natgillin/translations-raw huggingface dataset:
- feeling dizzy, tingling, feeling numb, or a burning feeling in your hands and feet (very common side effect, may affect more than 1 in 10 people), difficulty walking normally (common side effect, may affect up to 1 in 10 people).
Če se pojavi kateri od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikom: - občutek vrtoglavice, mravljinčenje, občutek otrplosti ali pekoč občutek v rokah in nogah (zelo pogost neželeni učinek, ki se lahko pojavi pri več kot 1 od 10 ljudi), težave pri hoji (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10 ljudi).
Package leaflet: Information for the patient VITRAKVI 20 mg/mL oral solution larotrectinib This medicine is subject to additional monitoring.
Navodilo za uporabo VITRAKVI 20 mg/ml peroralna raztopina larotrektinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Typical tube diameter, tube lengths and derived prime volumes are presented in Table 7.
Običajni premer sonde, dolžine sonde in ustrezne količine polnjenja so navedeni v preglednici 7.
The adverse drug reactions reported in patients treated with VITRAKVI are shown in Table 2 and Table 3.
Tabelarični pregled neželenih učinkov Neželeni učinki zdravila, o katerih so poročali pri bolnikih, zdravljenih z zdravilom VITRAKVI, so prikazani v preglednicah 2 in 3.
Co-administration with strong CYP3A4 inhibitors If co-administration with a strong CYP3A4 inhibitor is necessary, the VITRAKVI dose should be reduced by 50%.
Če je potrebna sočasna uporaba z močnimi zaviralci CYP3A4, je treba odmerek zdravila VITRAKVI zmanjšati za 50 %.
A pharmacokinetic study was conducted in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, and in healthy adult control subjects with normal hepatic function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Bolniki z okvaro jeter Farmakokinetično študijo so izvedli pri osebah z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter ter pri zdravih odraslih kontrolnih osebah z normalnim delovanjem jeter, ki so se ujemale glede na starost, indeks telesne mase in spol.
One reported Grade 3 case each of Neutrophil count decreased (Neutropenia), Paraesthesia, Myalgia, Weight increased (Abnormal weight gain).
Poročali so o po enem primeru 3. stopnje kot so zmanjšanje števila nevtrofilcev (neutropenija), parestezija, mialgija, povečanje telesne mase (nenormalno povečanje telesne mase).
- The recommended dose of VITRAKVI is 100 mg (5 mL), two times a day.
- Priporočeni odmerek zdravila VITRAKVI je 100 mg (5 ml), dvakrat na dan.
- Insert the bottle adapter into the bottle neck and ensure it is well fixed.
- Nastavek za steklenico vstavite v vrat steklenice in preverite, da je dobro pritrjen.
What VITRAKVI looks like and the contents of the bottle
Izgled zdravila VITRAKVI in vsebina pakiranja
- For doses below 1 mL a 1 mL oral syringe should be used.
- Za odmerke, manjše od 1 ml, je treba uporabiti 1-ml peroralno brizgo.
The majority of ALT and AST increases occurred in the first 3 months of treatment.
Vrednosti ALT in AST so se zvišale predvsem v prvih 3 mesecih zdravljenja.
two times a day.
dvakrat na dan, je bila približno 3 ure.
Following oral administration of a single 100 mg dose of radiolabeled larotrectinib to healthy adult subjects, unchanged larotrectinib (19%) and an O-glucuronide that is formed following loss of the hydroxypyrrolidine-urea moiety (26%) were the major circulating radioactive drug components.
Po enkratnem peroralnem odmerku 100 mg radioaktivno označenega larotrektiniba zdravim odraslim osebam sta bili glavni radioaktivni komponenti zdravila v obtoku nespremenjeni larotrektinib (19 %) in O-glukuronid, ki nastane po izgubi dela hidroksipirolidin-sečnine (26 %).
Elderly No dose adjustment is recommended in elderly patients (see section 5.2).
Pri starejših bolnikih odmerka ni priporočljivo prilagajati (glejte poglavje 5.2).
This is because it is not known if VITRAKVI passes into breast milk.
Ni znano, ali se zdravilo VITRAKVI izloča v materino mleko.
The highest reported grade was Grade 3 for adverse reactions anaemia, weight increased, fatigue, increased AST, dizziness, paraesthesia, nausea, myalgia, and leukocyte count decreased.
Najvišja stopnja anemije, povečanja telesne mase, utrujenosti, zvišanja vrednosti AST, vrtoglavice, parestezije, občutek siljenja na bruhanje, mialgije in zmanjšanja števila levkocitov, o katerih so poročali, je bila 3. stopnja.
Turn the bottle the right way up and take the syringe out of the adapter.
Steklenico obrnite v pravilni položaj in iz nastavka za steklenico odstranite brizgo.
(neutropenia, leukopenia) - feeling or being sick (nausea or vomiting) - constipation - muscle pain (myalgia) - muscle weakness - feeling tired (fatigue) - increased amount of liver enzymes in blood tests - weight increase.
- bolečine v mišicah (mialgija) - mišična šibkost - občutek utrujenosti (šibkosti) - povečano število jetrnih encimov v izvidih krvnih preiskav - povečanje telesne mase
Doses up to 200 mg once or twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
odmerki do 200 mg enkrat ali dvakrat na dan (25 mg, 100 mg kapsule ali 20 mg/ml peroralna raztopina)
Grade 2 ALT and AST increases were observed in 9 (7%) and 6 (5%) of patients, respectively, and Grade 1 ALT and AST increases were observed in 26 (21%) and 28 (22%) of patients, respectively.
Zvišanja vrednosti ALT in AST 1. stopnje so opazili pri 26 (21 %) oziroma 28 (22 %) bolnikih.
An increase in larotrectinib AUC0-inf was observed in subjects with mild, moderate and severe hepatic impairment of 1.3, 2 and 3.2-fold respectively versus those with normal hepatic function.
Pri osebah z blago, zmerno in hudo okvaro jeter so opazili zvečane vrednosti AUC0-inf larotrektiniba, in sicer za 1,3-, 2- oziroma 3,2-krat v primerjavi z osebami z normalnim delovanjem jeter.
The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI.
Pred uvedbo zdravljenja z zdravilom VITRAKVI je treba v vzorcu tumorja z validiranim testom potrditi prisotnost fuzije genov NTRK.
tacrolimus - a medicine used to treat an abnormal heart rhythm called quinidine - medicines used to treat migraines called dihydroergotamine, ergotamine - a medicine used to treat long-term pain called fentanyl - a medicine used to control involuntary movements or sounds called pimozide - a medicine to help you stop smoking called bupropion - medicines to reduce blood sugar levels called repaglinide, tolbutamide - a medicine that prevents blood clots called warfarin - a medicine used to reduce the amount of acid produced in the stomach called omeprazole - a medicine used to help control high blood pressure called valsartan - a group of medicines used to help lower cholesterol called statins - hormonal medicines used for contraception, see section “contraception - for men and women”
- zdravilo, ki pomaga pri odvajanju od kajenja, ki se imenuje bupropion - zdravila za zmanjševanje ravni sladkorja v krvi, ki se imenujejo repaglinid, tolbutamid - zdravilo, ki preprečuje nastajanje krvnih strdkov, ki se imenuje varfarin - zdravilom za zmanjševanje nastajanja kisline v želodcu, ki se imenuje omeprazol - zdravilo, ki se uporablja pri nadzoru visokega krvnega tlaka, ki se imenuje valsartan - skupina zdravila za zniževanje holesterola, ki se imenujejo statini
Women of reproductive potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo.
VITRAKVI is available as a capsule and oral solution formulation.
Zdravilo VITRAKVI je na voljo v obliki kapsule in peroralne raztopine.
VITRAKVI is only used when - these cancers are advanced or have spread to other parts of the body or if a surgery to remove the cancer is likely to cause severe complications and - there are no satisfactory treatment options.
- kadar so tumorji napredovali ali so se razširili na druge dele telesa ali bi kirurški poseg za odstranitev tumorja verjetno povzročil hude zaplete in
Grade 4 was the highest reported grade for adverse reactions neutrophil count decreased (1.6%) and ALT increased (< 1%).
Najvišja stopnja zmanjšanja števila nevtrofilcev (1,6 %) in zvišanja vrednosti ALT (< 1 %), o katerih so poročali, je bila 4. stopnja.
In 36 healthy adult subjects receiving single doses ranging from 100 mg to 900 mg, VITRAKVI did not prolong the QT interval to any clinically relevant extent.
Pri 36 zdravih odraslih osebah, ki so prejemale enkratne odmerke od 100 mg do 900 mg, zdravilo
Clear yellow to orange solution.
peroralna raztopina bistra rumena do oranžna raztopina
• Phase 1, open-label, dose escalation and expansion study; expansion phase required tumours with an NTRK gene fusion
• odprta študija faze 1, s stopnjevanjem odmerka in podaljšanjem študije; za vključitev v podaljšano fazo študije je bila potrebna dokazana fuzija genov NTRK
For details how to do so, please ask your doctor, pharmacist or nurse.
Za podrobnosti o tem, kako to lahko naredite, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In 3-months toxicity studies, larotrectinib had no histological effect on the male reproductive organs in rats and monkeys at the highest tested doses corresponding to approximately 7-times (male rats) and 10-times (male monkeys) the human AUC at the recommended clinical dose.
V 3-mesečnih študijah toksičnosti larotrektinib ni imel histoloških učinkov na reproduktivne organe samcev pri podganah in opicah pri največjih preskušanih odmerkih, ki ustrezajo približno 7-kratniku (pri podganjih samcih) in 10-kratniku (pri opičjih samcih) AUC pri ljudeh po priporočenem kliničnem odmerku.
Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.2).
Pri bolnikih z okvaro ledvic odmerka ni potrebno prilagajati (glejte poglavje 5.2).
A pharmacokinetic study was conducted in subjects with end stage renal disease requiring dialysis, and in healthy adult control subjects with normal renal function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Farmakokinetično študijo so izvedli pri osebah z ledvično boleznijo v končnem stadiju, ki so bili na dializi, ter pri zdravih odraslih kontrolnih osebah z normalnim delovanjem ledvic, ki so se ujemale glede na starost, indeks telesne mase in spol.
Each carton contains one bottle of 100 mL oral solution.
Vsaka škatla vsebuje eno steklenico s 100 ml peroralne raztopine.
Breast-feeding should be discontinued during treatment with VITRAKVI and for 3 days following the final dose.
Med zdravljenjem z zdravilom VITRAKVI in še 3 dni po zadnjem odmerku se ne sme dojiti.
Systemic toxicity was assessed in studies with daily oral administration up to 3 months in rats and monkeys.
Sistemsko toksičnost so ocenili v študijah na podganah in opicah; zdravilo so jim dajali peroralno, vsak dan do 3 mesece.
The other ingredients are: - Purified water - Sucrose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Sodium citrate (E 331) - Sodium dihydrogen phosphate dihydrate (E 339) - Citric acid (E 330) - Propylene glycol (E 1520) - Potassium sorbate (E 202) - Methyl parahydroxybenzoate (E 218) - Citrus fruit flavour - Natural flavour
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prečiščena voda saharoza hidroksipropilbetadeks glicerol (E 422) sorbitol (E 420) natrijev citrat (E 331) natrijev dihidrogenfosfat dihidrat (E 339) citronska kislina (E 330) propilenglikol (E 1520) kalijev sorbat (E 202) metil parahidroksibenzoat (E 218)
You should avoid getting pregnant while taking this medicine.
Med jemanjem tega zdravila ne smete zanositi.
How VITRAKVI works
Kako deluje zdravilo VITRAKVI
Salivary gland (n=14) Thyroid (n=9)b Soft tissue sarcoma (n=9) Colorectal (n=6) Melanoma (n=6) NSCLC (n=5)b, c Primary CNS (n=4) GIST (n=2)a
ščitnica (n = 9)b sarkom mehkih tkiv (n = 9) kolorektalni (n = 6) melanom (n = 6) NDPR (n = 5)b, c primarni tumor osrednjega živčevja
Salivary gland (n=3) GIST (n=2)a
GIST (n = 2)a
100 mg twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
100 mg dvakrat na dan (25 mg, 100 mg kapsule ali 20 mg/ml peroralna raztopina)
Each VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).
Vsaka VITRAKVI 25 mg kapsula vsebuje 25 mg larotrektiniba (v obliki sulfata).
Identification of NTRK gene fusions relied upon the molecular test methods: next generation sequencing (NGS) used in 98 patients, reverse transcription-polymerase chain reaction (RT-PCR) used in 1 patient and fluorescence in situ hybridization (FISH) used in 6 patients as routinely performed at certified laboratories.
Za identifikacijo fuzij genov NTRK so bile uporabljene molekularne testne metode: sekvenciranje druge generacije (NGS) pri 98 bolnikih, polimerazna verižna reakcija z reverzno transkriptazo
Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies.
4.2 Odmerjanje in način uporabe Zdravljenje z zdravilom VITRAKVI lahko uvedejo le zdravniki, ki imajo izkušnje z dajanjem zdravil za zdravljenje raka.
You must use effective methods of contraception while taking VITRAKVI and for at least 1 month after the last dose, if - you are able to become pregnant.
Med jemanjem zdravila VITRAKVI in najmanj 1 mesec po zadnjem odmerku morate uporabljati učinkovito kontracepcijsko metodo, če
- A suitable syringe should be used to administer VITRAKVI to the nasogastric feeding tube.
- Za vnašanje zdravila VITRAKVI v nazogastrično sondo za hranjenje je treba uporabiti ustrezno brizgo.
SD: stable disease + denotes ongoing response a independent review committee analysis by RECIST v1.1 b patients with a primary CNS tumour were evaluated per investigator assessment using either RANO or RECIST v1.1
+ v času analize opazovanje še ni zaključeno a Analiza neodvisnega odbora za pregled z uporabo kriterijev RECIST v1.1 b Ocena raziskovalca z uporabo kriterijev RANO ali RECIST v1.1 za bolnike s primarnim tumorjem osrednjega živčevja c nesekretorni
For paediatric patients older than 12 years of age, the recommended dose is likely to give similar Cmax and AUC as observed in adults.
Pričakuje se, da bodo vrednosti Cmax in AUC pri pediatričnih bolnikih starejših od 12 let pri priporočenem odmerku podobne kot pri odraslih.
Neonates and children with fluid restrictions may require minimal flushing volume of 0.5 to 1 mL or flushing with air to deliver VITRAKVI.
morda potrebna minimalna količina za spiranje, tj. 0,5 do 1 ml, ali spiranje z zrakom.
Table 5: Pooled efficacy results in solid tumours including and excluding primary CNS tumours Efficacy parameter
Preglednica 5: Združeni rezultati učinkovitosti pri solidnih tumorjih z ali brez primarnih tumorjev osrednjega živčevja
ALT and AST increases leading to dose modifications occurred in 7 (6%) patients and 6 (5%) patients, respectively (see section 4.4).
7 (6 %) oziroma 6 (5 %) bolnikih (glejte poglavje 4.4).
Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Vsaka VITRAKVI 100 mg kapsula vsebuje 100 mg larotrektiniba (v obliki sulfata).
Effect of gastric pH-elevating agents on larotrectinib Larotrectinib has pH-dependent solubility.
Učinki snovi, ki višajo vrednost pH v želodcu, na larotrektinib Topnost larotrektiniba je odvisna od pH.
Pre-weaning mortality (before PND 21) was observed at the high dose level corresponding to 2.5- to 4-times the AUC at the recommended dose.
PND) so opazili pri velikem odmerku, ki je ustrezal 2,5- do 4-kratniku AUC pri priporočenem odmerku.
System organ class Frequency All grades
Organski sistem Pogostnost Dojenčki in majhni otroci
VITRAKVI should be permanently discontinued in patients who are unable to tolerate VITRAKVI after three dose modifications.
Pri bolnikih, ki zdravila VITRAKVI po treh spremembah odmerka še vedno ne prenašajo, je treba uporabo zdravila VITRAKVI trajno ukiniti.
Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone
tiskarsko črnilo šelak barvilo indigotin (E 132) titanov dioksid (E 171) propilenglikol (E 1520) dimetikon
The 200 mg dose corresponds to a peak exposure (Cmax) similar to that observed with larotrectinib 100 mg BID at steady state.
Odmerek 200 mg ustreza najvišji izpostavljenosti (Cmax), podobno, kot je opažena v stanju dinamičnega ravnovesja za larotrektinib 100 mg dvakrat na dan.
An increase in larotrectinib Cmax and AUC0-inf, of 1.25 and 1.46-fold respectively was observed in renally impaired subjects versus those with normal renal function.
Pri bolnikih z okvaro ledvic so opazili zvečane vrednosti Cmax in AUC0-inf larotrektiniba, in sicer za 1,25- oziroma 1,46-krat v primerjavi z osebami z normalnim delovanjem ledvic.
Each carton contains 1 child-resistant glass bottle containing 100 mL oral solution.
Vsaka škatla vsebuje 1 za otroke varno steklenico s 100 ml peroralne raztopine.
Press the bottle cap and turn it anti-clockwise to open the bottle.
Pritisnite na zaporko steklenice in jo obrnite v nasprotni smeri urinega kazalca, tako da jo odprete.
No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) (see section 5.2).
Pri bolnikih z blago okvaro jeter (Child-Pugh A) se ne priporoča prilagoditve odmerka (glejte poglavje 5.2).
Males of reproductive potential with a non-pregnant woman partner of child bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose (see section 4.6).
Moškim v reproduktivni dobi, ki imajo partnerko v rodni dobi, ki ni noseča, je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo (glejte poglavje 4.6).
Males of reproductive potential with a non-pregnant woman partner of child-bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Moškim v rodni dobi, ki imajo partnerko v rodni dobi, ki ni noseča, je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo.
Biliary (n=2) SCLC (n=1)b, d Appendix (n=1) Breast (n=1)
DPR (n = 1)b, d slepič (n = 1)
clarithromycin, telithromycin, troleandomycin - a medicine used to treat Cushing's syndrome called ketoconazole - medicines used to treat HIV infection called atazanavir, indinavir, nelfinavir, ritonavir,
- zdravilo, ki se uporablja za zdravljenje Cushingovega sindroma, ki se imenuje ketokonazol - zdravila za zdravljenje okužb z virusom HIV, ki se imenujejo atazanavir, indinavir, nelfinavir,
In order to further confirm the appropriate dose recommended in paediatric patients, the MAH should submit an updated pop PK model based on additional PK sampling in patients aged 1 month to 6 years from study LOXO-TRK-15003 (SCOUT).
model, ki temelji na dodatnih PK vzorcih pri bolnikih starih od 1 meseca do 6 let iz študije LOXO-TRK-15003 (SCOUT)
Larotrectinib crosses the placenta in both species.
Pri obeh živalskih vrstah larotrektinib prehaja skozi placento.
Following oral administration of 100 mg radiolabeled larotrectinib to healthy adult subjects, 58% of the administered radioactivity was recovered in faeces and 39% was recovered in urine and when an IV microtracer dose was given in conjunction with a 100 mg oral dose of larotrectinib, 35% of the administered radioactivity was recovered in faeces and 53% was recovered in urine.
Po peroralnem dajanju 100 mg radioaktivno označenega larotrektiniba zdravim odraslim osebam je bilo v blatu 58 % dane radioaktivnosti, v urinu pa 39 %, po dajanju i.v.
Amber glass (type III) bottle with a child-resistant polypropylene (PP) cap with a polyethylene (PE) seal liner.
Steklenica iz stekla jantarjeve barve (tip III) z za otroke varno polipropilensko (PP) zaporko in polietilenskim (PE) tesnilom.
VITRAKVI 100 mg hard capsules Each hard capsule contains larotrectinib sulfate equivalent to 100 mg of larotrectinib.
VITRAKVI 100 mg trde kapsule Ena trda kapsula vsebuje larotrektinibijev sulfat, kar ustreza 100 mg larotrektiniba.
Carcinogenicity studies have not been performed with larotrectinib.
Študij karcenogenosti z larotrektinibom niso izvedli.
VITRAKVI 20 mg/mL oral solution larotrectinib
VITRAKVI 20 mg/ml peroralna raztopina larotrektinib
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Učinkovitost pri različnih vrstah tumorjev
saquinavir, rifabutin, efavirenz - a medicine used to treat depression called nefazodone - medicines used to treat epilepsy called phenytoin, carbamazepine, phenobarbital - a herbal medicine used to treat depression called St. John's wort - a medicine used to treat tuberculosis called rifampicin - a medicine used for strong pain relief called alfentanil - medicines used to prevent organ rejection after an organ transplant called ciclosporin, sirolimus,
- zeliščno zdravilo za zdravljenje depresije, ki se imenuje šentjanževka - zdravilo za zdravljenje tuberkuloze, ki se imenuje rifampicin - zdravilo za lajšanje močnih bolečin, ki se imenuje alfentanil - zdravila za preprečevanje zavrnitve organa po presaditvi organa, ki se imenujejo ciklosporin,
Clinical data in healthy adult subjects indicate that co-administration of VITRAKVI (100 mg twice daily for 10 days) increased the Cmax and AUC of oral midazolam 1.7-fold compared to midazolam alone, suggesting that larotrectinib is a weak inhibitor of CYP3A.
Klinični podatki pri zdravih odraslih kažejo, da sta se ob sočasni uporabi zdravila VITRAKVI (100 mg dvakrat na dan 10 dni) vrednosti Cmax in AUC peroralno zaužitega midazolama povečali za 1,7-krat v primerjavi z jemanjem samo midazolama, kar kaže na to, da je larotrektinib šibak zaviralec
Clinical signs of gastrointestinal toxicity were dose limiting in monkeys.
Pri opicah je bil odmerek omejen s kliničnimi znaki gastrointestinalne toksičnosti.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people): - you may look pale and feel your heart pumping, which could be symptoms of low red blood cells (anaemia) - flu like symptoms including fever, which could be symptoms of low white blood cells
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 ljudi) - lahko ste videti bolj bledi in čutite bitje svojega srca, kar so simptomi nizkega števila rdečih krvnih celic (anemija)
Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Pri bolnikih, ki jemljejo zdravilo VITRAKVI, je potrebna previdnost pri sočasni uporabi substratov CYP3A z ozkim terapevtskim oknom (npr. alfentanil, ciklosporin, dihidroergotamin, ergotamin,
Larotrectinib had no neurobehavioural findings in adult animals (rats, mice, cynomolgus monkeys) at exposure (Cmax) at least 7-fold higher than the human exposure.
Pri odraslih živalih (podganah, miših, opicah cinomolgus), izpostavljenih koncentracijam larotrektiniba (Cmax), ki je bila vsaj 7-krat večja kot izpostavljenost pri ljudeh, ni bilo nevrovedenjskih motenj.
If you miss a dose of VITRAKVI
Če ste pozabili vzeti zdravilo VITRAKVI
VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules
IME ZDRAVILA VITRAKVI 25 mg trde kapsule VITRAKVI 100 mg trde kapsule