FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Slovenian: Darunavir Mylan 400 mg in 800 mg tablete se lahko uporabljajo za zagotavljanje ustreznega odmerjanja za zdravljenje okužbe s HIV-1 pri odraslih in pediatričnih bolnikih, starih 3 leta in več in s telesno maso najmanj 40 kg, ki so :
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE ZA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Infections and infestations Uncommon herpes simplex
Slovenian: Infekcijske in parazitske bolezni občasni herpes simplex
English: Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat).
Slovenian: Zato je sočasna uporaba zdravil, pri katerih so zvečane plazemske koncentracije povezane z resnimi in/ali življenje ogrožujočimi dogodki, kontraindicirana (velja za darunavir, okrepljen z ritonavirjem ali s kobicistatom).
English: <PVC/PE/PVDC-Al blister pack only> Do not store above 25°C.
Slovenian: <Samo pretisni omot (PVC/PE/PVDC-Al)> Ne shranjujte pri temeperaturi nad 25 °C.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Slovenian: Podatki o sočasni uporabi parenteralnega midazolama in drugih zaviralcev proteaz kažejo na možnost 3-4 kratnega zvečanja plazemskih koncentracij midazolama.
English: - Tell your doctor if you notice any musculoskeletal problems.
Slovenian: - Povejte svojemu zdravniku, če opazite težave s kostno-mišičnim sistemom.
English: The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
Slovenian: V spodnji preglednici so prikazani rezultati analize učinkovitosti po 48 tednih zdravljenja v študiji GS-US-216-130:
English: Increasing baseline darunavir fold change in EC50 (FC) was associated with decreasing virologic response.
Slovenian: Povečevanje stopnje spremembe (FC - fold change) izhodiščne vrednosti EC50 je bila povezana z zmanjšanim virološkim odzivom.
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving darunavir.
Slovenian: Zaradi možnosti za prenos okužbe s HIV in možnosti za neželene učinke pri dojenčkih, je treba materam naročiti, naj v nobenem primeru ne dojijo, če jemljejo darunavir.
English: If you take more Darunavir Mylan than you should Contact your doctor, pharmacist or nurse immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Darunavir Mylan, kot bi smeli Nemudoma pokličite svojega zdravnika, farmacevta ali medicinsko sestro.
English: In the virologic failures of the ARTEMIS trial no cross-resistance with other PIs was observed.
Slovenian: Pri rezistencah, ki so se pojavile v preskušanju ARTEMIS, niso opazili navzkrižne odpornosti z drugimi ZP.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Pri nekaterih bolnikih, ki imajo kombinirano protiretrovirusno zdravljenje lahko pride do bolezni kosti, ki se imenuje osteonekroza (odmiranje kostnega tkiva, ki je posledica zmanjšanja prekrvavitve kosti).
English: - Tell your doctor if you have diabetes.
Slovenian: - Povejte svojemu zdravniku, če imate sladkorno bolezen.
English: In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Slovenian: Pri odločanju o uvedbi zdravljenja z darunavirjem skupaj z majhnim odmerkom ritonavirja je potrebno skrbno upoštevati zgodovino zdravljenja posameznega bolnika in vzorce mutacij, povezanih z različnimi učinkovinami.
English: Darunavir FC was less than 10 for 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Slovenian: FC darunavirja je manj kot 10 za 90 % od 3.309 kliničnih izolatov, odpornih na amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, sakvinavir in/ali tipranavir, kar pomeni, da virusi, odporni za večino zaviralcev proteaz, ostanejo občutljivi za darunavir.
English: ● antiretroviral therapy (ART)-naïve (see section 4.2).
Slovenian: • Predhodno nezdravljeni s protiretrovirusnimi zdravili (ART - antiretroviral treatment) (glejte poglavje 4.2).
English: Instructions for children - The child must take darunavir always together with ritonavir.
Slovenian: Navodila za otroke - Otrok mora darunavir vedno zaužiti skupaj z ritonavirjem.
English: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml a n=11 for AUC12h
Slovenian: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml a n=11 za AUC12h
English: Co-administration with CYP3Ametabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Slovenian: Sočasno dajanje s kortikosteroidi, ki se presnavljajo s CYP3A, ni priporočljivo, razen če morebitna korist za bolnika odtehta tveganje - v tem primeru je treba bolnike spremljati glede sistemskih učinkov kortikosteroidov.
English: Saquinavir 1,000 mg twice daily
Slovenian: sakvinavir 1.000 mg dvakrat na dan
English: Hence, the use of creatinine clearance as an estimate of renal elimination capacity may be misleading.
Slovenian: Zato je uporaba očistka kreatinina za oceno obsega izločanja preko ledvic lahko zavajujoča.
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after darunavir/ritonavir given with food.
Slovenian: Didanozin je treba jemati na tešče, zato ga je potrebno zaužiti 1 uro pred ali 2 uri po zaužitju darunavirja/ritonavirja in hrane.
English: Type AE Type C
Slovenian: Tip AE
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Slovenian: Smer puščice je za vsak farmakokinetični parameter določena na osnovi 90 % intervala zaupanja geometričnega povprečnega razmerja, ki je znotraj (↔), pod (↓) ali nad (↑) območjem 80-125 % spremembe (ni podatka je prikazano z “ND”).
English: 6/l (see sections 4.2 and 4.4).
Slovenian: 6/l (glejte poglavji 4.2 in 4.4).
English: The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child.
Slovenian: Zdravnik bo določil ali je za vašega otroka primernejše odmerjanje enkrat na dan ali odmerjanje dvakrat na dan.
English: [On carton only:] Open date: __________
Slovenian: Samo za škatle: Datum odprtja:____________
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes, darunavir with low dose ritonavir should not be used in paediatric patients below 3 years of age.
Slovenian: Ker stopnja razvoja hematoencefalne bariere in jetrnih encimov pri ljudeh ni zanesljivo določena, darunavirja skupaj z majhnim odmerkom ritonavirja ni dovoljeno uporabljati pri pediatričnih bolnikih, mlajših od 3 let.
English: In most cases, darunavir can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Slovenian: Večinoma se darunavir lahko uporablja skupaj z drugimi zdravili proti HIV, ki spadajo v druge skupine [npr. NRTI (nukleozidni zaviralci reverzne transkriptaze), NNRTI (nenukleozidni zaviralci reverzne transkriptaze), CCR5 antagonisti and FI (zaviralci fuzije)].
English: The dose of cobicistat to be used with darunavir in children less than 18 years of age has not been established.
Slovenian: Odmerka kobicistata za uporabo z darunavirjem pri otrocih, mlajših od 18 let, niso določili.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Kljub temu, da so ocenili, da je vzrokov več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, visokim indeksom telesne mase), so poročali o primerih osteonekroze, še posebej pri bolnikih z napredovalo boleznijo HIV in/ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji (CART - Combination Antiretroviral Therapy).
English: ART-experienced patients - once daily dosing
Slovenian: Bolniki, predhodno zdravljeni z ART - odmerjanje enkrat na dan
English: For co-administration with strong CYP3A4 inhibitors, the same recommendations apply independent of whether darunavir is boosted with ritonavir or with cobicistat (see section above).
Slovenian: Za sočasno uporabo z močnimi zaviralci CYP3A4 veljajo enaka priporočila, ne glede na to ali je darunavir okrepljen z ritonavirjem ali s kobicistatom (glejte poglavje zgoraj).
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Slovenian: Razmisliti je treba o uporabi alternativnih kortikosteroidov, ki so manj odvisni od presnavljanja s CYP3A, npr. o beklometazonu za intranazalno ali inhalacijsko uporabo, zlasti pri dolgotrajni uporabi.
English: Darunavir/ritonavir should not be used in children below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Slovenian: Darunavirja/ritonavirja se ne sme uporabljati pri otrocih, mlajših od 3 let, zaradi zadržkov glede varnosti (glejte poglavji 4.4 in 5.3).
English: 100 milligram between 30 and 40 kilograms
Slovenian: 100 miligramov med 30 in 40 kilogrami
English: Tenofovir disoproxil 245 mg once daily‡
Slovenian: dizoproksiltenofovirat 245 mg enkrat na dan‡
English: Pregnant or breast-feeding mothers should not take darunavir with cobicistat.
Slovenian: Noseče ali doječe matere ne smejo jemati darunavirja skupaj s kobicistatom.
English: Darunavir should be used with caution in patients with a known sulphonamide allergy.
Slovenian: Darunavir je treba uporabljati previdno pri bolnikih z znano alergijo na sulfonamide.
English: If switching the pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with darunavir/cobicistat, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer.
Slovenian: Pri zamenjavi farmakokinetičnega ojačevalca ritonavirja s kobicistatom je prva dva tedna zdravljenja s kombinacijo učinkovin darunavir/kobicistat potrebna previdnost, še posebno, če so bili odmerki katerega koli sočasno uporabljenega zdravila med uporabo ritonavirja kot farmakokinetičnega ojačevalca titrirani ali prilagojeni.
English: Therefore, no special precautions or dose adjustments are required in these patients (see sections 4.2 and 5.2).
Slovenian: Zato pri teh bolnikih posebna opozorila ali prilagoditve odmerka niso potrebni (glejte poglavji 4.2 in 5.2).
English: Even if you feel better, do not stop taking Darunavir Mylan and ritonavir without talking to your doctor.
Slovenian: Tudi če se počutite bolje, ne smete prenehati z jemanjem zdravila Darunavir Mylan in ritonavirja, ne da bi se posvetovali s svojim zdravnikom.
English: This guidance is based on the half-life of darunavir in the presence of cobicistat or ritonavir and the recommended dosing interval of approximately 24 hours.
Slovenian: To navodilo je temelji na razpolovnem času darunavirja v prisotnosti kobicistata ali ritonavirja in priporočenem režimu odmerjanja na približno 24 ur.
English: Ethinylestradiol (3 mg/0.02 mg once daily)
Slovenian: drospirenon etinilestradiol (3 mg/0,02 mg enkrat na dan)
English: Daily doses of 150, 450 and 1,000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats.
Slovenian: Dnevni odmerki pri miših so bili 150 mg/kg, 450 mg/kg in 1.000 mg/kg, pri podganah pa 50 mg/kg, 150 mg/kg in 500 mg/kg.
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Slovenian: Mylan utca 1, Komárom, 2900,
English: Dexamethasone (systemic)
Slovenian: deksametazon (sistemska oblika)
English: Both arms used an Optimised Background Regimen (OBR) consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs).
Slovenian: V obeh krakih preskušanja so uporabljali optimirano osnovno shemo zdravljenja (OBR), ki je vsebovala najmanj 2 protiretrovirusni zdravili (NRTI z ali brez NNRTI).
English: The doctor will inform you on how many Darunavir Mylan tablets and how much ritonavir (capsules, tablets or solution) the child must take.
Slovenian: Zdravnik vam bo povedal, koliko tablet zdravila Darunavir Mylan in koliko ritonavirja (kapsul, tablet ali peroralne raztopine) mora otrok zaužiti.
English: The lowest rates of developing resistant HIV virus are observed in ART-naïve patients who are treated for the first time with darunavir in combination with other ART.
Slovenian: Najnižjo stopnjo razvoja odpornih HIV virusov so opazili pri bolnikih, predhodno nezdravljenih z ART, ki so jih prvič zdravili z darunavirjem v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Outcomes at Week 48
Slovenian: Izidi po 48. tednih
English: Darunavir in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Slovenian: V kombinaciji z ritonavirjem, darunavir nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: - if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
Slovenian: - če ste alergični na darunavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na ritonavir, - če imate hude težave z jetri.
English: According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Slovenian: Skladno s trenutno veljavnimi smernicami, sočasno zdravljenje z dvema zaviralcema proteaze večinoma ni priporočena.
English: Increased concentrations of quetiapine may lead to coma (see section 4.3).
Slovenian: Zvečane koncentracije kvetiapina lahko povzročijo komo (glejte poglavje 4.3).
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Slovenian: Stopnje izpostavljenosti izpuščaju (vse vzročnosti) so bile 10,9; 4,2 in 3,8 na 100 bolnikov let (PYR - patient years) oziroma 2,4; 1,1 in 2,3 na 100 bolnikov let pri izpuščaju, povezanem z zdravilom.
English: Dasatinib Nilotinib Vinblastine Vincristine
Slovenian: ZDRAVILA Z DELOVANJEM NA NOVOTVORBE dasatinib nilotinib vinblastin vinkristin
English: The efficacy and safety of the use of darunavir with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Slovenian: Učinkovitost in varnost sočasne uporabe darunavirja skupaj s 100 mg ritonavirja in drugimi PI (npr. (fos)amprenavir, nelfinavir in tipranavir) pri bolnikih s HIV nista bili ugotovljeni.
English: Ask your pharmacist how to throw away any medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Slovenian: Na podlagi ugotovitev bo v prisotnosti darunavirja/ritonavirja morda potrebno odmerke karbamazepina zmanjšati za 25 % do 50 %.
English: Increased plasma concentrations of lovastatin or simvastatin may cause myopathy, including rhabdomyolysis.
Slovenian: Zvečanje plazemskih koncentracij lovastatina in simvastatina lahko povzroči miopatijo, vključno z rabdomiolizo.
English: Darunavir is not a cure for HIV infection.
Slovenian: Darunavir ne ozdravi okužbe z virusom HIV.
English: Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients receive rifabutin at doses other than 300 mg/day.
Slovenian: Na osnovi podatkov, pridobljenih s farmakokinetičnim modeliranjem, je 75 % zmanjšanje odmerka priporočljivo tudi, če bolniki prejemajo rifabutin v odmerkih, različnih od 300 mg/dan.
English: Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0.
Slovenian: Bolniki, ki niso dokončali preskušanja, so označeni kot neuspešni: bolnikom, ki so predčasno prenehali sodelovati v preskušanju, so pripisali vrednost spremembe 0.
English: ART-experienced paediatric patients from the age of 3 to < 6 years
Slovenian: Pediatrični bolniki, predhodno zdravljeni z ART, stari od 3 let do < 6 let
English: 150 mg once every other day rifabutin AUC rifabutin Cmin
Slovenian: 150 mg enkrat vsak drugi dan rifabutin AUC rifabutin Cmin
English: Latvija*
Slovenian: Lietuva*
English: In the virologic failures of the GS-US-216-130 trial no cross-resistance with other HIV PIs was observed.
Slovenian: V preskušanju GS-US-216-130 pri primerih virološkega neuspeha zdravljenja, niso opažali nazkrižne odpornosti na druge zaviralce proteaze HIV.
English: Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Kombinacijo darunavir/ritonavir se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
English: Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Slovenian: Darunavir je protiretrovirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom imunske pomanjkljivosti pri človeku (HIV).
English: What you need to know before you take Darunavir Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Darunavir Mylan
English: The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol and talc.
Slovenian: Filmska obloga tablete vsebuje delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol in smukec.
English: This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Slovenian: Navodilo temelji na 15 urnem razpolovnem času darunavirja v prisotnosti ritonavirja in priporočenem režimu odmerjanja na približno 12 ur.
English: ● For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least
Slovenian: • za zdravljenje okužbe s HIV-1 pri pediatričnih bolnikih, starih najmanj 3 leta in s telesno maso najmanj 15 kg.
English: For the treatment of pulmonary arterial hypertension Sildenafil
Slovenian: Za zdravljenje pljučne arterijske hipertenzije: sildenafil tadalafil
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Slovenian: V kliničnem preskušanju faze III (GS-US-216-130) s kombinacijo darunavir/kobicistat (N=313 bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili) je imelo 66,5 % preiskovancev vsaj en neželen učinek.
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-Odesacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Slovenian: Tudi AUC vsote aktivnih frakcij rifabutina (učinkovina + 25-O-deacetil presnovek) je bila povečana 1,6-krat, Cmax pa je ostal primerljiv.
English: Pregnant or breast-feeding mothers must not take darunavir with ritonavir unless specifically directed by the doctor.
Slovenian: Med nosečnostjo in dojenjem ne smete jemati darunavirja skupaj z ritonavirjem, razen če vam jemanje izrecno naroči vaš zdravnik.
English: Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance.
Slovenian: Kobicistat zavira tubularno sekrecijo kreatinina in lahko povzroči zmerno zvišanje serumskega kreatinina ter zmerno zmanjšanje očistka kreatinina.
English: Skin rash (more often when used in combination with raltegravir), itching.
Slovenian: Kožni izpuščaj (če se zdravilo uporablja v kombinaciji z raltegravirjem, se pojavlja pogosteje), srbenje.
English: Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat (see sections 4.3, 4.4 and 4.5).
Slovenian: Darunavir ima zato lahko različne kontraindikacije in priporočila za sočasno uporabo z drugimi zdravili, odvisno od tega, ali je okrepljen z ritonavirjem ali s kobicistatom (glejte poglavja 4.3, 4.4 in 4.5).
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Slovenian: Drugih učinkov na parjenje ali plodnost pri zdravljenju z darunavirjem v odmerkih do 1.000 mg/kg/dan in pri stopnjah izpostavljenosti (AUC - 0,5-kratnik) pod vrednostmi pri klinično priporočenem odmerku za človeka ni bilo.
English: Darunavir Mylan should be used with caution in patients with a known sulphonamide allergy.
Slovenian: Zdravilo Darunavir Mylan je treba uporabljati previdno pri bolnikih z znano alergijo na sulfonamide.
English: CARTON (BLISTERS AND BOTTLES)
Slovenian: ŠKATLA (ZA PRETISNE OMOTE IN PLASTENKE)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročali so tudi o avtoimunskih boleznih (kot je Gravesova bolezen in avtoimunski hepatitis), vendar je čas do njihovega nastanka različen in se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Rash considered by the investigator to be drug-related occurred at similar rates.
Slovenian: Pojavnost izpuščaja, ki je bil po oceni raziskovalce povezan z zdravilom, je bila podobna.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Slovenian: Populacijska analiza farmakokinetike pri bolnikih, okuženih s HIV, je pokazala, da farmakokinetika darunavirja ni bistveno drugačna v razponu starosti, ki so ga proučevali pri bolnikih, okuženih s HIV (od 18 do 75 let) (n=12, starost  65) (glejte poglavje 4.4).
English: - Tell your doctor if you have haemophilia.
Slovenian: - Povejte svojemu zdravniku, če imate hemofilijo.
English: Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and cobicistat and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).
Slovenian: Sočasno zdravljenje s katerim koli od naslednjih zdravil zaradi pričakovanega zmanjšanja plazemskih koncentracij darunavirja, ritonavirja in kobicistata ter možne izgube terapevtskega učinka (glejte poglavji 4.4 in 4.5).
English: For young children unable to swallow tablets, more suitable formulations containing darunavir should be checked for their availability.
Slovenian: Za majhne otroke, ki ne morejo požirati tablet, so morda na voljo druge ustreznejše farmacevtske oblike z darunavirjem.