natgillin/translations-raw huggingface dataset:
500 mg/ml oral drops, solution (1 ml = 20 drops) Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg 50 mg/ml syrup 
Lijek nemojte davati dojenčadi tijekom prva 3 mjeseca života ili bolesnicima težine manje od 5 kg Sirup od 50 mg/ml
2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to <invented name>. 
Otopina za injekciju/infuziju od 2 000 mg/5ml (tj. 400 mg/ml) Doziranje se određuje prema intenzitetu boli ili vrućice i individualnom odgovoru na <zaštićeno ime>.
A clear effect can be expected 30 to 60 minutes after oral administration. 
Jasan učinak može se očekivati od 30 do 60 minuta nakon peroralne primjene.
<12 months 1-5 1-3 years 
≥ 15 godina 1 - 2
10-12 years 13-18 13-14 years 18-21 
9 - 15 1 - 3 godine 4 - 6 16 - 23 4 - 6 godina 6 - 9 24 - 30 7 - 9 godina 10 - 12 31 - 45 10 - 12 godina 13 - 18 46 - 53 13 - 14 godina 18 - 21
500 mg/ml oral drops, solution (1 ml = 20 drops) Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to <invented name>. 
Otopina za injekciju/infuziju od 500 mg/ml Doziranje se određuje prema intenzitetu boli ili vrućice i individualnom odgovoru na <zaštićeno ime>.
18 September 2017 
18. rujna 2017.
Your doctor will tell you exactly how many capsules to take. 
Liječnik će Vam reći koliko točno kapsula trebate uzeti.
9/l, as recommended in Tables 1 and 2. 
9/l, kako je preporučeno u Tablicama 1 i 2.
PA/Al/PVC-Al blisters. 
PA/Al/PVC-Al blisteri.
*Confirmation period for responses: 12 weeks 
*Razdoblje za potvrdu odgovora: 12 tjedana
Elderly (≥65 years) 
Starije osobe (≥ 65 godina)
There are no adequate and well-controlled studies in pregnant women. 
Nema odgovarajućih i dobro kontroliranih ispitivanja u trudnica.
They may differ from the general information in this leaflet. 
One se mogu razlikovati od općih informacija u ovoj uputi.
Instead, wait until it is time for your next dose. 
Umjesto toga, pričekajte dok ne bude vrijeme za sljedeću dozu.
Follow the doctor's instructions carefully. 
Slijedite pažljivo upute liječnika.
Do not stop taking your medicine unless your doctor tells you to do so. 
Nemojte prestati uzimati svoj lijek, osim ako Vam liječnik ne kaže da to učinite.
Safety profile during maintenance phase 
Profil sigurnosti tijekom faze održavanja
Taking this medicine - Taking Rydapt at the same time each day will help you to remember to take your medicine. 
Uzimanje ovog lijeka - Uzimanje Rydapta u isto vrijeme svakoga dana pomoći će Vam da se sjetite uzeti lijek.
Induction, consolidation and maintenance 
Indukcija, konsolidacija i održavanje
NE: Not Estimated, NR: Not Reached 
NP: nije procijenjen, NO: nije ostvaren
Your doctor will discuss with you the most suitable method of contraception for you to use. 
Liječnik će razgovarati s Vama o najprikladnijoj metodi kontracepcije za Vas.
- Take Rydapt with food. 
- Uzimajte Rydapt uz obrok.
It is very important to follow your doctor's recommendations. 
Vrlo je važno da slijedite preporuke svoga liječnika.
Only 4% of the dose is recovered in urine. 
Samo 4% doze izlučuje se urinom.
Rydapt may reduce fertility in men and women. 
Rydapt može smanjiti plodnost u muškaraca i žena.
Rydapt should not be used in children and adolescents because it is not known whether it is safe and effective in this age group. 
Rydapt se ne smije koristiti u djece i adolescenata zato što nije poznato je li siguran i učinkovit u toj dobnoj skupini.
One blister contains 4 soft capsules. 
Jedan blister sadrži 4 meke kapsule.
All responses were considered and required a 12-week confirmation (see Table 8). 
Razmatrali su se svi odgovori i trebali su biti potvrđeni tijekom 12 tjedana (vidjeti Tablicu 8).
you will receive Rydapt alone for up to 12 months. 
primat ćete samo Rydapt u trajanju do 12 mjeseci.
The dimensions of the capsule are approximately 25.4 x 9.2 mm. 
Dimenzije kapsule su približno 25,4 x 9,2 mm.
No carcinogenicity studies have been performed. 
Nisu provedena ispitivanja karcinogenosti.
For all other adverse events, only grades 3 and 4 were collected. 
Za sve druge štetne događaje prikupljeni su samo oni 3. i 4. stupnja.
Responses to midostaurin are shown in Table 7. 
Odgovori na midostaurin prikazani su u Tablici 7.
- Take Rydapt twice a day at about 12-hour intervals (for example, with breakfast and with your evening meal). 
- Uzimajte Rydapt dvaput na dan u razmacima od oko 12 sati (na primjer, uz doručak i uz večernji obrok).
If you take more Rydapt than you should 
Ako uzmete više Rydapta nego što ste trebali
How long to take Rydapt - Continue taking Rydapt for as long as your doctor tells you. 
Koliko dugo uzimati Rydapt - Nastavite uzimati Rydapt dokle god Vam tako kaže liječnik.
Reported experience with overdose in humans is very limited. 
Zabilježena iskustva s predoziranjem u ljudi vrlo su ograničena.
You should discuss this with your doctor before starting treatment. 
Trebate razgovarati o tome sa svojim liječnikom prije nego započnete liječenje.
Activity was observed regardless of number of prior therapies, and presence or absence of an AHN. 
Aktivnost je opažena bez obzira na broj prethodnih terapija i prisutnost ili odsutnost AHN-a.
The primary analysis was conducted after a minimum follow-up of approximately 3.5 years after the randomisation of the last patient. 
Primarna analiza provedena je nakon najmanjeg praćenja od otprilike 3,5 godine nakon randomizacije zadnjeg bolesnika.
Contraception in women 
Kontracepcija kod žena
Rydapt could harm your baby. 
Rydapt može naškoditi Vašem djetetu.
The capsules should be taken with food (see sections 4.5 and 5.2). 
Kapsule treba uzeti s hranom (vidjeti dijelove 4.5 i 5.2).
Most of the events occurred within the first 6 months of treatment and were managed with supportive prophylactic medicinal products. 
Do većine događaja došlo je unutar prvih 6 mjeseci liječenja, a zbrinuti su suportivnim profilaktičkim lijekovima.
Analysis excludes ascites as a C-finding. 
Analiza isključuje ascites kao C-nalaz.
The median duration of follow-up was 43 months. 
Medijan trajanja praćenja bio je 43 mjeseca.
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. 
Liječenje treba nastaviti dokle god se može uočiti klinička korist ili dok se ne pojavi neprihvatljiva toksičnost.
Not significant 
Nije značajno
There are no data on the effect of Rydapt on human fertility. 
Nema podataka o učinku Rydapta na ljudsku plodnost.
The median duration of follow-up was 73 months, and the median duration of response has not been reached. 
Medijan trajanja praćenja bio je 73 mjeseca, a medijan trajanja odgovora nije bio postignut.
Do not exceed the dose prescribed by your doctor. 
Nemojte premašiti dozu koju Vam je propisao liječnik.
any time during induction (%) 
bilo kad tijekom indukcije (%)
- if you have problems with your lungs or problems breathing. 
- ako imate probleme s plućima ili probleme s disanjem.
Disturbance in attention 
Poremećaj pažnje često
Rydapt may harm your unborn baby and is not recommended during pregnancy. 
Rydapt može naškoditi nerođenom djetetu i ne preporučuje se tijekom trudnoće.
Midostaurin and its metabolites are distributed mainly in plasma rather than red blood cells. 
Midostaurin i njegovi metaboliti distribuiraju se uglavnom u plazmi, a ne u crvenim krvnim stanicama.
Most of the side effects are mild to moderate and will generally disappear after a few weeks of treatment. 
Većina nuspojava blaga je do umjerena i općenito će nestati nakon nekoliko tjedana liječenja.
This is because Rydapt can affect the way some medicines work. 
Razlog tome je što Rydapt može utjecati na način na koji neki lijekovi djeluju.
Time to peak concentration was also delayed in the presence of a high-fat meal. 
Vrijeme do vršne koncentracije također je bilo odgođeno uz prisutnost obroka s visokim udjelom masti.
For trial sites in North America, all grades were collected for 13 pre-specified adverse events. 
Za ispitivačke centre u Sjevernoj Americi, svi su stupnjevi bili prikupljeni za 13 unaprijed određenih štetnih događaja.
Safety pharmacology and single/repeat dose toxicity 
Sigurnosna farmakologija i toksičnost jednokratne/ponovljenih doza
This is equivalent to 8.4 ml beer or 3.5 ml wine. 
To je jednako kao 8,4 ml piva ili 3,5 ml vina.
Of the 116 patients enrolled, 89 were considered eligible for response assessment and constituted the primary efficacy population. 
Od 116 uključenih bolesnika, 89 se smatralo prikladnima za procjenu odgovora i sačinjavalo je populaciju za utvrđivanje primarne djelotvornosti.
The capsules should be swallowed whole with a glass of water. 
Kapsule se moraju progutati cijele uz čašu vode.
No. of patients still at risk 
of patients still at risk
QTc interval >500 msecs 
QTc interval > 500 msec
What Rydapt is and what it is used for What you need to know before you take Rydapt How to take Rydapt 
Što je Rydapt i za što se koristi Što morate znati prije nego počnete uzimati Rydapt Kako uzimati Rydapt
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above. 
Upitajte svog liječnika ili ljekarnika ako niste sigurni je li Vaš lijek jedan od prethodno navedenih lijekova.
Rydapt is recommended to be administered with food. 
Rydapt se preporučuje primjenjivati s hranom.
Lack of a major response (MR) or partial response (PR) by the end of the second cycle required discontinuation from the study treatment. 
U slučaju nedostatka velikog odgovora (MR, engl. major response) ili djelomičnog odgovora (PR, engl. partial response) do kraja drugog ciklusa bila je nužna obustava ispitivane terapije.
If you become pregnant while taking Rydapt, it may harm your baby. 
Ako zatrudnite dok uzimate Rydapt, to bi moglo naškoditi Vašem djetetu.
The two treatment groups were generally balanced with respect to the baseline demographics of disease characteristics. 
Dvije terapijske skupine bile su općenito uravnotežene s obzirom na početne demografske karakteristike i karakteristike bolesti.
The maximum concentration was reached between 2 and 3 hours after administration after single or repeated doses for all groups. 
Maksimalna koncentracija ostvarena je između 2 i 3 sata nakon primjene jednokratne doze ili ponovljenih doza za sve skupine.
Race/ethnicity 
Rasa/etnička pripadnost
Do not take Rydapt: - if you are allergic to midostaurin or to any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati Rydapt: - ako ste alergični na midostaurin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
It belongs to a class of medicines called protein kinase inhibitors. 
Pripada skupini lijekova koji se nazivaju inhibitorima protein kinaze.
Pregnant women should be advised of the potential risk to the foetus. 
Trudnice je potrebno obavijestiti o mogućem riziku za fetus.
- Swallow the capsules whole with a glass of water. 
- Progutajte cijele kapsule uz čašu vode.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. 
Vaše stanje kako bi provjerio ima li liječenje željeni učinak.
There were no effects on physical development, sensory function or behavioural function. 
Nije bilo učinaka na fizički razvoj, senzornu funkciju ili bihevioralnu funkciju.
What you need to know before you take Rydapt 
Što morate znati prije nego počnete uzimati Rydapt
Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy 
Mučnina i/ili povraćanje 3./4. stupnja usprkos optimalnoj antiemetičkoj terapiji
Major response, n 
Veliki odgovor, n
The overall incidence of ADRs during the maintenance phase was generally lower than during the induction and consolidation phase. 
Ukupna incidencija nuspojava tijekom faze održavanja bila je općenito niža nego tijekom indukcijske i konsolidacijske faze.
Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance. 
Profilaktički antiemetici moraju se primjenjivati u skladu s lokalnom medicinskom praksom ovisno o bolesnikovoj podnošljivosti.
AUCtau was decreased by 28% and 20% on day 7, respectively. 
AUCtau se smanjio za 28% odnosno za 20% 7. dana.
Single doses of up to 600 mg have been given with acceptable acute tolerability. 
Jednokratne doze do 600 mg davale su se s prihvatljivom akutnom podnošljivošću.
Finally, the long-term data from patients were analysed using a population pharmacokinetic approach. 
Naposljetku, dugoročni podaci o bolesnicima analizirani su pristupom populacijske farmakokinetike.
If you become pregnant or think you are pregnant, tell your doctor right away. 
Ako zatrudnite ili mislite da ste trudni, odmah obavijestite svog liječnika.
The protocol includes a comprehensive collection of baseline data (including biomarkers), post-study treatments, and evaluation of minimal residual disease (MRD). 
Protokol uključuje sveobuhvatno skupljanje početnih podataka (uključujući biomarkere), liječenje nakon ispitivanja i procjenu minimalne rezidualne bolesti (MRD).
Some other medicines can also affect how Rydapt works. 
Neki drugi lijekovi također mogu utjecati na to kako Rydapt djeluje.
NE 
No.
Median overall survival was 40.0 months (patients were only followed up for one year after treatment discontinuation for survival). 
Medijan ukupnog preživljenja bio je 40,0 mjeseci (u bolesnika se preživljenje pratilo samo godinu dana nakon obustave liječenja).
Rydapt (100 mg twice daily) N=142 
Rydapt (100 mg dvaput na dan) N=142
Your heart and lung function will also be checked regularly. 
Redovito će Vam se kontrolirati i funkcija pluća i srca.
The median time to response was 0.3 months (range: 0.1 to 3.7 months). 
Medijan vremena do odgovora bio je 0,3 mjeseca (raspon: 0,1 do 3,7 mjeseci).
Of the patients with race information reported, 88.1% were Caucasian. 
Od bolesnika za koje su prijavljeni podaci o rasi, 88,1% bili su bijelci.
QTc interval >470 msecs and ≤500 msecs 
QTc interval > 470 msec i ≤ 500 msec
Response to Rydapt was determined using a computational algorithm applied without any adjudication. 
Odgovor na Rydapt utvrđen je pomoću komputacijskog algoritma primijenjenog bez ikakvog prosuđivanja.
These medicines must be avoided during treatment with Rydapt. 
Ovi se lijekovi moraju izbjegavati tijekom liječenja Rydaptom.
The safety and efficacy of Rydapt in children and adolescents below 18 years have not been established (see section 5.1). 
Sigurnost i djelotvornost Rydapta u djece i adolescenata mlađih od 18 godina nisu ustanovljene (vidjeti dio 5.1).
- Patients with AML 
- Bolesnici s AML-om
Your doctor will ask you to take a pregnancy test before you start treatment with Rydapt to make sure you are not pregnant. 
Liječnik će Vas zamoliti da napravite test na trudnoću prije nego počnete liječenje Rydaptom kako biste bili sigurni da niste trudni.
In vitro evaluation of drug-drug interaction potential 
In vitro evaluacija potencijala interakcije između lijekova
Depending on how you respond to Rydapt, your doctor may lower your dose or temporarily interrupt the treatment. 
Ovisno o Vašem odgovoru na Rydapt, liječnik Vam može sniziti dozu ili privremeno prekinuti liječenje.
Any active serious infection should be under control prior to starting treatment with Rydapt monotherapy. 
Svaka aktivna ozbiljna infekcija treba biti pod kontrolom prije početka monoterapije Rydaptom.
The KIT D816V mutation was detected in 82% of patients. 
KIT D816V mutacija detektirana je u 82% bolesnika.
Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding). 
Od 116 bolesnika, 113 je imalo C-nalaz definiran kriterijima IWG-a za odgovor (isključujući ascites kao C-nalaz).
Response rates were assessed based on the modified Valent and Cheson criteria and responses were adjudicated by a study steering committee. 
Stope odgovora bile su procijenjene na temelju modificiranih kriterija Valenta i Chesona, a odgovore je prosudio upravni odbor za ispitivanje.
The primary endpoint was ORR evaluated by the Valent criteria during the first two cycles of treatment. 
Mjera primarnog ishoda bio je ORR ocijenjen prema Valentovim kriterijima tijekom prva dva ciklusa liječenja.
The primary endpoint was overall response rate (ORR). 
Mjera primarnog ishoda bila je ukupna stupa odgovora (ORR, engl. overall response rate).
These are disorders in which the body produces too many mast cells, a type of white blood cell. 
To su poremećaji kod kojih tijelo proizvodi previše mastocita, vrste bijelih krvnih stanica.
Patients with symptomatic congestive heart failure were excluded from clinical studies. 
Bolesnici sa simptomatskim kongestivnim zatajenjem srca bili su isključeni iz kliničkih ispitivanja.
If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm. 
Ako koristite hormonski kontraceptiv, morate također koristiti mehaničku metodu kontracepcije kao što je kondom ili dijafragma.
Other medicines and Rydapt 
Drugi lijekovi i Rydapt
Take special care when driving and using machines as you may develop dizziness and vertigo while you are taking Rydapt. 
Budite posebno oprezni kad upravljate vozilima i strojevima budući da možete osjetiti omaglicu i vrtoglavicu dok uzimate Rydapt.
Rydapt is not recommended to be used in children and adolescents (see section 4.2). 
Rydapt se ne preporučuje za upotrebu u djece i adolescenata (vidjeti dio 4.2).
In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM. 
In vitro midostaurin nije inhibirao aktivnost hERG kanala do granice topivosti od 12 µM.
What Rydapt is and what it is used for 
Što je Rydapt i za što se koristi
- Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering. 
- Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvo oštećenje pakiranja ili ako ima znakova neovlaštenog otvaranja.
Probability of Survival (%) 
Vjerojatnost preživljenja (%)
There is no known specific antidote for midostaurin. 
Ne postoji specifičan antidot za midostaurin.
Mating index, fertility index and conception rates were reduced at 0, 5 and 15 mg/kg/day, but not at 2 mg/kg/day. 
Indeks parenja, indeks plodnosti i stope začeća bile su smanjene pri 0, 5 i 15 mg/kg/dan, ali ne pri 2 mg/kg/dan.
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first, using the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Unutar svakog organskog sustava nuspojave su poredane po učestalosti, počevši od najučestalijih, prema sljedećoj konvenciji (CIOMS III): vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Stopping your treatment with Rydapt may cause your condition to become worse. 
Prekidanje liječenja Rydaptom može uzrokovati pogoršanje Vašeg stanja.
- If you are being treated for ASM, SM-AHN or MCL, you will receive Rydapt as a long-term treatment, possibly lasting for months or years. 
- Ako se liječite zbog ASM-a, SM-AHN-a ili MCL-a, primat ćete Rydapt kao dugoročnu terapiju koja bi mogla trajati mjesecima ili godinama.
Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F). 
Midostaurin ima distribuciju u tkivu geometrijske srednje vrijednosti od 95,2 l (Vz/F).
- If you are being treated for AML, after you finish taking Rydapt with chemotherapy medicines, 
- Ako se liječite zbog AML-a, nakon što završite uzimanje Rydapta s lijekovima za kemoterapiju,
Rydapt should be taken orally twice daily at approximately 12-hour intervals. 
Rydapt treba uzimati peroralno dvaput na dan u razmacima od otprilike 12 sati.
Secondary endpoints included duration of response, time to response, and overall survival. 
Mjere sekundarnog ishoda uključivale su trajanje odgovora, vrijeme do odgovora te ukupno preživljenje.
Talk to your doctor if you are told that you have to start taking one of them during Rydapt treatment. 
Obratite se svom liječniku ako Vam je rečeno da morate početi uzimati neki od njih tijekom liječenja Rydaptom.
ADRs that led to treatment discontinuation occurred in 9.2% of patients. 
Nuspojave koje su dovele do obustave liječenja pojavile su se u 9,2% bolesnika.
Final CSR: June 2023 
Završni CSR: lipanj 2023
The median duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months). 
Medijan trajanja izloženosti Rydaptu bio je 11,4 mjeseca (raspon: 0 do 81 mjeseca).
ANC: Absolute Neutrophil Count 
ABN: apsolutni broj neutrofila
In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for midostaurin-related toxicity. 
U situacijama kad ne postoje zadovoljavajuće druge terapijske mogućnosti, bolesnike je potrebno pažljivo pratiti zbog mogućih toksičnosti povezanih s midostaurinom.
Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system. 
Ispitivanja sigurnosne farmakologije ukazuju na to kako je malo vjerojatno da midostaurin ometa vitalne funkcije središnjeg živčanog sustava.
In clinical studies, the efficacy and safety of Rydapt were investigated following administration with a light meal. 
U kliničkim ispitivanjima, djelotvornost i sigurnost primjene Rydapta istražene su nakon primjene uz lagani obrok.
Rydapt may be held for as many cycles as necessary until QTc improves. 
Rydapt se može uskratiti koliko je god ciklusa potrebno dok se QTc ne popravi.
Total bilirubin increased* 
Povišen ukupni bilirubin*
Do not open, crush or chew them to ensure proper dosing and avoid the unpleasant taste of the capsule content. 
Nemojte ih otvarati, drobiti ili žvakati kako biste osigurali pravilno doziranje i izbjegli neugodan okus sadržaja kapsule.
In a subgroup analysis, no apparent OS benefit was observed in females, however, a treatment benefit was observed in females in all secondary efficacy endpoints (see Table 6). 
U analizi podskupina nije bila opažena vidljiva korist za OS kod žena, međutim, terapijska korist opažena je kod žena u pogledu svih mjera sekundarnog ishoda djelotvornosti (vidjeti Tablicu 6).
CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms. 
Težina prema CTCAE-u: 1. stupanj = blagi simptomi; 2. = umjereni simptomi; 3. = teški simptomi; 4. = simptomi opasni po život.
Final CSR: December 
Završni CSR: prosinac
Median Survival (months) 
Medijan preživljenja (mjeseci)
You should also tell your doctor if you are already taking Rydapt and you are prescribed a new medicine that you have not previously taken during treatment with Rydapt. 
Također trebate obavijestiti svog liječnika ako već uzimate Rydapt, a bude Vam propisan novi lijek kojeg niste ranije uzimali za vrijeme liječenja Rydaptom.
If you stop taking Rydapt 
Ako prestanete uzimati Rydapt
There is limited experience with midostaurin in AML patients aged 60-70 years and no experience in AML patients above 70 years. 
Postoje ograničena iskustva s midostaurinom u oboljelih od AML-a u dobi od 60-70 godina, a s oboljelima od AML-a starijima od 70 godina nema nikakvih iskustava.
CGP62221 exhibited a similar pattern. 
CGP62221 je pokazao sličan obrazac.
In general, midostaurin and its metabolites showed no major deviation from dose-proportionality after a single dose in the range of 25 mg to 100 mg. 
Općenito, midostaurin i njegovi metaboliti nisu pokazali veća odstupanja od proporcionalnosti s dozom nakon jednokratne doze u rasponu od 25 mg do 100 mg.
Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made. 
Zbog ograničenih farmakokinetičkih podataka u pedijatrijskih bolesnika, nije moguće napraviti usporedbu s farmakokinetikom midostaurina u odraslih.