FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean Percent Change from Baseline in Placebo-Controlled Studies on Background Statin LONG TERM (N=2310)
Slovenian: Povprečna odstotna sprememba v primerjavi z izhodiščem v študijah, kontroliranih s placebom, ob osnovnem zdravljenju s statinom
English: How to store Praluent
Slovenian: Shranjevanje zdravila Praluent
English: Unstable Angina b f
Slovenian: 0,01f nestabilna angina pektorisb
English: At week 12 (before up-titration), 77.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 46.2% in the ezetimibe group.
Slovenian: Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 77,2 % bolnikov v primerjavi s 46,2 % v skupini z ezetimibom.
English: Do not re-use a pen.
Slovenian: Brizge nikoli ne uporabite ponovno.
English: At week 12, 82.1% of patients in the alirocumab group reached an LDL-C ˂70 mg/dL (˂1.81 mmol/L) compared to 7.2% of patients in the placebo group.
Slovenian: H-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) je 12. teden doseglo 82,1 % bolnikov v skupini z alirokumabom in 7,2 % bolnikov v skupini s placebom.
English: At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -30.4% (95% CI: -36.6%, -24.2%; pvalue: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -30,4 % (95 % IZ: -36,6 %, -24,2 %; vrednost p: ˂ 0,0001).
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -39.1% (95% CI: -51.1%, -27.1%; p-value: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -39,1 % (95 % IZ: -51,1 %, -27,1 %; vrednost p: ˂ 0,0001).
English: Patients received either alirocumab 300 mg Q4W, alirocumab 75 mg Q2W, or placebo in addition to their existing lipid-modifying therapy (statin, non-statin therapy or diet alone).
Slovenian: Bolniki so poleg že uporabljanega lipolitičnega zdravljenja (statin, nestatinska zdravila ali dieta sama) prejemali 300 mg alirokumaba na 4 tedne, 75 mg alirokumaba na 2 tedna ali placebo.
English: At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -29.8% (95% CI: -34.4%, -25.3%; p-value: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -29,8 % (95 % IZ: -34,4 %, -25,3 %; vrednost p: ˂ 0,0001).
English: At week 12 (before up-titration), 50.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0.6% in the placebo group.
Slovenian: Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 50,2 % bolnikov v primerjavi z 0,6 % bolnikov v skupini s placebom.
English: Among the subgroup of patients up-titrated at week 12, an additional 10.5% mean reduction in LDL-C was achieved at week 24.
Slovenian: V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 10,5 % povprečno znižanje h-LDL.
English: Among the subgroup of patients up-titrated at week 12, an additional 1.4 % mean reduction in LDL-C was achieved at week 24.
Slovenian: V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 1,4 % povprečno znižanje h-LDL.
English: This trial evaluated patients who did not tolerate at least two statins (at least one at the lowest approved dose), In these patients, musculo-skeletal adverse events occurred at a lower rate in the alirocumab group (32.5%) as compared to the atorvastatin group (46.0%) (HR= 0.61 [95% CI, 0.38 to 0.99]), and a lower percentage of patients in the alirocumab group (15.9%) discontinued study treatment due to musculo-skeletal adverse events as compared to the atorvastatin group (22.2%).
Slovenian: Med temi bolniki je bil delež neželenih mišično-skeletnih dogodkov v skupini z alirokumabom manjši (32,5 %) kot v skupini z atorvastatinom (46,0 %) (ROg = 0,61, [95 % IZ 0,38 do 0,99]).
English: • You can inject into your: o thigh o belly (except for the 5 cm area around your navel) o outer side of your upper arm (See picture).
Slovenian: o stegno minut o trebuh (razen v predel 5 cm okrog popka)
English: At week 12 (before up-titration), 76.0% of patients in the alirocumab group reached an LDL-C of ˂70 mg/dL (˂ 1.81 mmol/L) as compared to 11.3% in the placebo group.
Slovenian: Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 76,0 % bolnikov v skupini z alirokumabom in 11,3 % bolnikov v skupini s placebom.
English: Cardiovascular Event e
Slovenian: Kumulativna pojavnost dogodka
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -61.9% (95% CI: -64.3%, -59.4%; p-value: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -61,9 % (95 % IZ: -64,3 %, -59,4 %; vrednost p: ˂ 0,0001).
English: EU/1/15/1031/004 1 pre-filled syringe EU/1/15/1031/005 2 pre-filled syringes EU/1/15/1031/006 6 pre-filled syringes
Slovenian: EU/1/15/1031/002 2 napolnjena injekcijska peresnika EU/1/15/1031/003 6 napolnjenih injekcijskih peresnikov
English: What Praluent is used for
Slovenian: Za kaj uporabljamo zdravilo Praluent
English: Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.
Slovenian: Ena napolnjena injekcijska brizga za enkratno uporabo vsebuje 150 mg alirokumaba v 1 ml raztopine.
English:  Keep holding the pen against your skin after releasing the button • The injection may take up to 20 seconds.
Slovenian: • Injiciranje lahko traja do 20 sekund.
English: A significantly higher proportion of patients achieved an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) in the alirocumab group as compared to placebo or ezetimibe at week 12 and week 24.
Slovenian: Po 12 in 24 tednih je dosegel h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) značilno večji delež bolnikov v skupini z alirokumabom kot v skupini s placebom ali ezetimibom.
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -45.9% (95% CI: -52.5%, -39.3%; p-value: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -45,9 % (95 % IZ: -52,5 %, -39,3 %; vrednost p: ˂ 0,0001).
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Slovenian: Imetnik dovoljenja za promet z zdravilom: sanofi-aventis groupe 54, rue La Boétie
English: The parts of the Praluent syringe are shown in this picture.
Slovenian: Navodila za uporabo Slika prikazuje dele injekcijske brizge zdravila Praluent.
English: Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjeni injekcijski peresnik vsebuje 75 mg alirokumaba v 1 ml raztopine (75 mg/ml).
English: EU/1/15/1031/007 1 pre-filled pen EU/1/15/1031/008 2 pre-filled pens EU/1/15/1031/009 6 pre-filled pens
Slovenian: EU/1/15/1031/008 2 napolnjena injekcijska peresnika EU/1/15/1031/009 6 napolnjenih injekcijskih peresnikov
English: Praluent 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Praluent 75 mg
English: Praluent 75 mg solution for injection in pre-filled syringe alirocumab
Slovenian: Praluent 75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
English: Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
Slovenian: V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 15,7 % povprečno znižanje h-LDL.
English: Each pre-filled syringe contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjeni injekcijski peresnik vsebuje 150 mg alirokumaba v 1 ml raztopine (150 mg/ml).
English: At week 12 (before up-titration), 34.9% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Slovenian: Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 34,9 % bolnikov v primerjavi z 0 % v skupni z ezetimibom.
English: Praluent 75 mg solution for injection in pre-filled syringe
Slovenian: Praluent 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi alirokumab
English: At week 12 (before up-titration), 57.7% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Slovenian: Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 57,7 % bolnikov v primerjavi z 0 % v skupni z ezetimibom.
English: Praluent 150 mg solution for injection in pre-filled syringe
Slovenian: Praluent 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi alirokumab
English: Patients received either alirocumab at a dose of 150 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Slovenian: Bolniki so poleg že uporabljanjega zdravljenja za prilagoditev lipidov prejemali ali alirokumab v odmerku 150 mg na 2 tedna ali placebo.
English: Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Slovenian: Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
English: Patients received either alirocumab 75 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Slovenian: Bolniki so poleg že uporabljanjega zdravljenja za prilagoditev lipidov prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali placebo.
English: OUTER CARTON - Pre-filled syringe 150 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - napolnjena injekcijska brizga 150 mg
English: The parts of the Praluent pen are shown in this picture.
Slovenian: Navodila za uporabo Slika prikazuje dele injekcijskega peresnika zdravila Praluent.
English: Apo B Total-C Lp(a) TG
Slovenian: a c e h‐LDL (med zdravljenjem)
English: OUTER CARTON - Pre-filled syringe 75 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - napolnjen injekcijski peresnik 75 mg
English: Praluent 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Praluent 150 mg
English: 24 months.
Slovenian: Odmerna shema na 4 tedne
English: Pre-filled syringe 150 mg:
Slovenian: Napolnjen injekcijski peresnik 150 mg
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy.
Slovenian: Bolniki so poleg že uporabljanjega statina prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali ezetimib 10 mg enkrat na dan.
English: Keep the pen in the outer carton in order to protect from light.
Slovenian: Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: LDL-C percent change from baseline was -31.6% (95% CI: -40.2%, -23.0%; p-value: ˂0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -31,6 % (95 % IZ:40,2 %, -23,0 %; vrednost p: ˂ 0,0001).
English: Read all of the instructions carefully before using the Praluent syringe.
Slovenian: Pred uporabo brizge zdravila Praluent natančno preberite navodila.
English: EU/1/15/1031/010 1 pre-filled syringe EU/1/15/1031/011 2 pre-filled syringes EU/1/15/1031/012 6 pre-filled syringes
Slovenian: EU/1/15/1031/012 6 napolnjenih injekcijskih brizg
English: Praluent 75 mg injection alirocumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Praluent 75 mg injekcija alirokumab s.c.
English: • itching (pruritus).
Slovenian: • srbenje.
English: In the cohort of patients on background statin, the mean baseline LDL-C was 112.7 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -55.3% compared to +1.1% for placebo.
Slovenian: Po 12 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne (analiza ZNZ) -55,3 % in s placebom +1,1 %.
English: Praluent 150 mg injection alirocumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Praluent 150 mg injekcija alirokumab s.c.
English: Total-C
Slovenian: 0,02f
English: In the cohort of patients not treated with a concomitant statin, the mean baseline LDL-C was 142.1 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -58.4% compared to +0.3% for placebo.
Slovenian: Po 12 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne (analiza ZNZ) -58,4 % in s placebom +0,3 %.
English: Medicinal product subject to medical prescription.
Slovenian: Previdnostni ukrepi pred ravnanjem z zdravilom
English: Intravenous use bag (PVC)
Slovenian: Intravenska uporaba vreča (PVC)
English: 25 g / 25 g Solution for infusion
Slovenian: 25 g/25 g Raztopina za infundiranje
English: Date of first authorisation: 19 November 2014 Date of latest renewal: 31 July 2019
Slovenian: Datum prve odobritve: 19. november 2014 Datum zadnjega podaljšanja: 31. julij 2019
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Slovenian: zaviralci proteaze virusa HIV darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: Treatment difference (95% CI of difference)
Slovenian: razlika v zdravljenju (95% IZ razlike)
English: You must take REZOLSTA every day and always with food.
Slovenian: Zdravilo REZOLSTA morate jemati vsak dan in vedno skupaj s hrano.
English: In some cases dosage of other medicines might need to be changed.
Slovenian: V nekaterih primerih bo morda treba spremeniti odmerek drugega zdravila.
English: - if you have severe liver problems.
Slovenian: - če imate hude težave z jetri.
English: Always take with food.
Slovenian: Zdravilo vedno jemljite s hrano.
English: If you notice within 12 hours, you must take the tablet immediately.
Slovenian: Če to opazite v 12 urah, morate vzeti tableto takoj.
English: - Swallow the tablet whole with a drink such as water or milk.
Slovenian: - Tableto zaužijte celo z nekaj pijače, lahko z vodo ali z mlekom.
English: These interactions are described in the interaction table below.
Slovenian: Navedene interakcije so opisane v spodnji preglednici.
English: 2 years 6 weeks after opening the bottle.
Slovenian: 2 leti 6 tednov po odprtju plastenke
English: Further dosage reduction of rifabutin has not been studied.
Slovenian: Nadaljnjega zniževanja odmerkov rifabutina niso proučevali.
English: Tell your healthcare provider about all medicines that you are taking.
Slovenian: Zdravstvenemu strokovnjaku povejte za vsa zdravila, ki jih jemljete.
English: What REZOLSTA is and what it is used for
Slovenian: Kaj je zdravilo REZOLSTA in za kaj ga uporabljamo
English: When co-administration is required, the daily dose of itraconazole should not exceed 200 mg.
Slovenian: Če je potrebna sočasna uporaba, dnevni odmerek itrakonazola ne sme presegati 200 mg.
English: In more than half of the reported cases, treatment with HIV PIs was continued or reintroduced if treatment had been discontinued.
Slovenian: Pri več kot polovici prijavljenih primerov so z zdravljenjem z zaviralci proteaz virusa HIV nadaljevali ali so le-tega ponovno uvedli, če je bilo ukinjeno.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve redbega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Make sure that you check the following points and tell your doctor if any of these apply to you.
Slovenian: Zagotovo preglejte naslednje postavke in zdravniku povejte, če katera od njih velja za vas.
English: The effects of REZOLSTA might be reduced if you take any of the following products.
Slovenian: Učinek zdravila REZOLSTA se lahko zmanjša, če jemljete katero od naslednjih zdravil.
English: People taking REZOLSTA may still develop infections or other illnesses associated with HIV infection.
Slovenian: Pri osebah, ki jemljejo zdravilo REZOLSTA, se lahko še vedno pojavijo okužbe ali druge bolezni, ki so povezane z okužbo z virusom HIV.
English: If you forget to take REZOLSTA
Slovenian: Če ste pozabili vzeti zdravilo REZOLSTA
English: Other medicines and REZOLSTA Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Druga zdravila in zdravilo REZOLSTA Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: REZOLSTA is not for use in children and adolescents, as it has not been studied in patients under 18 years.
Slovenian: Zdravilo REZOLSTA ni namenjeno uporabi pri otrocih in mladostnikih, saj uporabe pri bolnikih, ki so stari manj kot 18 let, niso proučili.
English: There are some medicines that you must not combine with REZOLSTA.
Slovenian: Obstajajo določena zdravila, ki jih ne smete kombinirati z zdravilom REZOLSTA.
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: Treba je podariti, da dvakrat tedensko odmerjanje po 150 mg morda ne zagotavlja optimalne izpostavljenosti rifabutinu, kar lahko zveča tveganje za rezistenco na rifamicin in neuspeh zdravljenja.
English: Studies in animals have demonstrated that cobicistat is excreted in milk.
Slovenian: Študije na živalih so pokazale, da se kobicistat izloča v mleko.
English: Your doctor should do blood tests before you start REZOLSTA.
Slovenian: Zdravnik bo opravil krvne preiskave, preden začnete jemati zdravilo REZOLSTA.
English: Interaction not studied with any of the components of REZOLSTA.
Slovenian: Medsebojno delovanje ni bilo proučevano z nobeno od sestavin zdravila REZOLSTA.
English: Do not stop taking REZOLSTA without talking to your doctor first After therapy has started, it must not be stopped without instruction of the doctor.
Slovenian: Ne prenehajte jemati zdravila REZOLSTA, ne da bi se prej posvetovali s svojim zdravnikom Ko enkrat začnete z zdravljenjem, ga ne smete prekiniti brez navodil, ki vam jih da zdravnik.
English: Do not take REZOLSTA - if you are allergic to darunavir, cobicistat or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila REZOLSTA - če ste alergični na darunavir, kobicistat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: REZOLSTA has only been used in limited numbers of patients 65 years or older.
Slovenian: Zdravilo REZOLSTA je bilo uporabljeno le pri majhnem številu bolnikov, starih 65 let ali več.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with REZOLSTA in all subsets of the paediatric population in the condition of treatment of HIV-1 infection.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom REZOLSTA za vse podskupine pediatrične populacije za zdravljenje okužbe z virusom HIV-1.
English: Decrease estimated creatinine clearance
Slovenian: Zmanjšanje ocenjenega očistka kreatinina
English: REZOLSTA must be taken in combination with other HIV medicines.
Slovenian: Zdravilo REZOLSTA je treba uporabljati v kombinaciji z drugimi zdravili proti virusu HIV.
English: If you belong to this age group, please discuss with your doctor if you can use REZOLSTA.
Slovenian: Če sodite v to starostno skupino, se z zdravnikom pogovorite, ali lahko uporabljate zdravilo REZOLSTA.
English: However, only limited data were available in patients above the age of 65 years.
Slovenian: Vendar so bili podatki o bolnikih, starejših od 65 let, omejeni.
English: Treatment of overdose with REZOLSTA consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja zdravila REZOLSTA sestoji iz splošnih podpornih ukrepov, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
English: Use with caution.
Slovenian: Potrebna je previdnost.
English: It is, therefore, important to talk to your doctor if you develop a rash.
Slovenian: Zato je pomembno, da se pogovorite z zdravnikom, če se pri vas pojavi izpuščaj.
English: Everolimus Irinotecan
Slovenian: everolimus irinotekan
English: Other severe side effects, seen up to 1 patient in 10, were diabetes.
Slovenian: Drug resen neželeni učinek, opažen pri največ 1 od 10 bolnikov je bila sladkorna bolezen.
English: These are mentioned above under the heading ‘Do not combine REZOLSTA with any of the following medicines:'
Slovenian: Omenjena so zgoraj pod naslovom "Zdravila REZOLSTA ne smete kombinirati z nobenim od naslednjih zdravil".
English: Description of clinical studies of REZOLSTA in adults
Slovenian: Opis kliničnih študij z zdravilom REZOLSTA pri odraslih
English: Darunavir The absolute oral bioavailability of a single 600 mg dose of darunavir alone is approximately 37%.
Slovenian: Absolutna peroralna biološka uporabnost enkratnega odmerka 600 mg darunavirja samostojno je približno 37%.
English: What you need to know before you take REZOLSTA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo REZOLSTA
English: Treatment with REZOLSTA will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection.
Slovenian: Zdravljenje z zdravilom REZOLSTA bo izboljšalo delovanje imunskega sistema (naravna obramba telesa) in zmanjšalo tveganje za bolezni, ki so povezane z okužbo z virusom HIV, vendar ne bo pozdravilo okužbe s HIV.
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Slovenian: Če je treba navedeni učinkovini uporabljati v takšni kombinaciji, je priporočeni odmerek rifabutina 150 mg trikrat na teden na določene dni v tednu (na primer na ponedeljek-sredo-petek).
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR14
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije, oznaka ATC: J05AR14
English: REZOLSTA may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo REZOLSTA ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
Slovenian: Ženskam, okuženim s HIV, dojenje odsvetujejo zaradi možnosti okužbe dojenčka s HIV preko vašega mleka in zaradi neznanih učinkov zdravila na vašega dojenčka.
English: HIV-1 RNA (copies/mL)
Slovenian: HIV-1 RNK (kopij/ml)
English: In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Slovenian: In vitro poskusi s človeškimi jetrnimi mikrosomi (HLM) kažejo, da se darunavir presnavlja predvsem z oksidacijo.
English: An increase in serum creatinine due to the inhibitory effect of cobicistat generally does not exceed 0.4 mg/dl.
Slovenian: Zvišanje koncentracije kreatinina v serumu zaradi zaviralnega učinka kobicistata večinoma ne preseže 0,4 mg/dl.
English: In juvenile rats receiving darunavir up to days 23-26, increased mortality was observed with convulsions in some animals.
Slovenian: Pri mladih podganah, ki so prejemale darunavir do 23-26 dni, so opazili zvečano smrtnost s konvulzijami pri nekaterih živalih.
English: Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV infected females compared to males.
Slovenian: Populacijska analiza farmakokinetike je pokazala nekoliko večjo izpostavljenost darunavirju (16,8%) pri ženskah, okuženih s HIV, kot pri moških.