natgillin/translations-raw huggingface dataset:
Oral mucositis and related clinical sequelae - HSC transplant study Palifermin (60 micrograms/kg/day) n = 106 
Oralni mukozitis in sorodne klinične posledice - študija HSC Transplant
Powder for solution for injection (powder for injection). 
prašek za raztopino za injiciranje (prašek za injekcijo) bel liofiliziran prašek
PHARMACEUTICAL PARTICULARS 
5.2 Farmakokinetične lastnosti
1 Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache. 
zvišani amilaza in lipaza v krvi1 1 Zdravilo Kepivance lahko pri nekaterih bolnikih zviša raven lipaze in amilaze.
These patient-reported outcomes were highly correlated to the clinician grading of 
Ti samoopisani izidi so močno korelirali s klinično razvrstitvijo oralnega mukozitisa po lestvici SZO.
NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection Palifermin 
Navodilo za uporabo Kepivance 6,25 mg prašek za raztopino za injiciranje palifermin
Post- myeloablative radiochemotherapy: 
Pred mieloablacijsko radiokemoterapijo:
• tingling of the mouth; 
• oteklost ustnic.
Days 
Otroci
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.
A total of 27 paediatric patients with leukaemia were randomized to 40, 60 or 80 micrograms/kg/day of palifermin for 3 days pre- and post- hematopoietic stem cell transplantation (HSCT). 
Skupno 27 pediatričnih bolnikov z levkemijo so randomizirali v skupine s po 40, 60 in 80
Dysgeusia Paraesthesia oral 
Bolezni živčevja disgevzija parestezije v ustih
NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection 
Kepivance 6,25 mg prašek za raztopino za injiciranje
Visually inspect the solution for discolouration and particulate matter before administration. 
Pred aplikacijo raztopino preglejte,
Kepivance should not be administered if discolouration or particulates are observed. 
Če opazite obarvanje ali delce, Kepivanca ne smete aplicirati.
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. 
spremljali sistemski toksični učinki (klinični znaki in/ali spremembe telesne mase) ter neželeni učinki na reproduktivne parametre/parametre plodnosti samcev in samic.
Caution should be used when dosing patients with hepatic impairment. 
Pri bolnikih z okvaro jeter bodite previdni pri odmerjanju.
Detailed information on this medicinal product is available on the website of the European Medicines 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Polysorbate 20 
L-histidin manitol saharoza polisorbat 20
Face oedema, oedema mouth 
edem, periferni edem, bolečina in pireksija oteklost ustnic, edem vek edem obraza, edem ust
For the primary endpoint, which was incidence of cataract development or progression at 12 months (defined as an increase of ≥ 0.3 in the LOCS III score), a greater proportion of subjects experienced cataract development in the palifermin group compared with the placebo group (28.6 % in the placebo group vs 48.1% in the palifermin group). 
(opredeljeno kot povečanje ocene po lestvici LOCS III za ≥ 0,3), je v skupini, zdravljeni s paliferminom, prišlo do razvoja katarakte pri večjem deležu preiskovancev kot v kontrolni skupini
Lip swelling, eyelid oedema 
OVOJNINAH NALEPKA NA VIALI
Ask your doctor or pharmacist for advice before taking this medicine. 
Preden začnete jemati to zdravilo, se posvetujte s svojim zdravnikom ali farmacevtom.
None were considered serious in nature. 
Noben se ni obravnaval kot resen.
open here 
odprite tukaj
There may be new information. 
Morda bo vsebovalo nove informacije.
Date of first authorisation: 18 July 2014 Date of latest renewal: 25 March 2019 
Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja: 25. marec 2015
These symptoms are not really flu, see below. 
Ti simptomi niso prava gripa, glejte spodaj.
This is normal and will not affect your dose. 
To je normalno in ne vpliva na vaš odmerek.
Research Triangle Park, NC 27709-4627 USA 
Research Triangle Park, NC 27709-4627
DK-3400 Hillerød 
DK-3400 Hillerød Danska
17% previously treated 
17 % predhodno zdravljeni
For more information see section 5.1. 
Za več informacij glejte poglavje 5.1.
- Contact a doctor immediately. 
- se takoj posvetujte z zdravnikom.
Experience with exposure during the second and third trimester is very limited. 
Izkušnje z izpostavljenostjo v drugem in tretjem trimesečju so omejene.
Clinical experience in patients aged above 65 years is limited. 
Klinične izkušnje pri bolnikih, starih več kot 65 let, so omejene.
• Record the date and location of each injection. 
• Zabeležite datum in lokacijo vsakega injiciranja.
- Serious allergic reaction 
- Resne alergijske reakcije
Results for this study are shown in Table 3. 
Rezultati te študije so prikazani v preglednici 3.
This includes any medicines obtained without a prescription. 
To vključuje tudi katero koli zdravilo, ki ste ga dobili brez recepta.
125 (full dose) 
125 (polni odmerek)
Do not make changes unless your doctor tells you. 
Ne spreminjajte ničesar, če vam tako ne naroči zdravnik.
The pack contains 3 inner cartons. 
Pakiranje vsebuje 3 notranje škatle.
Treatment can then continue with the next scheduled dose as planned. 
Zdravljenje se naj nadaljuje z naslednjim načrtovanim odmerkom.
The start and end of flu-like symptoms are different for every patient. 
Začetek in konec gripi podobnih simptomov sta pri vsakem bolniku drugačna.
This regular schedule helps to deliver the treatment as evenly as possible. 
Ta redni režim zagotavlja, da zdravilo prejemate kar najbolj enakomerno.
The majority of enzyme elevations were <3 times the upper limit of normal (ULN). 
Večina povečanja encimov je bila < 3-kratna zgornja meja normalne vrednosti (ULN, upper limit of normal).
Everyone has their own set of MS symptoms. 
Vsak bolnik z MS ima svoj skupek simptomov.
The study design and patient demographics are presented in Table 2. 
Zasnova študije in demografski podatki bolnikov so predstavljeni v preglednici 2.
- Contact a doctor for advice. 
- se za nasvet obrnite na zdravnika.
Patients who failed previous MS treatment were not included in the study. 
Bolniki, pri katerih predhodno zdravljenje MS ni bilo uspešno, niso bili vključeni v študijo.
Results in this subgroup were consistent with those in the overall population. 
Rezultati te podskupine so bili skladni z rezultati celotne populacije.
At very high doses, anovulatory and abortifacient effects were observed in animals. 
Pri zelo visokih odmerkih so pri živalih opazili anovulacijske in abortivne učinke.
The incidence of the adverse reactions below are expressed according to the following categories: 
Incidenca spodnjih neželenih učinkov je izražena po naslednjih kategorijah:
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 or over. 
To zdravilo se uporablja za zdravljenje recidivne-remitentne multiple skleroze (MS) pri odraslih, starih 18 let ali več.
Interferons are natural substances made in the body to help protect from infections and diseases. 
Interferoni so snovi, ki v telesu nastajajo naravno, in pomagajo pri obrambi pred okužbami in boleznimi.
Neutralising antibodies have the potential to reduce clinical efficacy. 
Nevtralizirajoča protitelesa potencialno lahko zmanjšajo klinično učinkovitost.
Speak to your doctor or pharmacist about how much to take and how long to take it. 
Pogovorite se z zdravnikom ali farmacevtom o tem, koliko tega zdravila lahko vzamete in kako dolgo ga lahko jemljete.
Decreases in white blood cell counts were not associated with an increased risk of infections or serious infections. 
Zmanjšanja števila belih krvnih celic niso bila povezana z večjim tveganjem za okužbe ali z resnimi okužbami.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially those used to treat epilepsy or depression. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, zlasti zdravila za zdravljenje epilepsije ali depresije.
The average molecular mass is approximately 44 kDa of which the protein moiety constitutes approximately 23 kDa. 
Povprečna molekulska masa je približno 44 kDa, od tega predstavlja beljakovinski del približno 23 kDa.
Results in this subgroup were numerically consistent with those in the overall population but not statistically significant. 
Rezultati te podskupine so bili številčno skladni z rezultati celotne populacije, vendar niso bili statistično značilni.
However, do not inject more than once in a 7-day period. 
Vendar pa si zdravila ne injicirajte več kot enkrat v 7-dnevnem obdobju.
*Dosed every 2 weeks (14 days) 
*odmerjanje vsaka 2 tedna (14 dni)
Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use. 
Depresija se z večjo pogostnostjo pojavlja pri populaciji z multiplo sklerozo in v povezavi z uporabo interferona.
Do not freeze or expose to high temperatures. 
Zdravila ne zamrzujte in ne izpostavljajte ga visokim temperaturam.
Therefore, the long-term safety of chronic administration of Plegridy to patients cannot be assessed on the basis of these studies. 
Zato dolgotrajne varnosti pri kroničnem dajanju zdravila Plegridy bolnikom ni mogoče oceniti na podlagi teh študij.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake »EXP«.
The primary endpoint was the annualised relapse rate (ARR) over 1 year. 
Primarni opazovani dogodek je bila letna stopnja recidivov (ARR, annualised relapse rate) v 1 letu.
In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given. 
V primeru prevelikega odmerjanja se lahko bolnik hospitalizira zaradi opazovanja in je bolniku potrebno dati ustrezno podporno zdravljenje.
The validity of extrapolating these non-clinical data to humans is unknown. 
Veljavnost ekstrapolacije teh predkliničnih podatkov na ljudi ni znana.
- Your doctor may still prescribe Plegridy for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your mood in the past. 
- Zdravnik vam lahko kljub temu predpiše zdravilo Plegridy, vendar je pomembno, da zdravnika obvestite, da ste v preteklosti imeli depresijo ali drugo težavo, ki vpliva na vaše razpoloženje.
- Blood problems 
- Težave s krvjo
• If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. 
• Če je do naslednjega načrtovanega odmerka manj kot 7 dni: Bolnik naj začne nov 2-tedenski režim odmerjanja, ki se začne, ko prejme svoj izpuščeni odmerek.
They may be signs of a possible liver problem. 
To so lahko znaki težav z jetri.
If you are new to Plegridy, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Plegridy before taking the full dose. 
Če se z zdravilom Plegridy zdravite na novo, vam bo zdravnik morda svetoval, da svoj odmerek postopoma zvišujete, da se lahko navadite na učinke zdravila Plegridy, preden uporabite polni odmerek.
The safety and effectiveness of Plegridy in this age group are not known. 
Varnost in učinkovitost zdravila Plegridy v tej starostni skupini nista znani.
Time* 
Odmerek Čas*
The safety and efficacy of Plegridy in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis. 
Varnost in učinkovitost zdravila Plegridy pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani pri multipli sklerozi.
- You will need blood tests to determine your numbers of blood cells, blood chemistry and your levels of liver enzymes. 
- Potrebno bo opraviti krvne preiskave za določitev števila vaših krvnih celic, kemijske sestave krvi in ravni vaših jetrnih encimov.
- Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8). 
- Bolniki s hudo depresijo in/ali samomorilnimi mislimi (glejte poglavji 4.4 in 4.8).
You can inject Plegridy yourself without the help of your doctor, if you have been trained how to do this. 
Zdravilo Plegridy si lahko injicirate sami, brez zdravnikove pomoči, če ste se tega naučili.
Additional supplies which are not included in the pack (See Figure B): 
Dodatni pripomočki, ki niso vključeni v pakiranje (glejte sliko B):
You should see a yellow plunger. 
Morali bi videti rumeni bat.
If clinically needed, the use of Plegridy may be considered during pregnancy. 
Če je klinično potrebno, se lahko pretehta možnost uporabe zdravila Plegridy med nosečnostjo.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred. 
Bolnikov postopek samoinjiciranja je treba občasno preverjati, zlasti, če se pojavijo reakcije na mestu injiciranja.
Table 2: Study design 
Preglednica 2: Zasnova študije
Patients exhibiting depression should be monitored closely during therapy and treated appropriately. 
Bolnike, ki kažejo depresijo, je treba med zdravljenjem skrbno nadzirati in ustrezno zdraviti.
Decreased peripheral blood counts 
Zmanjšanje perifernih krvnih vrednosti
Results over 2 years confirmed that efficacy was maintained beyond the placebo controlled first year of the study. 
Rezultati za 2 leti so potrdili, da se je učinkovitost ohranila tudi v obdobju po prvem letu s placebom kontrolirane študije.
Data from studies with other interferon beta compounds did not show teratogenic potential. 
Podatki iz študij z drugimi sestavinami interferona beta niso pokazale teratogenega potenciala.
Nephrotic syndrome (class effects) 
Nefrotski sindrom (učinki skupine)
Your doctor may find changes in your blood and the function of your kidneys. 
Zdravnik bo lahko našel spremembe v vaši krvi in delovanju vaših ledvic.
On average, flu-like symptoms begin approximately 10 hours after injection and last between 12 and 24 hours. 
Gripi podobni simptomi se začnejo povprečno približno 10 ur po injiciranju in trajajo 12 do 24 ur.
These blood clots could affect your kidneys. 
Ti krvni strdki lahko poškodujejo vaše ledvice.
The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study. 
Izkušnje iz randomizirane, nekontrolirane faze (2. leto) študije ADVANCE in iz podaljšane študije ATTAIN (v kateri so se bolniki zdravili do 4 leta) so bile skladne z izkušnjami iz 1-letne, s placebom kontrolirane faze študije ADVANCE.
Nevertheless, patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment. 
Kljub temu pa je treba pri bolnikih s pomembno obstoječo boleznijo srca, kot so kongestivno srčno popuščanje, bolezen koronarnih arterij ali aritmija, treba spremljati poslabšanje bolezni srca, zlasti med začetkom zdravljenja.
The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. 
Učinkovitost tega zdravila ni primerljiva z učinkovitostjo drugih pegiliranih ali nepegiliranih beljakovin enakega terapevtskega razreda.
Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of your flu-like symptoms. 
Vzemite paracetamol ali ibuprofen pol ure pred injiciranjem zdravila Plegridy in nadaljujte z jemanjem paracetamola ali ibuprofena, dokler gripi podobni simptomi trajajo.
If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded. 
Če ni jasno, ali je bilo zdravilo Plegridy shranjeno pri sobni temperaturi 30 dni ali več, ga je treba zavreči.
Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician. 
Bolnike je treba opozoriti, da morajo takoj poročati o vseh simptomih depresije in/ali samomorilnih misli zdravniku, ki je zdravilo predpisal.
Your pen is now ready to inject. 
Vaš injekcijski peresnik je sedaj pripravljen na injiciranje.
Only open the pack when you need a new syringe. 
Novo pakiranje odprite le, ko potrebujete novo brizgo.
- If you have used more than one injection of Plegridy in a 7-day period, contact your doctor or nurse straight away. 
- Če ste v 7-dnevnem obdobju uporabili več kot eno injekcijo zdravila Plegridy, se takoj posvetujte z zdravnikom ali medicinsko sestro.
Step 2: Collect your supplies and wash your hands. 
2. korak: Pripravite pripomočke in si umijte roke.
The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials. 
Varnost in učinkovitost zdravila Plegridy pri bolnikih, starih več kot 65 let, nista bili ustrezno preučeni, saj je število takih bolnikov, vključenih v klinična preskušanja, majhno.
MS is a long term illness that affects the central nervous system (CNS), including the brain and spinal cord, in which the body's immune system (its natural defences) damages the protective layer (myelin) that surrounds the nerves in the brain and spinal cord. 
MS je dolgotrajna bolezen, ki prizadene osrednji živčni sistem, vključno z možgani in hrbtenjačo, pri kateri telesni imunski sistem (njegova naravna obramba) poškoduje zaščitno plast (mielin), ki obdaja živce v možganih ali hrbtenjači.
See below for simple ways to manage these flu-like symptoms if you get them. 
Spodaj so preprosti načini za obvladovanje teh gripi podobnih simptomov, če se pojavijo.
Reversibility of the effects on menstrual cycle length was demonstrated. 
Pokazalo se je, da so učinki na dolžino menstrualnega cikla reverzibilni.
Study population 
Študijska populacija
b. Wipe your skin with an alcohol wipe. 
b. Kožo očistite z alkoholnim robčkom.
c. Check the medicine window and make sure the Plegridy medicine is clear and colourless. 
c. Preglejte okence za zdravilo in se prepričajte, da je zdravilo Plegridy bistro in brezbarvno.
If you have a fever, drink plenty of water to keep you hydrated. 
Če imate zvišano telesno temperaturo, spijte veliko vode, da ne dehidrirate.
• If 7 days or more to the next planned dose: Patients should administer their missed dose immediately. 
• Če je do naslednjega načrtovanega odmerka 7 dni ali več: Bolniku je treba izpuščeni odmerek dati takoj.
Your doctor will tell you how long you need to keep using Plegridy. 
Zdravnik vam bo povedal, kako dolgo boste morali uporabljati zdravilo Plegridy.
The Initiation Pack contains your first two injections to gradually adjust your dose. 
Začetno pakiranje vsebuje prvi dve injekciji za postopno prilagoditev odmerka.
How Plegridy works Plegridy seems to work by stopping the body's immune system from damaging your brain and spinal cord. 
Kaže, da zdravilo Plegridy deluje tako, da imunskemu sistemu telesa prepreči poškodovanje vaših možganov in hrbtenjače.
A patient should not administer two doses of Plegridy within 7 days of each other. 
Bolnik ne sme prejeti dveh odmerkov zdravila Plegridy v 7-dnevnem časovnem obdobju.
The European Medicines Agency has deferred the obligation to submit the results of studies with Plegridy in one or more subsets of the paediatric population in treatment of multiple sclerosis (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Plegridy za eno ali več podskupin pediatrične populacije z multiplo sklerozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
250 Binney Street Cambridge, MA 02142 USA 
Cambridge, MA 02142 ZDA
The process of covalently conjugating a PEG moiety to a protein can alter the in vivo properties of the unmodified protein, including decreased renal clearance and decreased proteolysis thus extending the circulating half-life. 
Postopek kovalentne konjugacije deleža PEG z beljakovino lahko spremeni lastnosti in vivo nemodificirane beljakovine, vključno z zmanjšanim ledvičnim očistkom in zmanjšano proteolizo, zato se podaljša cirkulirajoči razpolovni čas.
If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor. 
Če se pri bolniku pojavi poškodba na koži, ki jo lahko spremlja oteklina ali iztekanje tekočine iz mesta injiciranja, je treba bolniku svetovati, da se posvetuje z zdravnikom.
In animals, anovulatory effects were observed at very high doses (see section 5.3). 
Pri živalih so pri zelo visokih odmerkih opazili anovulacijske učinke (glejte poglavje 5.3).
This tells you that the injection is happening (see Figure G). 
To pomeni, da injiciranje poteka (glejte sliko G).
• If you have a skin reaction and it does not clear up in a few days, contact your doctor or nurse. 
• Če imate kožno reakcijo, ki v nekaj dneh ne izgine, se posvetujte z zdravnikom ali medicinsko sestro.
Giving your injection Step 4: Choose and clean your injection site 
Dajanje injekcije 4. korak: Izberite in očistite mesto injiciranja.
To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique. 
Za zmanjšanje tveganja reakcij na mestu injiciranja je treba bolnikom dati navodilo, da uporabljajo aseptično tehniko injiciranja.
In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours). 
Pri bolnikih, ki so imeli gripi podobne simptome, je bil mediani čas do njihovega nastopa 10 ur (interkvartilni razpon 7 do 16 ur) po injiciranju, mediano trajanje pa je bilo 17 ur (interkvartilni razpon 12 do 22 ur).
• Find a well-lit, clean, flat surface to work on, like a table. 
• Poiščite dobro osvetljeno, čisto in ravno površino, kot je na primer miza.
Day 28 
3. odmerek 28. dan
The observed Cmax (mean±SE) was 280 ± 79 pg/mL following repeat dosing of 125 micrograms every two weeks. 
Opaženi Cmax (povprečje ± SN) je bil 280 ± 79 pg/ml po ponavljajočem se odmerjanju 125 mikrogramov vsaka dva tedna.
b. Check the medicine window. 
b. Preglejte okence za zdravilo.
If you accidentally prick yourself or someone else with the needle in Plegridy, the area affected should be washed immediately with soap and water and a doctor or nurse should be contacted as soon as possible. 
Če sebe ali koga drugega po nesreči zbodete z iglo v zdravilu Plegridy, prizadeti predel takoj izperite z milom in vodo in se čim prej posvetujte z zdravnikom ali medicinsko sestro.
b. Check the expiry date. 
b. Preverite datum izteka roka uporabnosti.
Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8). 
Profilaktična in sočasna uporaba zdravil proti vnetju, analgetikov in/ali antipiretikov lahko prepreči ali ublaži gripi podobne simptome, ki se včasih pojavijo med zdravljenjem z interferonom (glejte poglavje 4.8).