FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ne preporučuje se istodobna primjena s kortikosteroidima koji se metaboliziraju putem CYP3A, osim kada potencijalna korist za bolesnika nadmašuje rizik, a u tom slučaju je bolesnike potrebno pratiti radi eventualnih sistemskih učinaka kortikosteroida.
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Croatian: Ako se ne mogu primjenjivati alternativni lijekovi, potrebno je započeti s primjenom tih lijekova tek nakon medicinske procjene i pod pomnim praćenjem liječnika radi eventualnih nuspojava kortikosteroida
English: Metabolism and nutrition disorders: Common:
Croatian: Poremećaji metabolizma i prehrane: Često:
English: There is no specific antidote for overdose with cobicistat.
Croatian: Ne postoji specifični antidot za predoziranje kobicistatom.
English: Sunset yellow FCF aluminium lake (E110), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172) (see section 2 of this leaflet).
Croatian: Bojilo sunset yellow FCF aluminium lake (E110), makrogol 3350 (E1521), poli(vinilni alkohol) (djelomično hidroliziran) (E1203), talk (E553B), titanijev dioksid (E171), žuti željezov oksid (E172) (pogledajte dio 2 ove upute).
English: What you need to know before you take Tybost Do not take Tybost
Croatian: Što morate znati prije nego počnete uzimati Tybost
English: • aching muscles, weakness
Croatian: • bolni mišići, slabost
English: It is recommended to start with the lowest recommended dose of rosuvastatin and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Croatian: Preporučuje se započeti s najnižom preporučenom dozom rosuvastatina i titrirati na temelju kliničkog odgovora uz istodobno praćenje zbog sigurnosnih razloga (npr. miopatija).
English: • Talk to your doctor or pharmacist if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Croatian: • Razgovarajte sa svojim liječnikom ili ljekarnikom ako imate ili ste imali bolest bubrega ili ako pretrage pokazuju probleme s bubrezima.
English: headache, dizziness, somnolence, dysgeusia
Croatian: glavobolja, omaglica, somnolencija, disgeuzija
English: Increased plasma concentrations of salmeterol are associated with the potential for serious and/or life-threatening reactions.
Croatian: Povećane koncentracije salmeterola u plazmi povezane su s potencijalom za ozbiljne i/ili po život opasne reakcije.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Croatian: Učinak teškog oštećenja funkcije jetre (Child-Pugh stadij C) na farmakokinetiku kobicistata nije ispitan.
English: Animal studies do not indicate harmful effects of cobicistat on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke kobicistata na plodnost.
English: Safety and efficacy have not been established for use of cobicistat with either atazanavir or darunavir when used in any other dosing regimen.
Croatian: Nisu utvrđene sigurnost i djelotvornost za primjenu kobicistata bilo s atazanavirom ili darunavirom kada se primjenjuje u bilo kojem drugom režimu doziranja.
English: Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults.
Croatian: Tybost je indiciran kao farmakokinetički pojačivač atazanavira 300 mg jedanput na dan ili darunavira 800 mg jedanput na dan kao dio kombinirane antiretrovirusne terapije u odraslih osoba zaraženih virusom humane imunodeficijencije-1 (HIV-1).
English: Do not stop your treatment without contacting your doctor.
Croatian: Ne prekidajte svoje liječenje bez prethodnog savjetovanja s Vašim liječnikom.
English: Do not stop taking Tybost Do not stop taking Tybost without talking to your doctor.
Croatian: Nemojte prestati uzimati Tybost bez prethodnog razgovora sa svojim liječnikom.
English: However, patients should be informed that dizziness has been reported during treatment with cobicistat-containing regimens.
Croatian: Međutim, bolesnike je potrebno obavijestiti da je tijekom liječenja režimima koji sadrže kobicistat prijavljena omaglica.
English: How to take Tybost
Croatian: Kako uzimati Tybost
English: Virologic success
Croatian: Virološki neuspjehc
English: 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.[Samo vanjsko pakiranje]
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Croatian: Stope prekida primjene ispitivanog lijeka zbog nuspojava povezanih s bilirubinom bile su niske i slične u obje skupine (4,9% ispitanika u skupini koja je primala kobicistatom pojačani lijek i 4,0% ispitanika u skupini koja je primala ritonavirom pojačani lijek).
English: • Do not breast-feed during treatment with Tybost.
Croatian: • Nemojte dojiti tijekom liječenja lijekom Tybost.
English: When administering ketoconazole with Tybost, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Croatian: Prilikom primjene ketokonazola s lijekom Tybost maksimalna dnevna doza ketokonazola ne smije biti veća od 200 mg na dan.
English: Following oral administration of cobicistat with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for cobicistat.
Croatian: Nakon peroralne primjene kobicistata s hranom u HIV-1 zaraženih ispitanika, vršne koncentracije kobicistata u plazmi zapažene su 4 sata nakon doze.
English: (may affect more than 1 in 10 people)
Croatian: (Mogu se javiti u manje od 1 na 10 osoba)
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
English: Tybost taken with atazanavir or darunavir should not be used with another antiviral medicine that requires boosting.
Croatian: Tybost uzet s atazanavirom ili darunavirom ne smije se primjenjivati s drugim antivirusnim lijekovima koji zahtijevaju pojačanje.
English: • increased levels of bilirubin in the blood (hyperbilirubinaemia)
Croatian: • povećanje razine bilirubina u krvi (hiperbilirubinemija)
English: When co-administering maraviroc and Tybost patients should receive maraviroc 150 mg twice daily.
Croatian: Prilikom istodobne primjene maraviroka i lijeka Tybost bolesnici moraju primiti maravirok 150 mg dva puta dnevno.
English: SEDATIVES/HYPNOTICS Buspirone
Croatian: SEDATIVI/HIPNOTICI
English: This effect on serum creatinine, leading to a decrease in the estimated creatine clearance, should be taken into consideration when cobicistat is administered to patients in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
Croatian: Ovaj učinak na serumski kreatinin, koji dovodi do smanjenja procijenjenog klirensa kreatininina, se mora razmotriti prilikom primjene kobicistata u bolesnika u kojih je procijenjeni klirens kreatininina korišten kao vodič kroz kliničko zbrinjavanje, uključujući prilagodbu doza istodobno primijenjenih lijekova.
English: Therefore, Tybost should not be used during breast-feeding.
Croatian: Stoga se Tybost ne smije primjenjivati tijekom dojenja.
English: The pharmacokinetics of cobicistat in paediatric subjects have not been established.
Croatian: Farmakokinetika kobicistata u pedijatrijskih ispitanika nije ustanovljena.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Croatian: Za razliku od ritonavira, kobicistat nije induktor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili UGT1A1.
English: • high sugar levels in the blood (hyperglycaemia)
Croatian: • visoke razine šećera u krvi (hiperglikemija)
English: • ergot derivatives: dihydroergotamine, ergometrine, ergotamine
Croatian: • derivati ergota: dihidroergotamin, ergometrin, ergotamin
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Croatian: Kobicistat je slab inhibitor CYP2D6 i u manjoj ga mjeri metabolizira CYP2D6.
English: Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Croatian: Izloženosti kobicistatu bile su nelinearne i veće nego proporcionalne dozi u rasponu od 50 mg do 400 mg te u skladu s inhibitorom temeljenim na mehanizmu CYP3A.
English: The following side effects may occur when taking Tybost with atazanavir.
Croatian: Sljedeće nuspojave mogu se pojaviti kad se Tybost uzima s atazanavirom.
English: • trazodone, a medicine used to treat depression
Croatian: • trazodon, lijek koji se primjenjuje za liječenje depresije
English: (may affect up to 1 in 100 people)
Croatian: (Mogu se javiti u manje od 1 na 100 osoba)
English: See sections 4.4, 4.8 and 5.2.
Croatian: Vidjeti dijelove 4.4, 4.8 i 5.2.
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Croatian: Ne očekuje se da će kobicistat inhibirati CYP1A2, CYP2B6, CYP2C8, CYP2C9 ili CYP2C19.
English: ANTIRETROVIRALS
Croatian: ANTIRETROVIRUSNI
English: When administering with cobicistat, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Croatian: Prilikom primjene s kobicistatom maksimalna dnevna doza itrakonazola ne smije biti veća od 200 mg na dan.
English: Tybost must not be used as a pharmacokinetic enhancer of any other HIV-1 protease inhibitor or any other antiretroviral medicinal product that requires boosting since dosing recommendations for such co-administration have not been established and may result in insufficient plasma level of the antiretroviral medicinal product(s) leading to loss of therapeutic effect and development of resistance (see section 4.2).
Croatian: Tybost se ne smije primjenjivati kao farmakokinetički pojačivač bilo kojeg drugog inhibitora proteaze HIV-1 ili nekog drugog antiretrovirusnog lijeka koji zahtijeva pojačanje obzirom da nisu utvrđene preporuke za doziranje za takvu istodobnu primjenu, a mogu rezultirati nedostatnom razinom antiretrovirusnog(ih) lijeka(ova) u plazmi koja dovodi do gubitka terapijskog učinka i razvoja rezistencije (vidjeti dio 4.2).
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mle
Croatian: Prekid primanja ispitivanog lijeka iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/mle
English: Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet.
Croatian: Narančasta, okrugla, bikonveksna, filmom obložena tableta promjera 10,3 mm, s utisnutom oznakom „GSI“ na jednoj strani tablete i bez oznake na drugoj strani tablete.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Croatian: Potreban je strog nadzor nuspojava povezanih s rifabutinom, uključujući neutropeniju i uveitis zbog očekivanog povećanja izloženosti dezacetilrifabutinu.
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Tybost.
Croatian: Za liječenje erektilne disfunkcije, preporuča se jedna doza sildenafila od najviše 25 mg u 48 sati, vardenafila od najviše 2,5 mg u 72 sata ili tadalafila od najviše 10 mg u 72 sata kod istodobne primjene s lijekom Tybost.
English: Discontinued study drug due to AE or deathd
Croatian: Prekid primanja ispitivanog lijeka zbog nuspojava ili smrtid
English: Some examples include, but are not limited to, itraconazole, ketoconazole, and voriconazole (see Table 2).
Croatian: Neki primjeri uključuju, ali nisu ograničeni na itrakonazol, ketokonazol i vorikonazol (vidjeti Tablicu 2).
English: Table 4: Pharmacokinetic parameters [mean ± SD (%CV)] of atazanavir in the pharmacokinetic sub-study of phase 3 Study GS-US-216-0114
Croatian: Tablica 4: Farmakokinetički parametri [srednja vrijednost ± SD (%CV)] atazanavira u farmakokinetičkom podispitivanju ispitivanja faze 3 GS-US-216-0114
English: • anticonvulsants: carbamazepine, phenobarbital, phenytoin
Croatian: • antikonvulzivi: karbamazepin, fenobarbital, fenitoin
English: Stopping Tybost and atazanavir or darunavir may reduce the success of future treatments prescribed by your doctor.
Croatian: Prestanak uzimanja lijeka Tybost i atazanavira ili darunavira može smanjiti uspjeh budućih liječenja koja propiše
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Croatian: Maravirok je supstrat CYP3A i njegova se koncentracija u plazmi povećava kad se istodobno primjenjuje s potentnim inhibitorima CYP3A.
English: Some patients have reported dizziness when Tybost was taken with atazanavir or darunavir.
Croatian: Neki su bolesnici prijavili omaglicu kad su lijek Tybost uzimali s atazanavirom ili darunavirom.
English: The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1.
Croatian: Doze lijeka Tybost i istodobno primijenjenog inhibitora proteaze, atazanavira ili darunavira, prikazane su u Tablici 1.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu, koja sadrži 30 filmom obloženih tableta i sredstvo za sušenje (silika gel).
English: • sildenafil and vardenafil, medicines used to treat impotence, and tadalafil, a medicine used to treat impotence and pulmonary hypertension
Croatian: • sildenafil i vardenafil, lijekovi koji se primjenjuju za liječenje impotencije i tadalafil, lijek koji se primjenjuje za liječenje impotencije i plućne hipertenzije
English: Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure which may be associated with an increased risk of virological failure and an increased risk of mother-to-child transmission of HIV infection.
Croatian: Liječenje kobicistatom i darunavirom tijekom trudnoće rezultira manjom izloženošću darunaviru, što može biti povezano s povećanim rizikom od virološkog neuspjeha i povećanim rizikom od prijenosa HIV infekcije s majke na dijete.
English: Tablet core Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide.
Croatian: Jezgra tablete Umrežena karmelozanatrij, magnezijev stearat, mikrokristalična celuloza, silicijev dioksid.
English: Co-administration of Tybost and antiretroviral medicinal products Tybost must be co-administered with either atazanavir 300 mg once daily or with darunavir 800 mg once daily (see section 4.2).
Croatian: Istodobna primjena lijeka Tybost i antiretrovirusnih lijekova Tybost se mora istodobno primjenjivati ili s atazanavirom 300 mg jedanput na dan ili s darunavirom 800 mg jedanput na dan (vidjeti dio 4.2).
English: For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to serious and/or life-threatening events (see section 4.3).
Croatian: Za lijekove koji se metaboliziraju putem CYP3A te više koncentracije u plazmi mogu potencijalno uzrokovati ozbiljne i/ili po život opasne događaje (vidjeti dio 4.3).
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Croatian: • bosentan, lijek koji se primjenjuje za liječenje plućne arterijske hipertenzije
English: Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of therapeutic effect.
Croatian: Kontraindicirana je istodobna primjena s lijekovima koji su snažni induktori CYP3A zbog mogućeg gubitka terapijskog učinka.
English: For further details, consult the Summary of Product Characteristics for maraviroc.
Croatian: Za više pojedinosti proučiti sažetak opisa svojstava lijeka za maravirok.
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of cobicistat in HIV-1 infected subjects (n = 68), respectively, were 1.2 ± 0.3 µg/ml, 10.9 ± 3.8 µg•h/ml, and 0.07 ± 0.07 µg/ml.
Croatian: Srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže nakon višekratnih doza kobicistata u HIV-1 zaraženih ispitanika (n = 68) bile su 1,2 ± 0,3 μg/ml, 10,9 ± 3,8 μg•h/ml, odnosno 0,07 ± 0,07 μg/ml.
English: • salmeterol, a medicine used to treat asthma
Croatian: • salmeterol, lijek koji se primjenjuje za liječenje astme
English: All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Croatian: Svi kortikosteroidi osim onih koji se primjenjuju na koži Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
English: Atazanavir + cobicistat + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination was non-inferior in achieving HIV-1 RNA < 50 copies/ml when compared to atazanavir + ritonavir + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Croatian: Atazanavir + kobicistat + kombinacija fiksne doze emtricitabina i tenofovirdizoproksilfumarata nije bila inferiorna u postizanju HIV-1 RNK < 50 kopija/ml u usporedbi s atazanavir + ritonavir + kombinacija fiksne doze emtricitabina i tenofovirdizoproksilfumarata.
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir- or primary protease inhibitor-associated resistance substitutions.
Croatian: Od 19 bolesnika, 1 je razvio rezistentnu supstituciju M184V povezanu s emtricitabinom bez s tenofovirom povezanih rezistentnih supstitucija ili primarnih rezistentnih supstitucija povezanih s inhibitorima proteaze.
English: Concomitant use of cobicistat 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.
Croatian: Istodobnom primjenom kobicistata i kortikosteroida koji se metaboliziraju putem CYP3A (npr. flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju.
English: Tybost film-coated tablets are orange, round, biconvex tablets, debossed on one side with “GSI” and plain-faced on the other side of the tablet.
Croatian: Tybost filmom obložene tablete su narančaste, okrugle, bikonveksne tablete, s utisnutom oznakom „GSI“ na jednoj strani tablete i bez oznake na drugoj strani tablete.
English: See sections 4.2, 4.8 and 5.2.
Croatian: Vidjeti dijelove 4.2, 4.8 i 5.2.
English: Following oral administration of [14C]cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Croatian: Nakon peroralne primjene [14C]kobicistata 86% i 8,2% doze izolirano je u fecesu, odnosno urinu.
English: No dose adjustment of cobicistat is required for patients with renal impairment, including those with severe renal impairment.
Croatian: Nije potrebna prilagodba doze kobicistata za bolesnike s oštećenjem bubrega uključujući i one s teškim oštećenjem bubrega.
English: Co-administration with cobicistat may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk..
Croatian: Istodobna primjena kobicistata može dovesti do povećanih koncentracija DOAC-a u plazmi, što može dovesti do povećane opasnosti od krvarenja.
English: There are no or limited clinical data with cobicistat in pregnant women.
Croatian: Nema podataka ili su klinički podaci o primjeni kobicistata u trudnica ograničeni.
English: Dose of HIV-1 protease inhibitor
Croatian: Doza inhibitora proteaze HIV-1
English: • blood in the urine (haematuria)
Croatian: • krv u urinu (hematurija)
English: Co-administration is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena (vidjeti dio 4.4).
English: No human data on the effect of cobicistat on fertility are available.
Croatian: Nisu dostupni podaci o učinku kobicistata na plodnost u ljudi.
English: • atorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin, medicines used to lower cholesterol
Croatian: • atorvastatin, fluvastatin, pitavastin, pravastatin i rosuvastatin, lijekovi koji se primjenjuju za snižavanje kolesterola
English: • herbal products: St. John's wort (Hypericum perforatum)
Croatian: • biljni lijekovi: gospina trava (Hypericum perforatum).
English: Effects on estimated creatinine clearance
Croatian: Učinci na procijenjeni klirens kreatinina
English: Rilpivirine is not expected to affect the plasma concentration of cobicistat.
Croatian: Ne očekuje se da će rilpivirin utjecati na koncentraciju kobicistata u plazmi.
English: There are limited data from the use of cobicistat and atazanavir in pregnant women.
Croatian: Podaci o primjeni kobicistata i atazanavira u trudnica su ograničeni.
English: Treatment with cobicistat and darunavir during the second and third trimesters of pregnancy has been shown to result in lower darunavir exposure compared to postpartum.
Croatian: Pokazalo se da liječenje kobicistatom i darunavirom tijekom drugog i trećeg tromjesečja trudnoće rezultira manjom izloženošću darunaviru u usporedbi s onom nakon porođaja.
English: Week 144b
Croatian: 144. tjedanb
English: Medicinal products that are extensively metabolised by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in exposure when co-administered with cobicistat.
Croatian: Čini se da su lijekovi koji se opsežno metaboliziraju putem enzima CYP3A i podliježu visokom metabolizmu prvog prolaska najpodložniji većim povećanjima u ekspoziciji kad se istodobno primjenjuju s kobicistatom.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bočicu s 30 filmom obloženih tableta i 90 (3 bočice od 30) filmom obloženih tableta.
English: hyperglycaemia, increased appetite Psychiatric disorders:
Croatian: hiperglikemija, povećan apetit Psihijatrijski poremećaji: Često:
English: • antiarrhythmics: amiodarone, quinidine
Croatian: • antiaritmici: amiodaron, kinidin
English: • metformin, medicine used for the treatment of type 2 diabetes
Croatian: • metformin, lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2
English: Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Croatian: Kontraindicirana je istodobna primjena s lijekovima čiji klirens uvelike ovisi o CYP3A i kod kojih su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima.
English: Therefore, the use of Tybost is not recommended in these patients (see sections 4.2 and 5.2).
Croatian: Stoga se primjena lijeka Tybost ne preporučuje u tih bolesnika (vidjeti dijelove 4.2 i 5.2).
English: • another protease inhibitor
Croatian: • drugi inhibitor proteaze