FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
Slovenian: Študija je pokazala, da je zdravilo Stivarga podaljšalo skupni čas preživetja bolnikov, saj so bolniki, zdravljeni z zdravilom Stivarga, v povprečju živeli 10,6 meseca, bolniki, ki so prejemali placebo, pa 7,8 meseca.
English: Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.
Slovenian: Bolniki z gastrointestinalnim stromalnim tumorjem morajo pred zdravljenjem z zdravilom Stivarga preskusiti zdravljenje z imatinibom in sunitinibom, bolniki s hepatocelularnim karcinomom pa zdravljenje s sorafenibom.
English: The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.
Slovenian: Študija je pokazala, da je zdravilo Stivarga podaljšalo preživetje, saj so bolniki, zdravljeni s tem zdravilom, v povprečju živeli 6,4 meseca, bolniki, ki so prejemali placebo, pa 5 mesecev.
English: Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects.
Slovenian: Če se pri bolniku pojavijo določeni neželeni učinki, bo morda treba začasno ali trajno prekiniti zdravljenje ali zmanjšati odmerek.
English: For patients with HCC, this led to an improvement in the length of time patients lived.
Slovenian: Pri bolnikih s hepatocelularnim karcinomom je ob tem prišlo do podaljšanje preživetja.
English: This will help protect them against leptospirosis.
Slovenian: To jih pomaga zaščititi pred leptospirozo.
English: The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs.
Slovenian: Učinkovitost zdravila Versican Plus L4 so raziskali v terenski študiji, v katero so vključili 129 psov.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Versican Plus L4, veljavno po vsej Evropski uniji, izdala dne 31. julija 2014.
English: The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%.
Slovenian: Terenska študija je pokazala, da je po cepljenju z zdravilom Versican Plus L4 zaščitne ravni protiteles proti leptospiri razvilo od 59 do 96 % psov.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus L4 večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Slovenian: Najpogostejši neželeni učinek cepiva Versican Plus L4 (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.
English: The strains of Leptospira bacteria in Versican Plus L4 are killed (inactivated) so that they do not cause disease.
Slovenian: Sevi bakterij Leptospira v zdravilu Versican Plus L4 so uničeni (inaktivirani), tako da ne povzročajo bolezni.
English: Versican Plus L4 is a vaccine.
Slovenian: Versican Plus L4 je cepivo.
English: Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Slovenian: Versican Plus L4 je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktivirane (uničene) seve bakterij Leptospira (icterohaemorrhagiae, canicola, bratislava ter grippotyphosa).
English: For revaccination a single dose of Versican Plus L4 is required annually.
Slovenian: Za ponovno cepljenje je potreben enkraten odmerek cepiva Versican Plus L4 enkrat na leto.
English: When Versican Plus L4 is given to dogs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko psi prejmejo cepivo Versican Plus L4, imunski sistem živali prepozna bakterije kot „tujke“ ter začne proti njim tvoriti protitelesa.
English: the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Slovenian: kasneje izpostavljene bakterijam Leptospira, se lahko imunski sistem nanje hitreje odzove.
English: 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).
Slovenian: Zdravilo Versican Plus L4 se uporablja za zaščito psov pred leptospirozo, tj. bakterijsko boleznijo, ki se lahko prenaša z okuženim urinom in povzroči krvavitve, hepatitis (vnetje jeter) in zlatenico ali nefritis (vnetje ledvic).
English: Versican Plus L4 is available as a suspension for injection.
Slovenian: Zdravilo Versican Plus L4 je na voljo v obliki suspenzije za injiciranje.
English: Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Slovenian: Zdravilo Versican Plus L4 vsebuje dodatek (aluminijev hidroksid), ki spodbuja imunski odziv.
English: What benefit has Versican Plus L4 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Versican Plus L4 izkazalo med študijami?
English: What is the risk associated with Versican Plus L4?
Slovenian: Kakšna tveganja so povezana z zdravilom Versican Plus L4?
English: Other information about Versican Plus L4:
Slovenian: Druge informacije o zdravilu Versican Plus L4:
English: Why has Versican Plus L4 been approved?
Slovenian: Zakaj je bilo zdravilo Versican Plus L4 odobreno?
English: In
Slovenian: Če so živali
English: How has Versican Plus L4 been studied?
Slovenian: Kako je bilo zdravilo Versican Plus L4 raziskano?
English: What is Versican Plus L4 used for?
Slovenian: Za kaj se zdravilo Versican Plus L4 uporablja?
English: What is Versican Plus L4?
Slovenian: Kaj je zdravilo Versican Plus L4?
English: How does Versican Plus L4 work?
Slovenian: Kako zdravilo Versican Plus L4 deluje?
English: Date of first authorisation: 20 June 2019
Slovenian: Datum prve odobritve: 20. junija 2019
English: ≥ 40 to < 50
Slovenian: Od ≥ 40 do < 50
English: Racial or Ethnic Groups
Slovenian: Rasne ali etnične skupine
English: Results are shown in Table 2.
Slovenian: Rezultati so prikazani v preglednici 2.
English: • Your doctor or pharmacist will tell you how many tablets to take and when to take them.
Slovenian: • Vaš zdravnik ali farmacevt vam bo povedal, koliko tablet morate vzeti in kdaj.
English: The safety and effectiveness of this medicine in this age group is not known.
Slovenian: Varnost in učinkovitost tega zdravila v tej starostni skupini nista znani.
English: Do not give Doptelet to people less than 18 years old.
Slovenian: Zdravila Doptelet ne dajajte osebam, mlajšim od 18 let.
English: b Cochran-Mantel-Haenszel Test. c Wilcoxon Rank Sum Test.
Slovenian: b Cochran-Mantel-Haenszlov test. c Wilcoxonov test vsot rangov.
English: - The other ingredients are:
Slovenian: Druge sestavine zdravila so:
English: This medicine can pass into breast milk.
Slovenian: To zdravilo lahko prehaja v materino mleko.
English: Effect of transporting proteins
Slovenian: Učinek transportnih beljakovin
English: The next dose should be taken at the usual time the next day.
Slovenian: Naslednji odmerek mora vzeti naslednjega dne ob običajnem času.
English: What you need to know before you take Doptelet 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Doptelet 3.
English: Reproductive and Developmental Toxicity
Slovenian: Reproduktivna in razvojna toksičnost
English: Excretion in Milk
Slovenian: Izločanje v mleko
English: Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding.
Slovenian: Trombociti so krvne celice, ki pomagajo pri strjevanju krvi in tako zmanjšajo ali preprečijo krvavitev.
English: • Swallow the tablets whole, once daily with food.
Slovenian: • Tableto pogoltnite celo enkrat na dan s hrano.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke !
English: Your doctor will help you decide whether the benefit of breast-feeding outweighs any possible risks to your baby while you are breast-feeding.
Slovenian: Zdravnik vam bo pomagal pri odločitvi o tem, ali so koristi dojenja večje od kakršnih koli možnih tveganj za vašega otroka med dojenjem.
English: A risk to the breast-feeding child cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: No dosage adjustment is expected for these patients.
Slovenian: Za te bolnike ni predvidena prilagoditev odmerka.
English: The safety and efficacy of avatrombopag in children aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost avatrombopaga pri otrocih, starih manj kot 18 let, še nista bili dokazani.
English: Doptelet is for oral use, and the tablets should be taken once daily with food (see section 5.2).
Slovenian: Zdravilo Doptelet je namenjeno peroralni uporabi, tablete pa je treba jemati enkrat na dan s hrano (glejte poglavje 5.2).
English: In vitro studies suggest that avatrombopag is highly bound to human plasma proteins (> 96%).
Slovenian: Študije in vitro kažejo, da se avatrombopag močno veže na humane plazemske beljakovine (> 96%).
English: What Doptelet is and what it is used for 2.
Slovenian: Kaj je zdravilo Doptelet in za kaj ga uporabljamo 2.
English: 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.
Slovenian: Skupno je bilo 24,8% bolnikov starih ≥ 65 let, 4,6% ≥ 75 let in samo 1 (0,2%) bolnik ≥ 85 let.
English: Category
Slovenian: Kategorija
English: If a dose is missed, it should be taken as soon as it is remembered.
Slovenian: Če bolnik pozabi vzeti odmerek, ga mora vzeti takoj, ko se spomni.
English: Of the 88% of drug-related material in the faeces, 77% was identified as parent (34%) and the 4-hydroxy metabolite (44%).
Slovenian: Od 88% z zdravilom povezanih snovi v blatu so 77% identificirali kot matično učinkovino (34%) in 4-hidroksi presnovek (44%).
English: • Start taking Doptelet 10 to 13 days before your planned medical procedure.
Slovenian: • Zdravilo Doptelet začnite jemati od 10 do 13 dni pred načrtovanim medicinskim posegom.
English: Co-administration with interferon preparations
Slovenian: Sočasno dajanje s pripravki interferona
English: Do not stop taking Doptelet unless your doctor tells you to.
Slovenian: Z jemanjem zdravila Doptelet ne prenehajte, razen če vam to naroči zdravnik.
English: Each film-coated tablet contains 120.8 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 120,8 mg laktoze monohidrata.
English: System organ class (MedDRA terminology*)
Slovenian: Organski sistem (Izrazi po MedDRA*)
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX08
Slovenian: Farmakoterapevtska skupina: antihemoragiki, drugi sistemski hemostatiki, oznaka ATC: B02BX08 Mehanizem delovanja
English: Avatrombopag was present in the milk of lactating rats, see section 5.3.
Slovenian: Avatrombopag je bil prisoten v mleku doječih podgan, glejte poglavje 5.3.
English: Effect of avatrombopag
Slovenian: Učinek avatrombopaga
English: • Talk to a doctor or pharmacist straight away.
Slovenian: • Takoj se posvetujte z zdravnikom ali farmacevtom.
English: Dosing should begin 10 to 13 days prior to the planned procedure.
Slovenian: Odmerjanje je treba začeti od 10 do 13 dni pred načrtovanim posegom.
English: There are no data on the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production.
Slovenian: Podatki o prisotnosti avatrombopaga v materinem mleku, učinkih na dojenega dojenčka ali učinkih na nastajanje mleka niso na voljo.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zaviralci P-gp
English: This adverse reaction was assessed as non-serious.
Slovenian: Neželeni učinek je bil ocenjen kot neresen.
English: Other medicines and Doptelet
Slovenian: Druga zdravila in zdravilo Doptelet
English: • Take your missed dose as soon as you remember, then take your next dose at the usual time.
Slovenian: • Izpuščeni odmerek vzemite takoj, ko se spomnite, naslednjega pa ob običajnem času.
English: Animal Toxicology and/or Pharmacology
Slovenian: Toksikologija in/ali farmakologija pri živalih
English: The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%).
Slovenian: Srednja vrednost razpolovnega časa (%CV) izločanja avatrombopaga iz plazme je približno 19 ur (19%).
English: Doptelet contains lactose (a type of sugar).
Slovenian: Zdravilo Doptelet vsebuje laktozo (vrsta sladkorja).
English: This effect was not associated with inflammatory response or any evidence of erosion or ulcer formation.
Slovenian: Ta učinek ni bil povezan z vnetnim odzivom ali kakršnim koli znakom erozije oz. nastanka razjed.
English: 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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Doptelet, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: 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).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100);
English: • low red blood cell count (anaemia)
Slovenian: • majhno število rdečih krvničk (slabokrvnost)
English: The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies.
Slovenian: Karcinoidi želodca so bili verjetno posledica daljše hipergastrinemije, ugotovljene pri študijah toksičnosti.
English: The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2).
Slovenian: Učinkovitost avatrombopaga je bila podobna v vseh podskupinah za komulativno populacijo v študijah 3. faze (Študija 1 in Študija 2).
English: Adverse reactions are classified by Preferred Term and System Organ Class, and by frequency.
Slovenian: Neželeni učinki so razvrščeni glede na prednostne izraze, organski sistem in pogostnost.
English: 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%).
Slovenian: Pri bolnikih so točke po MELD znašale od < 10 (37,5%), od 10 do 14 (46,3%) in od > 14 do < 24 (16,2%), vključeni pa so bili bolniki razreda A (56,4%), razreda B (38,1%) in razreda C (5,6%) po CTP.
English: Take Doptelet for as long as your doctor tells you.
Slovenian: Zdravilo Doptelet jemljite tako dolgo, kot vam je naročil zdravnik.
English: Doptelet works by helping to increase the number of platelets in the blood.
Slovenian: Zdravilo Doptelet deluje tako, da pomaga povečati število trombocitov v krvi.
English: Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets.
Slovenian: Pretisni omot (aluminijev film, prevlečen s poliamidom in polivinilkloridom, s pretisno aluminijevo ali polietilensko tereftalatno folijo), ki vsebuje 10 ali 15 filmsko obloženih tablet.
English: What Doptelet is and what it is used for
Slovenian: Kaj je zdravilo Doptelet in za kaj ga uporabljamo
English: Therefore, avatrombopag is recommended to be administered with food (see section 4.2).
Slovenian: Zato je priporočljivo dajanje avatrombopaga skupaj s hrano (glejte poglavje 4.2).
English: The proportion of subjects not requiring a platelet transfusion or any rescue procedure for bleeding was generally similar across the various subgroups.
Slovenian: Delež preiskovancev, pri katerih ni bila potrebna transfuzija trombocitov oz. nikakršen rešilni poseg zaradi krvavitve, je bil na splošno podoben v vseh podskupinah.
English: Duration of treatment Due to limited information, avatrombopag should not be taken for more than 5 days.
Slovenian: Zaradi pomanjkanja podatkov se avatrombopaga ne sme jemati več kot 5 dni.
English: In animal studies, avatrombopag had no effect on male and female fertility or early embryogenesis in rats (see section 5.3).
Slovenian: Pri študijah na živalih avatrombopag ni vplival na plodnost samcev in samic ali na zgodnjo embriogenezo pri podganah (glejte poglavje 5.3).
English: 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.
Slovenian: Stopnja resnosti želodčnih lezij je bila odvisna od odmerka in trajanja zdravljenja z avatrombopagom, med obdobjem okrevanja pa se je pokazala jasna tendenca k reverzibilnosti.
English: 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.
Slovenian: Avatrombopag in vitro ne zavira CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A, ne inducira CYP1A, CYP2B6, CYP2C in CYP3A ter blago inducira CYP2C8 in CYP2C9.
English: 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.
Slovenian: Pred začetkom jemanja zdravila Doptelet se posvetujte z zdravnikom ali farmacevtom: če pri vas obstaja tveganje za nastanek krvnih strdkov v venah ali arterijah ali je kateri od vaših družinskih članov v preteklosti imel krvne strdke.
English: The tablets are supplied in cartons containing one aluminium blister.
Slovenian: Tablete so dobavljene v škatlah z enim aluminijevim pretisnim omotom.
English: If you take more Doptelet than you should
Slovenian: Če ste vzeli večji odmerek zdravila Doptelet, kot bi smeli
English: The exposures (AUC) at doses that showed no gastric lesions across the species were 3- to 33-fold higher than the exposures in humans at the maximum recommended human dose (MRHD).
Slovenian: Izpostavljenost (AUC) pri odmerkih, pri katerih se pri nobeni vrsti niso pojavile želodčne lezije, je bila od 3- do 33-krat večja kot pri izpostavljenosti pri ljudeh ob največjem priporočenem odmerku za človeka (MRHD).
English: Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
Slovenian: Zdravljenje bolnikov s hudo okvaro jeter mora biti v skladu s klinično prakso podprto z natančnim spremljanjem glede pojava zgodnjih znakov poslabšanja bolezni ali novega nastopa hepatične encefalopatije, ascitesa in nagnjenosti k trombozi ali h krvavitvi, s spremljanjem vrednosti testov delovanja jeter, vrednosti testov za oceno stanja strjevanja krvi in po potrebi s slikanjem portalnega žilja.
English: Patients with chronic liver disease are known to be at increased risk for thromboembolic events.
Slovenian: Znano je, da pri bolnikih s kronično boleznijo jeter obstaja večje tveganje za tromboembolične dogodke.
English: • Doptelet is available in 20 mg tablets.
Slovenian: • Zdravilo Doptelet je na voljo v obliki 20 mg tablet.
English: Therefore, data from these animal studies do not fully model potential adverse effects related to platelet count increases due to avatrombopag in humans.
Slovenian: Zato podatki iz študij na teh živalih ne predstavljajo dobre podlage za možne neželene učinke, povezanih s povečanjem števila trombocitov zaradi avatrombopaga pri ljudeh.
English: 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.
Slovenian: Populacije bolnikov so bile pri kohorti z majhnim številom trombocitov ob izhodišču in kohorti z velikim številom trombocitov ob izhodišču enake, sestavljalo pa jih je 66% moških in 35% žensk; mediana starosti je bila 58 let ter 61% bele, 34% azijske in 3% črne rase.
English: In a multiple-dose pharmacokinetic study in healthy volunteers, steady state was reached by day 5 of dosing.
Slovenian: V farmakokinetični študiji z več odmerki, v katero so bili vključeni zdravi prostovoljci, je bilo stanje dinamičnega ravnovesja doseženo do 5. dne odmerjanja.
English: The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%).
Slovenian: Ocenjeno je bilo, da znaša srednja vrednost (%CV) očistka avatrombopaga 6,9 l/uro (29%).
English: • Your dose will depend on your platelet counts.
Slovenian: • Vaš odmerek je odvisen od vašega števila trombocitov.
English: 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.
Slovenian: Po enkratnem odmerku 20 mg 14C-avatrombopaga se je pri zdravih odraslih prostovoljcih 88% prejetega odmerka izločilo z blatom, 6% pa z urinom.
English: Doptelet 20 mg film-coated tablets are pale yellow, round, rounded on the upper and lower side, marked with “AVA” imprinted on one side and “20” on the other.
Slovenian: Filmsko obložene tablete Doptelet 20 mg so bledo rumene, okrogle, zaobljene na zgornji in spodnji strani, z vtisnjeno oznako »AVA« na eni strani in »20« na drugi.
English: Table 3: Drug interactions: Changes in pharmacokinetics of avatrombopag in the presence of co-administered drug
Slovenian: Preglednica 3: Medsebojno delovanje zdravil: spremembe farmakokinetičnih lastnosti avatrombopaga ob prisotnosti sočasno uporabljenega zdravila
English: Avatrombopag is a substrate for P-glycoprotein (P-gp) mediated transport (see Table 3).
Slovenian: Avatrombopag je substrat za prenos s p-glikoproteinom (P-gp) (glejte preglednico 3).
English: Concomitant use of avatrombopag with P-gp inhibitors resulted in alterations in exposure that were not clinically significant.
Slovenian: Sočasna uporaba avatrombopaga z zaviralci P-gp je povzročila spremembe izpostavljenosti, ki niso bile klinično pomembne.
English: 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.
Slovenian: Ker je na voljo le malo podatkov, se lahko avatrombopag pri bolnikih razreda C po Child-Pughovi lestvici uporablja samo, če so pričakovane koristi večje od pričakovanih tveganj.
English: 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.
Slovenian: V ključnih študijah s ponavljajočimi se odmerki je do glavnega toksičnega učinka avatrombopaga prišlo v želodcu pri velikih odmerkih z ustrezno varnostno mejo v primerjavi z izpostavljenosti pri največjem priporočenem odmerku za človeka; tudi v študijah kronične toksičnosti so bili ti učinki reverzibilni.