natgillin/translations-raw huggingface dataset:
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
Voriconazole/efavirenz (400 mg twice daily/300 mg once daily) 
Vorikonazol/efavirenz (400 mg dvaput na dan /300 mg jedanput na dan)
CD4+ count at 48 weeks was 215 cells/mm3 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%.
Fluconazole/efavirenz (200 mg once daily/400 mg once daily) 
Flukonazol/efavirenz (200 mg jedanput na dan /400 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)
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)
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 javljaju već prvog ili drugog dana liječenja i uglavnom nestanu nakon prva 2 do 4 tjedna.
General disorders and administration site conditions Common Fatigue *,†, ‡ See section c. Description of selected adverse reactions for more details. 
Opći poremećaji i reakcije na mjestu primjene često umor * † ‡ Vidjeti dio c.
Paroxetine/efavirenz (20 mg once daily/600 mg once daily) 
Paroksetin/efavirenz (20 mg jedanput na dan /600 mg jedanput na dan)
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) 
o elbasvir ili grazoprevir (za liječenje hepatitisa C) o Gospinu travu (Hypericum perforatum) (biljni pripravak za liječenje depresije i tjeskobe)
Simvastatin/efavirenz (40 mg once daily/600 mg once daily) 
Simvastatin/efavirenz (40 mg jedanput na dan /600 mg jedanput na dan)
The median increase from baseline in CD4+ count at 48 weeks of therapy was 128 cells/mm3 and the median increase in CD4+ percentage was 5%. 
stanica od početne vrijednosti do 48. tjedna liječenja iznosio je 128 stanica/mm3, a medijan porasta postotka CD4+ stanica iznosio je 5%.
Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz. 
Prije početka liječenja efavirenzom žene u reproduktivnoj dobi moraju napraviti test na trudnoću.
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). 
Ipak, s obzirom na to da se manje od 1% primijenjene doze efavirenza izlučuje nepromijenjeno mokraćom, očekuje se da bi utjecaj oštećenja bubrega na eliminaciju efavirenza trebao biti minimalan (vidjeti dio 4.2).
Fluoxetine/efavirenz 
Fluoksetin/efavirenz
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 treba se razmotriti praćenje jetrenih enzima.
Itraconazole/efavirenz (200 mg q12h/600 mg once daily) 
Antifungalni lijekovi Itrakonazol/efavirenz (200 mg q12h/600 mg jedanput na dan)
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 
Metabolički parametri Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi
No clinically significant pharmacokinetic change. 
Nema klinički značajnih farmakokinetičkih interakcija.
Buprenorphine/naloxone/ efavirenz 
Buprenorfin/nalokson/ efavirenz
Psychiatric adverse reactions have been reported in patients treated with efavirenz. 
U nekih su bolesnika liječenih efavirenzom zabilježeni psihijatrijski poremećaji.
ANTICONVULSANTS Carbamazepine/efavirenz (400 mg once daily/600 mg once daily) 
Karbamazepin/efavirenz (400 mg jedanput na dan /600 mg jedanput na dan)
AUC: ↑ 20% (↑ 8 to ↑ 34) Cmax: ↑ 21% (↑ 10 to ↑ 33) 
AUC: ↑ 20% (↑ 8 do ↑ 34) Cmax: ↑ 21% (↑ 10 do ↑ 33) Ova se kombinacija općenito dobro podnosila.
If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used. 
preporučuju se doze darunavira/ritonavira od 600/100 mg dvaput na dan.
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. 
Liječnik može razmotriti mogućnost uvođenja nekog drugog lijeka ili promijeniti dozu inhibitora proteaze. maravirok kombinirana tableta koja sadrži efavirenz, emtricitabin i tenofovir ne smije se uzimati s lijekom Efavirenz Teva, osim ako Vam tako nije preporučio Vaš liječnik, zato što taj lijek sadrži efavirenz, djelatnu tvar lijeka Efavirenz Teva - Lijekove za liječenje infekcije hepatitis C virusa: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voksilaprevir, glekaprevir/pibrentasvir.
Common Pruritus 
IMUNOSUPRESIVI
Resistant virus emerges rapidly when efavirenz is administered as monotherapy. 
Primjena efavirenza kao monoterapije brzo dovodi do nastanka rezistentnog soja virusa.
Pravastatin/efavirenz (40 mg once daily/600 mg once daily) 
Pravastatin/efavirenz (40 mg jedanput na dan /600 mg jedanput na dan)
Efavirenz Teva may reduce the amount of posaconazole in your blood. 
Efavirenz Teva može smanjiti koncentraciju posakonazola u krvi.
- Efavirenz Teva film-coated tablets are not suitable for children weighing less than 40 kg. - The dose for children weighing 40 kg or more is 600 mg once daily. 
- Efavirenz Teva filmom obložene tablete nisu prikladne za djecu tjelesne težine manje od 40 kg.
Fosamprenavir/saquinavir/ efavirenz 
Fosamprenavir/sakvinavir/ efavirenz
Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient 
Istovremenu primjenu posakonazola i efavirenza treba izbjegavati osim ako je potencijalna korist za bolesnika veća od potencijalnog rizika.
Efavirenz Teva", at the start of Section 2. 
Ti su lijekovi navedeni u odlomku „Ne uzimajte Efavirenz Teva“, na početku dijela 2.
OPIOIDS 
TABLETA
Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks. 
Simptomi živčanog sustava obično se javljaju ubrzo nakon započinjanja liječenja i uglavnom nestanu nakon prva 2-4 tjedna.
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. 
AUC: ↑ 11% (↑ 5 do ↑ 18) Cmax: ↑ 16% (↑ 6 do ↑ 26) Cmin: ↑ 13% (↑ 1 do ↑ 26)
- Tell your doctor: 
Obavijestite svog liječnika ako primijetite neku od sljedećih nuspojava:
↔efavirenz 
- zamagljen vid
AUC: ↓ 39% (↓ 27 to ↓ 50) Cmax: ↓ 29% (↓ 15 to ↓ 40) Cmin: ↓ 46% (↓ 31 to ↓ 58) 
Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58)
As a result, the amounts of Efavirenz Teva or other medicines in your blood may be affected. 
Kao rezultat toga mogu se promijeniti koncentracije lijeka Efavirenz
AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32) 
AUC: ↓ 18% (↓ 10 do ↓ 26) Cmax: ↓ 24% (↓ 15 do ↓ 32) Cmin: ↓ 10% (↑ 1 do ↓ 19)%
AUC: ↑ 7% (↑ 1 to ↑ 14) Cmax: ↑ 16% (↑ 2 to ↑ 32) These changes are not considered clinically significant. 
AUC: ↑ 7% (↑ 1 do ↑ 14) Cmax: ↑ 16% (↑ 2 do ↑ 32)
CCR5 antagonist Maraviroc/efavirenz (100 mg twice daily/600 mg once daily) 
Maravirok/efavirenz (100 mg dvaput na dan/600 mg jedanput na dan)
A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6). 
Uz hormonske kontraceptive treba koristiti i pouzdanu mehaničku metodu kontracepcije (vidjeti dio
Teva, your doctor may need to adjust your dose of the calcium channel blocker. 
Sažetak opisa svojstava lijeka za blokator kalcijevih kanala).
The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept. 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969). 
2, rujan 2009.) na temelju procjene gornje granice 95%-tnog intervala pouzdanosti za 0 događaja,
Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays. 
5.3 Neklinički podaci o sigurnosti primjene Uobičajeni testovi genotoksičnosti nisu pokazali mutagene niti klastogene učinke efavirenza.
In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended (see section 4.8). 
smanjenje koncentracije i neobični snovi (vidjeti dio 4.8).
Concomitant administration with efavirenz should be avoided due to the risk for QTc prolongation (see section 4.3). 
od pojave produljenja QTc intervala (vidjeti dio 4.3).
STATEMENT OF ACTIVE SUBSTANCE(S) 
Efavirenz protokol
Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food) 
ANTI-INFEKTIVI HIV - antivirusni lijekovi Inhibitori proteaze (IP) Atazanavir/ritonavir/efavirenz (400 mg jedanput na dan/100 mg jedanput na dan /600 mg jedanput na dan, sve uzimati uz hranu)
Uncommon Tinnitus†, vertigo Vascular disorders 
Poremećaji uha i labirinta manje često tinitus†, vertigo
Annex II Conditions to the marketing authorisation(s) 
Uvjeti odobrenja za stavljanje u promet
For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years: 
Za N-nitrozodimetilamin (NDMA) i N-nitrozodietilamin (NDEA) nositelj odobrenja za stavljanje lijeka u promet mora uvesti sljedeće specifikacije za djelatnu tvar lijeka:
Due date 
Krajnji rok
Conditions to the MA 
NDMA
Valsartan 320 
Prilog II.
The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion. 
Informacije o lijeku ostaju u skladu s konačnom verzijom donesenom tijekom postupka Koordinacijske skupine kako je navedeno u Prilogu III. mišljenju CHMP-a.
In January 2018, Syner-Medica Ltd sumitted a mutual recognition application for Syner-Kinase 10,000 IU, 25,000 IU, 100,000 IU, 250,000 IU and 500,000 IU powder for solution for injection or infusion in France, Germany, Spain and the Netherlands with the United Kingdom as the reference Member State (RMS). 
U siječnju 2018. tvrtka Syner-Medica Ltd podnijela je zahtjev za uzajamno priznavanje za prašak za otopinu za injekciju ili infuziju Syner-Kinase u dozama od 10 000 IU, 25 000 IU, 100 000 IU, 250 000 IU i 500 000 IU u Francuskoj, Njemačkoj, Španjolskoj i Nizozemskoj, pri čemu je Ujedinjena Kraljevina referentna država članica.