natgillin/translations-raw huggingface dataset:
Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Potreban je strog nadzor nuspojava povezanih s rifabutinom, uključujući neutropeniju i uveitis zbog očekivanog povećanja izloženosti dezacetilrifabutinu.
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.
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.
Discontinued study drug due to AE or deathd
Prekid primanja ispitivanog lijeka zbog nuspojava ili smrtid
Some examples include, but are not limited to, itraconazole, ketoconazole, and voriconazole (see Table 2).
Neki primjeri uključuju, ali nisu ograničeni na itrakonazol, ketokonazol i vorikonazol (vidjeti Tablicu 2).
Table 4: Pharmacokinetic parameters [mean ± SD (%CV)] of atazanavir in the pharmacokinetic sub-study of phase 3 Study GS-US-216-0114
Tablica 4: Farmakokinetički parametri [srednja vrijednost ± SD (%CV)] atazanavira u farmakokinetičkom podispitivanju ispitivanja faze 3 GS-US-216-0114
• anticonvulsants: carbamazepine, phenobarbital, phenytoin
• antikonvulzivi: karbamazepin, fenobarbital, fenitoin
Stopping Tybost and atazanavir or darunavir may reduce the success of future treatments prescribed by your doctor.
Prestanak uzimanja lijeka Tybost i atazanavira ili darunavira može smanjiti uspjeh budućih liječenja koja propiše
Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Maravirok je supstrat CYP3A i njegova se koncentracija u plazmi povećava kad se istodobno primjenjuje s potentnim inhibitorima CYP3A.
Some patients have reported dizziness when Tybost was taken with atazanavir or darunavir.
Neki su bolesnici prijavili omaglicu kad su lijek Tybost uzimali s atazanavirom ili darunavirom.
The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1.
Doze lijeka Tybost i istodobno primijenjenog inhibitora proteaze, atazanavira ili darunavira, prikazane su u Tablici 1.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu, koja sadrži 30 filmom obloženih tableta i sredstvo za sušenje (silika gel).
• sildenafil and vardenafil, medicines used to treat impotence, and tadalafil, a medicine used to treat impotence and pulmonary hypertension
• sildenafil i vardenafil, lijekovi koji se primjenjuju za liječenje impotencije i tadalafil, lijek koji se primjenjuje za liječenje impotencije i plućne hipertenzije
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.
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.
Tablet core Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide.
Jezgra tablete Umrežena karmelozanatrij, magnezijev stearat, mikrokristalična celuloza, silicijev dioksid.
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).
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).
For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to serious and/or life-threatening events (see section 4.3).
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).
• bosentan, a medicine used to treat pulmonary arterial hypertension
• bosentan, lijek koji se primjenjuje za liječenje plućne arterijske hipertenzije
Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of therapeutic effect.
Kontraindicirana je istodobna primjena s lijekovima koji su snažni induktori CYP3A zbog mogućeg gubitka terapijskog učinka.
For further details, consult the Summary of Product Characteristics for maraviroc.
Za više pojedinosti proučiti sažetak opisa svojstava lijeka za maravirok.
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.
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.
• salmeterol, a medicine used to treat asthma
• salmeterol, lijek koji se primjenjuje za liječenje astme
All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Svi kortikosteroidi osim onih koji se primjenjuju na koži Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
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.
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.
Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir- or primary protease inhibitor-associated resistance substitutions.
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.
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.
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.
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.
Tybost filmom obložene tablete su narančaste, okrugle, bikonveksne tablete, s utisnutom oznakom „GSI“ na jednoj strani tablete i bez oznake na drugoj strani tablete.
See sections 4.2, 4.8 and 5.2.
Vidjeti dijelove 4.2, 4.8 i 5.2.
Following oral administration of [14C]cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Nakon peroralne primjene [14C]kobicistata 86% i 8,2% doze izolirano je u fecesu, odnosno urinu.
No dose adjustment of cobicistat is required for patients with renal impairment, including those with severe renal impairment.
Nije potrebna prilagodba doze kobicistata za bolesnike s oštećenjem bubrega uključujući i one s teškim oštećenjem bubrega.
Co-administration with cobicistat may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk..
Istodobna primjena kobicistata može dovesti do povećanih koncentracija DOAC-a u plazmi, što može dovesti do povećane opasnosti od krvarenja.
There are no or limited clinical data with cobicistat in pregnant women.
Nema podataka ili su klinički podaci o primjeni kobicistata u trudnica ograničeni.
Dose of HIV-1 protease inhibitor
Doza inhibitora proteaze HIV-1
• blood in the urine (haematuria)
• krv u urinu (hematurija)
Co-administration is not recommended (see section 4.4).
Ne preporučuje se istodobna primjena (vidjeti dio 4.4).
No human data on the effect of cobicistat on fertility are available.
Nisu dostupni podaci o učinku kobicistata na plodnost u ljudi.
• atorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin, medicines used to lower cholesterol
• atorvastatin, fluvastatin, pitavastin, pravastatin i rosuvastatin, lijekovi koji se primjenjuju za snižavanje kolesterola
• herbal products: St. John's wort (Hypericum perforatum)
• biljni lijekovi: gospina trava (Hypericum perforatum).
Effects on estimated creatinine clearance
Učinci na procijenjeni klirens kreatinina
Rilpivirine is not expected to affect the plasma concentration of cobicistat.
Ne očekuje se da će rilpivirin utjecati na koncentraciju kobicistata u plazmi.
There are limited data from the use of cobicistat and atazanavir in pregnant women.
Podaci o primjeni kobicistata i atazanavira u trudnica su ograničeni.
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.
Pokazalo se da liječenje kobicistatom i darunavirom tijekom drugog i trećeg tromjesečja trudnoće rezultira manjom izloženošću darunaviru u usporedbi s onom nakon porođaja.
Week 144b
144. tjedanb
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.
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.
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.
Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bočicu s 30 filmom obloženih tableta i 90 (3 bočice od 30) filmom obloženih tableta.
hyperglycaemia, increased appetite Psychiatric disorders:
hiperglikemija, povećan apetit Psihijatrijski poremećaji: Često:
• antiarrhythmics: amiodarone, quinidine
• antiaritmici: amiodaron, kinidin
• metformin, medicine used for the treatment of type 2 diabetes
• metformin, lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2
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.
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.
Therefore, the use of Tybost is not recommended in these patients (see sections 4.2 and 5.2).
Stoga se primjena lijeka Tybost ne preporučuje u tih bolesnika (vidjeti dijelove 4.2 i 5.2).
• another protease inhibitor
• drugi inhibitor proteaze
The most frequently reported adverse reactions to cobicistat-boosted atazanavir were associated with elevated bilirubin levels (see Table 3).
Najčešće prijavljivane nuspojave na kobicistatom pojačani atazanavir bile su povezane s povišenim razinama bilirubina (vidjeti Tablicu 3).
Higher plasma concentrations of co-administered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions.
Više koncentracije istodobno primijenjenih lijekova u plazmi mogu za posljedicu imati povećane ili produljene terapijske učinke ili nuspojave.
Each tablet contains 59 micrograms sunset yellow FCF aluminium lake (E110).
Jedna tableta sadrži 59 mikrograma bojila sunset yellow FCF aluminium lake (E110).
PHOSPHODIESTERASE TYPE-5 (PDE-5) INHIBITORS Sildenafil
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistatboosted group and 9.0% in the ritonavir-boosted group.
Povećanje alanin aminotransferaze ili aspartat aminotransferaze za > 3 x GGN zabilježeno je u 12,8% ispitanika u skupini koja je primala kobicistatom pojačani lijek, odnosno u 9,0% ispitanika u skupini koja je primala ritonavirom pojačani lijek.
Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg + cobicistat 150 mg once daily or atazanavir 300 mg + ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Bolesnici su randomizirani u omjeru 1:1 kako bi primali ili atazanavir 300 mg + kobicistat 150 mg jednom dnevno ili atazanavir 300 mg + ritonavir 100 mg jednom dnevno, a svakom je primijenjen fiksni pozadinski režim koji sadrži tenofovirdizoproksilfumarat 300 mg i emtricitabin 200 mg primijenjen kao tableta kombinacije fiksne doze.
The effect of cobicistat on serum creatinine and eGFR in patients switching from ritonavir to cobicistat in Study GS-US-236-0118 was consistent with the effect in treatmentnaïve patients in Study GS-US-216-0114.
Učinak kobicistata na serumski kreatinin i eGFR u bolesnika koji su se prebacili s ritonavira na kobicistat u ispitivanju GS-US-236-0118 bio je u skladu s učinkom u bolesnika koji prethodno nisu bili liječeni u ispitivanju GS-US-216-0114.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Dokazano je da kobicistat smanjuje procijenjeni klirens kreatinina zbog inhibicije tubularne sekrecije kreatinina.
• difficulty sleeping, abnormal dreams, drowsiness, tiredness (fatigue)
• otežano spavanje, abnormalni snovi, omamljenost, umor.
How to store Tybost
Kako čuvati Tybost
Table 7: Virologic outcome of randomised treatment of Study GS-US-216-0114 at weeks 48 and Week 48a
Tablica 7: Virološki ishod randomiziranog liječenja u ispitivanju GS-US-216-0114 u 48. i 144. tjednu
Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure.
Liječenje kobicistatom i darunavirom tijekom trudnoće rezultirat će manjom izloženošću darunaviru.
• sedatives/hypnotics: orally administered midazolam, triazolam
• sedativi/hipnotici: midazolam primijenjen peroralno, triazolam.
Co-administration of cobicistat with medicinal products such as dihydroergotamine, ergotamine, ergometrine, orally administered midazolam, triazolam, amiodarone, quinidine, pimozide, lurasidone, alfuzosin, simvastatin, lovastatin, and sildenafil which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (see section 4.3).
Kontraindicirana je istodobna primjena kobicistata s lijekovima poput dihidroergotamina, ergotamina, ergometrina, peroralno primijenjenog midazolama, triazolama, amiodarona, kinidina, pimozida, lurasidona, alfuzozina, simvastatina, lovastatina i sildenafila čiji klirens uvelike ovisi o CYP3A i za koje su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima (vidjeti dio 4.3).
Adverse reactions for cobicistat-boosted atazanavir were consistent with the safety profile of ritonavirboosted atazanavir.
Nuspojave na kobicistatom pojačani atazanavir bile su u skladu sa sigurnosnim profilom ritonavirom pojačanog atazanavira.
Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Istodobna primjena s dabigatran eteksilatom, supstratom P-glikoproteina (P-gp) je kontraindicirana (vidjeti dio 4.5)
Tybost contains sunset yellow FCF aluminium lake which may cause allergic reactions.
Tybost sadrži bojilo sunset yellow FCF aluminium lake koje može uzrokovati alergijske reakcije.
When co-administration is necessary, it is recommended to start with a dose of atorvastatin 10 mg and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Kada je istodobna primjena neophodna, preporučuje se započeti s dozom atorvastatina od 10 mg i tritrirati na temelju kliničkog odgovora, uz istodobno praćenje zbog sigurnosnih razloga (npr. miopatija).
log10 copies/ml
≥ 50 kopija/ml.
When co-administration is necessary, do not exceed 10 mg rosuvastatin daily and clinical monitoring for safety (e.g. myopathy) is recommended.
Kada je istodobna primjena neophodna, doza ne bi smjela prelaziti 10 mg rosuvastatina na dan, a zbog sigurnosnih razloga (npr. miopatija) preporučuje se kliničko praćenje.
Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism.
Inhibicija metabolizma posredovanog CYP3A kobicistatom pojačava sistemsku izloženost supstratima CYP3A (kao što su atazanavir ili darunavir) koji imaju ograničenu peroralnu bioraspoloživost i kratki poluvijek zbog metabolizma ovisnog o CYP3A.
Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir (see sections 5.1 and 5.2).
Podaci o antivirusnoj djelotvornosti iz randomiziranih kontroliranih ispitivanja dostupni su za kobicistatom pojačani atazanavir, ali ne i za kobicistatom pojačani darunavir (vidjeti dijelove 5.1 i 5.2).
No dose adjustment of rilpivirine is required when atazanavir/cobicistat or darunavir/cobicistat are used concomitantly with rilpivirine.
Nije potrebna prilagodba doze rilpivirina kad se atazanavir/kobicistat ili darunavir/kobicistat primjenjuju istodobno s rilpivirinom.
Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir).
Tybost se ne smije započeti primjenjivati u bolesnika s klirensom kreatinina manjim od 70 ml/min ako jedan ili više istodobno primijenjenih lijekova zahtijeva prilagodbu doze na osnovi klirensa kreatinina (npr.emtricitabin, lamivudin, tenofovirdizoproksil ili adefovir).
Co-administration of Tybost with sildenafil for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Istodobna primjena lijeka Tybost i sildenafila za liječenje plućne arterijske hipertenzije je kontraindicirana (vidjeti dio 4.3).
Concomitant use contraindicated
Kontraindicirana istodobna primjena
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 ml/min).
Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu HIV-1 zaraženi, a koji imaju teško oštećenje funkcije bubrega (procijenjeni klirens kreatinina ispod 30 ml/min).
vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth Hepatobiliary disorders: Very common:
povraćanje, proljev, dispepsija, bol u abdomenu, distenzija abdomena, flatulencija, suha usta Poremećaji jetre i žuči: Vrlo često:
No teratogenic effects were observed in rats and rabbit developmental toxicity studies.
U ispitivanjima razvojne toksičnosti u štakora i kunića nisu opaženi teratogeni učinci.
Median baseline CD4+ cell count (range), cells/mm3
Medijan početnog broja stanica CD4+ (raspon), stanica/mm3
Darunavir 800 mg + ritonavir 100 mg once daily (n = 31)
Darunavir 800 mg + ritonavir 100 mg jednom dnevno (n = 31)
Plasma concentrations of these medicinal products may be increased when co-administered with cobicistat, resulting in reduced serum cortisol concentrations.
Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s kobicistatom, što dovodi do smanjenih koncentracija kortizola u serumu.
The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a phase 1 clinical Study GS-US-216-0115 in 31 healthy subjects that were administered darunavir 800 mg in combination with cobicistat 150 mg or ritonavir 100 mg, all once daily, for 10 days.
Farmakokinetički pojačavajući učinak kobicistata na darunavir procijenjen je u kliničkom ispitivanju faze 1 GS-US-216-0115 u 31 zdravog ispitanika kojima je primijenjen darunavir 800 mg u kombinaciji s kobicistatom 150 mg ili ritonavirom 100 mg, sve jednom dnevno tijekom 10 dana.
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with cobicistat.
Kobicistat reverzibilno inhibira MATE1, stoga se koncentracije metformina mogu povećati s istodobnom primjenom kobicistata.
Therefore, the use of Tybost is not recommended in these patients (see sections 4.4 and 5.2).
Stoga se primjena lijeka Tybost ne preporučuje u tih bolesnika (vidjeti dijelove 4.4 i 5.2).
Adverse reactions to cobicistat-boosted atazanavir during 144 weeks of clinical trial experience from Study GS-US-216-0114 are listed in Table 3, below, by body system organ class and frequency.
Nuspojave na kobicistatom pojačani atazanavir tijekom 144 tjedna iskustva kliničkih ispitivanja iz ispitivanja GS-US-216-0114 navedene su u Tablici 3, u nastavku, prema klasifikaciji sustava organa i učestalosti.
• apixaban, edoxaban, rivaroxaban and warfarin, medicines used to prevent and treat blood clots
• apiksaban, edoksaban, rivaroksaban i varfarin, lijekovi koji se primjenjuju za sprječavanje i liječenja krvnih ugrušaka
Co-administration of cobicistat with medicinal products that induce CYP3A is contraindicated or is not recommended (see sections 4.3 and 4.5) because decreased plasma concentrations of cobicistat could result in plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir or darunavir.
Istodobna primjena kobicistata s lijekovima koji induciraju CYP3A kontraindicirana je ili se ne preporučuje (vidjeti dijelove 4.3 i 4.5) jer smanjene koncentracije kobicistata u plazmi mogu za posljedicu imati razine kobicistata u plazmi koje nisu dostatne za postizanje odgovarajućeg farmakokinetičkog pojačanja atazanavira ili darunavira.
Pack sizes containing 1 bottle of 30 film-coated tablets or 3 bottles of 30 film-coated tablets.
Veličine pakiranja: 1 bočica s 30 filmom obloženih tableta ili 3 bočice od 30 filmom obloženih tableta.
Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long-term use.
Potrebno je uzeti u obzir alternativne kortikosteroide koji manje ovise o metabolizmu putem CYP3A, npr. beklometazon za intranazalnu ili inhalacijsku primjenu, osobito za dugoročnu primjenu.
 Tell your doctor if you are taking any of these HIV medicines.
 Obavijestite svog liječnika ako uzimate bilo koji od ovih lijekova.
Co-administration with Tybost may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors.
Koncentracije dabigatrana u plazmi mogu se povećati pri istodobnoj primjeni lijeka Tybost, s učinkom sličnim kao kod drugih jakih P-gp inhibitora.