natgillin/translations-raw huggingface dataset:
4.9 Overdose no
Kui eeltäidetud pensüstel on külmkapist välja võetud ja soojenenud toatemperatuurini (kuni 25°C), tuleb see 7 päeva jooksul ära kasutada või hävitada. av
The therapeutic margin of Nespo is very wide.
6. 5 Pakendi iseloomustus ja sisu R
Even at very high serum levels, no symptoms of overdose have been observed. ct du
Pakendis on üks või neli eeltäidetud pensüstelit, mis sisaldavad 130 µg Nespo süstelahust 0, 65 ml- s (200 µg/ ml).
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
Ärge raputage.
If clinically indicated, phlebotomy may be performed. ro lp
Kasutamata ravim või jäätmematerjal tuleb hävitada vastavalt kohalikele seadustele.
5.
EU/ 1/ 01/ 184/ 073 4- ne pakk m
PHARMACOLOGICAL PROPERTIES a
9.
Pharmacotherapeutic group:
TEKSTI LÄBIVAATAMISE KUUPÄEV il im
Anti-anaemic ATC Code:
Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel av
B03XA02. ic ed
http: // www. emea. europa. eu / R
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.
RAVIMPREPARAADI NIMETUS
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
2.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
ud Abiainete täielik loetelu vt lõik 6. 1.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
RAVIMVORM
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
pp Süstelahus (injektsioon) eeltäidetud pensüstelis (Sureclick).
249 in vivo activity.
KLIINILISED ANDMED
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
4. 2 Annustamine ja manustamisviis
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).
Juhised kasutamiseks, käsitsemiseks ja hävitamiseks on on
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.
esitatud lõigus 6. 6.
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
Nespo’ t peab manustama subkutaanselt või intravenoosselt, et hemoglobiin tõuseks kuni tasemeni 12 g/ dl av
This study was conducted in 705 anaemic patients with
Säilitusravi faas
or non-myeloid malignancies receiving multi-cycle chemotherapy.
Kui hemoglobiini hoidmiseks soovitud tasemel on vaja annust kohandada, on soovitatav muuta annust on
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
ligikaudu 25% võrra.
In both groups, the dose was
Kui hemoglobiin ületab 12 g/ dl (7, 5 mmol/ l), peab kaaluma il
In the once every three weeks group, 72% of patients required dose reductions.
R
In the once weekly group, 75% of patients required dose reductions.
Individuaalse varieeruvuse tõttu tuleb igal patsiendil tiitrida optimaalne raviannus. r- HuEPO av
This study supports 500 μ g once
R
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
Vajadusel peab annust tiitrima, et säilitada soovitud hemoglobiini sihtväärtust.
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
Kui hemoglobiin tõuseb üle 13 g/ dl (8, 1 mmol/ l), peab manustamise ajutiselt katkestama.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Ülitundlikkus darbepoetiin alfa, r- HuEPO või ravimi ükskõik millise abiaine suhtes.
Survival and tumour progression have been examined in five large controlled studies involving a total ro
Kroonilise neerupuudulikkusega patsientidel säilitatav hemoglobiini tase ei tohi ületada lõigus 4. 2 im
Two of the studies recruited patients who were being treated with chemotherapy.
Kontrollitud kliinilistes uuringutes ei ole täheldatud märkimisväärset kasu seoses epoetiinide R
The lp
Nespo’ ga ravitavatel patsientidel on täheldatud krampe.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Kroonilise neerupuudulikkusega patsiendid
with recombinant human erythropoietin and controls.
Kui kaaliumitsisaldus on tõusnud või tõusmas, tuleb kaaluda Nespo manustamise katkestamist kuni sisladuse korrigeerimiseni.
In the four placebo-controlled studies the hazard in
ud Kasvajaga patsiendid
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
lühendasid üldise elulemuse kestust ja suurendasid haiguse progressiooniga seotud suremust 4. kuul kemoteraapiat saanud metastaatilise rinnanäärme vähiga patsientidel, manustatuna üü
associated with various common cancers who received recombinant human erythropoietin compared ed
saavutamaks hemoglobiini sihtväärtust üle 12... 14 g/ dl (7, 5... 8, 7 mmol/ l)
to controls.
(vt lõik 5. 1).
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
4. 5 Koostoimed teiste ravimitega ja muud koostoimed
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Seni saadud kliinilised tulemused ei näita Nespo koostoimet muude ainetega.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Kui darbepoetiin alfat kasutatakse samaaegselt mõne sellise ravimiga, tuleb jälgida nende ravimite kontsentratsiooni veres ja hemoglobiini tõustes annust muuta.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
331 4. 6 Rasedus ja imetamine
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Ravi määramisel rasedatele naistele tuleb olla ettevaatlik.
5.2 Pharmacokinetic properties
en Nespo toimet autojuhtimise ja masinate käsitsemise võimele ei ole täheldatud.
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.
4. 8 Kõrvaltoimed
Chronic renal failure patients
Kogemus kliinilistest uuringutest
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Kroonilise neerupuudulikkusega patsiendid lu Kontrollitud uuringute andmed hõlmasid 1357 patsienti, kellest 766 raviti Nespo’ ga ja 591 r- HuEPO - gi
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
ga.
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg
kahjustused im
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
Vaskulaarsed häired
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was
Sage (≥1/ 100 kuni < 1/ 10)
th 73 hours (SD 24).
Kliinilistesse uuringutesse kaasati soliidtuumoriga (nt kopsu -, rinnanäärme -, jämesoole -, munasarjavähk) ja pahaloomulise lümfoidse kasvajaga (nt lümfoom, hulgimüeloom) patsiendid.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
332 Nespo’ ga seotud kõrvaltoimete sagedus kontrollitud kliinilistes uuringutes on järgmine:
In clinical studies, minimal
MedDRA organsüsteemi klassid
au accumulation was observed with either route of administration.
Esinemissagedus uuringupatsientidel
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
Naha ja nahaaluskoe kahjustused
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
Lööve/ erüteem
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.
Üldised häired ja manustamiskoha reaktsioonid
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
Väga sage (≥1/ 10)
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
Ödeem
Following intravenous administration, an approximate 25% difference between du
Sage (≥1/ 100 kuni < 1/ 10)
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
Süstekoha valulikkus
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
ud Turustamisjärgne kogemus
Half-life was also similar between adult and paediatric patients with lp
en Nespo turustamisjärgse kogemuse käigus on täheldatud järgnevaid kõrvaltoimeid:
CRF following both intravenous and subcutaneous administration. a
lõ • Allergilised reaktsioonid, sealhulgas anafülaktiline reaktsioon, angioödeem, nahalööve ja sügelus.
Cancer patients receiving chemotherapy in
• Krambid. ba lu 4. 9 Üleannustamine gi
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
Nespo terapeutiline vahemik on väga lai.
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
Isegi väga kõrge seerumikontsentratsiooni korral ei ole üleannustamissümptomeid täheldatud. üü
(SD 19.7).
FARMAKOLOOGILISED OMADUSED on
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).
5. 1 Farmakodünaamilised omadused il
Pharmacokinetic parameters did not M
B03XA02. im
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
hapnikuvarustuses.
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Mõlemas rühmas vähendati esialgset annust 40% võrra, kui hemoglobiin tõusis 14 päeva vältel rohkem kui 1 g/ dl (näit. esimese annuse vähendamine annuseni 300 µg üks kord iga kolme nädala järel
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.
Üks kord nädalas nädalas rühmas vajasid 75% patsientidest annuse vähendamist.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
On ebaselge, mil määral võib neid tulemusi üle kanda kasvajaga patsientidele, kelle ravimisel inimese rekombinantse erütropoetiiniga on hemoglobiini sihtväärtus alla 13 g/ dl, sest selliste parameetritega patsiente oli analüüsitud andmetes vähe.
5.3 Preclinical safety data
Intrvenoosse manustamise järgselt täheldati ligikaudu 25% üü
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.
en 6.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
2 aastat. m
251 effect (decreased tissue perfusion due to increased blood viscosity).
6. 5 Pakendi iseloomustus ja sisu R
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.
Pakendis on üks või neli eeltäidetud pensüstelit, mis sisaldavad 150 µg Nespo süstelahust 0, 3 ml- s (500 µg/ ml).
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.
Süstida tohib ainult
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Ärge raputage.
Placental transfer was minimal.
en Vahetage süstekohti, et vältida ebamugavustunnet süstekohal.
PHARMACEUTICAL PARTICULARS
pp 7.
th Sodium phosphate monobasic Sodium phosphate dibasic
EU/ 1/ 01/ 184/ 066 4- ne pakk m
au Sodium chloride Polysorbate 80
http: // www. emea. europa. eu / R
er Water 6.2
RAVIMPREPARAADI NIMETUS
for injections Incompatibilities
Nespo 300 mikrogrammi süstelahus eeltäidetud pensüstelis.
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
ud Abiainete täielik loetelu vt lõik 6. 1.
6.3 Shelf life ct
RAVIMVORM
2 years. du
pp Süstelahus (injektsioon) eeltäidetud pensüstelis (SureClick).
Store in a refrigerator (2°C – 8°C) Do not freeze. lp
lõ 4.
Keep the container in the outer carton, in order to protect from light. a
Ravi Nespo’ ga peab alustama eelpool nimetatud näidustuste osas kogenud arst. m
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
Säilitusravi faas
period of seven days at room temperature (up to 25°C).
Kui hemoglobiini tõus on ebapiisav (alla 1 g/ dl (0, 6 mmol/ l) nelja nädala jooksul), suurendage annust
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
Individuaalse varieeruvuse tõttu tuleb igal patsiendil tiitrida optimaalne raviannus. r- HuEPO av
6.5 Nature and contents of container M
hemoglobiin) ei ole adekvaatne pärast 9- nädalast ravi, võib edasine ravi olla ebaefektiivne. üü
Package containing one or four pre-filled pens of a 30 µg Nespo solution for injection in 0.3 ml (100 µg/ ml).
staadium, aneemia raskusaste, oodatav eluiga, keskkond, milles patsienti ravitakse ja patsiendi eelistus im
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
ud 4. 7 Toime reaktsioonikiirusele
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
en Nespo toimet autojuhtimise ja masinate käsitsemise võimele ei ole täheldatud.
Not all packs may be marketed.
pp Üldised
252 6.6 Special precautions for disposal
kahjustused im
The carton contains a package leaflet with the full instructions for use and handling.
Aeg- ajalt (≥1/ 1000 kuni < 1/ 100)
Do not administer more than one dose per pen.
Üldised häired ja
Any medicinal product remaining in the pre-filled pen should be disposed of.
Sage (≥1/ 100 kuni < 1/ 10)
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Ravimi kõrvaltoime
Do not shake.
Naha ja nahaaluskoe kahjustused
Allow the pre- filled pen to reach room temperature before injecting.
Sage (≥1/ 100 kuni < 1/ 10)
ed Rotate the injection sites to avoid discomfort at the site of injection.
Vaskulaarsed häired
is Any unused product or waste material should be disposed of in accordance with local requirements.
Sage (≥1/ 100 kuni < 1/ 10)
or th 7.
Trombemboolilised tüsistused, selahulgas kopsuemboolia
MARKETING AUTHORISATION HOLDER
Üldised häired ja manustamiskoha reaktsioonid
Via San Martino 12
Väga sage (≥1/ 10)
er I-20122 Milan Italy ng lo 8.
Ödeem
MARKETING AUTHORISATION NUMBERS no
Sage (≥1/ 100 kuni < 1/ 10)
EU/ 1/ 01/ 184/ 048 1 pack EU/ 1/ 01/ 184/ 060 4 pack ct
ud Turustamisjärgne kogemus
9.
en Nespo turustamisjärgse kogemuse käigus on täheldatud järgnevaid kõrvaltoimeid:
Date of first authoristion:
• Puhas punavere aplaasia.
8 June 2001 ro
lõ • Allergilised reaktsioonid, sealhulgas anafülaktiline reaktsioon, angioödeem, nahalööve ja sügelus.
Date of last renewal:
• Krambid. ba lu 4. 9 Üleannustamine gi
DATE OF REVISION OF THE TEXT a in ic
5. 1 Farmakodünaamilised omadused il
Detailed information on this medicinal product is available on the website of the European Medicines ed
Teostati ka süstemaatiline ülevaade, mis hõlmas üle 9000 kasvajaga patsienti 57 kliinilisest uuringust. av
253 1.
On ebaselge, mil määral võib neid tulemusi üle kanda kasvajaga patsientidele, kelle ravimisel inimese rekombinantse erütropoetiiniga on hemoglobiini sihtväärtus alla 13 g/ dl, sest selliste parameetritega patsiente oli analüüsitud andmetes vähe.
NAME OF THE MEDICINAL PRODUCT
346 5. 2 Farmakokineetilised omadused
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darbepoetiin alfa subkutaansel
Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ ml).
Subkutaanse manustamise järgselt oli AUC( 0- ∞) KNP- ga täiskasvanud ja pediaatrilistel patsientidel m
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
sarnane.
For excipients, see section 6.1.
Keemiaravi saavad kasvajaga patsiendid
PHARMACEUTICAL FORM
Pärast 2, 25 µg/ kg subkutaanset manustamist kasvajaga täiskasvanud patsientidele saavutati darbepoetiin alfa keskmine maksimaalne kontsentratsioon 10, 6 ng/ ml (SD 5, 9) keskmiselt 91 tunniga il
or Solution for injection (injection) in a pre-filled pen.
(SD 19, 7).
th au 4.
Nimetatud uuringus oli lõplik poolväärtusaeg keskmiselt 74 (SD 27) tundi.
CLINICAL PARTICULARS
5. 3 Prekliinilised ohutusandmed
4.1 Therapeutic indications
ud rasedusele, loote arengule, sünnitusele ega sünnijärgsele arengule.
er Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and ng paediatric patients. lo Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. no
FARMATSEUTILISED ANDMED
4.2 Posology and method of administration ct
pp 6. 1 Abiainete loetelu
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. du
ravimitega. üü
The pre-filled pen is only for subcutaneous administration.
2 aastat. m
The instructions for use, handling and disposal are given in section 6.6. ro lp
6. 4 Säilitamise eritingimused on
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Mitte külmutada.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
Kui eeltäidetud pensüstel on külmkapist välja võetud ja soojenenud toatemperatuurini (kuni 25°C), tuleb see 7 päeva jooksul ära kasutada või hävitada. av
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
Pakendis on üks või neli eeltäidetud pensüstelit, mis sisaldavad 300 µg Nespo süstelahust 0, 6 ml- s (500 µg/ ml).
Nespo in
Vt lõik 4. 4.
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
Pensüstelisse jäänud ravimijäägid tuleb hävitada.
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
Ärge raputage.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
pp 7.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
MÜÜGILOA HOIDJA
If it occurs, appropriate dose adjustment should be made as provided.
lõ Dompé Biotec S. p. A.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
9.
Guidance is given separately for adult and paediatric patients.
ESIMESE MÜÜGILOA VÄLJASTAMISE/ MÜÜGILOA UUENDAMISE KUUPÄEV
Treatment of paediatric patients younger than 1 year of age has not been studied:
8. juuni 2001 on
254 Adult patients with chronic renal failure
19. mai 2006
Correction Phase
10.
The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel av
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
http: // www. emea. europa. eu / R
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
349 1.
Dose increases must not be made more frequently than once every four weeks.
RAVIMPREPARAADI NIMETUS
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
Nespo 500 mikrogrammi süstelahus eeltäidetud pensüstelis.
ed considered.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at
Iga eeltäidetud pensüstel sisaldab 500 mikrogrammi darbepoetiin alfat (darbepoetin alfa) 1 ml- s (500 µg/ ml).
is approximately 25% lower than the previous dose.
en 3.
Thereafter the
pp Süstelahus (injektsioon) eeltäidetud pensüstelis (SureClick).
au Maintenance Phase
lõ 4.
er In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
Ravi Nespo’ ga peab alustama eelpool nimetatud näidustuste osas kogenud arst. m
Dialysis patients converting from once weekly to once every other week dosing ng with Nespo should initially receive a dose equivalent to twice the previous once weekly dose.
Nespo on saadaval kasutusvalmis eeltäidetud pensüstelis (SureClick).
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
Säilitusravi faas
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
ligikaudu 25% võrra.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%. du
pärast annuse vähendamist hemoglobiin ikka tõuseb, peab manustamise ajutiselt katkestama kuni hemoglobiin hakkab langema, misjärel taasalustatakse ravi ligikaudu 25% võrra eelnevast väiksema annusega. av
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
Kliinilised uuringud on näidanud, et pediaatrilised patsiendid vanuses 1... 18 aastat, kes saavad r- HuEPO- t kaks või kolm korda nädalas, võivad minna üle Nespo manustamisele üks kord nädalas, ja il
approximately 25%, depending on the rate of increase.
Individuaalse varieeruvuse tõttu tuleb igal patsiendil tiitrida optimaalne raviannus. r- HuEPO av
If the haemoglobin continues to increase, the lp
Säilitusravi faasis ei tohi annust muuta sagedamini kui iga kahe nädala järel.
dose should be reduced by approximately 25%.
Ravile halvasti alluv hüpertensioon.