natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Mircera on 20 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom Mircera, veljavno po vsej Evropski uniji, odobrila dne 20. julija 2007.
Most patients also received iron to prevent deficiency (low iron levels) during the studies.
Večina bolnikov je med študijami prejemala tudi železo za preprečevanje njegovega pomanjkanja (nizkih ravni železa).
The full EPAR for Mircera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mircera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
However, the way it interacts with the receptor is slightly different from natural erythropoietin, which gives it a longer effect.
Vendar pa je način njegove vezave na receptor nekoliko drugačen kot pri naravnem eritropoetinu, kar omogoča dolgotrajnejši učinek.
This document is a summary of the European public assessment report (EPAR) for Mircera.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mircera.
Mircera is intended for long-term use.
Zdravilo Mircera je predvideno za dolgotrajno uporabo.
Haemoglobin levels should be monitored every two weeks until they are stable, and then periodically.
Raven hemoglobina je treba preverjati vsaka dva tedna, dokler se ne ustali, kasneje pa v rednih časovnih presledkih.
In all six studies, the main measure of effectiveness was the change in haemoglobin levels.
V vseh šestih študijah je bilo glavno merilo učinkovitosti sprememba ravni hemoglobina.
Two of these studies involved patients who were starting treatment for anaemia.
Dve izmed teh študij sta vključevali bolnike, ki so se začeli zdraviti zaradi anemije.
Similar response rates were seen in the patients taking the comparator medicines.
Podobne stopnje odziva so bile pri bolnikih, ki so jemali primerjalna zdravila.
It is available in vials and in pre-filled syringes at various strengths ranging from 50 to 1,000 micrograms per millilitre.
Na voljo je v vialah in napolnjenih injekcijskih brizgah različnih jakosti v razponu od 50 do 1 000 mikrogramov na mililiter.
In patients with chronic kidney disease, the main cause of their anaemia is a lack of natural erythropoietin.
Pri bolnikih s kronično ledvično odpovedjo je glavni vzrok za anemijo pomanjkanje naravnega eritropoetina.
Treatment with Mircera must be started under the supervision of a doctor who has experience in the management of patients with kidney disease.
Zdravljenje z zdravilom Mircera je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z ledvičnim obolenjem.
Mircera can be injected under the skin or into a vein.
Zdravilo Mircera se lahko injicira pod kožo ali v veno.
The most common side effect with Mircera (seen in between 1 and 10 patients in 100) is hypertension (high blood pressure).
Najpogostejši neželeni učinek zdravila Mircera (opažen pri 1 do 10 bolnikih izmed 100) je hipertenzija (visok krvni tlak).
For more information about treatment with Mircera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mircera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Doses should be adjusted according to the patient's response, to obtain haemoglobin levels within the recommended range (between 10 and 12 grams per decilitre).
Odmerke je treba prilagoditi glede na bolnikov odziv, da se doseže raven hemoglobina v priporočenem razponu (od 10 do 12 gramov na deciliter).
Mircera has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease.
Zdravilo Mircera so proučevali v šestih glavnih študijah, ki so vključevale skupaj 2 399 odraslih z anemijo, povezano s kroničnim ledvičnim obolenjem.
As a result, Mircera can be given less often than natural erythropoietin.
Zato se lahko zdravilo Mircera daje manj pogosto kot naravni eritropoetin.
What benefit has Mircera shown during the studies?
Kakšne koristi je zdravilo Mircera izkazalo med študijami?
In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients on dialysis, and 158 (98%) of the 162 not on dialysis had a significant increase in haemoglobin levels with Mircera.
V študijah z bolniki, ki so se prvič začeli zdraviti zaradi anemije in so jemali zdravilo Mircera, je bilo pri 126 (93 %) izmed 135 bolnikov na dializi,in pri 158 (98 %) izmed 162 bolnikov, ki niso bili na dializi, ugotovljeno pomembno povečanje koncentracije hemoglobina.
The Committee decided that Mircera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Mircera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production.
Druge štiri študije (s 1 894 bolniki) so izvajali z bolniki na dializi, ki so že predhodno prejemali zdravila za stimulacijo tvorjenja rdečih krvničk.
Mircera is used to treat anaemia (low red blood cell counts) that is causing symptoms in adults with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Zdravilo Mircera se uporablja za zdravljenje anemije (nizkega števila rdečih krvničk), ki povzroča simptome pri odraslih s kroničnim ledvičnim obolenjem (dolgotrajnim, postopnim zmanjšanjem sposobnosti pravilnega delovanja ledvic).
Other information about Mircera:
Druge informacije o zdravilu Mircera
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mircera.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mircera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In these studies, patients either remained on the medicines they were already receiving, or changed to Mircera, injected into a vein or under the skin every two or four weeks.
V teh študijah so bolniki še naprej jemali zdravila, ki so jih že prejemali, ali pa namesto njih jemali zdravilo Mircera, injicirano v veno ali pod kožo vsaka dva ali štiri tedne.
In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to Mircera maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines.
V študijah z bolniki, ki so že prejemali zdravila za stimulacijo tvorjenja rdečih krvničk, so se pri bolnikih, ki so prešli na zdravilo Mircera, koncentracije hemoglobina vzdrževale enako učinkovito kot pri bolnikih, ki so še naprej jemali obstoječa zdravila.
What is the risk associated with Mircera?
Kakšna tveganja so povezana z zdravilom Mircera?
The CHMP concluded that Mircera corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins.
CHMP je sklenil, da zdravilo Mircera uravnava in vzdržuje koncentracijo hemoglobina pri bolnikih s kroničnim ledvičnim obolenjem in da so njegovi učinki primerljivi z učinki drugih epoetinov.
Mircera methoxy polyethylene glycol-epoetin beta
Mircera metoksipolietilenglikol epoetin beta
The epoetin beta is produced by ‘recombinant DNA technology': it is made by a cell that has received a gene, which makes it able to produce epoetin beta.
Epoetin beta se proizvaja s „tehnologijo rekombinantne DNK“, pri kateri celica prejme gen, s katerim lahko tvori epoetin beta.
For the full list of all side effects reported with Mircera, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Mircera, glejte navodilo za uporabo.
The first study, in 181 patients on dialysis (a blood clearance technique used in advanced kidney disease), looked at Mircera injected into a vein every two weeks over 24 weeks and compared it with epoetin alfa or beta.
V prvi študiji s 181 bolniki na dializi (tehniki čiščenja krvi, ki se uporablja pri napredovalem ledvičnem obolenju) so 24 tednov proučevali zdravilo Mircera, injicirano v veno vsaka dva tedna, in ga primerjali z epoetinom alfa ali beta.
Why has Mircera been approved?
Zakaj je bilo zdravilo Mircera odobreno?
The second study, in 324 patients not on dialysis, looked at Mircera injected under the skin every two weeks over 28 weeks, comparing it with darbepoetin alfa.
V drugi študiji s 324 bolniki, ki niso bili na dializi, so 28 tednov proučevali zdravilo Mircera, injicirano pod kožo vsaka dva tedna, in ga primerjali z darbepoetinom alfa.
Mircera must not be used in people who are hypersensitive (allergic) to methoxy polyethylene glycolepoetin beta or any of the other ingredients.
Zdravila Mircera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) metoksipolietilenglikol epoetin beta ali katero koli drugo sestavino zdravila.
The active substance in Mircera, methoxy polyethylene glycol-epoetin beta, works like natural erythropoietin to stimulate red blood cell production, because it can attach itself to the same receptors as erythropoietin.
Zdravilna učinkovina zdravila Mircera, metoksipolietilenglikol epoetin beta, deluje kot naravni eritropoetin pri stimulaciji tvorjenja rdečih krvničk, ker se lahko veže na iste receptorje kot eritropoetin.
The second study showed that patients taking Mircera and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/dl).
Druga študija je pokazala, da je bilo pri bolnikih, ki so jemali zdravilo Mircera, in bolnikih, ki so jemali darbepoetin alfa, opaženo podobno povečanje ravni hemoglobina (približno 2 g/dl).
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon eritropoetin spodbuja nastajanje rdečih krvnih celic iz kostnega mozga.
Mircera was compared with other medicines used to stimulate red blood cell production.
Primerjali so ga z drugimi zdravili, ki se uporabljajo za stimulacijo tvorjenja rdečih krvničk.
There was no overall change in haemoglobin levels over the course of these studies with any of the treatments.
Med trajanjem študij ni bila pri nobenem zdravljenju opažena sprememba koncentracije hemoglobina.
The dose and the frequency of dosing depend on whether or not Mircera is replacing another medicine used to stimulate the production of red blood cells.
Odmerek in pogostost odmerjanja sta odvisna od tega, ali zdravilo Mircera nadomešča drugo zdravilo, ki se uporablja za stimulacijo tvorbe rdečih krvničk, ali ne. Za podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Mircera is a solution for injection that contains the active substance methoxy polyethylene glycolepoetin beta.
Zdravilo Mircera je raztopina za injiciranje, ki vsebuje zdravilno učinkovino metoksipolietilenglikol epoetin beta.
The active substance in Mircera is made up of epoetin beta attached to a chemical called methoxypolyethylene glycol.
Zdravilna učinkovina zdravila Mircera je sestavljena iz epoetina beta, vezanega na kemijsko snov, imenovano metoksipolietilenglikol.
What is Mircera used for?
Za kaj se zdravilo Mircera uporablja?
Mircera was as effective as the comparator medicines in correcting and maintaining haemoglobin levels.
Zdravilo Mircera je bilo pri uravnavanju in vzdrževanju koncentracije hemoglobina enako učinkovito kot primerjalna zdravila.
How has Mircera been studied?
Kako je bilo zdravilo Mircera raziskano?
How is Mircera used?
Kako se zdravilo Mircera uporablja?
What is Mircera?
Kaj je zdravilo Mircera?
Invasive procedure was performed between Days 9 and 14.
Invazivni postopek so opravili med 9. in 14. dnem.
Your treatment will start at least 8 days before your surgery or procedure.
Vaše zdravljenje se bo začelo vsaj 8 dni pred vašo operacijo ali posegom.
It can be taken with or without food.
Lahko se vzame s hrano ali brez nje.
The risk may be increased due to an invasive procedure.
Tveganje se lahko zveča zaradi invazivnega posega.
Recommended dose: take one tablet once a day, at the same time each day, for seven days only.
Priporočeni odmerek: jemljite po eno tableto enkrat na dan, vsak dan ob istem času, samo sedem dni.
You can take it with food or between meals.
Lahko jo vzamete s hrano ali med enim in drugim obrokom.
Human plasma protein binding ratio is ≥ 99.9%.
Delež vezave na človeške plazemske beljakovine je ≥ 99,9 %.
Therefore, a risk to the breast-feeding child cannot be excluded.
Zato tveganja za dojenca ni mogoče izključiti.
- Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
- Povejte zdravniku, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
Total - n - Median (days) - (Q1, Q3) - P value [a]
Skupaj - n - Mediana (dni) - (Q1, Q3) - Vrednost p [a]
The p value and confidence interval were calculated using the Wald method.
Vrednost p in interval zaupanja sta bila izračunana po Waldovi metodi.
The effect of Mulpleo during pregnancy is not known.
Učinek zdravila Mulpleo med nosečnostjo ni znan.
In the analysis for pooled data, study was added as a stratum.
V analizi združenih podatkov je bila študija dodana kot stratum.
Do not give this medicine to children or adolescents under the age of 18 years, because the medicine has not been studied in children and adolescents.
Otroci in mladostniki Tega zdravila ne dajajte otrokom ali mladostnikom, mlajšim od 18 let, ker pri otrocih in mladostnikih tega zdravila niso proučevali.
If you forget to take a tablet
Če ste pozabili vzeli tableto
Patients with body weight <45 Kg
Bolniki s telesno maso <45 kg
The medicine helps to increase the number of platelets in your blood.
Zdravilo pomaga zvečati število krvnih ploščic v vaši krvi.
Platelets are blood components that help the blood to clot and so prevent bleeding.
Krvne ploščice so sestavine krvi, ki pomagajo pri strjevanju krvi in tako preprečujejo krvavitev.
Kingsfordweg 151, 1043GR Amsterdam The Netherlands
Kingsfordweg 151, 1043GR Amsterdam Nizozemska
The film-coated tablet is to be taken once daily with liquid, swallowed whole and should not be chewed, divided, or crushed.
Filmsko obloženo tableto je treba vzeti enkrat na dan s tekočino, jo pogoltniti celo in je ni dovoljeno žvečiti, razdeliti ali zdrobiti.
Comparison with placebo [b]: Difference of proportion (95% CI)
Primerjava s placebom [b]: razlika deležev (95 % IZ)
If possible, show them the pack, or this leaflet.
Če je mogoče, jim pokažite pakiranje zdravila ali to navodilo.
The safety and efficacy of lusutrombopag in children and adolescents (< 18 years of age) have not been established.
Varnost in učinkovitost lusutrombopaga pri otrocih in mladostnikih (starih < 18 let) nista bili dokazani.
Co-administration with interferon preparations
Uporaba skupaj s pripravki interferona
Food interaction
Interakcija s hrano
Do not take Mulpleo: - if you are allergic to lusutrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘What Mulpleo contains').
Ne jemljite zdravila Mulpleo: - če ste alergični na lusutrombopag ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6 pod ‘Kaj vsebuje zdravilo Mulpleo').
Take the tablet with a liquid and swallow it whole.
Tableto vzemite s tekočino in jo pogoltnite celo.
If you miss a tablet of Mulpleo, take it as soon as you remember on the same day.
Če ste pozabili vzeti tableto zdravila Mulpleo, jo vzemite istega dne takoj, ko se spomnite.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1348
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1348
All 3 received 7 days of treatment with lusutrombopag.
Vsi 3 so prejeli 7 dni zdravljenja z lusutrombopagom.
Paediatric population No pharmacokinetic data have been obtained in children.
Pediatrična populacija Pri otrocih niso pridobili farmakokinetičnih podatkov.
The procedure should be performed from day 9 after the start of lusutrombopag treatment.
Poseg je treba opraviti po 9. dnevu od začetka zdravljenja z lusutrombopagom.
Do not stop taking Mulpleo without talking to your doctor and do not take Mulpleo for more than 7 days.
Ne prenehajte jemati zdravila Mulpleo, ne da bi se pogovorili z zdravnikom in zdravila Mulpleo ne jemljite dalj kot 7 dni.
• sudden shortness of breath, especially with sharp pain in the chest or rapid breathing
• nenadna zasoplost, posebno sočasno z ostro bolečino v prsnem košu ali hitrim dihanjem;
You may be monitored for side effects associated with excessive platelets such as blood clots (see section 2, ‘Warnings and precautions', and section 4, ‘Possible side effects').
Mogoče vas bodo opazovali glede neželenih učinkov, povezanih s čezmernim številom krvnih ploščic, na primer krvnih strdkov (glejte poglavje 2, ‘Opozorila in previdnostni ukrepi', in poglavje 4, ‘Možni neželeni učinki').
What Mulpleo is and what it is used for
Kaj je zdravilo Mulpleo in za kaj ga uporabljamo
LUSU = lusutrombopag; Q1 = 25th percentile; Q3 = 75th percentile [a] P-value was calculated by the van Elteren test with platelet transfusion status as stratum.
LUSU = lusutrombopag; Q1 = 25. percentil; Q3 = 75. percentil [a] Vrednost p je bila izračunana z van Elternovim testom s statusom transfuzije trombocitov kot stratumom.
Signs of a blood clot: look out for any of the signs below:
Znaki krvnega strdka: bodite pozorni na tele znake:
Thus, the data from the toxicology program in these animals do not present potential adverse effects related to exaggerated pharmacology in humans.
Zato podatki iz toksikološkega programa pri teh živalih niso pokazali možnih neželenih učinkov, povezanih s pretiranim farmakološkim odzivom pri ljudeh.
Mulpleo is used to reduce the risk of bleeding during surgery and other procedures (including tooth extractions and endoscopy).
Zdravilo Mulpleo se uporablja za zmanjšanje nevarnosti krvavitve med operacijo in drugimi posegi (vključno z izdrtjem zob in endoskopijo).
The recommended dose is 3 mg lusutrombopag once daily for 7 days.
Odmerjanje Priporočeni odmerek je 3 mg lusutrombopaga enkrat na dan 7 dni.
If you have taken more Mulpleo than you should, talk to your doctor or go to the hospital.
Če ste vzeli več zdravila Mulpleo, kot bi ga smeli, se pogovorite z zdravnikom ali pojdite v bolnišnico.
Environmental risk assessment studies have shown that lusutrombopag has the potential to be very persistent, very bioaccumulative and toxic to the environment.
Ocena tveganja za okolje (Environmental Risk Assessment - ERA) Študije tveganja za okolje so pokazale, da je lusutrombopag zelo trdovraten, zelo bioakumulativen in toksičen za okolje.
Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX07
Farmakoterapevtska skupina: Antihemoragiki, drugi hemostatiki za sistemsko zdravljenje, oznaka ATC: B02BX07.
These patients should be clinically monitored when treated with lusutrombopag.
Te bolnike je treba klinično spremljati, kadar jih zdravimo z lusutrombopagom.
[b] Cochran-Mantel-Haenszel test with baseline platelet count as stratum.
[b] Cochran-Mantel-Haenszlov test z izhodiščnim številom trombocitov kot stratumom.
Geometric mean (%CV) other than for Tmax, which is median (range).
Geometrična sredina (% CV (odstotni koeficient variacije)), razen za Tmax, ki je mediana (razpon).
Since the protein-binding rate in serum of lusutrombopag is high, haemodialysis is not thought to be effective.
Ker je stopnja vezave lusutrombopaga na beljakovine v serumu velika, menimo, da hemodializa ni učinkovita.
It is given to adults who have low numbers of platelets because of chronic liver disease.
Dajejo ga odraslim, ki imajo majhno število krvnih ploščic zaradi kronične bolezni jeter.
Platelet counts should be measured frequently and the condition of patients should be observed closely.
Pogosto je treba meriti število trombocitov in skrbno opazovati bolnikovo stanje.
Lusutrombopag is rarely excreted into urine (approximately 1%).
Lusutrombopag se zelo malo izloča z urinom (približno 1 %).
Do not breast-feed during treatment with Mulpleo, as it is not known if the medicine passes into milk.
Ne dojite med zdravljenjem z zdravilom Mulpleo, ker ni znano, ali zdravilo prehaja v mleko.
Eight lusutrombopag-treated subjects and 2 placebo-treated subjects received less than 7 days of treatment as they met the criterion for a responder prior to Day 7.
Osem bolnikov, zdravljenih z lusutrombopagom, in 2 bolnika, ki sta prejemala placebo, so prejeli manj kot 7 dni zdravljenja, ker so pred 7. dnem izpolnili merilo za odziv na zdravljenje.
If you have severe liver disease, tell your doctor before taking Mulpleo.
Če imate hudo bolezen jeter, povejte zdravniku, preden vzamete zdravilo Mulpleo.
What Mulpleo is and what it is used for What you need to know before you take Mulpleo How to take Mulpleo
Kaj je zdravilo Mulpleo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Mulpleo Kako jemati zdravilo Mulpleo
Meanwhile, the short thoracolumbar supernumerary ribs were observed at doses without maternal toxicity.
medtem ko so kratka torakolumbalna nadštevilna rebra ugotavljali pri odmerkih brez toksičnosti za mater.
If a dose is missed it should be taken as soon as possible.
Če bolnik kak odmerek izpusti, ga mora vzeti čimprej.
No dosage adjustment is expected for these patients.
Pri teh bolnikih ne pričakujemo, da bo treba odmerek prilagoditi.
Do not change the dose or schedule for taking Mulpleo unless your doctor or pharmacist tells you to.
Ne spreminjajte odmerka ali časovnega razporeda jemanja zdravila Mulpleo, če vam zdravnik ali farmacevt ne naroči drugače.
Study drug was administered orally for up to 7 days.
Raziskovano zdravilo so dajali peroralno do 7 dni.
Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use.
O interakcijah med zdravili preko inhibicije in indukcije katerih koli encimov CYP4A v klinični uporabi niso poročali.
If you stop taking Mulpleo
Če ste prenehali jemati zdravilo Mulpleo
PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 7 filmsko obloženih tablet
Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts.
Potrebna je previdnost glede trombemboličnih dogodkov in to tako po invazivnih posegih kot tudi po zdravljenju ne glede na število trombocitov.
In rats, lusutrombopag and its metabolites are excreted in milk, and the concentrations in milk decreased as with those in plasma.
Pri podganah se lusutrombopag in njegovi presnovki izločajo v mleko, koncentracije v mleku pa so se zmanjšale tako kot koncentracije v plazmi.
The key secondary endpoints in Studies M0631 and M0634 were
Ključni sekundarni končni stanji v študijah M0631 in M0634 sta bili
Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering lusutrombopag with interferon preparations.
Znano je, da pripravki interferona zmanjšajo število trombocitov, zato je treba to upoštevati, kadar dajemo lusutrombopag skupaj s pripravki interferona.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Zdravilo Mulpleo vsebuje malo natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
Platelet Count (*10^4/uL)
Število trombocitov (*10^4/ul)
Lusutrombopag is absorbed with a peak concentration occurring 6 to 8 hours after oral administration.
Absorpcija Lusutrombopag se absorbira z najvišjo koncentracijo, ki nastopi 6 do 8 ur po peroralnem dajanju.
The pharmacokinetics of lusutrombopag was similar in both healthy subjects and the chronic liver disease population.
Farmakokinetika lusutrombopaga je bila podobna tako pri zdravih osebah kot v populaciji s kronično boleznijo jeter.