natgillin/translations-raw huggingface dataset:
Exelon must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Exelon patch. 
Prva tako ga ne smejo uporabljati bolniki, pri katerih obstaja sum, da so v preteklosti doživeli hudo alergijsko reakcijo, imenovano „alergijski kontaktni dermatitis“, na obliže zdravila Exelon.
For the transdermal patch, application site reactions are the most commonly seen side effects. 
Pri uporabi transdermalnega obliža so najpogostejši neželeni učinki reakcije na mestu uporabe obliža.
What is the risk associated with Exelon? 
Kakšna tveganja so povezana z zdravilom Exelon?
The types of side effects seen with Exelon depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used. 
Vrste neželenih učinkov, opaženih pri zdravilu Exelon, so odvisne od vrste demence, ki se zdravi, in od tega, ali se uporabljajo kapsule, peroralna raztopina ali transdermalni obliži.
Exelon has been studied in mild to moderately severe Alzheimer's disease. 
Zdravilo Exelon so proučevali pri blagi do zmerno hudi Alzheimerjevi bolezni.
By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease. 
Zdravilo Exelon z zaviranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi Alzheimerjeve demence in demence zaradi Parkinsonove bolezni ublažijo.
In the three studies of Exelon capsules in patients with Alzheimer's dementia, patients taking doses of Exelon between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance. 
V treh študijah zdravila Exelon pri bolnikih z Alzheimerjevo demenco je bilo pri tistih, ki so jemali od 6- do 9-miligramske odmerke zdravila Exelon, opaziti povprečno povečanje kognitivnih simptomov za 0,2 točke od izhodiščne vrednosti 22,9 točke na začetku študije, pri čemer nižji rezultat pomeni boljšo učinkovitost.
The patients with dementia due to Parkinson's disease taking Exelon capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points. 
Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule zdravila Exelon, je bilo opaziti izboljšanje kognitivnih simptomov za 2,1 točke, v primerjavi s poslabšanjem za 0,7 točke pri tistih, ki so jemali placebo, od izhodiščne vrednosti približno 24 točk.
For the full list of all side effects reported with Exelon, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exelon, glejte navodilo za uporabo.
The active substance in Exelon, rivastigmine, is an antidementia medicine. 
Zdravilna učinkovina zdravila Exelon, rivastigmin, je zdravilo za zdravljenje demence.
For the global score, patients taking Exelon capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo. 
Kar zadeva rezultat celostne ocene simptomov, je pri bolnikih, ki so jemali kapsule zdravila Exelon, prišlo do povečanja simptomov za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
Why has Exelon been approved? 
Zakaj je bilo zdravilo Exelon odobreno?
The global symptom score also improved more in the patients taking Exelon. 
Tudi rezultat celostne ocene simptomov je bil boljši pri bolnikih, ki so jemali zdravilo Exelon.
How has Exelon been studied? 
Kako je bilo zdravilo Exelon raziskano?
What is Exelon used for? 
Za kaj se zdravilo Exelon uporablja?
How does Exelon work? 
Kako zdravilo Exelon deluje?
What is Exelon? 
Kaj je zdravilo Exelon?
How is Exelon used? 
Kako se zdravilo Exelon uporablja?
• alcohol wipes or similar. 
• alkoholne lističe ali podobno.
Serious allergic reactions which may include: 
Resne alergijske reakcije, ki lahko vključujejo:
Treatment of paediatric patients younger than 1 year of age has not been studied: 
Zdravljenje pediatričnih bolnikov, mlajših od 1 leta, ni raziskano:
In addition, an updated RMP should be submitted - When new information is received that may impact on the current Safety Specification, 
Poleg tega je treba posodobljen RMP predložiti tudi: - kadar se pridobijo nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije,
This was seen more frequently than with r-HuEPO. 
To je bilo zabeleženo pogosteje kot pri r-HuEPO.
Optional separate additional insert: 
Fakultativno ločeno dodatno navodilo:
At first, only white blood cells seem to be affected. 
Sprva se zdi, da so prizadete le bele krvne celice.
Do not use Nespo if you think it has been frozen. 
Ne uporabite Nespa, če mislite, da je bil zmrznjen.
• Convulsions. 
• Konvulzije.
These measures will help to protect 
Takšni ukrepi pomagajo varovati
Do not warm Nespo in any other way (for example, do not warm it in a microwave or in hot water). 
Ne ogrevajte Nespa kako drugače (ne grejte ga npr. v mikrovalovni pečici ali vroči vodi).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials. 
Sistematično so pregledali tudi podatke o več kot 9000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
The therapeutic margin of Nespo is very wide. 
Terapevtska meja Nespa je zelo široka.
Postmarketing Experience 
Pomarketinške izkušnje
Correction Phase 
Obdobje korekcije
To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2. 
Da ne boste zvili igle, previdno snemite pokrovček igle, ne da bi ga upogibali, tako kot prikazujeta sliki 1 in 2.
• If you are a cancer patient you should be aware that Nespo may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer. 
• Če ste bolnik z rakom, morate vedeti, da lahko Nespo deluje kot rastni dejavnik za krvne celice in lahko v nekaterih okoliščinah neugodno vpliva na vašo bolezen.
∅ Do not press the red button until the safety guard is fully retracted. 
∅ Ne pritiskajte rdečega gumba, dokler ni varnostna zaščita povsem pomaknjena nazaj.
Treatment with Nespo is divided into two stages - correction and maintenance phase. 
Zdravljenje z Nespom delimo na dve obdobji - obdobje korekcije in obdobje vzdrževanja.
Do not touch the red button. 
Ne dotaknite se rdečega gumba.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR). 
Po smernicah Odbora za zdravila za uporabo v humani medicini (CHMP) za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba posodobljen RMP predložiti hkrati z naslednjim periodičnim poročilom o varnosti (PSUR).
In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life. 
Predklinične študije so pokazale, da je ledvični očistek minimalen (do 2% celotnega očistka) in ne vpliva na razpolovni čas v serumu.
• Pure Red Cell Aplasia. 
• Čisto aplazijo rdečih celic.
Via San Martino 12 I-20122 Milan Italy 
Via San Martino 12 I-20122 Milan Italija
What should I do before I give myself a subcutaneous injection of Nespo? 
Kaj moram narediti, preden si dam podkožno injekcijo Nespa?
If you see blood in the syringe, pull the needle out and re-insert it in another place. 
Če v brizgi opazite kri, izvlecite iglo in jo zabodite drugam.
Your doctor will inform you if your dose changes. 
Zdravnik vam bo povedal, če se vam odmerek spremeni.
This is because the red blood cells have a much longer life span in the circulating blood. 
Rdeče krvne celice imajo namreč v krvnem obtoku veliko daljšo življenjsko dobo.
• Do not put the cover back on used needles, as you may accidentally prick yourself. 
• Ne nameščajte pokrovčka nazaj na uporabljene igle, ker se lahko po nesreči zbodete.
Date of last renewal: 19 May 2006 
Datum podaljšanja dovoljenja za promet: 19. maj 2006
Never inject Nespo into a vein yourself. 
Nespo si nikdar sami ne injicirajte v veno.
Your doctor will tell you exactly when to stop taking Nespo. 
Zdravnik vam bo povedal, kdaj natančno morate nehati uporabljati Nespo.
Put the needle fully into the skin as shown by your nurse or doctor. 
Zabodite iglo do konca v kožo, kot vam je pokazala medicinska sestra ali zdravnik.
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or 
• Oteklost obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave pri požiranju ali dihanju
It is important to tell your doctor if you are taking either of these drugs. 
Pomembno je, da zdravniku poveste, če jemljete katero od njiju.
It is not known whether darbepoetin alfa is excreted in human milk. 
Ni znano, ali se darbepoetin alfa izloča v materinem mleku.
(4) Count slowly to 15 for injection to end. 
(4) Počasi štejte do 15, da se bo injiciranje končalo.
Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected. 
Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost zdravil za stimulacijo eritropoeze in jih je zato treba korigirati.
Choosing and preparing an injection site 
Izbira in priprava mesta za injiciranje
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu./
Using Nespo with food and drink 
Uporaba zdravila Nespo skupaj s hrano in pijačo
Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy. 
Vsem bolnikom morate kontrolirati krvni tlak, zlasti med začetkom zdravljenja z Nespom.
Count slowly to 15 seconds for injection to end. 
Počasi štejte do 15 sekund, da se injiciranje konča.
D Do keep enough downward pressure to fully retract the yellow safety guard and to keep the red D Do hold the pre-filled pen at a right angle (90º) to the injection site. 
D Pritisnite navzdol dovolj močno, da se bo rumena varnostna zaščita pomaknila povsem nazaj in D Držite napolnjeni injekcijski peresnik pravokotno (90 °) na mesto injiciranja.
Clinical Trial Experience 
Izkušnje iz kliničnih preskušanj
Your doctor, nurse, or pharmacist will tell you how much Nespo you need and how frequently it should be injected. 
Zdravnik, medicinska sestra ali farmacevt vam bo povedal, koliko Nespa potrebujete in kako pogosto si ga morate injicirati.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; lifeexpectancy; the environment in which the patient is being treated; and patient preference (see section 
Med dejavniki, ki jih je treba upoštevati pri takšni oceni, so vrsta in stadij tumorja, stopnja anemije, pričakovana življenjska doba, okolje, v katerem poteka bolnikovo zdravljenje in bolnikove želje (glejte poglavje 5.1).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authoristion: 8 June 2001 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 8. junij 2001
However, there is potential for an interaction with drugs that are highly bound to red blood cells e.g. cyclosporin, tacrolimus. 
Obstaja pa možnost za interakcije z zdravili, ki so v veliki meri vezana na rdeče krvne celice, npr. s ciklosporinom ali takrolimusom.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8167 patients). 
Ocena ogroženosti na podlagi metaanalize podatkov o celotnem preživetju je bila 1,08 v korist kontrolne skupine (95 % IZ: 0,99, 1,18; 42 preskušanj in 8167 bolnikov).
Unlocked with safety guard fully retracted 
Sproščen, s povsem nazaj pomaknjeno varnostno zaščito
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 ogroženost za celotno preživetje med 1,25 in 2,47 v korist bolnikov v kontrolnih skupinah.
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. 
Zdravljenje z Nespom mora uvesti zdravnik, ki ima izkušnje z navedenima indikacijama.
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti Nespa ne smete mešati ali aplicirati v infuziji z drugimi zdravili.
Injection site must be firm and tight 
Raztegnite Mesto injiciranja mora biti čvrsto in napeto.
In both groups, the dose was reduced by 40% of the previous dose (e.g., for first dose reduction, to 300 μg in the once every three weeks group and 1.35 μg /kg in the once weekly group) if haemoglobin increased by more than 1 g/dl in a 14-day period. 
V obeh skupinah so odmerek zmanjšali za 40 % predhodnega odmerka (npr. prvo zmanjšanje na 300 µg v skupini enkrat na tri tedne in na 1,35 µg/kg v skupini enkrat na teden), če se je hemoglobin v 14-dnevnem obdobju zvišal za več kot 10 g/l.
Nespo has not been tested in pregnant women. 
Nespo ni preizkušen pri nosečnicah.
Even at very high serum levels, no symptoms of overdose have been observed. 
Celo ob zelo visoki koncentraciji v serumu niso opazili simptomov prevelikega odmerjanja.
The clinical results obtained so far do not indicate any interaction of Nespo with other substances. 
Dosedanji klinični rezultati ne kažejo, da bi Nespo medsebojno deloval z drugimi snovmi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 (20 April 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1 načrta za obvladovanje tveganja (RMP - "risk management plan"), z dne 20. aprila 2006, predstavljenem v Modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown: 
V kontroliranih kliničnih študijah je uporaba Nespa in drugih eritropoezo stimulirajočih agensov (ESA):
• Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy) 
• Čista aplazija rdečih celic - (anemija, nenavadna utrujenost, pomanjkanje energije)
• high blood pressure which is being controlled with medicines prescribed by your doctor; 
• visok krvni tlak, obvladan z zdravili, ki vam jih je predpisal zdravnik,
In all studies in rats and dogs Nespo 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 Nespo povzročil izrazito zvišanje hemoglobina, hematokrita, števila rdečih krvnih celic in retikulocitov, kar ustreza pričakovanim farmakološkim učinkom.
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, priporočene v poglavju 4.2.
Nespo did not reveal any genotoxic potential nor did it have any effect on the proliferation of nonhaematological cells in vitro or in vivo. 
Nespo ni pokazal genotoksičnega potenciala in tudi ni vplival na proliferacijo nehematoloških celic niti in vitro ali in vivo.
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.
Dose increases must not be made more frequently than once every four weeks. 
Odmerka ne smete povečevati pogosteje kot enkrat na štiri tedne.
Make sure that skin under and around the pre-filled pen is firm and tight to provide enough resistance to fully retract the safety guard 
Poskrbite, da bo koža pod napolnjenim injekcijskim peresnikom in okrog njega dovolj čvrsta in napeta: zagotoviti mora toliko upora, da se varnostna zaščita pomakne povsem nazaj in se peresnik
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Nespo (see section 4.2). 
Če je krvni tlak po uvedbi ustreznih ukrepov težko obvladovati, lahko hemmoglobin znižate z zmanjšanjem ali zadržanjem odmerka Nespa (glejte poglavje 4.2).
Before you inject Nespo you must do the following: 
Pred injiciranjem zdravila Nespo, morate narediti naslednje:
• Sudden life-threatening allergic reactions (anaphylaxis) 
• Nenadne smrtno nevarne alergijske reakcije (anafilaksija)
Nespo works in exactly the same way as the natural hormone erythropoietin. 
Nespo deluje popolnoma enako kot naravni hormon eritropoetin.
Do not use any Nespo that is left in the syringe. 
Ne uporabljajte preostanka Nespa, ki je ostal v brizgi.
• High blood pressure (hypertension) • Fluid retention (oedema) 
• Visok krvni tlak (hipertenzija) • Zastajanje tekočine (edemi)
These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/kg weekly and 3 to 9 µg/kg every two weeks). 
Ti parametri se skladajo s farmakokinetiko, linearno povezano z odmerkom, v širokem odmernem območju (od 0,5 do 8 µg/kg na teden in od 3 do 9 µg/kg na dva tedna).
When using alternate injection sites, it is particularly important to create enough surface tension on the site to be able to successfully complete the injection. 
Če uporabljate druga mesta injiciranja, je posebej pomembno, da na izbranem mestu površino dovolj napnete in tako omogočite uspešno popolno injiciranje.
Following blood tests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/dl or less. 
Glede na vaše krvne izvide je zdravnik presodil, da potrebujete Nespo, ker imate koncentracijo hemoglobina 100 g/l ali manj.
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 pediatricpatients . 
Po intravenski uporabi so 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.
Locked with safety guard out 
Nesproščen, z varnostno zaščito zunaj
In order to correct your anaemia, your initial dose of Nespo per kilogram of your body weight will be either: 
Za odpravljanje anemije bo vaš začetni odmerek Nespa na kilogram telesne mase bodisi:
For instructions on use of the pre-filled pen, please read the section at the end of this leaflet. 
Navodila za uporabo napolnjenega injekcijskega peresnika preberite v poglavju na koncu tega lističa.
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF who were either receiving or not receiving dialysis determined pharmacokinetic profiles for sampling periods up to 1 week (168 hours) after a single subcutaneous or intravenous dose. 
S proučevanjem farmakokinetike darbepoetina alfa pri pediatričnih bolnikih (starih od 3 do 16 let) s kronično boleznijo ledvic, ki so bili ali niso bili na dializi, so določili farmakokinetične profile za obdobja vzorčenja do 1 tedna (168 ur) po enem samem subkutanem ali intravenskem odmerku.
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. 
Zdravljenje z Nespom je treba končati približno 4 tedne po koncu kemoterapije.
• The Nespo pre-filled pen should NEVER be reused. 
• Napolnjenega injekcijske peresnika Nespo ne smete NIKOLI ponovno uporabiti.
What Nespo contains 
Kaj vsebuje zdravilo Nespo
Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function. 
Aktivna bolezen jeter je bila v vseh študijah Nespa merilo za nevključitev, zato o bolnikih z okvarjenim delovanjem jeter ni podatkov.
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients. 
Preobčutljivost za darbepoetin alfa, r-HuEPO ali katerokoli pomožno snov.
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single period of seven days at room temperature (up to 25°C). 
Za ambulantno rabo je Nespo mogoče vzeti iz prostora za shranjevanje enkrat za največ eno sedemdnevno obdobje pri sobni temperaturi (do 25ºC).
In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually. 
Pri bolnikih s kronično odpovedjo ledvic in kliničnimi znaki ishemične bolezni srca ali kongestivnega srčnega popuščanja je treba ciljno vrednost hemoglobina določiti posamezno.
For Nespo no clinical data on exposed pregnancies are available. 
Za Nespo ni na voljo kliničnih podatkov o uporabi pri nosečnicah.
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume. 
Zloraba Nespa pri zdravih osebah lahko povzroči čezmerno zvečanje hematokrita.
No guidance regarding the correction of haemoglobin is available for paediatric patients 1 to 10 years of age. 
Za pediatrične bolnike v starosti od 1 do 10 let ni smernic za korekcijo hemoglobina.
The carton contains a package leaflet with the full instructions for use and handling. 
6.6 Posebni varnostni ukrepi za odstranjevanje Škatla vsebuje navodilo za uporabo, ki obsega popolna navodila za uporabo in ravnanje.
Clearance of darbepoetin alfa is 1.9 ml/hr/kg (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/kg). 
Očistek darbepoetina alfa je 1,9 ml/h/kg (standardni odklon 0,56), volumen porazdelitve (Vss) pa je približno enak volumnu plazme (50 ml/kg).
The following side effects have been experienced by some patients taking Nespo: 
Naslednji neželeni učinki so se pojavili pri nekaterih bolnikih, ki so dobivali Nespo:
Check the appearance of Nespo. 
Preverite videz Nespa.
D Do pull the grey cap straight off 
D Potegnite sivi pokrovček naravnost dol.
Since the liver is thought to be the principal route of elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease. 
Vendar jetra veljajo za glavno pot eliminacije Nespa in r-HuEPO, zato morate Nespo pri bolnikih z boleznimi jeter uporabljati previdno.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE(UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
9 Complete when yellow 
9 Injiciranje je končano, ko je okence rumeno.
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