FrancophonIA/ELRC3.0 huggingface dataset:
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Croatian: Zabilježena je pojava autoimunih poremećaja (kao što su Gravesova bolest i autoimuni hepatitis) u sklopu imunološke rekonstitucije; no zabilježeno je varijabilno vrijeme nastupa poremećaja koje može nastupiti i više mjeseci nakon započinjanja liječenja.
English: Ritonavir dosing regimen
Croatian: Shema doziranja ritonavira
English: In general, as mutations associated with ritonavir resistance accumulate, susceptibility to select other PIs may decrease due to cross-resistance.
Croatian: Općenito, s nakupljanjem mutacija povezanih s rezistencijom na ritonavir, zbog križne se rezistencije smanjuje i osjetljivost na druge IP.
English: Ritonavir binds to both human alpha 1-acid glycoprotein (AAG) and human serum albumin (HSA) with comparable affinities.
Croatian: Ritonavir se i na alfa1-kiseli glikoprotein (engl. alpha 1-acid glycoprotein, AAG) i na ljudski serumski albumin (engl. human serum albumin, HSA) veže usporedivim afinitetom.
English: If this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations.
Croatian: Ocijeni li se da je ta istodobna primjena neizbježna, potrebno je vidjeti Sažetak opisa svojstava lijeka za abemacikilib za preporuke vezane uz prilagodbu doze.
English: In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations.
Croatian: Ispitivanja in vitro i in vivo pokazala su da je ritonavir snažan inhibitor biotransformacija posredovanih CYP3A i CYP2D6.
English: Concomitant administration of glecaprevir/pibrentasvir and ritonavir is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Croatian: Istodobna primjena glekaprevira/pibrentasvira i ritonavira se ne preporučuje zbog povećanog rizika od porasta razine alanin-aminotransferaze (ALT) koji je povezan s povećanom izloženošću glekapreviru.
English: In a study completed in 1996 recruiting less advanced HIV-1 infected patients (CD4 200-500 cells/μl) without previous antiretroviral therapy, ritonavir in combination with zidovudine or alone reduced viral load in plasma and increased CD4 count.
Croatian: U ispitivanju dovršenom 1996. godine, u bolesnika s manje uznapredovalom HIV-1 infekcijom (CD4: 200 - 500 stanica/µl) bez prethodnog antiretrovirusnog liječenja, ritonavir u kombinaciji sa zidovudinom i ritonavir u monoterapiji, smanjio je broj virusnih čestica u plazmi i povećao broj CD4stanica.
English: • upper or lower stomach ache
Croatian: • bol u gornjem ili donjem dijelu želuca
English: The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects.
Croatian: U nastavku su navedeni lijekovi koji su kontraindicirani u kombinaciji s ritonavirom i, ako drugačije nije navedeno, kontraindikacija se temelji na sposobnosti ritonavira da inhibira metabolizam lijeka s kojim se istodobno daje, zbog čega bi se povećala izloženost tom istodobno primijenjenom lijeku i povećao rizik od klinički značajnih nuspojava.
English: The mean average change from baseline over 48 weeks for HIV RNA levels was -0.88 log10 in the ritonavir group versus -0.66 log10 in the ritonavir + zidovudine group versus -0.42 log10 in the zidovudine group.
Croatian: Srednja prosječna promjena razine HIV RNA nakon 48 tjedana u odnosu na početno stanje iznosila je −0,88 log10 u skupine liječene ritonavirom i −0,66 log10 u skupine koja je primala ritonavir + zidovudin, a −0,42 log10 u skupine koja je primala samo zidovudin.
English: Developmental toxicity in rabbits (embryolethality, decreased litter size and decreased foetal weights) occurred at a maternally toxic dosage.
Croatian: Razvojna toksičnost u kunića (embrioletalnost, smanjena veličina legla i smanjena tjelesna težina fetusa) zamijećena je uglavnom pri maternalno toksičnim dozama.
English: Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Croatian: Slijedom toga, istodobna primjena ritonavira doziranog kao antiretrovirusnog lijeka ili kao farmakokinetičkog pojačivača i tih glukokortikoida se ne preporučuje, osim ako očekivana korist od liječenja nadmašuje rizik od sistemnih učinaka kortikosteroida (vidjeti dio 4.4).
English: Increased plasma concentrations of alfuzosin which may lead to severe hypotension (see section 4.5).
Croatian: Povećane koncentracije alfuzosina u plazmi, što može izazvati jaku hipotenziju (vidjeti dio 4.5).
English: Ethinylestradiol
Croatian: Etinilestradiol
English: Anti-infectives Fusidic acid
Croatian: Antiinfektivi Fuzidična kiselina
English: Co-administration of tipranavir with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation including some fatalities.
Croatian: Kod istodobne primjene tipranavira s 200 mg ritonavira bilo je prijava slučajeva hepatitisa i dekompenzacije jetre, u nekim slučajevima sa smrtnim ishodom.
English: It is therefore important that you remain under the supervision of your doctor while taking Ritonavir Mylan.
Croatian: Stoga je važno da za vrijeme dok uzimate Ritonavir Mylan ostanete pod nadzorom svog liječnika.
English: Serum levels of ritonavir can be reduced by concomitant use of herbal preparations containing St John's wort (Hypericum perforatum).
Croatian: Serumske razine ritonavira mogu se sniziti pri njegovoj istodobnoj primjeni s biljnim pripravcima koji sadržavaju gospinu travu (Hypericum perforatum).
English: Particular caution should be used when prescribing ritonavir in patients taking digoxin since co-administration of ritonavir with digoxin is expected to increase digoxin levels.
Croatian: Poseban je oprez nužan pri propisivanju ritonavira bolesnicima koji uzimaju digoksin, jer se pri istodobnoj primjeni ritonavira i digoksina očekuje porast razina digoksina.
English: Dosage conversion from oral solution to tablets for children
Croatian: Preračunavanje doze pri prelasku s oralne otopine na tablete u djece Doza oralne otopine
English: (μg•h/ml) t1/2 (h)
Croatian: (mikrogram·h/ml) t½ (h)
English: Sedatives/hypnotics Clorazepate, diazepam, estazolam, flurazepam, oral and parenteral midazolam
Croatian: Sedativi/hipnotici Klorazepat, diazepam, estazolam, flurazepam, oralni i parenteralni midazolam
English: HDPE bottle with polypropylene screw cap with inbuilt desiccant.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena s ugrađenim sredstvom za sušenje.
English: Since ritonavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the medicine.
Croatian: Budući da se ritonavir opsežno metabolizira u jetri i da se u visokom stupnju veže na proteine, dijaliza vjerojatno ne bi značajnije pomogla u uklanjanju lijeka.
English: Ritonavir should not be given as a pharmacokinetic enhancer or as an antiretroviral agent to patients with decompensated liver disease.
Croatian: Ritonavir se ne smije davati kao farmakokinetički pojačivač ni kao antiretrovirusni lijek bolesnicima s dekompenziranom bolešću jetre.
English: Ritonavir is considered high in sodium.
Croatian: Smatra se da ritonavir ima visoki sadržaj natrija.
English: If you stop taking Ritonavir Mylan
Croatian: Ako prestanete uzimati Ritonavir Mylan
English: The degree of enhancement is related to the metabolic pathway of the co-administered protease inhibitor and the impact of the co-administered protease inhibitor on the metabolism of ritonavir.
Croatian: Stupanj pospješenja ovisi o metaboličkom putu istodobno primijenjenog inhibitora proteaza i o utjecaju istodobno primijenjenog inhibitora proteaza na metabolizam ritonavira.
English: Dizziness is a known undesirable effect that should be taken into account when driving or using machinery.
Croatian: Omaglica je poznata nuspojava o kojoj valja voditi računa pri upravljanju vozilima i radu sa strojevima.
English: Thereby, increasing the risk of extreme sedation and respiratory depression from these agents.
Croatian: Time se povećava rizik od ekstremne sedacije i depresije dišnog sustava izazvane tim lijekovima.
English: 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 30 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
English: Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily.
Croatian: Minimalni korisni učinak pospješenja farmakokinetike ritonavirom postiže se njegovim dozama većim od 100 mg dva puta na dan.
English: 16 q24 h
Croatian: 16 svakih 24 h
English: Caution should be exercised in administering ceritinib with ritonavir.
Croatian: Potreban je oprez kada se ceritinib primjenjuje zajedno s ritonavirom.
English: Due to the risk of QTc prolongation associated with DM-6705, if co-administration of delamanid with ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid Summary of Product Characteristics)
Croatian: Zbog rizika od produženja QTc intervala povezanog s metabolitom DM-6705, ukoliko je nužna istodobna primjena delamanida i ritonavira, preporučuje se učestalo praćenje EKG-a bolesnika tijekom cijelog razdoblja liječenja delamanidom (vidjeti dio 4.4 i Sažetak opisa svojstava lijeka za delamanid).
English: Concomitant use of ritonavir (400 mg twice daily and more) and voriconazole is contraindicated due to a reduction in voriconazole plasma concentrations and possible loss of effect (see section 4.5).
Croatian: Primjena ritonavira (400 mg dva puta na dan ili više) istodobno s vorikonazolom je kontraindicirana zbog smanjenja koncentracija vorikonazola u plazmi i mogućeg izostanka njegova djelovanja (vidjeti dio 4.5).
English: Co-administration of ritonavir with these medicinal products is expected to substantially increase their concentrations and may result in associated adverse reactions such as hypotension and prolonged erection (see section 4.5).
Croatian: Pri primjeni ritonavira istodobno s tim lijekovima očekuje se značajan porast njihovih koncentracija što za posljedicu može imati nuspojave poput hipotenzije i produžene erekcije (vidjeti dio 4.5).
English: A higher frequency of adverse reactions (e.g., dizziness, nausea, paraesthesia) and laboratory abnormalities (elevated liver enzymes) have been observed when efavirenz is co-administered with ritonavir dosed as an antiretroviral agent.
Croatian: Zamijećena je veća učestalost nuspojava (npr. omaglica, mučnina, parestezija) i laboratoriskih poremećaja (porast vrijednosti jetrenih enzima) kada se efavirenz davao istodobno s ritonavirom kao antiretrovirusnim lijekom.
English: There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability have not been determined.
Croatian: Budući da nema ritonavira za parenteralnu primjenu, stupanj apsorpcije ni apsolutna bioraspoloživost nisu određeni.
English: 20, single dose 200q12h ↑ 124% ↔ The concomitant use of tadalafil for the treatment of erectile dysfunction with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer should be with caution at reduced doses of no more than 10 mg tadalafil every 72 hours with increased monitoring for adverse reactions (see section 4.4).
Croatian: 20, jednokratna doza 200 svakih 12 h ↑ 124% ↔ Tadalafil za liječenje erektilne disfunkcije istodobno s ritonavirom kao antiretrovirusnim lijekom ili kao farmakokinetičkim pojačivačem treba davati oprezno, u manjim dozama, ne većima od 10 mg tadalafila svaka 72 sata i uz pažljivije praćenje mogućih nuspojava (vidjeti dio 4.4).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of ritonavir.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 100 mg ritonavira.
English: 300 q12 h, 3 days
Croatian: 300 svakih 12 h, 3 dana
English: Due to the risk of bedaquiline related adverse events, co-administration should be avoided.
Croatian: Zbog povećanog rizika od nuspojava uzrokovanih bedakilinom, istodobna primjena se mora izbjegavati.
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
Croatian: U randomiziranom, placebom i aktivno (moksifloksacin 400 mg jedanput na dan) nadziranom, ukriženom ispitivanju u 45 zdravih odraslih osoba, s 10 mjerenja tijekom 12 sati trećeg dana ispitivanja evaluiran je QTcF interval.
English: • upset stomach or indigestion
Croatian: • nadražen želudac ili probavne tegobe
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Croatian: Povećane koncentracije lovastatina i simvastatina u plazmi; time se povećava rizik od miopatije, uključujući rabdomiolizu (vidjeti dio 4.5).
English: 0.4 single oral dose
Croatian: 0,4 jednokratne oralne doze
English: 3 Based on cross-study comparison to 800 mg indinavir three times daily alone.
Croatian: 3 Zasniva se na usporedbi među ispitivanjima s 800 mg indinavira triput na dan,
English: No interaction study is available with ritonavir only.
Croatian: Ne postoje ispitivanja interakcija samo s ritonavirom.
English: It is not recommended to use ritonavir in patients receiving rivaroxaban, due to the risk of increased bleeding (see section 4.5).
Croatian: Ne preporučuje se primjena ritonavira kod bolesnika koji uzimaju rivaroksaban zbog rizika od pojačanog krvarenja (vidjeti dio 4.5).
English: Co-administration of saquinavir and ritonavir has led to severe adverse reactions, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease.
Croatian: Pri primjeni ritonavira istodobno sa sakvinavirom javile su se teške nuspojave, poglavito dijabetička ketoacidoza i poremećaji jetre, osobito u bolesnika s već prisutnom bolešću jetre.
English: HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Croatian: Ako je indicirano liječenje inhibitorom HMGCoA reduktaze, preporučuje se pravastatin ili fluvastatin.
English: Decreased white blood cells, decreased haemoglobin, decreased neutrophils, increased eosinophils, thrombocytopenia
Croatian: Smanjeni broj leukocita, snižena vrijednost hemoglobina, smanjeni broj neutrofila, povećani broj eozinofila, trombocitopenija
English: For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir.
Croatian: Za ostale preporuke o doziranju pročitati uputu o lijeku za druge inhibitore proteaza, odobrene za primjenu u kombinaciji s ritonavirom.
English: Anticoagulants Rivaroxaban
Croatian: Antikoagulansi Rivaroksaban
English: Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as serious liver damage can occur when taken with ritonavir.
Croatian: - Rifampicin i sakvinavir (prvi se daje za tuberkulozu, drugi za HIV), jer može nastupiti ozbiljno oštećenje jetre kada se ti lijekovi uzimaju s ritonavirom.
English: Feeling sick (nausea), vomiting or have stomach pain, because these may be signs of inflammation of the pancreas (pancreatitis).
Croatian: - Mučnina, povraćanje ili bol u želucu, jer to mogu biti znakovi upale gušterače (pankreatitis).
English: Higher doses of ritonavir have been shown to be associated with an increased incidence of adverse reactions.
Croatian: Pokazalo se da su veće doze povezane s povećanom učestalošću nuspojava.
English: Therefore, combination of bedaquiline with ritonavir should be avoided.
Croatian: Stoga se mora izbjegavati kombinacija bedakilina i ritonavira.
English: Elderly Pharmacokinetic data indicated that no dose adjustment is necessary for elderly patients (see section
Croatian: Stariji bolesnici Farmakokinetički podaci pokazuju da ne treba prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: INFORMATION IN BRAILLE Ritonavir Mylan
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ritonavir Mylan
English: Increased digoxin levels observed in patients receiving ritonavir may lessen over time as induction develops (see section 4.4).
Croatian: Povišene razine digoksina uočene u bolesnika koji primaju ritonavir mogu se s vremenom, s razvojem indukcije, sniziti (vidjeti dio 4.4).
English: Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P-gp inhibition by ritonavir.
Croatian: Serumske se koncentracije mogu povećati zbog inhibicije proteina rezistencije raka dojke (engl. breast cancer resistant protein, BCRP) i akutne inhibicije P-gp-a uslijed djelovanja ritonavira.
English: Darunavir must be given with ritonavir to ensure its therapeutic effect.
Croatian: Darunavir se mora davati s ritonavirom da bi se osigurao terapijski učinak.
English: Serum concentrations may be increased due to CYP3A inhibition by ritonavir, resulting in increased risk of tumour lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.3 and refer to the venetoclax SmPC).
Croatian: Serumske se koncentracije mogu povećati zbog inhibicijskog učinka ritonavira na CYP3A, što može povećati rizik od sindroma tumorske lize pri uvođenju liječenja i tijekom razdoblja povećavanja doze (vidjeti dio 4.3 i Sažetak opisa svojstava lijeka za venetoklaks).
English: The following adverse reactions of moderate to severe intensity with possible or probable relationship to ritonavir have been reported.
Croatian: Niže su navedene prijavljene nuspojave umjerene do velike jačine, koje su moguće ili vjerojatno bile povezane s ritonavirom.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3 - 4 fold increase in midazolam plasma levels.
Croatian: Podaci o istodobnoj primjeri parenteralnog midazolama s drugim inhibitorima proteaza upućuju na to da se razine midazolama u plazmi mogu povećati 34 puta.
English: Each film-coated tablet contains 100 mg ritonavir.
Croatian: Jedna filmom obložena tableta sadrži 100 mg ritonavira.
English: Serum concentrations of ibrutinib may be increased due to CYP3A inhibition by ritonavir, resulting in increased risk for toxicity including risk of tumor lysis syndrome.
Croatian: Serumske se koncentracije ibrutiniba mogu povećati zbog inhibicijskog učinka ritonavira na CYP3A4, što može povećati rizik od toksičnosti uključujući rizik od sindroma tumorske lize.
English: Ritonavir pharmacokinetic parameters were not statistically significantly associated with body weight or lean body mass. Ritonavir plasma exposures in patients 50 - 70 years of age when dosed 100 mg in combination with lopinavir or at higher doses in the absence of other protease inhibitors is similar to that observed in younger adults.
Croatian: Izloženost ritonaviru iz plazme u bolesnika 50 - 70 godina starosti, pri primjeni 100 mg ritonavira u kombinaciji s lopinavirom, ili u većim dozama ali bez drugog inhibitora proteaza, slična je onoj u mlađih bolesnika.
English: In a study completed in 2003, 50 HIV-1 infected, protease inhibitor and lamivudine naïve children age 4 weeks to 2 years received ritonavir 350 or 450 mg/m every 12 hours co-administered with zidovudine 160 mg/m every 8 hours and lamivudine 4 mg/kg every 12 hours.
Croatian: U ispitivanju dovršenom 2003. godine, 50 djece u dobi od 4 tjedna do 2 godine, zaražene virusom HIV-1, koja prethodno nisu primala ni inhibitor proteaza ni lamivudin, dobivala su ritonavir 350 ili 450 mg/m² svakih 12 sati istodobno sa zidovudinom 160 mg/m² svakih 8 sati i lamivudinom 4 mg/kg svakih 12 sati.
English: Concomitant use of ritonavir (500 mg twice daily) dosed as an antiretroviral agent and rifabutin due to an increase of rifabutin serum concentrations and risk of adverse reactions including uveitis (see section
Croatian: Pri istodobnoj primjeni ritonavira (500 mg dva puta na dan) doziranog kao antiretrovirusnog lijeka i rifabutina povećavaju se serumske koncentracije rifabutina, a time i rizik od nuspojava, uključujući uveitis (vidjeti dio 4.4).
English: The isopropylthiazole oxidation metabolite (M-2) is the major metabolite and has antiviral activity similar to that of parent compound.
Croatian: Glavni je metabolit onaj koji nastaje oksidacijom izopropiltiazola (M-2), s protuvirusnom aktivnošću sličnom onoj matične tvari.
English: Dysgeusia, oral and peripheral paraesthesia, headache, dizziness, peripheral neuropathy
Croatian: Vrlo često Disgeuzija, cirkumoralna i periferna parestezija, omaglica, periferna neuropatija
English: If you forget to take Ritonavir Mylan
Croatian: Ako ste zaboravili uzeti Ritonavir Mylan
English: Trazodone is a CYP3A4 substrate and co-administration of ritonavir is expected to increase trazodone levels.
Croatian: Trazodon je supstrat CYP3A4 i očekuje se da će istodobna primjena ritonavira povisiti razine trazodona.
English: However, if the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution.
Croatian: Međutim, ukoliko korist nadmašuje rizik, prilikom istodobne primjene bedakilina s ritonavirom potreban je oprez.
English: Co-administration of ibrutinib and ritonavir should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu ibrutinibia i ritonavira.
English: Tipranavir with ritonavir should not be used in treatment-naïve patients.
Croatian: Tipranavir s ritonavirom se ne bi smio primjenjivati kod bolesnika koji nisu prethodno liječeni.
English: Concurrent administration of bupropion with repeated doses of ritonavir is expected to decrease bupropion levels.
Croatian: Pri istodobnoj primjeni bupropiona s višekratnim dozama ritonavira očekuje se smanjenje razina bupropiona.
English: For some products, contraindications may be more relevant when ritonavir is used as an antiretroviral agent than when ritonavir is used as a pharmacokinetic enhancer (e.g. rifabutin and voriconazole):
Croatian: Kontraindikacije za primjenu nekih lijekova mogu biti jače ako se ritonavir daje kao antiretrovirusni lijek nego ako se daje kao farmakokinetički pojačivač (npr. s rifabutinom ili s vorikonazolom):
English: 600 q12 h Nevirapine Ritonavir Co-administration of ritonavir with nevirapine does not lead to clinically relevant changes in the pharmacokinetics of either nevirapine or ritonavir.
Croatian: Primjena ritonavira istodobno s nevirapinom ne uzrokuje klinički značajne promjene farmakokinetike ni nevirapina ni ritonavira.
English: The relatively high frequency of diarrhoea during treatment with ritonavir may compromise the absorption and efficacy (due to decreased compliance) of ritonavir or other concurrent medicinal products.
Croatian: Razmjerno velika učestalost proljeva tijekom liječenja ritonavirom može smanjiti apsorpciju i djelotvornost ritonavira i drugih lijekova koji se istodobno daju (zbog slabije suradljivosti).
English: Package leaflet: Information for the user Ritonavir Mylan 100 mg film-coated tablets ritonavir
Croatian: Uputa o lijeku: Informacije za korisnika Ritonavir Mylan 100 mg filmom obložene tablete ritonavir