natgillin/translations-raw huggingface dataset:
No dose reduction is required with short-term use only.
Pri kratkotrajni uporabi odmerka ni treba zmanjšati.
For adults and adolescents 15 years and over (> 53 kg) other strengths or pharmaceutical forms are available.
Za odrasle in mladostnike, stare 15 let ali več (> 53 kg), so na voljo druge jakosti ali farmacevtske oblike.
In selected cases when no other treatment options exist, single doses of metamizole during the first and second trimester might be acceptable after consultation with your doctor or pharmacist and after the benefits and risks of metamizole use have been carefully weighed up.
V določenih primerih, kadar ni na voljo drugih možnosti zdravljenja, in po posvetu z vašim zdravnikom ali farmacevtom ter po temeljitem pretehtanju razmerja med koristmi in tveganji lahko morda v prvem in drugem trimesečju nosečnosti vzamete enkratne odmerke metamizola.
* If necessary, the single dose can be increased to 6,2 ml (corresponding to 2,480 mg metamizole) and the daily dose to 12,5 ml (corresponding to 5,000 mg metamizole).
* Po potrebi se lahko posamezni odmerek poveča na 6,2 ml (kar ustreza 2.480 mg metamizola) in dnevni odmerek na 12,5 ml (kar ustreza 5 000 mg metamizola).
A clear effect is expected 30 to 60 minutes after using the medicine.
Opazen učinek je mogoče pričakovati v 30 do 60 minutah po uporabi zdravila.
500 mg/ml solution for injection/infusion
500 mg/ml raztopina za injiciranje/infundiranje
Other pharmaceutical forms/strengths are available which can be appropriately be dosed for smaller children (see section 4.3).
Na voljo so druge farmacevtske oblike/jakosti, ki jih je pri manjših otrocih mogoče ustrezno odmerjati (glejte poglavje 4.3).
Daily maximum dose kg age capsules capsules
Največji dnevni odmerek kg starost kapsule kapsule
The dose should be reduced in elderly people, in debilitated patients and in those with reduced renal function, as excretion of the breakdown products of metamizole may be delayed.
Odmerek je treba zmanjšati pri starejših ljudeh, oslabelih bolnikih in bolnikih z zmanjšanim delovanjem ledvic, saj je lahko izločanje razgradnih produktov metamizola pri njih dolgotrajnejše.
500 mg tablets/capsules (also applicable for 500mg powder for oral solution/effervescent powder/granules for oral solution)
500 mg tablete/kapsule (velja tudi za 500 mg prašek za peroralno raztopino/šumeči prašek/zrnca za peroralno raztopino)
It is essential to choose the lowest dose that controls pain and fever .
Treba je izbrati najmanjši odmerek, s katerim je mogoče obvladati bolečino in zvišano telesno temperaturo.
10-12 years (31-45 kg)
10-12 let (31-45 kg)
As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided.
Ker je hitrost izločanja pri bolnikih z okvaro ledvic ali jeter zmanjšana, se je treba izogibati večkratnim velikim odmerkom.
Use in children and adolescents For the treatment of pain children and adolescents up to 14 years old can take from 8 to 16 mg of <invented name> per kilogram body weight as an individual dose (see table above).
Uporaba pri otrocih in mladostnikih Za zdravljenje bolečine lahko otroci in mladostniki, stari do vključno 14 let, v posameznem odmerku vzamejo od 8 do 16 mg zdravila <izmišljeno ime> na kilogram telesne mase (glejte preglednico zgoraj).
The maximum daily dose for adults and adolescents over 15 years is 4 suppositories/sachets of effervescent powder (corresponding to 4,000 mg).
Največji dnevni odmerek pri odraslih in mladostnikih, starih 15 let ali več, so štiri svečke/vrečice šumečega praška (kar ustreza 4.000 mg).
3,450mg (corresponding to 6 capsules) is the maximum daily dose.
Največji dnevni odmerek je 3.450 mg (kar ustreza 6 kapsulam).
Daily maximum dose kg age tablets /sachets mg tablets/sachets mg
Največji dnevni odmerek kg starost tablete/vrečice mg tablete/vrečice mg
A clear effect can be expected 30 minutes after parenteral administration.
Opazen učinek je mogoče pričakovati v 30 minutah po parenteralnem vnosu.
The maximum daily dose is 8 mL; if needed, the daily dose may be increased up to 10 ml (corresponding to 5,000 mg of <invented name>).
Največji dnevni odmerek je 8 ml; po potrebi se lahko dnevni odmerek poveča do 10 ml (kar ustreza 5.000 mg zdravila <izmišljeno ime>).
The lowest dose needed to control pain and fever should always be selected.
Vedno je treba izbrati najmanjši odmerek, ki je potreben za obvladovanje bolečine in zvišane telesne temperature.
4-6 years (19-23 kg)
4-6 let (19-23 kg)
13-14 years (46-53 kg)
13-14 let (46-53 kg)
Paediatric population <Invented name> is contraindicated in infants below the age of 3 months or below 5 kg of body weight (see section 4.3).
Zdravilo <izmišljeno ime> je kontraindicirano pri dojenčkih, mlajših od 3 mesecev, ali s telesno maso manj kot 5 kg (glejte poglavje 4.3).
<12 months 1-5 1-3 years
< 12 mesecev 1-5 1-3 leta
However, in general the use of metamizole during the first and second trimester is not recommended.
Vendar pa se na splošno uporaba metamizola v prvem in drugem trimesečju nosečnosti odsvetuje.
<12 months 1-3 1-3 years
< 12 mesecev 1-3 1-3 leta
The maximum daily dose is 10,0 mL; if needed, the daily dose may be increased up to 12,5 ml (corresponding to 5,000 mg of <invented name>).
Največji dnevni odmerek je 10,0 ml; po potrebi se lahko dnevni odmerek poveča do 12,5 ml (kar ustreza 5.000 mg zdravila <izmišljeno ime>).
Other pharmaceutical forms/strengths are available which can be appropriately dosed for infants below the age of 3 months.
Na voljo so druge farmacevtske oblike/jakosti, ki jih je pri dojenčkih, mlajših od 3 mesecev, mogoče ustrezno odmerjati.
7-9 years (24-30 kg)
7-9 let (24-30 kg)
300 mg suppository
300 mg svečka
<invented name> should not be used for children younger than 15 years of age.
Zdravila <izmišljeno ime> ne smete uporabljati pri otrocih, mlajših od 15 let.
Daily maximum dose kg age tablets tablets
Največji dnevni odmerek kg starost tablete tablete
Other forms and strengths of this medicine are available for younger children; ask your doctor or pharmacist.
Za mlajše otroke so na voljo druge oblike in jakosti; posvetujte se z zdravnikom ali farmacevtom.
Other forms and strengths of this medicine are available for younger infants; ask your doctor or pharmacist.
Za mlajše dojenčke so na voljo druge oblike in jakosti; posvetujte se z zdravnikom ali farmacevtom.
The dose should be reduced in elderly people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of metamizole may be prolonged.
Starejša populacija, oslabeli bolniki in bolniki z zmanjšanim očistkom kreatinina Pri starejših ljudeh, oslabelih bolnikih in bolnikih z zmanjšanim očistkom kreatinina je treba odmerek zmanjšati, saj je lahko izločanje presnovnih produktov metamizola pri njih podaljšano.
In the case of fever, a dose of 10 mg metamizole per kilogram body weight is generally sufficient for children.
Ob zvišani telesni temperaturi pri otrocih na splošno zadostuje odmerek 10 mg metamizola na kilogram telesne mase.
4,000 mg (corresponding to 8 tablets/sachets) is the maximum daily dose.
Največji dnevni odmerek je 4.000 mg (kar ustreza 8 tabletam/vrečicam).
As the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses should be avoided.
Ker se ob okvari jeter ali ledvic hitrost izločanja zmanjša, se je treba izogibati večkratnim velikim odmerkom.
<Invented name> is not recommended for infants below the age of 3 months.
Zdravilo <izmišljeno ime> se ne priporoča pri dojenčkih, mlajših od 3 mesecev.
<invented name> should not be given to children under 3 months of age.
Zdravilo <izmišljeno ime> se ne sme dajati otrokom, mlajšim od 3 mesecev.
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.