FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from clinical trials demonstrated that the incidence of confirmed hypoglycaemia (at any time of the day and nocturnal) was lower in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients, in patients with type 2 diabetes treated in combination with either non-insulin anti-hyperglycaemic medicinal product or mealtime insulin.
Slovenian: Pri sladkornih bolnikih tipa 2, ki so poleg dolgodelujočega insulina prejemali ali neinsulinska antihiperglikemična zdravila ali insulin ob obrokih, so rezultati kliničnih preskušanj dokazali nižjo incidenco potrjenih hipoglikemij (kadar koli v teku dneva in nočnih) pri tistih, ki so dobivali zdravilo Toujeo, kot pri tistih, ki so dobivali insulin glargin 100 enot/ml.
English: The dose window of the DoubleStar pen shows the number of units of Toujeo to be injected.
Slovenian: Odmerno okence peresnika DoubleStar kaže število enot zdravila Toujeo, ki bodo injicirane.
English: Other medicines and Toujeo
Slovenian: Druga zdravila in zdravilo Toujeo
English: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Nemčija
English: Read this first Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen
Slovenian: Zdravilo Toujeo SoloStar vsebuje 300 enot/ml insulina glargin v 1,5-ml napolnjenem injekcijskem peresniku, ki se ga po dokončani uporabi zavrže.
English: HbA1c
Slovenian: Število zdravljenih oseb (mZNZa) HbA1c
English: Combination of Toujeo with pioglitazone
Slovenian: Uporaba zdravila Toujeo skupaj s pioglitazonom
English: Switch from other basal insulins to Toujeo
Slovenian: Prehod z drugih bazalnih insulinov na zdravilo Toujeo
English: • Never use a syringe to remove Toujeo from your DoubleStar pen.
Slovenian: • Nikoli ne uporabite brizge, da bi z njo jemali zdravilo Toujeo iz napolnjenega injekcijskega peresnika DoubleStar.
English: Toujeo 300 units/ml solution for injection in a pre-filled pen (SoloStar) INSTRUCTIONS FOR USE
Slovenian: Zdravilo Toujeo 300 enot/ml raztopina z injiciranje v napolnjenem injekcijskem peresniku (SoloStar)
English: Lipohypertrophy Lipoatrophy
Slovenian: Bolezni kože in podkožja lipohipertrofija lipoatrofija kožna amiloidoza
English: 1 step=2 units
Slovenian: KORAK in 2.
English: Toujeo 300 SoloStar Toujeo 300 DoubleStar
Slovenian: PODATKI V BRAILLOVI PISAVI Toujeo 300 DoubleStar
English: Each DoubleStar pen contains 3 ml of solution for injection, equivalent to 900 units.
Slovenian: En injekcijski peresnik DoubleStar vsebuje 3 ml raztopine za injiciranje; to ustreza 900 enotam.
English: Toujeo SoloStar 30 months.
Slovenian: 30 mesecev.
English: • Never use a syringe to remove insulin from your pen.
Slovenian: • Nikdar ne odvzemajte insulina iz peresnika z injekcijsko brizgo.
English: Each pen contains 1.5 ml of solution, equivalent to 450 units.
Slovenian: En injekcijski peresnik vsebuje 1,5 ml raztopine; to ustreza 450 enotam.
English: The overall efficacy and safety of Toujeo (insulin glargine 300 units/ml) once-daily on glycaemic control was compared to that of once-daily insulin glargine 100 units/ml in open-label, randomised, active-control, parallel studies of up to 26 weeks of duration, including 546 patients with type 1 diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Table 1 and 2).
Slovenian: Celokupno učinkovitost in varnost zdravila Toujeo (insulin glargin 300 enot/ml) enkrat na dan na urejenost glikemije so primerjali z insulinom glargin 100 enot/ml enkrat na dan v odprtih, randomiziranih, z zdravilno učinkovino kontroliranih študijah vzporednih skupin.
English: - Never use a syringe to remove insulin from your pen.
Slovenian: - Nikdar ne odvzemajte insulina iz peresnika z injekcijsko brizgo.
English: Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen
Slovenian: Toujeo 300 enot/ml SoloStar raztopina za injiciranje v napolnjenem injekcijskem peresniku Toujeo 300 enot/ml DoubleStar raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: This will change the way it works and may cause your blood sugar to become too low.
Slovenian: • Za injiciranje v veno - takšno injiciranje spremeni način delovanja zdravila in lahko povzroči, da se vam krvni sladkor preveč zniža.
English: Cutaneous amyloidosis
Slovenian: Toujeo SoloStar
English: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Nemčija.
English: 450 units per pen (SoloStar pen) 900 units per pen (DoubleStar pen)
Slovenian: 900 enot na peresnik (DoubleStar peresnik)
English: Toujeo is a clear and colourless solution.
Slovenian: Zdravilo Toujeo je bistra in brezbarvna raztopina.
English: Each pen contains 3 ml of solution for injection, equivalent to 900 units.
Slovenian: En injekcijski peresnik vsebuje 3 ml raztopine za injiciranje; to ustreza 900 enotam.
English: The solution should be clear, colourless and water-like.
Slovenian: • Če so v insulinu delci - raztopina mora biti bistra, brezbarvna in po videzu kot voda.
English: Toujeo 300 units/ml SoloStar solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen insulin glargine
Slovenian: Toujeo 300 enot/ml SoloStar raztopina za injiciranje v napolnjenem injekcijskem peresniku Toujeo 300 enot/ml DoubleStar raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1,5 ml (SoloStar)
English: Meal-time insulin analog Meal-time insulin analog+/-metformin
Slovenian: Zdravljenje v kombinaciji z insulinskim analogom ob obrokih insulinskim analogom ob obrokih +/- metforminom neinsulinskimi antihiperglikemičnimi zdravili
English: The dose increment in Toujeo SoloStar is one unit and the dose increment in Toujeo DoubleStar is 2 units.
Slovenian: S peresnikom Toujeo SoloStar je mogoče odmerek povečevati po 1 enoto in s peresnikom Toujeo DoubleStar po 2 enoti.
English: Even numbers are shown in line with the dose pointer:
Slovenian: Kako odčitati odmerek v odmernem okencu Soda števila so prikazana kot uravnana s kazalnikom odmerka:
English: The dose window shows the number of units of Toujeo to be injected.
Slovenian: Odmerno okence kaže število enot zdravila Toujeo, ki bodo injicirane.
English: Multipack: 9 (3 packs of 3) pens
Slovenian: Skupno pakiranje: 6 (2 pakiranji po 3) injekcijskih peresnikov Skupno pakiranje: 9 (3 pakiranja po 3) injekcijskih peresnikov
English: Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen insulin glargine
Slovenian: Toujeo 300 enot/ml DoubleStar, raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
English: Toujeo is a long-acting insulin.
Slovenian: Zdravilo Toujeo je dolgodelujoč insulin.
English: Medication errors due to mix-up between insulins, particularly between longacting insulins and rapid-acting insulins have been reported.
Slovenian: Med uporabo drugih insulinov so poročali o napakah pri uporabi zdravila, zlasti o napakah, pri katerih so bili namesto dolgodelujočih insulinov pomotoma uporabljeni hitrodelujoči.
English: Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins.
Slovenian: Da bi se izognili napakam zdravljenja zaradi zamenjave med zdravilom Toujeo in drugimi insulini, je potrebno nalepko insulina vedno preveriti pred vsakim injiciranjem.
English: If you stop using Toujeo
Slovenian: Če ste prenehali jemati zdravilo Toujeo
English: Read this first Toujeo DoubleStar contains 300 units/ml insulin glargine in a 3 ml disposable prefilled pen
Slovenian: Zdravilo Toujeo DoubleStar vsebuje 300 enot/ml insulina glargin v 3-ml napolnjenem injekcijskem peresniku, ki se ga po dokončani uporabi zavrže.
English: C Pull off the outer needle cap. Keep this for later.
Slovenian: C Odstranite zunanji pokrovček igle.
English: Throwing your pen away
Slovenian: Kako zavreči peresnik
English: Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
Slovenian: Med prehodom in v prvih tednih po njem je priporočljivo natančno spremljati presnovo.
English: Your blood sugar level may become too low (hypoglycaemia).
Slovenian: • Če ne jeste dovolj - koncentracija krvnega sladkorja se lahko preveč zniža (hipoglikemija).
English: Each DoubleStar pen delivers 2-160 units in steps of 2 units Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: 1 odmerni korak= 2 enoti Pred uporabo preberite priloženo navodilo!
English: STEP 1: Check your pen
Slovenian: KORAK: Preverite injekcijski peresnik
English: How to read the dose window
Slovenian: Kako uporabljati zdravilo Toujeo
English: Toujeo 300 units/ml solution for injection in a pre-filled pen (DoubleStar) INSTRUCTIONS FOR USE
Slovenian: Zdravilo Toujeo 300 enot/ml raztopina z injiciranje v napolnjenem injekcijskem peresniku (DoubleStar)
English: 60 units selected
Slovenian: Izbrani odmerek 4 enote
English: - That blood glucose need to be closely monitored during the switch and the initial weeks thereafter; - That they should consult their healthcare provider for further information;
Slovenian: - Med prehodom in v prvih tednih po njem morajo bolniki skrbno spremljati glukozo v krvi.
English: Dose pointer
Slovenian: KORAK).
English: A Choose a place to inject as shown in the picture labelled “Places to inject” B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
Slovenian: A Izberite mesto za injiciranje, kot prikazuje slika ˝Mesta za injiciranje˝.
English: • Details on how to minimize the safety concern addressed by the additional risk minimization measures through appropriate monitoring and management: - That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment.
Slovenian: - Insulin glargin 100 enot/ml in insulin glargin 300 enot/ml (zdravilo Toujeo SoloStar in Toujeo DoubleStar) nista bioekvivalentna in zato nista medsebojno zamenljiva brez prilagoditve odmerka.
English: Each pen contains 3 ml of solution, equivalent to 900 units.
Slovenian: En injekcijski peresnik vsebuje 3 ml raztopine; to ustreza 900 enotam.
English: Meal-time insulin analogue
Slovenian: Zdravljenje v kombinaciji z insulinskim analogom ob obrokih
English: If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3A and STEP 3 B).
Slovenian: Če se to zgodi: - zamenjajte iglo (glejte 6.
English: Date of first authorisation: 21 June 2016
Slovenian: Datum prve odobritve: 21. junij 2016
English: These are medicinal products within class where similar interactions could be predicted.
Slovenian: To so zdravila znotraj razreda, kjer je mogoče predvideti podobne interakcije.
English: Your doctor will give you a different medicine.
Slovenian: Vaš zdravnik vam bo dal drugo zdravilo.
English: Adults: one tablet each day with food
Slovenian: Odrasli: ena tableta na dan s hrano
English: This should be considered when assessing a patient's ability to drive or operate machinery.
Slovenian: To je treba upoštevati pri ocenjevanju bolnikove sposobnosti za vožnjo ali upravljanje strojev.
English: Most adverse reactions were Grade 1 or 2.
Slovenian: Največ neželenih učinkov je bilo stopnje 1 ali 2.
English: Most of this increase in creatinine and decrease in eGFR occurred within the first four weeks of treatment.
Slovenian: Večina povečanj kreatinina in zmanjšanj eGFR se je pojavila v prvih štirih tednih zdravljenja.
English: These events have often been transitory.
Slovenian: Ti neželeni učinki so pogosto prehodni.
English:  Tell your doctor if you are taking any of these medicines.
Slovenian:  Povejte svojemu zdravniku, če jemljete katero od teh zdravil.
English: H2-RECEPTOR ANTAGONISTS
Slovenian: ANTAGONISTI RECEPTORJEV H2
English: The film-coated tablet should not be chewed, crushed or split.
Slovenian: Filmsko obložene tablete se ne sme žvečiti, zdrobiti ali razdeliti.
English: No new adverse reactions were identified compared to those seen in adults.
Slovenian: Ugotovljenih ni bilo nobenih novih neželenih učinkov v primerjavi s tistimi, ki so bili ugotovljeni pri odraslih.
English: increased bilirubin1
Slovenian: zvišanje bilirubina1
English: The proportion of virologic failures was 22.2% (8/36).
Slovenian: Delež virološkega neuspeha je bil 22,2 % (8/36).
English: Cmax: ↔* *based on historic controls
Slovenian: Cmax: ↔* *na podlagi zgodovinskih kontrol
English: If you are taking one of these medicines your doctor will either give you a different medicine, or recommend how and when you take that medicine:
Slovenian: Če jemljete katero od teh zdravil, vam bo zdravnik bodisi dal drugo zdravilo ali priporočal, kako in kdaj naj vzamete zdravilo.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Slovenian: Te ugotovitve ne vplivajo na trenutna nacionalna priporočila o uporabi protiretrovirusne terapije pri nosečnicah za preprečitev vertikalnega prenosa okužbe z virusom HIV.
English: Talk to your doctor about an alternative regimen (see How to take Odefsey).
Slovenian: Z zdravnikom se pogovorite o alternativnem režimu (glejte Kako jemati zdravilo Odefsey).
English: Discontinued due to adverse event (AE)
Slovenian: Smrt Prekinitev zaradi neželenega učinka (adverse event, AE)
English: If you have taken Odefsey during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Odefsey jemali med nosečnostjo, bo zdravnik morda opravljal redne krvne preiskave in druge diagnostične preglede, s katerimi bo spremljal razvoj vašega otroka.
English: These changes in adrenal safety parameters were not clinically relevant.
Slovenian: Te spremembe parametrov varnosti nadledvične žleze niso bile klinično pomembne.
English: Odefsey reduces the amount of HIV in your body.
Slovenian: Zdravilo Odefsey zmanjša količino virusa HIV v vašem telesu.
English: Cimetidine Nizatidine Ranitidine
Slovenian: cimetidin nizatidin ranitidin
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnost je definirana kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do
English: b The difference of response rate at Week 48 is 1% (95% confidence interval -3% to 6%) using normal approximation.
Slovenian: b Razlika stopnje odziva v 48. tednu je 1 % (95-odstotni interval zaupanja -3 % do 6 %) z normalnim približanjem.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Slovenian: Trenutno ni znano, ali so te nevrološke motnje prehodne ali trajne.
English: Stopping Odefsey can seriously affect your response to future treatment.
Slovenian: Prenehanje jemanja zdravila Odefsey lahko resno vpliva na vaš odziv na prihodnje zdravljenje.
English: Keep or take the tablet bottle with you so that you can easily describe what you have taken.
Slovenian: S seboj imejte vsebnik s tabletami, da boste lahko opisali, kaj ste zaužili.
English: Thirty-five percent of patients were on a treatment regimen that did not contain tenofovir disoproxil fumarate.
Slovenian: Petintrideset bolnikov je bilo na režimu zdravljenja, ki ni vseboval dizoproksiltenofovirijevega fumarata.
English: Findings in adolescents (12 to less than 18 years of age) in Study C213 were generally in line with these data (for details see section 5.1).
Slovenian: Ugotovitve pri mladostnikih (starih od 12 do 18 let) v študiji C213 so bile na splošno v skladu s temi podatki (za podrobnosti glejte poglavje 5.1).
English: There are no adequate and well-controlled studies of Odefsey or its components in pregnant women.
Slovenian: Ni ustreznih, dobro kontroliranih študij z zdravilom Odefsey ali njegovimi učinkovinami pri nosečnicah.
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Slovenian: Vendar pa ni mogoče izključiti, da se izpostavljenost farmakološko aktivnemu, nevezanemu rilpivirinu pomembno poveča pri zmerni okvari.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Slovenian: 3 Študija je bila opravljena z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, pričakovane pri bolnikih, okuženih s HCV.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vsebniku poleg oznake {EXP}.
English: What Odefsey is and what it is used for
Slovenian: Kaj je zdravilo Odefsey in za kaj ga uporabljamo
English: There are insufficient data to justify the use in patients with prior NNRTI failure.
Slovenian: Podatki ne zadoščajo za utemeljitev uporabe pri bolnikih, kjer predhodno zdravljenje z NNRTI ni bilo uspešno.
English: Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Slovenian: Tenofovir se učinkovito odstrani s hemodializo s koeficientom ekstrakcije približno 54 %.
English: Possible side effects: tell a doctor immediately
Slovenian: Možni resni neželeni učinki: takoj obvestite svojega zdravnika
English: • increased levels of liver enzymes in the blood
Slovenian: • zvišane ravni jetrnih encimov v krvi
English: • problems with digestion resulting in discomfort after meals
Slovenian: • prebavne motnje, ki privedejo do slabega počutja po zaužitem obroku
English: ODE = Odefsey a Week 48 window was between Day 295 and 378 (inclusive).
Slovenian: ODE = Odefesey a Okno v 48. tednu je med 295. in 378. dnevom (vključno z njima).
English: The presence of V90I and V189I at baseline did not affect the response.
Slovenian: Prisotnost mutacij V90I in V189I na začetku ni vplivala na odziv.
English: In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
Slovenian: In vitro je vezava rilpivirina na humane plazemske proteine 99,7 %, v glavnem na albumin.
English: Therefore, information regarding drug-drug interactions with other antiretroviral medicinal products is not provided.
Slovenian: Informacije o medsebojnem delovanju z drugimi protiretrovirusnimi zdravili zato niso navedene.
English: In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Slovenian: Pri otrocih, katerih matere so jemale nukleozidne zaviralce reverzne transkriptaze (NRTI) med nosečnostjo, so bile koristi zaščite pred virusom HIV večje od tveganj za neželene učinke.
English: The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
Slovenian: Najpogosteje uporabljena kombinacija NRTI z rilpivirinom je bila FTC/TDF (24 preskušancev [66,7 %]).
English: Each of these active substances works by interfering with an enzyme called ‘reverse transcriptase', which is essential for the HIV-1 virus to multiply.
Slovenian: Vsaka od teh učinkovin deluje tako, da vpliva na encim, ki se imenuje „reverzna transkriptaza“ in je nujen za razmnoževanje virusa HIV-1.
English: • depressed mood
Slovenian: • depresivno razpoloženje
English: Cmax, Cmin
Slovenian: AUC, Cmax, Cmin
English: The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Slovenian: Razlika v stopnji novih viroloških neuspehov v analizi od 48. do 96. tedna med krakoma z rilpivirinom in efavirenzom ni bila statistično pomembna.
English: It is recommended that Odefsey be taken with food.
Slovenian: Priporočeno je jemanje zdravila Odefsey s hrano.
English: Odefsey is indicated for use as a complete regimen for the treatment of HIV-1 infection and should not be co-administered with other antiretroviral medicinal products.
Slovenian: Zdravilo Odefsey je indicirano za uporabo kot celovit režim za zdravljenje okužbe s HIV-1 in se ga ne sme uporabljati sočasno z drugimi protiretrovirusnimi zdravili.
English: • rifabutin, rifampicin, rifapentine
Slovenian: • rifabutin, rifampicin, rifapentin
English: • Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
Slovenian: • Dabigatran eteksilat, učinkovina, ki se uporablja za zdravljenje bolezni srca, saj bo moral zdravnik morda nadzirati ravni tega zdravila v vaši krvi.
English: A negative impact by NNRTI mutations other than those listed above (e.g., mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Slovenian: Drugega negativnega vpliva mutacij NNRTI, razen zgoraj navedenih (npr. mutacije K103N ali L100I kot samostojni mutaciji) ni mogoče izključiti, saj študije in vivo niso bile izvedene pri zadostnem številu bolnikov.
English: • Antibiotics used to treat bacterial infections containing:
Slovenian: • antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb in vsebujejo:
English: If you have hepatitis B infection, liver problems may become worse after you stop taking Odefsey.
Slovenian: Če imate okužbo s hepatitisom B, se lahko težave z jetri poslabšajo, ko prenehate jemati zdravilo Odefsey.
English: It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
Slovenian: Pomembno je, da zdravila Odefsey ne prenehate jemati, ne da bi se pogovorili z zdravnikom: glejte poglavje 3, Ne prenehajte jemati zdravila Odefsey.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Odefsey treatment without talking to your doctor first.
Slovenian: Če ste okuženi tako z virusom HIV kot s hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Odefsey, ne da bi se prej posvetovali z zdravnikom.
English: The virologic response was generally preserved throughout the study: of the 12 patients that completed the study, 10 patients were suppressed at the end of the study; in the other 2 patients an increase in viral load was observed only postpartum, for at least 1 patient due to suspected suboptimal adherence.
Slovenian: Virološki odziv je bil v celotni študiji na splošno ohranjen: od 12 bolnic, ki so zaključilie študijo, je imelo na koncu študije supresijo 10 bolnic; pri drugih 2 bolnicah pa so povišanje virusne obremenitve opazili samo v obdobju po nosečnosti, pri čemer je bil pri najmanj 1 bolnici razlog domnevno neoptimalno sodelovanje z zdravljenjem.
English: It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Slovenian: Priporočljivo je, da ne dojite, da s tem preprečite prenos virusa preko mleka na dojenčka.
English: Co-administration should be used with caution.
Slovenian: Pri sočasni uporabi je potrebna previdnost.
English: Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Slovenian: Ex vivo je bila vezava tenofoviralafenamida na humane plazemske proteine v vzorcih, zbranih med kliničnimi študijami, približno 80 %.
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Slovenian: Vrednosti srednje efektivne koncentracije (EC50) za emtricitabin so bile v razponu od 0,0013 do 0,64 µM.