natgillin/translations-raw huggingface dataset:
Safety data are based upon 650 patients with haematological malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study.
Podatki o varnosti temeljijo na izsledkih, dobljenih pri 650 bolnikih s hematološkimi malignomi, vključenih v 3 randomizirane, s placebom kontrolirane klinične študije in v študijo farmakokinetike.
Patients received Kepivance (n = 409) or placebo (n = 241) either before, or before and after, myelotoxic chemotherapy with or without total body irradiation and peripheral blood progenitor cell (PBPC) support.
Bolniki so dobivali Kepivance (n = 409) ali placebo (n = 241), in sicer pred ali pred in po mielotoksični kemoterapiji, z ali brez obsevanja celotnega telesa in podporo matičnih celic v periferni krvi.
Adverse reactions were consistent with the pharmacologic action of Kepivance on skin and oral epithelium (see Table 1).
Neželeni učinki so se skladali s farmakološkim delovanjem Kepivanca na kožo in ustni epitel (glejte tabelo 1).
Median time to onset was 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of 5 days.
Mediani čas do pojava je bil 6 dni po prvih 3 zaporednih dnevnih odmerkih Kepivanca; mediano so trajali 5 dni.
The adverse reactions of pain and arthralgia were consistent with Kepivance treated patients having received less opioid analgesia than placebo-treated patients (see Table 2).
Neželena učinka bolečina in artralgija se ujemata z dejstvom, da so bolniki, zdravljeni s Kepivancom, dobili manj opioidne analgezije kot bolniki, ki so dobivali placebo (glejte tabelo 2).
Adverse reactions occurring with ≥ 5% higher incidence with Kepivance compared to placebo
Neželeni učinki, ki so se pri Kepivancu pojavili z ≥ 5% večjo incidenco kot pri placebu
System organ class
organski sistem
Undesirable effect Very common (> 1/ 10)
neželeni učinek zelo pogosti (> 1/ 10)
Nervous system disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders General disorders and administration site conditions
bolezni živčevja bolezni prebavil bolezni kože in podkožja bolezni mišično- skeletnega sistema in vezivnega tkiva splošne težave in spremembe na mestu aplikacije
Taste perversion Mouth/ tongue thickness or discolouration Rash, pruritus and erythema Arthralgia Oedema, pain and fever
spremembe okusa zadebelitev ali obarvanje ust/ jezika izpuščaj, srbenje in eritem artralgija edemi, bolečine in vročina
Kepivance or placebo, and there were no observed differences in disease progression or survival.
Hematopoetsko okrevanje po infuziji matičnih celic v periferno kri je bilo pri prejemnikih Kepivanca in placeba podobno; razlik v napredovanju bolezni ali preživetju niso ugotovili.
Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache.
Kepivance lahko pri nekaterih bolnikih zviša raven lipaze in amilaze.
The incidences of these changes, presented for Kepivance relative to placebo, were: lipase (28% vs.
Ob tem se lahko pojavijo bolečine v trebuhu ali hrbtu ali pa tudi ne.
54%).
Pogostnosti teh sprememb sta bili pri Kepivancu v primerjavi s placebom: lipaza 28% v prim. s 23% in amilaza 62% v prim. s 54%.
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).
The following adverse reactions have been identified during post-marketing use of Kepivance: tongue disorder (e. g. redness, bumps, oedema); face oedema, and mouth oedema; hyperpigmentation of the skin; and anaphylactic/ allergic reactions.
Med pomarketinško uporabo Kepivanca so zabeležili naslednje neželene učinke: spremembe na jeziku (npr. pordelost, bule, edem), edem obraza in edem ust, hiperpigmentacijo kože in anafilaktične oz. alergijske reakcije.
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 therapy).
S Kepivancem 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).
For information on dose limiting toxicities see section 4.8.
Za informacije o toksičnih učinkih, ki omejujejo odmerek, glejte poglavje 4. 8.
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.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: oznaka ATC:
V03A F08.
V03AF08, Zdravila za zaščito organizma pred toksičnostjo citostatikov.
Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Njena molekulska masa je 16, 3 kilodaltonov.
It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve protein stability.
Od endogenega humanega KGF se razlikuje po tem, da ima za izboljšanje stabilnosti odstranjenih prvih 23 N- terminalnih aminokislin.
KGF is a protein that targets epithelial cells by binding to specific cell-surface receptors thereby stimulating proliferation, differentiation, and upregulation of cytoprotective mechanisms (eg, 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).
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.
Njegovo nastajanje se naravno poveča v odziv na poškodbo epitelijskega tkiva.
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.
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.
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), high-dose etoposide (60 mg/ kg), and high-dose cyclophosphamide (100 mg/ kg) 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).
Bolniki so v študiji dobivali visokoodmerno citotoksično terapijo, ki je obsegala frakcionirano obsevanje celotnega telesa (celotni odmerek 12 Gy), visokoodmerni etopozid (60 mg/ kg) in visokoodmerni ciklofosfamid (100 mg/ kg); sledila je podpora z matičnimi celicami v periferni krvi.
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.
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.
Other endpoints
5 Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3. / 4. stopnja po lestvici Svetovne zdravstvene organizacije [SZO]).
5 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.
The efficacy results are presented in Table 2.
Rezultate o učinkovitosti prikazuje tabela 2.
Palifermin (60 micrograms/ kg/ day) n = 106
(60 mikrogramov/ kg/ dan) n = 106
Median (25th, 75th percentile) days of WHO Grade 3/ 4 oral mucositis**
Mediana (25., 75. percentil) dni z oralnim mukozitisom 3. / 4. stopnje po SZO **
Patient incidence of WHO Grade 3/ 4 oral mucositis
Incidenca bolnikov z oralnim mukozitisom 3. / 4. stopnje po SZO
Median (25th, 75th percentile) days of WHO Grade 3/ 4 oral mucositis in affected patients
Mediana (25., 75. percentil) dni z oralnim mukozitisom 3. / 4. stopnje po SZO pri prizadetih bolnikih
Patient incidence of WHO Grade 4 oral 62% mucositis
Incidenca bolnikov z oralnim mukozitisom 4. stopnje
Median (25th, 75th percentile) days of WHO Grade 2/ 3/ 4 oral mucositis
Mediana (25., 75 percentil) dni z oralnim mukozitisom 2. / 3. / 4. stopnje po SZO Opioidna analgezija za oralni mukozitis:
14 (11, 19)
14 (11, 19) 8
8 (4, 12)
(4, 12)
Median (25th, 75th percentile) Cumulative Dose (morphine mg equivalents)
mediana (25., 75. percentil) dni mediani (25., 75. percentila) kumulativni odmerek (ekvivalent mg morfina)
535 (269, 1429)
11 (8, 14) 535 (269, 1429)
212 (3, 558)
7 (1, 10) 212 (3, 558)
* Using Cochran-Mantel-Haenszel (CMH) test stratified for study centre. ** WHO Oral Mucositis Scale:
* Z uporabo Cochran- Mantel- Haenszelovega (CMH) testa, stratificirano po študijskem centru. ** Lestvica oralnega mukozitisa po SZO:
Grade 1 = soreness/ erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
1. stopnja = bolečina/ eritem, 2. stopnja = eritem, razjede, bolnik lahko uživa čvrsto hrano, 3. stopnja = razjede, potrebna je zgolj tekoča hrana, 4. stopnja = hranjenje ni mogoče
After single intravenous doses of 20 to 250 micrograms/ kg (healthy volunteers) and 60 micrograms/ kg (cancer patients), palifermin exhibited rapid extravascular distribution In patients with haematological malignancies mean Vss was 5 l/ kg and mean clearance about 1300 ml/ hour/ kg with an average terminal half-life of approximately 4.5 hours.
Pri bolnikih s hematološkimi malignomi je bil povprečni Vss 5 l/ kg, povprečni očistek okrog 1300 ml/ uro/ kg in povprečni terminalni razpolovni čas približno 4, 5 ure.
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.
No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/ kg (healthy volunteers) or 60 micrograms/ kg (cancer patients).
60 mikrogramov/ kg (bolniki z rakom) ni prišlo do kopičenja palifermina.
Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss
KV (koeficient variabilnosti) za očistek znaša približno 50% in KV za Vss približno 60%.
No gender-related differences were observed in the pharmacokinetics of palifermin.
6 Farmakokinetika palifermina se med spoloma ni razlikovala.
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.
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).
6 decreased by 10% (n=6).
Pri bolnikih s končno odpovedjo ledvic (ki potrebujejo dializo) je bil očistek palifermina manjši za 10% (n = 6).
The pharmacokinetic profile in paediatric and geriatric populations (age above 70 years), or in patients with hepatic insufficiency, has not been assessed.
Farmakokinetične značilnosti v pediatrični in geriatrični populaciji (nad 70 let starosti) in pri bolnikih z insuficienco jeter niso raziskane.
In fertility/ general reproductive toxicity studies in rats, palifermin treatment was associated with systemic toxicity (clinical signs and/ or changes in body weight) and adverse effects on male and female reproductive/ fertility parameters at doses greater than or equal to 300 micrograms/ kg/ day.
V študijah toksičnih učinkov na plodnost/ splošno sposobnost razmnoževanja pri podganah so zdravljenje s paliferminom v odmerkih, ki so bili enaki ali večji od 300 mikrogramov/ kg/ dan, spremljali sistemski toksični učinki (klinični znaki in/ ali spremembe telesne mase) ter neželeni učinki na reproduktivne parametre/ parametre plodnosti samcev in samic.
No adverse effects on reproductive/ fertility parameters were observed at doses of up to 100 micrograms/ kg/ day.
Pri odmerkih do 100 mikrogramov/ kg/ dan niso opažali neželenih učinkov na reproduktivne parametre/ parametre plodnosti.
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.
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.
150 mikrogramov/ kg/ dan (kunci) povezano s toksičnimi učinki na razvoj (večja poimplantacijska izguba, manjša velikost legla in/ ali manjša teža ploda).
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.
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.
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.
Peri- and postnatal development has not been studied.
Peri - in postnatalnega razvoja niso proučevali.
Haematologic malignancies do not express the KGF receptor.
Hematološki malignomi nimajo eksprimiranih receptorjev KGF, toda bolnike, zdravljene s kemoterapijo in/ ali radioterapijo, bolj ogrožajo sekundarni tumorji.
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.
L-histidine Mannitol Sucrose Polysorbate 20 Diluted Hydrochloric acid
L- histidin manitol saharoza polisorbat 20 razredčena klorovodikova kislina
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Če za vzdrževanje intravenske linije uporabljate heparin, je treba linijo pred aplikacijo Kepivanca in
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 in vitro.
7 po njej izprati z raztopino natrijevega klorida, kajti za palifermin je in vitro dokazano, da se veže na heparin.
4 years.
4 leti.
7 After reconstitution:
Po pripravi:
24 hours at 2°C - 8°C, protected from light.
24 ur pri temperaturi med 2 °C in 8 °C, zaščiteno pred svetlobo.
Store in a refrigerator (2°C - 8°C).
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
6.25mg of powder in a vial (Type I glass) with a rubber stopper, an aluminium seal and a plastic flip- off cap.
6, 25 mg praška v viali (steklo tipa I) z gumijastim zamaškom, aluminijsko zaporo in plastično snemno zaporko.
Kepivance is a sterile but unpreserved product and is intended for single use only.
Kepivance je sterilen izdelek, vendar ne vsebuje konzervansov in je namenjen samo za enkratno uporabo.
Kepivance should be reconstituted with 1.2 ml water for injections.
Kepivance pripravite z 1, 2 ml vode za injekcije.
The diluent should be injected slowly into the Kepivance vial.
Vehikel počasi injicirajte v vialo Kepivanca.
Generally, dissolution of Kepivance takes less than 5 minutes.
Praviloma traja raztapljanje Kepivanca manj kot 5 minut.
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 Kepivance največ eno uro pustite, da doseže sobno temperaturo, vendar ga morate zaščititi pred svetlobo.
Kepivance left at room temperature for more than 1 hour should be discarded.
Kepivance, ki je bil na sobni temperaturi več kot 1 uro, morate zavreči.
Biovitrum AB (publ) SE-112 76 Stockholm Sweden
Biovitrum AB (publ) SE- 112 76 Stockholm Švedska
8 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
10 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE( UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke zdravilne učinkovine( učinkovin)
Amgen Inc 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Amgen Inc 5550 Airport Boulevard Boulder, Colorado 80301 ZDA
Amgen Inc 4000 Nelson Road Longmont, Colorado 80503 United States of America
Amgen Inc 4000 Nelson Road Longmont, Colorado 80503 ZDA
Minervum 7061 4817 ZK Breda The Netherlands
Minervum 7061 4817 ZK Breda Nizozemska
Kepivance 6.25 mg powder for solution for injection Palifermin
Kepivance 6, 25 mg prašek za raztopino za injiciranje Palifermin
L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid
L- histidin, manitol, saharoza, polisorbat 20 in razredčena klorovodikova kislina
For intravenous use For single use only Read the package leaflet before use
Za enkratno uporabo Pred uporabo natančno preberite priloženo navodilo!
Store in original package in order to protect from light.
Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
Kepivance 6.25 mg powder for injection Palifermin
Kepivance 6, 25 mg prašek za raztopino za injiciranje Palifermin
Kepivance 6.25 mg powder for solution for injection palifermin
Kepivance 6, 25 mg prašek za raztopino za injiciranje Palifermin
Read all of this leaflet carefully before you start using this medicine.
Pred uporabo tega zdravila natančno preberite navodilo.
What Kepivance is and what it is used for 2.
Kaj je zdravilo Kepivance in za kaj ga uporabljamo 2.
Before you use Kepivance 3.
Kaj morate vedeti, preden boste dobili zdravilo Kepivance 3.
How to use Kepivance 4.
Kako uporabljati zdravilo Kepivance 4.
Possible side effects 5 How to store Kepivance 6.
Možni neželeni učinki 5 Shranjevanje zdravila Kepivance 6.
WHAT KEPIVANCE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO KEPIVANCE IN ZA KAJ GA UPORABLJAMO
Kepivance should only be used in adults over the age of 18 years.
Kepivance smejo dobivati le odrasli, starejši od 18 let.
Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli.
Kepivance vsebuje zdravilno učinkovino palifermin: beljakovino, biotehnološko pridobljeno iz bakterij Escherichia coli.
Palifermin is similar to the protein called keratinocyte growth factor (KGF) that is naturally made by your body in small amounts.
Palifermin je podoben beljakovini, ki jo imenujemo keratinocitni rastni dejavnik (KGF) in ki v majhni količini naravno nastaja v človeškem telesu.
Palifermin acts in the same way as naturally occurring KGF by stimulating 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.
Kepivance is used to reduce the frequency, duration and severity of oral mucositis (soreness, dryness and inflammation of the mouth) and improve related symptoms in patients with haematological malignancies (blood cancers) receiving certain types of chemotherapy and/ or radiotherapy requiring autologous haematopoietic stem cell support (cells from your own body that produce blood).
Kepivance uporabljamo za zmanjšanje pogostnosti, trajanja in izrazitosti oralnega mukozitisa (bolečin, suhosti in vnetja v ustih) in za izboljšanje simptomov pri bolnikih, ki imajo hematološke maligne bolezni (krvnega raka) ter dobivajo določene vrste kemoterapije in/ ali obsevanja, zaradi katerih je potrebna podpora avtolognih hematopoetskih matičnih celic (krvotvornih celic iz vašega lastnega organizma).
BEFORE YOU USE KEPIVANCE
KAJ MORATE VEDETI, PREDEN BOSTE DOBILI ZDRAVILO KEPIVANCE
Do not use Kepivance:
Ne uporabljajte zdravila Kepivance:
• if you are allergic (hypersensitive) to palifermin‚ any other ingredients of Kepivance, or to Escherichia coli derived proteins.
• če ste alergični na (preobčutljivi za) palifermin, katerokoli drugo sestavino zdravila Kepivance ali beljakovine, pridobljene iz bakterije Escherichia coli.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed to you by a doctor.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
18 Pregnancy and breast-feeding
18 Nosečnost in dojenje
Kepivance has not been tested in pregnant women.
Kepivance ni preizkušen pri nosečnicah.
• are pregnant;
• ste noseči,
• think you may be pregnant; or
• mislite, da ste morda noseči, ali
It is not known whether Kepivance is present in human milk.
Ni znano, ali se Kepivance pojavi v materinem mleku.
Ask your doctor or pharmacist for advice before taking any medicine.
Preden začnete jemati katerokoli zdravilo, se posvetujte s svojim zdravnikom ali framacevtom.
The effect of Kepivance on the ability to drive or use machinery is not known.
Učinek zdravila Kepivance na sposobnost upravljanja vozil in strojev ni znan.
HOW TO USE KEPIVANCE
KAKO UPORABLJATI ZDRAVILO KEPIVANCE
As Kepivance is a powder it must be mixed with water for injections before being injected into a vein.
Kepivance je prašek, zato ga je treba pred injiciranjem v veno zmešati z vodo za injekcije.
The usual dose is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Običajni odmerek je 60 mikrogramov zdravila Kepivance na kilogram telesne mase na dan.