natgillin/translations-raw huggingface dataset:
Co-administration of simeprevir with Atripla is not recommended. 
Ne preporučuje se istodobna primjena simeprevira s Atriplom.
simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir. 
sofosbuvir/velpatasvir/voksilaprev ir
Maraviroc/Emtricitabine 
maravirok/emtricitabin
Co-administration of efavirenz with atazanavir/ritonavir is not recommended. 
Ne preporučuje se istodobna primjena atazanavira/ritonavira s
The following side effects are common (these may affect up to 1 in 10 patients) 
Sljedeće nuspojave su česte (mogu se pojaviti u do 1 na 10 bolesnika)
• blurred vision 
• zamućen vid
• tiredness 
• trnci
Atripla and raltegravir can be co-administered without dose adjustment. 
Atripla i raltegravir mogu se primjenjivati istodobno bez prilagodbe doze.
Simvastatin/Tenofovir disoproxil 
simvastatin/tenofovirdizoproksil
Patients with moderate or severe renal impairment require a dose adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2). 
U bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega nužno je prilagođavanje doziranja emtricitabina i tenofovirdizoproksila, što se ne može postići kombiniranom tabletom (vidjeti dio 4.2 i 5.2).
Rifabutin/Tenofovir disoproxil 
rifabutin/tenofovirdizoproksil
*/100 mg b.i.d./600 mg q.d.) 
(300 mg b.i.d.*/100 mg b.i.d./600 mg q.d.)
Atazanavir/ritonavir/Efavirenz (400 mg q.d./200 mg q.d./600 mg q.d., all administered with food) 
atazanavir/ritonavir/efavirenz (400 mg q.d./200 mg q.d./600 mg q.d., svi se primjenjuju s hranom)
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2). 
U bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega nužno je prilagođavanje intervala doziranja emtricitabina i tenofovirdizoproksila što se ne može postići kombiniranom tabletom (vidjeti dio 4.4 i 5.2).
EXP 
osip
Administration to 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. 
Primjena u bolesnika koji imaju: - u obiteljskoj anamnezi iznenadnu smrt ili kongenitalno produljenje QTc intervala na elektrokardiogramu ili neko drugo kliničko stanje za koje je poznato da produljuje QTc interval - anamnezu simptomatskih srčanih aritmija ili klinički značajne bradikardije ili kongestivnog srčanog zatajenja popraćenog smanjenom ejekcijskom frakcijom lijeve klijetke - teške poremećaje ravnoteže elektrolita, npr. hipokalijemiju ili hipomagnezijemiju.
Lopinavir/ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.) 
lopinavir/ritonavir/ tenofovirdizoproksil mg b.i.d./100 mg b.i.d./245 mg q.d.)
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 371 67 50 21 85 
Bristol-Myers Squibb spol. s r.o. Tel: + 386 1 236 47 00
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) 
simvastatin u obliku kiseline: AUC: ↓ 58% (↓ 39 do ↓ 68) Cmax: ↓ 51% (↓ 32 do ↓ 58)
AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90) 
levonorgestrel (aktivni metabolit): AUC: ↓ 83% (↓ 79 do ↓ 87) Cmax: ↓ 80% (↓ 77 do ↓ 83) Cmin: ↓ 86% (↓ 80 do ↓ 90) (indukcija metabolizma)
Buprenorphine/naloxone/Emtricitabine Interaction not studied. 
lijekovi klase NNRTI / efavirenz Interakcija nije ispitana.
Valproic acid/Efavirenz (250 mg b.i.d./600 mg q.d.) 
valproična kiselina / efavirenz (250 mg b.i.d./600 mg q.d.)
Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.) 
Antimikobakterici rifabutin/efavirenz (300 mg q.d./600 mg q.d.)
AUC: ↔*/** (↓ 10% to ↑ 26%) Cmax: ↔*/** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49) 
AUC: ↔*/** (↓ 10% do ↑ 26%) Cmax: ↔*/** (↓ 5% do ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 do ↑ 49) (indukcija CYP3A4). * U usporedbi s atazanavirom 300 mg/ritonavirom 100 mg q.d. koji se uzima navečer, bez efavirenza.
(CYP3A4 or P-gp induction - effect on elbasvir) 
Cmax: ↓ 45% (indukcija CYP3A4 ili P-gp-a - učinak na elbasvir)
Each Atripla film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). 
Jedna filmom obložena tableta Atriple sadržava 600 mg efavirenza, 200 mg emtricitabina i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). 
Jedna filmom obložena tableta sadržava 600 mg efavirenza, 200 mg emtricitabina i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
AUC: ↑ 34% (↑ 18 to ↑ 53) Cmax: ↑ 49% (↑ 32 to ↑ 69) 
klaritromicin 14-hidroksimetabolit: AUC: ↑ 34% (↑ 18 do ↑ 53) Cmax: ↑ 49% (↑ 32 do ↑ 69)
Clarithromycin/Efavirenz (500 mg b.i.d./400 mg q.d.) 
Antibiotici klaritromicin/efavirenz (500 mg b.i.d./400 mg q.d.)
Rifampicin/Tenofovir disoproxil (600 mg q.d./245 mg q.d.) 
rifamicipin/tenofovirdizoproksil (600 mg q.d./245 mg q.d.)
Prior PI-based regimen (N=34) 
Prethodni režim temeljen na inhibitorima proteaze (N=34)
Atripla [outer packaging only] 
16. PODACI NA BRAILLEOVOM PISMU Atripla [samo vanjsko pakiranje]
AUC: ↔ Cmax: ↔ Cmin: ↔ 
paroksetin: AUC: ↔ Cmax: ↔ Cmin: ↔
Pravastatin/Emtricitabine 
pravastatin/emtricitabin
2 This adverse reaction may occur as a consequence of proximal renal tubulopathy. 
Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
Fosamprenavir/ritonavir/Tenofovir disoproxil 
fosamprenavir/ritonavir/ tenofovirdizoproksil
Atazanavir/ritonavir/Efavirenz (400 mg q.d./100 mg q.d./600 mg q.d., all administered with food) 
atazanavir/ritonavir/efavirenz (400 mg q.d./100 mg q.d./600 mg q.d., svi se primjenjuju s hranom)
- Diltiazem or similar medicines (called calcium channel blockers): When you start taking 
- Diltiazem i slični lijekovi (poznati pod nazivom blokatori kalcijevih kanala): Kada započnete s uzimanjem Atriple, liječnik će Vam možda morati prilagoditi dozu blokatora kalcijevih kanala.
Atripla and fluoxetine can be co-administered without dose adjustment. 
Atripla i fluoksetin mogu se primjenjivati istodobno bez prilagođavanja doze.
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 4.4). 
U bolesnika s umjerenim odnosno teškim oštećenjem funkcije bubrega nužno je prilagođavanje intervala doziranja emtricitabina i tenofovirdizoproksila, što se ne može postići kombiniranom tabletom (vidjeti dio 4.2 i 4,4).
AUC: ↔ Cmax: ↔ 
emtricitabin: AUC: ↔ Cmax: ↔
Due to the similarity between lamivudine and emtricitabine, a component of Atripla, Atripla should not be administered concomitantly with lamivudine (see section 4.4). 
komponente Atriple, Atripla se ne bi trebala davati istodobno s lamivudinom (vidjeti dio 4.4).
• breast enlargement in males 
• povećanje dojki u muškaraca
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46) 
AUC: ↑ 21% (↑ 10 do ↑ 34) Cmax: ↑ 14% (↑ 4 do ↑ 26) Cmin: ↑ 25% (↑ 7 do ↑ 46) (inhibicija oksidativnog metabolizma u kojem sudjeluju enzimi CYP)
Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking Atripla). 
Vaša jetra radi (pogledajte dio 3, Ako prestanete uzimati Atriplu).
Paroxetine/Efavirenz (20 mg q.d./600 mg q.d.) 
paroksetin/efavirenz (20 mg q.d./600 mg q.d.)
Atripla and valproic acid can be co-administered without dose adjustment. 
Atripla i valproična kiselina mogu se primjenjivati istodobno bez prilagođavanja doze.
Atripla and paroxetine can be co-administered without dose adjustment. 
Atripla i paroksetin mogu se primjenjivati istodobno bez prilagođavanja doze.
Dosage adjustments of simvastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for simvastatin). 
Možda će biti potrebno prilagođavanje doze simvastatina kada se primjenjuje istodobno s Atriplom (pogledajte sažetak opisa svojstava lijeka za simvastatin).
Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ 
Cmax: ↑ 11% (↑ 6 do ↑ 16) Cmin: ↔ (indukcija CYP3A4)
- The active substances are efavirenz, emtricitabine and tenofovir disoproxil. 
- Djelatne tvari su efavirenz, emtricitabin i tenofovirdizoproksil.
Atovaquone and proguanil hydrochloride/Tenofovir disoproxil 
atovakvon i progvanil hidroklorid/tenofovirdizoproksil
The pharmacokinetics of efavirenz have not been studied in patients with renal impairment. 
Farmakokinetika efavirenza nije ispitana u bolesnika s oštećenjem funkcije bubrega.
Paroxetine/Emtricitabine 
paroksetin/emtricitabin
Voriconazole/Emtricitabine 
vorikonazol/emtracitibin
Cmax: ↑ 15% (CYP3A4 inhibition) 
AUC: ↑ 21% Cmin: ↑ 17% Cmax: ↑ 15% (inhibicija CYP3A4)
Itraconazole/Efavirenz (200 mg b.i.d./600 mg q.d.) 
Antimikotici itrakonazol/efavirenz (200 mg b.i.d./600 mg q.d.)
Atripla (see earlier in section 2, Do not take Atripla). 
Ako imate tešku bolest jetre, nemojte uzimati Atriplu (pogledajte iznad u poglavlju 2, Nemojte uzimati Atriplu).
AUC: ↓ 71% (↓ 67 to ↓ 74) Cmax: ↓ 51% (↓ 46 to ↓ 56) Cmin: ↓ 91% (↓ 88 to ↓ 92) 
Cmax: ↓ 51% (↓ 46 do ↓ 56) Cmin: ↓ 91% (↓ 88 do ↓ 92)
Dosage adjustments of atorvastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for atorvastatin). 
Možda će biti potrebno podešavanje doze atorvastatina kada se primjenjuje istodobno s Atriplom (pogledajte sažetak opisa svojstava lijeka za atorvastatin).
AUC: ↓ 71% 
norbuprenorfin: AUC: ↓ 71%
Didanosine/Tenofovir disoproxil 
didanozin/tenofovirdizoproksil
AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15% 
AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15% (indukcija CYP3A4)
Itraconazole/Tenofovir disoproxil 
itrakonazol/tenofovirdizoproksil
Fluoxetine/Emtricitabine 
fluoksetin/emtricitabin
Lopinavir/ritonavir/Emtricitabine 
fosamprenavir/ritonavir/emtricitab in
AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36% 
AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36% (indukcija UGT1A1)
Atripla 
OPIOIDI
Your doctor may need to consider giving you a different antifungal. 
Liječnik će možda morati razmotriti uvođenje drugog antimikotika.
Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures. 
U bolesnika s osteoporozom i visokim rizikom od prijeloma potrebno je razmotriti druge režime liječenja.
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0) 21 272 16 00 
Česká republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
DMPA/Tenofovir disoproxil 
DMPA/tenofovirdizoproksil
s r.o. 
V108I
AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58) 
AUC: ↓ 39% (↓ 21 do ↓ 53) Cmax: ↓ 37% (↓ 20 do ↓ 51) Cmin: ↓ 44% (↓ 27 do ↓ 58) (smanjenje koncentracija itrakozanola: indukcija CYP3A4)
General disorders and administration site conditions: Very common asthenia 
Opći poremećaji i reakcije na mjestu primjene: Vrlo često astenija
Saquinavir/ritonavir/Tenofovir disoproxil There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with ritonavir boosted saquinavir. 
Nije bilo klinički značajnih farmakokinetičkih interakcija kada je tenofovirdizoproksil primjenjivan istodobno sa sakvinavirom ojačanim ritonavirom. sakvinavir/ritonavir/emtricitabin Interakcija nije ispitana.
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) 
AUC: ↓ 60% (↓ 52 do ↓ 68) Cmax: ↓ 62% (↓ 55 do ↓ 78) (indukcija CYP3A4)
The pharmacokinetics of Atripla have not been studied in patients with hepatic impairment. 
Farmakokinetika Atriple nije ispitana u bolesnika s oštećenjem funkcije jetre.
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)
AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) 
AUC: ↓ 52% (↓ 33 do ↓ 66) Cmax: ↓ 45% (↓ 25 do ↓ 59) (indukcija CYP3A4)
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) (indukcija CYP3A4 i CYP2B6)
DMPA/Emtricitabine 
DMPA/emtricitabin
Sertraline/Tenofovir disoproxil 
sertralin/tenofovirdizoproksil
Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine. 
Vaša jetra radi ili Vam može propisati drugi lijek.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV. 
U cilju optimalnog liječenja infekcije HIV-om u bolesnika koji su istodobno zaraženi virusom HBV-a, liječnici se trebaju pridržavati trenutno važećih smjernica za liječenje HIV-a.
Atripla and rosuvastatin can be co-administered without dose adjustment. 
Atripla i rosuvastatin mogu se primjenjivati istodobno bez prilagodbe doze.
Lopinavir/ritonavir tablets/Efavirenz (400/100 mg b.i.d./600 mg q.d.) 
lopinavir/ritonavir meke kapsule ili oralna otopina/ efavirenz tablete lopinavira/ritonavira / efavirenz (400/100 mg b.i.d./600 mg q.d.)
Carbamazepine/Tenofovir disoproxil 
karbamazepin/tenofovirdizoproksi l
AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85) 
norelgestromin (aktivni metabolit): AUC: ↓ 64% (↓ 62 do ↓ 67) Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85)
Paroxetine/Tenofovir disoproxil 
paroksetin/tenofovirdizoproksil
Ritonavir/Tenofovir disoproxil 
ritonavir/tenofovirdizoproksil
*/100 mg b.i.d./245 mg q.d.) 
(600 mg/200 mg/245 mg q.d.)
Mechanism of action and pharmacodynamic effects Efavirenz is an NNRTI of HIV-1. 
Efavirenz je nenukleozidni inhibitor reverzne transkriptaze (NNRTI) virusa HIV-1.
Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.) 
Antivirusni lijekovi protiv HIV-a Inhibitori proteaze atazanavir/ritonavir/ tenofovirdizoproksil (300 mg q.d./100 mg q.d./245 mg q.d.)
Diltiazem/Tenofovir disoproxil 
diltiazem/tenofovirdizoproksil
Dosage adjustments of pravastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for pravastatin). 
Možda će biti potrebno podešavanje doze pravastatina kada se primjenjuje istodobno s Atriplom (pogledajte sažetak opisa svojstava lijeka za pravastatin).
The following side effects may be signs of lactic acidosis: - deep rapid breathing - drowsiness - feeling sick (nausea), being sick (vomiting) and stomach pain. 
duboko, brzo disanje omamljenost mučnina, povraćanje i bol u želucu.
ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg q.d./600 mg q.d.) 
karbamazepin/efavirenz (400 mg q.d./600 mg q.d.)
AUC: ↓ 83% Cmax: ↓ 87% 
Cmax: ↓ 87%
Dosage adjustment of lopinavir/ritonavir is necessary when given with efavirenz. 
Kada se primjenjuje zajedno s efavirenzom, nužno je podešavanje doze lopinavira/ritonavira.
Fluoxetine/Tenofovir disoproxil 
fluoksetin/tenofovirdizoproksil
AUC: ↓ 21% Cmax: ↔ 
lumefantrin: AUC: ↓ 21% Cmax: ↔
Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies. 
U bolesnika koji su tijekom kliničkih ispitivanja primali 600 mg efavirenza dnevno često su uočene nuspojave koje između ostalog uključuju omaglicu, nesanicu, somnolenciju, smanjenu koncentraciju i abnormalne snove.
However, dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil. 
No tijekom liječenja efavirenzom, emtricitabinom i tenofovirdizoproksilom zabilježeni su slučajevi omaglice.
AUC: ↔ Cmin: ↔ 
Cmax: ↔ Cmin: ↔
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 370 5 2790 762 
Slovenská republika Bristol-Myers Squibb spol. s r.o. Tel: + 421 2 59298411
Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.) 
sofosbuvir/velpatasvir (400 mg/100 mg q.d.) + efavirenz/emtricitabin/ tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
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)
Bupropion/Tenofovir disoproxil 
Bupropion/tenofovirdizoproksil
N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) 
simeprevir: AUC: ↓ 71% (↓ 67 do ↓ 74)
AUC: ↓ 50% Cmax: ↓ 45% 
AUC: ↓ 50% Cmax: ↓ 45% (indukcija UDP-G)
Co-administration of lopinavir/ritonavir and Atripla is not recommended. 
Ne preporučuje se istodobna primjena lopinavira/ritonavira s
PHARMACEUTICAL FORM AND CONTENTS 
Drugi lijekovi i Atripla
Atorvastatin/Tenofovir disoproxil 
pravastatin/tenofovirdizoproksil
Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted. 
Ako ste imali problema ili je potrebno prilagođavanje Vaše doze, liječnik će možda razmotriti zasebno davanje komponenti Atriple.
simvastatin. 
Atriplom.
Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) 
ledipasvir/sofosbuvir (90 mg/400 mg q.d.) + efavirenz/emtricitabin/ tenofovirdizoproksil
Dose adjustment of buprenorphine may not be necessary when co-administered with Atripla. 
Kada se buprenorfin primjenjuje istodobno s Atriplom, prilagođavanje doze buprenorfina možda neće biti potrebno.
Emtricitabine 
OBLIK
Keep the tablet bottle with you so that you can easily describe what you have taken. 
Ponesite bocu s tabletama sa sobom tako da možete lako opisati što ste uzeli.
Do not give this medicine to children under 12 years of age. 
Nemojte davati ovaj lijek djeci u dobi ispod 12 godina.
The recommended dose is one tablet once a day. 
Preporučena doza je jedna tableta jedanput na dan.
It also contains lactose. 
Također sadrži laktozu.
The clinical significance of this substitution is currently unknown. 
Klinička značajnost ove supstitucije trenutačno nije poznata.
Ask your doctor for effective contraceptive method suitable for you. 
Upitajte liječnika koja je učinkovita metoda kontracepcije pogodna za Vas.
• If you are currently taking any of the following medicines: 
• ako trenutno uzimate neki od sljedećih lijekova:
Summary of the safety profile in adults 
Sažetak sigurnosnog profila u odraslih
• The other ingredients are 
• Drugi sastojci su
The effects of higher doses are not known. 
Učinci viših doza nisu poznati.
< 12 g/dL despite 4 weeks at reduced dose 
< 12 g/dl unatoč 4 tjedna na sniženoj dozi
The most common variant was Y93H. 
Najčešća varijanta bila je Y93H.
• other liver problems apart from hepatitis C, for instance 
• druge tegobe s jetrom osim hepatitisa C, na primjer:
• you have diabetes. 
• imate šećernu bolest.
> or = 75 
> ili = 75
SVR12 was achieved in 18/18 patients. 
SVR12 je postignut u 18/18 bolesnika.
Ledipasvir is > 99.8% bound to human plasma proteins. 
Ledipasvir je > 99,8 % vezan za proteine ljudske plazme.
The tablet is 19 mm long and 10 mm wide. 
Tableta je dugačka 19 mm i široka 10 mm.
 If this applies to you, do not take Harvoni and tell your doctor immediately. 
Ako se ovo odnosi na Vas, nemojte uzimati Harvoni i odmah obavijestite svog liječnika.
Effects of food 
Utjecaj hrane
Do not chew, crush or split the tablet as it has a very bitter taste. 
Nemojte žvakati, drobiti niti lomiti tabletu, jer je vrlo gorkog okusa.
AUC, Cmax, Cmina, b 
Cmax, Cmina,b
• Your doctor can decide if you should take Harvoni and for how long; 
• Vaš liječnik može odlučiti trebate li uzimati Harvoni i koliko dugo;
Patients should be instructed not to take a double dose. 
Bolesnicima treba savjetovati da ne uzimaju dvostruku dozu.
Ribavirin was discontinued in 15% of the patients. 
Primjena ribavirina bila je obustavljena u 15 % bolesnika.
1.6-fold↑ 
1,6 puta↑
What Harvoni is and what it is used for 
Što je Harvoni i za što se koristi
The majority of patients (84%) had been infected through vertical transmission. 
Većina bolesnika (84 %) bila je zaražena vertikalnim prijenosom bolesti.
Ribavirin can be very damaging to an unborn baby. 
Ribavirin može izazvati teška oštećenja kod nerođenog djeteta.
Race: Black/ African 
Rasa: Crnci/ Afroamerikanci
e These are drugs within class where similar interactions could be predicted. 
Ovo su lijekovi iz iste klase za koje se mogu predvidjeti slične interakcije.
Treatment duration was fixed in each study. 
Trajanje liječenja bilo je fiksno u svakom ispitivanju.
Stable replicons 
Stabilni replikoni
Treatment and duration 
Liječenje i trajanje
These medicines can decrease the amount of ledipasvir in your blood. 
Ovi lijekovi mogu smanjiti količinu ledipasvira u Vašoj krvi.
The active metabolite is not observed. 
Aktivni metabolit nije opažen.
Like all medicines, this medicine may cause side effects. 
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave.
Study 1119 
Ispitivanje 1119
Your doctor will tell you for how many weeks you should take Harvoni. 
Liječnik će Vam reći koliko tjedana trebate uzimati Harvoni.
Do not stop taking this medicine unless your doctor tells you to. 
Nemojte prestati uzimati ovaj lijek osim ako Vam je tako rekao liječnik.
It is important not to miss a dose of this medicine. 
Važno je da ne propustite uzeti dozu ovog lijeka.
Severe bradycardia and heart block 
Teška bradikardija i srčani blok
• you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine). 
• trenutno uzimate ili ste u posljednjih nekoliko mjeseci uzimali lijek amiodaron za liječenje nepravilnih otkucaja srca (Vaš liječnik može razmotriti zamjensko liječenje ako ste uzimali ovaj lijek).
Discontinue ribavirin if: 
Prekinuti primjenu ribavirina ako:
Do not take a double dose (two doses close together). 
Nemojte uzeti dvostruku dozu (dvije doze u malom vremenskom razmaku).
Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur. 
Stoga, Vi i Vaš(a) partner(ica) morate poduzeti posebne mjere opreza tijekom spolnih odnosa ako postoji mogućnost nastanka trudnoće.
Of the 155 patients enrolled, 1 patient discontinued treatment whilst on placebo. 
Od 155 uključenih bolesnika, 1 je bolesnik prekinuo liječenje dok je uzimao placebo.
Number of responders at end of treatment 
Broj bolesnika s odgovorom na kraju liječenja
• swelling of the face, lips, tongue or throat (angioedema). 
• oticanje lica, usana, jezika ili grla (angioedem).
* Patients lost to follow-up or who withdrew consent excluded. 
*Bolesnici izgubljeni iz praćenja ili koji su povukli pristanak bili su isključeni. a.
h Bioequivalence/Equivalence boundary 80-125%. 
h. Granica bioekvivalencija/ekvivalencije od 80 % do 125 %.
If you do miss a dose, work out how long it is since you last took your Harvoni: 
Ako propustite uzeti dozu, izračunajte koliko je vremena prošlo otkad ste zadnji put uzeli Harvoni:
Evidence of slow oxidative metabolism via an unknown mechanism has been observed. 
Opažen je dokaz sporog oksidativnog metabolizma putem nepoznatog mehanizma.
The final study report shall be submitted by: 
Završno izvješće o ispitivanju treba dostaviti do:
Your doctor will know if any of the following conditions apply to you. 
Vaš će liječnik znati imate li neko od sljedećih stanja.
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience: 
Odmah obavijestite svojeg liječnika ako uzimate bilo kakve lijekove za srčane probleme i tijekom liječenja osjetite:
Patients in these studies had compensated liver disease. 
Bolesnici u tim ispitivanjima imali su kompenziranu bolest jetre.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. 
Značajni teratogeni i/ili embriocidni učinci pokazani su u svih životinjskih vrsta izloženih ribavirinu.
If you take Harvoni you may get one or more of the side effects below: 
Ako uzimate Harvoni, možete dobiti jednu ili više sljedećih nuspojava:
Patients with a CPT score > 12 were excluded. 
Bolesnici s rezultatom CPT > 12 bili su isključeni.
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. 
Ako slučajno uzmete više od preporučene doze, trebate se odmah obratiti svom liječniku ili otići u najbližu hitnu službu po savjet.
Body weight kg 
Tjelesna težina kg