natgillin/translations-raw huggingface dataset:
For all formulations 
Za vse farmacevtske oblike
Other pharmaceutical forms/strengths are available which can be appropriately dosed for smaller children. 
Na voljo so druge farmacevtske oblike/jakosti, ki jih je pri manjših otrocih mogoče ustrezno odmerjati.
Body weight kg age 
Telesna masa kg starost
Adults and adolescents of 15 years of age or older (weighting more than 53 kg) can be given 1 - 2 mL intravenously or intramuscularly as a single dose; if needed, the single dose may be increased up to 5 mL (corresponding to 2,500 mg <invented name>). 
Odrasli in mladostniki, stari 15 let ali več (ki tehtajo več kot 53 kg), lahko v posameznem odmerku intravensko ali intramuskularno prejmejo od 1 do 2 ml; po potrebi se lahko posamezni odmerek poveča do 5 ml (kar ustreza 2 500 mg zdravila <izmišljeno ime>).
1 suppository for children (equivalent to 300 mg metamizole) 
ena svečka za otroke (ustreza 300 mg metamizola)
Hepatic and renal impairment 
Okvara jeter ali ledvic
Adults and adolescents of 15 years of age or older (weighting more than 53 kg) can be given 1 - 2,5 mL intravenously or intramuscularly as a single dose; if needed, the single dose may be increased up to 6,2 mL (corresponding to 2,480 mg <invented name>). 
Odrasli in mladostniki, stari 15 let ali več (ki tehtajo več kot 53 kg), lahko v posameznem odmerku intravensko ali intramuskularno prejmejo od 1 do 2,5 ml; po potrebi se lahko posamezni odmerek poveča do 6,2 ml (kar ustreza 2.480 mg zdravila <izmišljeno ime>).
500 mg/ml oral drops, solution (1 ml = 20 drops) <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight 
500 mg/ml peroralne kapljice, raztopina (1 ml = 20 kapljic) Zdravilo <izmišljeno ime> je kontraindicirano pri dojenčkih, mlajših od 3 mesecev, ali s telesno maso manj kot 5 kg.
Daily maximum dose kg age 
Največji dnevni odmerek kg starost
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 
500 mg/ml peroralne kapljice, raztopina (1 ml = 20 kapljic) Tega zdravila ne smete dajati dojenčkom v prvih treh mesecih življenja ali bolnikom, ki tehtajo manj kot 5 kg.
Up to 3 suppositories for children (equivalent to up to 900 mg metamizole) 
do tri svečke za otroke (ustreza do 900 mg metamizola)
In the case of fever, a dose of 10 mg of <invented name> per kilogram body weight is generally sufficient for children: 
Ob zvišani telesni temperaturi pri otrocih na splošno zadostuje odmerek 10 mg zdravila <izmišljeno ime> na kilogram telesne mase.
<Invented name> intravenous route is contraindicated in infants under 1 year of age (see section 
Intravenski vnos zdravila <izmišljeno ime> je pri dojenčkih, mlajših od 1 leta, kontraindiciran (glejte poglavje 4.3).
3-11 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years 
1-3 leta 4-6 let 7-9 let 31-45 10-12 let 46-53 13-14 let
• Section 4.6 Fertility, pregnancy and lactation This wording below should be reflected in this section. 
• Poglavje 4.6 - Plodnost, nosečnost in dojenje
A clear effect can be expected 30 to 60 minutes after rectal administration. 
Opazen učinek je mogoče pričakovati v 30 do 60 minutah po rektalnem vnosu.
<12 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years Single doses can be given up to four times a day, depending on the maximum daily dose. 
< 9 < 12 mesecev 1-3 leta 4-6 let 7-9 let 31-45 10-12 let 46-53 13-14 let ≥ 15 let Posamezni odmerki se lahko dajo do štirikrat dnevno, odvisno od največjega dnevnega odmerka.
3-11 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years Single doses can be given up to four times a day, depending on the maximum daily dose. 
11 mesecev 1-3 leta 4-6 let 7-9 let 31-45 10-12 let 46-53 13-14 let ≥ 15 let Posamezni odmerki se lahko dajo do štirikrat dnevno, odvisno od največjega dnevnega odmerka.
32 - 53 10-14 years 1 - 2 ≥ 15 years 2 - 4 
32-53 10-14 let ≥ 15 let
In dependence on the daily maximum dose a single dose can be taken up to 4 times daily at intervals of 6-8 hours. 
Glede na največji dnevni odmerek se lahko posamezni odmerek vzame do štirikrat dnevno v presledkih od 6 do 8 ur.
For children and adolescents up to 14 years of age, a single dose of 8 to 16 mg metamizole sodium per kilogram of body weight is given. 
Otrokom in mladostnikom, starim do vključno 14 let, se v posameznem odmerku da od 8 do 16 mg natrijevega metamizolata na kilogram telesne mase.
500 mg tablets/capsules (also applicable for 500 mg powder for oral solution/powder for oral solution in sachet/effervescent powder/granules oral solution) The dose is dependent on the intensity of the pain or fever and the individual's sensitivity of response to <invented name>. 
500 mg tablete/kapsule (velja tudi za 500 mg prašek za peroralno raztopino/prašek za peroralno raztopino v vrečici/šumeči prašek/zrnca za peroralno raztopino) Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature in posameznikovo odzivnost na zdravilo <izmišljeno ime>.
Adults and adolescents over 15 years of age or older (weighing more than 53 kg) can use 1 suppository/sachets as a single dose up to four times a day. 
Odrasli in mladostniki, star 15 let ali več (ki tehtajo več kot 53 kg), lahko v posameznem odmerku vzamejo eno svečko/vrečico, do štirikrat dnevno.
Up to 4 suppositories for children (equivalent to up to 1200 mg metamizole) 
do štiri svečke za otroke (ustreza do 1.200 mg metamizola)
<invented name> is not recommended for children younger than 10 years of age due to the fixed amount of 250 mg metamizole contained in one tablet. 
Zdravilo <izmišljeno ime> se ne priporoča pri otrocih, mlajših od 10 let, ker je količina 250 mg metamizola, ki jo vsebuje ene tableta, fiksna.
Up to 5 suppositories for children (equivalent to up to 1500 mg metamizole) 
do pet svečk za otroke (ustreza do 1.500 mg metamizola)
Adults and adolescents of 15 years of age or older (weighting more than 53 kg) can take up to 1,000 mg metamizole as a single dose (2 tablets /sachets) which can be taken up to 4 times daily at intervals of 6-8 hours. 
Odrasli in mladostniki, stari 15 let ali več (ki tehtajo več kot 53 kg), lahko v posameznem odmerku vzamejo do 1.000 mg metamizola (2 tableti/vrečici), in sicer do štirikrat dnevno v presledkih od 6 do 8 ur.
Body weight kg age drops 
Telesna masa kg starost kapljice
Daily maximum dose kg age suppository/effervescent powder suppository/effervescent powder 
Največji dnevni odmerek kg starost svečka/šumeči prašek mg svečka/šumeči prašek mg
In dependence on the daily maximum dose a single dose can be given up to 6 times daily at intervals of 4-8 hours. 
Glede na največji dnevni odmerek se lahko posamezni odmerek da do šestkrat dnevno v presledkih od 4 do 8 ur.
Paediatric population <invented name> is not recommended for children younger than 15 years of age due to the fixed amount of 575mg metamizole contained in one capsule. 
Zdravilo <izmišljeno ime> se ne priporoča pri otrocih, mlajših od 15 let, ker je količina 575 mg metamizola, ki jo vsebuje ena kapsula, fiksna.
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>. 
500 mg/ml peroralne kapljice, raztopina (1 ml = 20 kapljic) Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature in posameznikovo odzivnost na zdravilo <izmišljeno ime>.
In dependence on the daily maximum dose a single dose can be administrated up to 4 times daily at intervals of 6-8 hours corresponding to a maximum daily dose of 4,000 mg. A clear effect can be expected 30 to 60 minutes after rectal administration. 
Glede na največji dnevni odmerek se lahko posamezni odmerek vzame do štirikrat dnevno v presledkih od 6 do 8 ur, kar ustreza največjemu dnevnemu odmerku 4.000 mg.
Adults and adolescents of 15 years of age or older (> 53 kg) can take 1 capsule (575 mg metamizole) as a single dose, which can be taken up to 6 times daily at intervals of 4 - 6 hours. 
Odrasli in mladostniki, stari 15 let ali več (> 53 kg), lahko v posameznem odmerku vzamejo 1 kapsulo (575 mg metamizola), in sicer do šestkrat dnevno v presledkih od 4 do 6 ur.
Adults and adolescents of 15 years of age or older (> 53 kg) can take 575 mg metamizole as a single dose, which can be taken up to 6 times daily at intervals of 4 - 6 hours corresponding to a maximum daily dose of 3,450mg. 
Odrasli in mladostniki, stari 15 let ali več (> 53 kg), lahko v posameznem odmerku vzamejo 575 mg metamizola, in sicer do šestkrat dnevno v presledkih od 4 do 6 ur, kar ustreza največjemu dnevnemu odmerku 3.450 mg.
Paediatric population <invented name> is not recommended for children younger than 15 years of age due to the fixed amount of 500mg metamizole contained in one tablet/capsule/sachet. 
Zdravilo <izmišljeno ime> se ne priporoča pri otrocih, mlajših od 15 let, ker je količina 500 mg metamizola, ki jo vsebuje ena tableta/kapsula/vrečica, fiksna.
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>. 
2.000 mg/5 ml (tj. 400 mg/ml) raztopina za injiciranje/infundiranje Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature in posameznikovo odzivnost na zdravilo <izmišljeno ime>.
The dose is dependent on the intensity of the pain or fever and the individual's sensitivity of response to <invented name>. 
Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature ter posameznikovo odzivnost na zdravilo <izmišljeno ime>.
Adults and adolescents of 15 years of age or older (> 53 kg) can take up to 1,000 mg metamizole as a single dose, which can be taken up to 4 times daily at intervals of 6-8 hours corresponding to a maximum daily dose of 4,000mg. 
Odrasli in mladostniki, stari 15 let ali več (> 53 kg), lahko v posameznem odmerku vzamejo do 1.000 mg metamizola, in sicer do štirikrat dnevno v presledkih od 6 do 8 ur, kar ustreza največjemu dnevnemu odmerku 4.000 mg.
Up to 6 suppositories for children (equivalent to up to 1800 mg metamizole) 
do šest svečk za otroke (ustreza do 1.800 mg metamizola)
1,000 mg suppository (also applicable for 1,000 mg effervescent powder) Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to <invented name>. 
1.000 mg svečka (velja tudi za 1.000 mg šumeči prašek) Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature in posameznikovo odzivnost na zdravilo <izmišljeno ime>.
Adolescents of 15 years of age or older (> 53 kg) and adults can administrate 1,000 mg metamizole as a single dose. 
Mladostniki, stari 15 let ali več (> 53 kg), in odrasli lahko v posameznem odmerku vzamejo 1.000 mg metamizola.
2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age 500 mg/ml solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age 
2.000 mg/5 ml (tj. 400 mg/ml) raztopina za injiciranje/infundiranje Zdravilo <izmišljeno ime> je kontraindicirano pri dojenčkih, mlajših od 3 mesecev, ali s telesno maso manj kot 5 kg. intravensko dajanje:
Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to <invented name>. 
Odmerek se določi glede na intenzivnost bolečine ali zvišane telesne temperature in posameznikovo odzivnost na zdravilo <izmišljeno ime>.
In children and adolescents up to 14 years old, 8-16 mg metamizole per kg body weight can be given as a single dose. 
Otrokom in mladostnikom, starim do vključno 14 let, se lahko v posameznem odmerku da od 8 do 16 mg metamizola na kilogram telesne mase.
<invented name> is not recommended for children younger than 15 years of age due to the fixed amount of 1000mg metamizole contained in one suppository/sachet. 
Zdravilo <izmišljeno ime> se ne priporoča pri otrocih, mlajših od 15 let, ker je količina 1.000 mg metamizola, ki jo vsebuje ena svečka/vrečica, fiksna.
<invented name> is not recommended for children younger than 4 years of age due to the fixed amount of 300mg metamizole contained in one suppository. 
Zdravilo <izmišljeno ime> se ne priporoča pri otrocih, mlajših od 4 let, ker je količina 300 mg metamizola, ki jo vsebuje ena svečka, fiksna.
10-12 years 13-18 13-14 years 18-21 
7-9 let 10-12 let 13-14 let
Adults and adolescents from 15 years of age (>53 kg) can take up to 1,000 mg as a single dose. 
Odrasli in mladostniki, stari 15 let ali več (> 53 kg), lahko v posameznem odmerku vzamejo do 1.000 mg metamizola.
A clear effect can be expected 30 to 60 minutes after oral administration. 
Opazen učinek je mogoče pričakovati v 30 do 60 minutah po peroralnem vnosu.
Daily maximum dose kg age drops drops 
Največji dnevni odmerek kg starost kapljice kapljice
Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg 2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg Do not give this medicine via intravenous route to infants younger than 1 year of age 500 mg/ml solution for injection/infusion 
2.000 mg/5 ml (tj. 400 mg/ml) raztopina za injiciranje/infundiranje Tega zdravila ne smete dajati dojenčkom v prvih treh mesecih življenja ali bolnikom, ki tehtajo manj kot 5 kg.
For all formulations including fixed combination medicinal products 
Za vse farmacevtske oblike, vključno z zdravili s fiksno kombinacijo: o Nosečnost, dojenje in plodnost
Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg Do not give this medicine via intravenous route to infants younger than 1 year of age All formulations including fixed combination medicinal products o Pregnancy, breast-feeding and fertility 
Tega zdravila ne smete dajati dojenčkom v prvih treh mesecih življenja ali bolnikom, ki tehtajo manj kot 5 kg.
*Confirmation period for responses: 12 weeks 
* obdobje za potrditev odzivov: 12 tednov
9/l, as recommended in Tables 1 and 2. 
9/l, kot je priporočeno v preglednicah 1 in 2.
There are no adequate and well-controlled studies in pregnant women. 
Pri nosečnicah niso izvedli nobene primerne in dobro kontrolirane študije.
* Frequency is based on laboratory values. 
* pogostnost na osnovi laboratorijskih vrednosti
They may differ from the general information in this leaflet. 
Lahko se razlikujejo od splošnih informacij v tem navodilu za uporabo.
It is very important to follow your doctor's recommendations. 
Zelo pomembno je, da upoštevate priporočila zdravnika.
This is equivalent to 8.4 ml beer or 3.5 ml wine. 
To ustreza 8,4 ml piva ali 3,5 ml vina.
Contraception in women 
Kontracepcija pri ženskah
Only 4% of the dose is recovered in urine. 
Samo 4 % danega odmerka so prestregli v urinu.
Analysis excludes ascites as a C-finding. 
Analiza izključuje ascites, kot izvid C.
NE: Not Estimated, NR: Not Reached 
NO: ni ocenjeno, ND: ni doseženo
28 capsules. 
28 kapsul.
No carcinogenicity studies have been performed. 
Študij kancerogenosti niso izvajali.
Most of the events occurred within the first 6 months of treatment and were managed with supportive prophylactic medicinal products. 
Dogodki so se večinoma pojavili v prvih 6 mesecih zdravljenja, obvladali pa so jih s podpornimi profilaktičnimi zdravili.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. 
Zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje pri vas dosega želene učinke.
Responses to midostaurin are shown in Table 7. 
Odzivi na midostavrin so prikazani v preglednici 7.
All responses were considered and required a 12-week confirmation (see Table 8). 
Upoštevali so vse odzive, potrebna pa je bila potrditev izvida po 12 tednih (glejte preglednico 8).
The median duration of follow-up was 73 months, and the median duration of response has not been reached. 
Mediano trajanje spremljanja je bilo 73 mesecev, mediane vrednosti trajanja odziva pa niso dosegli.
Secondary endpoints included duration of response, time to response, and overall survival. 
Sekundarni cilji opazovanja so vključevali trajanje odziva, čas do odziva in celokupno preživetje.
The primary analysis was conducted after a minimum follow-up of approximately 3.5 years after the randomisation of the last patient. 
Primarno analizo so izvedli po času spremljanja najmanj približno 3,5 leta po randomizaciji zadnjega bolnika.
Rydapt may reduce fertility in men and women. 
Zdravilo Rydapt lahko zmanjša plodnost pri moških in pri ženskah.
Follow the doctor's instructions carefully. 
Skrbno se držite zdravnikovih navodil.
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. 
Z zdravljenjem je treba nadaljevati, dokler je mogoče opaziti klinične koristi oziroma dokler ne pride do nesprejemljivega toksičnega delovanja.
The capsules should be taken with food (see sections 4.5 and 5.2). 
Kapsule je treba zaužiti skupaj s hrano (glejte poglavji 4.5 in 5.2).
Taking this medicine - Taking Rydapt at the same time each day will help you to remember to take your medicine. 
Jemanje zdravila - Jemanje zdravila Rydapt vsak dan ob istem času vam lahko pomaga, da ne boste pozabili vzeti zdravila.
Rydapt (100 mg twice daily) N=142 
Rydapt (100 mg dvakrat na dan) N=142
There were no effects on physical development, sensory function or behavioural function. 
Odmerjanje ni vplivalo na telesni razvoj, senzorične funkcije in vedenjske funkcije.
- Take Rydapt twice a day at about 12-hour intervals (for example, with breakfast and with your evening meal). 
- Zdravilo Rydapt vzemite dvakrat na dan s približno 12-urnim presledkom (na primer z zajtrkom in večernim obrokom).
Rydapt should not be used in children and adolescents because it is not known whether it is safe and effective in this age group. 
Pri otrocih in mladostnikih se zdravila Rydapt ne sme uporabljati, ker ni znano, ali je uporaba zdravila v tej starostni skupini varna in učinkovita.
Finally, the long-term data from patients were analysed using a population pharmacokinetic approach. 
Nazadnje so dolgoročne podatke pri bolnikih analizirali z metodami populacijske farmakokinetike.
The dimensions of the capsule are approximately 25.4 x 9.2 mm. 
Kapsula je velika približno 25,4 x 9,2 mm.
The median time to response was 0.3 months (range: 0.1 to 3.7 months). 
Mediani čas do odziva je bil 0,3 meseca (od 0,1 do 3,7 meseca).
Patients with symptomatic congestive heart failure were excluded from clinical studies. 
Bolniki s simptomatskim kongestivnim popuščanjem srca so bili izključeni iz kliničnih študij.
Hypokalaemia* 
hipokaliemija*
One blister contains 4 soft capsules. 
En pretisni omot vsebuje 4 mehke kapsule.
Of the 116 patients enrolled, 89 were considered eligible for response assessment and constituted the primary efficacy population. 
Od 116 vključenih bolnikov jih je bilo 89 ocenjenih kot primernih za presojo odziva in ti bolniki so predstavljali populacijo za primarno oceno učinkovitosti.
Your doctor will discuss with you the most suitable method of contraception for you to use. 
Z zdravnikom se pogovorite, katera metoda kontracepcija bi bila za vas najbolj primerna.
Do not take Rydapt: - if you are allergic to midostaurin or to any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Rydapt: - če ste alergični na midostavrin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The capsules should be swallowed whole with a glass of water. 
Kapsule je treba zaužiti cele skupaj s kozarcem vode.
Response to Rydapt was determined using a computational algorithm applied without any adjudication. 
Odziv na zdravilo Rydapt je bil določen s pomočjo komputacijskega algoritma, ki je bil uporabljen brez presoje vrednosti.
The KIT D816V mutation was detected in 82% of patients. 
Mutacijo KIT D816V so odkrili pri 82 % bolnikov.
Median overall survival was 40.0 months (patients were only followed up for one year after treatment discontinuation for survival). 
Mediano celokupno preživetje je bilo 40,0 meseca (preživetje bolnikov so spremljali samo eno leto po zaključku zdravljenja).
Pregnant women should be advised of the potential risk to the foetus. 
Nosečnice je treba opozoriti na možno tveganje za plod.
Environmental risk assessment studies have shown that midostaurin has the potential to be persistent, bioaccumulative and toxic to the environment. 
Študije za oceno tveganja za okolje kažejo, da je midostavrin potencialno lahko obstojen, bioakumulativen in toksičen za okolje.
For trial sites in North America, all grades were collected for 13 pre-specified adverse events. 
V študijskih centrih po Severni Ameriki so zbirali podatke o vseh stopnjah za 13 vnaprej opredeljenih neželenih učinkov.
Rydapt may harm your unborn baby and is not recommended during pregnancy. 
Zdravilo Rydapt lahko škoduje nerojenemu otroku in ni priporočeno v času nosečnosti.
The primary endpoint was overall response rate (ORR). 
Primarni cilj opazovanja je bila celokupna stopnja odziva (ORR - overall response rate).
Response rates were assessed based on the modified Valent and Cheson criteria and responses were adjudicated by a study steering committee. 
Stopnjo odziva so ocenjevali na osnovi modificiranih kriterijev po Valentu in Chesonu, odzive pa so obravnavali člani nadzornega odbora študije.
It belongs to a class of medicines called protein kinase inhibitors. 
Sodi v skupino zdravil, ki jih imenujemo zaviralci protein kinaz.
Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding). 
Izmed 116 bolnikov jih je 113 imelo izvid C po opredelitvi s kriteriji odziva IWG (pri čemer ascites ni štel med izvide C).
Although the study was designed to be assessed with the modified Valent and Cheson criteria, as a post-hoc exploratory analysis, efficacy was also assessed per the 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria. 
Čeprav je bila študija oblikovana za ocenjevanje po modificiranih kriterijih po Valentu in Chesonu, kot naknadna eksploratorna analiza, je bila učinkovitost ovrednotena tudi po dogovorejnih kriterijih mednarodne delovne skupine 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM).
Overall survival n/N (%) 
celokupno preživetje n/N (%)
What you need to know before you take Rydapt 
Kaj morate vedeti, preden boste vzeli zdravilo Rydapt
All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels. 
Vse spodaj navedene ugotovitve pri živalih so opažali pri izpostavljenosti midostavrinu, ki je bila precej manjša od terapevtskih ravni.
Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy 
navzea in/ali bruhanje 3. oziroma 4. stopnje kljub optimalnemu antiemetičnemu zdravljenju
There are no data on the effect of Rydapt on human fertility. 
O vplivu zdravila Rydapt na plodnost pri človeku ni na voljo nobenih podatkov.
- Take Rydapt with food. 
- Zdravilo Rydapt jemljite skupaj s hrano.
White blood cell counts (WBCs) should be monitored regularly, especially at treatment initiation. 
Belo krvno sliko je treba redno spremljati, zlasti na začetku zdravljenja.
The median duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months). 
Mediano trajanje izpostavljenosti zdravilu Rydapt je bilo 11,4 meseca (od 0 do 81 mesecev).
There is no known specific antidote for midostaurin. 
Za midostavrin ni znan noben specifičen antidot.