natgillin/translations-raw huggingface dataset:
The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer. 
Predloženi podatki so bili preveč omejeni, da bi omogočali oceno razmerja med koristmi in tveganji uporabe zdravila Teysuno v kombinaciji z drugimi zdravili na osnovi platine pri bolnikih z napredovalim rakom želodca.
Send a question via our website www.ema.europa.eu/contact the place of pyrimidine and interferes with the enzymes involved in making new DNA. 
5-FU v telesu zavzame mesto pirimidina in ovira encime, vključene v tvorjenju nove DNK.
Page 6/6 
Stran 5/5
Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder: 
Pred preklicem začasnega umika dovoljenj za promet z zdravilom bodo nacionalni pristojni organi, ki jih usklajuje referenčna država članica, zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednji pogoj:
The marketing authorisation holder demonstrates bioequivalence in the fed state, in compliance with the guidance on the investigation of bioequivalence in place at the time of lifting the suspension. 
Imetnik dovoljenja za promet z zdravilom mora ob preklicu začasnega umika dokazati biološko enakovrednost pri jemanju zdravila s hrano v skladu s smernicami za proučevanje biološke enakovrednosti.
Conditions for the lifting of the marketing authorisations suspension 
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
Long term effects are not yet known. 
Dolgoročni učinki še niso znani.
Long term safety 
Dolgoročna varnost
Peri- and postnatal development has not been studied. 
Peri- in postnatalnega razvoja niso proučevali.
5550 Airport Boulevard Boulder, Colorado 80301 United States of America 
5550 Airport Boulevard Boulder, Colorado 80301 ZDA
Not known (frequency cannot be estimated from available data): 
Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti):
It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - plan to have a baby. 
Zdravniku morate povedati, če: - ste noseči, - mislite, da ste morda noseči, ali
For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet. 
Za informacije o pripravi in dajanju zdravila Kepivance glejte informacije za zdravstveno osebje na koncu teh navodil.
The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies. 
Dolgoročna varnost zdravila Kepivance ni povsem ugotovljena, kar zadeva celotno preživetje, preživetje brez napredovanja in sekundarne malignome.
These events were consistent with those observed at the recommended dose but were generally more severe. 
Ti dogodki so se skladali z dogodki, zabeleženimi ob priporočenih odmerkih, a so bili na splošno hujši.
Safety and efficacy has not been evaluated in older people. 
Varnost in učinkovitost pri starejših osebah nista bili ovrednoteni.
Palifermin (60 micrograms/kg/day) n = 106 
Palifermin (60 mikrogramov/kg/dan) n = 106
Generally, dissolution of Kepivance takes less than 5 minutes. 
Praviloma traja raztapljanje zdravila Kepivance manj kot 5 minut.
Systemic exposure did not appear to increase with the dose. 
Prav tako ni bilo videti, da bi se sistemska izpostavljenost povečevala z odmerkom.
Adverse reactions from clinical trials and spontaneous reporting 
Neželeni učinki iz kliničnih preskušanj in spontanega poročanja
Once reconstituted, store in a refrigerator and use within 24 hours. 
Ko je zdravilo pripravljeno, ga shranjujte v hladilniku in porabite v 24 urah.
Kepivance should only be used in adults over the age of 18 years. 
Zdravilo Kepivance smejo dobivati le odrasli, starejši od 18 let.
Each pack contains 6 vials. 
Eno pakiranje vsebuje 6 vial.
Please inform your doctor if you are receiving or have recently received heparin. 
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali heparin.
These reactions were primarily mild to moderate in severity and were reversible. 
Učinki so bili predvsem blagi do zmerni in so bili reverzibilni.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to Kepivance neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Date of latest renewal: 23 September 2010 
Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established. 
Varnost in učinkovitost zdravila Kepivance pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
Although palifermin was safe at all doses tested the incidence of skin reactions increased with the dose. 
Čeprav je bil palifermin varen pri vseh testiranih odmerkih, je incidenca kožnih reakcij naraščala z odmerkom.
In the absence of compatibility studies, this medicinal product must not be mixed with other 
Zaradi pomanjkanja študij o kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
What Kepivance is and what it is used for 
Kaj je zdravilo Kepivance in za kaj ga uporabljamo
If you are pregnant you should not use Kepivance unless clearly necessary. 
Če ste noseči, zdravila Kepivance ne uporabljajte, razen če je to nujno potrebno.
Lack of efficacy and risk of infection with high dose melphalan conditioning regimen 
Pomanjkanje učinkovitosti in tveganje za okužbo ob pripravljalnem režimu z visokimi odmerki melfalana
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
Neither of the two dosing regimens demonstrated statistically significant results versus placebo. 
Nobena od zgornjih dveh shem odmerjanja ni pokazala statistično značilnih rezultatov v primerjavi s placebom.
Visual acuity was not affected at 6 or 12 months in either treatment group. 
Ostrina vida po 6 ali 12 mesecih v nobeni skupini ni bila prizadeta.
In this study, 212 patients were randomised and received either palifermin or placebo. 
V študiji je bilo randomiziranih 212 bolnikov, ki so dobivali palifermin ali placebo.
What Kepivance is and what it is used for What you need to know before you use Kepivance 
Kaj je zdravilo Kepivance in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Kepivance
Other medicines and Kepivance 
Druga zdravila in zdravilo Kepivance
It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve 
Od endogenega humanega KGF se razlikuje po tem, da ima za izboljšanje stabilnosti odstranjenih prvih 23 N-terminalnih aminokislin.
Due to limited data in patients, heparins should be used with care in patients receiving palifermin and appropriate blood coagulation tests should be carried out to monitor their treatment. 
Zaradi omejenih podatkov pri bolnikih je treba heparine uporabljati previdno pri bolnikih, ki prejemajo palifermin in opraviti ustrezne teste koagulacije krvi za spremljanje njihovega zdravljenja.
• increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance). 
• motnje okušanja in • zvišana raven lipaze in amilaze (prebavnih encimov) v krvi (ki ne zahteva zdravljenja in se običajno povrne na normalno raven po prenehanju zdravljenja z zdravilom Kepivance).
Based on these limited data no recommendation on dose adjustment can be 
Na podlagi teh omejenih podatkov ni mogoče dati priporočil o prilagajanju odmerka.
As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low. 
Ker je zdravilo Kepivance beljakovinsko zdravilo, je tveganje za medsebojno delovanje z drugimi zdravili majhno.
However, the administration of palifermin did not affect heparin´s anticoagulant effect in the experimental conditions (single dose, subtherapeutic dose regimen). 
Dajanje palifermina pa ni vplivalo na antikoagulacijski učinek heparina v eksperimentalnih pogojih (enkratni odmerek, subterapevtski režim odmerjanja).
After reconstitution: 24 hours at 2 °C - 8 °C, protected from light. 
6 let Po pripravi: 24 ur pri temperaturi med 2 °C in 8 °C, zaščiteno pred svetlobo.
The potential risk to the human embryo or foetus is unknown. 
Možno tveganje za človeški zarodek in plod ni znano.
Currently available data are described in section 5.2 but no recommendation on dose adjustment can be made. 
Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o prilagajanju odmerka ni mogoče dati.
Kepivance is a sterile but unpreserved product and is intended for single use only. 
Zdravilo Kepivance je sterilno, vendar ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
Kepivance has not been tested in pregnant women. 
Zdravilo Kepivance ni preizkušeno pri nosečnicah.
The pharmacodynamic effect of palifermin, as measured by the change in Ki67 expression, tended to be lower when administered with heparin but the clinical relevance of this finding is unclear. 
Farmakodinamični učinek palifermina, izmerjen s spremembo izraženosti Ki67, je bil nižji ob dajanju s heparinom, vendar pa klinični pomen te ugotovitve ni jasen.
Other endpoints included the incidence, duration and severity of oral mucositis and the requirement for opioid analgesia. 
Med drugimi končnimi točkami so bile incidenca, trajanje in izrazitost oralnega mukozitisa in potreba po opioidni analgeziji.
For information on dose limiting toxicities see section 4.8. 
Za informacije o toksičnih učinkih, ki omejujejo odmerek, glejte poglavje 4.8.
Studies in animals have shown reproductive and developmental toxicity (see section 5.3). 
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja in razvoj (glejte poglavje 5.3).
It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding. 
Ni znano, ali se zdravilo Kepivance izloča v materinem mleku, zato ženske, ki dojijo, ne smejo dobiti zdravila Kepivance.
In two studies in healthy volunteers, co-administration of Kepivance and heparin resulted in approximately 5 times higher systemic exposure to palifermin, due to a lower volume of distribution. 
V dveh študijah z zdravimi prostovoljci je sočasno dajanje zdravila Kepivance in heparina povzročilo približno petkrat večjo sistemsko izpostavljenost paliferminu zaradi manjšega volumna porazdelitve.
No overt cases of pancreatitis have been reported in this patient population. 
V tej populaciji bolnikov ni bilo manifestnih primerov pankreatitisa.
Do not use this medicine after the expiry date which is stated on the carton and vial label, after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali, z oznako "Upor.
Kepivance might interact with a medicine called heparin. 
Zdravilo Kepivance lahko vpliva na zdravilno učinkovino, imenovano heparin.
To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells). 
Za zdravljenje vašega krvnega raka morda dobivate kemoterapijo, radioterapijo in presaditev avtolognih hematopoetskih matičnih celic (krvotvornih celic iz vašega lastnega organizma).
The contents should be swirled gently during dissolution. 
Vsebino morate med raztapljanjem previdno vrteti.
In a study to assess potential carcinogenicity in transgenic rasH2 mice, no treatment related increases in the incidence of neoplastic lesions were observed. 
V študiji za presojo potencialne kancerogenosti na transgenskih rasH miših niso opažali, da bi se incidence neoplastičnih lezij povečale v zvezi z zdravljenjem.
Kepivance will be given to you by a doctor or nurse with experience in cancer treatment. 
Zdravilo Kepivance vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo zdravil proti raku.
Diluted Hydrochloric acid 
razredčena klorovodikova kislina
The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day. 
Običajni odmerek zdravila Kepivance je 60 mikrogramov na kilogram telesne mase na dan.
Do not shake or vigorously agitate the vial. 
Viale ne stresajte in ne mešajte s silo.
In this Phase 3 clinical study, palifermin treated patients demonstrated significant benefits in patient-reported outcomes of mouth and throat soreness and its impact on swallowing, drinking, eating and talking. 
V klinični študiji 3. faze so bolniki, ki so dobivali palifermin, doživeli pomembne koristi v zvezi s samoopisanim izidom bolečin v ustih in žrelu ter njihovim vplivom na požiranje, pitje, hranjenje in govorjenje.
Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms. 
Zdravilo Kepivance uporabljamo za zmanjšanje pogostosti, trajanja in izrazitosti simptomov oralnega mukozitisa.
The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies. 
Farmakokinetiko palifermina so raziskali pri zdravih prostovoljcih in bolnikih s hematološkimi malignomi.
Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss. 
(koeficient variabilnosti)za očistek znaša približno 50 % in KV za Vss približno 60 %.
Pain and arthralgia are other common adverse reactions, consistent with Kepivance treated patients having received less opioid analgesia than placebo-treated patients (see Table 2). 
Bolečina in artralgija sta druga pogosta neželena učinka, ki se ujemata z dejstvom, da so bolniki, zdravljeni z zdravilom Kepivance, dobili manj opioidne analgezije kot bolniki, ki so dobivali placebo (glejte preglednico 2).
Palifermin should therefore not be given to patients with known or suspected non-haematological malignancies. 
Palifermina zato ne smete dajati bolnikom z znanimi ali domnevnimi nehematološkimi malignostmi.
Common (affects 1 to 10 users in 100) side effects are: 
Pogosti (prizadenejo 1 do 10 bolnikov od 100 bolnikov) neželeni učinki so:
Median time to onset was approximately 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of approximately 5 days. 
Mediani čas do pojava je bil približno 6 dni po prvih 3 zaporednih dnevnih odmerkih zdravila Kepivance; mediano so trajali približno 5 dni.
• change in colour of the mouth or tongue; 
• spremenjena barva ust ali jezika,
Very common (affects more than 1 user in 10) side effects are: 
Zelo pogosti (prizadenejo več kot 1 od 10 bolnikov) neželeni učinki so:
It is not known whether Kepivance is present in human milk. 
Ni znano, ali se zdravilo Kepivance pojavi v materinem mleku.
In patients with severe renal impairment (creatinine clearance < 30 ml/min), clearance was decreased by 22% (n = 5). 
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je bil očistek manjši za 22 % (n = 5).
One of the side effects of these treatments is oral mucositis. 
Eden od neželenih učinkov tega zdravljenja je oralni mukozitis.
The main efficacy endpoint of the study was the number of days during which patients experienced severe oral mucositis (grade 3/4 on the World Health Organisation (WHO) scale). 
Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3./4.
Salient findings in toxicology studies in rat and monkey were generally attributable to the pharmacological activity of palifermin, specifically, proliferation of epithelial tissues. 
Glavni izsledki toksikoloških študij pri podganah in opicah so šli na splošno na račun farmakološkega delovanja palifermina, specifično na račun proliferacije epitelijskih celic.
Kepivance should be reconstituted with 1.2 ml water for injections. 
Zdravilo Kepivance je treba pripraviti z 1,2 ml vode za injekcije.
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
There are no adequate data from the use of Kepivance in pregnant women. 
O uporabi zdravila Kepivance pri nosečnicah ni zadostnih podatkov.
In addition, there was a higher incidence of infections in patients administered palifermin pre- and post-chemotherapy (49.5%) compared with patients who received placebo (24.6%). 
Poleg tega so pri bolnikih, ki so prejemali palifermin pred in po kemoterapiji, opazili večjo incidenco okužb (49,5 %), kot pri bolnikih, ki so prejemali placebo (24,6 %).
The frequency listed below is defined using the following convention: very common (> 1/10), common (≥ 1/100 to < 1/10), not known (frequency cannot be estimated from available data). 
pogosti (≥ 1/100 do < 1/10), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed. 
Farmakokinetične značilnosti pri bolnikih z insuficienco jeter niso raziskane.
Compared with the placebo group, the pre/post-chemotherapy group had a higher incidence of herpes virus infection (9% vs 0%), oral fungal infection (7% vs 2%) and sepsis/septic shock (12% vs 2%). 
V primerjavi s skupino, ki je prejemala placebo, je imela skupina, ki je prejemala palifermin pred in po kemoterapiji, večjo incidenco okužbe z virusom herpesa (9 % v primerjavi z 0 %), glivične okužbe ust (7 % v primerjavi z 2 %) in sepse/septičnega šoka (12 % v primerjavi z 2 %).
Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) did not influence palifermin pharmacokinetics. 
Blaga do zmerna okvara ledvic (očistek kreatinina od 30 do 80 ml/min) ni vplivala na farmakokinetiko palifermina.
The diluent should be injected slowly into the Kepivance vial. 
Vehikel morate počasi injicirati v vialo zdravila Kepivance.
Renal impairment Dose adjustment in patients with renal impairment is not necessary (see section 5.2). 
Okvara ledvic Prilagoditev odmerka pri bolnikih z okvaro ledvic ni potrebna (glejte poglavje 5.2).
Treatment with these doses was also associated with maternal effects (clinical signs and/or changes in body weight/food consumption), suggesting that palifermin was not selectively toxic to development in either species. 
Zdravljenje s takšnimi odmerki so spremljali tudi učinki pri samicah-materah (klinični znaki in/ali spremembe telesne mase/uživanja hrane), kar kaže, da palifermin ne pri eni ne pri drugi živalski vrsti ni bil selektivno toksičen za razvoj.
The palifermin clinical program in the setting of myelotoxic therapy requiring haematopoietic stem cell (HSC) support included 650 patients with haematologic malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study. 
Klinični program s paliferminom ob mielotoksični terapiji s potrebo po podpori s hematopoetskimi matičnimi celicami (HSC) je zajel 650 bolnikov s hematološkimi malignomi; vključeni so bili v 3 randomizirane, s placebom kontrolirane klinične študije in študijo farmakokinetike.
6.25 mg of powder in a vial (Type I glass) with a rubber stopper, an aluminium seal and a plastic flip 
6,25 mg praška v viali (steklo tipa I) z gumijastim zamaškom, aluminijsko zaporo in plastično snemno zaporko.
• darkening of an area of skin (hyperpigmentation); 
• temneje obarvani predeli kože (hiperpigmentacija),
The most commonly reported adverse drug reactions (reported in > 1/10 patients) are reactions consistent with the pharmacologic action of Kepivance on skin and oral epithelium, e.g. oedema, including peripheral oedema, and hypertrophia of oral structures. 
Najpogostejši neželeni učinki zdravila (opaženi pri > 1 bolniku od 10) so bili učinki, ki so se skladali s farmakološkim delovanjem zdravila Kepivance na kožo in ustni epitel, npr. edem, vključno s perifernim edemom, in hipertrofija struktur v ustih.
- The active substance is palifermin. 
- Zdravilna učinkovina je palifermin.
KGF is a protein that targets epithelial cells by binding to specific cell-surface receptors thereby stimulating proliferation, differentiation, and upregulation of cytoprotective mechanisms (e.g., induction of antioxidant enzymes). 
Na te celice se veže prek specifičnih receptorjev na celični površini in tako spodbudi proliferacijo, diferenciacijo in povečanje mehanizmov za zaščito celice (npr. indukcijo antioksidantnih encimov).
The study included three treatment arms and was designed to compare each of the palifermin arms (pre- and pre/post-) to 
Študija je vključevala 3 terapevtske skupine, njen namen pa je bil primerjati vsako od skupin, ki sta prejemali palifermin (pred in pred/po), s placebom.
In patients with end-stage renal disease (requiring dialysis) palifermin clearance was decreased by 10% (n = 6). 
Pri bolnikih s končno odpovedjo ledvic (ki potrebujejo dializo) je bil očistek palifermina manjši za 10 % (n = 6).
There was an imbalance in age distribution with more elderly (> 65 years) patients in the palifermin group. 
Starostna porazdelitev v obeh skupinah ni bila enakomerna, ker je bilo v skupini, zdravljeni s paliferminom, več starejših (> 65 let) bolnikov.
Kepivance is used to treat oral mucositis (soreness, dryness and inflammation of the mouth) which has occurred as a side effect of treatments for your blood cancer. 
Zdravilo Kepivance uporabljamo za zdravljenje oralnega mukozitisa (bolečin, suhosti in vnetja v ustih), ki se pojavi kot neželeni učinek zdravljenja vašega krvnega raka.
The efficacy and safety of palifermin have only been established in association with conditioning regimens for autologous haematopoietic stem cell support that comprise total body irradiation and high dose chemotherapy (cyclophosphamide and etoposide) (see section 5.1). 
Učinkovitost in varnost palifermina sta bili ugotovljeni le v povezavi s pripravljalnimi režimi za podporo avtolognih hematopoetskih matičnih celic, sestavljenimi iz obsevanja celega telesa in kemoterapije z visokimi odmerki (ciklofosfamida in etopozida) (glejte poglavje 5.1).
In-vitro and in-vivo data suggest that palifermin binds to unfractionated as well as low molecular weight heparins. 
Podatki in vitro in in vivo kažejo, da se palifermin veže tako na nefrakcionirane kot na nizkomolekularne heparine.
These no observed adverse effect level (NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure. 
Ti odmerki brez opaženih neželenih učinkov (t. i. odmerki NOAEL - no observed adverse effect level) so bili povezani s sistemsko izpostavljenostjo, ki je bila do 2,5-krat večja od predvidene klinične izpostavljenosti.
- If you have any further questions, ask your doctor or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte zdravnikom ali s farmacevtom.
A single dose of 250 micrograms/kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects. 
Pri posamičnem odmerku 250 mikrogramov/kg, ki so ga apliciraliintravensko 8 zdravim prostovoljcem, niso ugotovili nobenih hudih ali resnih učinkov.
Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects. 
Proliferacijo epitelijskih celic so ugotavljali z imunohistokemičnim barvanjem Ki67 pri zdravih preiskovancih.
Anaphylactic reaction/Hypersensitivity 
Bolezni imunskega sistema anafilaktične reakcije/preobčutljivost
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration, since palifermin has been shown to bind to heparin 
Če za vzdrževanje intravenske linije uporabljate heparin, je treba linijo pred aplikacijo zdravila Kepivance in po njej izprati z raztopino natrijevega klorida, kajti za palifermin je in vitro dokazano, da se veže na heparin.