natgillin/translations-raw huggingface dataset:
In the pre-antiviral treatment phase, patients received open-label eltrombopag to increase the platelet count to ≥90,000/µl for ENABLE 1 and ≥100,000/µl for ENABLE 2.
U fazi prije antivirusnog liječenja, bolesnici su otvoreno primali eltrombopag kako bi povećali broj trombocita na ≥90 000/µl u ENABLE 1 i ≥100 000/µl u ENABLE 2 ispitivanju.
• Place the tip of the syringe into the inside of the child's cheek.
• Postavite vršak štrcaljke djetetu s unutarnje strane obraza.
In contrast, the administration of eltrombopag 2 hours before or 4 hours after a high-calcium meal or with low-calcium food [<50 mg calcium] did not alter plasma eltrombopag exposure to a clinically significant extent (see section 4.2).
Nasuprot tome, primjena eltrombopaga 2 sata prije ili 4 sata nakon obroka s visokim udjelom kalcija ili s hranom s niskim udjelom kalcija [< 50 mg kalcija] nije promijenila plazmatsku razinu eltrombopaga u klinički značajnoj mjeri (vidjeti dio 4.2).
Based on urinary excretion and metabolites eliminated in faeces, the oral absorption of drug-related material following administration of a single 75 mg eltrombopag solution dose was estimated to be at least 52%.
Na temelju izlučivanja mokraćom i metabolita eliminiranih stolicom, oralna apsorpcija lijeka nakon primjene jedne doze otopine eltrombopaga od 75 mg, procijenjena je da iznosi barem 52%.
Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans.
Primjena eltrombopaga u dozi od 75 mg jednom dnevno tijekom 7 dana u 24 zdrava muškarca nije inhibirala niti inducirala metabolizam supstrata za 1A2 (kofein), 2C19 (omeprazol), 2C9 (flurbiprofen) ili 3A4 (midazolam) u ljudi.
Uridine diphosphoglucuronyl transferase UGT1A1 and UGT1A3 are responsible for glucuronidation, and bacteria in the lower gastrointestinal tract may be responsible for the cleavage pathway.
Uridin difosfoglukuronil transferaze UGT1A1 i UGT1A3 su odgovorne za glukuronidaciju, a bakterije u donjem dijelu probavnog sustava bi mogle biti odgovorne za put odstranjivanja cijepanjem.
Dose adjustment is not required when eltrombopag is co-administered with either telaprevir or boceprevir.
Nije potrebna prilagodba doze kad se eltrombopag primjenjuje istodobno s telaprevirom ili boceprevirom.
Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets.
Aluminijski blisteri (PA/Al/PVC/Al) u kutiji koji sadrže 14 ili 28 filmom obloženih tableta i višestruko pakiranje koje sadrži 84 (3 pakiranja po 28) filmom obloženih tableta.
Minor metabolites due to glucuronidation and oxidation were also detected.
Manje značajni metaboliti nastali glukuronidacijom i oksidacijom su također detektirani.
Paediatric population (aged 1 to 17 years) The safety and efficacy of eltrombopag in paediatric patients have been investigated in two studies.
Pedijatrijska populacija (u dobi od 1 do 17 godina) Sigurnost i djelotvornost eltrombopaga u pedijatrijskih bolesnika bile su istraživane u dva ispitivanja.
HCV protease inhibitors
Inhibitori HCV proteaze
For 4 hours before you take
U razdoblju od 4 sata prije uzimanja lijeka
During antiviral therapy, the dose of eltrombopag should be adjusted as necessary to avoid dose reductions of peginterferon due to decreasing platelet counts that may put patients at risk of bleeding (see Table 2).
Tijekom antivirusnog liječenja treba po potrebi prilagođavati dozu eltrombopaga kako bi izbjegli smanjivanje doze peginterferona zbog smanjenja broja trombocita koje bi moglo bolesnicima predstavljati rizik za krvarenje (vidjeti tablicu 2).
• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• infekcija u nosu, sinusima, grlu i gornjim dišnim putevima, obična prehlada (infekcija gornjeg dijela dišnog sustava)
The safety and efficacy of eltrombopag has not been established in children and adolescents (<18 years) with chronic HCV related thrombocytopenia or SAA.
Sigurnost i djelotvornost eltrombopaga u djece i adolescenata (<18 godina) s trombocitopenijom povezanom s kroničnim HCV-om ili teškom aplastičnom anemijom nisu ustanovljene.
• antacids, a type of medicine for indigestion and heartburn
• antacide, vrstu lijekova za probavne tegobe i žgaravicu
In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.
U kliničkim ispitivanjima s TPO-R agonistima u bolesnika s MDS-om pronađeni su slučajevi s prolaznim povećanjem broja blasta te postoje izvještaji o slučajevima progresije MDS-a u akutnu mijeloičnu leukemiju (AML).
In the HCV studies the safety population consisted of all randomised patients who received double-blind study medicinal product during Part 2 of ENABLE 1 (Revolade treatment n=450, placebo treatment n=232) and ENABLE 2 (Revolade treatment n=506, placebo treatment n=253).
U ispitivanjima HCV-a sigurnosnu populaciju su činili svi randomizirani bolesnici koji su primali lijek iz dvostruko slijepog ispitivanja tijekom 2. dijela ENABLE 1 (liječenje Revoladeom n=450, liječenje placebom n=232) i ENABLE 2 ispitivanja (liječenje Revoladeom n=506, liječenje placebom n=253).
There was substantial variability and significant overlap in exposures between patients with hepatic impairment and healthy volunteers.
Postojala je i značajna varijabilnost i preklapanje u izloženostima između bubrežnih bolesnika i zdravih dobrovoljaca.
For TPO-R agonists there is a concern that they may stimulate the progression of existing haematopoietic malignancies such as MDS.
Za agoniste TPO-R postoji zabrinutost da bi mogli stimulirati progresiju postojećih hematopoetskih zloćudnih bolesti poput MDS-a.
Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see section 4.4).
Bolesnike s tim karakteristikama treba pažljivo motriti zbog moguće pojave znakova i simptoma jetrene dekompenzacije (vidjeti dio 4.4).
No specific risk factors were identified in those patients who experienced a TEE with the exception of platelet counts ≥200,000/µl (see section 4.4).
Nisu identificirani specifični čimbenici rizika u bolesnika koji su doživjeli tromboembolijski događaj s iznimkom broja trombocita ≥200 000/µl (vidjeti dio 4.4).
Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration.
Apsorbirani eltrombopag doseže vršnu koncentraciju 2-6 sati nakon peroralne primjene.
A dose of 100 mg eltrombopag once daily must not be exceeded.
Ne smije se prekoračiti doza od 100 mg eltrombopaga jednom dnevno.
In vitro studies also demonstrated that eltrombopag is a breast cancer resistance protein (BCRP) substrate and inhibitor (IC50 value of 2.7 μM (1.2 μg/ml).
In vitro ispitivanja su također pokazala da je eltrombopag supstrat i inhibitor proteina rezistencije raka dojke (BCRP) (IC50 vrijednost od 2,7 μM (1,2 μg/ml).
In the controlled clinical studies in chronic ITP with eltrombopag, increases in serum ALT, AST and bilirubin were observed (see section 4.4).
U kontroliranim kliničkim ispitivanjima kroničnog ITP-a s eltrombopagom, opažena su povišenja serumskog ALT-a, AST-a i bilirubina (vidjeti dio 4.4).
Make sure the lid is not on the mixing bottle.
Provjerite da poklopac nije na boci za miješanje.
Eltrombopag must not be used to normalise platelet counts.
Eltrombopag se ne smije koristiti za normalizaciju broja trombocita.
• increase of liver enzymes (aspartate aminotransferase (AST))
• porast jetrenih enzima (aspartat aminotransferaza (AST))
Platelet counts must be monitored weekly for 4 weeks following discontinuation of eltrombopag.
Broj trombocita je neophodno pratiti jednom tjedno tijekom 4 tjedna nakon prestanka uzimanja eltrombopaga.
In case of an overdose, consideration should be given to oral administration of a metal cation-containing preparation, such as calcium, aluminium, or magnesium preparations to chelate eltrombopag and thus limit absorption.
U slučaju predoziranja potrebno je razmotriti peroralnu primjenu preparata koji sadrže katione metala kao što su kalcij, aluminij ili magnezij, koji će kelirati eltrombopag i tako smanjiti njegovu apsorpciju.
Additional adverse reactions observed in paediatric studies (aged 1to 17 years).
Dodatne nuspojave uočene u pedijatrijskim ispitivanjima (u dobi od 1 do 17 godina).
Cataracts were observed in toxicology studies of eltrombopag in rodents (see section 5.3).
Pojava katarakte zamijećena je u toksikološkim studijama eltrombopaga na glodavcima (vidjeti dio 5.3).
Two phase III, randomised, double-blind, placebo-controlled studies RAISE (TRA102537) and TRA100773B and two open-label studies REPEAT (TRA108057) and EXTEND (TRA105325) evaluated the safety and efficacy of eltrombopag in adult patients with previously treated ITP.
Dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III, RAISE (TRA102537) i TRA100773B, i dvije otvorene studije REPEAT (TRA108057) i EXTEND (TRA105325), procjenjivale su djelotvornost i sigurnost eltrombopaga u odraslih bolesnika s prethodno liječenim ITP-om.
The other ingredients are: mannitol, sucralose and xanthan gum.
Drugi sastojicu su: manitol, sukraloza i ksantanska guma.
Eye examinations
Pregled očiju
In both HCV studies, a significantly greater proportion of patients treated with eltrombopag (n=201, 21%) achieved SVR compared to those treated with placebo (n=65, 13%) (see Table 7).
U oba HCV ispitivanja, značajno veći udio bolesnika koji je liječen eltrombopagom (n=201, 21%), postigao je SVR u odnosu na bolesnike koji su primali placebo (n=65, 13%) (vidjeti tablicu 7).
Patients with bleeding (WHO Grades 2-4) at any time during 6 months, n (%)
Bolesnici s krvarenjem (WHO stupanj 2-4) u bilo koje vrijeme tijekom 6 mjeseci, n (%)
PETIT (TRA108062) was a 3-part, staggered-cohort, open-label and double-blind, randomised, placebo-controlled study.
PETIT (TRA108062) je bilo ispitivanje od tri dijela, raspoređena kohorta, otvoreno i dvostruko slijepo, randomizirano, placebom kontrolirano.
Following discontinuation of eltrombopag, platelet counts return to baseline levels within 2 weeks in the majority of patients, which increases the bleeding risk and in some cases may lead to bleeding.
Nakon prekida, u većine bolesnika broj trombocita se vraća na početnu razinu unutar 2 tjedna, što povećava rizik od krvarenja, a u nekim slučajevima može dovesti i do manifestnog krvarenja.
During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/µl for at least 4 weeks) has been achieved.
Tijekom liječenja eltrombopagom, kompletnu krvnu sliku (KKS), uključujući i broj trombocita i razmaz periferne krvi, treba kontrolirati jednom tjedno do postizanja stabilnog broja trombocita (≥50 000/µl tijekom barem 4 tjedna).
Revolade 12.5 mg, 25 mg, 50 mg and 75 mg film-coated tablets:
Revolade 12,5 mg, 25 mg, 50 mg i 75 mg filmom obložene tablete:
You may be at higher risk of blood clots: as you get older if you have had to stay in bed for a long time if you have cancer if you are taking the contraceptive birth control pill or hormone replacement therapy if you have recently had surgery or received a physical injury if you are very overweight (obese) if you are a smoker if you have advanced chronic liver disease If any of these apply to you, tell your doctor before starting treatment.
Rizik od krvnih ugrušaka povećava se: što ste stariji ako ste morali duže vrijeme boraviti u krevetu ako bolujete od raka ako uzimate oralne kontraceptive ili hormonsko nadomjesno liječenje ako ste nedavno bili operirani ili ste se ozlijedili ako imate povećanu tjelesnu težinu (pretilost) ako ste pušač ako imate uznapredovalu kroničnu bolest jetre Recite liječniku prije nego započnete liječenje ako mislite da se nešto od navedenog odnosi na Vas.
• increased levels of liver enzymes (aspartate aminotransferase (AST))
• povećane razine jetrenih enzima (aspartat aminotransferaza (AST))
Eltrombopag may increase the risk for development or progression of reticulin fibres within the bone marrow.
Eltrombopag može povisiti rizik od razvoja ili progresivnog umnažanja retikulinskih niti u koštanoj srži.
Initial dose regimen
Početni režim doziranja
There are no findings in juvenile rats to suggest a greater risk of toxicity with eltrombopag treatment in paediatric vs. adult ITP patients.
Nema nalaza u juvenilnih štakora koji bi upućivali na veći rizik od toksičnosti uz liječenje eltrombopagom u pedijatrijskih u odnosu na odrasle bolesnike s ITP-om.
Absorption and bioavailability
Apsorpcija i bioraspoloživost
In clinical studies with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
U kliničkim ispitivanjima s eltrombopagom kod teške aplastične anemije, u 4% bolesnika (5/133) dijagnosticiran je MDS.
The risk of TEEs has been found to be increased in patients with chronic liver disease (CLD) treated with 75 mg eltrombopag once daily for 2 weeks in preparation for invasive procedures.
Nađen je povećani rizik za TED kod bolesnika s kroničnom bolešću jetre liječenih dozom od 75 mg eltrombopaga jednom na dan tijekom 2 tjedna priprema za invazivne zahvate.
The safety of Revolade was assessed using the pooled double-blind, placebo-controlled studies TRA100773A and B, TRA102537 (RAISE) and TRA113765, in which 403 patients were exposed to Revolade and 179 to placebo, in addition to data from the completed open-label studies TRA108057, TRA105325 (EXTEND) and TRA112940.
Sigurnost Revoladea procijenjena je pomoću udruženih dvostruko slijepih, placebom kontroliranih ispitivanja TRA100773A i B, TRA102537 (RAISE) i TRA113765, u kojima su 403 bolesnika bila izložena Revoladeu i 179 placebu, uz podatke iz završenih otvorenih ispitivanja TRA108057, TRA105325 (EXTEND) i TRA112940.
Side effects with frequency not known Frequency cannot be estimated from the available data
Učestalost se ne može procijeniti iz dostupnih podataka
Co-administration of a single dose of eltrombopag 200 mg with boceprevir 800 mg every 8 hours did not alter plasma boceprevir AUC(0-), but increased Cmax by 20%, and decreased Cmin by 32%.
Istodobna primjena jedne doze eltrombopaga od 200 mg s boceprevirom u dozi od 800 mg svakih 8 sati nije promijenila AUC(0-) boceprevira u plazmi, ali mu je povećala Cmax za 20% i smanjila Cmin za 32%.
In RAISE and TRA100773B studies, in the subgroup of ITP patients with baseline platelet count ≤15,000/μl the median platelet counts did not reach the target level (>50,000/l), although in both studies 43% of these patients treated with eltrombopag responded after 6 weeks of treatment.
U ispitivanjima RAISE i TRA100773B, u podgrupi bolesnika s ITP-om s početnim brojem trombocita ≤15 000/μl, medijan broja trombocita nije dosegao ciljnu vrijednost (>50 000/l), iako je u obje studije 43% od bolesnika liječenih eltrombopagom odgovorilo na liječenje nakon 6 tjedana.
Eltrombopag is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures.
Eltrombopag nije indiciran za liječenje trombocitopenije u bolesnika s kroničnom bolešću jetre kao priprema za invazivne postupke.
The risk-benefit balance should be considered in patients at risk of TEEs of any aetiology.
Treba razmotriti omjer rizika i koristi kod bolesnika koji imaju povećani rizik za TED-ove bilo koje etiologije.
At baseline the median platelet count was 20,000/µl, haemoglobin was 8.4 g/dl, ANC was 0.58 x 10
Na početku je medijan broja trombocita bio 20 000/μl, hemoglobin je bio 8,4 g/dl, ABN je bio 0,58 x 10
At baseline, 71% of patients in the eltrombopag group and 69% in the placebo group reported any bleeding (WHO Grades 1-4).
Na početku je 71% bolesnika u eltrombopag skupini te 69% u placebo skupini prijavilo bilo kakvo krvarenje (WHO stupanj 1-4).
When treatment is considered appropriate, caution is required when administering eltrombopag to patients with hepatic impairment (see sections 4.2 and 4.8).
Kada se liječenje smatra prikladnim, potreban je oprez kod primjene eltrombopaga kod bolesnika s oštećenjem jetre (vidjeti dijelove 4.2 i 4.8).
If you forget to take Revolade Take the next dose at the usual time.
Uzmite sljedeću dozu u uobičajeno vrijeme.
The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Drugi sastojci su: hipromeloza, makrogol 400, magnezijev stearat, manitol (E421), mikrokristalična celuloza, povidon, natrijev škroboglikolat, titanijev dioksid (E171).
• infection of the urinary system
• infekcije u mokraćnom sustavu
Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
U usporedbi sa zdravim dobrovoljcima, bolesnici s blagim oštećenjem jetre imali su približno 111% (95% CI: 45% do 283%) više vrijednosti AUC(0-) eltrombopaga u plazmi, dok su bolesnici s umjerenim oštećenjem jetre imali 183% (95% CI: 90% do 459%) više vrijednosti AUC(0-) eltrombopaga u plazmi.
Five of the 6 patients treated with eltrombopag experienced the thrombotic complication at a platelet count >200,000/µl and within 30 days of the last dose of eltrombopag.
Pet od 6 bolesnika liječenih eltrombopagom je imalo trombotičke komplikacije pri broju trombocita >200 000/µl i unutar 30 dana od posljednje doze eltrombopaga.
Sustained response was seen in 50% of the initial responders during 20 out of 24 weeks in the PETIT 2 study and 15 out of 24 weeks in the PETIT Study.
Održani odgovor je uočen kod 50% bolesnika s odgovorom na početku tijekom 20 od 24 tjedna u ispitivanju PETIT 2 i tijekom 15 od 24 tjedna u ispitivanju PETIT.
It is not known whether eltrombopag/metabolites are excreted in human milk.
Nije poznato izlučuju li se eltrombopag ili njegovi metaboliti u majčino mlijeko.
Eltrombopag was detected in the plasma of all F1 rat pups for the entire 22 hour sampling period following administration of medicinal product to the F0 dams, suggesting that rat pup exposure to eltrombopag was likely via lactation.
Eltrombopag je detektiran u plazmi svih F1 mladunaca štakora, tijekom sva 22 sata uzimanja uzoraka nakon primjene lijeka u F0 grupi, što upućuje na to da je izloženost mladunaca eltrombopagu nastupila putem mlijeka (laktacijom).
Use lowest dose of eltrombopag and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding.
Primijeniti najnižu dozu eltrombopaga i/ili popratnog ITP liječenja za održavanje broja trombocita na razini kojom se može izbjeći ili smanjiti krvarenje.
QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Produljenje QTc intervala je zabilježeno u kliničkim ispitivanjima bolesnika s ITP-om i trombocitopeničnih bolesnika s HCV-om.
When switching between the tablet and powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks.
Kada bolesnik prelazi s formulacije tablete na formulaciju praška za oralnu suspenziju, potrebno je pratiti broj trombocita svaki tjedan tijekom 2 tjedna.
Eltrombopag can be administered in addition to other ITP medicinal products.
Eltrombopag se može primijeniti uz druge lijekove za liječenje ITP-a.
The proportion of eltrombopag-treated patients with any bleeding (Grades 1-4) and clinically significant bleeding (Grades 2-4) was reduced from baseline by approximately 50% from Day 15 to the end of treatment throughout the 6-month treatment period.
Udio bolesnika liječenih eltrombopagom s bilo kojim oblikom krvarenja (stupanj 1-4) i klinički značajnim krvarenjem (stupanj 2-4) smanjen je u odnosu na početnu vrijednost za otprilike 50% od 15. dana do kraja ispitivanja, tijekom svih 6 mjeseci liječenja.
The administration of eltrombopag tablet or powder for oral suspension formulations with a highcalcium meal (e.g. a meal that included dairy products) significantly reduced plasma eltrombopag AUC0-∞ and Cmax.
Primjena eltrombopag tablete ili praška za oralnu suspenziju uz obrok s visokim udjelom kalcija (npr. obrok koji je uključivao mliječne proizvode) značajno je smanjio plazmatski AUC0-∞ i Cmax eltrombopaga.
• digestive system problems including being sick (vomiting), change in appetite (increased or decreased), stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
• tegobe s probavnim sustavom uključujući mučninu (povraćanje), promjenu apetita (povećani ili smanjeni), bol/nelagodu u trbuhu, nadutost trbuha, vjetrove, promjenu boje stolice
30 sachets.
30 vrećica.
If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate (see sections 4.4 and 4.8).
Ako se uoče nove citogenetske abnormalnosti, mora se ocijeniti je li primjeren nastavak liječenja eltrombopagom (vidjeti dijelove 4.4 i 4.8).
b p-value a a Logistic regression model adjusted for randomisation stratification variables b 21 out of 63 (33%) patients treated with eltrombopag who were taking an ITP medicinal product at baseline permanently discontinued all baseline ITP medicinal products.
b p-vrijednost a a Model logističke regresije prilagođen za varijable randomizirane u stratuse b 21 od 63 (33%) bolesnika liječenih eltrombopagom koji su uzimali druge lijekove za liječenje ITP na početku ispitivanja, trajno je prekinulo sve prethodno liječenje za ITP.
TRA115450 (PETIT2): The primary endpoint was a sustained response, defined as the proportion of patients receiving eltrombopag, compared to placebo, achieving platelet counts ≥50,000/µl for at least 6 out of 8 weeks (in the absence of rescue therapy), between weeks 5 to 12 during the double-blind randomised period.
TRA115450 (PETIT2): Mjera primarnog ishoda bila je održani odgovor, definiran kao udio bolesnika koji su primali eltrombopag, u usporedbi s placebom, i koji su postigli broj trombocita ≥50 000/µl tijekom najmanje 6 od 8 tjedana (bez simptomatske terapije), između 5. i 12. tjedna tijekom dvostruko slijepog randomiziranog razdoblja.
• Pull back on the plunger to the 20 ml mark on the syringe.
• Povucite klip natrag do oznake za 20 ml na štrcaljki.
Immune (primary) thrombocytopenia (ITP) studies
Ispitivanja imunosne (primarne) trombocitopenije (ITP)
The sachets are co-packaged in a kit with a 40 ml HDPE mixing bottle, and 30 single-use 20 ml oral dosing syringes (polypropylene/silicon rubber) with 1 ml graduations.
Vrećice su pakirane zajedno u kompletu s HDPE bočicom za miješanje od 40 ml i 30 dozirnih štrcaljki za usta od 20 ml za jednokratnu uporabu (polipropilen/silikonska guma) s oznakama od 1 ml.
Very common side effects that may show up in blood tests: • decreased number of red blood cells (anaemia)
Vrlo česte nuspojave koje se mogu vidjeti u krvnim pretragama: • smanjeni broj crvenih krvnih stanica (anemija)
Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Revolade je indiciran za liječenje bolesnika u dobi od 1 godine i starijih s primarnom imunosnom trombocitopenijom (ITP) u trajanju od 6 mjeseci ili duže od dijagnoze i koji su refrakterni na druge vidove liječenja (npr. kortikosteroide, imunoglobuline) (vidjeti dijelove 4.2 i 5.1).
Retinal haemorrhages, mostly Grade 1 or 2, have been reported in HCV patients receiving interferon, ribavirin and eltrombopag (2% of the eltrombopag group and 2% of the placebo group.
Retinalna krvarenja, većinom 1. i 2. stupnja zabilježena su u bolesnika s HCV-om koji su primali interferon, ribavirin i eltrombopag (2% u skupini koja je primala eltrombopag i 2% u placebo skupini).