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65) 
simeprevir: AUC: ↓ 71% (↓ 67 do ↓
Cmax: ↑ 23% (↓ 1 to ↑ 53) * 
Cmax: ↑ 23% (↓ 1 do ↑ 53)* efavirenz:
See package leaflet for further information. 
Vidjeti dio Opis odabranih nuspojava za detaljnije informacije.
AUC: ↓ 21% Cmax: ↔ 
AUC: ↓ 21% Cmax: ↔ efavirenz:
Cmax: ↓ 20% (↓ 15 to ↓ 24) 
Cmax: ↓ 24 % (↓ 15 do
Efavirenz: AUC: ↑ 17% (↑ 6 to ↑ 29) ** 
AUC: ↔* (↓ 9 do ↑ 10) Cmax: ↑ 17%* (↑ 8 do ↑ 27) Cmin: ↓ 42%* (↓ 31 do
The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in 
Medijan porasta broja CD4+ stanica od početne vrijednosti do 48. tjedna liječenja iznosio je 238 stanica/mm3, a medijan porasta postotka CD4+ stanica iznosio je 13%.
AUC: ↓ 36% C12: ↓ 21% 
AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36% (indukcija UGT1A1)
OPIOIDS 
LIJEKA
EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a 
EFV + IDV + NRTI IDV + NRTI
Cmin: ↓ 63% (↓ 44 to ↓ 75) Desacetyl diltiazem: 
Cmax: ↓ 60% (↓ 50 do ↓ 68) Cmin: ↓ 63% (↓ 44 do ↓ 75) dezacetil-diltiazem:
The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172) and silicon dioxide. 
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, žuti željezov oksid (E172) i silicijev dioksid (E551).
Cmin: ↑ 12%*/** (↓16 to ↑49) (CYP3A4 induction). 
Cmax: ↑ 11% (↑ 6 do ↑ 16) Cmin: ↔ (indukcija CYP3A4)
The capsule shell contains: gelatine, sodium laurilsulfate, titanium dioxide (E171) and silicon dioxide. 
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, titanijev dioksid (E171) i silicijev dioksid (E551).
Norbuprenorphine: 
vorikonazol:
Efficacy results for studies ACTG 364 and 020 are found in Table 4. 
U Tablici 4 prikazani su rezultati djelotvornosti u ispitivanjima ACTG 364 i 020.
Ethinyloestradiol: AUC: ↔ 
etinilestradiol:
Darunavir: 
rifabutin:
EU/1/99/110/003: bottle EU/1/99/110/004: blister 
EU/1/99/110/004 - blister
(CYP3A4 induction) In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal. 
Cmax: ↓ 45% (↓ 25 do ↓ 59) (indukcija CYP3A4) U ispitivanju intravenskih ovisnika zaraženih HIVom istodobna primjena efavirenza i metadona dovela je do sniženja koncentracije metadona u plazmi i znakova ustezanja od opijata.
(CYP3A induction by efavirenz) 
↑ 50)b efavirenz:
Artemether: 
lorazepam:
Simvastatin acid: AUC: ↓ 58% (↓ 39 to ↓ 68) 
AUC: ↓ 58% (↓ 39 do
How to store SUSTIVA 
Kako čuvati lijek SUSTIVA
Efficacy results for studies ACTG 364 and 020 are found in Table 3. 
U Tablici 3 prikazani su rezultati djelotvornosti u ispitivanjima ACTG 364 i 020.
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy. 
Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi.
Cmax: ↑ 11% (↑ 6 to ↑ 16) 
AUC: ↑ 17% (↑ 6 do
Cmax: ↓ 13% (↓ 0 to ↓ 23) 
Cmax: ↓ 13% (↓ 0 do ↓ 23) 4-hidroksi atorvastatin:
Cmax: ↓ 34% (↓ 21 to ↓ 47) 
Cmax: ↓ 34% (↓ 21 do ↓ 47) hidroksibupropion:
Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily) 
Preporuke za istodobnu primjenu s efavirenzom klaritromicin/efavirenz (500 mg svakih 12h/400 mg jedanput na dan)
Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔ 
ritonavir: jutarnji AUC: ↑ 18% (↑ 6 do ↑ 33) večernji AUC: ↔ jutarnji Cmax: ↑ 24% (↑ 12 do ↑ 38) večernji Cmax: ↔ jutarnji Cmin: ↑ 42% (↑ 9 do
Tablet core 
Zatajenje jetre
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 100 mg. 
2. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Jedna tvrda kapsula sadrži 100 mg efavirenza.
Cmax: ↓ 12% (↓ 1 to ↓ 26) 
Cmax: ↓ 12% (↓ 1 do ↓ 26) 2-hidroksi atorvastatin:
Bottle: EU/1/99/110/008 
EU/1/99/110/008
Itraconazole/Efavirenz (200 mg q12h/600 mg once daily) 
Antifungalni lijekovi itrakonazol/efavirenz (200 mg svakih 12h/600 mg jedanput na dan)
Tell your doctor immediately. 
Odmah obavijestite svog liječnika.
Use in children of more than 2 years old 
Primjena u djece starije od 2 godine
There are two alternative treatment schedules: 
Postoje dva alternativna rasporeda terapije:
There are two groups: 
Postoje dvije skupine:
In particular, tell your doctor if you have: 
Obavezno obavijestite svog liječnika ako imate:
The following information is intended for healthcare professionals only (see section 3 for further information): 
Sljedeće informacije namijenjene su samo zdravstvenim radnicima (vidjeti dio 3 za dodatne informacije):
● Coombs test positive 
• pozitivan Coombsov test
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. 
Terapijski učinak treba procijeniti nakon svakog ciklusa; ako se terapijski učinak ne opazi nakon 6 mjeseci, liječenje treba prekinuti.
Allergic reactions are rare. 
Alergijske reakcije su rijetke.
Kawasaki disease 
Kawasakijeva bolest
Date of latest renewal: 24 April 2017 
Datum posljednje obnove odobrenja: 24. travnja 2017.
● feeling cold 
● osjećaj hladnoće
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments. 
Raspodjeljuje se relativno brzo između plazme i ekstravaskularne tekućine, nakon približno 3 - 5 dana postiže se ravnoteža između intra- i ekstravaskularnih odjeljaka.
It is worth considering that these 2 subjects contributed to the higher frequency of infusions with reactions in this group. 
Valja uzeti u obzir da su ta 2 ispitanika pridonijela većoj učestalosti infuzija s reakcijama u toj skupini.
Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours. 
Simptomi TRALI-ja obično se razviju tijekom ili unutar 6 sati od transfuzije, često unutar 1 - 2 sata.
This half-life may vary from patient to patient, in particular in primary immunodeficiency. 
Taj poluvijek može se razlikovati od bolesnika do bolesnika, a naročito u primarnoj imunodeficijenciji.
Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes. 
Procjena vitalnih znakova u kliničkim ispitivanjima pedijatrijske populacije nije pokazala nikakav obrazac klinički značajnih promjena.
You must not be given a double dose to make up for a forgotten dose. 
Ne smijete primiti dvostruku dozu kako bi se nadoknadila zaboravljena doza.