natgillin/translations-raw huggingface dataset:
Artemether/lumefantrine/ Efavirenz (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Antimalarici artemeter/lumefantrin/efavirenz (20/120 mg tableta, 6 doza od po 4 tablete, tijekom 3 dana/600 mg jedanput na dan artemeter:
Velpatasvir/ sofosbuvir/ voxilaprevir
velpatasvir/sofosbuvir/voksilaprevir ↓velpatasvir ↓voksilaprevir
Bupropion: AUC: ↓ 55% (↓ 48 to ↓ 62)
bupropion: AUC: ↓ 55% (↓ 48 do
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz.
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 600 mg efavirenza.
Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP.
Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza „Rok valjanosti“.
Each SUSTIVA film-coated tablet contains 600 mg of the active substance efavirenz.
Jedna SUSTIVA filmom obložena tableta sadrži 600 mg djelatne tvari efavirenz.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/008 - bottle
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/110/008 - bočica
Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA 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 lijeka SUSTIVA 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.
Cmax: ↓ 20% (↓ 2 to ↓ 26)
Cmax: ↓ 20% (↓ 2 do ↓ 26)
Examples of soft foods are applesauce, grape jelly, yogurt,
Primjeri mekane hrane su kašica od jabuke, žele od grožđa, jogurt ili hrana za dojenčad.
Gastrointestinal disorders common abdominal pain, diarrhoea, nausea, vomiting uncommon pancreatitis
Poremećaji probavnog sustava često bolovi u abdomenu, proljev, mučnina, povraćanje manje često pankreatitis
At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Na početku ispitivanja je medijan HIV-1 RNK u plazmi iznosio 4,8 log10 kopija/ml, medijan broja CD4+ stanica iznosio je 367 stanica/mm3, a medijan postotka CD4+ iznosio je 18%.
No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Nisu zabilježene malformacije ploda u ženki štakora i kunića koje su primale efavirenz.
The biliary hyperplasia regressed upon cessation of dosing.
Nakon prekida primjene lijeka bilijarna hiperplazija se povukla.
AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
AUC: ↓ 18% (↓ 10 do ↓ 26) Cmax: ↓ 24 % (↓ 15 do
Capsule core: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate
Jezgra kapsule: natrijev laurilsulfat, laktoza hidrat, magnezijev stearat, natrijev škroboglikolat
SUSTIVA should never be used alone to treat HIV.
Lijek SUSTIVA nikada ne smijete uzimati kao jedini lijek za liječenje HIV infekcije.
The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, and magnesium stearate.
Drugi sastojci u jezgri tablete su: umrežena karmelozanatrij, mikrokristalična celuloza, natrijev laurilsulfat, hidroksipropilceluloza, laktoza hidrat i magnezijev stearat.
Fluoxetine/Efavirenz
fluoksetin/efavirenz
SUSTIVA may reduce the amount of itraconazole in your blood.
SUSTIVA može smanjiti koncentraciju itrakonazola u krvi. - posakonazol.
% (95% C.I.)
% (95% C.I. c) stanica/mm
Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.
Koncentracije u plazmi onih tvari koje su supstrati tih enzima mogu se smanjiti pri istodobnoj primjeni s efavirenzom.
The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Primjena lijeka efavirenz uz hranu može povećati izloženost efavirenzu i dovesti do povećanja učestalosti nuspojava (vidjeti dio 4.4).
MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/001-004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/110/001 - 004
Ethinyloestradiol + Norgestimate/ Efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
HORMONSKI KONTRACEPTIVI peroralni: etinilestradiol + norgestimat / efavirenz (0,035 mg + 0,25 mg jedanput na dan/600 mg jedanput na dan)
Concomitant administration of glecaprevir/pibrentasvir with efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect.
Istodobna primjena glekaprevira/pibrentasvira s efavirenzom može značajno smanjiti koncentracije glekaprevira i pibrentasvira u plazmi, uzrokujući smanjen terapijski učinak.
Itraconazole: AUC: ↓ 39% (↓ 21 to ↓ 53)
itrakonazol: AUC: ↓ 39% (↓ 21 do
Diltiazem: AUC: ↓ 69% (↓ 55 to ↓ 79)
diltiazem: AUC: ↓ 69% (↓ 55 do
Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Jezgra tablete karmelozanatrij, umrežena celuloza, mikrokristalična natrijev laurilsulfat hidroksipropilceluloza laktoza hidrat magnezijev stearat
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
Vigabatrin/Efavirenz Gabapentin/Efavirenz
Preporuke za istodobnu primjenu s efavirenzom vigabatrin/efavirenz gabapentin/efavirenz
The reproductive performance of offspring born to female rats given efavirenz was not affected.
Nije bilo utjecaja na sposobnost razmnožavanja potomaka ženki štakora koje su dobivale efavirenz.
LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A 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)
* When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
(indukcija CYP3A4) * u usporedbi s kombinacijom atazanavir 300 mg/ritonavir 100 mg jedanput na dan navečer, bez efavirenza.
Simvastatin: AUC: ↓ 69% (↓ 62 to ↓ 73)
simvastatin: AUC: ↓ 69% (↓ 62 do
Telaprevir (relative to 750 mg q8h): AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24)
telaprevir (u odnosu na 750 mg svakih 8h) AUC: ↓ 18% (↓ 8 do ↓ 27) Cmax: ↓ 14 % (↓ 3 do ↓ 24) Cmin: ↓ 25% (↓ 14 do ↓ 34) efavirenz:
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.
Među koinficiranim bolesnicima u ispitivanju 006 porast AST-a više od pet puta iznad GGN zabilježen je u 13% bolesnika koji su primali efavirenz i u 7% u kontrolnoj skupini, a porast ALT-a više od pet puta iznad GGN zabilježen je u 20% bolesnika na efavirenzu i u 7% bolesnika u kontrolnoj skupini.
ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 ml single dose/400 mg single dose)
ANTACIDI aluminijev hidroksid-magnezijev hidroksid-simetikon antacid/efavirenz (30 ml u jednokratnoj dozi/400 mg u jednokratnoj dozi) famotidin/efavirenz (40 mg u jednokratnoj dozi/400 mg u jednokratnoj dozi)
Depomedroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM single dose DMPA)
injekcija: depomedroksiprogesteron acetat (DMPA)/efavirenz (DMPA u jednokratnoj dozi od 150 mg i.m.)
Sertraline: AUC: ↓ 39% (↓ 27 to ↓ 50)
sertralin: AUC: ↓ 39% (↓ 27 do
Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.
Ne očekuje se da bi istodobna primjena efavirenza s lijekovima koji mijenjaju pH želuca utjecala na apsorpciju efavirenza.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 600 mg film-coated tablets
NAZIV LIJEKA SUSTIVA 600 mg filmom obložene tablete
Five of these NNRTI-resistant isolates were found to have K103N or a valine-toisoleucine 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 5 od tih izolata rezistentnih na NNRTI ustanovljena je zamjena K103N ili zamjena valina izoleucinom na mjestu 108 (V108I) u reverznoj transkriptazi.
Clarithromycin: AUC: ↓ 39% (↓ 30 to ↓ 46)
klaritromicin: AUC: ↓ 39% (↓ 30 do
At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.
Na početku ispitivanja je medijan HIV-1 RNK u plazmi iznosio 5,88 log10 kopija/ml, medijan broja CD4+ stanica iznosio je 1144 stanica/mm3, a medijan postotka CD4+ iznosio je 25%.
Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Za više informacija pogledati podatke o propisivanju lijekova glekaprevir/pibrentasvir.
Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; psychiatric adverse reactions including severe depression, death by suicide, and psychosis like behaviour; and seizures have been reported in patients treated with efavirenz.
U bolesnika liječenih efavirenzom prijavljene su teške kožne reakcije poput Stevens-Johnsonovog sindroma i multiformnog eritema, psihijatrijske nuspojave, uključujući tešku depresiju, samoubojstvo i psihotično ponašanje te napadaji.
The tablets are printed with inks containing hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) and titanium dioxide (E171).
Tablete su označene tintama koje sadrže hipromelozu (E464), propilenglikol, boju karmin crvena (E120), indigo karmin (E132) i titanijev dioksid (E171).
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).
Međutim, in vitro je uočena i inhibicija te neto učinak istodobne primjene sa supstratima tih enzima nije razjašnjen (vidjeti dio 5.2).
15 Do not give the child any additional food for 2 hours.
14 Dajte djetetu da ponovno pojede sav sadržaj (ilustracija f). 15 Nemojte davati djetetu nikakvu dodatnu hranu u naredna 2 sata.
Coadministration of sofosbuvir/velpatasvir with efavirenz is not recommended.
Istodobna primjena sofosbuvira/velpatasvira s efavirenzom se ne preporučuje.
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.
Kod istodobne primjene efavirenza i artemeter/lumefantrin tableta potreban je oprez jer snižene koncentracije artemetera, dihidroartemisinina ili lumefantrina mogu rezultirati smanjenom antimalarijskom djelotvornošću.
Methadone/Efavirenz (stable maintenance, 35-100 mg once daily/600 mg once daily)
OPIOIDI metadon/efavirenz (stabilna doza održavanja, 35100 mg jedanput na dan/600 mg jedanput na dan)
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)
Hepatitis C antivirals Boceprevir/Efavirenz (800 mg 3 times daily/600 mg once daily)
Hepatitis C antivirusni lijekovi boceprevir/efavirenz (800 mg triput na dan/600 mg jednaput na dan )
Co-administration of efavirenz with atazanavir/ritonavir is not recommended.
Ne preporučuje se istodobna primjena efavirenza s atazanavirom/ritonavirom.
White, printed with "SUSTIVA" on the body and "100 mg" on the cap. SUSTIVA 200 mg hard capsules
Bijele, s otisnutom oznakom „SUSTIVA“ na tijelu i „100 mg“ na kapici.
PHARMACEUTICAL FORM AND CONTENTS
4. FARMACEUTSKI OBLIK I SADRŽAJ Bočica:
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.
Cmin: ↓ 47% (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction)
Cmax: ↓ 21% (↓ 15 do ↓ 26) Cmin: ↓ 47% (↓ 41 do ↓ 53) (sniženje koncentracije karbamazepina: indukcija CYP3A4; sniženje koncentracije efavirenza: indukcija CYP3A4 i CYP2B6)
Table 3: Efficacy results for studies ACTG 364 and 020
Tablica 3: Rezultati djelotvornosti iz ispitivanja ACTG 364 i 020
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) (indukcija CYP3A4) Povišenje vrijednosti farmakokinetičkih parametara efavirenza ne smatra se klinički značajnim.
one 100 mg capsule
jedna kapsula od 100 mg
Atovaquone and proguanil hydrochloride/Efavirenz (250/100 mg single dose/600 mg once daily)
atovakon i progvanilklorid/efavirenz (250/100 mg u jednokratnoj dozi/600 mg jedanput na dan)
Dose adjustment of buprenorphine or efavirenz may not be necessary when coadministered.
Pri istodobnoj primjeni možda neće biti potrebna prilagodba doze buprenorfina ili efavirenza.
Table 4: Efficacy results for studies ACTG 364 and 020
Tablica 4: Rezultati djelotvornosti iz ispitivanja ACTG 364 i 020
Recommendation concerning co-administration with efavirenz
Preporuke za istodobnu primjenu s efavirenzom
Dose adjustment of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
Može biti potrebno prilagođavati dozu simvastatina (vidjeti Sažetak opisa svojstava lijeka za simvastatin).
Methadone: AUC: ↓ 52% (↓ 33 to ↓ 66)
metadon: AUC: ↓ 52% (↓ 33 do
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 uzeto uz hranu)
Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Može biti potrebno prilagođavati dozu atorvastatina (vidjeti Sažetak opisa svojstava lijeka za atorvastatin).
CCR5 antagonist Maraviroc/Efavirenz (100 mg twice daily/600 mg once daily)
Antagonist CCR5 maravirok/efavirenz (100 mg dvaput na dan/600 mg jedanput na dan)
Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2 - 4 weeks.
Simptomi živčanog sustava obično se javljaju ubrzo nakon započinjanja liječenja i uglavnom nestanu nakon prva 2-4 tjedna.
CD4+ percentage was 13%.
3, a medijan postotka CD4+ iznosio je 25%.
Lopinavir/ritonavir soft capsules or oral solution/Efavirenz
lopinavir/ritonavir meke kapsule ili oralna otopina/efavirenz lopinavir/ritonavir tablete/efavirenz
three 100 mg capsules + one 50 mg capsule
tri kapsule od 100 mg + jedna kapsula od 50 mg
Carbamazepine may make SUSTIVA less likely to work.
Karbamazepin može smanjiti djelotvornost lijeka SUSTIVA.
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 režimima koji uključuju efavirenz.
Raltegravir/Efavirenz (400 mg single dose/ -)
Inhibitori integraze raltegravir/efavirenz (400 mg u jednokratnoj dozi/ -)
ANTIHISTAMINES Cetirizine/Efavirenz (10 mg single dose/600 mg once daily)
ANTIHISTAMINICI cetirizin/efavirenz (10 mg jednokratna doza/600 mg jedanput na dan)
Carbamazepine: AUC: ↓ 27% (↓ 20 to ↓ 33)
karbamazepin: AUC: ↓ 27% (↓ 20 do
Each hard capsule contains 57.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 57,0 mg laktoze (u obliku hidrata).
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
SUSTIVA 50 mg hard capsules
SUSTIVA 50 mg tvrde kapsule
Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended.
Istodobna primjena glekaprevira/pibrentasvira s efavirenzom se ne preporučuje.
QT Prolonging Drugs
Lijekovi koji produljuju QT interval
Each hard capsule contains 28.5 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 28,5 mg laktoze (u obliku hidrata).
Simeprevir/Efavirenz (150 mg once daily /600 mg once daily)
simeprevir/efavirenz (150 mg jedanput na dan /600 mg jedanput na dan)
Cmin: ↓ 44% (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction) Hydroxyitraconazole:
Cmax: ↓ 37% (↓ 20 do ↓ 51) Cmin: ↓ 44% (↓ 27 do ↓ 58) (snižena koncentracija itrakonazola: indukcija CYP3A4) hidroksiitrakonazol:
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%.
Medijan porasta broja CD4+ stanica od početne vrijednosti do 48. tjedna liječenja iznosio je 128 stanica/mm3, a medijan porasta postotka CD4+ stanica iznosio je 5%.
one 200 mg capsule + one 50 mg capsule
jedna kapsula od 200 mg + jedna kapsula od 50 mg
Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b Efavirenz:
↑ 86) b večernji Cmin: ↑ 24% (↑ 3 do ↑ 50)b efavirenz: AUC: ↑ 21% (↑ 10 do
Protease inhibitors (PI) Atazanavir/ ritonavir/Efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
ANTIINFEKTIVI 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 uzeto uz hranu)
SUSTIVA 200 mg hard capsules
SUSTIVA 200 mg tvrde kapsule
SUSTIVA 200 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 200 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.
The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
Kapsule imaju oznaku otisnutu tintom koja sadrži boju karmin crvenu (E120), indigo karmin (E132) i titanijev dioksid (E171).
INFORMATION IN BRAILLE SUSTIVA 600 mg
16. PODACI NA BRAILLEOVOM PISMU SUSTIVA 600 mg
Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
U kliničkim ispitivanjima efavirenza prijavljen je blag do umjeren osip, koji se obično povlačio u nastavku liječenja.
The combination was generally well tolerated.
Ova kombinacija mora se primjenjivati uz oprez.
Cmax: ↑ 14% (↑ 4 to ↑ 26)
Cmax: ↑ 14% (↑ 4 do ↑ 26) Cmin: ↑ 25% (↑ 7 do ↑ 46)
one 100 mg capsule + one 50 mg capsule
jedna kapsula od 100 mg + jedna kapsula od 50 mg
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.