natgillin/translations-raw huggingface dataset:
An increased risk of adverse reactions associated with Eviplera and its individual components may be seen in the event of an overdose.
U slučaju predoziranja moguć je povećani rizik od nuspojava povezanih s lijekom Eviplera i njegovim pojedinačnim djelatnim tvarima.
Omeprazole (20 mg once daily)/ Rilpivirine1
Omeprazol (20 mg jedanput na dan)/ rilpivirin1
CD4+ median increase from baseline (x 106 cells/L)
Medijan povećanja broja CD4+ stanica u odnosu na početak (x 106 stanica/l)
Eviplera must not be used in combination with proton pump inhibitors as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Eviplera se ne smije primjenjivati u kombinaciji s inhibitorima protonske pumpe, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
Eviplera should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may cause significant dose dependent decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Eviplera se ne smije primjenjivati u kombinaciji s deksametazonom za sustavnu primjenu (osim kao jednostruke doze), jer istovremena primjena može prouzročiti značajno, o dozi ovisno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment (see sections 4.2 and 5.2).
Prilagodba doze lijeka Eviplera u bolesnika s blagim ili umjerenim oštećenjem jetre vjerojatno neće biti potrebna (vidjeti dijelove 4.2 i 5.2).
Indigo carmine aluminium lake Lactose monohydrate Polyethylene glycol Red iron oxide
Film ovojnica hipromeloza boja indigo carmine aluminium lake laktoza hidrat polietilenglikol željezov oksid, crveni boja sunset yellow aluminium lake (E110)
Resistance testing and/or historical resistance data should guide the use of Eviplera (see section 5.1).
U primjeni lijeka Eviplera treba se rukovoditi testiranjem rezistencije i/ili prethodno dobivenim podacima o rezistenciji (vidjeti dio 5.1).
Sex Male Female Ethnicity White Black/African American Asian Other Not allowed to ask per local regulations Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/mL Median baseline CD4+ cell count (range), x 106 cells/L Percentage of patients with HBV/HCV co-infection
Medijan početne vrijednosti HIV-1 RNK (raspon) log10 kopija/ml u plazmi Medijan početnog broja stanica CD4+ (raspon), × 106 stanica/l Postotak bolesnika s istovremenom infekcijom HBV/HCV
Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Simeprevir (150 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
*compared to 25 mg once daily rilpivirine alone
Cmax: ↑ 43%* *u usporedbi samo s 25 mg rilpivirina jedanput na dan
Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Sofosbuvir (400 mg jedanput dnevno)/ rilpivirine (25 mg jedanput dnevno)
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.