FrancophonIA/ELRC3.0 huggingface dataset:
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Slovenian: Emtricitabintrifosfat in tenofovirdifosfat sta šibka zaviralca DNA-polimeraz sesalcev.
English: - Diltiazem or similar medicines (called calcium channel blockers): When you start taking
Slovenian: - Diltiazem ali podobna zdravila (imenovana zaviralci kalcijevih kanalčkov): Ko začnete jemati zdravilo Atripla, vam bo zdravnik morda moral prilagoditi odmerek zaviralca kalcijevih kanalčkov.
English: Paroxetine/Efavirenz (20 mg q.d./600 mg q.d.)
Slovenian: paroksetin/efavirenz (20 mg dnevno/600 mg dnevno)
English: Saquinavir/ritonavir/Tenofovir disoproxil There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with ritonavir boosted saquinavir.
Slovenian: Klinično pomembnih farmakokinetičnih interakcij pri sočasni uporabi dizoproksiltenofovirata in sakvinavirja, okrepljenega z ritonavirjem, ni bilo.
English: Atripla and valproic acid can be co-administered without dose adjustment.
Slovenian: Zdravilo Atripla in valprojska kislina se lahko uporabljata sočasno.
English: Rosuvastatin/Tenofovir disoproxil
Slovenian: rosuvastatin/dizoproksiltenofovirat
English: Paroxetine/Emtricitabine
Slovenian: paroksetin/emtricitabin
English: Atripla was administered on an empty stomach (see section 4.2).
Slovenian: Zdravilo Atripla so bolniki jemali na tešče (glejte poglavje 4.2).
English: Sertraline/Tenofovir disoproxil
Slovenian: sertralin/ dizoproksiltenofovirat
English: Maraviroc/Tenofovir disoproxil (300 mg b.i.d./245 mg q.d.)
Slovenian: maravirok/ dizoproksiltenofovirat (300 mg dvakrat dnevno/245 mg dnevno)
English: • increased appetite
Slovenian: • povečan tek.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔
Slovenian: Cmax: ↑ 11 % (↑ 6 do ↑ 16) Cmin: ↔ (indukcija CYP3A4)
English: Psychiatric adverse reactions have been reported in patients treated with efavirenz.
Slovenian: Pri bolnikih, ki so prejemali efavirenz, so poročali o psihiatričnih neželenih učinkih.
English: Cmax: ↑ 15% (CYP3A4 inhibition)
Slovenian: AUC: ↑ 21 % Cmin: ↑ 17 % Cmax: ↑ 15 % (inhibicija CYP3A4)
English: Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔ Morning Cmax: ↑ 24% (↑ 12 to ↑ 38)
Slovenian: AUC zjutraj: ↑ 18 % (↑ 6 do ↑ 33) AUC zvečer: ↔
English: AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15%
Slovenian: AUC: ↓ 13 % Cmin: ↓ 31 % Cmax: ↓ 15 % (indukcija CYP3A4)
English: Simvastatin/Tenofovir disoproxil
Slovenian: simvastatin/ dizoproksiltenofovirat
English: AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36%
Slovenian: AUC: ↓ 36 % C12h: ↓ 21 % Cmax: ↓ 36 % (indukcija UGT1A1)
English: No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Slovenian: Pri fetusih podgan in kuncev, ki so prejemali efavirenz, niso opazili malformacij.
English: The following side effects are common (these may affect up to 1 in 10 patients)
Slovenian: Naslednji neželeni učinki so pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: There is limited metabolism of emtricitabine.
Slovenian: Presnova emtricitabina poteka v manjšem obsegu.
English: Women should not get pregnant during treatment with Atripla and for 12 weeks thereafter.
Slovenian: Ženske med jemanjem in 12 tednov po prenehanju jemanja zdravila Atripla ne smejo zanositi.
English: Itraconazole/Tenofovir disoproxil
Slovenian: itrakonazol/ dizoproksiltenofovirat
English: Didanosine/Tenofovir disoproxil
Slovenian: didanozin/ dizoproksiltenofovirat
English: Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”,
Slovenian: Interakcije med zdravilom Atripla ali posameznimi učinkovinami zdravila in drugimi zdravili so navedene v tabeli 1 spodaj (povečanje je označeno z znakom „↑“, zmanjšanje z „↓“, brez spremembe z „↔“).
English: Atripla (see earlier in section 2, Do not take Atripla).
Slovenian: Če imate hudo bolezen jeter, ne jemljite zdravila Atripla (glejte nazaj v poglavju 2, Ne jemljite zdravila Atripla).
English: Lopinavir/ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
Slovenian: lopinavir/ritonavir/ dizoproksiltenofovirat (400 mg dvakrat dnevno/100 mg dvakrat dnevno/245 mg dnevno)
English: Fluoxetine/Emtricitabine
Slovenian: fluoksetin/emtricitabin
English: Proximal renal tubulopathy generally resolved or improved after tenofovir disoproxil discontinuation.
Slovenian: Proksimalna ledvična tubulopatija je po prekinitvi dizoproksiltenofovirata običajno izzvenela ali se je izbojšala.
English: Following oral administration of a single 300 mg dose of tenofovir disoproxil to HIV-1 infected patients in the fasted state, maximum tenofovir concentrations were achieved within one hour and the Cmax and AUC (mean ± S.D.) (%CV) values were 296 ± 90 ng/ml (30%) and 2,287 ± 685 ng•h/ml (30%), respectively.
Slovenian: Vrednost Cmax (povprečje ± S. D.) ( % CV) je bila 296 ± 90 ng/ml (30 %), vrednost AUC (povprečje ± S. D.) ( % CV) pa 2287 ± 685 ng•h/ml (30 %).
English: (CYP3A4 or P-gp induction - effect on grazoprevir)
Slovenian: Cmax: ↓ 87 % (indukcija CYP3A4 ali P-gp - učinek na grazoprevir)
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: Sofosbuvir (400 mg dnevno) + efavirenz/emtricitabin/tenofovir dizoproksiltenofovirat (600 mg/200 mg/245 mg dnevno)
English: Valproic acid/Efavirenz (250 mg b.i.d./600 mg q.d.)
Slovenian: valprojska kislina/efavirenz (250 mg dvakrat dnevno/600 mg dnevno)
English: Atorvastatin/Tenofovir disoproxil
Slovenian: atorvastatin/ dizoproksiltenofovirat
English: Table 2: Adverse reactions associated with Atripla listed by the component(s) of Atripla to which the adverse reactions are attributable
Slovenian: Tabela 2: Neželeni učinki, povezani z zdravilom Atripla, našteti po učinkovini/-ah zdravila Atripla, ki se ji/-m neželeni učinek pripisuje zdravilo Atripla efavirenz emtricitabin dizoproksiltenofovirat
English: AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58)
Slovenian: AUC: ↓ 39 % (↓ 21 do ↓ 53) Cmax: ↓ 37 % (↓ 20 do ↓ 51) Cmin: ↓ 44 % (↓ 27 do ↓ 58) (zmanjšanje koncentracij itrakonazola: indukcija CYP3A4)
English: Posaconazole/Efavirenz (-/400 mg q.d.)
Slovenian: pozakonazol/efavirenz (-/400 mg dnevno)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAKE NA PLASTIČNEM VSEBNIKU IN ŠKATLI
English: Atripla and vigabatrin or gabapentin can be coadministered without dose adjustment.
Slovenian: Zdravilo Atripla in vigabatrin se lahko uporabljata sočasno, ne glede na odmerek.
English: Fosamprenavir/ritonavir/Efavirenz (700 mg b.i.d./100 mg b.i.d./600 mg q.d.)
Slovenian: fosamprenavir/ritonavir/efavirenz (700 mg dvakrat dnevno/100 mg dvakrat dnevno/600 mg dnevno)
English: Concomitant administration of atovaquone/proguanil with Atripla should be avoided.
Slovenian: Potrebno se je izogibati sočasni uporabi atovakvona/progvanila z zdravilom Atripla atovakvon in progvanil hidroklorid/emtricitabin
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Slovenian: Če bolnik že jemlje šentjanževko, naj z njenim jemanjem preneha.
English: Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Slovenian: AUC: ↓ 37 % (↓ 17 do ↓ 52) Cmax: ↓ 28 % (↓ 7 do ↓ 44) Cmin: ↓ 37 % (↓ 17 do ↓ 52)
English: Simvastatin/Efavirenz (40 mg q.d./600 mg q.d.)
Slovenian: simvastatin/efavirenz (40 mg dnevno/600 mg dnevno)
English: • decreases in potassium in the blood
Slovenian: • znižano raven kalija v krvi;
English: 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.
Slovenian: V kliničnih študijah pri bolnikih, ki so prejemali 600 mg efavirenza na dan, so pogosto poročali o neželenih učinkih, ki so med drugim vključevali naslednje simptome: omotico, nespečnost, somnolenco, motnje koncentracije in nenormalne sanje.
English: Voriconazole/Tenofovir disoproxil
Slovenian: vorikonazol/ dizoproksiltenofovirat
English: Valproic acid/Tenofovir disoproxil
Slovenian: valprojska kislina/ dizoproksiltenofovirat
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
Slovenian: AUC: ↓ 60 % (↓ 52 do ↓ 68) Cmax: ↓ 62 % (↓ 55 do ↓ 78)(indukcija CYP3A4)
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
Slovenian: AUC: ↓ 26 % (↓ 15 do ↓ 36) Cmax: ↓ 20 % (↓ 11 do ↓ 28) Cmin: ↓ 32 % (↓ 15 do ↓ 46) (indukcija CYP3A4 in CYP2B6)
English: Ritonavir/Efavirenz (500 mg b.i.d./600 mg q.d.)
Slovenian: ritonavir/efavirenz (500 mg dvakrat dnevno/600 mg dnevno)
English: Atripla and fluoxetine can be co-administered without dose adjustment.
Slovenian: Zdravilo Atripla in fluoksetine se lahko uporabljata sočasno, ne glede na odmerek.
English: • dry mouth
Slovenian: • zamegljen vid;
English: DMPA/Emtricitabine
Slovenian: DMPA/emtricitabin
English: Talk to your doctor or pharmacist before taking Atripla.
Slovenian: Pred začetkom jemanja zdravila Atripla se posvetujte s svojim zdravnikom ali s farmacevtom.
English: The pharmacokinetics of efavirenz have not been studied in patients with renal impairment.
Slovenian: Farmakokinetike efavirenza pri bolnikih z ledvično okvaro niso raziskovali.
English: Pravastatin/Efavirenz (40 mg q.d./600 mg q.d.)
Slovenian: pravastatin/efavirenz (40 mg dnevno/600 mg dnevno)
English: Bupropion/Tenofovir disoproxil
Slovenian: bupropion/ dizoproksiltenofovirat
English: How to store Atripla
Slovenian: Kaj vsebuje zdravilo Atripla
English: Clarithromycin/Efavirenz (500 mg b.i.d./400 mg q.d.)
Slovenian: Antibiotiki klaritromicin/efavirenz (500 mg dvakrat dnevno/400 mg dnevno)
English: Voriconazole/Efavirenz (200 mg b.i.d./400 mg q.d.)
Slovenian: vorikonazol/efavirenz (200 mg dvakrat dnevno/400 mg dnevno)
English: • chills
Slovenian: • srbenje;
English: Rashes may be caused by Atripla.
Slovenian: Zdravilo Atripla lahko povzroči izpuščaje.
English: Co-administration of atazanavir/ritonavir and Atripla is not recommended.
Slovenian: Sočasne uporabe atazanavirja/ritonavirja in zdravila Atripla ne priporočamo.
English: */100 mg b.i.d./245 mg q.d.)
Slovenian: (300 mg dnevno/100 mg dnevno/245 mg dnevno)
English: Paroxetine/Tenofovir disoproxil
Slovenian: paroksetin/ dizoproksiltenofovirat
English: Ear and labyrinth disorders: Uncommon tinnitus, vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: Občasni tinitus, vrtoglavica
English: AUC: ↓ 21% Cmax: ↔
Slovenian: lumefantrin: AUC: ↓ 21 % Cmax: ↔
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Dosage adjustments of pravastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for pravastatin).
Slovenian: Ob sočasni uporabi pravastatina in zdravila Atripla bo morda potrebno prilagoditi odmerek pravastatina (glejte povzetek glavnih značilnosti zdravila pravastatin).
English: Dosage adjustments of atorvastatin may be required when co-administered with Atripla (refer to the Summary of Product Characteristics for atorvastatin).
Slovenian: Ob sočasni uporabi atorvastatina in zdravila Atripla je treba odmerek atorvastatina prilagoditi (glejte povzetek glavnih značilnosti zdravila za atorvastatin).
English: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.)
Slovenian: sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg enkrat dnevno) + efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26)
Slovenian: AUC: ↑ 11 % (↑ 5 do ↑ 18) Cmax: ↑ 16 % (↑ 6 do ↑ 26) Cmin: ↑ 13 % (↑ 1 do ↑ 26) (indukcija CYP3A4) Povečanje farmakokinetičnih parametrov efavirenza se ne smatra za klinično pomembno.
English: Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Slovenian: darunavir/ritonavir/ dizoproksiltenofovirat (300 mg dvakrat dnevno*/100 mg dvakrat dnevno/245 mg dnevno)
English: Co-administration of efavirenz with atazanavir/ritonavir is not recommended.
Slovenian: Sočasna uporaba efavirenza in atazanavirja/ritonavirja ni priporočljiva.
English: AUC: ↓ 50% Cmax: ↓ 45%
Slovenian: AUC: ↓ 50 % Cmax: ↓ 45 % (indukcija UDP-G)
English: Ritonavir/Tenofovir disoproxil
Slovenian: ritonavir/ dizoproksiltenofovirat
English: Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifabutin/efavirenz (300 mg dnevno/600 mg dnevno)
English: - The active substances are efavirenz, emtricitabine and tenofovir disoproxil.
Slovenian: - Učinkovine so efavirenz, emtricitabin in dizoproksiltenofovirat.
English: Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Slovenian: AUC: ↓ 75 % (↓ 59 do ↓ 84) Cmax: ↓ 64 % (↓ 57 do ↓ 69) Cmin: ↓ 62 % (↓ 44 do ↓ 75)
English: Atripla and raltegravir can be co-administered without dose adjustment.
Slovenian: Zdravilo Atripla in raltegravir se lahko uporabljata sočasno.
English: DMPA/Tenofovir disoproxil
Slovenian: DMPA/ dizoproksiltenofovirat
English: Seizures
Slovenian: Odmerjanje
English: hepatic steatosis, hepatitis
Slovenian: jetrna steatoza, hepatitis zdravilo Atripla efavirenz emtricitabin dizoproksiltenofovirat
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Serija:
English: Itraconazole/Efavirenz (200 mg b.i.d./600 mg q.d.)
Slovenian: Antimikotiki itrakonazol/efavirenz (200 mg dvakrat dnevno/600 mg dnevno)
English: Atripla and paroxetine can be co-administered without dose adjustment.
Slovenian: Zdravilo Atripla in paroksetin se lahko uporabljata sočasno, ne glede na odmerek.
English: Tenofovir disoproxil
Slovenian: dizoproksiltenofovirat
English: Atripla can be reinitiated in patients interrupting therapy because of rash.
Slovenian: Pri bolnikih, ki so prekinili zdravljenje zaradi izpuščaja, se zdravljenje z zdravilom Atripla lahko nadaljuje znova.
English: The clinical significance of these effects is not known.
Slovenian: Klinični pomen teh učinkov na vrednost AUC etinilestradiola ni znan.
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz
Slovenian: * p-vrednost < 0,05, primerjava skupine, ki je prejemala efavirenz + emtricitabin + dizoproksiltenofovirat skupino, ki je prejemala efavirenz + lamivudin/zidovudin pri vseh bolnikih s Fisherjevim testom natančnosti 1 Druge mutacije za odpornost na efavirenz so vključevale A98G (n=1), K103E (n=1), V179D (n=1) in
English: Co-administration of lopinavir/ritonavir and Atripla is not recommended.
Slovenian: Sočasne uporabe lopinavirja/ritonavirja in zdravila Atripla ne priporočamo.
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Slovenian: AUC: ~↓ 25 % (↓ 42 do ↓ 3) Cmax: ~↓ 28 % (↓ 50 do ↑ 5) Cmin: ~↓ 26 % (↓ 46 do ↑ 10) Sočasna uporaba atazanavirja/ritonavirja s tenofovirjem je povzročila povečanje izpostavljenosti tenofovirju.
English: Contents of the pack and other information What Atripla contains
Slovenian: Druga zdravila in zdravilo Atripla
English: Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted.
Slovenian: Če imate težave ali je potrebno prilagoditi odmerek, vam bo zdravnik morda predpisal posamezne učinkovine zdravila Atripla.
English: (h)
Slovenian: GMR
English: Fluoxetine/Tenofovir disoproxil
Slovenian: fluoksetin/dizoproksiltenofovirat
English: Atripla and rosuvastatin can be co-administered without dose adjustment.
Slovenian: Zdravilo Atripla in rosuvastatin se lahko uporabljata sočasno.
English: AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90)
Slovenian: Cmax: ↓ 80 % (↓ 77 do ↓ 83)
English: Use only if no other alternative is available.
Slovenian: Uporabite ga samo, če ni na voljo nobene druge možnosti.
English: Do not take a double dose (two doses close together).
Slovenian: Ne vzemite dvojnega odmerka (dveh odmerkov blizu skupaj).
English: Treatment duration was fixed in each study.
Slovenian: Trajanje zdravljenja je bilo določeno za vsako študijo.
English: Study 1468 (LEPTON)
Slovenian: Študija 1468 (LEPTON)
English: • other liver problems apart from hepatitis C, for instance
Slovenian: • druge težave z jetri razen hepatitisa C, na primer
English: Study 1119
Slovenian: Študija 1119
English: The recommended dose is one tablet once a day.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan.
English: Summary of the safety profile in adults
Slovenian: Povzetek varnostnega profila pri odraslih
English: The clinical significance of this substitution is currently unknown.
Slovenian: Klinična pomembnost substitucije trenutno ni znana.
English: No effect = 1.00. b All interaction studies conducted in healthy volunteers.
Slovenian: Ni učinka = 1,00. b. Vse študije interakcij so opravili pri zdravih prostovoljcih.
English: e These are drugs within class where similar interactions could be predicted.
Slovenian: e. To so zdravila v razredu, kjer je bilo mogoče predvideti podobne interakcije.
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur.
Slovenian: Zato morate vi in vaš partner sprejeti posebne ukrepe pri spolni aktivnosti, če obstaja kakršna koli možnost, da pride do nosečnosti.
English: Effects of food
Slovenian: Učinki hrane
English: Date of first authorisation: 17 November 2014 Date of latest renewal: 01 August 2019
Slovenian: Datum prve odobritve: 17. november 2014 Datum zadnjega podaljšanja: 01. avgust 2019
English: Then take the next dose at your usual time.
Slovenian: Naslednji odmerek vzemite ob svojem običajnem času.
English: It also contains lactose.
Slovenian: Vsebuje tudi laktozo.
English: • you have diabetes.
Slovenian: • imate sladkorno bolezen.
English: Ribavirin can be very damaging to an unborn baby.
Slovenian: Ribavirin lahko močno poškoduje nerojenega otroka.
English: 6 years.
Slovenian: 6 let
English: Ribavirin was discontinued in 15% of the patients.
Slovenian: Zdravljenje z ribavirinom so prekinili pri 15 % bolnikov.
English: The majority of patients (84%) had been infected through vertical transmission.
Slovenian: Večina bolnikov (84 %) se je okužila z vertikalnim prenosom.
English: Race: Black/ African
Slovenian: Rasa: Črnci/afriški Američani
English: Treatment and duration
Slovenian: Zdravljenje in trajanje
English: The most common variant was Y93H.
Slovenian: Najpogostejša različica je bila Y93H.
English: Patients should be instructed not to take a double dose.
Slovenian: Bolniku je treba naročiti, naj ne vzame dvojnega odmerka.
English: Discontinue ribavirin if:
Slovenian: Ukinite ribavirin, če:
English: Number of responders at end of treatment
Slovenian: Število odzivnih bolnikov ob koncu zdravljenja
English: • The other ingredients are
Slovenian: • Druge sestavine zdravila so
English: (may affect more than 1 in 10 people)
Slovenian: (pojavijo se lahko pri do 1 od 10 bolnikov)
English: The tablet is 19 mm long and 10 mm wide.
Slovenian: Tableta je dolga 19 mm in široka 10 mm.
English: Ledipasvir is > 99.8% bound to human plasma proteins.
Slovenian: Ledipasvir se > 99,8-odstotno veže na humane beljakovine v plazmi.
English: < 12 g/dL despite 4 weeks at reduced dose
Slovenian: < 12 g/dl kljub 4-tedenski uporabi zmanjšanega odmerka
English: The effects of higher doses are not known.
Slovenian: Učinki višjih odmerkov so neznani.
English: Do not chew, crush or split the tablet as it has a very bitter taste.
Slovenian: Tablete ne žvečite, drobite ali delite, saj ima zelo grenak okus.
English: > or = 75
Slovenian: > ali = 75
English: * Patients lost to follow-up or who withdrew consent excluded.
Slovenian: * Bolniki, izgubljeni za spremljanje ali ki so umaknili pristanek, so bili izključeni.
English: Skin disorders Frequency Not known: Stevens-Johnson syndrome
Slovenian: Neznana pogostnost: Stevens-Johnsonov sindrom
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Slovenian: Plastenko s tabletami imejte s seboj, da boste znali opisati, kaj ste vzeli.
English: County Cork
Slovenian: County Cork Irska
English: Severe bradycardia and heart block
Slovenian: Huda bradikardija in srčni blok
English: h Bioequivalence/Equivalence boundary 80-125%.
Slovenian: h. Meja bioekvivalence/ekvivalence 80-125 %.
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Ne prenehajte jemati tega zdravila, razen če vam to naroči vaš zdravnik.
English: 1.6-fold↑
Slovenian: 1,6-krat↑
English: The two studies were identical in study design.
Slovenian: Zasnovi obeh študij sta bili enaki.
English: g This study was conducted in the presence of another two direct-acting antiviral agents.
Slovenian: g. Ta študija je bila opravljena v prisotnosti dveh drugih učinkovin z direktnim delovanjem na viruse.
English: • Your doctor can confirm that your treatment has worked and you are free of the hepatitis C
Slovenian: • da lahko vaš zdravnik potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C.
English: Patient population (including HIV co-infected patients)
Slovenian: Populacija bolnikov (vključno z bolniki s sočasno okužbo s HIV)
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Slovenian: Takoj obvestite zdravnika, če jemljete katero koli zdravilo za zdravljenje težav s srcem in med zdravljenjem opazite:
English: • If you are currently taking any of the following medicines:
Slovenian: • če sočasno jemljete katero izmed naslednjih zdravil:
English: Patients with a CPT score > 12 were excluded.
Slovenian: Bolnike z rezultatom CPT > 12 so izključili.
English: These medicines can decrease the amount of ledipasvir in your blood.
Slovenian: Ta zdravila lahko zmanjšajo količino ledipasvirja v krvi.
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Slovenian: Zdravnik bo morda moral povečati pogostnost krvnih preiskav, da bo lahko spremljal, kako dobro se lahko vaša kri strjuje.
English: Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Slovenian: Bolnike, pri katerih se ugotovi veliko tveganje za bradiaritmijo, je treba 48 ur neprekinjeno spremljati v ustrezni klinični ustanovi.
English: Do not drive or operate machines if you feel tired after taking your medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite in ne upravljajte strojev, če se po jemanju vašega zdravila počutite utrujeno.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake “EXP”.
English: Exposure to ledipasvir decreases with increasing body weight but the effect is not considered to be clinically relevant.
Slovenian: Izpostavljenost ledipasvirju se z večanjem telesne mase zmanjšuje, vendar se učinek ne obravnava za klinično pomembnega.
English: In genotype 4, 5 and 6 infection, only small numbers of patients have been evaluated (total of 5 patients with failure).
Slovenian: Pri okužbi z genotipom 4, 5 in 6 so ovrednotili le majhno število bolnikov (skupaj 5 bolnikov z neuspehom).
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • če ste alergični na ledipasvir, sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).