natgillin/translations-raw huggingface dataset:
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
The safety and efficacy of Kepivance has not been established in patients with KGF receptor expressing non-haematological malignancies. 
Varnost in učinkovitost zdravila Kepivance nista ugotovljeni pri bolnikih z nehematološkimi malignomi, ki imajo eksprimirane receptorje KGF.
Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2). 
Varnost in učinkovitost pri bolnikih z okvaro jeter nista bili ovrednoteni (glejte poglavje 5.2).
Fractionation of increased levels of amylase revealed the increase to be predominantly salivary in origin. 
Frakcioniranje zvišane amilaze je pokazalo, da izvira pretežno iz sline.
Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli. 
Zdravilo Kepivance vsebuje zdravilno učinkovino palifermin: beljakovino, biotehnološko pridobljeno iz bakterij Escherichia coli.
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. 
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.
Palifermin is a growth factor that primarily stimulates epithelial cells through the KGF receptor. 
Palifermin je rastni faktor, ki v prvi vrsti spodbuja epitelijske celice prek receptorjev KGF.
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. 
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.
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. 
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.
In this study (n = 281), patients with multiple myeloma received conditioning with melphalan (200 mg/m2) prior to autologous haematopoietic stem cell transplantation. 
V študiji (n = 281) so bili bolniki z multiplim mielomom pred avtologno presaditvijo krvotvornih matičnih celic deležni pripravljalne terapije z melfalanom (200 mg/m2).
L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid 
L-histidin, manitol, saharoza, polisorbat 20 in razredčena klorovodikova kislina
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. 
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.
• skin rash, itching and redness (pruritus and erythaema); 
• izpuščaj na koži, srbenje in pordelost (pruritus in eritem);
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). 
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).
Palifermin should not be used in association with myeloablative chemotherapy-only conditioning. 
Palifermina se ne sme uporabljati v povezavi s pripravljalnim zdravljenjem, ki obsega zgolj mieloablacijsko kemoterapijo.
These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure. 
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.
A phase I dose escalation study was conducted in paediatric patients aged 1-16 years. 
Pri pediatrični populaciji v starosti od 1 do 16 let je bila opravljena študija 1. faze s povečevanjem odmerka.
Kepivance should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of cytotoxic chemotherapy. 
Uporaba pri kemoterapiji Zdravila Kepivance ne smete uporabiti v 24 urah pred, med ali v 24 urah po apliciranju citotoksične kemoterapije.
What you need to know before you use Kepivance 
Kaj morate vedeti, preden boste uporabili zdravilo Kepivance Ne uporabljajte zdravila Kepivance:
Kepivance should not be used during pregnancy unless clearly 
Zdravila Kepivance med nosečnostjo ne smete uporabljati, razen če je nujno potrebno.
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. 
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.
Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology 
Palifermin je humani keratinocitni rastni faktor (KGF - keratinocyte growth factor), pridobljen s tehnologijo rekombinantne DNA iz Escherichia coli.
Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light. 
Pred injiciranjem lahko zdravilo Kepivance največ 1 uro pustite, da doseže sobno temperaturo, vendar ga morate zaščititi pred svetlobo.
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. 
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.
Hypersensitivity, including Anaphylactic reactions, has also been associated with palifermin. 
S paliferminov je povezana tudi preobčutljivost, vključno z anafilaktičnimi reakcijami.
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. 
Zadnje tri odmerke pred kemoterapijo in radioterapijo morate dobiti vsaj 24 do 48 ur pred začetkom kemoterapije in radioterapije.
In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis. 
V kliničnem preskušanju je uporaba zdravila Kepivance v 24 urah pred ali po kemoterapiji povečala izrazitost oralnega mukozitisa in podaljšala njegovo trajanje.
Reconstituted Kepivance should not be left at room temperature for more than one hour, and should be protected from light. 
Pripravljenega zdravila Kepivance ne smete pustiti na sobni temperaturi več kot eno uro in ga morate zaščititi pred svetlobo.
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). 
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.
Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer 
Zdravljenje z zdravilom Kepivance lahko izvaja samo zdravnik z izkušnjami pri zdravljenju raka.
Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons. 
Palifermin je beljakovina s 140 aminokislinami.
- if you are allergic to palifermin, Escherichia coli derived proteins or any other ingredients of 
- če ste alergični na palifermin, beljakovine, pridobljene iz bakterije Escherichia coli ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6).
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. 
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.
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). 
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).
In a postmarketing clinical trial investigating multiple myeloma patients receiving melphalan 200 mg/m2 as conditioning regimen, palifermin administration with four days between the last pre dose and the first post dose did not show a therapeutic benefit in the frequency or duration of severe oral mucositis compared to placebo. 
V kliničnem preskušanju v obdobju trženja pri bolnikih z multiplim mielomom, ki so za pripravljalno zdravljenje prejeli melfalan v odmerku 200 mg/m2, uporaba palifermina s 4-dnevnim presledkom med zadnjim odmerkom pred terapijo in prvim odmerkom po njej ni pokazala nobene terapevtske prednosti v primerjavi s placebom, kar zadeva pogostnost ali trajanje hudega oralnega mukozitisa.
The conditioning regimen consisted of total body irradiation (TBI), etoposide and cyclophosphamide. 
Pripravljalni režim je bil sestavljen iz obsevanja celotnega telesa, etopozida in ciklofosfamida.
Each vial contains 6.25 mg of palifermin. 
Ena viala vsebuje 6,25 mg palifermina.
6 vials containing powder for solution for injection 
6 vial s praškom za raztopino za injiciranje
This dose will be given to you as an intravenous injection (into a vein). 
Tak odmerek boste dobili v intravenski injekciji (injekciji v veno).
- The other ingredients are mannitol, sucrose, L-histidine, polysorbate 20 and diluted 
- Pomožne snovi so manitol, saharoza, L-histidin, polisorbat 20 in razredčena klorovodikova
Kepivance left at room temperature for more than 1 hour should be discarded. 
Zdravilo Kepivance, ki je bilo na sobni temperaturi več kot 1 uro, morate zavreči.
The last three doses should be administered post myeloablative radiochemotherapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least seven days after the most recent Kepivance administration (see section 4.4). 
Prvega od njih je treba aplicirati po infundiranju hematopoetskih matičnih celic, vendar še isti dan in obenem najmanj sedem dni po zadnji prejšnji aplikaciji zdravila Kepivance (glejte poglavje 4.4).
KGF receptors are known to be expressed on the lens of the eye. Cataractogenic effects of palifermin cannot be excluded (see section 5.1). 
Kataraktogenih učinkov palifermina ni mogoče izključiti (glejte poglavje 5.1).
No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/kg (healthy volunteers) or 60 micrograms/kg (adult patients) or 40 to 80 
Po 3 zaporednih dnevnih odmerkih 20 in 40 mikrogramov/kg (zdravi prostovoljci) oz. 60 mikrogramov/kg (odrasli bolniki) ali 40 do 80 mikrogramov/kg
The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative radiochemotherapy. 
Prve tri odmerke je treba uporabiti pred mieloablacijsko terapijo, in sicer tako, da bolnik dobi tretji odmerek v 24 do 48 urah pred mieloablacijsko radiokemoterapijo.
• hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb, 
• reakcija na koži dlani in stopal (na dlaneh ali stopalih se pojavi mravljinčavost/srbečica,
Vaginal oedema and vulvovaginal erythema 
artralgija vaginalni edem in vulvovaginalni eritem
Oral mucosal hypertrophy / Hypertrophy of tongue papillae,Oral mucosal discolouration / Tongue discolouration, Tongue disorder (e.g. redness, bumps), Tongue oedema 
Bolezni prebavil hipertrofija ustne sluznice/hipertrofija papil na jeziku, obarvanje ustne sluznice/obarvanje jezika nepravilnosti jezika (npr. pordelost, bule), edem jezika
Dose limiting toxicities were observed in 36% (5 of 14) patients receiving 6 doses of 80 micrograms/kg/day administered intravenously over 2 weeks (3 doses preceding and three doses following myeloablative therapy). 
Toksične učinke, ki so omejevali odmerek, so zabeležili pri 36 % (5 od 14) bolnikov, ki so dobili 6 odmerkov po 80 mikrogramov/kg/dan intravensko v 2 tednih (3 odmerke pred in 3 odmerke po mieloablacijski terapiji).
Kepivance is not recommended in children (0 to 18 years). 
Pri otrocih, starih od 0 do 18 let, zdravila Kepivance ne priporočamo.
Safety data are based on patients with haematological malignancies enrolled in randomised, placebocontrolled clinical studies, including one pharmacokinetic study, and post marketing experience. 
vključenih v randomizirane, s placebom kontrolirane klinične študije, vključno s študijo farmakokinetike, in na podlagi izkušenj v obdobju trženja.
The duration between last dose of Kepivance before myeloablative radiochemotherapy and the first dose of Kepivance after myeloablative radiochemotherapy should be at least seven days. 
Med zadnjim odmerkom zdravila Kepivance pred mieloablacijsko radiokemoterapijo in prvim odmerkom zdravila Kepivance po mieloablacijski radiokemoterapiji mora preteči najmanj sedem dni.
There is no experience with Kepivance doses greater than 80 micrograms/kg/day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative 
Z zdravilom Kepivance ni izkušenj v odmerkih, večjih od 80 mikrogramov/kg/dan, apliciranih intravensko v obdobju 2 tednov (3 odmerki pred in 3 odmerki po mieloablacijski terapiji).
Cataractogenic effects of palifermin cannot be excluded following results of ophthalmologic examinations in a subset of patients (n = 66; 14 in the placebo group, 52 in the palifermin group) who were followed for 12 months after the acute phase of the above post-approval study. 
Glede na rezultate oftalmološkega pregleda podskupine bolnikov (n = 66; 14 v kontrolni skupini, 52 v skupini, zdravljeni s paliferminom), ki so jih spremljali 12 mesecev po akutni fazi navedene študije po pridobitvi dovoljenja za promet, kataraktogenih učinkov palifermina ni mogoče izključiti.
Prior to administration, visually inspect the solution for discolouration and particulate matter before administration, see section 6.6. 
Pred aplikacijo morate pregledati, da raztopina ni obarvana in ne vsebuje delcev, glejte poglavje 6.6.
Rash, pruritus and erythema Skin hyperpigmentation Palmar-plantar erythrodysaesthesia syndrome (dysaesthesia, erythema, oedema on the palms and soles) 
Bolezni kože in podkožja izpuščaj, srbenje in eritem hiperpigmentacija kože sindrom eritrodisestezije dlani in stopal (disestezija, eritem in edem na dlaneh in stopalih)
The first of the three doses given after the chemotherapy and radiotherapy must be given at least 7 days after the most recent 
Prve tri odmerke po kemoterapiji in radioterapiji morate dobiti najmanj 7 dni po zadnjem dajanju zdravila Kepivance.
There was no evidence of a delay in time to haematopoietic recovery in patients who received palifermin as compared to patients who received placebo. 
Hematopoetsko okrevanje pri prejemnikih palifermina se v primerjavi s prejemniki placeba ni izkazalo za počasnejše.
Median (25th, 75th percentile) days of Median (25th, 75th percentile) days of 
Mediana (25., 75. percentil) dni z oralnim mukozitisom 3./4.
Patient incidence of WHO Grade 4 oral Median (25th, 75th percentile) days of 
Incidenca bolnikov z oralnim mukozitisom 4. stopnje Mediana (25., 75 percentil) dni z oralnim mukozitisom 2./3./4.
Once reconstituted, Kepivance contains 5 mg/ml of palifermin. 
Zdravilo Kepivance po pripravi vsebuje 5 mg/ml palifermina.
Palifermin works in the same way as keratinocyte growth factor (KGF) which is made naturally by 
Palifermin deluje enako kot keratinocitni rastni dejavnik (KGF), ki v majhni količini naravno nastaja v človeškem telesu.
** WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible 
bolnik lahko uživa čvrsto hrano, 3. stopnja = razjede, potrebna je zgolj tekoča hrana, 4. stopnja = hranjenje ni mogoče
Patient Incidence of Febrile Neutropenia 92% 75% * Using Cochran-Mantel-Haenszel (CMH) test stratified for study centre. 
mediani (25., 75. percentila) kumulativni odmerek (ekvivalent mg morfina) Incidenca bolnikov s popolno parenteralno prehrano (PPP) Incidenca bolnikov s febrilno nevtropenijo * Z uporabo Cochran-Mantel-Haenszelovega (CMH) testa, stratificirano po študijskem centru.
Non-haematological malignancies 
Nehematološki malignomi
Haematopoietic recovery following PBPC infusion was similar between patients who received Kepivance or placebo, and there were no observed differences in disease progression or survival. 
Kepivance in placeba podobno; razlik v napredovanju bolezni ali preživetju niso ugotovili.
Kepivance is a growth factor that stimulates the proliferation of KGF receptor expressing epithelial cells. 
V zdravilu Kepivance je rastni faktor, ki spodbuja proliferacijo epitelijskih celic z eksprimiranimi receptorji KGF.
Palifermin 
Dojenje
Endogenous KGF is an epithelial cell specific growth factor which is produced by mesenchymal cells and is naturally upregulated in response to epithelial tissue injury. 
Endogeni KGF je za epitelijske celice specifičen rastni faktor, ki nastaja v mezenhimskih celicah.
The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses. 
Priporočeni odmerek zdravila Kepivance je 60 mikrogramov/kg/dan v intravenski bolusni injekciji, in sicer tri dni zapored pred mieloablacijsko radiokemoterapijo in tri dni zapored po njej, tako da dobi bolnik skupaj šest odmerkov.
Approximately dose-linear pharmacokinetics were observed in healthy volunteers after single dose administration up to 250 micrograms/kg. 
Pri zdravih prostovoljcih so po uporabi posamičnega odmerka do 250 mikrogramov/kg ugotovili približno z odmerkom linearno farmakokinetiko.
Palifermin stimulates the growth of specific cells called epithelial cells that form the tissue lining of your mouth and digestive tract, as well as other tissues such as skin. 
Epitelijske celice tvorijo tkivno prevleko v ustih, prebavilih in tudi drugod, npr. na koži.
• redness, bumps or swelling of the tongue; 
• pordelost, bule ali oteklost jezika, • oteklost (edem) obraza ali ust,
• an increase in the thickness in the mouth or tongue; 
• zadebelitev ust ali jezika,
What Kepivance looks like and contents of the pack Kepivance is a white powder supplied in vials. 
Zdravilo Kepivance je bel prašek v vialah.
In embryo/foetal development toxicity studies in rats and rabbits, palifermin treatment was associated with developmental toxicity (increased post-implantation loss, reduced litter size, and/or reduced foetal weight) at doses of 500 and 150 micrograms/kg/day, respectively. 
V študijah razvojnih toksičnih učinkov pri zarodkih in plodovih podgan in kuncev, je bilo zdravljenje s paliferminom v odmerkih 500 mikrogramov/kg/dan (podgane) oz. 150 mikrogramov/kg/dan (kunci)
No adverse developmental effects were observed in rats and rabbits at doses of up to 300 and 60 micrograms/kg/day, respectively. 
Pri podganah niso opazili nobenih neugodnih učinkov na razvoj ob odmerkih do 300 mikrogramov/kg/dan, pri kuncih pa do 60 mikrogramov/kg/dan.
A randomised, placebo-controlled, double-blind study was conducted post-approval to evaluate the efficacy of palifermin given pre- or pre- and post- chemotherapy (CT). 
Randomizirana, s placebom kontrolirana, dvojno slepa študija za oceno učinkovitosti palifermina,
Store in the original carton, in order to protect from light. 
Shranjujte v originalni škatli, da bo zdravilo zaščiteno pred svetlobo.
Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03A F08. 
ATC: V03AF08.
However, patients treated with chemotherapy and/or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands. 
Nekateri od teh bi lahko imeli eksprimirane receptorje KGF in bi jih teoretično lahko spodbujali ligandi receptorjev KGF.
A 3-fold or greater increase in Ki67 staining was observed in buccal biopsies from 3 of 6 healthy subjects given palifermin at 40 micrograms/kg/day intravenously for 3 days, when measured 24 hours after the third dose. 
Pri 3 od 6 zdravih preiskovancev, ki so 3 dni dobivali palifermin v odmerku 40 mikrogramov/kg/dan, so z meritvijo 24 ur po 3. odmerku v bukalnih bioptičnih vzorcih ugotovili 3- ali večkraten porast obarvanja Ki67.
In studies in rats, no adverse effects on reproductivity/fertility parameters were observed at doses of up to 100 micrograms/kg/day. 
Študije na podganah pri odmerkih do 100 mikrogramov/kg/dan niso pokazale neželenih učinkov na parametre razmnoževanja/plodnosti.
No gender-related differences were observed in the pharmacokinetics of palifermin. 
Farmakokinetika palifermina se med spoloma ni razlikovala.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to 
Preobčutljivost na zdravilno učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1 ali beljakovine, pridobljene iz bakterije Escherichia coli.
Dose-dependent epithelial cell proliferation was observed 48 hours post-dosing in healthy subjects given single intravenous doses of 120 to 250 micrograms/kg. 
Pri zdravih preiskovancih, ki so dobili en sam intravenski odmerek od 120 do 250 mikrogramov/kg, so 48 ur po odmerku zabeležili od odmerka odvisno proliferacijo epitelijskih celic.
• eyelid swelling; 
• splošna oteklost (edemi),
Contents of the pack and other information 
5 Shranjevanje zdravila Kepivance Vsebina pakiranja in dodatne informacije
Kepivance should not be administered subcutaneously due to poor local tolerability. 
Zaradi slabega lokalnega prenašanja zdravila Kepivance ne smete dajati subkutano.