natgillin/translations-raw huggingface dataset:
Versican Plus L4 is used to protect dogs against leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation). 
Versican Plus L4 se koristi za zaštitu pasa od leptospiroze, bakterijske bolesti koja se može prenijeti putem zaraženog urina, a rezultira krvarenjem, hepatitisom (upalom jetre) i žuticom ili nefritisom (upalom bubrega).
The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later. 
Cjepivo se primjenjuje u štenadi u dobi od šest tjedana u obliku supkutane injekcije i ponavlja se nakon četiri tjedna.
In 
Ubuduće ako se
Versican Plus L4 is a vaccine. 
Versican Plus L4 je cjepivo.
Other information about Versican Plus L4: 
Druge informacije o Versican Plus L4:
What is the risk associated with Versican Plus L4? 
Koji su rizici povezani s Versican Plus L4?
Versican Plus L4 is available as a suspension for injection. 
Dostupan je kao suspenzija za injekciju.
Why has Versican Plus L4 been approved? 
Zašto je Versican Plus L4 odobren?
What is Versican Plus L4? 
Što je Versican Plus L4?
What benefit has Versican Plus L4 shown during the studies? 
Koje koristi Versican Plus L4 su utvrđene tijekom ispitivanja?
What is Versican Plus L4 used for? 
Za što se Versican Plus L4 koristi?
How has Versican Plus L4 been studied? 
Kako se Versican Plus L4 ispitivao?
How does Versican Plus L4 work? 
Na koji način Versican Plus L4 djeluje?
≥ 40 to < 50 
≥ 40 do < 50
Date of first authorisation: 20 June 2019 
Datum prvog odobrenja: 20. lipnja 2019
Do not give Doptelet to people less than 18 years old. 
Nemojte davati Doptelet osobama mlađim od 18 godina.
Results are shown in Table 2. 
Rezultati su prikazani u Tablici 2.
The next dose should be taken at the usual time the next day. 
Sljedeću dozu treba uzeti u uobičajeno vrijeme sljedećeg dana.
EU/1/19/1373/001 EU/1/19/1373/002 
EU/1/19/1373/002
* Medical Dictionary for Regulatory Activities (MedDRA) version 19.1. 
* Medicinski rječnik za regulatorne poslove (MedDRA) verzija 19.1.
• Your doctor or pharmacist will tell you how many tablets to take and when to take them. 
• Vaš će Vam liječnik ili ljekarnik reći koliko tableta trebate uzeti i kada.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke .
• Swallow the tablets whole, once daily with food. 
• Tabletu progutajte cijelu, jedanput dnevno, s hranom.
Effect of transporting proteins 
Učinci transportnih proteina
System organ class (MedDRA terminology*) 
Klasifikacija organskih sustava (MedDRA terminologija*)
Reproductive and Developmental Toxicity 
Reproduktivna i razvojna toksičnost
If you take more Doptelet than you should 
Ako uzmete više Dopteleta nego što ste trebali
The safety and effectiveness of this medicine in this age group is not known. 
Sigurnost i djelotvornost ovog lijeka u toj dobnoj skupini nisu poznate.
Excretion in Milk 
Izlučivanje u mlijeku
Do not stop taking Doptelet unless your doctor tells you to. 
Nemojte prestati uzimati Doptelet osim ako Vam tako ne kaže liječnik.
What Doptelet is and what it is used for 
Što je Doptelet i za što se koristi
Doptelet contains lactose (a type of sugar). 
Doptelet sadrži laktozu (vrsta šećera).
This adverse reaction was assessed as non-serious. 
Procijenjeno je da ta nuspojava nije ozbiljna.
• low red blood cell count (anaemia) 
• nizak broj crvenih krvnih zrnaca (anemija)
This effect was not associated with inflammatory response or any evidence of erosion or ulcer formation. 
Ovaj učinak nije bio povezan s upalnim odgovorom ni bilo kojim dokazom erozije ili stvaranja ulkusa.
Doptelet is for oral use, and the tablets should be taken once daily with food (see section 5.2). 
Doptelet je namijenjen za peroralnu primjenu, a tablete treba uzimati jednom dnevno s hranom (vidjeti dio 5.2).
Other medicines and Doptelet 
Drugi lijekovi i Doptelet
What Doptelet looks like and contents of the pack 
Kako Doptelet izgleda i sadržaj pakiranja
A total of 24.8% of patients were ≥ 65 years of age, 4.6% ≥ 75 years of age, and only 1 (0.2%) ≥ 85 years of age. 
Ukupno je 24,8% bolesnika bilo ≥ 65 godina, 4,6% ≥ 75 godina, a samo 1 (0,2%) ≥ 85 godina.
Take Doptelet for as long as your doctor tells you. 
Doptelet uzimajte onoliko dugo koliko Vam kaže liječnik.
• Start taking Doptelet 10 to 13 days before your planned medical procedure. 
• Počnite uzimati Doptelet 10 do 13 dana prije planiranog medicinskog postupka.
• Take your missed dose as soon as you remember, then take your next dose at the usual time. 
• Propuštenu dozu uzmite čim se sjetite, a sljedeću dozu uzmite u uobičajeno vrijeme.
Frequencies are defined as: 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). 
Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
Talk to your doctor or pharmacist before taking Doptelet if: - you are at risk of blood clots in your veins or arteries, or members of your family have had blood clots. 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Doptelet ako: kod Vas postoji rizik od stvaranja krvnih ugrušaka u venama ili arterijama ili ako su članovi vaše obitelji imali ugruške.
Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding. 
Trombociti su krvne stanice koje pomažu u zgrušavanju krvi, pa time smanjuju ili sprječavaju krvarenje.
Co-administration with interferon preparations 
Istodobna primjena s pripravcima interferona
Dosing should begin 10 to 13 days prior to the planned procedure. 
Doziranje treba započeti 10 do 13 dana prije planiranog postupka.
Your doctor will help you decide whether the benefit of breast-feeding outweighs any possible risks to your baby while you are breast-feeding. 
Vaš će Vam liječnik pomoći odlučiti jesu li koristi od dojenja veće od mogućeg rizika za Vaše dijete dok dojite.
The tablets are supplied in cartons containing one aluminium blister. 
Tablete se isporučuju u kutijama koje sadrže po jedan aluminijski blister.
If a dose is missed, it should be taken as soon as it is remembered. 
Ako se doza propusti, treba je uzeti čim prije.
This medicine can pass into breast milk. 
Ovaj se lijek može prenijeti u majčino mlijeko.
• Talk to a doctor or pharmacist straight away. 
• Odmah razgovarajte s liječnikom ili ljekarnikom.
* at steady state, except for cyclosporine which was administered as a single dose 
* u stanju dinamičke ravnoteže, osim za ciklosporin koji je primjenjen u jednoj dozi
Doptelet works by helping to increase the number of platelets in the blood. 
Doptelet djeluje tako što pomaže povećati broj trombocita u krvi.
A risk to the breast-feeding child cannot be excluded. 
Ne može se isključiti rizik za dijete koje se doji.
The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%). 
Srednja vrijednoist poluvijeka eliminacije avatrombopaga iz plazme (%CV) je približno 19 sati (19%).
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Doptelet therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Dopteletom, uzimajući u obzir koristi dojenja za dijete i korist liječenja za ženu.
- you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6). 
ako ste alergični na avatrombopag ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Animal Toxicology and/or Pharmacology 
Toksikologija i/ili farmakologija u životinja
No metabolites of avatrombopag were detected in plasma. 
Nisu pronađeni metaboliti avatrombopaga u plazmi.
There are no data on the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production. 
Nema podataka o prisutnosti avatrombopaga u majčinu mlijeku, učincima na dojeno dijete ni učincima na stvaranje mlijeka.
Avatrombopag was present in the milk of lactating rats, see section 5.3. 
Avatrombopag je bio prisutan u mlijeku štakora, vidjeti dio 5.3.
Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX08 
Farmakoterapijska skupina: Antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX08 Mehanizam djelovanja
The safety and efficacy of avatrombopag in children aged less than 18 years have not been established. 
Pedijatrijska populacija Sigurnost i djelotvornost avatrombopaga u djece mlađe od 18 godina nisu još ustanovljene.
The patient should undergo their procedure 5 to 8 days after the last dose of avatrombopag. 
Bolesnik se treba podvrgnuti postupku 5. do 8. dan nakon zadnje doze avatrombopaga.
It belongs to a group of medicines called thrombopoietin receptor agonists. 
On pripada skupini lijekova koji se nazivaju agonisti receptora trombopoetina.
Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans. 
Želučani karcinoidi u glodavaca povezani s hipergastrinemijom se općenito smatraju niskog rizika ili važnosti za ljude.
Due to the limited information available, avatrombopag should only be used in Child-Pugh class C patients when the expected benefit outweighs the expected risks. 
Zbog ograničenih dostupnih informacija, avatrombopag se smije koristiti samo u bolesnika s Child Pugh stupnjem C kada je očekivana korist veća od očekivanih rizika.
Elderly No dose adjustment is required for patients aged 65 years and older (see section 5.2). 
Nisu potrebne prilagodbe doze u bolesnika u dobi od 65 godina i starijih (vidjeti dio5.2).
Poly(vinyl alcohol) (E1203) Talc (E553b) 
Poli(vinilni alkohol) (E1203) Talk (E553b)
• Doptelet is available in 20 mg tablets. 
• Doptelet je dostupan u tabletama od 20 mg.
What you need to know before you take Doptelet 3. 
Što morate znati prije nego počnete uzimati Doptelet
If you stop taking Doptelet 
Ako prestanete uzimati Doptelet
Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets. 
Blister (poliamidni i polivinilkloridni laminarni aluminijski film s folijom za protiskivanje od aluminija i polietilentereftalata) koji sadrži 10 ili 15 filmom obloženih tableta.
Doptelet has no or negligible influence on the ability to drive and use machines. 
Doptelet ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
There is no specific antidote for overdose with avatrombopag. 
Nema specifičnog antidota za predoziranje avatrombopagom.
Patient populations were similar between the low and high baseline platelet count cohorts, and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black. 
Populacija bolesnika je bila slična među skupinama s niskom i visokom početnom vrijednošću broja trombocita, a sastojala se od 66% muškaraca i 35% žena, s medijanom dobi 58 godina, te 61% bijelaca, 34% azijata i 3% crnaca.
No dosage adjustment is expected for these patients. 
Kod ovih se bolesnika ne očekuju prilagodbe doze.
The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2). 
Djelotvornost avatrombopaga je bila slična u raznim podskupinama za objedinjenu populaciju ispitivanja faze 3 (Ispitivanje 1 i Ispitivanje 2).
Effect of avatrombopag 
Učinak avatrombopaga
Based on the known metabolic profile of avatrombopag and the fact that only 6% of the dose is excreted in urine, the likelihood of effects of renal impairment on pharmacokinetics of avatrombopag is considered to be very low (see sections 4.2 and 4.8). 
Na temelju poznatog metaboličkog profila avatrombopaga i činjenice da se samo 6% doze izlučuje u urinu, smatra se kako je vjerojatnost učinka oštećenja bubrega na farmakokinetiku avatrombopaga vrlo mala (vidjeti dio 4.2 i 4.8).
No dose adjustment is recommended (see section 5.2). 
Ne preporučuje se prilagodba doze (vidjeti dio 5.2).
Duration of treatment Due to limited information, avatrombopag should not be taken for more than 5 days. 
Zbog ograničenih podataka, avatrombopag se ne smije uzimati duže od 5 dana.
Each film-coated tablet contains 120.8 mg of lactose monohydrate. 
Jedna filmom obložena tableta sadrži 120,8 mg laktoza hidrata.
Consider the potential increased thrombotic risk when administering Doptelet to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency). 
Uzmite u obzir moguće povećanje rizika od tromboze kod primjene Dopteleta u bolesnika s poznatim faktorima rizika za tromboemboliju, uključujući genski uvjetovana protrombotska stanja (faktor V Leiden, protrombin 20210A, deficijencija antitrombina ili deficijencija proteina C ili S).
Therefore, data from these animal studies do not fully model potential adverse effects related to platelet count increases due to avatrombopag in humans. 
Stoga podaci iz ovih ispitivanja na životinjama nisu potpuni model mogućih nuspojava povezanih s povećanjem broja trombocita uzrokovanog primjenom avatrombopaga u ljudi.
The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies. 
Smatralo se da su želučani karcinoidi vjerojatno nastali zbog produljene hipergastrinemije uočene u ispitivanjima toksičnosti.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Ispitivanja na životinjama su nedostatna za konačan zaključak o reproduktivnoj toksičnosti (vidi dio 5.3).
Avatrombopag has not been studied in patients with severe renal impairment (see section 5.2); however, given the short duration of treatment, no dose adjustment is recommended. 
Avatrombopag nije ispitan u bolesnika s teškim oštećenjem bubrega (vidjeti dio 5.2); no s obzirom na kratko trajanje liječenja ne preporučuju se prilagodbe doze.
Contains lactose, see leaflet for further information. 
Sadrži laktozu, za više informacija pogledajte uputu o lijeku.
• Your dose will depend on your platelet counts. 
• Vaša će doza ovisiti o broju tromobocita.
Responders were defined as patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomisation and up to 7 days following a scheduled procedure. 
Bolesnici s odgovorom definirani su kao bolesnici kojima nije trebala transfuzija trombocita niti bilo kakav drugi postupak za terapiju spasa (rescue) zbog krvarenja nakon randomizacije i do 7 dana nakon nekog od zakazanih postupaka.
The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%). 
Srednja vrijednost (%CV) klirensa avatrombopaga se procjenjuje na 6,9 l/h (29%).
Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.25-times the lowest approved dosage) to 80 mg (1.3-times the highest recommended dosage). 
Avatrombopag je pokazao farmakokinetiku proporcionalnu dozi nakon jedne doze od 10 mg (0,25-struka vrijednost najmanje odobrene doza) do 80 mg (1,3-struka vrijednost najviše preporučene doze).
The proportion of subjects not requiring a platelet transfusion or any rescue procedure for bleeding was generally similar across the various subgroups. 
Udio ispitanika kojima nije bila potrebna transfuzija trombocita ili neki drugi postupak za terapiju spasa zbog krvarenja bio je općenito sličan u svim podskupinama.
P-gp inhibitors 
Pgp inhibitori
Therefore, avatrombopag is recommended to be administered with food (see section 4.2). 
Stoga se preporučuje uzimanje avatrombopaga s hranom (vidi dio 4.2).
Doptelet contains lactose 
Doptelet sadrži laktozu
The pharmacokinetic parameters of avatrombopag in milk were similar to those in plasma with an exposure ratio of avatrombopag-related radioactivity (milk to plasma) of 0.94. 
Farmakokinetički parametri avatrombopaga u mlijeku bili su slični onima u plazmi uz omjer izlaganja radioaktivnosti povezanoj s avatrombopagom (mlijeko prema plazmi) od 0,94.
Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity. 
Avatrombopag ne potiče proizvodnju trombocita u miševa, štakora, majmuna ni pasa zbog specifičnosti jedinstvenog TPO receptora.
While the benefit-risk profile for procedures that were not specifically included in the clinical studies is likely to be comparable, the efficacy and safety of avatrombopag have not been established in major surgeries like laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs. 
Iako će profil koristi i rizika za postupke koji nisu bili posebno uključeni u klinička ispitivanja vjerojatno biti usporediv, djelotvornost i sigurnost avatrombopaga nisu utvrđene u većim kirurškim zahvatima poput laparotomije, torakotomije, otvorene operacije srca, kraniotomije ili uklanjanja organa.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 
Učinci su u nekliničkim ispitivanjima uočeni samo pri izloženosti koja se smatra dovoljno većom u odnosu na maksimalnu izloženost u ljudi, ukazujući na malu relevantnost za kliničku primjenu.
Of the 88% of drug-related material in the faeces, 77% was identified as parent (34%) and the 4-hydroxy metabolite (44%). 
Od 88% u stolici izlučene tvari lijeka, 77% su činili nepromijenjeni lijek (34%) i 4-hidroksi-metabolit (44%).
How to take Doptelet 
Kako uzimati Doptelet
The effect of avatrombopag on human fertility has not been established. 
Učinak avatrombopaga na plodnost u ljudi nije ustanovljen.
Doptelet is not expected to affect you being able to drive, cycle or use tools or machines. 
Ne očekuje se da će Doptelet utjecati na Vašu sposobnost vožnje automobila ili bicikla, odnosno korištenja strojeva ili alata.
Avatrombopag does not inhibit CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A, does not induce CYP1A, CYP2B6, CYP2C, and CYP3A, and weakly induces CYP2C8 and CYP2C9 in vitro. 
Avatrombopag ne inhibira CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A, ne inducira CYP1A, CYP2B6, CYP2C i CYP3A i slabo inducira CYP2C8 i CYP2C9 in vitro.
Thrombotic/thromboembolic events 
Trombotski/tromboembolijski događaji
If you forget to take Doptelet 
Ako ste zaboravili uzeti Doptelet
Doptelet was not studied in patients with prior thromboembolic events. 
Doptelet nije ispitivan u bolesnika s prethodnim tromboembolijskim događajima.
You should be scheduled to undergo your procedure 5 to 8 days after the last dose of Doptelet. 
Planiranom postupku trebate se podvrgnuti 5. do 8. dan nakon zadnje doze Dopteleta.
Eligible patients were scheduled to undergo their procedure (low bleeding risk procedures, such as endoscopy and colonoscopy (60.8%); moderate bleeding risk, such as liver biopsy and chemoembolization for HCC (17.2%); or high bleeding risk, such as dental procedures and radiofrequency ablation (22.1%)) 5 to 8 days after their last dose of treatment. 
Prikladni bolesnici trebali su biti podvrgnuti invazivnom postupku (postupci s niskim rizikom od krvarenja, poput endoskopije i kolonoskopije (60,8%), umjerenim rizikom od krvarenja, poput biopsije jetre ili kemoembolizacije za HCC (17,2%), ili postupci s visokim rizikom od krvarenja, poput stomatoloških postupaka i radiofrekvencijske ablacije (22,1%) od 5 do 8 dana nakon zadnje doze lijeka.
Avatrombopag is a substrate for P-glycoprotein (P-gp) mediated transport (see Table 3). 
Avatrombopag je supstrat za transport posredovan p-glikoproteinom (Pgp) (vidjeti Tablicu 3).
The severity of gastric lesions was dependent on the dose and duration of avatrombopag administration and showed a clear trend towards reversibility during the recovery period. 
Težina želučanih lezija ovisila je o dozi i trajanju primjene avatrombopaga te je pokazala jasan trend prema reverzibilnosti tijekom razdoblja oporavka.
Patients' MELD scores ranged from < 10 (37.5%), 10 to 14 (46.3%) and from > 14 to < 24 (16.2%), and included patients with CTP Class A (56.4%), Class B (38.1%), and Class C (5.6%). 
MELD rezultati u bolesnika su se kretali od < 10 (37,5%), od 10 do 14 (46,3%) i od > 14 do < 24 (16,2%) te uključivali bolesnike s CTP (Child-Turcotte-Pugh) A (56,4%), B (38,1%), i C (5,6%).
Patients with chronic liver disease are known to be at increased risk for thromboembolic events. 
U bolesnika s kroničnom bolešću jetre poznat je povećan rizik od tromboembolijskih događaja.
Patients were then randomised 2:1 to either avatrombopag or placebo. 
Bolesnici su zatim bili randomizirani u omjeru 2:1 na avatrombopag ili na placebo.
Each carton contains one blister of 10 or 15 film-coated tablets. 
Svaka kutija sadrži jedan blister s 10 ili 15 filmom obloženih tableta.
The primary toxicity of avatrombopag in pivotal repeated-dose studies was in the stomach at high doses with adequate safety margins when compared to the exposure at the maximum recommended human dose; these effects were reversible even in the chronic toxicity studies. 
Primarna toksičnost avatrombopaga u pivotalnim ispitivanjima ponavljanog doziranja bila je želučana toksičnost pri visokim dozama uz odgovarajuće sigurnosne margine u usporedbi s izloženošću maksimalnoj preporučenoj dozi za ljude; ovi su učinci bili reverzibilni čak i u ispitivanjima kronične toksičnosti.
Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1. 
Preosjetljivost na avatrombopag ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The recommended daily dose of avatrombopag is based on the patient's platelet count (see Table 1). 
Preporučena dnevna doza avatrombopaga temelji se na broju trombocita u bolesnika (vidjeti Tablicu 1).
Following administration of a single 20 mg 14C-avatrombopag dose to healthy male volunteers, 88% of the dose was recovered in faeces and 6% in urine. 
14C avatrombopaga od 20 mg u zdravih muških dobrovoljaca, 88% doze se izlučilo u stolici, a 6% u urinu.
Human studies demonstrated that the renal route is not a major pathway for either unchanged avatrombopag or its metabolite's elimination. 
Ispitivanja u ljudi su pokazala kako izlučivanje putem bubrega nije glavni put eliminacije nepromijenjenog avatrombopaga ni njegova metabolita.
In 4-week or longer repeated-dose toxicity studies, treatment-related gastric lesions were observed in mice, rats, and cynomolgus monkeys. 
U ispitivanjima toksičnosti ponovljenih doza tijekom 4 tjedna ili dulje, želučane lezije povezane s liječenjem su uočene u miševa, štakora i makaki majmuna.
However, there was a significant reduction (by approximately 50%) in the between- and within-subject variability of avatrombopag AUC and Cmax when administered with food (see sections 4.2 and 4.5). 
No došlo je do značajnog smanjenja (za oko 50%) interindividualno i intraindividualno u varijabilnosti AUC-a i Cmax avatrombopaga kad se uzima zajedno s hranom (vidjeti dio 4.2 i 4.5).
The oxidative metabolism of avatrombopag is mainly mediated by CYP2C9 and CYP3A4. 
Oksidativni metabolizam avatrombopaga se uglavnom posreduje preko CYP2C9 i CYP3A4.
It is unknown whether avatrombopag or its metabolites are excreted in human milk. 
Nije poznato izlučuje li se avatrombopag ili njegovi metaboliti u majčino mlijeko.
In animal studies, avatrombopag had no effect on male and female fertility or early embryogenesis in rats (see section 5.3). 
U ispitivanjima na životinjama avatrombopag nije imao učinka na plodnost u muškaraca i žena, kao ni na ranu embriogenezu u štakora (vidi dio 5.3).