natgillin/translations-raw huggingface dataset:
The exposure at the lowest dose was 1.2 or 0.8 times the human clinical exposure based on AUC in adult or paediatric ITP patients at 75 mg/day and 0.6 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Temeljeno na AUC, izloženost pri najnižim dozama bila je 1,2 ili 0,8 puta veća od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 0,6 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan.
The longest platelet transfusion-free period for responders was 287 days (median).
Najduže razdoblje bez transfuzije trombocita za bolesnike s odgovorom bilo je 287 dana (medijan).
revolade 25 mg sachets
revolade 25 mg vrećice
Screw the lid onto the mixing bottle.
Navijte poklopac na bočicu za miješanje.
Syringe tip
Česte nuspojave
It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient's platelet response prior to considering another dose adjustment.
Da biste kod bolesnika vidjeli odgovor trombocita na bilo koje prilagodbe doze, potrebno je pričekati barem 2 tjedna prije nego se odlučite na novu prilagodbu doze lijeka.
A similar platelet response was maintained throughout the study, with 52% and 16% of patients responding at the end of the 6-month treatment period.
Sličan je odgovor (prema broju trombocita) održan tijekom cijelog ispitivanja, odnosno 52% bolesnika koji su primali eltrombopag, i 16% bolesnika koji su primali placebo odgovorilo je na liječenje na kraju šestomjesečnog perioda.
Common Blood bilirubin increased, weight decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, international normalised ratio increased, activated partial thromboplastin time prolonged, blood glucose increased, blood albumin decreased Uncommon Electrocardiogram QT prolonged Grouped term with preferred terms oliguria, renal failure and renal impairment
Pretrage često povećana razina bilirubina u krvi, smanjenje tjelesne težine, sniženi broj leukocita, sniženi hemoglobin, snižen broj neutrofila, povećan INR, produženo aktivirano parcijalno tromboplastinsko vrijeme, povišena koncentracija glukoze u krvi, sniženi albumin u krvi manje često produljenje QT intervala u elektrokardiogramu Grupni pojam s preporučenim pojmovima oligurija, zatajenje bubrega i oštećenje bubrega
• Push the cap firmly back on to the lid of the mixing bottle.
• Gurnite zatvarač čvrsto natrag na poklopac bočice za miješanje.
Hepatotoxixity
Hepatotoksičnost
Revolade 25 mg powder for oral suspension:
Revolade 25 mg prašak za oralnu suspenziju:
In addition, the benefits of treatment in terms of the proportion achieving sustained virological response (SVR) compared with placebo were modest in these patients (especially for those with baseline albumin ≤35g/l) compared with the group overall.
U nastavku, koristi od liječenja prema udjelu postignutog održanog virološkog odgovora (SVR) u tih bolesnika su bile skromne u usporedbi s placebom (pogotovo za one čija je početna vrijednost albumina ≤35 g/l) kada je uspoređeno s cijelom skupinom (vidjeti dio 5.1).
• Put the tip of the syringe all the way into the water
• Gurnite vršak štrcaljke do kraja u vodu.
• Slowly push the plunger all the way into the syringe.
• Polako gurnite klip do kraja u štrcaljku.
Within two weeks of stopping Revolade, your blood platelet count will usually drop back down to what it was before starting Revolade.
Krvarenje ili modrice nakon prestanka liječenja Unutar dva tjedna od prestanka uzimanja lijeka Revolade, broj trombocita će obično pasti na razinu od prije početka uzimanja lijeka Revolade.
At 4 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human exposure in HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 13 weeks and in rats after 39 weeks of dosing.
Pri 4 puta većoj izloženosti od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan dan i 2 puta većoj kliničkoj izloženosti od bolesnika s HCV-om pri dozi od 100 mg/dan, mjerenoj AUC-om, katarakta je zabilježena u miševa nakon 13 tjedana i u štakora nakon 39 tjedana primjene lijeka.
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 section 4.4).
Eltrombopag ne smiju uzimati bolesnici s ITP-om s oštećenjem jetre (≥5 bodova po Child-Pugh ljestvici) osim ako očekivana dobrobit ne nadmašuje već poznati rizik za trombozu portalne vene (vidjeti dio 4.4).
Endosteal hyperostosis was observed in a 28-week toxicity study in rats at a non-tolerated dose of 60 mg/kg/day (6 times or 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).
Endostealna hiperostoza je zamijećena u 28-tjednom ispitivanju toksičnosti na štakorima, pri netolerirajućim dozama od 60 mg/kg/dan (doza 6 ili 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).
Eltrombopag dose may need to be increased based on these platelet counts.
Možda će biti potrebno povećanje doze eltrombopaga temeljem broja trombocita.
Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times or 8 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 7 times the human clinical exposure in HCV patients at 100 mg/day, based on Cmax).
Eltrombopag nije pokazao mutageno ili klastogeno svojstvo u probi bakterijskih mutacija ili u dvije in vivo probe na štakorima (DNA sinteza u jezgricama i nepredviđena DNA sinteza pri izloženosti 10 ili 8 puta većoj od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 7 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na Cmax).
Patients with low albumin levels (≤35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients.
Bolesnici koji su imali niske razine albumina (≤35 g/l) ili MELD indeks ≥10 imali su 2 puta veći rizik od TED nego oni s visokim razinama albumina; oni stariji od ≥60 godina imali su dva puta veći rizik od TED u odnosu na mlađe bolesnike.
See also ‘Bleeding or bruising after you stop treatment' in section 4.
Pogledajte također „Krvarenje ili modrice nakon prestanka liječenja“ u dijelu 4. U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
Platelet counts should be monitored every week prior to starting antiviral therapy.
Prije početka antivirusnog liječenja potrebno je pratiti broj trombocita svaki tjedan.
Revolade 25 mg film-coated tablets are round, biconvex, white, debossed with ‘GS NX3' and ‘25' on one side.
Revolade 25 mg filmom obložene tablete su okrugle, bikonveksne, bijele tablete s utisnutim oznakama „GS NX3“ i „25“ na jednoj strani.
Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day.
Odrasli - uobičajena početna doza za hepatitis C je jedna tableta lijeka Revolade od 25 mg na dan.
In controlled studies in thrombocytopenic patients with HCV (n=1439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs.
U kontroliranim ispitivanjima trombocitopeničnih bolesnika s HCV-om (n=1439), 38 od 955 bolesnika (4%) liječenih eltrombopagom doživjelo je TED, dok je u placebo skupini TED imalo 6 od 484 bolesnika (1%).
The longest platelet transfusion-free period for non-responders was 27 days (median).
Najduže razdoblje bez transfuzije trombocita za bolesnike bez odgovora bilo je 27 dana (medijan).
The longest RBC transfusion-free period for responders was 266 days (median).
Najduže razdoblje bez transfuzije eritrocita za bolesnike s odgovorom bilo je 266 dana (medijan).
Revolade 12.5 mg film-coated tablets EU/1/10/612/010
Revolade 12,5 mg filmom obložene tablete EU/1/10/612/010
• Insert the syringe tip into the hole in the bottle lid. 9.
• Umetnite vršak štrcaljke u rupu na poklopcu bočice.
For patients taking 25 mg once daily, the dose should be increased to 50 mg daily before increasing the dose amount by 50 mg. A dose of 150 mg daily must not be exceeded.
Bolesnicima koji uzimaju 25 mg jednom dnevno, potrebno je povećati dozu na 50 mg dnevno prije povećavanja doze za 50 mg.
Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Eltrombopag nije bio karcinogen za miševe u dozama do 75 mg/kg/dan ili u štakora pri dozama do 40 mg/kg/dan (izloženost veća do 4 ili 2 puta od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjereno AUC).
Adults and children (6 to 17 years) - the usual starting dose for ITP is one 50 mg tablet of Revolade a day.
Odrasli i djeca (6 do 17 godina) - uobičajena početna doza za ITP je jedna tableta lijeka Revolade od 50 mg na dan.
In controlled studies in thrombocytopenic patients with HCV receiving interferon therapy (n=1,439), progression of pre-existing baseline cataract(s) or incident cataracts was reported in 8% of the eltrombopag group and 5% of the placebo group.
U kontroliranim ispitivanjima bolesnika s trombocitopenijom i HCV-om koji su primali terapiju interferonom (n=1439) progresija već postojeće (ishodišno prisutne) katarakte ili pojava katarakte zabilježena je u 8% bolesnika u skupini koja je primala eltrombopag, te 5% u skupini koja je primala placebo.
Table 8 Geometric mean (95% confidence intervals) of steady-state plasma eltrombopag pharmacokinetic parameters in adults with ITP
Tablica 8 Geometrijska srednja vrijednost (95%-ni interval pouzdanosti) farmakokinetskih parametara eltrombopaga u stanju dinamičke ravnoteže, za odrasle osobe s ITP-om doza eltrombopaga, jednom dnevno
In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag and 6 out of 484 patients (1%) in the placebo group experienced thromboembolic events (TEEs).
U kontroliranim ispitivanjima bolesnika s trombocitopenijom i HCV-om koji su primali terapiju temeljenu na interferonu (n=1439), 38 od 955 bolesnika (4%) koji su primali eltrombopag, te 6 od 484 bolesnika (1%) u grupi s placebom imalo je tromboembolijske događaje (TED).
Based on estimates from the population pharmacokinetic analysis, Asian ITP patients had approximately 49% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients who were predominantly Caucasian (see section 4.2).
Na temelju procjena iz spomenute analize azijski bolesnici s ITP-om, imali su otprilike 49% više plazmatske vrijednosti AUC(0-) eltrombopaga u odnosu na ne-azijske bolesnike pretežno bijele rase (vidjeti dio 4.2).
Immune (primary) thrombocytopenia
Imunosna (primarna) trombocitopenija
There were no effects of note on red cell mass or reticulocyte counts after dosing for up to 28 weeks in rats, 52 weeks in dogs and 2 years in mice or rats at maximally tolerated doses which were 2 to 4 times human clinical exposure in adult or paediatric ITP patients at 75 mg/day and ≤2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Nije bilo značajnijih učinaka na ukupan broj crvenih krvnih stanica ili broj retikulocita nakon primjene lijeka do 28 tjedana u štakora, 52 tjedna u pasa ili 2 godine u miševa ili štakora, u maksimalnim toleriranim dozama koje su bile 2-4 puta više od kliničke izloženosti u odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i ≤2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjerene AUC-om.
Common Pyrexia*, chest pain, asthenia *Very common in paediatric ITP Uncommon Feeling hot, vessel puncture site haemorrhage, feeling jittery, inflammation of wound, malaise, sensation of foreign body
Opći poremećaji i reakcije na mjestu primjene često pireksija*, bol u prsištu, astenija *Vrlo često kod pedijatrijskog ITP-a manje često osjećaj vrućine, krvarenje na mjestu uboda iglom, osjećaj nervoze, upala rane, malaksalost, osjećaj stranog tijela
However blood clots can also form with normal or even low platelet counts.
Međutim oni mogu nastati i kad je broj trombocita snižen ili normalan.
≥50,000/µl to ≤100,000/µl
50 000/µl do 100 000/µl
Eltrombopag did not affect male fertility in rats at doses up to 40 mg/kg/day, the highest dose tested (3 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Eltrombopag nije utjecao na plodnost mužjaka štakora u dozama do 40 mg/kg/dan, najvišoj testiranoj dozi (3 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC).
Contact a doctor or pharmacist immediately.
Vaš liječnik ili ljekarnik.
There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels ≤35 g/l or model for end stage liver disease (MELD) score ≥10, when treated with eltrombopag in combination with interferon-based therapy.
U trombocitopeničnih bolesnika s HCV-om s uznapredovalom kroničnom bolešću jetre definiranom niskim razinama albumina ≤35 g/l ili indeksom modela završne faze bolesti jetre (MELD) ≥10, pri liječenju eltrombopagom u kombinaciji s terapijom temeljenoj na interferonima postoji povećan rizik od razvoja nuspojava, uključujući i potencijalno letalnu dekompenzaciju jetre i tromboembolijske događaje.
>100,000/µl to ≤150,000/µl
>100 000/µl do 150 000/µl
Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade a day.
Odrasli i djeca (6 do 17 godina) - uobičajena početna doza za ITP su dvije vrećice lijeka Revolade od 25 mg na dan.
The longest RBC transfusion-free period for non-responders was 29 days (median).
Najduže razdoblje bez transfuzije eritrocita za bolesnike bez odgovora bilo je 29 dana (medijan).
Platelet count response between 50,000-400,000/l in the absence of rescue treatment was achieved by significantly more patients in the eltrombopag treated group during the 6 month treatment period, p <0.001.
Tijekom 6 mjeseci liječenja, u značajno većeg broja bolesnika koji su primali eltrombopag je postignut odgovor na liječenje s brojem trombocita između 50 000 i 400 000/l, bez dodatnog (rescue) liječenja, p <0,001.
In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringeport capability is provided.
Uz to, priložen je zatvarač s navojem (etilenvinilacetat / LDPE) u koji se može umetnuti štrcaljka.
Revolade 12.5 mg film-coated tablets
Revolade 12,5 mg filmom obložene tablete
Eltrombopag did not affect female fertility, early embryonic development or embryofoetal development in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure in adult or adolescent (12-17 years old) ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Eltrombopag nije utjecao na plodnost ženki, rani embrionalni razvoj ili embriofetalni razvoj štakora u dozama do 20 mg/kg/dan (2 puta veća od kliničke izloženosti odraslih bolesnika ili adolescenata (u dobi od 12 do 17 godina) s ITP-om pri dozi od 75 mg/dan i ekvivalent kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC).
Revolade 12.5 mg film-coated tablets eltrombopag
Revolade 12,5 mg filmom obložene tablete eltrombopag
Revolade 75 mg film-coated tablets EU/1/10/612/007
Revolade 75 mg filmom obložene tablete EU/1/10/612/007
Liver enzymes measured between Days 2 and 18 after ingestion peaked at a 1.6-fold ULN in AST, a 3.9-fold ULN in ALT, and a 2.4-fold ULN in total bilirubin, The platelet counts were 672,000/µl on Day 18 after ingestion and the maximum platelet count was 929,000/µl.
Broj trombocita je 18. dana nakon ingestije iznosio 672 000/µl, a najviši izmjereni broj trombocita je bio 929 000/µl.
What Revolade looks like and contents of the pack Revolade 12.5 mg film-coated tablets are round, biconvex, white, debossed with ‘GS MZ1' and ‘12.5' on one side.
Revolade 12,5 mg filmom obložene tablete su okrugle, bikonveksne, bijele tablete s utisnutim oznakama „GS MZ1“ i „12,5“ na jednoj strani.
Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS' and ‘75' on one side.
Ružičasta, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 10,3 mm) s utisnutim oznakama „GS FFS“ i „75“ na jednoj strani.
Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 50 mg.
Kada broj trombocita bude opet ≤100 000/µl, ponovo započeti liječenje eltrombopagom u dnevnoj dozi smanjenoj za 50 mg.
Common Myalgia, muscle spasm, musculoskeletal pain, bone pain, back pain Uncommon Muscular weakness Renal and urinary disorders Common Proteinuria, blood creatinine increased, thrombotic microangiopathy with renal failure Uncommon Renal failure, leukocyturia, lupus nephritis, nocturia, blood urea increased, urine protein/creatinine ratio increased
Poremećaji bubrega i mokraćnog sustava često proteinurija, porast kreatinina u krvi, trombotična mikroangiopatija sa zatajenjem bubrega manje često zatajenje bubrega, leukociturija, lupusni nefritis, nokturija, porast ureje u krvi, povišen omjer protein/kreatinin u urinu
Thrombocytopenia is likely to reoccur in ITP patients upon discontinuation of treatment with eltrombopag.
Nakon prekida liječenja eltrombopagom u bolesnika s ITP-om najvjerojatnije će se ponovo javiti trombocitopenija.
Thrombocytopenia following discontinuation of treatment
Trombocitopenija nakon prekida liječenja
If you are taking interferon-based treatments together with Revolade to treat low platelet count due to hepatitis C, some liver problems can get worse.
Neki problemi s jetrom se mogu pogoršati ako uzimate terapiju temeljenu na interferonu zajedno s lijekom Revolade za liječenje sniženog broja trombocita kao posljedicu hepatitisa C.
Pooled data
Zbirni podaci
Common Rash, alopecia, hyperhidrosis, pruritus generalised, petechiae Uncommon Urticaria, dermatosis, cold sweat, erythema, melanosis,
Poremećaji kože i potkožnog tkiva često osip, alopecija, hiperhidroza, generalizirani svrbež, petehije manje često urtikarija, dermatoze, hladan znoj, eritem, melanoza, poremećaji pigmentacije, diskoloracija kože, ljuštenje kože
Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg tablet of Revolade a day.
Djeca (1 do 5 godina) - uobičajena početna doza za ITP je jedna tableta lijeka Revolade od 25 mg na dan.
30 single-use oral dosing syringes
30 dozirnih štrcaljki za usta za jednokratnu uporabu
White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3' and ‘25' on one side.
Bijela, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 10,3 mm) s utisnutim oznakama „GS NX3“ i „25“ na jednoj strani.
Common Rash, dry skin, eczema, rash pruritic, erythema, hyperhidrosis, pruritus generalised, alopecia Uncommon Skin lesion, skin discolouration, skin hyperpigmentation, night sweats
Poremećaji kože i potkožnog tkiva vrlo često svrbež često osip, suha koža, ekcem, pruritički osip, eritem, hiperhidroza, generalizirani svrbež, alopecija manje često oštećenje kože, diskoloracija kože, hiperpigmentacija kože, noćno znojenje
Chronic hepatitis C (HCV) associated thrombocytopenia
Trombocitopenija povezana s kroničnim hepatitisom C (HCV)
Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU' and ‘50' on one side.
Revolade 50 mg filmom obložene tablete su okrugle, bikonveksne, smeđe tablete s utisnutim oznakama „GS UFU“ i „50“ na jednoj strani.
In the phase II refractory SAA clinical study with eltrombopag at a dose of 150 mg/day (with ethnic or age related modifications as indicated) (ELT116826), the incidence of new cytogenetic abnormalities was observed in 22.6% of adult patients [7/31 (where 3 of them had changes in chromosome 7)].
U kliničkom ispitivanju faze II refraktorne teške aplastične anemije s eltrombopagom pri dozi od 150 mg/dan (s etničkim ili s dobi povezanim modifikacijama doze po potrebi) (ELT116826), incidencija novih citogenetskih abnormalnosti bila je uočena u 22,6% odraslih bolesnika [7/31 (gdje su 3 od njih imala promjene na kromosomu 7)]. Svih 7 bolesnika imalo je normalnu citogenetiku na početku.
Common Anaemia, eosinophilia, leukocytosis, thrombocytopenia, haemoglobin decreased, white blood cell count decreased Uncommon Anisocytosis, haemolytic anaemia, myelocytosis, band neutrophil count increased, myelocyte present, platelet count increased, haemoglobin increased
Poremećaji krvi i limfnog sustava često anemija, eozinofilija, leukocitoza, trombocitopenija, sniženje hemoglobina, smanjenje broja leukocita manje često anizocitoza, hemolitička anemija, mijelocitoza, povišenje broja nesegmentiranih neutrofila, pojava mijelocita, porast broja trombocita, povišenje hemoglobina
There are limited data on the use of eltrombopag in HCV and SAA patients aged over 75 years.
Podaci o uporabi eltrombopaga u bolesnika s HCV-om i bolesnika s teškom aplastičnom anemijom starijih od 75 godina su ograničeni.
25 mg powder for oral suspension
25 mg prašak za oralnu suspenziju
Adults - the usual starting dose for hepatitis C is one 25 mg sachet of Revolade a day.
Odrasli - uobičajena početna doza za hepatitis C je jedna vrećica lijeka Revolade od 25 mg na dan.
Revolade 75 mg film-coated tablets
Revolade 75 mg filmom obložene tablete
Symptoms include: - black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people) - blood in your stools - vomiting blood or something that looks like coffee grounds
Simptomi uključuju: - crne katranaste stolice (promjena boje stolice je manje česta nuspojava koja se može javiti u do
Genotype 1/4/6
Genotip 1/4/6e Razina albumina f
There were no bone changes observed in mice or rats after lifetime exposure (2 years) at 4 times or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Nisu nađene promjene na kostima miševa i štakora nakon izloženosti tijekom cijelog života (2 godine) pri 4 ili 2 puta većoj od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC.
• abdominal (stomach) pain, enlarged abdomen, blood in your stools
• bol u trbuhu, povećanje opsega trbuha, krv u stolici
Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 12,5 mg eltrombopaga.
Fertility was not affected in male or female rats at exposures that were comparable to those in humans.
Pri razinama izloženosti lijeku koja je usporediva s onima kod ljudi nije utvrđen utjecaj na plodnost bilo kod ženki ili mužjaka štakora.
Revolade 25 mg powder for oral suspension
Revolade 25 mg prašak za oralnu suspenziju
• fast or irregular heartbeat (palpitations), shortness of breath
• brzi ili nepravilni otkucaji srca (palpitacije), nedostatak zraka produktivni kašalj, curenje nosa, gripa, herpes, grlobolja i nelagoda pri gutanju
Revolade 75 mg film-coated tablets eltrombopag
Revolade 75 mg filmom obložene tablete eltrombopag