FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Rivastigmine Teva, rivastigmine, is an antidementia medicine.
Slovenian: Zdravilna učinkovina zdravila Rivastigmine Teva je rivastigmin, ki je zdravilo za zdravljenje demence.
English: The full EPAR for Rivastigmine Teva can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rivastigmine Teva je na voljo tukaj.
English: Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da koristi zdravila Rivastigmine Teva, tako kot pri zdravilu Exelon, odtehtajo znana tveganja.
English: What is Rivastigmine Teva?
Slovenian: Kaj je zdravilo Rivastigmine Teva?
English: What is Rivastigmine Teva used for?
Slovenian: Za kaj se zdravilo Rivastigmine Teva uporablja?
English: How has Rivastigmine Teva been studied?
Slovenian: Kako je bilo zdravilo Rivastigmine Teva raziskano?
English: How is Rivastigmine Teva used?
Slovenian: Kako se zdravilo Rivastigmine Teva uporablja?
English: How does Rivastigmine Teva work?
Slovenian: Kako zdravilo Rivastigmine Teva deluje?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2015
Slovenian: Datum prve odobritve: 13. julij 2015
English: The studies presented in Table 1 were conducted in healthy subjects unless otherwise noted.
Slovenian: Študije, navedene v tabeli 1, so bile izvedene pri zdravih osebah, če ni drugače navedeno.
English: Do not give this medicine to children and adolescents under 18 years of age.
Slovenian: Tega zdravila ne smete dajati otrokom in mladostnikom, mlajšim od 18 let.
English: The safety profile in these studies was overall comparable to that seen in adults.
Slovenian: V teh študijah je bil varnostni profil na splošno primerljiv z varnostnim profilom pri odraslih.
English: Your doctor will discuss the potential benefits and risks of taking EVOTAZ to you and your child.
Slovenian: Zdravnik vam bo pojasnil možne koristi in tveganja jemanja zdravila EVOTAZ za vas in vašega otroka.
English: A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Slovenian: Domnevno gre za vzročno povezavo, vendar pa mehanizem delovanja ni bil pojasnjen.
English: If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: The mechanism of interaction is unknown.
Slovenian: Mehanizem interakcije ni znan.
English: It is recommended that the INR (International Normalized Ratio) be monitored.
Slovenian: Priporočamo nadziranje vrednosti INR (internacionalno normalizirano razmerje).
English: Electrocardiogram monitoring is recommended.
Slovenian: Priporočamo nadziranje elektrokardiograma.
English: EU/1/15/1025/001 30 film-coated tablets EU/1/15/1025/002 90 (3 bottles of 30) film-coated tablets
Slovenian: EU/1/15/1025/001 30 filmsko obloženih tablet EU/1/15/1025/002 90 (3 plastenke po 30) filmsko obloženih tablet
English: Treatment should consist of general supportive measures including monitoring of vital signs and ECG as well as observation of the patient's clinical status.
Slovenian: Zdravljenje mora obsegati splošne podporne ukrepe, vključno z nadziranjem vitalnih znakov in EKG, ter opazovanje kliničnega stanja bolnika.
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Slovenian: Pri več kot polovici sporočenih primerov so zdravljenje z zaviralci proteaz nadaljevali oziroma ga znova uvedli, če je bilo prekinjeno.
English: b Week 144 window is between day 967 and 1,050 (inclusive)
Slovenian: b Okvir 144. tedna je med 967. in 1.050. dnevom (vključno z njima).
English: The median age of subjects was 36 years (range: 19-70).
Slovenian: Mediana starost bolnikov je bila 36 let (razpon:19-70).
English: The clinical relevance of these non-clinical data is unknown.
Slovenian: Klinični pomen teh predkliničnih podatkov ni znan.
English: HORMONAL CONTRACEPTIVES Progestin/estrogen
Slovenian: HORMONSKI KONTRACEPTIVI Progestin/estrogen
English: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italy
Slovenian: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italija
English: Some patients required hospitalisation for additional management and some had complications.
Slovenian: Pri nekaterih bolnikih je bila zaradi dodatnega zdravljenja potrebna hospitalizacija, pri nekaterih bolnikih pa so se pojavili zapleti.
English: Your doctor will discuss with you which combination of these medicines with EVOTAZ is best for you.
Slovenian: Zdravnik vam bo pojasnil, katera kombinacija teh zdravil z zdravilom EVOTAZ je za vas najprimernejša.
English: Effects on estimated creatinine clearance
Slovenian: Učinki na ocenjeni kreatininski očistek
English: In this way atazanavir reduces the risk of developing illnesses linked to HIV infection.
Slovenian: Atazanavir tako zmanjša tveganje za razvoj bolezni, ki so povezane z okužbo z virusom HIV.
English: The use of EVOTAZ should only be considered during pregnancy if the potential benefit justifies the potential risk.
Slovenian: Med nosečnostjo se sme zdravilo EVOTAZ uporabljati le, če možne koristi upravičujejo možna tveganja.
English: CCR5 Antagonists
Slovenian: Antagonisti CCR5
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative toxicity of atazanavir.
Slovenian: Manjše število podatkov o uporabi atazanavirja pri nosečnicah (med 300 in 1.000 izpostavljenih nosečnosti) ne kaže na malformacijsko toksičnost atazanavirja.
English: Missing data during window but on study drug a Week 48 window is between day 309 and 378 (inclusive)
Slovenian: Manjkajoči podatki, vendar pa uporaba študijskega zdravila a Okvir 48. tedna je med 309. in 378. dnevom (vključno z njima).
English: What EVOTAZ is and what it is used for 2.
Slovenian: Kaj je zdravilo EVOTAZ in za kaj ga uporabljamo 2.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Vse vnetne simptome je treba oceniti in po potrebi uvesti ustrezno zdravljenje.
English: No differences in frequency of bilirubin elevations were observed between these patients and those without viral hepatitis.
Slovenian: Razlik v pogostnosti zvišanja vrednosti bilirubina med temi bolniki in bolniki brez virusnega hepatitisa niso opažali.
English: Atorvastatin 10 mg single dose
Slovenian: Atorvastatin 10 mg enkratni odmerek
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom)
Slovenian: Če za preprečevanje nosečnosti trenutno jemljete peroralne kontraceptive ali uporabljate kontracepcijske obliže, morate uporabljati še dodatno ali drugačno obliko kontracepcije (npr. kondom).
English: Interactions between EVOTAZ and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Slovenian: Interakcije med zdravilom EVOTAZ in drugimi zdravili so prikazane v tabeli 1 v nadaljevanju (zvišanje je prikazano kot “↑”, znižanje kot “↓”, brez spremembe pa kot “↔”).
English: An alternate (non-hormonal) reliable method of contraception is recommended.
Slovenian: Priporočamo uporabo druge (nehormonske) zanesljive metode kontracepcije.
English: Adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to 1/1,000).
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in redki (≥ 1/10.000 do 1/1.000).
English: The safety and efficacy of EVOTAZ in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila EVOTAZ pri otrocih, mlajših od 18 let, nista bili dokazani.
English: When treating HIV infection, it is not always easy to identify what side effects are caused by EVOTAZ, by the other medicines you are taking, or by the HIV infection itself.
Slovenian: Pri zdravljenju okužbe z virusom HIV ni vedno lahko ugotoviti, če so neželeni učinki posledica jemanja zdravila EVOTAZ, drugih zdravil, ki jih jemljete, ali pa posledica okužbe z virusom HIV same.
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Slovenian: Elektrokardiografske spremembe (sinusna bradikardija, podaljšanje intervala PR, intervala QT in kompleksa QRS) so opazili le v prvih 2 tednih študije peroralne toksičnosti pri psih.
English: Alternative antibiotics should be considered.
Slovenian: Razmisliti je treba o uporabi drugih antibiotikov.
English: In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
Slovenian: O pojavu zlatenice so v večini primerov poročali v nekaj dneh do nekaj mesecih po uvedbi zdravljenja (glejte poglavje 4.4).
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Slovenian: Menijo, da so ti simptomi posledica izboljšanja telesnega imunskega odziva, ki omogoča telesu, da se brani pred okužbami, ki so bile prej prisotne brez izraženih simptomov.
English: The dose of the H2-receptor antagonist should not exceed a dose comparable to famotidine 20 mg twice daily.
Slovenian: Odmerek antagonista histaminskih receptorjev H2 ne sme preseči odmerka, ekvivalentnega famotidinu 20 mg dvakrat na dan.
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.)
Slovenian: Mehanizem tega zmanjšanja ni znan (glejte poglavji 4.2 in 4.4.)
English: Buspirone Clorazepate Diazepam Estazolam Flurazepam Zolpidem
Slovenian: Buspiron Klorazepat Diazepam Estazolam Flurazepam Zolpidem
English: If you forget to take EVOTAZ
Slovenian: Če ste pozabili vzeti zdravilo EVOTAZ
English: EVOTAZ may be used by adults aged 18 years of age and older who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS).
Slovenian: Zdravilo EVOTAZ lahko uporabljajo odrasli, stari 18 let in starejši, okuženi z virusom HIV, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
English: What you need to know before you take EVOTAZ 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo EVOTAZ 3.
English: If co-administration is required, the daily dose of ketoconazole or itraconazole should not exceed 200 mg.
Slovenian: Če je sočasno zdravljenje potrebno, dnevni odmerek ketokonazola ali itrakonazola ne sme preseči 200 mg.
English: c Includes subjects who had ≥50 copies/ml in the week 48 or 144 windows, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/ml.
Slovenian: c Vključuje bolnike, ki so imeli v okviru 48. ali 144. tedna ≥ 50 kopij/ml, bolnike, ki so bili predčasno izključeni zaradi pomanjkanja ali izgube učinkovitosti, bolnike, ki so bili izključeni zaradi razlogov, ki niso bili neželeni učinki, smrt ali pomanjkanje oziroma izguba učinkovitosti, in so imeli v času izključitve virološko vrednost ≥ 50 kopij/ml.
English: These medicines control human immunodeficiency virus (HIV) infection by stopping production of a protein that HIV needs for its multiplication.
Slovenian: Ta zdravila delujejo na okužbo z virusom humane imunske pomanjkljivosti (HIV) tako, da zavrejo nastajanje beljakovine, ki jo virus HIV potrebuje za svoje razmnoževanje.
English: Desacetyl-diltiazem AUC ↑165%
Slovenian: Dezacetil-diltiazem AUC ↑165%
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Slovenian: Podobne koncentracije atazanavirja so za 13 % podaljšale trajanje akcijskega potenciala (APD90) v študiji s kunčjimi Purkynjevimi vlakni.
English: Additional minor metabolic pathways consist of N-dealkylation and hydrolysis.
Slovenian: Dodatna manj pomembna presnovna pot obsega N-dealkilacijo in hidrolizo.
English: A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure.
Slovenian: Test koagulacije lahko pomaga odkriti bolnike s povečanim tveganjem za krvavitve zaradi večje izpostavljenosti dabigatranu.
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Slovenian: Zavedati se je treba, da z uporabo rifabutina v odmerku 150 mg 2-krat na teden izpostavljenost rifabutinu morda ne bo optimalna, kar lahko predstavlja tveganje za pojav odpornosti proti rifamicinu in neuspeh zdravljenja.
English: d Includes patients who discontinued due to adverse event (AE) or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Slovenian: d Vključuje bolnike, ki so bili izključeni zaradi neželenih učinkov ali smrti, kadar koli od 1. dneva do konca časovnega okvira, če zaradi tega v določenem okviru ni bilo viroloških podatkov o zdravljenju.
English: Table 3: Virologic outcome of randomised treatment of study GS-US-216-0114 at weeks 48a and 144b
Slovenian: Tabela 3: Virološki izid randomiziranega zdravljenja v študiji GS-US-216-0114 v 48.a in 144.b tednu
English: Potential cardiac effects of this product in humans cannot be ruled out (see sections 4.4 and 4.8).
Slovenian: Potencialnih učinkov tega zdravila na srce pri človeku ni mogoče izključiti (glejte poglavji 4.4 in 4.8).
English: Subsequent 9 month oral toxicity studies in dogs showed no drug-related electrocardiographic changes.
Slovenian: Nadaljnja 9-mesečna študija peroralne toksičnosti pri psih ni pokazala z uporabo zdravila povezanih elektrokardiografskih sprememb.
English: Interaction not studied with any of the components of EVOTAZ.
Slovenian: Medsebojno delovanje ni bilo proučevano z nobeno od sestavin zdravila EVOTAZ.
English: Treatment outcomes at weeks 48 and 144 for study GS-US-216-0114 are presented in Table 3.
Slovenian: Izidi zdravljenja v 48. in 144. tednu študije GS-US-216-0114 so predstavljeni v tabeli 3.
English: EVOTAZ has no or negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo EVOTAZ nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Slovenian: Na ta način se zmanjša količina virusa HIV v telesu in posledično okrepi imunski sistem.
English: The use of EVOTAZ in children and adolescents has not yet been studied.
Slovenian: Uporabe zdravila EVOTAZ pri otrocih in mladostnikih niso raziskovali.
English: A long-term carcinogenicity study in mice did not show any carcinogenic potential.
Slovenian: Dolgoročne študije kancerogenosti pri miših niso pokazale kancerogenega potenciala.
English: You may continue to develop infections or other illnesses linked to HIV infection.
Slovenian: Kljub zdravljenju se še vedno lahko razvijejo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
English: PULMONARY ARTERIAL HYPERTENSION
Slovenian: PLJUČNA ARTERIJSKA HIPERTENZIJA
English: Concomitant use contraindicated
Slovenian: Sočasna uporaba je kontraindicirana
English: Table 1: Interactions between EVOTAZ and other medicinal products Medicinal products by therapeutic area
Slovenian: Tabela 1: Interakcije med zdravilom EVOTAZ in drugimi zdravili
English: Dasatinib Nilotinib Vinblastine Vincristine
Slovenian: Dasatinib Nilotinib Vinblastin Vinkristin
English: An increase from baseline in serum creatinine solely due to cobicistat's inhibitory effect generally does not exceed 0.4 mg/dl.
Slovenian: Povečanje vrednosti kreatinina v serumu od izhodišča, ki je izključno posledica zaviralnega učinka kobicistata, na splošno ne presega 0,4 mg/dl.
English: Atazanavir has been shown in vivo not to induce its own metabolism, nor to increase the biotransformation of some medicinal products metabolised by CYP3A4.
Slovenian: In vivo je bilo dokazano, da atazanavir ne inducira svoje lastne presnove in tudi ne poveča biotransformacije nekaterih zdravil, ki se presnavljajo s CYP3A4.
English: Cmax: ↑41% Cmin: not determined
Slovenian: Cmax: ↑41% Cmin: ni bila določena
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Slovenian: Na voljo sta naslednji velikosti pakiranj: škatla z 1 plastenko s 30 filmsko obloženimi tabletami in škatla z 90 (3 plastenke po 30) filmsko obloženimi tabletami.
English: It does this by slowing down the breakdown of atazanavir which will make it stay in the body for longer.
Slovenian: Deluje tako, da upočasni razpad atazanavirja, zaradi česar se atazanavir dlje časa zadrži v telesu.
English: It is unknown if cobicistat, the other component of EVOTAZ, is excreted in human milk but it has been shown in animals that it is excreted in milk.
Slovenian: Ni znano, ali se kobicistat, druga sestavina zdravila EVOTAZ, izloča v materino mleko, vendar je bilo dokazano, da se izloča v mleko pri živalih.
English: For patients not taking tenofovir, EVOTAZ once daily with food should be administered simultaneously with, and/or at least 10 hours after, a dose of the H2-receptor antagonist.
Slovenian: Pri bolnikih, ki se ne zdravijo s tenofovirjem, je treba zdravilo EVOTAZ uporabljati enkrat na dan skupaj s hrano, in sicer sočasno z in/ali vsaj 10 ur po odmerku antagonista histaminskih receptorjev H2.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Slovenian: V primeru sočasnega protivirusnega zdravljenja hepatitisa B ali C je treba upoštevati tudi povzetke glavnih značilnosti sočasno uporabljenih zdravil.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet
English: Tenofovir DF may decrease the AUC and Cmin of atazanavir.
Slovenian: Tenofovir DF lahko zmanjša vrednosti AUC in Cmin atazanavirja.
English: Other medicines and EVOTAZ
Slovenian: Druga zdravila in zdravilo EVOTAZ
English: What EVOTAZ is and what it is used for
Slovenian: Kaj je zdravilo EVOTAZ in za kaj ga uporabljamo
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryo-development study.
Slovenian: Pri brejih samicah kuncev so pri poginulih ali moribundnih samicah ugotovili makroskopske lezije na želodcu in črevesu pri maternalnih odmerkih, 2- in 4-krat večjih od največjega odmerka, uporabljenega v definitivni študiji embrionalnega razvoja.
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily, and clinical monitoring for safety (e.g. myopathy) is recommended.
Slovenian: Če je sočasna uporaba potrebna, odmerek rosuvastatina ne sme biti večji od 10 mg na dan, priporočljivo pa je tudi klinično spremljanje glede varnosti (npr. miopatija).
English: In study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
Slovenian: V študiji GS-US-216-0114 je do zmanjšanja ocenjenega kreatininskega očistka prišlo kmalu po uvedbi zdravljenja s kobicistatom, nato pa so se vrednosti ustalile.
English: In clinical studies, paediatric patients 3 months to less than 18 years of age had a mean duration of treatment with atazanavir of 115 weeks.
Slovenian: V kliničnih študijah je zdravljenje pediatričnih bolnikov, starih od 3 mesece do manj kot 18 let, z atazanavirjem v povprečju trajalo 115 tednov.
English: To enhance bioavailability, EVOTAZ is to be taken with food.
Slovenian: Za okrepitev biološke uporabnosti je zdravilo EVOTAZ treba jemati skupaj s hrano.
English: EVOTAZ must not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Slovenian: Zdravila EVOTAZ se ne sme uporabljati v kombinaciji z zdravili, ki so substrati za CYP3A4 in imajo ozek terapevtski indeks.
English: Desacetyl-diltiazem Cmax ↑172%
Slovenian: Dezacetil-diltiazem Cmax ↑172%
English: Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Slovenian: Bolnike s hemofilijo je zato treba opozoriti na možnost pogostejših krvavitev.
English: SEDATIVES/HYPNOTICS Midazolam
Slovenian: SEDATIVI/HIPNOTIKI Midazolam
English: Expected: ↔ Atazanavir ↔ Ritonavir
Slovenian: Pričakovano: ↔ Atazanavir ↔ Ritonavir
English: EVOTAZ should not be used in children less than 3 months of age because of safety concerns especially taking into account the potential risk of kernicterus associated with the atazanavir component.
Slovenian: Zdravila EVOTAZ se ne sme uporabljati pri otrocih, mlajših od 3 mesecev, zaradi varnostnih zadržkov, še posebej ob upoštevanju možnega tveganja za razvoj ikterusa možganskih jeder, povezanega z atazanavirjem.
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Slovenian: Delež prekinitev zdravljenja v študiji zaradi neželenih učinkov, povezanih z bilirubinom, je bil majhen in podoben v obeh skupinah (4,9 % v skupini z okrepitvijo s kobicistatom in 4,0 % v skupini z okrepitvijo z ritonavirjem).
English: Amlodipine Felodipine Nicardipine Nifedipine Verapamil
Slovenian: Amlodipin Felodipin Nikardipin Nifedipin Verapamil
English: Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Slovenian: Bolnikom je treba pojasniti znake in simptome kožnih reakcij in njihov morebiten pojav skrbno nadzirati.
English: When compared to their single-agent profiles all findings could be attributed to either atazanavir or cobicistat.
Slovenian: Pri primerjavi s profilom posameznih učinkovin so vse ugotovitve lahko pripisali bodisi atazanavirju bodisi kobicistatu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with EVOTAZ in the treatment of HIV-1 infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom EVOTAZ za zdravljenje okužbe z virusom HIV-1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: No subject developed the tenofovir-associated resistance substitution K65R or K70E or any primary resistance substitution associated with protease inhibitors.
Slovenian: Noben bolnik ni razvil s tenofovirjem povezane rezistenčne substitucije K65R, K70E ali katere koli primarne rezistenčne substitucije, povezane z zaviralci proteaz.
English: If you stop taking EVOTAZ Do not stop taking EVOTAZ before talking to your doctor.
Slovenian: Če ste prenehali jemati zdravilo EVOTAZ Zdravila EVOTAZ ne smete prenehati jemati, ne da bi se o tem prej posvetovali z zdravnikom.
English: Atazanavir increases tenofovir concentrations.
Slovenian: Atazanavir poveča koncentracije tenofovirja.
English: Virologic response rate was evaluated in both treatment arms and virologic response was defined as achieving an undetectable viral load (<50 HIV-1 RNA copies/ml).
Slovenian: V obeh skupinah zdravljenja so vrednotili delež virološkega odziva, virološki odziv pa je bil opredeljen kot doseganje nedokazljivega virusnega bremena (< 50 HIV-1 RNA kopij/ml).
English: 90 (3 bottles of 30) film-coated tablets.
Slovenian: 90 (3 plastenke po 30) filmsko obloženih tablet