FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, flatulence uncommon pancreatitis acute, pancreatic enzymes increased
Croatian: Poremećaji probavnog sustava vrlo često proljev često povraćanje, mučnina, bol u abdomenu, distenzija abdomena, dispepsija, flatulencija manje često akutni pankreatitis, povišene vrijednosti gušteračnih enzima
English: If you vomit within 1 hour of taking the medicine, another dose of Symtuza should be taken with food as soon as possible.
Croatian: Ako povratite unutar sat vremena od uzimanja lijeka, trebate uzeti još jednu dozu lijeka Symtuza što je prije moguće, s hranom.
English: Darunavir and cobicistat
Croatian: Darunavir i kobicistat
English: Co-administration of tenofovir alafenamide with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Croatian: Očeukje se da će istodobna primjena tenofoviralafenamida i drugih lijekova koji inhibiraju P-gp (npr. kobicistata, ritonavira, ciklosporina) povećati apsorpciju i plazmatske koncentracije tenofoviralafenamida.
English: Based on theoretical considerations boceprevir may decrease darunavir and/or cobicistat plasma concentrations and adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide.
Croatian: Na temelju teorijskih razmatranja, boceprevir bi mogao sniziti plazmatske koncentracije darunavira i/ili kobicistata te štetno utjecati na unutarstaničnu aktivaciju i kliničku antivirusnu djelotvornost tenofoviralafenamida.
English: For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with Symtuza.
Croatian: Kod istodobne primjene ovih neuroleptika s lijekom Symtuza razmotrite smanjenje doze neuroleptika.
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Croatian: Trinaest posto (13%) doze emtricitabina pronađeno je mokraći u obliku tri metabolita.
English: ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Croatian: ANTIKOAGULANSI/INHIBITORI AGREGACIJE TROMBOCITA
English: No emergent resistance to E/C/F/TAF (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) was detected through Week 48.
Croatian: 48. tjedna nije opažena pojava rezistencije na E/K/F/TAF (elvitegravir/kobicistat/emtricitabin/ tenofoviralafenamid).
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Croatian: Darunavir pokazuje antivirusnu aktivnost in vitro protiv širokog raspona primarnih izolata virusa HIV-1 skupine M (A, B, C, D, E, F, G) i skupine O, uz vrijednosti EC50 u rasponu od < 0,1 do 4,3 nM.
English: No clinically relevant pharmacokinetic differences due to age have been identified for cobicistat, emtricitabine or tenofovir alafenamide in the age range ≤ 65 years.
Croatian: Nisu utvrđene klinički značajne dobno uvjetovane farmakokinetičke razlike za kobicistat, emtricitabin ni tenofoviralafenamid u rasponu dobi ≤ 65 godina.
English: Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, dronedarone, ivabradine, quinidine, ranolazine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - dapoxetine - domperidone - naloxegol - pimozide, quetiapine, sertindole, lurasidone (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Croatian: Istodobna primjena sa sljedećim lijekovima zbog mogućih ozbiljnih i/ili po život opasnih nuspojava (vidjeti dio 4.5): - alfuzozin - amiodaron, dronedaron, ivabradin, kinidin, ranolazin - kolhicin, kada se koristi u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije (vidjeti dio 4.5) - rifampicin - derivati ergota (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - dapoksetin - domperidon - naloksegol - pimozid, kvetiapin, sertindol, lurazidon (vidjeti dio 4.5) - triazolam, peroralno primijenjen midazolam (za mjere opreza pri parenteralnoj primjeni midazolama vidjeti dio 4.5) - sildenafil, kada se koristi za liječenje plućne arterijske hipertenzije, avanafil, simvastatin,
English: Week 48 and 96 Virologic Outcomes in EMERALD Trial Week 48
Croatian: Tablica 6: Virološki ishodi u 48. i 96. tjednu EMERALD ispitivanja 48. tjedan
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue of 2'-deoxycytidine.
Croatian: Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (engl. nucleoside reverse transcriptase inhibitor, NRTI) i nukleozidni analog 2'-doksicitidina.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (unusual infections due to a weakened immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started, including Symtuza.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom (SIDA) koji su već imali oportunističke infekcije (neuobičajene infekcije zbog oslabljenog imunološkog sustava) mogu se ubrzo nakon početka primjene lijeka za HIV, uključujući lijek Symtuza, pojaviti znakovi i simptomi upale od prijašnjih infekcija.
English: Methylergonovine
Croatian: Metilergonovin
English: The median increases from baseline were greater in the D/C/F/TAF group compared with the DRV/ cobicistat (COBI)+F/ tenofovir disoproxil fumarate (TDF) group at Week 48.
Croatian: Medijani povišenja od početnih vrijednosti bili su veći u skupini koja se liječila kombinacijom D/K/F/TAF nego u onoj koja je primala DRV/kobicistat (KOBI)+F/tenofovirdizoproksilfumarat (TDF) u 48. tjednu.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Croatian: Utjecaj teškog oštećenja jetrene funkcije (Child-Pugh stadij C) na farmakokinetiku kobicistata nije ispitivan.
English: The median terminal plasma half-life of cobicistat following administration of Symtuza is 3.6 hours.
Croatian: Medijan terminalnog poluvijeka kobicistata u plazmi nakon primjene lijeka Symtuza iznosi 3,6 sati.
English: Contact your doctor or nearest emergency department immediately for advice.
Croatian: Ako uzmete više lijeka Symtuza nego što ste trebali Odmah se za savjet obratite svom liječniku ili najbližoj hitnoj službi.
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Croatian: Izdvojeni virusi nisu mogli rasti u prisutnosti darunavira u koncentracijama iznad 400 nM. Virusi izdvojeni u tim uvjetima, koji su pokazivali smanjenu osjetljivost na darunavir (raspon: 23 - 50 puta), imali su 2 - 4 aminokiselinske supstitucije u genu proteaze.
English: The tablet core contains croscarmellose sodium, magnesium stearate, microcrystalline cellulose and colloidal silicon dioxide.
Croatian: Jezgra tablete sadrži umreženu karmelozunatrij, magnezijev stearat, mikrokristaličnu celulozu i koloidni silicijev dioksid.
English: • emtricitabine, an anti-HIV medicine known as a nucleoside reverse transcriptase inhibitor
Croatian: • emtricitabin, lijek za HIV poznat kao nukleozidni inhibitor reverzne transkriptaze
English: Using Cyst C as filtration marker, the median change in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI Cyst C) formula (N=22) was +4.4 mL/min/1.73 m² with D/C/F/TAF.
Croatian: Koristeći cistatin C kao biljeg filtracije utvrđeno je da je medijan promjene procijenjene brzine glomerularne filtracije izračunate jednadžbom CKD-EPI (eGFRCKD-EPI CystC) (N=22) iznosio +4,4 ml/min/1,73 m² uz D/K/F/TAF.
English: Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with Symtuza is not recommended.
Croatian: Ne preporučuje se istodobna primjena tadalafila za liječenje plućne arterijske hipertenzije i lijeka Symtuza.
English: Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed in patients with mild to moderate hepatic impairment.
Croatian: Nisu primijećene klinički važne promjene u farmakokinetici tenofovira u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije.
English: The bioavailability of all components of Symtuza was comparable to that when darunavir 800 mg, cobicistat 150 mg, and emtricitabine/tenofovir alafenamide 200/10 mg were co-administered as separate formulations; bioequivalence was established following single-dose administration under fed conditions in healthy subjects (N = 96).
Croatian: Bioraspoloživost svih sastavnica lijeka Symtuza bila je usporediva s onom kada su se darunavir u dozi od 800 mg, kobicistat u dozi od 150 mg i emtricitabin/tenofoviralafenamid u dozi od 200/10 mg primjenjivali istodobno kao zasebni lijekovi; bioekvivalentnost je utvrđena u zdravih ispitanika (N = 96) nakon primjene jedne doze na pun želudac.
English: Symtuza should not be used in paediatric patients below 3 years of age (see sections 4.2 and 5.3).
Croatian: Symtuza se ne smije primjenjivati u pedijatrijskih bolesnika mlađih od 3 godine (vidjeti dijelove 4.2 i
English: Symtuza and sofosbuvir, sofosbuvir/ledipasvir, or daclatasvir can be used concomitantly without dose adjustment
Croatian: Symtuza se može primjenjivati istodobno sa sofosbuvirom, kombinacijom sofosbuvir/ledipasvir ili daklatazvirom bez prilagodbe doze.
English: At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm
Croatian: Na početku ispitivanja medijan plazmatske vrijednosti HIV-1 RNK iznosio je 4,7 log10 kopija/ml, medijan broja CD4+ stanica 456 stanica/mm
English: • If you notice within 12 hours of the time you usually take Symtuza, you must take the tablet immediately, with food.
Croatian: • Ako primijetite da niste uzeli lijek unutar 12 sati od uobičajenog vremena uzimanja lijeka Symtuza, tabletu morate uzeti odmah s hranom.
English: OPIOID ANTAGONIST Naloxegol
Croatian: ANTAGONISTI OPIOIDA
English: • abnormal blood test results such as some tests for your kidney.
Croatian: • odstupanja u rezultatima krvnih pretraga, kao što su neke pretrage kojima se procjenjuje rad gušterače.
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4+-T lymphocytes.
Croatian: Antivirusna aktivnost tenofoviralafenamida protiv laboratorijskih i kliničkih izolata virusa HIV-1 iz skupine B ocjenjivala se na limfoblastoidnim staničnim linijama, mononuklearnim stanicama iz periferne krvi, primarnim monocitnim/makrofagnim stanicama i CD4+ T-limfocitima.
English: In the study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Croatian: Djelotvornost, sigurnost i farmakokinetika emtricitabina i tenofoviralafenamida ocjenjivale su se u otvorenom ispitivanju (GS-US-292-0106) u kojem je 50 prethodno neliječenih adolescenata zaraženih virusom HIV-1 primalo emtricitabin i tenofoviralafenamid (10 mg) zajedno s elvitegravirom i kobicistatom u tableti s fiksnom kombinacijom doza.
English: Included subjects who had HIV-1 RNA ≥ 50 copies/mL in the Week 48/96 window; subjects who discontinued early due to lack or loss of efficacy per investigator's assessment; subjects who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a HIV-1 RNA ≥ 50 copies/mL.
Croatian: Uključeni ispitanici koji su imali HIV-1 RNK ≥50 kopija/mL u rasponu oko 48./96. tjedna; ispitanici koji su prerano prekinuli liječenje radi nedostatka ili gubitka djelotvornosti prema procjeni ispitivača; ispitanici koji su prekinuli liječenje zbog drugih razloga osim nuspojava, smrti ili nedostatka ili gubitka djelotvornosti i u vrijeme prekida uzimanja lijeka su imali HIV-1 RNK ≥ 50 kopija/mL.
English: If a dose of Symtuza is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of Symtuza with food as soon as possible.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Symtuza i primijeti to unutar 12 sati od uobičajenog vremena uzimanja, treba ga uputiti da propisanu dozu lijeka Symtuza uzme što prije s hranom.
English: C]-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of [
Croatian: C]-darunavira pojačanog ritonavirom u dozi od 400/100 mg približno 79,5%
English: Croscarmellose sodium Magnesium stearate Cellulose, microcrystalline Silica, colloidal anhydrouse
Croatian: Karmelozanatrij, umrežena Magnezijev stearat Celuloza, mikrokristalična Silicijev dioksid, koloidni, bezvodni
English: Symtuza and antacids can be used concomitantly without dose adjustment.
Croatian: Symtuza se može primjenjivati istodobno s antacidima bez prilagodbe doze.
English: Caution should be used with co-administration of Symtuza and parenteral midazolam.
Croatian: Nužan je oprez pri istodobnoj primjeni lijeka Symtuza i parenteralno primijenjenog midazolama.
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate), 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 800 mg darunavira (u obliku darunaviretanolata), 150 mg kobicistata, 200 mg emtricitabina i 10 mg tenofoviralafenamida (u obliku tenofoviralafenamidfumarata).
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 μM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 μM).
Croatian: Emtricitabin je u staničnoj kulturi pokazao antivirusnu aktivnost protiv virusa HIV-1 iz skupina A, B, C, D, E, F i G (vrijednosti EC50 kretale su se u rasponu od 0,007 do 0,075 µM) i aktivnost protiv određenih sojeva virusa HIV-2 (vrijednosti EC50 kretale su se u rasponu od 0,007 do 1,5 µM).
English: If you vomit more than 1 hour after taking the medicine, then you do not need to take another dose of Symtuza until the next regularly scheduled time.
Croatian: Ako povratite nakon sat vremena od uzimanja lijeka, ne trebate uzeti još jednu dozu lijeka Symtuza prije sljedeće doze prema uobičajenom rasporedu.
English: Janssen-Cilag AB Tel: +46 8 626 50 00 jacse@its.jnj.com
Croatian: Janssen-Cilag AB Tfn: +46 8 626 50 00 jacse@its.jnj.com
English: It is not known whether darunavir, cobicistat, or tenofovir alafenamide are excreted in human milk.
Croatian: Nije poznato izlučuju li se darunavir, kobicistat ili tenofoviralafenamid u majčino mlijeko.
English: Janssen-Cilag A/S Tlf: +45 45 94 82 82 jacdk@its.jnj.com
Croatian: Danmark Janssen-Cilag A/S Tlf: +45 45 94 8282 jacdk@its.jnj.com
English: Amiodarone, dronedarone, ivabradine, quinidine, or ranolazine to treat certain heart disorders (e.g. abnormal heart rhythm)
Croatian: Namjena lijeka alfuzozin za liječenje povećane prostate amiodaron, dronedaron, ivabradin, kinidin ili ranolazin za liječenje određenih srčanih poremećaja (npr. nepravilnog srčanog ritma)
English: Thioridazine
Croatian: Tioridazin
English: • tenofovir alafenamide, an anti-HIV medicine known as a nucleotide reverse transcriptase inhibitor
Croatian: • tenofoviralafenamid, lijek za HIV poznat kao nukleotidni inhibitor reverzne transkriptaze
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Croatian: Tenofovir se unutar stanice naknadno fosforilira u farmakološki aktivan metabolit tenofovirdifosfat.
English: Concomitant use of salmeterol and Symtuza is not recommended.
Croatian: Ne preporučuje se istodobna primjena salmeterola i lijeka Symtuza.
English: Cobicistat is not expected to induce CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, or P-gp (MDR1).
Croatian: Ne očekuje se da će kobicistat inducirati CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1 ili P-gp (MDR1).
English: • abnormal blood test results such as some tests for your pancreas.
Croatian: • odstupanja u rezultatima krvnih pretraga, kao što su nalazi testova kojima se ocjenjuje rad bubrega.
English: Co-administration of domperidone with Symtuza is contraindicated.
Croatian: Istodobna primjena domperidona s lijekom Symtuza je kontraindicirana.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat, emtricitabine or tenofovir alafenamide.
Croatian: Nisu utvrđene klinički značajne spolom uvjetovane farmakokinetičke razlike za kobicistat, emtricitabin ni tenofoviralafenamid.
English: Based on theoretical considerations Symtuza is expected to increase concentrations of clonazepam (inhibition of CYP3A)
Croatian: Temeljeno na teorijskim postavkama očekuje se da će Symtuza povećati koncentracije klonazepama (CYP3A inhibicija)
English: Non-clinical data on darunavir reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Croatian: Neklinički podaci o darunaviru ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: Herbal products St. John's wort (Hypericum Perforatum)
Croatian: Biljni lijekovi Gospina trava (Hypericum perforatum)
English: Caution should be exercised when combining one of these anti-neoplastic agents with Symtuza.
Croatian: Potreban je oprez kada se neki od ovih antineoplastika kombinira s lijekom Symtuza.
English: In addition to the opportunistic infections, autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection, due to an improvement in the body's immune response.
Croatian: Nakon što započnete liječenje HIV infekcije, osim oportunističkih infekcija mogu se javiti i autoimuni poremećaji (kada imunološki sustav napada zdravo tjelesno tkivo) kao posljedica poboljšanog imunološkog odgovora.
English: No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Croatian: Nisu primijećene značajne razlike u farmakokinetici kobicistata između ispitanika s teškim oštećenjem bubrežne funkcije i zdravih ispitanika, što je u skladu s niskim stupnjem bubrežnog klirensa kobicistata.
English: How to store Symtuza
Croatian: Kako čuvati lijek Symtuza
English: Based on theoretical considerations DRV/COBI may increase ergot derivative exposure.
Croatian: Na temelju teorijskih razmatranja, DRV/KOBI može povisiti izloženost derivatima ergota.
English: common pruritus, urticaria uncommon angioedema rare drug reaction with eosinophilia and systemic symptoms a, Stevens-Johnson syndrome not known toxic epidermal necrolysis a, acute generalised exanthematous pustulosis
Croatian: često pruritus, urtikarija manje često angioedem rijetko reakcija na lijek praćena eozinofilijom i sistemskim simptomima a, Stevens-Johnsonov sindrom nepoznato toksična epidermalna nekroliza a, akutna generalizirana egzantematozna pustuloza Poremećaji mišićno-koštanog sustava i vezivnog tkiva često artralgija, mialgija manje često osteonekroza
English: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci o primjeni emtricitabina ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala te reproduktivne i razvojne toksičnosti.
English: In the Phase 3 trial of Symtuza in treatment-naïve patients, increases in serum creatinine and decreases in eGFRCG occurred at the first on-treatment assessment (Week 2) and remained stable through 96 weeks.
Croatian: Pri prvoj ocjeni tijekom liječenja (2. tjedan) u ispitivanju faze 3 lijeka Symtuza provedenom u prethodno neliječenih bolesnika zabilježen je porast vrijednosti serumskog kreatinina i pad eGFRCG, koji su nakon toga ostali stabilni do 96. tjedna.
English: HIV-1 RNA ≥ 50 copies/mL Virologic Failure Leading to Discontinuation Discontinued study drug due to other reasons and last available HIV-1 RNA ≥ 50 copies/mL
Croatian: HIV-1 RNK ≥ 50 kopija/mL Virološki neuspjeh - koji je doveo do prekida liječenja Virološki neuspjeh - prekid zbog drugih razloga i posljednja dostupna HIV-1 RNK ≥ 50 kopija/mL Nema viroloških podataka Razlozi
English: Subjects with ≥1 emergent RAM, n (%) Protease
Croatian: Ispitanici u kojih se pojavila ≥ 1 mutacija povezana s rezistencijom, n (%)
English: The mean baseline plasma HIV-1 RNA and the median baseline CD4+ cell count were 4.48 log10 copies/mL (SD = 0.61) and 453 x 10
Croatian: Srednja vrijednost početne vrijednosti HIV-1 RNK u plazmi bila je 4,48 log10 kopija/mL (SD = 0,61), a medijan početne vrijednosti broja CD4+ stanica 453 x 10
English: When used for birth control, non-hormonal contraception methods are recommended.
Croatian: Za zaštitu od začeća preporučuju se metode nehormonske kontracepcije. - etinilestradiol/drospirenon.
English: The combination of lurasidone, pimozide, quetiapine or sertindole and Symtuza is contraindicated (see section 4.3).
Croatian: Kombinacija lurazidona, pimozida, kvetiapina te sertindola i lijeka Symtuza je kontraindicirana (vidjeti dio 4.3).
English: The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
Croatian: Antivirusna aktivnost emtricitabina protiv laboratorijskih i kliničkih izolata virusa HIV-1 ocjenjivala se na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i mononuklearnim stanicama iz periferne krvi.
English: Ergotamine
Croatian: Ergotamin
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Croatian: Kobicistat se metabolizira oksidacijom posredovanom enzimima CYP3A (glavni put) i CYP2D6 (sporedni put) te ne prolazi glukuronidaciju.
English: Concomitant administration of Symtuza with dabigatran or ticagrelor is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Symtuza s dabigatranom ili tikagrelorom je kontraindicirana (vidjeti dio 4.3).
English: If a patient vomits more than 1 hour after taking the medicine, the patient does not need to take another dose of Symtuza until the next regularly scheduled time.
Croatian: Ako bolesnik povrati nakon sat vremena od uzimanja lijeka, ne treba uzeti još jednu dozu lijeka Symtuza prije sljedeće doze prema uobičajenom rasporedu.
English: Caution is warranted and clinical monitoring is recommended.
Croatian: Nalaže se oprez i preporučuje kliničko praćenje bolesnika.
English: In case a patient vomits within 1 hour of taking the medicine, another dose of Symtuza should be taken with food as soon as possible.
Croatian: U slučaju da bolesnik povrati unutar sat vremena nakon uzimanja lijeka, treba uzeti još jednu dozu lijeka Symtuza što prije, s hranom.
English: Concomitant use of everolimus and Symtuza is not recommended.
Croatian: Ne preporučuje se istodobna primjena everolimusa i lijeka Symtuza.
English: No teratogenic effects were observed in rats and rabbit developmental toxicity studies.
Croatian: U ispitivanjima toksičnosti za razvoj štakora i kunića nisu opaženi teratogeni učinci.