natgillin/translations-raw huggingface dataset:
Patients had to be stably suppressed for at least 8 weeks prior to study entry, have no current or past history of resistance to any of the three components of Eviplera, and have HIV-1 RNA < 50 copies/mL at screening. 
Bolesnici su trebali imati stabilnu supresiju najmanje 8 tjedana prije ulaska u ispitivanje, nisu smjeli imati, ni tada ni prije, rezistenciju na neku od tri komponente lijeka Eviplera te su morali imati količinu
Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily) 
Simeprevir (150 mg jedanput na dan)/ rilpivirin (25 mg jedanput na dan)
Rifampicin (600 mg once daily)/ Rilpivirine1 
Rifampicin (600 mg jedanput na dan)/ rilpivirin1
By baseline viral load (copies/mL) 
Prema početnom virusnom opterećenju (kopija/ml)
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition (e.g. dabigatran etexilate). 
P-gp koji su osjetljiviji na intestinalnu inhibiciju P-gp (npr. dabigatran eteksilat).
Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily) 
Sofosbuvir/velpatasvir (400 mg/100 mg jedanput dnevno)/ emtricitabin/rilpivirin/tenofovirdizoproksil (200 mg/25 mg/245 mg jedanput dnevno)
(may affect up to 1 in 1,000 people) 
(mogu se javiti u manje od 1 na 1000 osoba)
ORAL CONTRACEPTIVES Ethinylestradiol/Norethindrone/ Emtricitabine 
Etinilestradiol/noretindron/emtricitabin
Norgestimate/Ethinylestradiol/ Tenofovir disoproxil 
Norgestimat/etinilestradiol/ tenofovirdizoproksil
5 This adverse reaction may occur as a consequence of proximal renal tubulopathy. 
5 Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
• Decreases in potassium in the blood 
• sniženje kalija u krvi
Rilpivirine hydrochloride 
Rilpivirinklorid
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20 
Jezgra tablete karmelozanatrij, umrežena laktoza hidrat magnezijev stearat celuloza, mikrokristalična polisorbat 20 povidon kukuruzni škrob, prethodno geliran
AUC: ↑ 16%* Cmin: ↔* Cmax: ↑ 43%* 
AUC: ↑ 16%* Cmin: ↔*
ANTIDIABETICS Metformin/Emtricitabine 
LIJEKOVI Metformin/emtricitabin
A subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase III clinical studies, C209 and C215, for patients receiving the emtricitabine/tenofovir disoproxil background regimen) is presented in Table 5. 
Analiza virološkog odgovora (< 50 HIV-1 RNK kopija/ml) prema podskupinama u 48. i 96. tjednu te virološkog neuspjeha prema početnom virusnom opterećenju (objedinjeni podaci iz dvaju kliničkih ispitivanja III. faze, C209 i C215, za bolesnike koji su primali emtricitabin/tenofovirdizoproksil kao osnovni terapijski režim) prikazana je u tablici 5. Stopa odgovora (potvrđeno nemjerljivo virusno opterećenje < 50 HIV-1 RNK kopija/ml) u 96. tjednu u skupini koja je primala rilpivirin bila je usporediva s onom u skupini koja je primala efavirenz.
Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1 
Famotidin (40 mg jednostruka doza koja se uzima 4 sata nakon rilpivirina)/rilpivirin1
Ketoconazole (400 mg once daily)/ Rilpivirine1 
Ketokonazol (400 mg jedanput na dan)/ rilpivirin1
Norethindrone (1 mg once daily)/ Rilpivirine 
Noretindron (1 mg jedanput na dan)/ rilpivirin
Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
Rifampicin (600 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
Atorvastatin (40 mg once daily)/ Rilpivirine1 
Atorvastatin (40 mg jedanput na dan)/ rilpivirin1
Table 4: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult patients in studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 
Tablica 4: Demografske značajke i početne značajke bolesti u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 96. tjednu
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 4.4). 
Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebna je prilagodba intervala doziranja emtricitabina i tenofovirdizoproksila koja se ne može postići kombiniranom tabletom (vidjeti dijelove 4.2 i 4.4).
• Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI). 
Emtricitabin, nukleozidni inhibitor reverzne transkriptaze (NRTI).
Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1 
Famotidin (40 mg jednostruka doza koja se uzima 12 sati prije rilpivirina)/rilpivirin1
Paracetamol/Tenofovir disoproxil 
Paracetamol/ tenofovirdizoproksil
Lopinavir/Ritonavir: 
Lopinavir/ritonavir: AUC: ↔
At 96 weeks in the pooled Phase III C209 and C215 studies of treatment-naïve patients, in the rilpivirine arm the mean change from baseline in total cholesterol (fasted) was 5 mg/dL, in high-density lipoprotein (HDL)-cholesterol (fasted) 4 mg/dL, in low density lipoprotein (LDL)-cholesterol (fasted) 1 mg/dL, and in triglycerides (fasted) -7 mg/dL. At 48 weeks in Phase III study GS-US-264-0106 of virologically suppressed patients switching to Eviplera from a regimen containing a ritonavir-boosted PI, the mean change from baseline in total cholesterol (fasted) was -24 mg/dL, in HDL-cholesterol (fasted) -2 mg/dL, in LDL-cholesterol (fasted) -16 mg/dL, and in triglycerides (fasted) -64 mg/dL. 
Prema objedinjenim podacima nakon 96 tjedana u ispitivanjima III. faze C209 i C215 na bolesnicima koji prethodno nisu bili liječeni, u skupinama koje su primale rilpivirin srednja vrijednost promjene od početne vrijednosti ukupnog kolesterola (natašte) bila je 5 mg/dl, HDL (lipoprotein visoke gustoće) kolesterola (natašte) 4 mg/dl, LDL (lipoprotein niske gustoće) kolesterola (natašte) 1 mg/dl, a triglicerida (natašte) −7 mg/dl.
Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis) 
Tablica 6: Ishodi fenotipske rezistencije u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 96. tjednu (na temelju analize rezistencije)
The combination of Eviplera and antacids should be used with caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, gastric pH increase). 
Kombinaciju lijeka Eviplera i antacida treba primjenjivati s oprezom, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2). 
Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebna je prilagodba intervala doziranja emtricitabina i tenofovirdizoproksila koja se ne može postići kombiniranom tabletom (vidjeti dijelove 4.2 i 5.2).
Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate). 
Jedna filmom obložena tableta sadrži 200 mg emtricitabina, 25 mg rilpivirina (u obliku klorida) i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
The most common emergent resistance mutations in Eviplera-treated patients were M184V/I and E138K in RT. All patients remained susceptible to tenofovir. 
Najčešće mutacije povezane s rezistencijom koja se pojavila na liječenje u bolesnika liječenih lijekom Eviplera bile su MV184V/I i E138K u RT.
Immune system disorders Common: 
Poremećaji imunološkog sustava
Table 3: Phenotypic resistance and cross-resistance outcomes from studies C209 and C215 (pooled data) for patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil at week 96 (based on resistance analysis) 
Tablica 3: Ishodi ispitivanja fenotipske rezistencije i križne rezistencije u ispitivanjima C209 i C215 (objedinjeni podaci) u bolesnika koji su primali rilpivirinklorid u kombinaciji s emtricitabinom/tenofovirdizoproksilom u 96. tjednu (na temelju analize rezistencije)
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2). 
Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebno je prilagoditi interval doziranja emtricitabina i tenofovirdizoproksila, što se ne može postići kombiniranom tabletom (vidjeti dijelove 4.4 i 5.2).
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1 
Famotidin (40 mg jednostruka doza koja se uzima 2 sata prije rilpivirina)/rilpivirin1
Each Eviplera film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate). 
Jedna filmom obložena tableta lijeka Eviplera sadrži 200 mg emtricitabina, 25 mg rilpivirina (u obliku klorida) i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
Atazanavir (300 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
• tenofovir disoproxil 
• tenofovirdizoproksil
Table 5: Virologic outcomes of randomised treatment of studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 48 (primary) and week 96 
Tablica 5: Virološki ishodi randomiziranog liječenja u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 48. tjednu (primarno) i 96. tjednu Rilpivirin + emtricitabin/tenofovirdizoproksil
Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily) 
Darunavir (300 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
lactic acidosis3 
laktacidoza3
Maraviroc (300 mg twice daily)/ Tenofovir disoproxil (245 mg once daily) 
Maravirok (300 mg dvaput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
Ethinylestradiol/Norethindrone/ Tenofovir disoproxil 
Etinilestradiol/noretindron/ tenofovirdizoproksil
Didanosine (400 mg once daily)/ Rilpivirine1 
Didanozin (400 mg jedanput na dan)/ rilpivirin1
Eviplera must not be used in combination with products containing St. John's wort as coadministration may cause significant decreases in rilpivirine plasma concentrations. 
Eviplera se ne smije primjenjivati u kombinaciji s lijekovima koji sadrže gospinu travu, jer njihova istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi.
Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). 
Istovremena primjena lijeka Eviplera s azolnim antimikoticima može prouzročiti povećanje koncentracije rilpivirina u plazmi (inhibicija enzima CYP3A).
The combination of Eviplera and H2-receptor antagonists should be used with particular caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH). 
H2-receptora treba primjenjivati s osobitim oprezom, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil (245 mg once daily) 
Lopinavir (400 mg dvaput na dan)/ ritonavir (100 mg dvaput na dan)/tenofovirdizoproksil (245 mg jedanput na dan)
(may affect up to 1 in 100 people) 
(mogu se javiti u manje od 1 na 100 osoba)
PROTON PUMP INHIBITORS Omeprazole/Emtricitabine 
INHIBITORI PROTONSKE PUMPE
Steady-state administration of rilpivirine hydrochloride 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, 
U stanju dinamičke ravnoteže, primjena rilpivirinklorida od 75 mg jedanput na dan rezultirala je srednjom vrijednosti Cmax približno 2,6 puta većom, a primjena doze od 300 mg jedanput na dan srednjom vrijednosti Cmax približno 6,7 puta većom od srednje vrijednosti Cmax u stanju dinamičke ravnoteže primijećene uz preporučenu dozu rilpivirinklorida od 25 mg jedanput na dan.
AUC: ↔ Cmin: ↔ Cmax: ↑ 17% 
Etinilestradiol: AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Eviplera should be used. 
H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon uzimanja lijeka Eviplera.
Sildenafil/Tenofovir disoproxil 
Sildenafil/tenofovirdizoproksil
AUC: ↓ 14% Cmax: ↓ 15% Cmin: ↓ 7% 
Simeprevir: AUC ↓ 14% Cmax: ↓ 15% Cmin: ↓ 7%
• carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines to treat epilepsy and prevent seizures) • rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis) 
• karbamazepin, okskarbazepin, fenobarbital i fenitoin (lijekovi za liječenje epilepsije i sprječavanje napadaja)
Rifabutin/Tenofovir disoproxil 
Rifabutin/ tenofovirdizoproksil
Rifabutin (300 mg once daily)/ Rilpivirine (50 mg once daily) 
Rifabutin (300 mg jedanput na dan)/rilpivirin (50 mg jedanput na dan)
Eviplera must not be used in combination with these anticonvulsants as co-administration may cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Eviplera se ne smije primjenjivati u kombinaciji s ovim antiepilepticima, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
• Pain in the abdomen (tummy) caused by inflammation of the pancreas 
• bolovi u trbuhu prouzročeni upalom gušterače
Women of childbearing potential / contraception in males and females The use of Eviplera must be accompanied by the use of effective contraception. 
Uz primjenu lijeka Eviplera mora se koristiti učinkovita kontracepcija.
Famotidine/Tenofovir disoproxil 
Famotidin/ tenofovirdizoproksil
Concomitant use of Eviplera with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). 
Istovremena primjena lijeka Eviplera s IP pojačanim ritonavirom uzrokuje povećanje koncentracije rilpivirina u plazmi (inhibicija enzima CYP3A).
Eviplera must not be used in combination with rifampicin as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Eviplera se ne smije primjenjivati u kombinaciji s rifampicinom, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔ 
Ketokonazol: AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
Renal impairment 
Virološki neuspjehc
Rifabutin (300 mg once daily)/ Rilpivirine (25 mg once daily) 
Rifabutin (300 mg jedanput na dan)/rilpivirin (25 mg jedanput na dan)
In treatment-naïve HIV-1 infected patients 
U virološki suprimiranih bolesnika zaraženih virusom HIV-1
Eviplera [outer packaging only] 
16. PODACI NA BRAILLEOVOM PISMU Eviplera [samo vanjsko pakiranje]
Atorvastatin/Tenofovir disoproxil 
Atorvastatin/tenofovirdizoproksil
Interaction not studied with Eviplera. 
Nisu ispitane interakcije s lijekom Eviplera.
Atazanavir/Ritonavir/Rilpivirine Interaction not studied. 
Atazanavir/ritonavir/rilpivirin
• Joint stiffness 
• ukočenost zglobova
Rilpivirine + Emtricitabine/ Tenofovir disoproxil n = 550 
Efavirenz + emtricitabin/tenofovirdizoproksil n = 550
Rilpivirine + Emtricitabine/Tenofovir disoproxil n = 550 
Efavirenz + emtricitabin/ tenofovirdizoproksil n = 550
Eviplera must not be used in combination with rifapentine as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Eviplera se ne smije primjenjivati u kombinaciji s rifapentinom, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
GS-3310074: 
GS-3310074: AUC: ↔ Cmax: ↔
Common: 
Očekivano:
Very common: headache1, 2, 3, dizziness1, 2, 3 Common: 
glavobolja1, 2, 3, omaglica1, 2, 3
AUC: ↔ Cmax: ↔ Cmin: ↔ 
Emtricitabin: AUC: ↔ Cmax: ↔ Cmin: ↔
Triacetin 
Didanozin
Metformin/Tenofovir disoproxil 
Metformin/ tenofovirdizoproksil
AUC: ↔ Cmin: ↔ Cmax: ↓ 9% 
Rilpivirin: AUC: ↔ Cmin: ↔ Cmax: ↓ 9%
Omeprazole/Tenofovir disoproxil 
Omeprazol/ tenofovirdizoproksil
H2-antagonists can only be taken once a day if you take Eviplera. 
Ako uzimate Evipleru, H2-antagoniste smijete uzimati samo jedanput na dan.
IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/ Emtricitabine 
Takrolimus/tenofovirdizoproksil/emtricitabin Takrolimus: AUC: ↔
Cardiovascular 
Kardiovaskularni učinci
AUC: ↔ Cmin: ↔ Cmax: ↔ 
Noretindron: AUC: ↔ Cmin: ↔ Cmax: ↔
Methadone/Tenofovir disoproxil 
Metadon/tenofovirdizoproksil
Severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia (see section 4.4). 
konjunktivitisom, angioedemom, povećanom funkcijom jetre prema nalazima pretraga i/ili eozinofilijom (vidjeti dio 4.4).
pain1, fatigue2 
bol1, umor2
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261). 
Eviplera ili svim njegovim djelatnim tvarima u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1261).
Voxilaprevir 
IMUNOSUPRESIVI
Didanosine/Tenofovir disoproxil 
Didanozin/ tenofovirdizoproksil
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 istovremeno zaraženih HBV-om, liječnici se trebaju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
• Stomach pain 
• bolovi u trbuhu
Digoxin/Tenofovir disoproxil 
Digoksin/tenofovirdizoproksil
AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14% 
R(-) metadon: AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
rabeprazole 
GLUKOKORTIKOIDI
• any signs of inflammation or infection 
• bilo kakav znak upale ili infekcije • tegobe s kostima
Recommendation concerning co-administration with Eviplera 
Preporuke za istovremenu primjenu s lijekom Eviplera
Rilpivirine: AUC: ↔ 
Rifampicin: AUC: ↔ Cmax: ↔
Hypromellose 
ANTIARITMICI
Contents of the pack and other information What Eviplera contains 
Što Eviplera sadrži
Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance (CrCl) 50-80 mL/min). 
U bolesnika s blagim oštećenjem bubrega (klirens kreatinina (CrCl) 50 - 80 ml/min) ograničeni podaci kliničkih ispitivanja podupiru doziranje lijeka Eviplera jedanput na dan.
Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms/0.5 ml Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms/0.5 ml Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms/0.5 ml Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms/0.5 ml 
A konjugirano na 16,7 do 33,3 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe C konjugirano na 7,1 do 12,5 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe W135 konjugirano na 3,3 do 8,3 mikrograma na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe
5 vials + 5 vials 
Y konjugirano na 5,6 do 10,0 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae
The effects of treatment were greatest in the first year. 
Terapija je najviše djelovala tijekom prve godine.
Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Jinarc nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food. 
Jutarnju dozu lijeka treba uzimati najmanje 30 minuta prije doručka, dok se večernja doza može uzimati uz obrok ili bez njega.
Jinarc is available as tablets (15, 30, 45, 60 and 90 mg). 
Dostupan je u obliku tableta (15, 30, 45, 60 i 90 mg).
Doses may need to be reduced in patients taking certain other medicines. 
Doze treba smanjiti ako bolesnik uzima određene druge lijekove.
Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects. 
Bolesnici trebaju započeti s dozom od 45 mg ujutro i 15 mg uvečer (45+15 mg), a dozu zatim treba povećati na 60+30 mg ili 90+30 mg, ovisno o količini koju bolesnik može podnijeti.
Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment. 
Bolesnici trebaju piti puno vode ili drugih tekućina (osim soka od grejpa) tijekom liječenja.
Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015. 
Jinarc je dobio odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 27. svibnja 2015.
Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter. 
Krvne nalaze s ciljem provjere funkcije jetre bolesnika treba provesti prije početka terapije lijekom Jinarc, te ih zatim ponoviti svaki mjesec tijekom 18 mjeseci i svaka tri mjeseca nakon toga.
Vasopressin controls the amount of water and sodium that the kidneys remove. 
Vazopresin kontrolira količinu vode i natrija koju bubrezi izlučuju.
What measures are being taken to ensure the safe and effective use of Jinarc? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jinarc?
Other information about Jinarc 
Ostale informacije o lijeku Jinarc
The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity. 
Tvrtka će također provesti istraživanje kako bi utvrdila sigurnost lijeka, kao i rizik od otrovanja jetre.
The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day). 
Najčešće nuspojave lijeka Jinarc (koje se mogu javiti u više od 2 na 10 osoba) jesu žeđ, poliurija (povećana proizvodnja mokraće), nokturija (potreba za mokrenjem tijekom noći) i polakiurija (povećana potreba za mokrenjem tijekom dana).
Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems). 
Jinarc može povisiti koncentracije određenih jetrenih enzima u krvi (što je znak mogućih problema s jetrom).