natgillin/translations-raw huggingface dataset:
Tapering for tri-lineage (white blood cells, red blood cells, and platelets) responders For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of eltrombopag may be reduced by 50%.
Kod bolesnika koji postignu odgovor u sve tri loze, uključujući transfuzijsku neovisnost, koji traje najmanje 8 tjedana: doza eltrombopaga može se smanjiti za 50%.
In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) occurred more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
U 2 kontrolirana klinička ispitivanja trombocitopeničnih bolesnika s HCV-om, dekompenzacija jetre (ascites, hepatička encefalopatija, krvarenje iz varikoziteta, spontani bakterijski peritonitis) pojavila se češće u skupini koja je primala eltrombopag (11%) nego u skupini koja je primala placebo (6%).
After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 2 weeks should be observed before increasing the dose.
Nakon započinjanja liječenja eltrombopagom u bolesnika s oštećenjem jetre, bolesnika je potrebno pratiti u razdoblju od 2 tjedna prije povećavanja doze.
Patients should be closely monitored for signs and symptoms of TEE.
Bolesnike treba pažljivo pratiti zbog moguće pojave znakova i simptoma TED.
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije manje često opekline od sunca
Also there was no effect on embryofoetal development in rabbits at doses up to 150 mg/kg/day, the highest dose tested (0.3 to 0.5 times the human clinical exposure in ITP patients at 75 mg/day and HCV patients at 100 mg/day, based on AUC).
Također nije bilo učinka na embriofetalni razvoj zečeva u dozama do 150 mg/kg/dan, najvišoj testiranoj dozi (0,3 do 0,5 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i bolesnika s HCV-om pri dozi od 100 mg/dan,temeljeno na AUC).
Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets
Revolade 12,5 mg filmom obložene tablete Revolade 25 mg filmom obložene tablete Revolade 50 mg filmom obložene tablete Revolade 75 mg filmom obložene tablete
FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Nakon toga, KKS uključujući broj trombocita, te razmaz periferne krvi treba kontrolirati jednom mjesečno.
At poorly tolerated doses in rats and dogs (>10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and>4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short-term studies.
U slabo podnošljivim dozama u štakora i pasa (>10 ili 7 puta kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i >4 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjereno AUC-om) zabilježeni su smanjen broj retikulocita i regenerativna eritroidna hiperplazija koštane srži (samo u štakora) tijekom kratkoročnih studija.
Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo) (see section 4.4).
Tromboza portalne vene bio je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na < 1% za placebo) (vidjeti dio 4.4).
Chronic hepatitis C associated thrombocytopenia studies
Ispitivanja kroničnog hepatitisa C povezanog s trombocitopenijom
• increase in bilirubin (a substance produced by the liver)
• povišeni bilirubin (tvar koju proizvodi jetra)
It is not known whether eltrombopag increases the risk of cytogenetic abnormalities in patients with SAA.
Nije poznato povećava li eltrombopag rizik od citogenetskih abnormalnosti u bolesnika s teškom aplastičnom anemijom.
Common Sleep disorder, depression Uncommon Apathy, mood altered, tearfulness
Psihijatrijski poremećaji često poremećaji spavanja, depresija manje često apatija, promjene raspoloženja, plačljivost
• joint pain, back pain, bone pain, pain in the hands or feet, muscle spasms
• bol u zglobovima, leđima, kostima, rukama ili nogama, grčevi u mišićima
• swelling, pain, heat, redness, or tenderness in one leg
• oticanja, boli, vrućine, crvenila ili osjetljivosti jedne noge
Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo).
Tromboza portalne vene bila je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na <1% za placebo).
The following side effects have been reported to be associated with treatment with Revolade in patients with severe aplastic anaemia (SAA):
Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u bolesnika s teškom aplastičnom anemijom:
5.2 Pharmacokinetic properties
5.2 Farmakokinetička svojstva Farmakokinetika
Eltrombopag should be initiated at a dose of 25 mg once daily.
Liječenje eltrombopagom treba započeti dozom od 25 mg jednom dnevno.
Caution is required when administering eltrombopag to patients with hepatic disease.
Potreban je oprez kod primjene eltrombopaga u bolesnika s bolešću jetre.
The most common adverse reactions in paediatric ITP patients 1 year and older (≥3% and greater than placebo) were upper respiratory tract infection, nasopharyngitis, cough, pyrexia, abdominal pain, oropharyngeal pain, toothache and rhinorrhoea.
Najčešće nuspojave u pedijatrijskih bolesnika s ITP-om u dobi od 1 i više godina (≥ 3% i više od placeba) bile su infekcija gornjeg dijela dišnog sustava, nazofaringitis, kašalj, pireksija, bol u abdomenu, orofaringealna bol, zubobolja i rinoreja.
How to store Revolade
Kako čuvati Revolade
The most common adverse reactions occurring in at least 10% of patients included headache, anaemia, decreased appetite, cough, nausea, diarrhoea, hyperbilirubinaemia, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and oedema.
Najčešće nuspojave koje su se pojavile u najmanje 10% bolesnika uključivale su glavobolju, anemiju, smanjeni apetit, kašalj, mučninu, proljev, hiperbilirubinemiju, alopeciju, svrbež, mialgiju, pireksiju, umor, bolest sličnu gripi, asteniju, zimicu i edeme.
The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment (see section 4.4).
Moguća je pojava trombocitopenije nakon prestanka liječenja (vidjeti dio 4.4).
The long-term safety of eltrombopag should be considered prior to starting therapy.
Prije uvođenja terapije treba razmotriti dogotrajnu sigurnost eltrombopaga.
The most common adverse reactions occurring in at least 10% of patients included headache, dizziness, cough, oropharyngeal pain, nausea, diarrhoea, abdominal pain, transaminases increased, arthralgia, pain in extremity, fatigue and pyrexia.
Najčešće nuspojave koje su se pojavile u najmanje 10% bolesnika uključivale su glavobolju, omaglicu, kašalj, orofaringealnu bol, mučninu, proljev, bol u abdomenu, porast transaminaza, artralgiju, bol u ekstremitetima, umor, i pireksiju.
There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy (see sections 4.4 and 4.8).
U trombocitopeničnih bolesnika s uznapredovalom kroničnom bolešću jetre koji su na liječenju eltrombopagom, bilo tijekom priprema za invazivne zahvate ili u bolesnika s HCV-om na antivirusnom liječenju, postoji povišen rizik od štetnih događaja, uključujući dekompenzaciju jetre i tromboembolijske događaje (vidjeti dijelove 4.4 i 4.8).
Based on estimates from the population pharmacokinetic analysis, female ITP patients had approximately 23% higher plasma eltrombopag AUC(0-) as compared to male patients, without adjustment for body weight differences.
Na temelju procjena iz spomenute analize, žene s ITP-om imale su otprilike 23% više plazmatske vrijednosti AUC(0-) eltrombopaga u odnosu na muškarce, a bez prilagođavanja obzirom na tjelesnu težinu.
Increase daily dose by 25 mg to a maximum of 100 mg/day.
Povećati dnevnu dozu za 25 mg do maksimalno 100 mg/dan.
†, dysuria
†, dizurija
Other liver problems (bile not flowing properly) are uncommon and may affect up to 1 in 100 people.
Ostale jetrene tegobe (otežan protok žuči) su manje česte nuspojave koje se mogu javiti u do 1 na 100 osoba.
The suspension should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Suspenziju treba uzeti barem dva sata prije ili četiri sata nakon bilo kojeg pripravka kao što su antacidi, mliječni proizvodi (ili druge vrste hrane koje sadrže kalcij), nadomjesni preparati minerala koji sadrže polivalentne katione (npr. željezo, kalcij, magnezij, aluminij, selen i cink) (vidjeti dijelove 4.5 i 5.2).
Signs of bone marrow changes may show up as abnormal results in your blood tests.
Znakovi promjena na koštanoj srži mogu se očitovati kao poremećeni rezultati krvnih pretraga.
However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased preand post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Međutim pri dozama toksičnim za ženku štakora od 60 mg/kg/dan (6 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i 3 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan temeljeno na AUC), primjena eltrombopaga je bila povezana s letalitetom embrija (povišeni pre- i post-implantacijski gubitak), smanjenjem fetalne tjelesne težine i težine gravidnog uterusa u studiji plodnosti ženki te niskom incidencijom cervikalnih rebara i smanjenjem fetalne tjelesne težine u studijama embriofetalnog razvoja.
A total of 114 patients with previously treated ITP were randomised 2:1 eltrombopag (n=76) to placebo (n=38).
Ukupno 114 bolesnika s prethodno liječenim ITP-om randomizirano je u omjeru 2:1, u skupinu koja je dobivala eltrombopag (n=76) i skupinu koja je dobivala placebo (n=38).
After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 3 weeks should be observed before increasing the dose.
Nakon uvođenja svake nove doze u bolesnika s oštećenjem jetre, bolesnika je potrebno pratiti u razdoblju od 3 tjedna prije povećavanja doze.
Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets eltrombopag
Revolade 12,5 mg filmom obložene tablete Revolade 25 mg filmom obložene tablete Revolade 50 mg filmom obložene tablete Revolade 75 mg filmom obložene tablete eltrombopag
Common Iron overload, decreased appetite, hypoglycaemia, increased appetite
Poremećaji metabolizma i prehrane često preopterećenje željezom, smanjeni apetit, hipoglikemija, povećani apetit
• 1 single-use oral dosing syringe (supplied in the kit)
• 1 dozirna štrcaljka za usta za jednokratnu uporabu (nalazi se u kompletu)
Common Blood bilirubin increased (hyperbilirubinemia), jaundice Not known Drug-induced liver injury* * Cases of drug-induced liver injury have been reported in patients with ITP and HCV
Poremećaji jetre i žuči vrlo često porast transaminaza često porast bilirubina u krvi (hiperbilirubinemija), žutica nepoznato oštećenje jetre uzrokovano lijekom* * Slučajevi oštećenja jetre uzrokovanog lijekom prijavljeni su u bolesnika s ITP-om i HCV-om
HMG CoA reductase inhibitors
Učinci eltrombopaga na druge lijekove Inhibitori HMG CoA reduktaze
• interruption in blood supply to spleen (splenic infarction)
• prekid u opskrbi slezene krvlju (infarkt slezene)
The co-administration of 200 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 25% and 18%, respectively.
Istodobna primjena 200 mg ciklosporina smanjila je Cmax eltrombopaga za 25% i AUCinf eltrombopaga za 18%.
Very common
Vrlo česte nuspojave
Following identification of a stable dose of eltrombopag, full blood count (FBC) with white blood cell count (WBC) differential should be performed monthly.
Nakon postizanja stabilne doze eltrombopaga, jednom mjesečno treba provoditi analizu kompletne krvne slike i diferencijalne slike leukocita.
The tablets should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Tablete treba uzeti barem dva sata prije ili četiri sata nakon bilo kojeg pripravka kao što su antacidi, mliječni proizvodi (ili druge vrste hrane koje sadrže kalcij), nadomjesni preparati minerala koji sadrže polivalentne katione (npr. željezo, kalcij, magnezij, aluminij, selen i cink) (vidjeti dijelove 4.5 i 5.2).
constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles
nadutost trbuha, poremećaji okusa, upala želuca, hemoroidi, nadraženost crijeva
Number of cumulative weeks with platelet counts 50,000-400,000/µl, Mean (SD) Patients with ≥75% of assessments in the target range (50,000 to 400,000/l), n (%)
Bolesnici sa ≥75% nalaza unutar ciljnog raspona vrijednosti (50 000 do 400 000/l), n (%)
Based on model estimate, female HCV patient had approximately 41% higher plasma eltrombopag AUC(0-) as compared to male patients.
Temeljem procijenjenog modela, bolesnice s HCV-om imale su približno 41% više vrijednosti AUC(0-) eltrombopaga u plazmi u usporedbi s muškim bolesnicima.
Therefore, eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see sections 4.2 and 4.4).
Stoga, eltrombopag ne bi smjeli uzimati bolesnici s ITP-om s oštećenjem jetre (≥5 bodova prema Child-Pugh ljestvici) osim ako očekivana dobrobit ne nadmašuje već poznati rizik za trombozu portalne vene (vidjeti dijelove 4.2 i 4.4).
Based on estimates from the population pharmacokinetic analysis, Asian patients had approximately 55% higher plasma eltrombopag AUC(0-) values as compared to patients of other races who were predominantly Caucasian (see section 4.2).
Temeljem procjena analize populacijske farmakokinetike, bolesnici iz Azije imali su približno 55% veće vrijednosti AUC(0-) eltrombopaga u plazmi u usporedbi s bolesnicima drugih rasa koji su bili većinom bijele rase (vidjeti dio 4.2).
Give the medicine to the child. Do this straight away when you have mixed the dose.
Napravite to čim ste zamiješali dozu.
The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and cognitive skills.
Kada se razmatra sposobnost bolesnika da izvodi zadatke koji zahtijevaju prosudbu, motoričke i kognitivne sposobnosti treba imati na umu klinički status bolesnika i profil nuspojava eltrombopaga, uključujući omaglicu i smanjenu budnost.
• Insert the tip of the syringe into the hole in the lid of the mixing bottle.
• Umetnite vršak štrcaljke u rupu u poklopcu bočice za miješanje.
Dose adjustments are based upon the platelet count response.
Prilagodba doze temelji se na odgovoru prema broju trombocita.
• Throw away the used oral dosing syringe.
• Bacite iskorištenu dozirnu štrcaljku za usta.
ITP is caused by a low blood platelet count (thrombocytopenia).
ITP je uzrokovan sniženim brojem trombocita (trombocitopenija).
It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.
Preporučeno je pričekati 2 tjedna kako bi vidjeli učinke ove i svih narednih prilagodbi doza.
Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide black (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Ovojnica tablete Hipromeloza (E464) željezov oksid crveni (E172) željezov oksid crni (E172) makrogol 400 (E1521) titanijev dioksid (E171)
At non-tolerated doses in pre-weaning juvenile rats dosed from Days 4-32 (approximately equating to a 2-year-old human at the end of the dosing period), ocular opacities were observed (histology not performed) at 9 times the maximum human clinical exposure in paediatric ITP patients at 75 mg/day, based on AUC.
U juvenilnih štakora prije odbijanja od sise, koji su primali doze od 4.-32. dana (što otprilike odgovara 2-godišnjem djetetu na kraju razdoblja primjene doze), pri dozama koje se ne podnose dobro bila su uočena zamućenja oka (histologija nije obavljena) pri izloženosti koja je 9 puta veća od maksimalne kliničke izloženosti u pedijatrijskih bolesnika s ITP-om pri 75 mg/dan, mjerene AUC-om.
• toothache
• zubobolja
If after 2 weeks of eltrombopag therapy at 100 mg the required platelet level to initiate antiviral therapy is not achieved, eltrombopag should be discontinued.
Liječenje eltrombopagom treba prekinuti ako se nakon 2 tjedna primjene lijeka u dozi od 100 mg ne postigne broj trombocita potreban za započinjanje antivirusnog liječenja.
Three patients had cytogenetic abnormalities at baseline.
Troje bolesnika imalo je citogenetske abnormalnosti na početku.
Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Ovojnica tablete Hipromeloza (E464) željezov oksid crveni (E172) željezov oksid žuti (E172) makrogol 400 (E1521) titanijev dioksid (E171)
Treatment-related cataracts were detected in rodents and were dose and time-dependent.
U glodavaca je zabilježena pojava katarakte vezane uz liječenje eltrombopagom, a koja je bila ovisna o dozi i duljini primjene.
ATC code: B02BX 05.
Farmakoterapijska skupina: Antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX 05.
In ITP and SAA patients a lower starting dose of eltrombopag should be used.
U bolesnika s ITP-om i teškom aplastičnom anemijom potrebno je koristiti niže početne doze eltrombopaga.
• Start with the plunger pushed all the way into the syringe.
• Započnite s klipom gurnutim do kraja u štrcaljku.
Your doctor will carry out tests to check that you do not have this blood condition before you start Revolade.
Prije početka liječenja lijekom Revolade, Vaš će liječnik provesti testiranje kako bi provjerio da nemate ovu krvnu bolest.
In vitro studies with eltrombopag suggest a potential phototoxicity risk; however, in rodents there was no evidence of cutaneous phototoxicity (10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 5 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) or ocular phototoxicity (4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
In vitro ispitivanja s eltrombopagom sugeriraju potencijalni rizik od fototoksičnosti, međutim, u glodavaca nije bilo dokaza kožne fototoksičnosti (10 ili 7 puta veća od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 5 puta kliničke izloženosti bolesnika s HCVom pri dozi od 100 mg/dan, temeljeno na AUC) ili fototoksičnosti za oči (4 puta veća od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 3 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC).
50,000/µl to 150,000/µl
50 000/µl do 150 000/µl
Revolade 25 mg powder for oral suspension eltrombopag
Revolade 25 mg prašak za oralnu suspenziju eltrombopag
Revolade 75 mg film-coated tablets are round, biconvex, pink, debossed with ‘GS FFS' and ‘75' on one side.
Revolade 75 mg filmom obložene tablete su okrugle, bikonveksne, ružičaste tablete s utisnutim oznakama „GS FFS“ i „75“ na jednoj strani.
Common Dry eye, vision blurred, eye pain, visual acuity reduced Uncommon Lenticular opacities, astigmatism, cataract cortical, lacrimation increased, retinal haemorrhage, retinal pigment epitheliopathy, visual impairment, visual acuity tests abnormal, blepharitis, keratoconjunctivitis sicca
Poremećaji oka često suhoća očiju, zamagljen vid, bol oka, smanjenje vidne oštrine manje često opaciteti leće, astigmatizam, kortikalna katarakta, pojačano suzenje, krvarenje u retini, retinalna pigmentna epiteliopatija, poremećaji vida, abnormalni testovi vidne oštrine, blefaritis, suhi keratokonjunktivitis
Heat-sealed foil laminate sachets.
Vrećice od toplinski zavarene laminirane folije.
>150,000/µl to 250,000/µl
>150 000/µl do 250 000/µl
White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1' and ‘12.5' on one side.
Bijela, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 7,9 mm) s utisnutim oznakama „GS MZ1“ i „12,5“ na jednoj strani.
The product contact material is the polyethylene heat seal layer.
Materijal u kontaktu s lijekom je toplinski zavaren sloj polietilena niske gustoće.
• feeling sick (nausea)
• osjećaj vrtnje (vrtoglavica)
It is important to tell a doctor if you develop these symptoms.
Ako razvijete ove simptome, važno je da obavijestite liječnika o tome.
• blisters in the mouth
Za primjenu kroz usta
Common Hypokalaemia, decreased appetite, blood uric acid increased Uncommon Anorexia, gout, hypocalcaemia
Poremećaji metabolizma i prehrane često hipokalijemija, smanjeni apetit, povišena razina mokraćne kiseline u krvi manje često anoreksija, giht, hipokalcijemija,
• 1 reusable mixing bottle with lid and cap (supplied in the kit)
• 1 bočica za miješanje za višekratnu uporabu s poklopcem i zatvaračem (nalazi se u kompletu)
A very high blood platelet count may increase the risk of blood clotting.
Povišeni broj trombocita može povisiti rizik za nastanak krvnih ugrušaka.
• Pull cap off the lid of the mixing bottle
• Maknite zatvarač s poklopca s bočice za miješanje
Tests to check your bone marrow
Testovi za provjeru koštane srži
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Ujedinjeno Kraljevstvo Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Eltrombopag ne treba primjenjivati kod bolesnika s ITP-om i oštećenjem jetre (≥5 bodova po Child-Pugh ljestvici), osim ako očekivana dobrobit ne nadmašuje već poznati rizik za nastanak tromboze portalne vene.
Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-) values as compared to male patients.
Ženski pedijatrijski bolesnici s ITP-om imali su otprilike 25% više vrijednosti plazmatskog AUC(0-) eltrombopaga u odnosu na muške bolesnike.
At ≥6 times the human clinical exposure in adult ITP patients at 75 mg/day and 3 times the human clinical exposure in adult HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 6 weeks and rats after 28 weeks of dosing.
Pri ≥6 puta većoj izloženosti od kliničke izloženosti odraslih bolesnika s ITPom pri dozi od 75 mg/dan i 3 puta većoj kliničkoj izloženosti od odraslih bolesnika s HCV-om pri dozi od 100 mg/dan, mjerenoj AUC-om, katarakta je zamijećena u miševa nakon 6 tjedana i štakora nakon 28 tjedana primjene lijeka.