FrancophonIA/ELRC3.0 huggingface dataset:
English: Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.
Slovenian: Ker je zdravilo Ninlaro pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, predložila nadaljnje podatke o njegovih koristih iz drugih študij, vključno s študijo pri bolnikih, ki se predhodno še niso zdravili.
English: The active substance in Ninlaro, ixazomib, is a proteasome inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Ninlaro, iksazomib, je zaviralec proteasoma.
English: What information is still awaited for Ninlaro?
Slovenian: Katere informacije o zdravilu Ninlaro še pričakujemo?
English: Why is Ninlaro approved?
Slovenian: Zakaj je bilo zdravilo Ninlaro odobreno?
English: For the full list of all side effects and restrictions with Ninlaro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ninlaro glejte navodilo za uporabo.
English: Data from the main study indicate that Ninlaro improves patients' progression-free survival.
Slovenian: Podatki iz glavne študije kažejo, da zdravilo Ninlaro pri bolnikih izboljša preživetje brez napredovanja bolezni.
English: Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow).
Slovenian: Ninlaro je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z diseminiranim plazmacitomom (rakom kostnega mozga).
English: Ninlaro can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Slovenian: Predpisovanje in izdaja zdravila Ninlaro je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem diseminiranega plazmacitoma.
English: Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.
Slovenian: Ni videti, da bi zdravilo Ninlaro ob dodajanju lenalidomidu in deksametazonu pomembno povečalo pogostnost resnih neželenih učinkov, bolnikom pa omogoča priročno jemanje kapsul v domačem okolju.
English: The study compared Ninlaro with placebo (a dummy treatment), both taken together with lenalidomide and dexamethasone.
Slovenian: V študiji so primerjali zdravilo Ninlaro s placebom (zdravilom brez zdravilne učinkovine), oboje pa so bolniki jemali skupaj z lenalidomidom in deksametazonom.
English: Treatment may need to be stopped temporarily or the dose reduced if the patient has certain side effects.
Slovenian: Če se pri bolniku pojavijo določeni neželeni učinki, bo morda treba začasno prekiniti zdravljenje ali zmanjšati odmerek.
English: How does Ninlaro work?
Slovenian: Kako zdravilo Ninlaro deluje?
English: However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine.
Slovenian: Vendar bo morala družba, ki trži zdravilo, zaradi negotovosti v zvezi z obsegom izboljšanja po poznejši analizi predložiti potrditvene podatke.
English: How is Ninlaro used?
Slovenian: Kako se zdravilo Ninlaro uporablja?
English: Ninlaro contains the active substance ixazomib.
Slovenian: Zdravilo Ninlaro vsebuje zdravilno učinkovino iksazomib.
English: - Restart the feeding.
Slovenian: - Ponovno začnite s hranjenjem.
English: After first opening: 30 days.
Slovenian: Po prvem odprtju: 30 dni
English: The studies were ongoing at the time of approval.
Slovenian: V času odobritve so študije še potekale.
English: A partial response was observed in 1 patient.
Slovenian: Delni odziv so opazili pri 1 bolniku.
English: This could be symptoms of nervous system problems.
Slovenian: To so lahko simptomi nevroloških težav.
English: It may also help to shrink the cancer.
Slovenian: Prav tako lahko pomaga pri zmanjševanju tumorja.
English: Total number of patients (n)*
Slovenian: Skupno število bolnikov (n)*
English: % with duration ≥ 6 months % with duration ≥ 12 months
Slovenian: % s trajanjem ≥ 6 mesecev % s trajanjem ≥ 12 mesecev
English: Take your next dose at the usual time.
Slovenian: Vzemite naslednji odmerek ob običajnem času.
English: Use within 30 days of opening.
Slovenian: Uporabite v 30 dneh po odprtju.
English: Tests and checks
Slovenian: Preskusi in preverjanja
English: - Once the bottle is open, you must use your medicine within 30 days of opening.
Slovenian: - Ko steklenico odprete, morate zdravilo uporabiti v 30 dneh od odprtja.
English: If this happens, do not drive, cycle or use any tools or machines.
Slovenian: Če se to zgodi, ne upravljajte vozil, ne vozite kolesa in ne upravljajte orodij ali strojev.
English: - This leaflet has been written as though the person taking the medicine is reading it.
Slovenian: - To navodilo je napisano, kot da ga bere oseba, ki jemlje zdravilo.
English: Clinical relevance of this finding has not been established.
Slovenian: Klinični pomen te ugotovitve ni bil dokazan.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za dojenčka/otroka se ne da izključiti.
English: PD: progressive disease
Slovenian: PD: napredovala bolezen SD: stabilna bolezen
English: - Do not use this medicine if you notice that capsules look damaged.
Slovenian: - Ne uporabljajte tega zdravila, če opazite, da so kapsule poškodovane.
English: This may influence the ability to drive and use machines during this time period.
Slovenian: To lahko vpliva na sposobnost vožnje in upravljanja strojev v tem obdobju.
English: This leaflet was last revised in <{MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}.
English: In the event of overdose, physicians should follow general supportive measures and treat symptomatically.
Slovenian: V primeru prevelikega odmerjanja morajo zdravniki upoštevati ustrezne splošne podporne ukrepe in zdraviti simptomatsko.
English: Due to the bitter taste, the capsule should not be opened, chewed or crushed.
Slovenian: Zaradi grenkega okusa se kapsule ne sme odpirati, žvečiti ali zdrobiti.
English: Duration of response (median, months)
Slovenian: trajanje odziva (mediana, meseci)
English: If you are giving this medicine to your child, please replace “you” with “your child” throughout.
Slovenian: Če dajete to zdravilo svojemu otroku, se v celotnem besedilu »vi« nanaša na »vašega otroka«.
English: Important information about some of the ingredients
Slovenian: Pomembne informacije o nekaterih sestavinah
English: PK data is available only in 2 patients over 65 years.
Slovenian: Farmakokinetični podatki so na voljo le za 2 bolnika, starejša od 65 let.
English: Do not open, chew or crush the capsule as it has a very bitter taste.
Slovenian: Kapsule ne odprite, žvečite ali zdrobite, saj ima zelo grenak okus.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: To zdravilo vedno jemljite natančno tako, kot vam je naročila zdravnik ali farmacevt.
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: How to take this medicine
Slovenian: Kako jemati to zdravilo
English: 31 March 2027
Slovenian: 31. marca 2027
English: Grades 3 and 4
Slovenian: Stopnji 3 in 4
English: The effect may be quantitatively different depending on tumour type, as well as on concomitant genetic alterations (see section 5.1).
Slovenian: Učinek je lahko kvantitativno različen, odvisno od tipa tumorja, kakor tudi od sočasnih genskih sprememb (glejte poglavje 5.1).
English: • Paediatric patients ≥ 1 month to
Slovenian: • pediatrični bolniki, stari ≥ 1 meseca do
English: Eighty-eight percent (88%) [95% CI: 81, 95] of patients treated were alive one year after the start of therapy.
Slovenian: Oseminosemdeset odstotkov (88 %) [95-% IZ: 81, 95] zdravljenih bolnikov je bilo živih eno leto po začetku zdravljenja.
English: The male growth reduction was associated with delayed puberty.
Slovenian: Zmanjšano rast pri moškem spolu so povezali z zapoznelo puberteto.
English: 30 June 2024
Slovenian: 30. junija 2024
English: If you use hormonal contraceptives, you should also use a barrier method, such as a condom.
Slovenian: Če uporabljate hormonske konraceptive, morate uporabljati tudi pregradno kontracepcijsko metodo, kot je npr. kondom.
English: No patient permanently discontinued the treatment due to Grade 3-4 ALT and AST increases.
Slovenian: Pri nobenem bolniku niso trajno ukinili zdravljenja zaradi zvišanja vrednosti ALT in AST 3.
English: - you have sex with a woman able to become pregnant.
Slovenian: - imate spolne odnose z žensko, ki je v rodni dobi.
English: If you are not able to take the medicine as your doctor prescribed talk to your doctor straight away.
Slovenian: Če ne morete vzeti zdravila, kot vam je predpisal zdravnik, se takoj posvetujte z zdravnikom.
English: 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.
Slovenian: Ob zaključku zbiranja podatkov je zdravljenje trajalo od 2,8 do 9,2 meseca in je pri 6 od 9 bolnikov še potekalo.
English: Median time on treatment for the overall safety population was 7.4 months (range: 0.03 to 40.7).
Slovenian: Mediana časa zdravljenja za celotno varnostno populacijo je bila 7,4 meseca (razpon: od 0,03 do 40,7).
English: Taking VITRAKVI with food and drink
Slovenian: Zdravilo VITRAKVI skupaj s hrano in pijačo
English: Sorbitol: patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Slovenian: Sorbitol: bolniki z dedno intoleranco za fruktozo (HFI, hereditary fructose intolerance) ne smejo jemati tega zdravila.
English: Data defining exposure in small children (1 month to <6 years of age) at the recommended dose is limited (n=33).
Slovenian: Podatki, ki določajo izpostavljenost pri majhnih otrocih (starih od 1 meseca do < 6 let) pri priporočenem odmerku, so omejeni (n = 33).
English: Your doctor may decide to lower the dose, or pause or stop the treatment.
Slovenian: Zdravnik se lahko odloči za zmanjšanje odmerka ali prekinitev oziroma prenehanje zdravljenja.
English: b Children (2 to 11 years): no Grade 4 reactions were reported.
Slovenian: b Otroci (stari od 2 do 11 let): niso poročali o učinkih 4. stopnje.
English: 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).
Slovenian: 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).
English: Breasta, c
Slovenian: dojkea, c
English: Before you are given VITRAKVI, your doctor will do a test to check if you have the change in the NTRK gene.
Slovenian: Preden boste prejeli zdravilo VITRAKVI, bo zdravnik opravil test, s katerim bo preveril, ali imate spremenjen gen NTRK.
English: 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).
Slovenian: 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).
English: Twenty-three percent of all patients had received no prior systemic therapy.
Slovenian: Triindvajset odstotkov vseh bolnikov ni imelo nobenega predhodnega sistemskega zdravljenja.
English: The blood-to-plasma concentration ratio was approximately 0.9.
Slovenian: Razmerje med koncentracijo zdravila v krvi in plazmi je bilo približno 0,9.
English: This is because some medicines may affect the way VITRAKVI works or VITRAKVI may affect how other medicines work.
Slovenian: Nekatera zdravila namreč lahko vplivajo na delovanje zdravila VITRAKVI oziroma zdravilo VITRAKVI lahko vpliva na delovanje drugih zdravil.
English: - Your child's doctor will work out the right dose for your child based on their height and weight.
Slovenian: - Pediater vašega otroka bo določil ustrezen odmerek za vašega otroka glede na njegovo višino in telesno maso.
English: Elderly There are limited data in elderly.
Slovenian: Podatki za starejše so omejeni.
English: Favourable effects of VITRAKVI have been shown on the basis of overall response rate and response duration in a limited number of tumour types.
Slovenian: Ugodni učinki zdravila VITRAKVI so bili prikazani na podlagi splošne stopnje odziva in trajanja odziva pri omejenem številu vrst tumorjev.
English: - you are allergic to larotrectinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na larotrektinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: All the reported Grade 3 adverse reactions occurred in less than 5% of patients, with the exception of anaemia (7%).
Slovenian: Vsi neželeni dogodki 3. stopnje, o katerih so poročali, so se pojavili pri manj kot 5 % bolnikov, razen anemije (7 %).
English: The molecular causes for primary resistance to larotrectinib are not known.
Slovenian: Molekularni vzroki za primarno odpornost na larotrektinib niso znani.
English: In addition, larotrectinib had no effect on spermatogenesis in rats.
Slovenian: Poleg tega larotrektinib ni vplival na spermatogenezo pri podganah.
English: Other medicines and VITRAKVI
Slovenian: Druga zdravila in zdravilo VITRAKVI
English: 30 September 2021
Slovenian: 30.septembra 2021
English: The safety profile in elderly patients (≥ 65 years) is consistent with that seen in younger patients (< 65 years).
Slovenian: Varnostni profil pri starejših bolnikih (≥ 65 let) je skladen s profilom pri mlajših bolnikih (< 65 let).
English: A decrease in pregnancy rate was also reported despite normal mating at the high-dose level.
Slovenian: Pri visokih odmerkih so poročali tudi o zmanjšani stopnji nosečnosti kljub normalnem parjenju.
English: Nervous system effects (i.e. altered hindlimb functionality and, likely, increases in eyelid closure) demonstrated partial recovery.
Slovenian: Pri učinkih na živčni sistem (tj. spremenjeni funkcionalnosti zadnje okončine in verjetno povečanem zapiranju vek) so opazili delno okrevanje.
English: - Swallow the VITRAKVI capsules whole with a glass of water.
Slovenian: - Kapsule zdravila VITRAKVI pogoltnite cele s kozarcem vode.
English: NR: not reached
Slovenian: NE: ni mogoče oceniti NR: ni doseženo
English: Take the medicine pack and this leaflet with you.
Slovenian: S seboj imejte ovojnino zdravila in to navodilo.
English: Larotrectinib was administered to juvenile rats from postnatal day (PND) 7 to 70.
Slovenian: Larotrektinib so dajali mladim podganam od 7. do 70. dneva po porodu (PND, postnatal day).
English: How much to take Adults (from 18 years)
Slovenian: Odrasli (starejši od 18 let)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Zdravnik bo pred in med zdravljenjem opravil krvne preiskave, s katerimi bo preveril raven ALT in AST in delovanje jeter.
English: c Paediatric patient (6 months old at enrolment) with locally advanced unresectable infantile fibrosarcoma with complete surgical response.
Slovenian: c Pediatrični bolnik (starost ob vključitvi 6 mesecev) z lokalno napredovalim, neresektabilnim infantilnim fibrosarkomom, s popolnim odzivom po kirurškem posegu.
English: It is important to take VITRAKVI for as long as your doctor tells you.
Slovenian: Pomembno je, da jemljete zdravilo VITRAKVI tako dolgo, kot vam je svetoval zdravnik.
English: - Along with this medicine you need a bottle adapter (28 mm diameter) and a syringe that can be used to give medicines by mouth.
Slovenian: - Poleg tega zdravila boste potrebovali nastavek za steklenico (premera 28 mm) in brizgo, ki se jo lahko uporabi za peroralno dajanje zdravil.
English: Half-life (t½) is approximately 3 hours and steady state is reached within 8 days with a systemic accumulation of 1.6 fold.
Slovenian: Razpolovni čas (t½) je približno 3 ure in stanje dinamičnega ravnovesja je doseženo v 8 dneh, sistemsko kopičenje pa je bilo 1,6-kratno.
English: VITRAKVI blocks the action of TRK fusion proteins and so may slow or stop the growth of the cancer.
Slovenian: Zdravilo VITRAKVI zavre delovanje fuzijskih proteinov TRK in lahko upočasni ali zaustavi rast raka.
English: The overall incidence was 30% for dizziness, 10% for paraesthesia and 3% for gait disturbance.
Slovenian: Incidenca vrtoglavice je bila 30 %, 10 % za parestezijo in 3 % za motnje hoje.
English: Patients enrolled to Study 2 (“NAVIGATE”) were required to have TRK fusion-positive cancer.
Slovenian: Bolniki, ki so sodelovali v študiji 2 (»NAVIGATE«), so morali imeti raka z dokazano fuzijo TRK.
English: - The feeding should be stopped and the tube flushed with at least 10 mL water.
Slovenian: - Hranjenje je treba ustaviti in sondo izprati z najmanj 10 ml vode.
English: Embryotoxicity / Teratogenicity
Slovenian: Embriotoksičnost/teratogenost
English: 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.
Slovenian: Ni znano, ali prisotnost sočasnega onkogenega dejavnika poleg fuzije genov NTRK vpliva na TRK inhibicijo.
English: - For instructions for use of oral syringes and feeding tubes see section 6.6.
Slovenian: - Za navodila glede uporabe peroralnih brizg in sond za hranjenje glejte poglavje 6.6.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinek drugih zdravil na larotrektinib
English: 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.
Slovenian: 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.
English: VITRAKVI contains:
Slovenian: Zdravilo VITRAKVI vsebuje:
English: The majority of adverse reactions were Grade 1 or 2.
Slovenian: Večina teh neželenih učinkov je bila ocenjena kot 1. ali 2. stopnje.
English: Skin lesions were not seen in monkeys.
Slovenian: Kožnih lezij pri opicah niso opazili.
English: Growth and nervous system effects were seen at 0.5- to 4-times the AUC at the recommended dose.
Slovenian: Učinke na rast in živčni sistem so opazili pri 0,5- do 4-kratniku AUC pri priporočenem odmerku.
English: You should not use VITRAKVI during pregnancy since the effect of VITRAKVI on the unborn is not known.
Slovenian: Med nosečnostjo ne smete jemati zdravila VITRAKVI, ker učinek zdravila VITRAKVI na nerojenega otroka ni znan.
English: Majority of Grade 3 elevations were transient appearing in first or second month of treatment and resolving to Grade 1 by months 3-4.
Slovenian: 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.
English: Pull the plunger down to the mark equal to the dose in mL prescribed by your doctor.
Slovenian: Povlecite bat navzdol do oznake, ki je enaka odmerku v ml, ki vam ga je predpisal zdravnik.
English: The mean absolute bioavailability of larotrectinib was 34% (range: 32% to 37%) following a single 100 mg oral dose.
Slovenian: Srednja absolutna biološka uporabnost larotrektiniba je bila 34 % (razpon: 32 % do 37 %) po enkratnem peroralnem odmerku 100 mg.
English: Symptoms of overdose are not established.
Slovenian: Simptomi prevelikega odmerjanja niso ugotovljeni.
English: - 1.6 mg propylene glycol in 1 mL.
Slovenian: - 1,6 mg propilenglikola v 1 ml.
English: Put the syringe in the mouth, pointing towards the inside of the cheek - this will help you swallow the medicine naturally.
Slovenian: Peroralno brizgo dajte v usta, tako da je usmerjena proti notranjosti lica - to vam bo pomagalo pri naravnem požiranju zdravila.
English: Paediatric patients with body surface area less than 1.0 m2
Slovenian: Padiatrični bolniki s telesno površino manj kot 1,0 m2
English: NOTE: See exceptions regarding neonates and patients with fluid restrictions in the sub-point directly below.
Slovenian: OPOMBA: Glede izjem pri novorojenčkih in bolnikih z omejenim vnosom tekočine glejte naslednjo točko.
English: Patients with and without documented NTRK gene fusion were allowed to participate in Study 1 and Study 3 (“SCOUT”).
Slovenian: Bolniki z ali brez dokumentirane fuzije gena NTRK so lahko sodelovali v študiji 1 in študiji 3 (»SCOUT«).
English: VITRAKVI can increase the amount of the liver enzymes ALT and AST in your blood.
Slovenian: Zdravilo VITRAKVI lahko poviša vrednosti jetrnih encimov ALT in AST v vaši krvi.
English: 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).
Slovenian: 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).
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na steklenici poleg oznake »EXP«.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The tube should be flushed again with at least 10 mL water to ensure VITRAKVI is delivered and to clear the tube.
Slovenian: Sondo je treba ponovno splakniti z najmanj 10 ml vode, da se zagotovi dostava zdravila VITRAKVI in da je sonda izpraznjena.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: 70% white and 53% male; and ECOG PS 0-1 (89%), or 2 (11%).
Slovenian: 70 % belcev in 53 % moških; in ECOG PS 0-1 (89 %) ali 2 (11 %).