natgillin/translations-raw huggingface dataset:
AUC: ↓ 60 % (↓ 52 to ↓ 68) Cmax: ↓ 62 % (↓ 55 to ↓ 78) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
AUC: ↓ 60% (↓ 52 do ↓ 68) Cmax: ↓ 62% (↓ 55 do ↓ 78) (indukcija CYP3A4) Istodobna primjena efavirenza s atorvastatinom, pravastatinom ili simvastatinom nije utjecala na vrijednosti AUC ni Cmax efavirenza
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period) - whistling, ringing or other persistent noise in the ears - tremor (shaking) - flushing
ushita ili razdražljivosti), paranoja, suicidalne misli, katatonija (stanje u kojem je bolesnik neko vrijeme nepomičan i ne govori) - zviždanje, zvonjava ili drugi uporno prisutan šum u ušima - tremor (nevoljno drhtanje) - navale crvenila
Stocrin may reduce the amount of itraconazole in your blood.
Stocrin može smanjiti koncentraciju itrakonazola u krvi. -posakonazol.
AUC12: ↓ 45 % (↓ 38 to ↓ 51) Cmax: ↓ 51 % (↓ 37 to ↓ 62) Efavirenz concentrations not measured, no effect is expected.
Cmax: ↓ 51% (↓ 37 do ↓ 62) Koncentracije efavirenza nisu mjerene, ne očekuje se nikakav učinak.
AUC: ↓ 26 % (↓ 15 to ↓ 36) Cmax: ↓ 20 % (↓ 11 to ↓ 28) Cmin: ↓ 32 % (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
AUC: ↓ 26% (↓ 15 do ↓ 36) Cmax: ↓ 20% (↓ 11 do ↓ 28) Cmin: ↓ 32% (↓ 15 do ↓ 46) (indukcija CYP3A4 i CYP2B6)
- 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 prijavljeno 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
Co-administration of efavirenz/emtricitabine/tenofovir disoproxil with sofosbuvir/velpatasvir has been shown to significantly decrease plasma concentrations of velpatasvir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of velpatasvir.
Utvrđeno je da istodobna primjena efavirenza/emtricitabina/ tenofovirdizoproksila sa sofosbuvirom/velpatasvirom značajno snižava koncentracije velpatasvira u plazmi zbog indukcije CYP3A efavirenzom, što može dovesti do gubitka terapijskog učinka velpatasvira.
Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
U bolesnika koji su uzimali efavirenz zabilježene su konvulzije, uglavnom u onih s poznatom anamnezom napadaja.
AUC: ↓ 71% (↓ 67 to ↓ 74) Cmax: ↓ 51% (↓ 46 to ↓ 56) Cmin: ↓ 91% (↓ 88 to ↓ 92) Efavirenz:
AUC: ↓ 71% (↓ 67 do ↓ 74) Cmax: ↓ 51% (↓ 46 do ↓ 56) Cmin: ↓ 91% (↓ 88 do ↓ 92) efavirenz:
It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
Preporučuje se uzimati Stocrin na prazan želudac, po mogućnosti prije spavanja.
Stocrin is recommended to be taken on an empty stomach preferably at bedtime.
Preporučuje se efavirenz uzimati na prazan želudac, po mogućnosti prije spavanja.
Individuals with these conditions may take Stocrin oral solution, which is free from lactose.
Osobe koje ne podnose šećere mogu uzimati Stocrin oralnu otopinu, koja ne sadrži laktozu.
Outer carton: STOCRIN 50 mg tablets
Kutija: STOCRIN 50 mg tablete
The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Povišene koncentracije efavirenza zapažene nakon primjene lijeka STOCRIN uz hranu mogu povećati učestalost nuspojava (vidjeti dijelove 4.4 i
• if you are currently taking any of the following medicines (see also “Other medicines and Stocrin”): - astemizole or terfenadine (used to treat allergy symptoms) - bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) - midazolam or triazolam (used to help you sleep) - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - 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) - triazole antifungal agents - certain antimalarial treatments - methadone (used to treat opiate addiction) - elbasvir/grazoprevir
• ako trenutno uzimate neki od sljedećih lijekova (također vidjeti dio „Drugi lijekovi i Stocrin“): - astemizol ili terfenadin (za liječenje simptoma alergije) - bepridil (za liječenje bolesti srca) - cisaprid (za liječenje žgaravice) - ergot alkaloide (na primjer ergotamin, dihidroergotamin, ergonovin i metilergonovin) (za liječenje migrene i cluster glavobolja) - midazolam ili triazolam (primjenjuju se za uspavljivanje) - pimozid (za liječenje nekih psihičkih bolesti) - gospinu travu (Hypericum perforatum) (biljni pripravak za liječenje depresije i tjeskobe) - flekainid, metoprolol (za liječenje nepravilnih otkucaja srca) - pojedine antibiotike (makrolide, fluorokinolone, imidazol) - lijekove za liječenje gljivičnih infekcija koji sadrže triazol - pojedine lijekove za liječenje malarije - metadon (za liječenje ovisnosti o opijatima) - elbasvir/grazoprevir.
Methadone(a medicine used to treat opiate addiction):your doctor may recommend an alternative treatment.
metadon (lijek koji se koristi za liječenje ovisnosti o opijatima): liječnik će Vam možda preporučiti zamjensko liječenje.
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 5 od tih izolata rezistentnih na NNRTI ustanovljena je zamjena K103N ili zamjena valina izoleucinom na mjestu 108 (V108I) u reverznoj transkriptazi.
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.
Medicines used to lower blood fats (also called statins):atorvastatin, pravastatin, simvastatin.
lijekove koji se koriste za snižavanje masnoća u krvi (zovu se i statini): atorvastatin, pravastatin,simvastatin.
AUC: ↓ 43 % (↓ 34 to ↓ 50) Cmax: ↓ 12 % (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
AUC: ↓ 43% (↓ 34 do ↓ 50) Cmax: ↓ 12% (↓ 1 do ↓ 26) 2-hidroksi atorvastatin:
Famotidine/Efavirenz (40 mg single dose/400 mg single dose)
famotidin/efavirenz (40 mg u jednokratnoj dozi/400 mg u jednokratnoj dozi)
Stocrin 50 mg film-coated tablets are supplied in bottles of 30 tablets.
Stocrin 50 mg filmom obložene tablete dostupne su u boci sa 30 tableta.
Ginkgo bilobaextracts (herbal preparation)
ekstrakti Ginkga bilobe (biljni pripravak).
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).
• With the bottle upright, fit the tip of the syringe into the bottle adapter.
• Držeći bocu uspravno, namjestite vrh štrcaljke u nastavak za bocu.
Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz (see section 5.3).
Prije početka liječenja efavirenzom žene reproduktivne dobi moraju napraviti test na trudnoću (vidjeti dio 5.3).
Other medicines used forHIV infection: protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
- inhibitore proteaze: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavirom pojačan atazanavir, sakvinavir ili fosamprenavir/sakvinavir.
Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional suggesting diminished absorption at higher doses.
O dozi ovisno povišenje Cmax i AUC zabilježeno je kod primjene doza do 1600 mg.
An oral syringe with a push-in bottle-neck adapter is included in the carton.
U kutiji je priložena oralna štrcaljka s nastavkom za bocu koji se utisne u grlo boce.
Outer carton: STOCRIN 200 mg tablets
Kutija: STOCRIN 200 mg tablete
Co-administration of simeprevir with efavirenz is not recommended.)
Istodobna primjena simeprevira s efavirenzom se ne preporučuje.
Atovaquone: AUC: ↓ 75% (↓ 62 to ↓ 84)
indinavir: AUC: ↓ 25% (↓ 16 do ↓ 32)
Stocrin 200 mg film-coated tablets are supplied in bottles of 90.
Stocrin 200 mg filmom obložene tablete dostupne su u boci sa 90 tableta.
Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
implantat: etonogestrel/efavirenz Može se očekivati smanjena izloženost etonogestrelu (indukcija CYP3A4).
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm
Nisu provedena kontrolirana ispitivanja efavirenza u bolesnika s uznapredovalom HIV bolešću, kao što su osobe s < 50 CD4 stanica/mm
Medium chain triglycerides Benzoic acid (E210) Strawberry/mint flavour
6.1 Popis pomoćnih tvari trigliceridi, srednje duljine lanca benzoatna kiselina (E210) aroma jagode/mente
Dose adjustments 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).
Lopinavir/ritonavir tablets/ Efavirenz
lopinavir/ritonavir meke kapsule ili oralna otopina/efavirenz lopinavir/ritonavir tablete/efavirenz
AUC: ↓ 39 % (↓ 21 to ↓ 53) Cmax: ↓ 37 % (↓ 20 to ↓ 51) Cmin: ↓ 44 % (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
AUC: ↓ 39% (↓ 21 do ↓ 53) Cmax: ↓ 37% (↓ 20 do ↓ 51) Cmin: ↓ 44% (↓ 27 do ↓ 58) (snižena koncentracija itrakonazola: indukcija CYP3A4) hidroksiitrakonazol:
Stocrin 600 mg film-coated tablets are supplied in bottles of 30 tablets.
Stocrin 600 mg filmom obložene tablete dostupne su u boci sa 30 tableta.
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ml at 48 weeks was 60 % (95 %, C.I.
Stopa ispitanika koji su odgovorili na liječenje, prema NC=F analizi postotka bolesnika koji su imali < 400 HIV-RNK kopija/ml plazme nakon 48 tjedana, bila je 60% (95%, C.I. 47, 72) te 53% (C.I. 40, 66), izračunato prema postotku bolesnika s < 50 HIV-RNK kopija/ml plazme.
AUC: ↓ 69 % (↓ 55 to ↓ 79) Cmax: ↓ 60 % (↓ 50 to ↓ 68) Cmin: ↓ 63 % (↓ 44 to ↓ 75) Desacetyl diltiazem:
AUC: ↓ 69% (↓ 55 do ↓ 79) Cmax: ↓ 60% (↓ 50 do ↓ 68) Cmin: ↓ 63% (↓ 44 do ↓ 75) dezacetil-diltiazem:
Dose adjustments of atorvastatin may be required (refer to the Summary of Product Characteristics for the atorvastatin).
Može biti potrebno prilagođavati dozu atorvastatina (vidjeti sažetak opisa svojstava lijeka za atorvastatin).
Ritonavir: Morning AUC: ↑ 18 % (↑ 6 to
AUC: ↑ 17% (↑ 6 do
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 funkcije bubrega na eliminaciju efavirenza trebao bi biti minimalan (vidjeti dio 4.2).
EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
EFV + NFV + NRTI 65 70 (59, 82) EFV + NRTI
- bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) - midazolam or triazolam (used to help you sleep) - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - 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) - triazole antifungal agents - certain antimalarial treatments - methadone (used to treat opiate addiction) - elbasvir/grazoprevir
- astemizol ili terfenadin (za liječenje simptoma alergije) - bepridil (za liječenje bolesti srca) - cisaprid (za liječenje žgaravice) - ergot alkaloide (na primjer ergotamin, dihidroergotamin, ergonovin i metilergonovin) (za liječenje migrene i cluster glavobolja) - midazolam ili triazolam (primjenjuju se za uspavljivanje) - pimozid, imipramin, amitriptilin ili klomipramin (za liječenje nekih psihičkih bolesti) - gospinu travu (Hypericum perforatum) (biljni pripravak za liječenje depresije i tjeskobe) - flekainid, metoprolol (za liječenje nepravilnih otkucaja srca) - pojedine antibiotike (makrolide, fluorokinolone, imidazol) - lijekove za liječenje gljivičnih infekcija koji sadrže triazol - pojedine lijekove za liječenje malarije - metadon (za liječenje ovisnosti o opijatima) - elbasvir/grazoprevir.
Stocrin oral solution (30 mg/ml)
Stocrin oralna otopina (30 mg/ml)
Stocrin 30 mg/ml oral solution efavirenz
Stocrin 30 mg/ml oralna otopina efavirenz
AUC: ↓ 39 % (↓ 27 to ↓ 50) Cmax: ↓ 29 % (↓ 15 to ↓ 40) Cmin: ↓ 46 % (↓ 31 to ↓ 58) Efavirenz:
AUC: ↓ 39% (↓ 27 do ↓ 50) Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58) efavirenz:
AUC: ↓ 27 % (↓ 20 to ↓ 33) Cmax: ↓ 20 % (↓ 15 to ↓ 24) Cmin: ↓ 35 % (↓ 24 to ↓ 44) Efavirenz:
AUC: ↓ 27% (↓ 20 do ↓ 33) Cmax: ↓ 20% (↓ 15 do ↓ 24) Cmin: ↓ 35% (↓ 24 do ↓ 44) efavirenz:
AUC: ↓ 64 % (↓ 62 to ↓ 67) Cmax: ↓ 46 % (↓ 39 to ↓ 52) Cmin: ↓ 82 % (↓ 79 to ↓ 85) Levonorgestrel
AUC: ↓ 64% (↓ 62 do ↓ 67) Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85) levonorgestrel (aktivni metabolit):
AUC: ↓ 38 % (↓ 28 to ↓ 47) Cmax: ↓ 32 % (↓ 15 to ↓ 46) Cmin: ↓ 45 % (↓ 31 to ↓ 56) Efavirenz:
AUC: ↓ 38% (↓ 28 do ↓ 47) Cmax: ↓ 32% (↓ 15 do ↓ 46) Cmin: ↓ 45% (↓ 31 do ↓ 56) efavirenz:
AUC: ↓ 37 % (↓ 14 to ↓ 55) Cmax: ↓ 35 % (↓ 12 to ↓ 52) Cmin: ↓ 43 % (↓ 18 to ↓ 60) Efavirenz:
AUC: ↓ 37% (↓ 14 do ↓ 55) Cmax: ↓ 35% (↓ 12 do ↓ 52) Cmin: ↓ 43% (↓ 18 do ↓ 60) efavirenz:
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 dpoc_czechslovak @merck.com
Stocrin can reduce the amount of statins in your blood.
Stocrin može smanjiti koncentraciju statina u krvi.
AUC : ↓ 13 % Cmin : ↓ 31 % Cmax: ↓ 15% (CYP3A4 induction) Efavirenz:
Cmax: ↓ 15% (indukcija CYP3A4) efavirenz:
• Turn the bottle upside down with the syringe still in place.
• Preokrenite bocu s nataknutom štrcaljkom.
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 protokol koji uključuje i efavirenz i indinavir potrebno je uzeti u obzir opsežnost opaženih farmakokinetičkih interakcija budući da nije utvrđen klinički značaj sniženih koncentracija indinavira.
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 funkcije bubrega na eliminaciju efavirenza trebao bi biti minimalan (vidjeti dio 4.4).
Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily)
klaritromicin/efavirenz (500 mg svakih 12h/400 mg jedanput na dan)
Serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
U bolesnika liječenih efavirenzom prijavljene su ozbiljne psihijatrijske nuspojave.
Cmax: ↓ 44% (↓ 20 to ↓ 61)
Cmax: ↓ 24% (↓ 18 do ↓ 30)
Efavirenz kg
Efavirenz Doza (mg)
STOCRIN 50 mg film-coated tablets
STOCRIN 50 mg filmom obložene tablete
STOCRIN 50 mg film-coated tablets Each film-coated tablet contains 50 mg of efavirenz.
STOCRIN 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg efavirenza.
AUC: ↓ 36 % (↓ 32 to ↓ 40) Cmax: ↓ 21 % (↓ 15 to ↓ 26) Cmin: ↓ 47 % (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction) The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
AUC: ↓ 36% (↓ 32 do ↓ 40) Cmax: ↓ 21% (↓ 15 do ↓ 26) Cmin: ↓ 47% (↓ 41 do ↓ 53) (sniženje koncentracije karbamazepina: indukcija CYP3A4; sniženje koncentracije efavirenza: indukcija CYP3A4 i CYP2B6)
(CYP2B6 induction)
(indukcija CYP3A4)
• Each Stocrin film-coated tablet contains 50 mg of the active substance efavirenz.
• Jedna Stocrin filmom obložena tableta sadrži 50 mg djelatne tvari efavirenza.
STOCRIN 200 mg film-coated tablets
STOCRIN 200 mg filmom obložene tablete
STOCRIN 200 mg film-coated tablets Each film-coated tablet contains 200 mg of efavirenz.
STOCRIN 200 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 200 mg efavirenza.
Fluconazole/Efavirenz (200 mg once daily/400 mg once daily)
flukonazol/efavirenz (200 mg jedanput na dan/400 mg jedanput na dan)
STOCRIN 600 mg film-coated tablets
STOCRIN 600 mg filmom obložene tablete
Stocrin may reduce the amount of posaconazole in your blood.
Stocrin može smanjiti koncentraciju itrakonazola u krvi. posakonazol.
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
• Each Stocrin film-coated tablet contains 600 mg of the active substance efavirenz.
• Jedna Stocrin filmom obložena tableta sadrži 600 mg djelatne tvari efavirenza.
• Each Stocrin film-coated tablet contains 200 mg of the active substance efavirenz.
• Jedna Stocrin filmom obložena tableta sadrži 200 mg djelatne tvari efavirenza.
STOCRIN 600 mg film-coated tablets Each film-coated tablet contains 600 mg of efavirenz.
STOCRIN 600 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 600 mg efavirenza.
Bristol-Myers Squibb Pharmaceuticals Ltd. Tel: +44 (0800) 731 1736
Bristol-Myers Squibb S.r.l. Tel: +39 06 50 39 61
STOCRIN 30 mg/ml oral solution
STOCRIN 30 mg/ml oralna otopina
Sofosbuvir: Cmax ↑38%
Cmax: ↑ 38% vorikonazol:
• Separate the syringe from the adapter.
• Odvojite štrcaljku od nastavka za bocu.
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 s 200 mg dvaput na dan bez efavirenza ** u usporedbi s 600 mg jedanput na dan bez vorikonazola (kompetitivna inhibicija oksidativnog metabolizma)
Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Koncentracije lopinavira: slično kao kod primjene lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan bez efavirenza nelfinavir/efavirenz (750 mg svakih 8h/600 mg jedanput na dan)
Simvastatin/Efavirenz (40 mg once daily/600 mg once daily)
pravastatin/efavirenz (40 mg jedanput na dan/600 mg jedanput na dan)
Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Bolesnici koji imaju: iznenadnu smrt ili kongenitalno produljenje QTc intervala na elektrokardiogramu u obiteljskoj anamnezi, ili bilo koje drugo kliničko stanje za koje je poznato da uzrokuje produljenje QTc intervala. simptomatske srčane aritmije u anamnezi ili klinički značajnu bradikardiju ili kongestivno zatajenje srca praćeno sa smanjenjem ejekcijske frakcije lijeve klijetke. teške poremećaje ravnoteže elektrolita, npr. hipokalijemiju ili hipomagnezemiju.
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.
Cmin: ↓ 44%
Cmin: ↓ 44% efavirenz:
Indinavir/Efavirenz (800 mg q8h/200 mg once daily)
indinavir/efavirenz (800 mg svakih 8h/200 mg jedanput na dan)
Dose adjustments 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).
EFV + IDV + NRTIs IDV + NRTIs
NFV + NRTI
Hepatic impairment
‡, vrtoglavica
AUC: ↓ 25 % (↓ 16 to ↓ 32) Cmax: ↓ 17 % (↓ 6 to ↓ 26) Cmin: ↓ 50 % (↓ 40 to ↓ 59) Efavirenz:
Cmax: ↓ 17% (↓ 6 do ↓ 26) Cmin: ↓ 50% (↓ 40 do ↓ 59) efavirenz:
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.
AUC: ↑ 21 % (↑ 10 to ↑ 34) Cmax: ↑ 14 % (↑ 4 to ↑ 26) Cmin: ↑ 25 % (↑ 7 to ↑ 46) (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
AUC: ↑ 21% (↑ 10 do ↑ 34) Cmax: ↑ 14% (↑ 4 do ↑ 26) Cmin: ↑ 25% (↑ 7 do ↑ 46) (inhibicija oksidativnog metabolizma posredovanog izoenzimima CYP-a)
Wipe the adapter and replace the cap tightly over it.
Obrišite nastavak za bocu i čvrsto je zatvorite zaštitnim zatvaračem.
Stocrin 50 mg film-coated tablets efavirenz
STOCRIN 50 mg filmom obložene tablete efavirenz
STOCRIN 50 mg film-coated tablets efavirenz
Stocrin 50 mg filmom obložene tablete efavirenz
Stocrin contains efavirenz and may cause dizziness,impaired concentration, and drowsiness.
Stocrinsadrži efavirenz imože prouzročiti omaglicu, smetnje koncentracije i omamljenost.
Stocrin kg
Tjelesna težina kg
Stocrin 600 mg film-coated tablets efavirenz
STOCRIN 600 mg filmom obložene tablete efavirenz
STOCRIN 200 mg film-coated tablets efavirenz
STOCRIN 200 mg filmom obložene tablete efavirenz
AUC : ↑ 21 % Cmin: ↑ 17 % Cmax: ↑ 15% (CYP3A4 inhibition)
Cmax: ↑ 15% (inhibicija CYP3A4)
Bupropion: AUC: ↓ 55% (↓ 48 to ↓ 62)
maravirok: AUC12: ↓ 45% (↓ 38 do
AUC: ↓ 51% Cmax: ↓ 21% Dihydroartemisinin: AUC: ↓ 46% Cmax: ↓ 38% Lumefantrine:
dihidroartemisinin: AUC: ↓ 46% Cmax: ↓ 38%
AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
AUC: ↓ 75% (↓ 62 do ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
Indinavir/ritonavir/Efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Preporuke za istodobnu primjenu s efavirenzom indinavir/ritonavir/efavirenz (800 mg dvaput na dan/100 mg dvaput na dan/600 mg jedanput na dan)
3, or in PI or NNRTI-experienced patients.
3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
Simeprevir/Efavirenz (150 mg once daily /600 mg once daily)
Preporuke za istodobnu primjenu s efavirenzom simeprevir/efavirenz (150 mg jedanput na dan /600 mg jedanput na dan)
Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
AUC: ↓ 43% (↓ 7 do ↓ 65) Cmax: ↔
Buprenorphine:
bupropion:
It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Vrlo je važno da Temybric Ellipta primjenjujete svakoga dana prema uputama liječnika.
The first time you use Temybric Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Kada koristite Temybric Ellipta po prvi puta, ne morate provjeravati radi li inhalator ispravno; on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.