FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.
Croatian: Mehanizam ovog smanjenja nije poznat (vidjeti dijelove 4.2 i 4.4.).
English: 12 weeks) than those observed historically in HIV infected, non-pregnant patients.
Croatian: 12 tjedana) od onih prethodno opaženih u bolesnica zaraženih HIV-om koje nisu bile trudne.
English: Table 2: Interactions between atazanavir and other medicinal products Medicinal products by therapeutic area
Croatian: Tablica 2: Interakcije između atazanavira i drugih lijekova Lijekovi prema terapijskom području
English: It is important that you take Atazanavir Krka with food (a meal or a substantial snack) as this helps the body absorb the medicine.
Croatian: Važno je da Atazanavir Krka uzimate s hranom (uz obrok ili obilniji međuobrok) jer to pomaže tijelu da apsorbira lijek.
English: How to store Atazanavir Krka Contents of the pack and other information
Croatian: Kako čuvati Atazanavir Krka Sadržaj pakiranja i druge informacije
English: AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Croatian: Srednja vrijednost AUC(0-∞) bila je 42% veća u bolesnika s oštećenjem funkcije jetre nego u zdravih ispitanika.
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir.
Croatian: Umjerena količina podataka u trudnica (između 300 i 1000 ishoda trudnoća) ukazuje da atazanavir nema toksične malformacijske učinke.
English: Difference estimatee [95% CI]
Croatian: Približna razlika [95% CI]
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Atazanavir Krka with food and drink
Croatian: Atazanavir Krka s hranom i pićem
English: Other interactions Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Interakcije između atazanavira i drugih lijekova navedene su u sljedećoj tablici (povišenje je označeno kao “↑”, sniženje kao “↓”, bez promjene kao “↔”).
English: Your doctor will discuss with you which combination of these medicines with Atazanavir Krka is best for you.
Croatian: Liječnik će razgovarati s Vama koja je kombinacija lijekova s lijekom Atazanavir Krka za Vas najbolja.
English: Atazanavir Krka is an antiviral (or antiretroviral) medicine.
Croatian: Atazanavir Krka je antivirusni (ili antiretrovirusni) lijek.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), obratite se svom liječniku prije nego što uzmete ovaj lijek.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE08.
Croatian: Farmakoterapijska skupina: antivirotici za sistemsku primjenu, inhibitori proteaze, ATK oznaka: J05AE08
English: Some people will need special care before or while taking Atazanavir Krka.
Croatian: Nekim će osobama trebati posebna skrb prije ili tijekom uzimanja lijeka Atazanavir Krka.
English: Caution is warranted and therapeutic concentration monitoring is recommended when available.
Croatian: Traži se oprez i preporučuje se praćenje terapijske koncentracije,
English: Switching to capsules from other formulations is encouraged as soon as patients are able to consistently swallow capsules.
Croatian: Preporučuje se prijelaz na kapsule s drugih formulacija čim bolesnici mogu pouzdano progutati kapsule.
English: When transitioning between formulations, a change in dose may be needed.
Croatian: Kada se prelazi na s jednog oblika na drugi, možda će biti potrebna promjena doze.
English: You must not take Atazanavir Krka with certain medicines.
Croatian: Ne smijete uzimati Atazanavir Krka s određenim lijekovima.
English: Your doctor should do blood tests prior you start Atazanavir Krka and during treatment.
Croatian: Vaš liječnik treba napraviti krvne pretrage prije početka liječenja lijekom Atazanavir Krka i tijekom liječenja.
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Croatian: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven
English: (See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Croatian: (Vidjeti dio 4.4 "Prekid primjene ritonavira samo pod restriktivnim uvjetima").
English: The use of Atazanavir Krka with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Croatian: Primjena lijeka Atazanavir Krka s ritonavirom može se uzeti u obzir tijekom trudnoće samo ako moguća korist opravdava mogući rizik.
English: Your doctor has prescribed Atazanavir Krka for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
Croatian: Liječnik Vam je propisao Atazanavir Krka zato što ste zaraženi HIV-om koji uzrokuje sindrom stečene imunodeficijencije (SIDA).
English: Caution should be used with medicinal products known to induce PR prolongations.
Croatian: Potreban je oprez kod primjene lijekova za koje se zna da produljuju PR interval.
English: that co-administration with famotidine is not recommended but if required, atazanavir without ritonavir should be administered either 2 hours after famotidine or 12 hours before.
Croatian: - ne preporučuje se istovremena primjena s famotidinom, ali ako je ona neophodna, atazanavir bez ritonavira treba primijeniti ili 2 sata nakon famotidina ili 12 sati prije njega.
English: Treatment of overdose with Atazanavir Krka should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Croatian: Liječenje predoziranja lijekom Atazanavir Krka treba se sastojati od općih potpornih mjera, uključujući praćenje vitalnih znakova i elektrokardiogram (EKG), te promatranja kliničkog stanja bolesnika.
English: Atazanavir Krka capsules may be used by adults and children 6 years of age and older.
Croatian: Atazanavir Krka kapsule mogu uzimati odrasli i djeca u dobi od 6 ili više godina.
English: a Atazanavir peak concentrations and AUCs were found to be approximately 26-40% higher during the postpartum period (4
Croatian: Utvrđeno je da su vršne koncentracije i AUC atazanavira približno 26-40% više tijekom postpartalnog razdoblja (4
English: Atazanavir Krka capsules must be taken with ritonavir and have to be taken with food.
Croatian: Atazanavir Krka kapsule moraju se uzimati s ritonavirom i treba ih uzimati s hranom.
English: Paediatric patients (at least 3 months of age and weighing at least 5 kg):
Croatian: Pedijatrijski bolesnici (u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg):
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Njemačka Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije lijeka u promet.
English: *Lack of pharmacokinetics interaction bounds 70-143% Effect on atazanavir and ritonavir exposure has not been studied.
Croatian: *Nedostatak veze farmakokinetičke interakcije 70-143% Nije ispitivan utjecaj na izloženost atazanaviru i ritonaviru.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom HIV-infekcijom (SIDA) i oportunističkom infekcijom u povijesti bolesti mogu se pojaviti znakovi i simptomi upale od prethodnih infekcija ubrzo nakon početka antiHIV liječenja.
English: In this way Atazanavir Krka reduces the risk of developing illnesses linked to HIV infection.
Croatian: Tako Atazanavir Krka smanjuje rizik od razvoja bolesti povezanih s HIV-infekcijom.
English: Frequency is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Croatian: Tablica 7: Ishodi djelotvornosti (pedijatrijski bolesnici u dobi od 6 godina do manje od 18 godina) u 48. tjednu (Ispitivanje AI424-020)
English: Atazanavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Croatian: Atazanvir treba primijeniti 2 sata prije ili 1 sat nakon antacida i puferiranih lijekova.
English: The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age.
Croatian: Klinički podaci iz ovog ispitivanja nisu prikladni da bi se podržala primjena atazanavir kapsula (s ritonavirom ili bez njega) u djece mlađe od 6 godina.
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of atazanavir is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Croatian: Pedijatrijska populacija Procjena farmakokinetike, sigurnosti, podnošljivosti i djelotvornosti atazanavira temelji se na podacima iz multicentričnog kliničkog ispitivanja otvorenog tipa AI424-020 koje je provedeno u bolesnika u dobi od 3 mjeseca do 21 godine.
English: The use of Atazanavir Krka in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Croatian: Primjena lijeka Atazanavir Krka u djece mlađe od 3 mjeseca i tjelesne težine manje od 5 kg nije ispitana zbog rizika od pojave ozbiljnih komplikacija.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, (RMP) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: As a result, greater peak to trough ratios are observed; however at recommended doses, geometric mean atazanavir exposures (cmin, cmax and AUC) in paediatric patients are expected to be similar to those observed in adults.
Croatian: Kao posljedica, opaženi su veći omjeri vršnih i najnižih vrijednosti no očekuje se da kod preporučenih doza, geometrijska srednja vrijednost i izloženosti atazanaviru (Cmin, Cmax i AUC) u pedijatrijskih bolesnika bude slična onoj primjećenoj u odraslih osoba.
English: Didanosine should be taken at the fasted state 2 hours after atazanavir taken with food.
Croatian: Didanozin treba uzeti natašte 2 sata nakon uzimanja atazanvira, koji se uzima s hranom.
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if atazanavir is coadministered with clarithromycin.
Croatian: Ne može se dati preporuka za sniženje doze; stoga je potreban oprez kad se atazanvir primjenjuje istovremeno s klaritromicinom.
English: It is not known whether atazanavir with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Croatian: Nije poznato hoće li atazanavir s ritonavirom primijenjen majci tijekom trudnoće pogoršati fiziološku hiperbilirubinemiju i dovesti do kernikterusa novorođenčeta i dojenčeta.
English: Per protocol analysise
Croatian: Analiza prema protokolu e
English: The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Croatian: Rizik od daljnjeg smanjenja izloženosti atazanaviru očekuje se kad se atazanavir daje s lijekovima za koje se zna da smanjuju izloženost atazanaviru (npr., tenofovirdizoproksil ili antagonisti H2-receptora).
English: - Liver problems may uncommonly happen.
Croatian: - Manje često se mogu pojavit problemi s jetrom.
English: * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Croatian: * Prijavljen je učinak atazanavira i ritonavira na prvu dozu glekaprevira i pibrentasvira.
English: Talk to your doctor immediately if you get dizzy, lightheaded or if you suddenly faint.
Croatian: Obratite se odmah liječniku ako osjećate omaglicu, ošamućenost ili se iznenada onesvijestite.
English: Ketoconazole and itraconazole should be used cautiously with atazanavir /ritonavir, high doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Croatian: Ketokonazol i itrakonazol treba primjenjivati s oprezom kad se daju s atazanvirom s ritonavirom; ne preporučuju se visoke doze ketokonazola i itrakonazola (>200 mg na dan).
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for other formulations).
Croatian: Provjerite tablicu doziranja za određeni oblik (vidjeti Sažetak opisa svojstava lijeka za te oblike).
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Croatian: 150 mg dvaput tjedno možda neće osigurati optimalnu izloženost rifabutinu, što će dovesti do rizika od razvoja rezistencije na rifampicin i neuspješnog liječenja.
English: What Atazanavir Krka is and what it is used for
Croatian: Što je Atazanavir Krka i za što se koristi
English: e)
Croatian: f)
English: Atazanavir Krka 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Croatian: Atazanavir Krka od 300 mg s ritonavirom od 100 mg možda neće osigurati dovoljnu izloženost atazanaviru, osobito kad djelovanje atazanavira ili cijelog terapijskog protokola može biti promijenjeno zbog rezistencije na lijek.
English: Take Atazanavir Krka capsules with food (a meal or a substantial snack).
Croatian: Uzimajte Atazanavir Krka kapsule s hranom (uz obrok ili obilniji međuobrok).
English: Other formulations of this medicine may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms).
Croatian: Drugi oblici ovog lijeka dostupni su za pedijatrijske bolesnike u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg (vidjeti relevantan Sažetak opisa svojstava lijeka za alternativne oblike).
English: Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is co- administered with atazanavir, based on these data.
Croatian: Budući da se pokazalo da niska doza ritonavira (100 mg dvaput na dan) nema značajan učinak na koncentraciju metadona, na temelju tih se podataka ne očekuje interakcija kod istovremene primjene metadona i atazanavira.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Krka.
Croatian: Inhibitori PDE5 koji se primjenjuju za liječenje erektilne disfunkcije: potreban je poseban oprez kad se propisuju inhibitori PDE5 (sildenafil, tadalafil ili vardenafil) za liječenje erektilne disfunkcije u bolesnika koji primaju Atazanavir Krka.
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, atazanavir /ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Croatian: Na temelju podataka dobivenih s drugim pojačanim inhibitorima proteaze i ketokonazola, gdje je AUC ketokonazola pokazivao trostruko povećanje, očekuje se da će atazanvir s ritonavirom povećati koncentraciju ketokonazola ili itrakonazola.
English: The content of the capsule is yellowishwhite to yellow-white powder.
Croatian: Sadržaj kapsule je žućkastobijeli do žutobijeli prašak.
English: Your doctor may adjust the dose of Atazanavir Krka according to your anti-HIV therapy.
Croatian: Liječnik će možda prilagoditi dozu lijeka Atazanavir Krka prema Vašoj anti-HIV terapiji.
English: G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
Croatian: A71, G73, V82, I84 i L90 (0-2, 3, 4 ili više) na početku.
English: During attempts to overcome the decreased exposure by increasing the dose of atazanavir or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Croatian: Tijekom pokušaja da se prevlada smanjena izloženost povećanjem doze atazanvira ili drugih inhibitora proteaze s ritonavirom, opažena je velika učestalost jetrenih reakcija.
English: Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Croatian: Antivirusno djelovanje in vitro: atazanavir u staničnoj kulturi ima anti-HIV-1 (uključujući sve ispitane skupine) i anti-HIV-2 djelovanje.
English: Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Croatian: Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNA ≥ 400 kopija/ml).
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).
Croatian: Potrebno je razmotriti sniženje doze glukokortikoida uz pažljivo praćenje lokalnih i sistemskih učinaka ili prebacivanje na glukokortikoid koji nije supstrat enzima CYP3A4 (npr.,
English: If the patient has developed SJS or DRESS associated with the use of Atazanavir Krka, Atazanavir Krka may not be restarted.
Croatian: Ako je bolesnik razvio SJS ili DRESS povezan s primjenom lijeka Atazanavir Krka, Atazanavir Krka se možda neće ponovno uvesti u terapiju.
English: See section 2 "Atazanavir Krka contains lactose monohydrate".
Croatian: Vidjeti dio 2. "Atazanavir Krka sadrži laktozu hidrat".
English: Protease inhibitors: The co-administration of atazanavir /ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Croatian: Inhibitori proteaze: Istovremena primjena atazanvira s ritonavirom i drugih inhibitora proteaze nije ispitana, ali pretpostavlja se da bi povećala izloženost drugim inhibitorima proteaze.
English: Co-administration of alfuzosin concentrations which can result in hypotension.
Croatian: Postoji mogućnost povišenih koncentracija alfuzosina koje mogu dovesti do hipotenzije.
English: In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with atazanavir oral powder of 80 weeks.
Croatian: U kliničkim ispitivanjima AI424-397 i AI424-451 u pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 11 godina, srednje trajanje liječenja atazanavir oralnim praškom iznosilo je 80 tjedana.
English: Children receiving Atazanavir Krka may require their heart to be monitored.
Croatian: Kod djece koja uzimaju Atazanavir Krka možda će biti potrebno pratiti rad srca.
English: 300 mg hard capsules:
Croatian: 300 mg tvrde kapsule:
English: - During this time, postpartum patients should follow the same dose recommendation as for non- pregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Croatian: - Tijekom ovog vremena, bolesnice u postpartalnom razdoblju trebaju nastaviti s istom dozom kakva se preporučuje bolesnicama koje nisu trudne, uključujući one koje istovremeno primaju lijekove za koje se zna da utječu na izloženost atazanaviru (vidjeti dio 4.5).
English: Each hard capsule contains 79.43 mg lactose monohydrate.
Croatian: Jedna tvrda kapsula sadrži 79,43 mg laktoza hidrata.
English: Patients should not breast-feed while taking Atazanavir Krka.
Croatian: Bolesnice ne smiju dojiti dok uzimaju Atazanavir Krka.
English: If an oral contraceptive is administered with atazanavir/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Croatian: Ako se oralna kontracepcija primjenjuje s atazanvirom s ritonavirom preporučje se da oralna kontracepcija sadrži najmanje 30 μg etinilestradiola i da se bolesnici istakne važnost redovitog uzimanja kontracepcije kod ovog kontracepcijskog režima.
English: 30 hard capsules
Croatian: 30 tvrdih kapsula
English: Renal impairment: in healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Croatian: Posebne populacije Oštećenje funkcije bubrega: U zdravih je ispitanika eliminacija neizmijenjenog atazanavira putem bubrega iznosila približno 7% primijenjene doze.
English: In clinical trial AI424-182 atazanavir /ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Croatian: U kliničkom je ispitivanju AI424-182 atazanavir/ritonavir (300/100 mg ili 400/100 mg) u kombinaciji sa zidovudinom/lamivudinom bio primijenjen u 41 trudnice tijekom drugog ili trećeg tromjesečja.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Croatian: Pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa) također je bila prijavljena prilikom imunološke reaktivacije; međutim, prijavljeno vrijeme do nastanka je jako varijabilno te ovi događaji mogu nastati puno mjeseci nakon početka liječenja.
English: Atazanavir concentrations were greatly decreased when coadministered with didanosine (buffered tablets) and stavudine.
Croatian: Koncentracije atazanavira jako su se smanjile kad je primijenjen istovremeno s didanozinom (puferirane tablete) i stavudinom.
English: Age/Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Croatian: Dob/Spol: Ispitivanje farmakokinetike atazanavira provedeno je u 59 zdravih muškaraca i žena
English: Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the cmax was within 11% of fasting values.
Croatian: Istovremena primjena s obrokom bogatim mastima nije utjecala na AUC atazanavira u odnosu na stanje natašte i Cmax je bio unutar 11%
English: Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received atazanavir capsules with ritonavir are presented in Table 7.
Croatian: Podaci o djelotvornosti opaženoj u 41 pedijatrijskog bolesnika u dobi od 6 godina do manje od 18 godina koji su primali atazanavir kapsule s ritonavirom prikazani su u tablici 7.
English: Atazanavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Croatian: Atazanvir se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Croatian: Ako primijetite ikakve simptome infekcije, odmah o tome obavijestite svog liječnika.