natgillin/translations-raw huggingface dataset:
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
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.
Following intravenous administration, an approximate 25% difference between du
Po intravenski uporabi so med pediatričnimi in
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
et 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
pediatricpatients.
m pediatričnih bolnikih.
Half-life was also similar between adult and paediatric patients with lp
Tudi razpolovni čas je bil pri odraslih in pediatričnih bolnikih s
CRF following both intravenous and subcutaneous administration. a
o kronično boleznijo ledvic podoben, tako po intravenski kot po subkutani uporabi.
Cancer patients receiving chemotherapy in
pr Onkološki bolniki, ki dobivajo kemoterapijo
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
za 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).
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
Ti parametri se skladajo s farmakokinetiko, linearno povezano z odmerkom, v širokem
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).
a odmernem območju (od 0, 5 do 8 µg/ kg na teden in od 3 do 9 µg/ kg na dva tedna).
Pharmacokinetic parameters did not M
Med večkratnim
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
nj 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 lje (< 2- kratnega) povečanja koncentracije v serumu, ni pa bilo med ponavljajočo uporabo nobenega 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 vo 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 terminalni razpolovni čas 74 ur (standardni odklon 27 ur). do
5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti ā
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, ve
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
števila rdečih krvnih celic in retikulocitov, kar ustreza pričakovanim farmakološkim učinkom.
11 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
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.
in brez vpliva na interval QT. ni
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
ali nepričakovanega mitogenega odziva.
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Kancerogenega potenciala darbepoetina alfa niso ocenili v dolgoročnih študijah na živalih. v
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
zadeva brejost, razvoj zarodka in ploda, skotitev ali postnatalni razvoj.
No alteration of fertility was detected.
Zd
or 6.1 List of excipients
6. 1 Seznam pomožnih snovi
au Sodium chloride Polysorbate 80
natrijev hidrogenfosfat natrijev dihidrogenfosfat natrijev klorid polisorbat 80
er Water 6.2
11 voda za injekcije
for injections Incompatibilities
6. 2 Inkompatibilnosti
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
Zaradi pomanjkanja študij kompatibilnosti Nespa ne smete mešati ali aplicirati v infuziji z drugimi zdravili.
6.3 Shelf life ct
6. 3 Rok uporabnosti
2 years. du
2 leti.
6.4 Special precautions for storage ro
et 6. 4 Posebna navodila za shranjevanje
Store in a refrigerator (2°C – 8°C).
m Shranjujte v hladilniku (pri temperaturi med 2ºC in 8ºC).
Do not freeze. lp
o Ne zamrzujte.
Keep the container in the outer carton, in order to protect from light. a
pr Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
Za ambulantno rabo je Nespo mogoče vzeti iz prostora za shranjevanje enkrat za največ eno
period of seven days at room temperature (up to 25°C).
za sedemdnevno obdobje pri sobni temperaturi (do 25ºC).
refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
Ko brizgo vzamete iz hladilnika in doseže sobno temperaturo (do 25ºC), jo morate uporabiti v 7 dneh, sicer jo morate zavreči.
6.5 Nature and contents of container M
a 6. 5 Vrsta ovojnine in vsebina
Package containing one or four pre-filled syringe(s) of a 10 µg Nespo solution for injection in 0.4 ml (25 µg/ ml).
nj Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje lje Nespo z 10 µg v 0, 4 ml (25 µg/ ml). vo Injekcijske brizge so lahko v pakiranju s pretisnimi omoti (pakiranje z 1 oz.
The syringes may be presented in either blistered (1- & 4-pack) or non-blistered packaging (1-pack only).
4) ali brez pretisnih omotov (samo pakiranje z 1). do
See section 4.4.
Glejte poglavje 4. 4. ā
Not all packs may be marketed.
Na trgu ni vseh navedenih pakiranj. ve
12 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje a
Do not administer more than one dose per syringe.
Z eno injekcijsko brizgo ne aplicirajte več kot enega m
Any medicinal product remaining in the pre-filled syringe should be disposed of.
Ostanek zdravila v napolnjeni injekcijski brizgi morate zavreči. ni
Allow the pre- filled syringe to reach room temperature before injecting.
injiciranjem morate napolnjeno injekcijsko brizgo pustiti, da doseže sobno temperaturo.
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection.
občutku na mestu injiciranja. ra
ed Any unused product or waste material should be disposed of in accordance with local requirements.
Zd
th Via San Martino 12 I-20122 Milan
Via San Martino 12 I- 20122 Milan Italija
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 001 1 Pack Blister lo EU/ 1/ 01/ 184/ 002 4 Pack Blister EU/ 1/ 01/ 184/ 033 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 001 – pakiranje po 1 v pretisnem omotu EU/ 1/ 01/ 184/ 002 – pakiranje po 4 v pretisnem omotu EU/ 1/ 01/ 184/ 033 – pakiranje po 1 brez pretisnega omota
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION ct
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Date of first authoristion:
Datum pridobitve dovoljenja za promet:
8 June 2001 du
8. junij 2001
Date of last renewal:
et Datum podaljšanja dovoljenja za promet:
19 May 2006 ro
19. maj 2006
Detailed information on this medicinal product is available on the website of the European Medicines ic
o pr Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
Agency (EMEA) http: / /www. emea. europa. eu/ ed M
za http: // www. emea. europa. eu. /
th haemoglobin can be measured at longer intervals.
Potem lahko hemoglobin kontrolirate v daljših presledkih..
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week lo dosing, Nespo may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. no
Ko je z uporabo Nespa enkrat na teden ali enkrat na dva tedna ciljni hemoglobin dosežen, Nespo je pri bolnikih, ki niso na dializi, druga možnost subkutana uporaba zdravila enkrat na mesec; začetni vo odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival na dva tedna.
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo.
Klinične študije so pokazale, da lahko odrasli bolniki, ki dobivajo r- HuEPO enkrat, dvakrat ali trikrat na teden, preidejo na Nespo enkrat na teden ali enkrat na dva tednaNespo.
15 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.
Paediatric patients with chronic renal failure
15 Pediatrični bolniki s kronično odpovedjo ledvic
Thereafter the haemoglobin can be measured at longer intervals. ng No guidance regarding the correction of haemoglobin is available for paediatric patients 1 to 10 years lo of age. no
Potem lahko hemoglobin kontrolirate v daljših presledkih.
16 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.
ed haemoglobin at the desired level.
Zdravljenje simptomatske anemije pri onkoloških bolnikih
or Nespo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l)) in order to increase haemoglobin to not greater than 12 g/ dl
et Bolniki z anemijo (npr. koncentracijo hemoglobina ≤ 100 g/ l (6, 2 mmol/ l)) morajo Nespo dobiti
th (7.5 mmol/ l).
m subkutano s ciljem, da se hemoglobin zviša na ne več kot 120 g/ l (7, 5 mmol/ l).
au Due to intra-patient variability, occasional individual haemoglobin values for a patient above and
Variabilnosti hemoglobina se je treba
er below the desired haemoglobin level may be observed.
za prilagoditi z uravnavanjem odmerka, pri čemer je treba upoštevati ciljno območje koncentracije hemoglobina od 100 g/ l (6, 2 mmol/ l) do 120 g/ l (7, 5 mmol/ l).
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl ng (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Smernice za prilagoditev odmerka, če
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustments for when haemoglobin lo values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below. no
a hemoglobin preseže 120 g/ l (7, 5 mmol/ l), so navedene spodaj.
The recommended initial dose is 500 μ g (6.75 μ g/ kg) given once every three weeks, or once weekly dosing can be given at 2.25 μ g/ kg body weight.
nj Priporočeni začetni odmerek je 500 µg (6, 75 µg/ kg) enkrat na tri tedne, uporabiti pa je mogoče tudi lje odmerjanje 2, 25 µg/ kg telesne mase enkrat na teden.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
Če bolnikov klinični odziv (utrujenost, odziv hemoglobina) po devetih tednih ni zadosten, nadaljnje zdravljenje morda ne bo učinkovito. vo
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Zdravljenje z Nespom je treba končati približno 4 tedne po koncu kemoterapije. do
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.
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.
Appropriate dose titration between lp
V poštev pride ustrezno titriranje ā
500 μ g, 300 μ g, and 150 μ g should be considered. a
odmerka med 500 µg, 300 µg in 150 µg. ve
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
Bolnike morate natančno kontrolirati.
should be reduced by approximately 25 to 50%.
Če hemoglobin preseže 120 g/ l (7, 5 mmol/ l), morate odmerek zmanjšati za približno 25 do 50%.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Če koncentracija hemoglobina preseže 130 g/ l (8, 1 mmol/ l), morate a
Therapy should be reinitiated at ic
Potem, ko se hemoglobin zniža na 120 g/ l (7, 5 mmol/ l) ali manj, je m
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
treba terapijo znova uvesti z odmerkom, približno 25% manjšim od prejšnjega. ni
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 zmanjšati za 25 do 50%. ilo
4.3 Contraindications
4. 3 Kontraindikacije v
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Preobčutljivost za darbepoetin alfa, r- HuEPO ali katerokoli pomožno snov. ra
Poorly controlled hypertension.
Zd
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).
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
17 Za zagotovitev učinkovite eritropoeze je treba vsem bolnikom pred začetkom zdravljenja in med zdravljenjem kontrolirati stanje železa; potrebna utegne biti terapija z dodatki železa.
Deficiencies of
Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
If the bone marrow is consistent with
Če se izvid kostnega mozga sklada s čisto aplazijo rdečih celic, je potrebno testiranje za antieritropoetinska
th PRCA, testing for anti-erythropoietin antibodies should be performed.
et protitelesa.
au Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
m V povezavi z rekombinantnimi eritropoetičnimi beljakovinami (vključno z darbepoetinom alfa) je opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles.
This has been
O tem so
er predominantly reported in patients with CRF treated subcutaneously.
o poročali predvsem pri bolnikih s kronično odpovedjo ledvic, ki so zdravilo dobivali subkutano.
Since the liver is thought to be the principal route of no
pr 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).
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
za Aktivna bolezen jeter je bila v vseh študijah Nespa merilo za nevključitev, zato o bolnikih z okvarjenim delovanjem jeter ni podatkov.
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
a r- HuEPO, zato morate Nespo pri bolnikih z boleznimi jeter uporabljati previdno.
This du
To je lahko vo povezano s smrtno nevarnimi zapleti na srčno- žilnem sistemu.
may be associated with life-threatening complications of the cardiovascular system. ro
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko do
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
povzroči alergijske reakcije.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
Pri bolnikih s kronično odpovedjo ledvic vzdrževana koncentracija hemoglobina ne sme preseči ā
In clinical studies, an in
V kliničnih študijah so ugotovili večje ve
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 ic
tveganje smrti, resnih srčnožilnih dogodkov in tromboze na žilnem dostopu, kadar so eritropoezo stimulirajoče agense (ESA) uporabljali tako, da je bil ciljni hemoglobin nad 120 g/ l (7, 5 mmol/ l). a
Controlled clinical trials have not shown significant benefits attributable to the administration of M
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi uporabe epoetinov, če m
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
koncentracija hemoglobina preseže raven, potrebno za obvladanje simptomov anemije in preprečitev transfuzij krvi. ni
Convulsions have been reported in patients receiving Nespo.
Pri bolnikih, ki so dobivali Nespo, so ilo
Chronic renal failure patients
Bolniki s kronično odpovedjo ledvic v ra
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
Zd
th in patients with anaemia associated with cancer.
et V kontroliranih kliničnih študijah je uporaba Nespa in drugih eritropoezo stimulirajočih agensov
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
o • skrajšala čas do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu,
• er shortened time to tumour progression in patients with advanced head and neck cancer receiving ng 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. lo
pr zdravljenih z obsevanjem, če je bila ciljna vrednost hemoglobina več kot 140 g/ l (8, 7 mmol/ l).
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
Uporaba ESA v tej populaciji bolnikov ni indicirana.
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l) ct
za • skrajšala celotno preživetje in povečala število smrti, ki jih je bilo mogoče pripisati napredovanju bolezni po 4 mesecih, pri bolnicah z metastatskim rakom dojke, zdravljenih s kemoterapijo, če je bila ciljna vrednost hemoglobina od 120 do 140 g/ l (od 7, 5 do 8, 7 mmol/ l).
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation du
a nj • povečala tveganje smrti pri bolnikih z aktivno maligno boleznijo, ki niso dobivali ne kemoterapije ne obsevanja, če je bila ciljna vrednost hemoglobina 120 g/ l (7, 5 mmol/ l).
therapy. ESAs are not indicated for use in this patient population. ro
ESA v tej populaciji lje bolnikov niso indicirani. vo Glede na zgoraj navedeno, je treba v nekaterih kliničnih primerih anemijo pri bolnikih z rakom prednostno zdraviti s transfuzijo krvi.
The decision to administer recombinant lp
Odločitev za uporabo rekombinantnih eritropoetinov mora do
Factors that should be considered a
temeljiti na oceni koristi in tveganja in mora biti sprejeta v sodelovanju z bolnikom, upoštevaje posameznikove specifične klinične okoliščine.
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
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). ā ve
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in M
V rednih presledkih je treba kontrolirati tudi število a
order to minimise the potential risk of thromboembolic events.
trombocitov in koncentracijo hemoglobina. m
Platelet counts and haemoglobin level should also be monitored at regular intervals.
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij ni
4.5 Interaction with other medicinal products and other forms of interaction
Obstaja pa ilo
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
možnost za interakcije z zdravili, ki so v veliki meri vezana na rdeče krvne celice, npr. s ciklosporinom ali takrolimusom.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
Če darbepoetin alfa dajete sočasno s temi zdravili, je treba njihovo koncentracijo v v
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.
krvi kontrolirati in odmerke prilagajati, ko se koncentracija hemoglobina zvišuje. ra
19 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje Zd
ed 4.7 Effects on ability to drive and use machines
19 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
au 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.
patients who received r-HuEPO.
766 jih je dobivalo Nespo in 591 r- HuEPO.
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
a nj Pogostnosti neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih kliničnih študijah, so: lje Organski sistem po MedDRA
studies are: a
Pogostnost vo
Subject Incidence
Neželeni učinek
Cardiac Disorders ic
Srčne bolezni
Very Common (≥ 1/ 10)
zelo pogosti (≥ 1/ 10)
Skin and Subcutaneous Tissue Disorders ed
Bolezni kože in podkožja
Rash/ Erythema
izpuščaj/ eritem
Vascular disorders M
Žilne bolezni
20 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
Injection site pain
Nelagodje na mestu injiciranja je bilo praviloma blago in prehodno.
is The following adverse reactions have been identified during postmarketing use of Nespo:
20 Med pomarketinško uporabo Nespa so ugotovili naslednje neželene učinke: