natgillin/translations-raw huggingface dataset:
- Do not use this medicine if you notice that capsules look damaged.
- Ne uporabljajte tega zdravila, če opazite, da so kapsule poškodovane.
This may influence the ability to drive and use machines during this time period.
To lahko vpliva na sposobnost vožnje in upravljanja strojev v tem obdobju.
This leaflet was last revised in <{MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}.
In the event of overdose, physicians should follow general supportive measures and treat symptomatically.
V primeru prevelikega odmerjanja morajo zdravniki upoštevati ustrezne splošne podporne ukrepe in zdraviti simptomatsko.
Due to the bitter taste, the capsule should not be opened, chewed or crushed.
Zaradi grenkega okusa se kapsule ne sme odpirati, žvečiti ali zdrobiti.
Duration of response (median, months)
trajanje odziva (mediana, meseci)
If you are giving this medicine to your child, please replace “you” with “your child” throughout.
Če dajete to zdravilo svojemu otroku, se v celotnem besedilu »vi« nanaša na »vašega otroka«.
Important information about some of the ingredients
Pomembne informacije o nekaterih sestavinah
PK data is available only in 2 patients over 65 years.
Farmakokinetični podatki so na voljo le za 2 bolnika, starejša od 65 let.
Do not open, chew or crush the capsule as it has a very bitter taste.
Kapsule ne odprite, žvečite ali zdrobite, saj ima zelo grenak okus.
Always take this medicine exactly as your doctor or pharmacist has told you.
To zdravilo vedno jemljite natančno tako, kot vam je naročila zdravnik ali farmacevt.
Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči resnosti.
How to take this medicine
Kako jemati to zdravilo
Grades 3 and 4
Stopnji 3 in 4
The effect may be quantitatively different depending on tumour type, as well as on concomitant genetic alterations (see section 5.1).
Učinek je lahko kvantitativno različen, odvisno od tipa tumorja, kakor tudi od sočasnih genskih sprememb (glejte poglavje 5.1).
• Paediatric patients ≥ 1 month to
• pediatrični bolniki, stari ≥ 1 meseca do
Eighty-eight percent (88%) [95% CI: 81, 95] of patients treated were alive one year after the start of therapy.
Oseminosemdeset odstotkov (88 %) [95-% IZ: 81, 95] zdravljenih bolnikov je bilo živih eno leto po začetku zdravljenja.
The male growth reduction was associated with delayed puberty.
Zmanjšano rast pri moškem spolu so povezali z zapoznelo puberteto.
30 June 2024
30. junija 2024
If you use hormonal contraceptives, you should also use a barrier method, such as a condom.
Če uporabljate hormonske konraceptive, morate uporabljati tudi pregradno kontracepcijsko metodo, kot je npr. kondom.
No patient permanently discontinued the treatment due to Grade 3-4 ALT and AST increases.
Pri nobenem bolniku niso trajno ukinili zdravljenja zaradi zvišanja vrednosti ALT in AST 3.
- you have sex with a woman able to become pregnant.
- imate spolne odnose z žensko, ki je v rodni dobi.
If you are not able to take the medicine as your doctor prescribed talk to your doctor straight away.
Če ne morete vzeti zdravila, kot vam je predpisal zdravnik, se takoj posvetujte z zdravnikom.
At the time of data cut-off, time on treatment ranged from 2.8 to 9.2 months and was ongoing in 6 out of 9 patients.
Ob zaključku zbiranja podatkov je zdravljenje trajalo od 2,8 do 9,2 meseca in je pri 6 od 9 bolnikov še potekalo.
Median time on treatment for the overall safety population was 7.4 months (range: 0.03 to 40.7).
Mediana časa zdravljenja za celotno varnostno populacijo je bila 7,4 meseca (razpon: od 0,03 do 40,7).
Taking VITRAKVI with food and drink
Zdravilo VITRAKVI skupaj s hrano in pijačo
Sorbitol: patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Sorbitol: bolniki z dedno intoleranco za fruktozo (HFI, hereditary fructose intolerance) ne smejo jemati tega zdravila.
Data defining exposure in small children (1 month to <6 years of age) at the recommended dose is limited (n=33).
Podatki, ki določajo izpostavljenost pri majhnih otrocih (starih od 1 meseca do < 6 let) pri priporočenem odmerku, so omejeni (n = 33).
Your doctor may decide to lower the dose, or pause or stop the treatment.
Zdravnik se lahko odloči za zmanjšanje odmerka ali prekinitev oziroma prenehanje zdravljenja.
b Children (2 to 11 years): no Grade 4 reactions were reported.
b Otroci (stari od 2 do 11 let): niso poročali o učinkih 4. stopnje.
to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), and not known (cannot be estimated from available data).
Skupine pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Breasta, c
dojkea, c
Before you are given VITRAKVI, your doctor will do a test to check if you have the change in the NTRK gene.
Preden boste prejeli zdravilo VITRAKVI, bo zdravnik opravil test, s katerim bo preveril, ali imate spremenjen gen NTRK.
For these reasons, VITRAKVI should only be used if there are no treatment options for which clinical benefit has been established, or where such treatment options have been exhausted (i.e., no satisfactory treatment options).
Zato je treba zdravilo VITRAKVI uporabiti le, če niso možna zdravljenja, za katere je bila dokazana klinična korist, ali kjer so bile take možnosti zdravljenja izčrpane (t. j. ni zadovoljivih možnosti zdravljenja).
Twenty-three percent of all patients had received no prior systemic therapy.
Triindvajset odstotkov vseh bolnikov ni imelo nobenega predhodnega sistemskega zdravljenja.
The blood-to-plasma concentration ratio was approximately 0.9.
Razmerje med koncentracijo zdravila v krvi in plazmi je bilo približno 0,9.
This is because some medicines may affect the way VITRAKVI works or VITRAKVI may affect how other medicines work.
Nekatera zdravila namreč lahko vplivajo na delovanje zdravila VITRAKVI oziroma zdravilo VITRAKVI lahko vpliva na delovanje drugih zdravil.
- Your child's doctor will work out the right dose for your child based on their height and weight.
- Pediater vašega otroka bo določil ustrezen odmerek za vašega otroka glede na njegovo višino in telesno maso.
Elderly There are limited data in elderly.
Podatki za starejše so omejeni.
Favourable effects of VITRAKVI have been shown on the basis of overall response rate and response duration in a limited number of tumour types.
Ugodni učinki zdravila VITRAKVI so bili prikazani na podlagi splošne stopnje odziva in trajanja odziva pri omejenem številu vrst tumorjev.
- you are allergic to larotrectinib or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na larotrektinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
All the reported Grade 3 adverse reactions occurred in less than 5% of patients, with the exception of anaemia (7%).
Vsi neželeni dogodki 3. stopnje, o katerih so poročali, so se pojavili pri manj kot 5 % bolnikov, razen anemije (7 %).
The molecular causes for primary resistance to larotrectinib are not known.
Molekularni vzroki za primarno odpornost na larotrektinib niso znani.
In addition, larotrectinib had no effect on spermatogenesis in rats.
Poleg tega larotrektinib ni vplival na spermatogenezo pri podganah.
Other medicines and VITRAKVI
Druga zdravila in zdravilo VITRAKVI
30 September 2021
30.septembra 2021
The safety profile in elderly patients (≥ 65 years) is consistent with that seen in younger patients (< 65 years).
Varnostni profil pri starejših bolnikih (≥ 65 let) je skladen s profilom pri mlajših bolnikih (< 65 let).
A decrease in pregnancy rate was also reported despite normal mating at the high-dose level.
Pri visokih odmerkih so poročali tudi o zmanjšani stopnji nosečnosti kljub normalnem parjenju.
Nervous system effects (i.e. altered hindlimb functionality and, likely, increases in eyelid closure) demonstrated partial recovery.
Pri učinkih na živčni sistem (tj. spremenjeni funkcionalnosti zadnje okončine in verjetno povečanem zapiranju vek) so opazili delno okrevanje.
- Swallow the VITRAKVI capsules whole with a glass of water.
- Kapsule zdravila VITRAKVI pogoltnite cele s kozarcem vode.
NR: not reached
NE: ni mogoče oceniti NR: ni doseženo
Take the medicine pack and this leaflet with you.
S seboj imejte ovojnino zdravila in to navodilo.
Larotrectinib was administered to juvenile rats from postnatal day (PND) 7 to 70.
Larotrektinib so dajali mladim podganam od 7. do 70. dneva po porodu (PND, postnatal day).
How much to take Adults (from 18 years)
Odrasli (starejši od 18 let)
It is used in adults, adolescents and children to treat solid tumours (cancer) in various parts of the body that are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).
Uporablja se pri odraslih, mladostnikih in otrocih za zdravljenje solidnih tumorjev (raka), ki se lahko pojavijo na različnih delih telesa in nastanejo zaradi sprememb gena NTRK (gen za nevrotropne receptorje tirozin kinaze).
Your doctor will do blood tests before and during treatment to check the level of ALT and AST and check how well your liver is working.
Zdravnik bo pred in med zdravljenjem opravil krvne preiskave, s katerimi bo preveril raven ALT in AST in delovanje jeter.
c Paediatric patient (6 months old at enrolment) with locally advanced unresectable infantile fibrosarcoma with complete surgical response.
c Pediatrični bolnik (starost ob vključitvi 6 mesecev) z lokalno napredovalim, neresektabilnim infantilnim fibrosarkomom, s popolnim odzivom po kirurškem posegu.
It is important to take VITRAKVI for as long as your doctor tells you.
Pomembno je, da jemljete zdravilo VITRAKVI tako dolgo, kot vam je svetoval zdravnik.
- Along with this medicine you need a bottle adapter (28 mm diameter) and a syringe that can be used to give medicines by mouth.
- Poleg tega zdravila boste potrebovali nastavek za steklenico (premera 28 mm) in brizgo, ki se jo lahko uporabi za peroralno dajanje zdravil.
Half-life (t½) is approximately 3 hours and steady state is reached within 8 days with a systemic accumulation of 1.6 fold.
Razpolovni čas (t½) je približno 3 ure in stanje dinamičnega ravnovesja je doseženo v 8 dneh, sistemsko kopičenje pa je bilo 1,6-kratno.
VITRAKVI blocks the action of TRK fusion proteins and so may slow or stop the growth of the cancer.
Zdravilo VITRAKVI zavre delovanje fuzijskih proteinov TRK in lahko upočasni ali zaustavi rast raka.
The overall incidence was 30% for dizziness, 10% for paraesthesia and 3% for gait disturbance.
Incidenca vrtoglavice je bila 30 %, 10 % za parestezijo in 3 % za motnje hoje.
Patients enrolled to Study 2 (“NAVIGATE”) were required to have TRK fusion-positive cancer.
Bolniki, ki so sodelovali v študiji 2 (»NAVIGATE«), so morali imeti raka z dokazano fuzijo TRK.
- The feeding should be stopped and the tube flushed with at least 10 mL water.
- Hranjenje je treba ustaviti in sondo izprati z najmanj 10 ml vode.
It is therefore not known if the presence of a concomitant oncogenic driver in addition to an NTRK gene fusion affects the efficacy of TRK inhibition.
Ni znano, ali prisotnost sočasnega onkogenega dejavnika poleg fuzije genov NTRK vpliva na TRK inhibicijo.
- For instructions for use of oral syringes and feeding tubes see section 6.6.
- Za navodila glede uporabe peroralnih brizg in sond za hranjenje glejte poglavje 6.6.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinek drugih zdravil na larotrektinib
If your doctor has told you that you or your child have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you or your child take or receive this medicine.
Če vam je zdravnik povedal, da vi (ali vaš otrok) ne prenašate nekaterih sladkorjev ali če so pri vas ugotovili dedno intoleranco za fruktozo, redko genetsko bolezen, pri kateri ne morete razgraditi fruktoze, se posvetujte z zdravnikom, preden vi (ali vaš otrok) vzamete ali dobite to zdravilo.
VITRAKVI contains:
Zdravilo VITRAKVI vsebuje:
The majority of adverse reactions were Grade 1 or 2.
Večina teh neželenih učinkov je bila ocenjena kot 1. ali 2. stopnje.
Skin lesions were not seen in monkeys.
Kožnih lezij pri opicah niso opazili.
Growth and nervous system effects were seen at 0.5- to 4-times the AUC at the recommended dose.
Učinke na rast in živčni sistem so opazili pri 0,5- do 4-kratniku AUC pri priporočenem odmerku.
You should not use VITRAKVI during pregnancy since the effect of VITRAKVI on the unborn is not known.
Med nosečnostjo ne smete jemati zdravila VITRAKVI, ker učinek zdravila VITRAKVI na nerojenega otroka ni znan.
Majority of Grade 3 elevations were transient appearing in first or second month of treatment and resolving to Grade 1 by months 3-4.
Večina zvišanj 3. stopnje je bila prehodnih in se je pojavila v prvem ali drugem mesecu zdravljenja ter se je vrnila na 1. stopnjo do 3 - 4 meseca.
Pull the plunger down to the mark equal to the dose in mL prescribed by your doctor.
Povlecite bat navzdol do oznake, ki je enaka odmerku v ml, ki vam ga je predpisal zdravnik.
The mean absolute bioavailability of larotrectinib was 34% (range: 32% to 37%) following a single 100 mg oral dose.
Srednja absolutna biološka uporabnost larotrektiniba je bila 34 % (razpon: 32 % do 37 %) po enkratnem peroralnem odmerku 100 mg.
Symptoms of overdose are not established.
Simptomi prevelikega odmerjanja niso ugotovljeni.
- 1.6 mg propylene glycol in 1 mL.
- 1,6 mg propilenglikola v 1 ml.
Put the syringe in the mouth, pointing towards the inside of the cheek - this will help you swallow the medicine naturally.
Peroralno brizgo dajte v usta, tako da je usmerjena proti notranjosti lica - to vam bo pomagalo pri naravnem požiranju zdravila.
Paediatric patients with body surface area less than 1.0 m2
Padiatrični bolniki s telesno površino manj kot 1,0 m2
NOTE: See exceptions regarding neonates and patients with fluid restrictions in the sub-point directly below.
OPOMBA: Glede izjem pri novorojenčkih in bolnikih z omejenim vnosom tekočine glejte naslednjo točko.
Patients with and without documented NTRK gene fusion were allowed to participate in Study 1 and Study 3 (“SCOUT”).
Bolniki z ali brez dokumentirane fuzije gena NTRK so lahko sodelovali v študiji 1 in študiji 3 (»SCOUT«).
VITRAKVI can increase the amount of the liver enzymes ALT and AST in your blood.
Zdravilo VITRAKVI lahko poviša vrednosti jetrnih encimov ALT in AST v vaši krvi.
Patients should be advised not to drive and use machines, until they are reasonably certain VITRAKVI therapy does not affect them adversely (see section 4.4).
Bolnikom je treba svetovati naj ne vozijo in upravljajo strojev, dokler niso povsem prepričani, da zdravljenje z zdravilom VITRAKVI pri njih nima škodljivih učinkov (glejte poglavje 4.4).
- Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na steklenici poleg oznake »EXP«.
Liver function including ALT and AST assessments should be monitored before the first dose and monthly for the first 3 months of treatment, then periodically during treatment, with more frequent testing in patients who develop transaminase elevations.
Delovanje jeter, vključno z vrednostmi ALT in AST, je treba preveriti pred prvim odmerkom in enkrat mesečno prve 3 mesece zdravljenja, nato pa občasno med zdravljenjem in pogosteje pri bolnikih, pri katerih se pojavijo zvišane vrednosti transaminaz.
Body weight gain was decreased in pre-weaning male and female pups, with a post-weaning increase in females at the end of exposure whereas reduced body weight gain was seen in males also post-weaning without recovery.
Povečanje telesne mase se je pri mladičih moškega in ženskega spola pred odstavitvijo zmanjšalo, pri čemer je pri ženskem spolu na koncu izpostavljenosti po odstavitvi prišlo do povečanja, medtem ko so pri moškem spolu zmanjšano povečanje telesne mase opazili tudi po odstavitvi, brez izboljšanja.
The tube should be flushed again with at least 10 mL water to ensure VITRAKVI is delivered and to clear the tube.
Sondo je treba ponovno splakniti z najmanj 10 ml vode, da se zagotovi dostava zdravila VITRAKVI in da je sonda izpraznjena.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
70% white and 53% male; and ECOG PS 0-1 (89%), or 2 (11%).
70 % belcev in 53 % moških; in ECOG PS 0-1 (89 %) ali 2 (11 %).
No clinical data is available on the effect of a moderate inducer, but a decrease in larotrectinib exposure is expected.
Na voljo ni kliničnih podatkov o vplivu na zmerne induktorje, vendar pa se pričakuje zmanjšanja izpostavljenosti larotrektinibu.
Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Zato ni mogoče izključiti, ali sočasna uporaba larotrektiniba s substrati OATP1B1 (npr. valsartan, statini) lahko poveča njihovo izpostavljenost.
Propylene glycol: co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Propilenglikol: Sočasno jemanje katerega koli substrata alkohol-dehidrogenaze, kot je etanol, lahko povzroči hude neželene učinke pri novorojenčkih.
Do not take a double dose to make up for a forgotten dose or if you vomit after taking this medicine.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek ali če po jemanju tega zdravila bruhate.
The patient should be advised to swallow the capsule whole with a glass of water.
Bolniku je treba svetovati, da pogoltne celo kapsulo in hkrati popije kozarec vode.
Contraception - for men and women
Kontracepcija - pri moških in ženskah
- Your doctor will review your dose and change it as needed.
- Zdravnik bo preveril odmerek in ga po potrebi spremenil.
VITRAKVI has a moderate influence on the ability to drive and use machines.
Zdravilo VITRAKVI ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
[range]
[razpon]
Of these 37 patients, 38% were 28 days to < 2 years (n=14), 41% were 2 years to < 12 years (n=15), and 22% were 12 years to < 18 years (n=8).
Med temi 37 bolniki jih je bilo 38 % starih od 28 dni do < 2 leti (n = 14), 41 % jih je bilo starih od 2 leti do < 12 let (n = 15) in 22 % jih je bilo starih od 12 let do < 18 let (n = 8).
ANNEX IV CONCLUSION ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Patients with Grade 2 ALT and/or AST increases, should be followed with serial laboratory evaluations every one to two weeks after the observation of Grade 2 toxicity until resolved to establish whether a dose interruption or reduction is required.
Bolnike s povečanjem vrednosti ALT in/ali povečanjem vrednosti AST 2. stopnje je treba po ugotovljeni toksičnosti 2. stopnje spremljati z rednimi laboratorijskimi preiskavami vsak teden oziroma vsaka dva tedna, da se ugotovi, ali je potrebna prekinitev zdravljenja ali zmanjšanje odmerka.
It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
Ni znano ali larotrektinib lahko zmanjša učinkovitost sistemskih hormonskih kontraceptivov.
None of these adverse reactions led to treatment discontinuation.
Pri nobenem od teh neželenih učinkov ni bila potrebna prekinitev zdravljenja.
For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised.
Pri vseh neželenih učinkih 2. stopnje se lahko nadaljuje z odmerjanjem, vendar je priporočljivo skrbno spremljanje bolnika, da se prepreči povečanje toksičnosti.
The starting dose of VITRAKVI should be reduced by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment.
Začetni odmerek zdravila VITRAKVI je treba zmanjšati za 50 % pri bolnikih z zmerno (Child-Pugh B) do hudo (Child-Pugh C) okvaro jeter.
Point mutations in the TRKC kinase domain with clinically identified acquired resistance to larotrectinib include G623R, G696A, and F617L.
Točkovne mutacije v domeni kinaze TRKC s klinično ugotovljeno pridobljeno odpornostjo na larotrektinib vključujejo G623R, G696A in F617L.
NA: not applicable due to small numbers or lack of response NE: not evaluable
DOR: trajanje odziva NA: ni primerno zaradi majhnega števila ali pomanjkanja odziva
The capsules can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Kapsule se smejo vzeti s hrano ali brez nje, vendar se jih ne sme jemati skupaj z grenivko ali sokom grenivke.
The adverse drug reactions are classified according to the System Organ Class.
Neželeni učinki zdravila so razvrščeni glede na organski sistem.
c Adolescents (12 to <18 years): no Grades 3 and 4 reactions were reported.
c Mladostniki (stari od 12 do manj kot 18 let): niso poročali o učinkih 3. in 4. stopnje.
In-frame gene fusion events resulting from chromosomal rearrangements of the human genes NTRK1, NTRK2, and NTRK3 lead to the formation of oncogenic TRK fusion proteins.
Okvirno genske fuzije, ki izvirajo iz kromosomske prerazporeditve človeških genov NTRK1, NTRK2 in NTRK3, povzročajo nastanek onkogenih fuzijskih proteinov TRK.
The outer diameter of the nasogastric feeding tube should be selected based on the patient characteristics.
Zunanji premer nazogastrične sonde za hranjenje je treba izbrati glede na značilnosti bolnika.
Median progression free survival had not been reached at the time of analysis.
V času analize ni bila dosežena mediana preživetja brez napredovanja bolezni.
- Your child's doctor will review the dose and change it as needed.
- Pediater vašega otroka bo preveril odmerek in ga po potrebi spremenil.
Pooled primary analysis set
Združeni rezultati primarnih analiz
Larotrectinib is an adenosine triphosphate (ATP)-competitive and selective tropomyosin receptor kinase (TRK) inhibitor that was rationally designed to avoid activity with off-target kinases.
Larotrektinib je kompetitivni zaviralec adenozin trifosfata (ATP) ter selektivni zaviralec tropomiozin receptorske kinaze (TRK), ki je bil racionalno zasnovan za izogibanje aktivnosti z ne-tarčnimi kinazami.
Binding of larotrectinib to human plasma proteins in vitro was approximately 70% and was independent of drug concentration.
Vezava larotrektiniba na beljakovine v humani plazmi in vitro je bila približno 70 % in ni bila odvisna od koncentracije zdravila.
Dose limiting skin lesions were only seen in rats and were primarily responsible for mortality and morbidity.
Kožne lezije, zaradi katerih je bila velikost odmerka omejena in so bile primarno odgovorne za umrljivost in obolevnost, so opazili samo pri podganah.
Talk to your doctor, pharmacist or nurse or go to a hospital straight away.
Obvestite zdravnika, farmacevta ali medicinsko sestro ali takoj pojdite v bolnišnico.
Turn the bottle upside down.
Steklenico obrnite na glavo.
Therefore, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Ženskam, ki uporabljajo sistemske hormonske kontraceptive, je treba svetovati, naj dodatno uporabljajo še pregradno kontracepcijsko metodo.
- VITRAKVI can be taken with or without food.
- Zdravilo VITRAKVI lahko jemljete s hrano ali brez nje.
Overview of studies
Pregled študij
In the adult sub-population (n=65), the ORR was 68%.
V odrasli podpopulaciji (n = 65) je bil celokupni delež odziva 68 %.
- Store in a refrigerator (2 °C - 8 °C).
- Shranjujte v hladilniku (2 °C - 8 °C).