FrancophonIA/ELRC3.0 huggingface dataset:
English: PREZISTA co-administered with cobicistat should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of co-administration with an inhibitor of CYP3A4 (see section
Slovenian: Kombinacija PREZISTA/kobicistat se ne sme uporabljati skupaj z protiretrovirusnimi učinkovinami, ki zahtevajo farmakokinetično okrepitev s sočasnim jemanjem zaviralca CYP3A4 (glejte poglavje 4.5).
English: The PREZISTA 800 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Slovenian: Zdravilo PREZISTA 800 miligramov se ne sme uporabljati pri otrocih, mlajših od 3 let ali s telesno maso manj kot 40 kg.
English: ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% 14-OH-clarithromycin concentrations were not detectable when combined with PREZISTA/ritonavir.
Slovenian: ANTIBIOTIKI klaritromicin 500 mg dvakrat na dan klaritromicin AUC ↑ 57% klaritromicin Cmin ↑ 174% klaritromicin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% Pri kombiniranju z zdravili PREZISTA/ritonavir koncentracije 14-hidroksi-klaritromicina niso bile zaznavne.
English: PREZISTA co-administered with low dose ritonavir should not be used in combination with these medicines.
Slovenian: Zdravila PREZISTA z majhnim odmerkom ritonavirja ne smete uporabljati v kombinaciji s temi zdravili.
English: PREZISTA co-administered with low dose ritonavir and etravirine 200 mg twice daily can be used without dose adjustments.
Slovenian: Zdravilo PREZISTA se, skupaj z majhnim odmerkom ritonavirja in z 200 mg etravirina dvakrat na dan lahko uporablja brez prilagajanja odmerkov.
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of PREZISTA/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Slovenian: Pediatrični bolniki, ki imajo izkušnje z ART, stari 3 leta do < 6 let Farmakokinetiko, varnost, prenosljivost in učinkovitost zdravil PREZISTA/ritonavir dvakrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili pri 21 s HIV-1 okuženih pediatričnih bolnikih, ki že imajo izkušnje z ART, starih 3 do < 6 let in s telesno maso 10 kg do < 20 kg, so ocenili v odprtem preskušanju faze II, ARIEL.
English: Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
Slovenian: Ustrezne koncentracije kombinacije niso bile dosežene, ker se je izpostavljenost (AUC) darunavirju zmanjšala za 40%.
English: The combination of rifapentine and boosted PREZISTA is not recommended.
Slovenian: Kombinacija rifapentina in okrepljenega zdravila PREZISTA ni priporočljiva.
English: The evidence of efficacy of PREZISTA co-administered with ritonavir (600/100 mg twice daily) in ART-experienced patients is based on the 96 weeks analysis of the Phase III trial TITAN in ART-experienced lopinavir naïve patients, on the 48 week analysis of the Phase III trial ODIN in ART-experienced patients with no DRV-RAMs, and on the analyses of 96 weeks data from the Phase IIb trials POWER 1 and 2 in ART-experienced patients with high level of PI resistance.
Slovenian: Dokazi o učinkovitosti zdravila PREZISTA z ritonavirjem (600/100 mg dvakrat na dan), pri bolnikih z izkušnjami z ART, temeljijo na analizi podatkov po 96 tednih zdravljenja v kliničnem preskušanju faze III (preskušanje TITAN) pri bolnikih, bolnikih z izkušnjami z ART, ki še niso prejemali lopinavirja, na analizi podatkov po 48 tednih preskušanja faze III (ODIN) pri bolnikih z iskušnjami z ART, ki nimajo DRV-RAMov ter na analizi podatkov po 96 tednih zdravljenja iz kliničnih preskušanj faze IIb (preskušanja POWER 1, in 2) pri bolnikih z izkušnjami z ART z visoko stopnjo odpornosti za PI.
English: 600 mg once daily efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
Slovenian: 600 mg enkrat na dan efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz zaradi zaviranja CYP3A) (↓ darunavir zaradi indukcije CYP3A)
English: A dose reduction of the co-administered drug may be needed in these cases.
Slovenian: V takšnih primerih bo morda potrebno zmanjšati odmerek sočasno uporabljenega zdravila.
English: PREZISTA 400 mg or 800 mg must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Slovenian: Zdravilo PREZISTA 400 mg ali 800 mg se mora vedno uporabljati peroralno s farmakokinetičnima ojačevalcema, s kobicistatom ali z majhnim odmerkom ritonavirja, in v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 5.2).
English: Outcomes at Week 48
Slovenian: Izidi v 48. tednu
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Slovenian: atorvastatin 10 mg enkrat na dan atorvastatin AUC ↑ 3-4-krat atorvastatin Cmin ↑ ≈5,5-10-krat atorvastatin Cmax ↑ ≈2-krat darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
English: - symptoms of infection, herpes simplex - erectile dysfunction, enlargement of breasts - sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Slovenian: razdražljivost, bolečina - znaki okužbe, herpes simplex - motnje erekcije, zvečanje dojk - težave s spanjem, zaspanost, depresija, tesnoba, nenavadne sanje, zmanjšanje spolne sle
English: • In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Slovenian: • Pri vseh drugih bolnikih z izkušnjami z ART, pri katerih ni rezultatov testiranja genotipa je priporočeno odmerjanje 600 mg darunavirja dvakrat na dan, skupaj s 100 mg ritonavirja dvakrat na dan, s hrano.
English: Although the effect on CYP2C8 has only been studied in vitro, co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 (such as paclitaxel, rosiglitazone, repaglinide) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Slovenian: Kljub temu, da so učinke na CYP2C8 preskušali samo in vitro, lahko sočasna uporaba darunavirja, ritonavirja in zdravil, ki se presnavljajo predvsem s CYP2C8 (paklitaksel, rosiglitazon, repaglinid), povzroči zmanjšanje sistemske izpostavljenosti tem zdravilom, kar lahko zmanjša ali skrajša njihov terapevtski učinek.
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Slovenian: Zato ne moremo izključiti izpodrivanja z drugimi zdravili, ki se z veliko afiniteto vežejo na alfa1- kisli glikoprotein (glejte poglavje 4.5).
English: Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed in case digoxin is given to patients on darunavir/ritonavir therapy.
Slovenian: Zaradi majhne terapevtske širine digoksina, se priporoča, da bolniki, ki se že zdravijo z darunavir/ritonavirjem, na začetku prejemajo najnižji možni odmerek digoksina.
English: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2).
Slovenian: Zdravilo PREZISTA je v kombinaciji z majhnim odmerkom ritonavirja in z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih in pediatričnih bolnikov, okuženih z virusom humane imunske pomanjkljivosti (HIV-1), starih najmanj 3 leta in s telesno maso najmanj 15 kg (glejte poglavje 4.2).
English: The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) once daily.
Slovenian: Običajni odmerek zdravila PREZISTA je 800 miligramov (dve 400-miligramski tableti zdravila PREZISTA ali ena 800-miligramska tableta zdravila PREZISTA) enkrat na dan.
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/ml.
Slovenian: Z virusom HIV-1 okuženi bolniki, ki so bili primerni za to študijo, so imeli v izbirnem (screening) postopku genotip brez mutacij, ki bi bile povezane z odpornostjo na darunavir, in koncentracijo HIV-1 RNK v plazmi ≥ 1000 kopij/ml.
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P-gp)
Slovenian: digoksin enkratni odmerek 0,4 mg digoksin AUC ↑ 61% digoksin Cmin ND digoksin Cmax ↑ 29% (↑ koncentracije digoksina verjetno zaradi izaviranja Pgp)
English: Concomitant use of salmeterol and boosted PREZISTA is not recommended.
Slovenian: Sočasna uporaba salmeterola in okrepljenega zdravila PREZISTA ni priporočljiva.
English: If parenteral midazolam is co-administered with boosted PREZISTA, it should be done in an intensive care unit (ICU) or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Slovenian: Če je treba okrepljeno zdravilo PREZISTA uporabljati sočasno s parenteralno obliko midazolama, ju je treba odmerjati na oddelku intenzivne terapije ali v podobni enoti, kar zagotavlja skrbno spremljanje bolnika in ustrezno zdravljenje v primeru depresije dihanja in/ali dolgotrajne sedacije.
English: If you notice within 6 hours, you must take your missed dose immediately.
Slovenian: Če to opazite v 6 urah, morate izpuščeni odmerek vzeti takoj.
English: HIV Protease inhibitors (PIs) - with co-administration of low dose ritonavir Lopinavir/ritonavir
Slovenian: Zaviralci proteaze (PI) - z ritonavirjem v majhnem odmerku lopinavir/ritonavir
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) The dose of cobicistat to be used with PREZISTA in children less than 18 years of age has not been established.
Slovenian: Pediatrični bolniki, ki imajo izkušnje z ART (stari 3 do 17 let in s telesno maso najmanj 40 kg) Odmerka kobicistata za uporabo z zdravilom PREZISTA pri otrocih, mlajših od 18 let niso določili.
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 600 milligram PREZISTA together with 100 milligram ritonavir twice daily.
Slovenian: Odmerek za odrasle, ki so že jemali protiretrovirusna zdravila (to bo določil zdravnik) Odmerek je lahko: - 600 miligramov zdravila PREZISTA skupaj s 100 miligrami ritonavirja dvakrat na dan.
English: Warfarin concentrations may be affected when co-administered with darunavir with low dose ritonavir.
Slovenian: Koncentracije varfarina so lahko spremenjene ob sočasni uporabi darunavirja z ritonavirjem.
English: PREZISTA is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.
Slovenian: Zdravilo PREZISTA uporabljamo za zdravljenje odraslih in otrok, starejših od 3 let s telesno maso najmanj 15 kilogramov, ki so okuženi z virusom HIV in so že uporabljali druga protiretrovirusna zdravila.
English: Do not use the dosing pipette for any other medicines.
Slovenian: Odmerne pipete ne smete uporabiti za katero koli drugo zdravilo.
English: Boosted PREZISTA may increase the exposure to grazoprevir.
Slovenian: Okrepljeno zdravilo PREZISTA lahko zveča izpostavljenost grazoprevirju.
English: ritonavir oral solution: 80 milligram per milliliter
Slovenian: peroralna raztopina ritonavirja: 80 miligramov na mililiter
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment.
Slovenian: Pri bolnikih s kroničnim hepatitisom, cirozo in pri bolnikih, ki imajo pred zdravljenjem zvišane koncentracije transaminaz, je treba razmisliti o pogostejšem spremljanju koncentracij AST/ALT, kar še posebej velja v prvih mesecih zdravljenja z zdraviloma PREZISTA/ritonavir.
English: Medicinal products that affect darunavir exposure (cobicistat as pharmacoenhancer) Darunavir and cobicistat are metabolised by CYP3A, and co-administration with CYP3A inducers may therefore result in subtherapeutic plasma exposure to darunavir.
Slovenian: Zdravila, ki vplivajo na izpostavljenost darunavirju (farmakokinetični ojačevalec je kobicistat) Darunavir in kobicistat se presnavljata s CYP3A in sočasna uporaba z induktorji CYP3A lahko povzroči, da je izpostavljenost darunavirju v plazmi nižja od terapevtske.
English: Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.
Slovenian: Pomožne snovi z znanim učinkom: 3,43 mg/ml natrijevega metilparahidroksibenzoata (E219).
English: Co-administration with boosted PREZISTA may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Slovenian: Sočasna uporaba z okrepljenim zdravilom PREZISTA lahko pomembno zveča izpostavljenost dabigatranu ali tikagrelorju.
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the PREZISTA/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Slovenian: < 50 kopij/ml HIV-1 RNK je imelo 60,4% bolnikov v kraku študije z zdravilom PREZISTA/ritonavir, v primerjavi s 55,2% v kraku študije z zdravilom lopinavir/ritonavir [razlika: 5,2%, 95 IZ (-2,8;13,1)].
English: Concomitant systemic use of clotrimazole and boosted PREZISTA may increase plasma concentrations of darunavir and/or clotrimazole.
Slovenian: Sočasna sistemska uporaba klotrimazola in okrepljenega zdravila PREZISTA lahko zviša plazemske koncentracije darunavirja in/ali klotrimazola.
English: Common side effects (may affect up to 1 in 10 people) - vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence - headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - bruhanje, občutek siljenja na bruhanje, bolečina ali napetost v trebuhu, dispepsija, napenjanje - glavobol, utrujenost, omotica, zaspanost, odrevenelost, mravljinčenje ali bolečina v rokah ali nogah, izguba moči, nezmožnost zaspati
English: Rilpivirine 150 mg once daily rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
Slovenian: rilpivirin 150 mg enkrat na dan rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
English: Boosted PREZISTA can be expected to increase the plasma concentrations of calcium channel blockers.
Slovenian: Pričakovati je, da okrepljeno zdravilo PREZISTA zviša plazemske koncentracije zaviralcev kalcijevih kanalčkov.
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of
Slovenian: Odmerek za otroke, stare 3 leta in več, s telesno maso najmanj 40 kg, ki še niso prejemali protiretrovirusnih zdravil (to bo določil zdravnik) - Običajni odmerek zdravila PREZISTA je 800 miligramov (dve tableti zdravila PREZISTA po
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Slovenian: V kliničnem preskušanju darunavirja/ritonavirja (n=3.063) se je pri 0,4% bolnikov pojavil hud kožni izpuščaj, ki ga je lahko spremljala zvišana telesna temperatura in/ali zvišane koncentracije transaminaz.
English: If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Slovenian: Če je bilo to opaženo več kot 12 ur od časa, ko je odmerek ponavadi zaužit, izpuščenega odmerka ne sme zaužiti in nadaljuje z naslednjim odmerkom po običajnem režimu odmerjanja.
English: See the Summary of Product Characteristics for PREZISTA 100 mg/ml oral suspension, 75 mg, 150 mg, 300 mg or 600 mg tablets.
Slovenian: Glejte povzetke glavnih značilnosti zdravil PREZISTA 100 mg/ml peroralna suspenzija, 75 mg, 150 mg, 300 mg ali 600 mg tablete.
English: Boceprevir 800 mg three times daily boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
Slovenian: boceprevir 800 mg trikrat na dan boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
English: • 21 ART-experienced HIV-1 infected paediatric patients aged from 3 to < 6 years and weighing 10 kg to < 20 kg (16 participants from 15 kg to < 20 kg) who received PREZISTA oral suspension with low dose ritonavir twice daily in combination with other antiretroviral agents.
Slovenian: • 21 s HIV-1 okuženih pediatričnih bolnikov, starih 3 do < 6 let in s telesno maso 10 kg do < 20 kg (16 preiskovancev s telesno maso 15 kg do < 20 kg), z izkušnjami z ART, ki so prejemali zdravilo PREZISTA peroralna suspenzija skupaj z majhnim odmerkom ritonavirja dvakrat na dan in drugimi protiretrovirusnimi zdravili.
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: 300 mg enkrat na dan atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: If this is noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Slovenian: Če je bilo to opaženo več kot 6 ur od časa, ko je odmerek ponavadi zaužit, izpuščenega odmerka ne sme zaužiti in nadaljuje z naslednjim odmerkom po običajnem režimu odmerjanja.
English: PREZISTA does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila PREZISTA niso potrebna posebna navodila.
English: Concentrations of these medicinal products may be increased when co-administered with PREZISTA with low dose ritonavir resulting in the potential for increased adverse events usually associated with these agents.
Slovenian: Koncentracije teh zdravil se lahko pri sočasnem dajanju z zdravilom PREZISTA skupaj z majhnim odmerkom ritonavirja zvišajo, kar lahko zveča možnost za neželene učinke, ki se običajno pojavljajo pri uporabi teh zdravil.
English: In deciding to initiate treatment with PREZISTA in such ART-experienced patients, genotypic testing should guide the use of PREZISTA (see sections 4.2, 4.3, 4.4 and 5.1).
Slovenian: Pri odločanju za uvedbo zdravljenja z zdravilom PREZISTA pri bolnikih z izkušnjami z ART je treba upoštevati rezultate testiranja genotipa (glejte poglavja 4.2, 4.3, 4.4 in 5.1).
English: PREZISTA 800 mg film-coated tablets EU/1/06/380/007 - 30 film-coated tablets EU/1/06/380/008 - 90 film-coated tablets (3 x 30)
Slovenian: PREZISTA 800 mg filmsko obložene tablete EU/1/06/380/007 - 30 filmsko obloženih tablet EU/1/06/380/008 - 90 filmsko obloženih tablet (3 x 30)
English: Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.
Slovenian: Tudi če se počutite bolje, ne smete prenehati z jemanjem zdravila PREZISTA in ritonavirja, ne da bi se posvetovali s svojim zdravnikom.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with boosted PREZISTA has not been established.
Slovenian: Varnega in učinkovitega odmerka sildenafila (za zdravljenje pljučne arterijske hipertenzije), skupaj z okrepljenim zdravilom PREZISTA niso ugotovili.
English: Medicinal products that may be affected by darunavir boosted with cobicistat The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Slovenian: Učinkovine na katere lahko vpliva darunavir, okrepljenim s kobicistatom Za substrate CYP3A4, CYP2D6, P-glikoprotein, OATP1B1 in OATP1B3 so priporočila enaka, kot za darunavir, okrepljen z ritonavirjem (glejte kontraindikacije in priporočila, navedena v prejšnjih odstavkih).
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using PREZISTA/ritonavir, interruption or discontinuation of treatment should be considered promptly.
Slovenian: Če pri bolnikih, ki se zdravijo z zdraviloma PREZISTA/ritonavir, opazite znake o novih ali o poslabšanju obstoječih motenj v delovanju jeter (vključno s klinično pomembnim zvišanjem koncentracije jetrnih encimov in/ali simptomi kot so utrujenost, anoreksija, navzea, zlatenica, temen urin, boleča jetra, hepatomegalija), je nemudoma treba razmisliti o prekinitvi ali ukinitvi zdravljenja.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZISTA used in combination with cobicistat or low dose ritonavir treatment.
Slovenian: Pri bolnikih s kroničnim hepatitisom, cirozo in pri bolnikih, ki imajo pred zdravljenjem zvišane koncentracije transaminaz, je treba razmisliti o pogostejšem spremljanju koncentracij AST/ALT, kar še posebej velja v prvih mesecih zdravljenja z zdravilom PREZISTA v kombinaciji s kobicistatom ali z majhnim odmerkom ritonavirja.
English: Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Slovenian: Druga resna neželena učinki sta bila sladkorna bolezen (pogosto) in vnetje trebušne slinavke (občasno).
English: Also contains sunset yellow FCF (E110).
Slovenian: Vsebuje tudi barvilo sončno rumeno FCF (E110).
English: No dose adjustment for PREZISTA/ritonavir is recommended.
Slovenian: Prilagajanje odmerkov zdravila PREZISTA/ritonavir ni priporočljivo.
English: Concomitant use of colchicine and boosted PREZISTA may increase the exposure to colchicine.
Slovenian: Pri sočasni uporabi kolhicina in okrepljenega zdravila PREZISTA, se lahko zveča izpostavljenost kolhicinu.
English: Concomitant use of boosted PREZISTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Slovenian: Sočasna uporaba okrepljenega zdravila PREZISTA in kortikosteroidov, ki se presnavljajo s CYP3A (npr.: flutikazonpropionat ali drugi inhalacijski oziroma nazalni kortikosteroidi) lahko zvečajo tveganje za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvične žleze.