natgillin/translations-raw huggingface dataset:
expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1). a
Med dejavniki, ki jih je treba upoštevati pri takšni oceni, so vrsta in stadij tumorja, stopnja anemije, pričakovana življenjska doba, okolje, v katerem vo poteka bolnikovo zdravljenje in bolnikove želje (glejte poglavje 5. 1). do
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds in
Če hemoglobin pri bolnikih s čvrstimi tumorji ali limfoproliferativnimi malignomi preseže 120 g/ l (7, 5 mmol/ l), natančno upoštevajte prilagoditev odmerka, opisano v poglavju 4. 2, da boste zmanjšali morebitno tveganje za trombembolične incidente.
12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in ic
V rednih presledkih je treba kontrolirati tudi število ā
order to minimise the potential risk of thromboembolic events.
trombocitov in koncentracijo hemoglobina. ve
For Nespo no clinical data on exposed pregnancies are available.
Za Nespo ni na voljo kliničnih podatkov o uporabi pri nosečnicah. v ra
199 Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Zd
ed 4.8 Undesirable effects
199 4. 8 Neželeni učinki
Chronic renal failure patients
et Bolniki s kronično odpovedjo ledvic
Injection site pain was reported as attributable to treatment in studies where Nespo was administered no
o pr V študijah, v katerih so Nespo uporabljali subkutano, so kot z zdravljenjem povezani učinek opisovali bolečino na mestu injiciranja.
MedDRA system organ class Cardiac Disorders lp
a nj Organski sistem po MedDRA Srčne bolezni
Subject Incidence Very Common (≥ 1/ 10)
Pogostnost zelo pogosti (≥
Adverse Drug Reaction Hypertension
1/ 10) lje
Skin and Subcutaneous Tissue Disorders a
Neželeni učinek hipertenzija
Common (≥ 1/ 100 to < 1/ 10)
Bolezni kože in podkožja
Vascular disorders in
pogosti (≥ 1/ 100 do < 1/ 10) Žilne bolezni
Uncommon (≥ 1/ 1,000 to
občasni (≥ 1/ 1. 000 do vo < 1/ 100)
< 1/ 100) ic
pogosti (≥ 1/ 100 do < 1/ 10) do
General Disorders and Administration Site Conditions ed
bolečina na mestu injiciranja
Common (≥ 1/ 100 to < 1/ 10)
mestu aplikacije
Injection site pain
Onkološki bolniki ā
Adverse reactions were determined based on pooled data from seven randomised, double-blind, M
Neželene učinke so ugotavljali na podlagi kumulativnih podatkov sedmih randomiziranih, dvojno ve
placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
slepih, s placebom kontroliranih študij Nespoa pri skupaj 2112 bolnikih (Nespo 1200, placebo 912).
Patients with solid tumours (e. g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e. g., lymphoma, multiple myeloma) were enrolled in the clinical studies.
Te klinične študije so vključile bolnike s čvrstimi tumorji (npr. rakom pljuč, dojke, kolona, jajčnika) in limfatičnimi malignomi (npr. limfomom, multiplim mielomom). a m
200 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Pogostnost neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih kliničnih študijah, so: ni
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Organski sistem po MedDRA ilo
General Disorders and Administration Site Conditions
Splošne težave in spremembe na mestu aplikacije Zd
Common (≥ 1/ 100 to < 1/ 10)
bolečina na mestu injiciranja pogosti (≥ 1/ 100 do < 1/ 10)
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
Če je
In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
200 diagnosticirana čista aplazija rdečih celic, morate terapijo z Nespoom prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4. 4).
Even at very high serum levels, no symptoms of overdose have been observed. ct du
et simptomov prevelikega odmerjanja.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
m V primeru policitemije je treba uporabo Nespa prehodno prekiniti (glejte poglavje 4. 2).
5.
o pr 5.
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.
a nj Humani eritropoetin je endogen glikoproteinski hormon, ki primarno uravnava eritropoezo, in sicer preko specifične interakcije z eritropoetinskim receptorjem na eritroidnih matičnih celicah v kostnem lje mozgu.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Nastajanje endogenega eritropoetina je okvarjeno pri kronični odpovedi ledvic; vo primarni vzrok anemije pri takšnih bolnikih je pomanjkanje eritropoetina.
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
bistveno pripomoreta tako pomanjkanje eritropoetina kot slabši odziv eritroidnih matičnih celic na endogeni eritropoetin.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Darbepoetin alfa ā
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
ima pet N- vezanih ogljikohidratnih verig, endogeni hormon in rekombinantni humani eritropoetini ve
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Kljub tem a
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
molekulskim spremembam darbepoetin alfa ohranja zelo ozko specifičnost za eritropoetinski receptor. m
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo ni
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom ilo
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.
na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji (p < 0, 001). v
ed 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
Klinične študije so pokazale, da je darbepoetin alfa podobno učinkovit, če je uporabljen v posamični ra
is randomised, double-blind, multinational study.
Zd
In the once every three weeks group, 72% of patients required dose reductions.
Študija potrjuje, da je uporaba 500 µg enkrat na tri tedne primerljiva uporabi enkrat na teden, kar
This study supports 500 μ g once
201 zadeva incidenco preiskovancev, ki so od 5. tedna do konca terapevtske faze dobili vsaj eno transfuzijo eritrocitov.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Receptorji za eritropoetin so lahko izraženi na površini različnih tumorskih celic
Survival and tumour progression have been examined in five large controlled studies involving a total ro
et Preživetje bolnikov in napredovanje tumorja so raziskali v petih velikih kontroliranih študijah, ki so
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
m skupaj zajele 2833 bolnikov.
with recombinant human erythropoietin and controls.
o študijah je bila > 130 g/ l, v preostalih treh pa od 120 do 140 g/ l.
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
pr celotnem preživetju bolnikov, zdravljenih z rekombinantnim humanim eritropoetinom, in bolnikov v kontrolni skupini.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human M
za nepojasnjeno in statistično značilno večjo umrljivost med bolniki z anemijo zaradi različnih pogostih vrst raka, ki so dobivali rekombinantni humani eritropoetin, v primerjavi z bolniki v kontrolnih skupinah.
erythropoietin and those in the control group.
a incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
nj eritropoetin, in bolniki v kontrolni skupini. lje Sistematično so pregledali tudi podatke o več kot 9000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Ocena ogroženosti na podlagi metaanalize podatkov o celotnem preživetju je vo bila 1, 08 v korist kontrolne skupine (95% IZ:
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Ni pa jasno, v kolikšni meri bi te ugotovitve lahko veljale za uporabo ā
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
rekombinantnega eritropoetina pri bolnikih z rakom, ki dobivajo kemoterapijo, če je ciljna ve
202 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
koncentracija hemoglobina manjša od 130 g/ l; analizirani podatki so namreč obsegali le malo bolnikov s takšnimi značilnostmi. a
5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti m
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.
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 ilo
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Terminalni razpolovni čas intravensko apliciranega darbepoetina alfa je 21 ur Zd
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
202 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.
Following intravenous administration, an approximate 25% difference between du
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.
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 ro
AUC( 0– ∞) po subkutani uporabi je bila pri odraslih in pediatričnih bolnikih s
pediatricpatients.
et kronično boleznijo ledvic podobna.
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
o pr Pri odraslih onkoloških bolnikih je darbepoetin alfa po subkutani uporabi 2, 25 µg/ kg dosegel povprečno največjo koncentracijo 10, 6 ng/ ml (standardni odklon 5, 9) v povprečno 91 urah (standardni odklon 19, 7).
(SD 19.7).
za odmernem območju (od 0, 5 do 8 µg/ kg na teden in od 3 do 9 µg/ kg na dva tedna).
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).
Med večkratnim odmerjanjem v teku 12 tednov (odmerjanje vsak teden ali na dva tedna) se farmakokinetični parametri niso spremenili.
Pharmacokinetic parameters did not M
Ko se je bližalo stanje dinamičnega ravnovesja, je prišlo do pričakovanega zmernega
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
a (< 2- kratnega) povečanja koncentracije v serumu, ni pa bilo med ponavljajočo uporabo nobenega
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
nj nepričakovanega kopičenja.
A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 µg/ kg darbepoetin alfa administered SC every 3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of the terminal half-life.
Farmakokinetična študija, opravljena pri bolnikih z anemijo zaradi kemoterapije, ki so v kombinaciji s kemoterapijo dobivali 6, 75 µg/ kg darbepoetina alfa subkutano na 3 lje tedne, je omogočila popolno opredelitev terminalnega razpolovnega časa.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
V tej študiji je bil povprečni terminalni razpolovni čas 74 ur (standardni odklon 27 ur). vo
5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti do
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
Vse neželene učinke ob zelo velikih odmerkih so ocenili za posledice pretiranega farmakološkega ā
203 effect (decreased tissue perfusion due to increased blood viscosity).
delovanja (manjša perfuzija tkiva zaradi večje viskoznosti krvi).
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.
hipertrofija vranice ter razširitev kompleksa QRS na EKG pri psih, vendar brez motenj srčnega ritma in brez vpliva na interval QT. a
Nespo did not reveal any genotoxic potential nor did it have any effect on the proliferation of non- haematological cells in vitro or in vivo.
Nespo ni pokazal genotoksičnega potenciala in tudi ni vplival na proliferacijo nehematoloških celic m
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
dolgoročnih študijah na živalih. ilo
for injections Incompatibilities
203 6. 2 Inkompatibilnosti
Package containing one or four clear glass vial(s) with rubber stopper(s) of 60 µg Nespo solution for injection in 1 ml (60 µg/ ml).
a Pakiranje z eno vialo/ štirimi vialami iz prozornega stekla z gumijastim zamaškom/ gumijastimi
Not all pack sizes may be marketed.
nj zamaški, v katerih je raztopina za injiciranje Nespo s 60 µg Nespa v 1 ml (60 µg/ ml). lje Viale so iz stekla tipa I in imajo gumijaste zamaške, prekrite s fluoropolimerom. vo Na trgu ni vseh navedenih pakiranj.
204 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje do
EU/ 1/ 01/ 184/ 029 1 Pack EU/ 1/ 01/ 184/ 030 4 pack lo no
EU/ 1/ 01/ 184/ 029 – pakiranje po 1 EU/ 1/ 01/ 184/ 030 – pakiranje po 4
or Solution for injection (injection) in a pre-filled pen.
pr Raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku (SureClick).
The pre-filled pen is only for subcutaneous administration.
Nespo (SureClick) je na voljo pripravljen za uporabo v napolnjenih injekcijskih peresnikih.
206 Adult patients with chronic renal failure
206 Odrasli bolniki s kronično odpovedjo ledvic
provide adequate control of the symptoms of anaemia. ed
Nespa, ki je potreben za ustrezno obvladanje simptomov anemije..
207 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
208 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Če se hemoglobin po zmanjšanju odmerka še naprej zvišuje, uporabo začasno prekinite, dokler se hemoglobin ne začne zniževati; potem terapijo znova uvedite z odmerkom, približno 25% manjšim od prejšnjega.
209 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi Zd
Deficiencies of
209 Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
To je lahko povezano s smrtno nevarnimi zapleti na srčno- žilnem sistemu. lje Pokrovček igle na napolnjenem injekcijskem peresniku vsebuje suho naravno gumo (derivat lateksa), vo ki lahko povzroči alergijske reakcije.
210 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 takšnih bolnikih naj Zd
211 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje ra
ed 4.7 Effects on ability to drive and use machines
211 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
212 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Pogostnost neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih ilo
or th • Pure Red Cell Aplasia.
212 • Čisto aplazijo rdečih celic.
213 in vivo activity.
hormonu.
au in a 14-day period.
213 teden), če se je hemoglobin v 14- dnevnem obdobju zvišal za več kot 10 g/ l.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
m eritropoetin so lahko izraženi na površini različnih tumorskih celic
214 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
koncentracija hemoglobina manjša od 130 g/ l; analizirani podatki so namreč obsegali le malo bolnikov m
er Data from 809 patients receiving Nespo in European clinical studies were analysed to assess the dose ng required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection. lo
214 Za določitev odmerka, potrebnega za vzdrževanje hemoglobina, so analizirali 809 bolnikov, ki so Nespo dobivali v evropskih kliničnih študijah; med povprečnim tedenskim odmerkom, uporabljenim intravensko ali subkutano, niso ugotovili razlik.
215 effect (decreased tissue perfusion due to increased blood viscosity).
hipertrofija vranice ter razširitev kompleksa QRS na EKG pri psih, vendar brez motenj srčnega ritma m
er Water 6.2
215 voda za injekcije
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
Ko napolnjeni injekcijski peresnik vzamete iz hladilnika in doseže sobno temperaturo (do 25ºC), ga morate uporabiti v 7 dneh, sicer ga morate zavreči.
Package containing one or four pre-filled pens of a 10 µg Nespo solution for injection in 0.4 ml (25 µg/ ml).
a nj 6. 5 Vrsta ovojnine in vsebina lje Pakiranje vsebuje napolnjen injekcijski peresnik z raztopino za injiciranje Nespo z 10 µg v 0, 4 ml (25 µg/ ml). vo
See section 4.4.
Glejte do
Not all packs may be marketed.
Na trgu ni vseh navedenih pakiranj. ā ve
216 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
The carton contains a package leaflet with the full instructions for use and handling.
Škatla vsebuje navodilo za uporabo, ki obsega popolna navodila za uporabo in ravnanje. a m
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
Napolnjeni injekcijski peresnik Nespo (SureClick) aplicira celoten odmerek posamezne jakosti. ni
Any medicinal product remaining in the pre-filled pen should be disposed of.
Ostanek zdravila v napolnjenem injekcijskem peresniku morate zavreči. ilo
Allow the pre- filled pen to reach room temperature before injecting.
injiciranjem morate napolnjen injekcijski peresnik pustiti, da doseže sobno temperaturo. ra
ed Rotate the injection sites to avoid discomfort at the site of injection.
Zd
is Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
er I-20122 Milan Italy ng lo 8.
216 8.
MARKETING AUTHORISATION NUMBERS no
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/ 1/ 01/ 184/ 045 1 pack EU/ 1/ 01/ 184/ 057 4 pack ct
EU/ 1/ 01/ 184/ 045 – pakiranje po 1 EU/ 1/ 01/ 184/ 057 – pakiranje po 4
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Date of first authoristion:
et Datum pridobitve dovoljenja za promet:
8 June 2001 ro
8. junij 2001 Datum podaljšanja dovoljenja za promet:
19 May 2006 lp
19. maj 2006
10.
m o 10.
DATE OF REVISION OF THE TEXT a in ic
DATUM ZADNJE REVIZIJE BESEDILA
Detailed information on this medicinal product is available on the website of the European Medicines ed
pr za Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu. /
Agency (EMEA) http: / /www. emea. europa. eu/ M
a nj lje vo do ā ve a m ni ilo v ra Zd
218 Adult patients with chronic renal failure
218 Odrasli bolniki s kronično odpovedjo ledvic
219 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
220 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Če se hemoglobin po zmanjšanju odmerka še naprej zvišuje, uporabo začasno prekinite, dokler se hemoglobin ne začne zniževati; potem terapijo znova uvedite z odmerkom, približno 25% manjšim od prejšnjega.
221 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi Zd
Deficiencies of
221 Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
222 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 takšnih bolnikih naj Zd
In these patients an upper limit of 12 g/ dl (7.5 mmol/ l) should be aimed for, unless severe symptoms (e. g. angina) dictate otherwise.
bi bila ciljna zgornja meja 120 g/ l, razen če hudi simptomi (npr. angina pektoris) ne narekujejo drugače.
223 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje ra
ed 4.7 Effects on ability to drive and use machines
223 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
224 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Pogostnost neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih ilo
or th • Pure Red Cell Aplasia.
224 • Čisto aplazijo rdečih celic.
225 in vivo activity.
hormonu.
au in a 14-day period.
225 teden), če se je hemoglobin v 14- dnevnem obdobju zvišal za več kot 10 g/ l.
226 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
koncentracija hemoglobina manjša od 130 g/ l; analizirani podatki so namreč obsegali le malo bolnikov m