FrancophonIA/ELRC3.0 huggingface dataset:
English: Diluted Hydrochloric acid
Slovenian: razredčena klorovodikova kislina
English: The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Slovenian: Običajni odmerek zdravila Kepivance je 60 mikrogramov na kilogram telesne mase na dan.
English: Do not shake or vigorously agitate the vial.
Slovenian: Viale ne stresajte in ne mešajte s silo.
English: 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.
Slovenian: 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.
English: Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms.
Slovenian: Zdravilo Kepivance uporabljamo za zmanjšanje pogostosti, trajanja in izrazitosti simptomov oralnega mukozitisa.
English: The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies.
Slovenian: Farmakokinetiko palifermina so raziskali pri zdravih prostovoljcih in bolnikih s hematološkimi malignomi.
English: Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss.
Slovenian: (koeficient variabilnosti)za očistek znaša približno 50 % in KV za Vss približno 60 %.
English: 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).
Slovenian: 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).
English: Palifermin should therefore not be given to patients with known or suspected non-haematological malignancies.
Slovenian: Palifermina zato ne smete dajati bolnikom z znanimi ali domnevnimi nehematološkimi malignostmi.
English: Common (affects 1 to 10 users in 100) side effects are:
Slovenian: Pogosti (prizadenejo 1 do 10 bolnikov od 100 bolnikov) neželeni učinki so:
English: 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.
Slovenian: Mediani čas do pojava je bil približno 6 dni po prvih 3 zaporednih dnevnih odmerkih zdravila Kepivance; mediano so trajali približno 5 dni.
English: • change in colour of the mouth or tongue;
Slovenian: • spremenjena barva ust ali jezika,
English: Very common (affects more than 1 user in 10) side effects are:
Slovenian: Zelo pogosti (prizadenejo več kot 1 od 10 bolnikov) neželeni učinki so:
English: It is not known whether Kepivance is present in human milk.
Slovenian: Ni znano, ali se zdravilo Kepivance pojavi v materinem mleku.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min), clearance was decreased by 22% (n = 5).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je bil očistek manjši za 22 % (n = 5).
English: One of the side effects of these treatments is oral mucositis.
Slovenian: Eden od neželenih učinkov tega zdravljenja je oralni mukozitis.
English: 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).
Slovenian: Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3./4.
English: Salient findings in toxicology studies in rat and monkey were generally attributable to the pharmacological activity of palifermin, specifically, proliferation of epithelial tissues.
Slovenian: Glavni izsledki toksikoloških študij pri podganah in opicah so šli na splošno na račun farmakološkega delovanja palifermina, specifično na račun proliferacije epitelijskih celic.
English: Kepivance should be reconstituted with 1.2 ml water for injections.
Slovenian: Zdravilo Kepivance je treba pripraviti z 1,2 ml vode za injekcije.
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
English: There are no adequate data from the use of Kepivance in pregnant women.
Slovenian: O uporabi zdravila Kepivance pri nosečnicah ni zadostnih podatkov.
English: 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%).
Slovenian: 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 %).
English: 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).
Slovenian: pogosti (≥ 1/100 do < 1/10), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed.
Slovenian: Farmakokinetične značilnosti pri bolnikih z insuficienco jeter niso raziskane.
English: 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%).
Slovenian: 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 %).
English: Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) did not influence palifermin pharmacokinetics.
Slovenian: Blaga do zmerna okvara ledvic (očistek kreatinina od 30 do 80 ml/min) ni vplivala na farmakokinetiko palifermina.
English: The diluent should be injected slowly into the Kepivance vial.
Slovenian: Vehikel morate počasi injicirati v vialo zdravila Kepivance.
English: Renal impairment Dose adjustment in patients with renal impairment is not necessary (see section 5.2).
Slovenian: Okvara ledvic Prilagoditev odmerka pri bolnikih z okvaro ledvic ni potrebna (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 6.25 mg of powder in a vial (Type I glass) with a rubber stopper, an aluminium seal and a plastic flip
Slovenian: 6,25 mg praška v viali (steklo tipa I) z gumijastim zamaškom, aluminijsko zaporo in plastično snemno zaporko.
English: • darkening of an area of skin (hyperpigmentation);
Slovenian: • temneje obarvani predeli kože (hiperpigmentacija),
English: 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.
Slovenian: 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.
English: - The active substance is palifermin.
Slovenian: - Zdravilna učinkovina je palifermin.
English: 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).
Slovenian: 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).
English: The study included three treatment arms and was designed to compare each of the palifermin arms (pre- and pre/post-) to
Slovenian: 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.
English: In patients with end-stage renal disease (requiring dialysis) palifermin clearance was decreased by 10% (n = 6).
Slovenian: Pri bolnikih s končno odpovedjo ledvic (ki potrebujejo dializo) je bil očistek palifermina manjši za 10 % (n = 6).
English: There was an imbalance in age distribution with more elderly (> 65 years) patients in the palifermin group.
Slovenian: Starostna porazdelitev v obeh skupinah ni bila enakomerna, ker je bilo v skupini, zdravljeni s paliferminom, več starejših (> 65 let) bolnikov.
English: 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.
Slovenian: Zdravilo Kepivance uporabljamo za zdravljenje oralnega mukozitisa (bolečin, suhosti in vnetja v ustih), ki se pojavi kot neželeni učinek zdravljenja vašega krvnega raka.
English: 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).
Slovenian: 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).
English: In-vitro and in-vivo data suggest that palifermin binds to unfractionated as well as low molecular weight heparins.
Slovenian: Podatki in vitro in in vivo kažejo, da se palifermin veže tako na nefrakcionirane kot na nizkomolekularne heparine.
English: These no observed adverse effect level (NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure.
Slovenian: 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.
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte zdravnikom ali s farmacevtom.
English: A single dose of 250 micrograms/kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects.
Slovenian: Pri posamičnem odmerku 250 mikrogramov/kg, ki so ga apliciraliintravensko 8 zdravim prostovoljcem, niso ugotovili nobenih hudih ali resnih učinkov.
English: Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects.
Slovenian: Proliferacijo epitelijskih celic so ugotavljali z imunohistokemičnim barvanjem Ki67 pri zdravih preiskovancih.
English: Anaphylactic reaction/Hypersensitivity
Slovenian: Bolezni imunskega sistema anafilaktične reakcije/preobčutljivost
English: 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
Slovenian: 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.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
English: The safety and efficacy of Kepivance has not been established in patients with KGF receptor expressing non-haematological malignancies.
Slovenian: Varnost in učinkovitost zdravila Kepivance nista ugotovljeni pri bolnikih z nehematološkimi malignomi, ki imajo eksprimirane receptorje KGF.
English: Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2).
Slovenian: Varnost in učinkovitost pri bolnikih z okvaro jeter nista bili ovrednoteni (glejte poglavje 5.2).
English: Fractionation of increased levels of amylase revealed the increase to be predominantly salivary in origin.
Slovenian: Frakcioniranje zvišane amilaze je pokazalo, da izvira pretežno iz sline.
English: Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli.
Slovenian: Zdravilo Kepivance vsebuje zdravilno učinkovino palifermin: beljakovino, biotehnološko pridobljeno iz bakterij Escherichia coli.
English: The incidence of ulcerative oral mucositis was 57.9% in the placebo arm, 68.7% in the pre/post CT group and 51.4% in the pre-CT group.
Slovenian: Pojavnost ulcerativnega oralnega mukozitisa je bila 57,9-% v skupini s placebom, 68,7-% v skupini, ki je palifermin prejemala pred/po KT, in 51,4-% v skupini, ki je palifermin prejemala pred KT.
English: Palifermin is a growth factor that primarily stimulates epithelial cells through the KGF receptor.
Slovenian: Palifermin je rastni faktor, ki v prvi vrsti spodbuja epitelijske celice prek receptorjev KGF.
English: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support.
Slovenian: Zdravilo Kepivance je indicirano za zmanjšanje incidence, trajanja in izrazitosti oralnega mukozitisa pri odraslih bolnikih s hematološkimi malignomi, zdravljenih z mieloablacijsko radiokemoterapijo, ki je povezana z veliko incidenco hudega mukozitisa, in ki potrebujejo podporo z avtolognimi hematopoetskimi matičnimi celicami.
English: In a single dose study the clearance of palifermin was approximately 30% lower in 8 healthy subjects aged 66-73 years after a dose of 90 micrograms/kg than in younger subjects (≤ 65 years) after a dose of 180 micrograms/kg.
Slovenian: V študiji enkratnega odmerka je bil očistek palifermina približno 30 % nižji pri 8 zdravih prostovoljcih v starosti od 66 do 73 let po odmerku 90 mikrogramov/kg kot pri mlajših preiskovancih (≤ 65 let) po odmerku 180 mikrogramov/kg.
English: In this study (n = 281), patients with multiple myeloma received conditioning with melphalan (200 mg/m2) prior to autologous haematopoietic stem cell transplantation.
Slovenian: V študiji (n = 281) so bili bolniki z multiplim mielomom pred avtologno presaditvijo krvotvornih matičnih celic deležni pripravljalne terapije z melfalanom (200 mg/m2).
English: L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid
Slovenian: L-histidin, manitol, saharoza, polisorbat 20 in razredčena klorovodikova kislina
English: You will be given Kepivance for three days in a row before chemotherapy and radiotherapy and for three days in a row after chemotherapy and radiotherapy for a total of six doses.
Slovenian: Zdravilo Kepivance boste dobivali tri dni zapored pred kemoterapijo in radioterapijo ter tri dni zapored po kemoterapiji in radioterapiji, tako da skupaj dobite šest odmerkov.
English: • skin rash, itching and redness (pruritus and erythaema);
Slovenian: • izpuščaj na koži, srbenje in pordelost (pruritus in eritem);
English: Systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female fertility parameters were seen at doses ≥ 300 micrograms/kg/day (5-fold higher than the recommended human dose).
Slovenian: Sistemsko toksičnost (klinične znake in/ali spremembe telesne mase) in neželene učinke na parametre plodnosti pri samcih in samičkah so opazil pri odmerkih ≥ 200 mikrogramov/kg/dan (petkrat več, kot je priporočeni odmerek za ljudi).
English: Palifermin should not be used in association with myeloablative chemotherapy-only conditioning.
Slovenian: Palifermina se ne sme uporabljati v povezavi s pripravljalnim zdravljenjem, ki obsega zgolj mieloablacijsko kemoterapijo.
English: These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure.
Slovenian: Ti NOAEL odmerki so bili (glede na AUC) povezani s sistemsko izpostavljenostjo, ki je bila pri podganah 9,7-krat večja, pri kuncih pa 2,1-krat večja od predvidene klinične izpostavljenosti.
English: A phase I dose escalation study was conducted in paediatric patients aged 1-16 years.
Slovenian: Pri pediatrični populaciji v starosti od 1 do 16 let je bila opravljena študija 1. faze s povečevanjem odmerka.
English: Kepivance should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of cytotoxic chemotherapy.
Slovenian: Uporaba pri kemoterapiji Zdravila Kepivance ne smete uporabiti v 24 urah pred, med ali v 24 urah po apliciranju citotoksične kemoterapije.
English: What you need to know before you use Kepivance
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Kepivance Ne uporabljajte zdravila Kepivance:
English: Kepivance should not be used during pregnancy unless clearly
Slovenian: Zdravila Kepivance med nosečnostjo ne smete uporabljati, razen če je nujno potrebno.
English: In a small multiple-dose study in paediatric patients (1 to 16 years old) receiving 40, 60 or 80 micrograms/kg/day for 3 days pre- and post- HSCT, there was no effect of age on the pharmacokinetics of palifermin although a large variability was observed in the estimated parameters.
Slovenian: Pediatrična populacija V majhni študiji večkratnih odmerkov pri pediatričnih bolnikih (starih od 1 leta do 16 let), ki so prejemali 40, 60 ali 80 mikrogramov/kg/dan v obdobju 3 dni pred in po presaditvi hematopoetskih matičnih celic, niso opazili učinka starosti na farmakokinetiko palifermina, čeprav so opazili velike razlike v ocenjenih parametrih.
English: Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology
Slovenian: Palifermin je humani keratinocitni rastni faktor (KGF - keratinocyte growth factor), pridobljen s tehnologijo rekombinantne DNA iz Escherichia coli.
English: Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Slovenian: Pred injiciranjem lahko zdravilo Kepivance največ 1 uro pustite, da doseže sobno temperaturo, vendar ga morate zaščititi pred svetlobo.
English: The incidence of severe (grades 3 and 4) oral mucositis in the 3 groups was 36.8%, 38.3% and 23.9% for the placebo, pre/post CT and pre-CT groups respectively, with no statistical significance being demonstrated.
Slovenian: Pojavnost hudega (3. in 4. stopnje) oralnega mukozitisa v treh skupinah je bila 36,8-% v skupini s placebom, 38,3-% v skupini, ki je palifermin prejemala pred/po KT, in 23,9-% v skupini, ki je palifermin prejemala pred KT, pri tem pa ni bilo statistično značilnih razlik.
English: Hypersensitivity, including Anaphylactic reactions, has also been associated with palifermin.
Slovenian: S paliferminov je povezana tudi preobčutljivost, vključno z anafilaktičnimi reakcijami.
English: The last of the three doses given before chemotherapy andradiotherapy, must be given at least 24 to 48 hours before the chemotherapy and radiotherapy starts.
Slovenian: Zadnje tri odmerke pred kemoterapijo in radioterapijo morate dobiti vsaj 24 do 48 ur pred začetkom kemoterapije in radioterapije.
English: In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis.
Slovenian: V kliničnem preskušanju je uporaba zdravila Kepivance v 24 urah pred ali po kemoterapiji povečala izrazitost oralnega mukozitisa in podaljšala njegovo trajanje.
English: Reconstituted Kepivance should not be left at room temperature for more than one hour, and should be protected from light.
Slovenian: Pripravljenega zdravila Kepivance ne smete pustiti na sobni temperaturi več kot eno uro in ga morate zaščititi pred svetlobo.
English: There was a lower incidence of severe oral mucositis in patients receiving 80 micrograms/kg/day but no effect on the incidence of acute graft-versus-host disease (GVHD).
Slovenian: Pri bolnikih, ki so prejemali 80 mikrogramov/kg/dan, so opazili nižjo incidenco hudega oralnega mukozitisa, ni pa bilo nikakršnega učinka na incidenco akutne reakcije presadka proti gostitelju.
English: Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer
Slovenian: Zdravljenje z zdravilom Kepivance lahko izvaja samo zdravnik z izkušnjami pri zdravljenju raka.
English: Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Slovenian: Palifermin je beljakovina s 140 aminokislinami.
English: - if you are allergic to palifermin, Escherichia coli derived proteins or any other ingredients of
Slovenian: - če ste alergični na palifermin, beljakovine, pridobljene iz bakterije Escherichia coli ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: Palifermin was administered as a daily intravenous injection of 60 micrograms/kg for 3 consecutive days prior to initiation of cytotoxic therapy and for 3 consecutive days following infusion of peripheral blood progenitor cells with nine days between the last pre dose and first post dose.
Slovenian: Palifermin je bil uporabljen v dnevni intravenski injekciji 60 mikrogramov/kg 3 dni zapored pred začetkom citotoksične terapije in 3 dni zapored po infundiranju matičnih celic v periferno kri, pri čemer je med zadnjim odmerkom pred terapijo in prvim odmerkom po terapiji minilo devet dni.
English: Efficacy and safety of palifermin were established in a randomised, double-blind, placebo-controlled study in which patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (12 Gy total dose; Day -8 to -5), high-dose etoposide (60 mg/kg; Day -4), and high-dose cyclophosphamide (100 mg/kg; Day -2) followed by PBPC support for the treatment of haematological malignancies ((Non-Hodgkin's Lymphoma (NHL), Hodgkin's disease, Acute Myeloid Leukaemia (AML), Acute Lymphocytic Leukaemia (ALL), Chronic Myeloid Leukaemia (CML), Chronic Lymphocytic Leukaemia (CLL), or multiple myeloma).
Slovenian: Učinkovitost in varnost palifermina so ugotavljali v randomizirani, dvojno slepi, s placebom kontrolirani študiji bolnikov s hematološkimi malignomi (ne-Hodgkinov limfom (NHL), Hodgkinova bolezen, akutna mieloična levkemija (AML), akutna limfatična levkemija (ALL), kronična mieloična levkemija (KML), kronična limfatična levkemija (KLL) ali multipli mielom).