natgillin/translations-raw huggingface dataset:
Therapy should be reinitiated at ed
Potem, ko se hemoglobin zniža na 120 g/ l (7, 5 mmol/ l) ali manj, je a
M
treba terapijo znova uvesti z odmerkom, približno 25% manjšim od prejšnjega. m
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Če se koncentracija hemoglobina v 4 tednih zviša za več kot 20 g/ l (1, 25 mmol/ l), je odmerek treba ni
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Preobčutljivost za darbepoetin alfa, r- HuEPO ali katerokoli pomožno snov. v ra
161 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Deficiencies of
161 Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
th PRCA, testing for anti-erythropoietin antibodies should be performed.
Če se izvid kostnega mozga sklada s čisto aplazijo rdečih celic, je potrebno testiranje za antieritropoetinska protitelesa.
au Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
et V povezavi z rekombinantnimi eritropoetičnimi beljakovinami (vključno z darbepoetinom alfa) je opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles.
er predominantly reported in patients with CRF treated subcutaneously.
m poročali predvsem pri bolnikih s kronično odpovedjo ledvic, ki so zdravilo dobivali subkutano.
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have ng neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8). lo Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function.
Ugotovljeno je, da ta protitelesa navzkrižno reagirajo z vsemi eritropoetičnimi beljakovinami;
Since the liver is thought to be the principal route of no
o bolnikov, pri katerih obstaja sum ali pri katerih je potrjeno, da imajo nevtralizirajoča protitelesa proti
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
pr eritropoetinu, ne smete prevesti na darbepoetin alfa (glejte poglavje 4. 8).
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
Aktivna bolezen jeter je bila v vseh študijah Nespa merilo za nevključitev, zato o bolnikih z
This du
Vendar jetra veljajo za glavno pot eliminacije Nespa in r- HuEPO, zato morate Nespo pri bolnikih z boleznimi jeter uporabljati previdno.
may be associated with life-threatening complications of the cardiovascular system. ro
a Prav tako morate Nespo uporabljati previdno pri bolnikih z anemijo srpastih celic ali epilepsijo.
In clinical studies, an lp
To je lahko lje povezano s smrtno nevarnimi zapleti na srčno- žilnem sistemu. vo Pri bolnikih s kronično odpovedjo ledvic vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije, priporočene v poglavju 4. 2.
increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater a
V kliničnih študijah so ugotovili večje tveganje smrti, resnih srčnožilnih dogodkov in tromboze na žilnem dostopu, kadar so eritropoezo do
than 12 g/ dl (7.5 mmol/ l). in
stimulirajoče agense (ESA) uporabljali tako, da je bil ciljni hemoglobin nad 120 g/ l (7, 5 mmol/ l).
Controlled clinical trials have not shown significant benefits attributable to the administration of ic
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi uporabe epoetinov, če ā
epoetins when haemoglobin concentration is increased beyond the level necessary to control ed
koncentracija hemoglobina preseže raven, potrebno za obvladanje simptomov anemije in preprečitev ve
M
transfuzij krvi.
Convulsions have been reported in patients receiving Nespo.
Pri bolnikih, ki so dobivali Nespo, so a
Chronic renal failure patients
Bolniki s kronično odpovedjo ledvic ni
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
Dodatna terapija z železom je priporočljiva pri vseh bolnikih, ki imajo feritin v serumu pod 100 µg/ l ilo
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 v
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.
Zd
162 Serum potassium levels should be monitored regularly during Nespo therapy.
Med zdravljenjem z Nespom je treba redno kontrolirati koncentracijo kalija v serumu.
Epoetins are growth factors that primarily stimulate red blood cell production.
162 Epoetini so rastni dejavniki, ki stimulirajo predvsem nastajanje rdečih krvnih celic.
ed there is a concern that epoetins could stimulate the growth of tumours.
Tako kot pri vseh rastnih dejavnikih tudi pri epoetinih obstaja skrb, da bi lahko spodbudili rast tumorjev.
is or 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):
th •
• skrajšala čas do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu,
au shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), ESAs are not indicated for use in this patient population.
Uporaba ESA v tej populaciji bolnikov ni indicirana.
• er shortened overall survival and increased deaths attributed to disease progression at 4 months in ng patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l) lo
m • skrajšala celotno preživetje in povečala število smrti, ki jih je bilo mogoče pripisati napredovanju
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in no
o bolezni po 4 mesecih, pri bolnicah z metastatskim rakom dojke, zdravljenih s kemoterapijo, če je
patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for use in this patient population. ct
pr bila ciljna vrednost hemoglobina od 120 do 140 g/ l (od 7, 5 do 8, 7 mmol/ l).
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.
• povečala tveganje smrti pri bolnikih z aktivno maligno boleznijo, ki niso dobivali ne kemoterapije
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.
za ne obsevanja, če je bila ciljna vrednost hemoglobina 120 g/ l (7, 5 mmol/ l).
Factors that should be considered ro
ESA v tej populaciji bolnikov niso indicirani.
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- lp
a Glede na zgoraj navedeno, je treba v nekaterih kliničnih primerih anemijo pri bolnikih z rakom
expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1). a
nj prednostno zdraviti s transfuzijo krvi.
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds in
Odločitev za uporabo rekombinantnih eritropoetinov mora temeljiti na oceni koristi in tveganja in mora biti sprejeta v sodelovanju z bolnikom, upoštevaje lje posameznikove specifične klinične okoliščine.
12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in ic
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
order to minimise the potential risk of thromboembolic events.
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.
Platelet counts and haemoglobin level should also be monitored at regular intervals. ed
V rednih presledkih je treba kontrolirati tudi število trombocitov in koncentracijo hemoglobina. ā ve
4.5 Interaction with other medicinal products and other forms of interaction M
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
Obstaja pa a
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
možnost za interakcije z zdravili, ki so v veliki meri vezana na rdeče krvne celice, npr. s ciklosporinom m
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.
Če darbepoetin alfa dajete sočasno s temi zdravili, je treba njihovo koncentracijo v krvi kontrolirati in odmerke prilagajati, ko se koncentracija hemoglobina zvišuje. ni
For Nespo no clinical data on exposed pregnancies are available.
Za Nespo ni na voljo kliničnih podatkov o uporabi pri nosečnicah. v
163 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, ra
ed 4.8 Undesirable effects
163 4. 8 Neželeni učinki
is General
Splošno
or There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
V povezavi z darbepoetinom alfa so bile opisane resne alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, dispnejo, izpuščajem na koži in urtikarijo.
th au Clinical Trial Experience
Izkušnje iz kliničnih preskušanj
er Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 ng patients who received r-HuEPO.
V
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. lo
m skupini, ki je dobivala Nespo, je bilo 83% bolnikov na dializi, 17% pa ne.
Injection site pain was reported as attributable to treatment in studies where Nespo was administered no
o V študijah, v katerih so Nespo uporabljali subkutano, so kot z zdravljenjem povezani učinek opisovali
via subcutaneous injection.
pr bolečino na mestu injiciranja.
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ct
Nelagodje na mestu injiciranja je bilo praviloma blago in prehodno ter se je pojavilo predvsem po prvi injekciji.
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical du
za Pogostnosti neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih kliničnih študijah, so:
studies are: ro
Pogostnost
MedDRA system organ class Cardiac Disorders lp
nj Srčne bolezni
Subject Incidence Very Common (≥ 1/ 10)
zelo pogosti (≥ 1/ 10)
Adverse Drug Reaction Hypertension
hipertenzija
Skin and Subcutaneous Tissue Disorders a
Bolezni kože in podkožja
Common (≥ 1/ 100 to < 1/ 10)
pogosti (≥ 1/ 100 do < 1/ 10) lje
Vascular disorders in
Žilne bolezni
Uncommon (≥ 1/ 1,000 to
občasni (≥ 1/ 1. 000 do < 1/ 100) vo
General Disorders and Administration Site Conditions ed
Splošne težave in spremembe na mestu aplikacije
Adverse reactions were determined based on pooled data from seven randomised, double-blind, M
Onkološki bolniki ā
placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
Te ve
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.
klinične študije so vključile bolnike s čvrstimi tumorji (npr. rakom pljuč, dojke, kolona, jajčnika) in limfatičnimi malignomi (npr. limfomom, multiplim mielomom). a
164 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 m
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Organski sistem po MedDRA Bolezni kože in podkožja ilo
Vascular disorders
Žilne bolezni v
General Disorders and Administration Site Conditions
edemi Splošne težave in spremembe na ra
Common (≥ 1/ 100 to < 1/ 10)
mestu aplikacije bolečina na mestu injiciranja pogosti (≥ 1/ 100 do < 1/ 10) Zd
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
164 • Alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, izpuščajem in urtikarijo.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
et V primeru policitemije je treba uporabo Nespa prehodno prekiniti (glejte poglavje 4. 2).
5.
m o 5.
5.1 Pharmacodynamic properties in
pr 5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group:
za Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti.
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
The production of erythropoietin primarily occurs in and is regulated by the M
a preko specifične interakcije z eritropoetinskim receptorjem na eritroidnih matičnih celicah v kostnem
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; lje 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.
Pri teh bolnikih k anemiji vo bistveno pripomoreta tako pomanjkanje eritropoetina kot slabši odziv eritroidnih matičnih celic na endogeni eritropoetin. do
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Dodatne sladkorne skupine se molekulsko ne ločijo od tistih na endogenem ā
165 in vivo activity.
hormonu.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
Kljub tem molekulskim spremembam darbepoetin alfa ohranja zelo ozko specifičnost za eritropoetinski receptor. a
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo m
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 ni
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). ilo
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 injekciji bodisi enkrat na tri tedne, enkrat na dva tedna ali vsak teden, brez potrebe po povečanju v
is randomised, double-blind, multinational study.
eritrocitov so pri bolnikih na kemoterapiji raziskali v randomizirani, dvojno slepi mednarodni študiji.
er every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase. ng In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic lo patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001). no
165 V prospektivni, randomizirani, dvojno slepi s placebom kontrolirani študiji pri 344 anemičnih bolnikih z limfoproliferativnimi malignomi, ki so dobivali kemoterapijo, so ugotovili značilno zmanjšanje potreb po transfuziji in boljši odziv hemoglobina (p < 0, 001).
Survival and tumour progression have been examined in five large controlled studies involving a total ro
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.
et skupaj zajele 2833 bolnikov.
with recombinant human erythropoietin and controls.
m 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.
o kontrolni skupini.
to controls.
za skupinah.
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
Rezultata celotnega preživetja v teh preskušanjih ni mogoče zadovoljivo pojasniti z različno incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani eritropoetin, in bolniki v kontrolni skupini.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
a nj 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 lje bila 1, 08 v korist kontrolne skupine (95% IZ:
0.99, 1.18; 42 trials and 8167 patients).
0, 99, 1, 18; 42 preskušanj in 8167 bolnikov). vo Pri bolnikih, zdravljenih z rekombinantnim humanim eritropoetinom, so ugotovili večje relativno tveganje za trombembolične dogodke (RT 1, 67, 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.
Obstajajo konsistentni dokazi, da lahko bolnikom z rakom zdravljenje z rekombinantnim humanim do
166 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Ni pa jasno, v kolikšni meri bi te ugotovitve lahko veljale za uporabo rekombinantnega eritropoetina pri bolnikih z rakom, ki dobivajo kemoterapijo, če je ciljna koncentracija hemoglobina manjša od 130 g/ l; analizirani podatki so namreč obsegali le malo bolnikov ā
5.2 Pharmacokinetic properties
s takšnimi značilnostmi. ve
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 ni
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Farmakokinetiko darbepoetina alfa so raziskali pri bolnikih s kronično odpovedjo ledvic po intravenski v
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg (SD
Terminalni razpolovni čas intravensko apliciranega darbepoetina alfa je 21 ur ra
is 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
Biološka uporabnost po subkutani Zd
or Bioavailability is 37% with subcutaneous administration.
uporabi je 37%.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
166 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
Primerjava s farmakokinetičnimi podatki odraslih bolnikov s kronično boleznijo ledvic, pri katerih je vzorčenje trajalo enako dolgo, je pokazala, da je farmakokinetika darbepoetina alfa pri pediatričnih in odraslih bolnikih s kronično boleznijo ledvic podobna.
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
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.
CRF following both intravenous and subcutaneous administration. a
et kronično boleznijo ledvic podoben, tako po intravenski kot po subkutani uporabi.
Cancer patients receiving chemotherapy in
m Onkološki bolniki, ki dobivajo kemoterapijo
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
o Pri odraslih onkoloških bolnikih je darbepoetin alfa po subkutani uporabi 2, 25 µg/ kg dosegel
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
pr povprečno največjo koncentracijo 10, 6 ng/ ml (standardni odklon 5, 9) v povprečno 91 urah (standardni odklon 19, 7).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
za odmerjanjem v teku 12 tednov (odmerjanje vsak teden ali na dva tedna) se farmakokinetični parametri niso spremenili.
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Ko se je bližalo stanje dinamičnega ravnovesja, je prišlo do pričakovanega zmernega (< 2- kratnega) povečanja koncentracije v serumu, ni pa bilo med ponavljajočo uporabo nobenega
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.
nj kemoterapije, ki so v kombinaciji s kemoterapijo dobivali 6, 75 µg/ kg darbepoetina alfa subkutano na 3 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 lje terminalni razpolovni čas 74 ur (standardni odklon 27 ur). vo 5. 3 Predklinični podatki o varnosti
5.3 Preclinical safety data
V vseh študijah pri podganah in psih je Nespo povzročil izrazito zvišanje hemoglobina, hematokrita, do