FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Predklinične študije so pokazale, da je ledvični očistek minimalen (do 2% celotnega očistka) in ne vpliva na razpolovni čas v serumu.
English: • Pure Red Cell Aplasia.
Slovenian: • Čisto aplazijo rdečih celic.
English: Via San Martino 12 I-20122 Milan Italy
Slovenian: Via San Martino 12 I-20122 Milan Italija
English: What should I do before I give myself a subcutaneous injection of Nespo?
Slovenian: Kaj moram narediti, preden si dam podkožno injekcijo Nespa?
English: If you see blood in the syringe, pull the needle out and re-insert it in another place.
Slovenian: Če v brizgi opazite kri, izvlecite iglo in jo zabodite drugam.
English: Your doctor will inform you if your dose changes.
Slovenian: Zdravnik vam bo povedal, če se vam odmerek spremeni.
English: This is because the red blood cells have a much longer life span in the circulating blood.
Slovenian: Rdeče krvne celice imajo namreč v krvnem obtoku veliko daljšo življenjsko dobo.
English: • Do not put the cover back on used needles, as you may accidentally prick yourself.
Slovenian: • Ne nameščajte pokrovčka nazaj na uporabljene igle, ker se lahko po nesreči zbodete.
English: Date of last renewal: 19 May 2006
Slovenian: Datum podaljšanja dovoljenja za promet: 19. maj 2006
English: Never inject Nespo into a vein yourself.
Slovenian: Nespo si nikdar sami ne injicirajte v veno.
English: Your doctor will tell you exactly when to stop taking Nespo.
Slovenian: Zdravnik vam bo povedal, kdaj natančno morate nehati uporabljati Nespo.
English: Put the needle fully into the skin as shown by your nurse or doctor.
Slovenian: Zabodite iglo do konca v kožo, kot vam je pokazala medicinska sestra ali zdravnik.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or
Slovenian: • Oteklost obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave pri požiranju ali dihanju
English: It is important to tell your doctor if you are taking either of these drugs.
Slovenian: Pomembno je, da zdravniku poveste, če jemljete katero od njiju.
English: It is not known whether darbepoetin alfa is excreted in human milk.
Slovenian: Ni znano, ali se darbepoetin alfa izloča v materinem mleku.
English: (4) Count slowly to 15 for injection to end.
Slovenian: (4) Počasi štejte do 15, da se bo injiciranje končalo.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
Slovenian: Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost zdravil za stimulacijo eritropoeze in jih je zato treba korigirati.
English: Choosing and preparing an injection site
Slovenian: Izbira in priprava mesta za injiciranje
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu./
English: Using Nespo with food and drink
Slovenian: Uporaba zdravila Nespo skupaj s hrano in pijačo
English: Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy.
Slovenian: Vsem bolnikom morate kontrolirati krvni tlak, zlasti med začetkom zdravljenja z Nespom.
English: Count slowly to 15 seconds for injection to end.
Slovenian: Počasi štejte do 15 sekund, da se injiciranje konča.
English: 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.
Slovenian: 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.
English: Clinical Trial Experience
Slovenian: Izkušnje iz kliničnih preskušanj
English: Your doctor, nurse, or pharmacist will tell you how much Nespo you need and how frequently it should be injected.
Slovenian: Zdravnik, medicinska sestra ali farmacevt vam bo povedal, koliko Nespa potrebujete in kako pogosto si ga morate injicirati.
English: 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
Slovenian: 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).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authoristion: 8 June 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 8. junij 2001
English: However, there is potential for an interaction with drugs that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Slovenian: Obstaja pa možnost za interakcije z zdravili, ki so v veliki meri vezana na rdeče krvne celice, npr. s ciklosporinom ali takrolimusom.
English: 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).
Slovenian: 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).
English: Unlocked with safety guard fully retracted
Slovenian: Sproščen, s povsem nazaj pomaknjeno varnostno zaščito
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Slovenian: 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.
English: Nespo treatment should be initiated by physicians experienced in the above mentioned indications.
Slovenian: Zdravljenje z Nespom mora uvesti zdravnik, ki ima izkušnje z navedenima indikacijama.
English: In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti Nespa ne smete mešati ali aplicirati v infuziji z drugimi zdravili.
English: Injection site must be firm and tight
Slovenian: Raztegnite Mesto injiciranja mora biti čvrsto in napeto.
English: 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.
Slovenian: 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.
English: Nespo has not been tested in pregnant women.
Slovenian: Nespo ni preizkušen pri nosečnicah.
English: Even at very high serum levels, no symptoms of overdose have been observed.
Slovenian: Celo ob zelo visoki koncentraciji v serumu niso opazili simptomov prevelikega odmerjanja.
English: The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
Slovenian: Dosedanji klinični rezultati ne kažejo, da bi Nespo medsebojno deloval z drugimi snovmi.
English: 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.
Slovenian: 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.
English: In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
Slovenian: V kontroliranih kliničnih študijah je uporaba Nespa in drugih eritropoezo stimulirajočih agensov (ESA):
English: • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Slovenian: • Čista aplazija rdečih celic - (anemija, nenavadna utrujenost, pomanjkanje energije)
English: • high blood pressure which is being controlled with medicines prescribed by your doctor;
Slovenian: • visok krvni tlak, obvladan z zdravili, ki vam jih je predpisal zdravnik,
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pri bolnikih s kronično odpovedjo ledvic vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije, priporočene v poglavju 4.2.
English: Nespo did not reveal any genotoxic potential nor did it have any effect on the proliferation of nonhaematological cells in vitro or in vivo.
Slovenian: Nespo ni pokazal genotoksičnega potenciala in tudi ni vplival na proliferacijo nehematoloških celic niti in vitro ali in vivo.
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Slovenian: Ciljna koncentracija hemoglobina v teh dveh študijah je bila > 130 g/l, v preostalih treh pa od 120 do 140 g/l.
English: Dose increases must not be made more frequently than once every four weeks.
Slovenian: Odmerka ne smete povečevati pogosteje kot enkrat na štiri tedne.
English: 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
Slovenian: 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
English: 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).
Slovenian: Če je krvni tlak po uvedbi ustreznih ukrepov težko obvladovati, lahko hemmoglobin znižate z zmanjšanjem ali zadržanjem odmerka Nespa (glejte poglavje 4.2).
English: Before you inject Nespo you must do the following:
Slovenian: Pred injiciranjem zdravila Nespo, morate narediti naslednje:
English: • Sudden life-threatening allergic reactions (anaphylaxis)
Slovenian: • Nenadne smrtno nevarne alergijske reakcije (anafilaksija)
English: Nespo works in exactly the same way as the natural hormone erythropoietin.
Slovenian: Nespo deluje popolnoma enako kot naravni hormon eritropoetin.
English: Do not use any Nespo that is left in the syringe.
Slovenian: Ne uporabljajte preostanka Nespa, ki je ostal v brizgi.
English: • High blood pressure (hypertension) • Fluid retention (oedema)
Slovenian: • Visok krvni tlak (hipertenzija) • Zastajanje tekočine (edemi)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Če uporabljate druga mesta injiciranja, je posebej pomembno, da na izbranem mestu površino dovolj napnete in tako omogočite uspešno popolno injiciranje.
English: Following blood tests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/dl or less.
Slovenian: Glede na vaše krvne izvide je zdravnik presodil, da potrebujete Nespo, ker imate koncentracijo hemoglobina 100 g/l ali manj.
English: 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 .
Slovenian: 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.
English: Locked with safety guard out
Slovenian: Nesproščen, z varnostno zaščito zunaj
English: In order to correct your anaemia, your initial dose of Nespo per kilogram of your body weight will be either:
Slovenian: Za odpravljanje anemije bo vaš začetni odmerek Nespa na kilogram telesne mase bodisi:
English: For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.
Slovenian: Navodila za uporabo napolnjenega injekcijskega peresnika preberite v poglavju na koncu tega lističa.
English: 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.
Slovenian: 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.
English: Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy.
Slovenian: Zdravljenje z Nespom je treba končati približno 4 tedne po koncu kemoterapije.
English: • The Nespo pre-filled pen should NEVER be reused.
Slovenian: • Napolnjenega injekcijske peresnika Nespo ne smete NIKOLI ponovno uporabiti.
English: What Nespo contains
Slovenian: Kaj vsebuje zdravilo Nespo
English: Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function.
Slovenian: Aktivna bolezen jeter je bila v vseh študijah Nespa merilo za nevključitev, zato o bolnikih z okvarjenim delovanjem jeter ni podatkov.
English: Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Slovenian: Preobčutljivost za darbepoetin alfa, r-HuEPO ali katerokoli pomožno snov.
English: 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).
Slovenian: Za ambulantno rabo je Nespo mogoče vzeti iz prostora za shranjevanje enkrat za največ eno sedemdnevno obdobje pri sobni temperaturi (do 25ºC).
English: In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
Slovenian: Pri bolnikih s kronično odpovedjo ledvic in kliničnimi znaki ishemične bolezni srca ali kongestivnega srčnega popuščanja je treba ciljno vrednost hemoglobina določiti posamezno.
English: For Nespo no clinical data on exposed pregnancies are available.
Slovenian: Za Nespo ni na voljo kliničnih podatkov o uporabi pri nosečnicah.
English: Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
Slovenian: Zloraba Nespa pri zdravih osebah lahko povzroči čezmerno zvečanje hematokrita.
English: No guidance regarding the correction of haemoglobin is available for paediatric patients 1 to 10 years of age.
Slovenian: Za pediatrične bolnike v starosti od 1 do 10 let ni smernic za korekcijo hemoglobina.
English: The carton contains a package leaflet with the full instructions for use and handling.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Škatla vsebuje navodilo za uporabo, ki obsega popolna navodila za uporabo in ravnanje.
English: 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).
Slovenian: 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).
English: The following side effects have been experienced by some patients taking Nespo:
Slovenian: Naslednji neželeni učinki so se pojavili pri nekaterih bolnikih, ki so dobivali Nespo:
English: Check the appearance of Nespo.
Slovenian: Preverite videz Nespa.
English: D Do pull the grey cap straight off
Slovenian: D Potegnite sivi pokrovček naravnost dol.
English: 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.
Slovenian: Vendar jetra veljajo za glavno pot eliminacije Nespa in r-HuEPO, zato morate Nespo pri bolnikih z boleznimi jeter uporabljati previdno.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE(UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: 9 Complete when yellow
Slovenian: 9 Injiciranje je končano, ko je okence rumeno.
English: 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.
Slovenian: Kontrolirana klinična preskušanja niso pokazala pomembnih koristi uporabe epoetinov, če koncentracija hemoglobina preseže raven, potrebno za obvladanje simptomov anemije in preprečitev
English: The safety and effectiveness of once every three weeks dosing of Nespo therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Slovenian: Varnost in učinkovitost zdravljenja z Nespom enkrat na tri tedne za zmanjšanje potrebe po transfuzijah eritrocitov so pri bolnikih na kemoterapiji raziskali v randomizirani, dvojno slepi mednarodni študiji.
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8).
Slovenian: Ugotovljeno je, da ta protitelesa navzkrižno reagirajo z vsemi eritropoetičnimi beljakovinami; bolnikov, pri katerih obstaja sum ali pri katerih je potrjeno, da imajo nevtralizirajoča protitelesa proti eritropoetinu, ne smete prevesti na darbepoetin alfa (glejte poglavje 4.8).
English: 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.
Slovenian: 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
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti sistem farmakovigilance (opisan v verziji 3.0, predstavljen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet), ki mora biti vzpostavljen in mora delovati pred časom, ko je zdravilo v prometu, in med časom, ko je v prometu.
English: • 0.45 micrograms once weekly
Slovenian: • 0,45 mikrogramov enkrat na teden.
English: The haemoglobin should be measured every one or two weeks until it is stable.
Slovenian: Hemoglobin morate kontrolirati na en do dva tedna, dokler vrednost ni stabilna.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Slovenian: Eritropoetinski receptorji so lahko izraženi na površini različnih tumorskih celic.
English: If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, please tell your doctor, nurse or pharmacist.
Slovenian: Če imate katerikoli od teh simptomov ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
English: Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy.
Slovenian: Prav tako morate Nespo uporabljati previdno pri bolnikih z anemijo srpastih celic ali epilepsijo.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Slovenian: Ne injicirajte v občutljivo, rdečo ali zatrdelo kožo.
English: If darbepoetin alfa is given concomitantly with any of these drugs, blood levels of these drugs should be monitored and the dosage adjusted as the haemoglobin rises.
Slovenian: Če darbepoetin alfa dajete sočasno s temi zdravili, je treba njihovo koncentracijo v krvi kontrolirati in odmerke prilagajati, ko se koncentracija hemoglobina zvišuje.
English: This section contains information on how to properly use the Nespo pre-filled pen.
Slovenian: To poglavje obsega informacije o pravilni uporabi napolnjenega injekcijskega peresnika Nespo.
English: D You may hear a second click as the red button pops back up.
Slovenian: D Ko bo rdeči gumb skočil nazaj navzgor, boste morda slišali drugi klik.
English: Do not remove the cover from the syringe until you are ready to inject.
Slovenian: Ne odstranite ovojnine z brizge, dokler niste pripravljeni za injiciranje.
English: What Nespo is and what is it used for
Slovenian: KAJ JE ZDRAVILO NESPO IN ZA KAJ GA UPORABLJAMO
English: D Do maintain pressure on the skin during the injection
Slovenian: D Med injiciranjem pritiskajte na kožo
English: If you have forgotten a dose of Nespo, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste pozabili odmerek Nespa, se pogovorite z zdravnikom, da vam bo povedal, kdaj si injicirajte
English: 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 Nespo is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
Slovenian: Ko je terapevtski cilj pri posameznem bolniku dosežen, je treba odmerek zmanjšati za 25 do 50 % in tako zagotoviti uporabo najmanjšega odobrenega odmerka Nespa, potrebnega za vzdrževanje takšne koncentracije hemoglobina, ki obvladuje simptome anemije.