FrancophonIA/ELRC3.0 huggingface dataset:
English: Consideration should be given to interrupting treatment with emtricitabine/tenofovir disoproxil in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Slovenian: Pri bolnikih z zmanjšanjem očistka kreatinina na < 50 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi zdravljenja z emtricitabinom/dizoproksiltenofoviratom.
English: Tacrolimus/Tenofovir disoproxil /Emtricitabine
Slovenian: takrolimus/ dizoproksiltenofovirat/emtricitabin takrolimus:
English: Cmin: ↑ 42% (↑ 37 to ↑ 49)
Slovenian: Cmin: ↑ 42 % (↑ 37 do ↑ 49)
English: Antimycobacterials Rifampicin /Tenofovir disoproxil
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifampicin/dizoproksiltenofovirat tenofovir:
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: NC
Slovenian: AUC: ↑ 26 % (↑ 20 do ↑ 32) Cmax: ↓ 5 % (↓ 11 do ↑ 1) Cmin: n/i
English: Adefovir dipivoxil and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Slovenian: Adefovirdipivoksilata in emtricitabina/dizoproksiltenofovirata se ne sme uporabljati sočasno (glejte poglavje 4.4).
English: Hepatic impairment
Slovenian: glavobol omotičnost
English: Cmin: ↑ 42% (↑ 34 to ↑ 49)
Slovenian: Cmin: ↑ 42 % (↑ 34 do ↑ 49)
English: Proximal renal tubulopathy generally resolved or improved after tenofovir disoproxil discontinuation.
Slovenian: Proksimalna ledvična tubulopatija je po prekinitvi zdravljenja z dizoproksiltenofoviratom običajno izzvenela ali se je izbojšala.
English: dizziness headache
Slovenian: omotičnost glavobol
English: AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Slovenian: AUC: ↑ 50 % (↑ 42 do ↑ 59) Cmax: ↑ 64 % (↑ 54 do ↑ 74) Cmin: ↑ 59 % (↑ 49 do ↑ 70)
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Slovenian: AUC: ↑ 5 % (↓ 2 do ↑ 13) Cmax: ↑ 5 % (↓ 3 do ↑ 14) Cmin: n/i
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV:
Slovenian: Če zdravilo Emtricitabin/dizoproksiltenofovirat Mylan jemljete za zdravljenje okužbe s HIV ali za zmanjšanje tveganja za okužbo s HIV:
English: Studies with tenofovir disoproxil
Slovenian: Študije z dizoproksiltenofoviratom
English: • Always take this medicine exactly as your doctor has told you.
Slovenian: • Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Slovenian: Povečana izpostavljenost tenofovirja lahko potencira neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Slovenian: • izobraževalno gradivo PrEP za predpisujoče zdravnike z naslovom ''Pomembne varnostne informacije za predpisujoče zdravnike glede zdravila Emtricitabin/dizoproksiltenofovirat Mylan pri indikaciji zaščite pred izpostavitvijo (PrEP)'';
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Slovenian: (NRTI, nucleoside reverse transcriptase inhibitors), je korist zaščite pred virusom HIV odtehtala tveganje za neželene učinke.
English: What Emtricitabine/Tenofovir disoproxil Mylan looks like and contents of the pack
Slovenian: Izgled zdravila Emtricitabin/dizoproksiltenofovirat Mylan in vsebina pakiranja
English: Lamivudine+ zidovudine+efavirenz
Slovenian: lamivudin + zidovudin +
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Slovenian: AUC: ↓ 3 % (↓ 8 % do ↑ 15) Cmax: ↓ 24 % (↓ 44 do ↓ 12) Cmin: n/i tenofovir:
English: EU/1/16/1133/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/16/1133/002
English: (may affect up to 1 in 10 people)
Slovenian: (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Age (Yrs), Mean (SD) Race, N (%) Black/African American White Mixed/Other Asian Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening
Slovenian: Hispanska/latinskoameriška etnična pripadnost, N (%)
English: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Slovenian: Skupno povečanje kostne gostote je bilo v skupini, zdravljeni z dizoproksiltenofoviratom, manjše kot v skupini, zdravljeni s stavudinom ali zidovudinom.
English: Co-administration of tenofovir disoproxil and didanosine:
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina
English: The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Slovenian: Večja izpostavljenost tenofovirju bi lahko okrepila neželene učinke, povezane s tenofovirjem, vključno z ledvičnimi boleznimi.
English: Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.
Slovenian: Če imate kakršna koli vprašanja o preprečevanju okužbe s HIV ali prenašanju HIV na druge ljudi, se posvetujte z zdravnikom.
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
Slovenian: AUC: ↓ 7 % (↓ 13 do ↓ 1) Cmax: ↓ 11 % (↓ 20 do ↑ 1) Cmin: n/i
English: (may affect up to 1 in 1,000 people) • Lactic acidosis (see Possible serious side effects)
Slovenian: • laktična acidoza (glejte Možni resni neželeni učinki) • zamaščena jetra
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta
English: AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
Slovenian: AUC: ↑ 39 % (↑ 33 do ↑ 44) Cmax: ↑ 55 % (↑ 45 do ↑ 66) Cmin: ↑ 52 % (↑ 45 do ↑ 59)
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol /Tenofovir disoproxil
Slovenian: norgestimat/etinilestradiol/dizoprok siltenofovirat norgestimat:
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV is:
Slovenian: Priporočeni odmerek zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zmanjšanje tveganja za okužbo s HIV je:
English: AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
Slovenian: AUC: ↑ 40 % (↑ 34 do ↑ 46) Cmax: ↑ 44 % (↑ 33 do ↑ 55) Cmin: ↑ 84 % (↑ 76 do ↑ 92)
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Slovenian: AUC: ↓ 1 % (↓ 8 do ↑ 6) Cmax: ↑ 7 % (↓ 6 do ↑ 22) Cmin: n/i
English: METHOD AND ROUTE OF ADMINISTRATION Oral use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
Slovenian: AUC: ↓ 2 % (↓ 5 do ↑ 0) Cmax: ↓ 1 % (↓ 7 do ↑ 6) Cmin: n/i
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5) Cmin: NC
Slovenian: AUC: ↓ 5 % (↓ 9 do ↓ 1) Cmax: ↓ 11 % (↓ 17 do ↓ 5) Cmin: n/i tenofovir:
English: No dose adjustment of tacrolimus is required.
Slovenian: Prilagoditev odmerka takrolimusa ni potrebna.
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Slovenian: darunavir/ritonavir/dizoproksilteno fovirat (300 mg q.d./100 mg q.d./
English: The adverse reactions considered at least possibly related to treatment with the components of emtricitabine/tenofovir disoproxil from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Slovenian: Spodaj v preglednici 3 so po organskih sistemih in pogostnosti navedeni neželeni učinki, ki so vsaj možno povezani z zdravljenjem s sestavinama emtricitabinom/dizoproksiltenofoviratom pri bolnikih s HIV-1 na podlagi kliničnih študij in izkušenj po prihodu zdravila na tržišče.
English: Sofosbuvir: AUC: ↔ Cmax: ↓ 30% Cmin: N/A
Slovenian: AUC: ↔ Cmax: ↓ 30 % Cmin: N/V
English: Co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Slovenian: Sočasna uporaba emtricitabina/dizoproksiltenofovirata in didanozina ni priporočljiva (glejte poglavje 4.4).
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Slovenian: AUC: ↑ 40 % (↑ 34 do ↑ 45) Cmax: ↑ 46 % (↑ 39 do ↑ 54) Cmin: ↑ 70 % (↑ 61 do ↑ 79)
English: • back pain caused by kidney problems
Slovenian: • bolečine v križu zaradi ledvične okvare
English: BMD Z scores declined by 0.012 for lumbar spine and by 0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Slovenian: Z-vrednosti MGK so se pri 64 osebah, ki so se 96 tednov zdravile z dizoproksiltenofoviratom, zmanjšale za −0,012 za ledveno hrbtenico in za −0,338 za celo telo.
English: • HIV paediatric renal educational brochure
Slovenian: • izobraževalno gradivo glede ledvic pri HIV za pediatrične bolnike;
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Slovenian: Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktacidozi (zvišanju mlečne kisline v krvi), ki je včasih smrtna.
English: HIV paediatric renal educational brochure:
Slovenian: Izobraževalno gradivo glede ledvic pri HIV za pediatrične bolnike:
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Slovenian: Osebam brez okužbe s HIV, ki so imele različne stopnje jetrne okvare po klasifikaciji Child-Pugh-Turcotte (CPT), so dali enkratni 245 mg odmerek dizoproksiltenofovirata.
English: Oral administration.
Slovenian: Navodilo shranite.
English: Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to
Slovenian: Cmax: ↑ 55 % (↑ 41 do ↑ 71) Cmin: ↑ 301 % (↑ 257 do atazanavir:
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9) Cmin: NC
Slovenian: AUC: ↑ 4 % (↓ 3 do ↑ 11) Cmax: ↑ 3 % (↓ 3 do ↑ 9) Cmin: n/i emtricitabin:
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata ob sočasni uporabi z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila ugotovljena.
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108) Cmin: NC
Slovenian: AUC: ↓ 4 % (↓ 15 do ↑ 8) Cmax: ↑ 102 % (↓ 96 do
English: Renal management in HIV-1 infected patients
Slovenian: Obravnava ledvic pri bolnikih, okuženih z virusom HIV-1
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Slovenian: Pri bolnikih s HIV-1, zdravljenih z dizoproksiltenofoviratom in z dejavniki tveganja za ledvično disfunkcijo, so po uvedbi velikih odmerkov ali več nesteroidnih protivnetnih zdravil (NSAID) poročali o primerih akutne ledvične odpovedi.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata ob sočasni uporabi z sofosbuvirjem/velpatasvirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila ugotovljena.
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Slovenian: AUC: ↓ 4 % (↓ 32 do ↑ 34) Cmax: ↓ 5 % (↓ 27 do ↑ 24) Cmin: n/i etinilestradiol:
English: 245 mg (n = 1584)
Slovenian: Dizoproksiltenofovirat 245 mg (n = 1.584)
English: THE SIGHT AND REACH OF CHILDREN
Slovenian: POGLEDA OTROK
English: asthenia
Slovenian: Zdravila
English: Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Slovenian: Pred jemanjem zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zmanjšanje tveganja za okužbo s HIV:
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC
Slovenian: AUC: ↓ 4 % (↓ 7 do ↓ 1) Cmax: ↓ 4 % (↓ 9 do ↑ 2) Cmin: n/i tenofovir:
English: Hepatic impairment:
Slovenian: Bolezni sečil:
English: What Emtricitabine/Tenofovir disoproxil Mylan contains
Slovenian: Kaj vsebuje zdravilo Emtricitabin/dizoproksiltenofovirat Mylan
English: In the Partners PrEP clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 during the study.
Slovenian: V klinični študiji Partners PrEP v času serokonverzije pri osebah, ki so se okužile s HIV-1 v času izvajanja študije, ni bila odkrita nobena različica HIV-1, ki bi izražala K65R, K70E, M184V ali M184I.
English: diarrhoea, nausea diarrhoea, vomiting, nausea
Slovenian: driska, navzea driska, bruhanje, navzea
English: Ribavirin/Tenofovir disoproxil
Slovenian: ribavirin/dizoproksiltenofovirat ribavirin:
English: Emtricitabine/Tenofovir disoproxil Mylan.
Slovenian: Emtricitabin/dizoproksiltenofovirat Mylan.
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Slovenian: Emtricitabina/dizoproksiltenofovirata naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
English: How to take Emtricitabine/Tenofovir disoproxil Mylan
Slovenian: Kako jemati zdravilo Emtricitabin/dizoproksiltenofovirat Mylan
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Slovenian: AUC: ↓ 9 % (↓ 16 do ↓ 1) Cmax: ↓ 7 % (↓ 22 do ↑ 11) Cmin: n/i emtricitabin:
English: • fatty liver
Slovenian: • okoreli sklepi
English: Emtricitabine/tenofovir disoproxil
Slovenian: Emtricitabin/dizoproksiltenofovirat
English: How to store Emtricitabine/Tenofovir disoproxil Mylan 6.
Slovenian: Shranjevanje zdravila Emtricitabin/dizoproksiltenofovirat Mylan 6.
English: Synergistic antiviral activity was observed with the combination of emtricitabine and tenofovir in vitro.
Slovenian: Pri kombinaciji emtricitabina in tenofovirja in vitro so opazili sinergistično protivirusno aktivnost.
English: • pain in the abdomen (tummy) caused by inflammation of the pancreas
Slovenian: • bolečine v trebuhu zaradi vnetja trebušne slinavke
English: pain, asthenia
Slovenian: bolečina, astenija
English: • Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Mylan contains lactose later in this section).
Slovenian: • Z zdravnikom se posvetujte, če imate intoleranco za laktozo (glejte ''Zdravilo
English: Darunavir: AUC: ↔ Cmax: ↔ Cmin: ↓ 34%
Slovenian: AUC: ↔ Cmax: ↔ Cmin: ↓ 34 %
English: Protease inhibitors Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d.
Slovenian: Protiretrovirusne učinkovine Zaviralci proteaz atazanavir/ritonavir/dizoproksilteno fovirat (300 mg q.d./100 mg q.d./ 245 mg q.d.)
English: A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Slovenian: Pri bolnikih s HIV-1, zdravljenih z dizoproksiltenofoviratom v kombinaciji z ritonavirjem ali kobicistatom okrepljenim zaviralcem proteaze, so poročali o večjem tveganju za ledvično okvaro.
English: In the iPrEx clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 after enrolment in the study.
Slovenian: V klinični študiji iPrEx v času serokonverzije pri osebah, ki so se okužile s HIV-1 po vključitvi v študijo, ni bila odkrita nobena različica HIV-1, ki bi izražala K65R, K70E, M184V ali M184I.
English: Emtricitabine/Tenofovir disoproxil Mylan [To appear on outer carton only]
Slovenian: PODATKI V BRAILLOVI PISAVI Emtricitabin/dizoproksiltenofovirat Mylan [samo na zunanji ovojnini]
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Slovenian: Med jemanjem zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zmanjšanje tveganja za okužbo s HIV:
English: Lamivudine/Tenofovir disoproxil
Slovenian: lamivudin/dizoproksiltenofovirat lamivudin:
English: Tenofovir disoproxil
Slovenian: Dizoproksiltenofovirat
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Mylan therapy
Slovenian: • da je pred začetkom zdravljenja z zdravilom Emtricitabin/dizoproksiltenofovirat Mylan pri pediatričnih bolnikih treba oceniti začetne vrednosti delovanja ledvic;
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zveča koncentracija lipidov in glukoze v krvi.
English: Other medicines and Emtricitabine/Tenofovir disoproxil Mylan
Slovenian: Shranjevanje zdravila Emtricitabin/dizoproksiltenofovirat Mylan
English: Tabulated summary of adverse reactions
Slovenian: Povzetek neželenih učinkov, prikazan v preglednici
English: P-valuea, b mITT Analysis
Slovenian: Placebo Emtricitabin/dizoproksiltenofovirat P-vrednosta,b
English: Cmax: ↑ 42% (↑ 27 to ↑ 57) Cmin: ↔
Slovenian: Cmax: ↑ 42 % (↑ 27 do ↑ 57)
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: sofosbuvir (400 mg enkrat dnevno) + efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: Interrupting use of Emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Slovenian: Enako velja tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog.
English: Manufacturer
Slovenian: Starostniki
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Mylan treatment
Slovenian: Ob odkritju nenormalnega delovanja ledvic ali sumu nanj se je treba posvetovati z nefrologom in razmisliti o prekinitvi zdravljenja;
English: Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: emtricitabin: AUC: ↔ Cmax:: ↔ Cmin: ↔
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑
Slovenian: Cmax: ↑ 79 % (↑ 56 to ↑ 104) Cmin: ↑ 163 % (↑ 137 do
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Slovenian: sofosbuvir/velpatasvir (400 mg/100 mg enkrat dnevno) + efavirenz/emtricitabin/dizoproksilte nofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja in atazanavirja/ritonavirja lahko povečajo neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: • The active substances are emtricitabine and tenofovir disoproxil.
Slovenian: • Učinkovini sta emtricitabin in dizoproksiltenofovirat.
English: Rilpivirine: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: rilpivirin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Elderly
Slovenian: astenija
English: Adefovir dipivoxil /Tenofovir disoproxil
Slovenian: Nukleozidni zaviralci reverzne transkriptaze (NRTI) didanozin/dizoproksiltenofovirat
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja in lopinavirja/ritonavirja lahko povečajo neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: ANTI-INFECTIVES
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽB
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Slovenian: ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno) + emtricitabin/rilpivirin/ dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasnega dajanja dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksilaprevirja in darunavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic.
English: Immediate Packaging Content (concentration)
Slovenian: Pot uporabe Stična ovojnina Vsebina (koncentracija)
English: MA (EU) Number (Invented) name
Slovenian: (Izmišljeno) ime
English: 1 ml (30 mg/ml)
Slovenian: 1 ml (30 mg/ml) 1 napolnjen injekcijski peresnik
English: 1 pre-filled syringe pre-filled syringe (glass) in pre-filled pen
Slovenian: 1 ml (30 mg/ml) 1 napolnjena injekcijska brizga napolnjena injekcijska brizga (steklo) v napolnjenem injekcijskem peresniku
English: The optimal duration of treatment has not been formally established.
Slovenian: Optimalno trajanje zdravljenja še ni bilo formalno potrjeno.
English: The patients were followed for 30 days.
Slovenian: Bolnike so spremljali 30 dni.
English: Patients were treated for up to one year.
Slovenian: Bolniki so bili zdravljeni do enega leta.
English: Thus, the results from this subset are in line with the overall trial results.
Slovenian: Rezultati te podskupine se torej skladajo s celotnimi rezultati preskušanja.
English: Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Slovenian: S kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
English: • Your doctor may order blood tests
Slovenian: • lahko vaš zdravnik naroči krvne preiskave.
English: White (n=1356) Black (n=966) Chinese (n=573)
Slovenian: Belci (n=1356) Črnci (n=966) Kitajci (n=573)
English: • Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been established.
Slovenian: • Pediatrični bolniki Varnost in učinkovitost klopidogrela pri otrocih in mladostnikih še nista ugotovljeni.
English: In addition, clinical tolerance was good in all patients.
Slovenian: Dodatno je bilo klinično prenašanje dobro pri vseh bolnikih.
English: The relative difference in antiplatelet response between genotype groups varies across studies depending on the method used to evaluate response, but is typically greater than 30%.
Slovenian: Relativna razlika antitrombocitnega odziva med genotipskima skupinama se med študijami razlikuje glede na metodo, uporabljeno za oceno odziva, a je praviloma večja od 30%.
English: Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Slovenian: Ker so bili visoki odmerki ASA povezani s povišanim tveganjem za krvavitve, se priporoča, da odmerek ASA ni večji od 100 mg.
English: The MAH must ensure that the system of pharmacovigilance, as described in version version 8 dated November 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 8, datirani z november 2009, ki je predstavljena v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa,