natgillin/translations-raw huggingface dataset:
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih študijah, kontroliranih s placebom, je bilo razmerje ogroženosti za celotno preživetje med 1,25 in 2,47 v korist bolnikov v kontrolnih skupinah.
The carton contains a package leaflet with the full instructions for use and handling.
V škatli je priloženo Navodilo za uporabo s celotnimi navodili za uporabo in ravnanje z zdravilom.
Aranesp works in exactly the same way as the natural hormone erythropoietin.
Zdravilo Aranesp deluje popolnoma enako kot naravni hormon eritropoetin.
Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.
Proti koncu ciklusa kemoterapije (še posebej, če ste dobili veliko kemoterapije) pa se vam lahko število rdečih krvnih celic zmanjša in tako postanete anemični.
Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
Zdravnik se lahko odloči za spremembo načina injiciranja (pod kožo ali v veno).
Do not touch the cleaned area of the skin
Ne dotikajte se očiščenega predela kože.
The maximum amount of Aranesp that can be safely administered in single or multiple doses has not been determined.
Največja količina zdravila Aranesp, ki jo je mogoče varno injicirati v enem ali več odmerkih, ni določena.
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Če je krvni tlak po uvedbi ustreznih ukrepov težko obvladovati, lahko hemoglobin znižate z zmanjšanjem ali zadržanjem odmerka zdravila Aranesp (glejte poglavje 4.2).
For the purpose of ambulatory use, Aranesp may be removed from storage once for a maximum single period of seven days at room temperature (up to 25ºC).
Za ambulantno rabo je zdravilo Aranesp mogoče vzeti iz prostora za shranjevanje enkrat za največ eno sedemdnevno obdobje pri sobni temperaturi (do 25 °C).
This may be associated with life-threatening complications of the cardiovascular system.
To je lahko povezano s smrtno nevarnimi zapleti na srčno-žilnem sistemu.
• Check that it is the correct dose that your healthcare provider has prescribed.
• Preverite, da imate pravilen odmerek, ki vam ga je predpisal zdravstveni delavec.
If someone else is injecting for you, they can also use the back of your arms.
Če vam zdravilo injicira kdo drug, vam ga lahko da tudi v zadnjo stran nadlakta.
Aranesp has not been tested in pregnant women.
Zdravilo Aranesp ni preizkušeno pri nosečnicah.
Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Anemija (slabokrvnost) je stanje, pri katerem v krvi ni dovolj rdečih krvnih celic; simptomi so lahko utrujenost, šibkost in težko dihanje.
The rashes may progress to widespread peeling of the skin and life-threatening complications.
Izpuščaji lahko napredujejo v razširjeno lupljenje kože in smrtno nevarne zaplete.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological effect (decreased tissue perfusion due to increased blood viscosity).
Vse neželene učinke ob zelo velikih odmerkih so ocenili za posledice pretiranega farmakološkega delovanja (manjša perfuzija tkiva zaradi večje viskoznosti krvi).
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Dodatne sladkorne skupine se molekulsko ne ločijo od tistih na endogenem hormonu.
Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Vsem bolnikom morate kontrolirati krvni tlak, zlasti med začetkom zdravljenja z zdravilom Aranesp.
However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Obstaja pa možnost za interakcije s snovmi, ki so v veliki meri vezane na rdeče krvne celice, npr. s ciklosporinom ali takrolimusom.
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Zdravnik bo uporabil najmanjši učinkoviti odmerek za obvladovanje simptomov anemije.
For more information or help, contact your healthcare provider.
Za več informacij ali pomoč kontaktirajte zdravstvenega delavca.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Darbepoetin alfa spodbuja eritropoezo prek istih mehanizmov kot endogeni hormon.
• 0.45 micrograms once weekly.
• 0,45 mikrogramov enkrat na teden.
Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.
Podatki so predstavljeni ločeno za bolnike s kronično odpovedjo ledvic in bolnike z rakom; to odraža različen profil neželenih reakcij v teh populacijah.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Odločitev za uporabo rekombinantnih eritropoetinov mora temeljiti na oceni koristi in tveganja in mora biti sprejeta v sodelovanju z bolnikom, upoštevaje posameznikove specifične klinične okoliščine.
SJS/TEN, erythema multiforme, blistering, skin exfoliation
SJS/TEN, multiformni eritem, mehurji, lupljenje kože
What Aranesp is and what it is used for
Kaj je zdravilo Aranesp in za kaj ga uporabljamo
More severe cases have been observed with long-acting epoetins.
Z dolgodelujočimi epoetini so opažali hujše primere.
In these studies, no meaningful differences were identified between the safety profile for paediatric patients and that previously reported for adult patients (see section 4.8).
V teh študijah niso ugotovili pomembnih razlik med varnostnim profilom pri pediatričnih bolnikih in predhodno opisanem varnostnem profilu pri odraslih bolnikih (glejte poglavje 4.8).
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
Za zagotovitev učinkovite eritropoeze je treba vsem bolnikom pred začetkom zdravljenja in med zdravljenjem kontrolirati stanje železa; potrebna utegne biti terapija z dodatki železa.
Darbepoetin alfa did not reveal any genotoxic potential nor did it have any effect on the proliferation of non-haematological cells in vitro or in vivo.
Darbepoetin alfa ni pokazal genotoksičnega potenciala in tudi ni vplival na proliferacijo nehematoloških celic niti in vitro ali in vivo.
Your healthcare professional should always record the exact product you are using.
Vaš zdravnik mora vedno natančno zabeležiti, katero zdravilo prejemate.
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
Nelagodje na mestu injiciranja je bilo praviloma blago in prehodno ter se je pojavilo predvsem po prvi injekciji.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aranesp therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Aranesp, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:
Za odpravljanje anemije bo vaš začetni odmerek zdravila Aranesp na kilogram telesne mase bodisi:
Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Podatki iz kontroliranih študij zajemajo 1.357 bolnikov: 766 jih je dobivalo zdravilo Aranesp in 591 r-HuEPO.
How do you or the person injecting you, use the Aranesp pre-filled syringe?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo zdravila Aranesp?
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Treatment of paediatric patients younger than 1 year of age has not been studied in randomised clinical trials (see section 5.1).
Zdravljenje pediatričnih bolnikov, mlajših od 1 leta, ni bilo raziskano v randomiziranih kliničnih preskušanjih (glejte poglavje 5.1).
In clinical studies, minimal accumulation was observed with either route of administration.
V kliničnih študijah so pri obeh načinih uporabe opažali minimalno kopičenje.
Incidence of adverse reactions are listed below by system organ class and frequency.
Pogostnosti neželenih učinkov so naštete spodaj glede na organski sistem in pogostnost.
Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water).
Ne ogrevajte zdravila Aranesp kako drugače (ne grejte ga npr. v mikrovalovni pečici ali vroči vodi).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
ESAs are not indicated for use in this patient population.
Uporaba ESA v tej populaciji bolnikov ni indicirana.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično odpovedjo ledvic vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4.2.
Stretch your skin firmly by moving your thumb and fingers in opposite directions, creating an area about 5 cm (2-inches) wide.
Kožo čvrsto raztegnite tako, da palec in prste razmaknete v nasprotni smeri in tako ustvarite približno 5 cm širok predel.
Talk with your healthcare provider about proper disposal.
Z zdravstvenim delavcem se posvetujte o pravilnem odlaganju.
Where the same sampling duration was used, observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF.
Kjer je vzorčenje trajalo enako dolgo, so opaženi farmakokinetični podatki in modeliranje farmakokinetike populacije pokazali, da je bila farmakokinetika darbepoetina alfa pri pediatričnih in odraslih bolnikih s kronično boleznijo ledvic podobna.
Effect on tumour growth
Vpliv na rast tumorja
If you are receiving chemotherapy
Če dobivate kemoterapijo
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi uporabe epoetinov, če koncentracija hemoglobina preseže raven, potrebno za obvladanje simptomov anemije in preprečitev transfuzij krvi.
The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Pot injiciranja je enaka kot pri r-HuEPO, zdravnik pa vam bo povedal, koliko zdravila morate uporabiti in kdaj.
Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Opomba: Potem ko boste napolnjeni injekcijski peresnik odmaknili od kože, bo samodejno prekril iglo.
What should I do before I give myself a subcutaneous injection of Aranesp?
Kaj moram narediti, preden si dam podkožno injekcijo zdravila Aranesp?
The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Eritropoetin nastaja predvsem v ledvicah, ki ga tudi uravnavajo v odziv na spremembe v oksigenaciji tkiva.
Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy.
Zdravljenje z zdravilom Aranesp je treba končati približno 4 tedne po koncu kemoterapije.
Do not use it if the date has passed the last day of the month shown.
Zdravila ne uporabite, če je že pretekel zadnji dan navedenega meseca.
• Convulsions (fits and seizures)
• konvulzije (krči in napadi)
Release button
Spustite gumb
Injecting the solution with the air bubble is harmless.
Injiciranje raztopine z zračnim mehurčkom ne bo škodovalo.
Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
Zdravnik, medicinska sestra ali farmacevt vam bo povedal, koliko zdravila Aranesp potrebujete in kako pogosto si ga morate injicirati.
Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.
Ne vračajte napolnjenega injekcijskega peresnika nazaj v hladilnik, ko je le-ta dosegel sobno temperaturo.
In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
V vseh študijah pri podganah in psih je darbepoetin alfa povzročil izrazito zvišanje hemoglobina, hematokrita, števila rdečih krvnih celic in retikulocitov, kar ustreza pričakovanim farmakološkim učinkom.
• 0.75 micrograms once every two weeks, or
• 0,75 mikrogramov enkrat na dva tedna ali
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed.
Ugotovili so tudi izboljšanje utrujenosti, merjene z lestvico FACT-utrujenost (Functional Assessment of Cancer Therapy-fatigue).
A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Opravljena je bila tudi analiza podatkov na ravni bolnikov, in sicer za več kot 13.900 bolnikov z rakom (ki so dobivali kemoterapijo, radioterapijo, kombinirano kemo-radioterapijo ali nobenega zdravljenja) iz 53 kontroliranih kliničnih preskušanj z več epoetini.
Hypersensitivity reactions were also very common in the placebo groups.
Preobčutljivostne reakcije so bile zelo pogoste tudi v skupinah s placebom.
If you experience these symptoms you should contact your doctor.
Če se vam pojavijo takšni simptomi, se morate posvetovati z zdravnikom.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Darbepoetin alfa ima pet N-vezanih ogljikohidratnih verig, endogeni hormon in rekombinantni humani eritropoetini (r-HuEPO) pa imajo tri.
Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: B03XA02.
Farmakoterapevtska skupina: Zdravila za zdravljenje slabokrvnosti, druga zdravila za zdravljenje slabokrvnosti, oznaka ATC: B03XA02.
Very common: may affect more than 1 in 10 people • Allergic reactions
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov • alergijske reakcije
- If you have symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure.
- Če imate simptome, med katerimi so hud glavobol, zaspanost, zmedenost, težave z vidom, slabost v želodcu, bruhanje ali napadi krčev (konvulzije), to lahko pomeni, da imate zelo visok krvni tlak.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%.
Dodatno zdravljenje z železom je priporočljivo pri vseh bolnikih, ki imajo feritin v serumu pod 100 µg/l ali nasičenost transferina pod 20 %.
These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Pred takšnimi resnimi izpuščaji na koži se pogosto pojavijo zvišana telesna temperatura in/ali gripi podobni simptomi.
Pure red cell aplasia
čista aplazija rdečih celic
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Glede na zgoraj navedeno, je treba v nekaterih kliničnih primerih anemijo pri bolnikih z rakom prednostno zdraviti s transfuzijo krvi.
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if you need to change doses of Aranesp.
Če se na zdravilo Aranesp ne boste odzvali zadostno, bo zdravnik preveril vaš odmerek in vam povedal, če boste morali spremeniti odmerke zdravila Aranesp.
In a phase 1 pharmacokinetic study, following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the paediatric patients.
V farmakokinetični študiji faze I so po intravenski uporabi med pediatričnimi in odraslimi bolniki ugotovili približno 25 % razliko v površini pod krivuljo od časa 0 do neskončnosti (AUC(0-∞)); vendar je bila ta razlika manjša od 2-kratnega razpona AUC(0-∞), ugotovljenega pri pediatričnih bolnikih.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Check the appearance of Aranesp.
Preverite videz zdravila Aranesp.
Before you use an Aranesp pre-filled syringe with automatic needle guard, read this important information:
Pred uporabo zdravila Aranesp v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT
980202 in 980211), poleg neželenega učinka možganska kap, ki je bil kot neželeni učinek prepoznan v študiji
The target haemoglobin concentration in two studies was > 13 g/dL; in the remaining three studies it was 12-14 g/dL.
Ciljna koncentracija hemoglobina v teh dveh študijah je bila > 130 g/l, v preostalih treh pa od 120 do 140 g/l.
Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
Aktivna bolezen jeter je bila v vseh študijah zdravila Aranesp merilo za nevključitev, zato o bolnikih z okvarjenim delovanjem jeter ni podatkov.
It is not known whether darbepoetin alfa is excreted in human milk.
Ni znano, ali se darbepoetin alfa izloča v materino mleko.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
Ko je terapevtski cilj pri posameznem bolniku dosežen, je treba odmerek zmanjšati za 25 do 50 % in tako zagotoviti uporabo najmanjšega odobrenega odmerka zdravila Aranesp, potrebnega za vzdrževanje takšne koncentracije hemoglobina, ki obvladuje simptome anemije.
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Humani eritropoetin je endogen glikoproteinski hormon, ki primarno uravnava eritropoezo, in sicer preko specifične interakcije z eritropoetinskim receptorjem na eritroidnih matičnih celicah v kostnem mozgu.
What you need to know before you use Aranesp
Kaj morate vedeti, preden boste uporabili zdravilo Aranesp
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Če je za ohranitev hemoglobina na želeni ravni potrebna prilagoditev odmerka, je odmerek priporočljivo prilagoditi za približno 25 %.
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.
Zdravilo Aranesp se daje v eni injekciji, bodisi enkrat na teden ali enkrat na tri tedne, in sicer pod kožo.
Red start button
Rdeči sprožilni gumb
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Zdravljenje z zdravilom Aranesp mora uvesti zdravnik, ki ima izkušnje z navedenima indikacijama.
• Bruising and bleeding at the site of injection
• modrica in krvavitev na mestu injiciranja
- Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.
- Zloraba pri zdravih osebah lahko povzroči smrtno nevarne težave na srcu ali ožilju.
Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and
Vir: vključenih je 5 randomiziranih, dvojno slepih, aktivno kontroliranih študij (970200, 970235, 980117,
• The used pre-filled syringe should be disposed of in accordance with local requirements.
• Uporabljeno napolnjeno injekcijsko brizgo zavrzite v skladu z lokalnimi predpisi.
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dL or less.
Glede na vaše krvne izvide je zdravnik presodil, da potrebujete zdravilo Aranesp, ker imate koncentracijo hemoglobina 100 g/l ali manj.
These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS complex in dogs but no dysrhythmia and no effect on the QT interval were observed.
Med temi učinki so bili mielofibroza, hipertrofija vranice ter razširitev kompleksa QRS na EKG pri psih, vendar brez motenj srčnega ritma in brez vpliva na interval QT.
Other medicines and Aranesp
Druga zdravila in zdravilo Aranesp
Yellow safety guard
Rumeni varnostni ščitnik
If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
Če se spremeni, boste začeli z enakim odmerkom, kot ste ga dobivali dotlej, zdravnik pa bo s kontrolami krvi preveril, ali je anemija še vedno ustrezno obvladana.
Yellow window (injection complete)
Rumeno okence (injiciranje dokončano)
The haemoglobin should be measured every one or two weeks until it is stable.
Hemoglobin morate kontrolirati na en ali dva tedna, dokler vrednost ni stabilna.
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
Klinične študije so pokazale, da je darbepoetin alfa podobno učinkovit, če je uporabljen v posamični injekciji bodisi enkrat na tri tedne, enkrat na dva tedna ali vsak teden, brez potrebe po povečanju celotnega odmerka.
Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Ne pozabite: če imate kakršne koli težave, brez obotavljanja prosite za pomoč in nasvet zdravnika ali medicinsko sestro.
Never inject Aranesp into a vein yourself.
Zdravila Aranesp si nikdar sami ne injicirajte v veno.
• Sudden life-threatening allergic reactions (anaphylaxis)
• nenadne smrtno nevarne alergijske reakcije (anafilaksija)
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
Zaradi večje vsebnosti ogljikovih hidratov ostane koncentracija darbepoetina alfa v obtoku višja od najmanjše stimulacijske koncentracije za eritropoezo dalj časa kot po enakovrednem molarnem odmerku r-HuEPO; tako je mogoče z manj pogosto uporabo darbepoetina alfa doseči enak biološki odziv.
Prepare and clean your injection site.
Pripravite in očistite mesto injiciranja.