natgillin/translations-raw huggingface dataset:
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
Nimetatud hinnangu tegemisel peab arvestama järgnevate faktoritega: kasvaja tüüp ja il
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
Kui ravi Nespo’ ga on tingimata näidustatud, peab naine imetamise lõpetama.
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
en Nespo toimet autojuhtimise ja masinate käsitsemise võimele ei ole täheldatud.
provide adequate control of the symptoms of anaemia. ed
4. 8 Kõrvaltoimed
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Kogemus kliinilistest uuringutest
M
ba
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
ga.
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.
Üldised häired ja
The initial every other week dose of Nespo (μ g/ every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.
Sage (≥1/ 100 kuni < 1/ 10)
Because of
manustamiskoha reaktsioonid R
255 individual variability, titration to optimal therapeutic doses is expected for individual patients.
356 Nespo’ ga seotud kõrvaltoimete sagedus kontrollitud kliinilistes uuringutes on järgmine:
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
MedDRA organsüsteemi klassid
Paediatric patients with chronic renal failure
Esinemissagedus uuringupatsientidel
Correction Phase
Ravimi kõrvaltoime
For patients ≥ 11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
Sage (≥1/ 100 kuni < 1/ 10)
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.
Lööve/ erüteem
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks)
Sage (≥1/ 100 kuni < 1/ 10)
ed increase the dose by approximately 25%.
Väga sage (≥1/ 10)
is If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by
Sage (≥1/ 100 kuni < 1/ 10)
or approximately 25%, depending on the rate of increase.
Süstekoha valulikkus
If the haemoglobin continues to increase,
ud Turustamisjärgne kogemus
th the dose should be reduced by approximately 25%.
en Nespo turustamisjärgse kogemuse käigus on täheldatud järgnevaid kõrvaltoimeid:
If after a dose reduction, haemoglobin continues
Üksikjuhtudel on ennekõike KNP- ga patsientidel, kes saavad ravi
au to 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.
• Krambid. ba lu 4. 9 Üleannustamine gi
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
Nespo terapeutiline vahemik on väga lai.
Maintenance Phase
Isegi väga kõrge seerumikontsentratsiooni korral ei ole üleannustamissümptomeid täheldatud. üü
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
FARMAKOLOOGILISED OMADUSED on
administered as a single injection once weekly or once every two weeks.
B03XA02. im
Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose du
Erütropoetiini toodetakse eelkõige neerudes ja reguleeritakse vastavalt muutustele koe av
equivalent to twice the previous once weekly dose.
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
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Nespo may be administered ro
Üks kord nädalas nädalas rühmas vajasid 75% patsientidest annuse vähendamist.
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
358 5. 2 Farmakokineetilised omadused
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that a
Muutust viljakuses ei täheldatud.
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
2 aastat. m
those receiving r-HuEPO once weekly may be converted to once every other week Nespo.
6. 5 Pakendi iseloomustus ja sisu R
The initial ic
Pakendis on üks või neli eeltäidetud pensüstelit, mis sisaldavad 500 µg Nespo süstelahust 1 ml- s (500 µg/ ml).
weekly or once every other week pediatric dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.
Ärge raputage.
Because of individual variability, titration to ed
Kasutamata ravim või jäätmematerjal tuleb hävitada vastavalt kohalikele seadustele.
optimal therapeutic doses is expected for individual patients.
EU/ 1/ 01/ 184/ 068 4- ne pakk m
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration M
9.
should be used.
MÜÜGILOA TINGIMUSED üü m
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
pp B.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
● MUUD TINGIMUSED m
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
365 R av im il on m üü
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
PAKENDI MÄRGISTUS ba lõ pp en ud VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
If after a dose reduction, haemoglobin continues to
BLISTERÜMBRISES EELTÄIDETUD SÜSTALDE KARP
256 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.
RAVIMPREPARAADI NIMETUS
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to provide adequate control of the symptoms of anaemia.
Nespo 10 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
2.
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
TOIMEAINE( TE) SISALDUS
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the
ud Iga 0, 4 ml eeltäidetud süstal sisaldab 10 mikrogrammi darbepoetiin alfat (25 mikrogrammi/ ml)
ed haemoglobin at the desired level.
en 3.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
4.
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).
5.
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
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
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.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Hoida laste eest varjatud ja kättesaamatus kohas. m
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.
7.
Appropriate dose titration between lp
TEISED ERIHOIATUSED (VAJADUSEL) on
500 μ g, 300 μ g, and 150 μ g should be considered. a
8.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
9.
Therapy should be reinitiated at ic
SÄILITAMISE ERITINGIMUSED av
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
Hoida külmkapis.
or below.
Mitte külmutada.
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%.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
4.3 Contraindications
11.
Poorly controlled hypertension.
Via San Martino 12 I- 20122 Milan Itaalia
257 4.4 Special warnings and precautions for use
367 12.
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).
13.
Deficiencies of
ud 14.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis
Retseptiravim.
is may also compromise the erythropoietic response.
en 15.
A reticulocyte count should be considered as part of
KASUTUSJUHEND
or the evaluation.
pp 16.
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
lõ ba lu gi üü m on il im av R
th PRCA, testing for anti-erythropoietin antibodies should be performed.
EELTÄIDETUD SÜSTLA BLISTERÜMBRIS
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.
Nespo 10 µg süstelahus Darbepoetiin alfa
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
MÜÜGILOA HOIDJA NIMI
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
en Dompé
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
3.
This du
KÕLBLIKKUSAEG
may be associated with life-threatening complications of the cardiovascular system. ro
pp EXP:
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
PARTII NUMBER
upper limit of the target haemoglobin concentration recommended in section 4.2.
Lot:
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
MUU ba lu i. v. / s. c.
than 12 g/ dl (7.5 mmol/ l). ed
0, 4 ml gi üü m on il im av R
Controlled clinical trials have not shown significant benefits attributable to the administration of M
369 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
Nespo should be used with caution in patients with epilepsy.
1.
Convulsions have been reported in patients receiving Nespo.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Chronic renal failure patients
Nespo 10 µg Darbepoetin alfa i. v. / s. c.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
ud 2.
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.
en 3.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
pp EXP:
Cancer patients
PARTII NUMBER
ed Effect on tumour growth
lõ Lot:
Erythropoietin
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
is receptors may be expressed on the surface of a variety of tumour cells.
0, 4 ml lu 6.
or there is a concern that epoetins could stimulate the growth of tumours.
MUU gi
therapy. ESAs are not indicated for use in this patient population. ro
RAVIMPREPARAADI NIMETUS
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.
Nespo 10 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
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.
TOIMEAINE( TE) SISALDUS
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
ABIAINED
5.1). ed
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
order to minimise the potential risk of thromboembolic events.
lõ 4.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
RAVIMVORM JA PAKENDI SUURUS
4.5 Interaction with other medicinal products and other forms of interaction
1 eeltäidetud süstal
259 4.6 Pregnancy and lactation
5.
For Nespo no clinical data on exposed pregnancies are available.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
6.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Hoida laste eest varjatud ja kättesaamatus kohas. m
ed 4.7 Effects on ability to drive and use machines
7.
is or 4.8 Undesirable effects
KÕLBLIKKUSAEG il
th General
Kõlblik kuni: im
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
9.
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
Mitte külmutada.
patients who received r-HuEPO.
10.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
The injection site du
11.
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
Via San Martino 12 I- 20122 Milan Itaalia
studies are: a
371 12.
Adverse Drug Reaction
PARTII NUMBER
Cardiac Disorders ic
Partii nr:
Very Common (≥ 1/ 10)
14.
Common (≥ 1/ 100 to < 1/ 10)
KASUTUSJUHEND
Rash/ Erythema
pp 16.
Vascular disorders M
lõ ba lu gi üü m on il im av R
Uncommon (≥ 1/ 1,000 to < 1/ 100)
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
Thromboembolic Events
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Common (≥ 1/ 100 to < 1/ 10)
Nespo 10 µg süstelahus Darbepoetiin alfa i. v. / s. c.
Injection site pain
ud 2.
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
KÕLBLIKKUSAEG
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
PARTII NUMBER
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
lõ Lot:
Adverse Drug Reaction Rash/ Erythema
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Thromboembolic events, including pulmonary embolism
MUU gi
General Disorders and Administration Site Conditions
Dompé Biotec S. p. A. üü m on il im av R
Very Common (≥ 1/ 10)
373 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Oedema
1.
ed Postmarketing Experience
TOIMEAINE( TE) SISALDUS
is The following adverse reactions have been identified during postmarketing use of Nespo:
Iga 0, 375 ml eeltäidetud süstal sisaldab 15 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml)
or th • Pure Red Cell Aplasia.
en 3.
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
ABIAINED
au patients with CRF treated subcutaneously.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
RAVIMVORM JA PAKENDI SUURUS
4.9 Overdose no
1 eeltäidetud süstal 4 eeltäidetud süstalt 5.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
MANUSTAMISVIIS JA - TEE
PHARMACOLOGICAL PROPERTIES a
lu Intravenoosne või subkutaanne gi
5.1 Pharmacodynamic properties in
Enne ravimi kasutamist lugege pakendi infolehte üü
Anti-anaemic ATC Code:
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS m
The production of erythropoietin primarily occurs in and is regulated by the M
7.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
8.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
KÕLBLIKKUSAEG il im
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
9.
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
SÄILITAMISE ERITINGIMUSED av
261 in vivo activity.
Mitte külmutada.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
R
Cancer patients receiving chemotherapy
10.
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.
MÜÜGILOA HOIDJA NIMI JA AADRESS
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
Dompé Biotec S. p. A.
This study was conducted in 705 anaemic patients with
12.
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
EU/ 1/ 01/ 184/ 003 1 süstal pakis
In both groups, the dose was
ud EU/ 1/ 01/ 184/ 004 4 süstalt pakis
th reduced by 40% of the previous dose (e. g., for first dose reduction, to 300 μ g in the once every three weeks group and 1.35 μ g / kg in the once weekly group) if haemoglobin increased by more than 1 g/ dl
PARTII NUMBER
au in a 14-day period.
en Partii nr:
In the once weekly group, 75% of patients required dose reductions.
pp 14.
This study supports 500 μ g once
RAVIMI VÄLJASTAMISTINGIMUSED
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
Retseptiravim.
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
lõ 15.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
EELTÄIDETUD SÜSTLA BLISTERÜMBRIS
Two of the studies recruited patients who were being treated with chemotherapy.
1.
The lp
RAVIMPREPARAADI NIMETUS
In the four placebo-controlled studies the hazard in
ud 2.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
en Dompé
associated with various common cancers who received recombinant human erythropoietin compared ed
3.
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
pp EXP:
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
PARTII NUMBER
0.99, 1.18; 42 trials and 8167 patients).
Lot:
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
5.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
MUU ba lu i. v. / s. c.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
0, 375 ml gi üü m on il im av R
262 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
376 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
5.2 Pharmacokinetic properties
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
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.
1.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
ud 2.
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg
MANUSTAMISVIIS
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
en 3.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was
pp EXP:
th 73 hours (SD 24).
lõ 4.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
PARTII NUMBER
In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI lu 0, 375 ml gi
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
MUU üü
Following intravenous administration, an approximate 25% difference between du
377 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
CRF following both intravenous and subcutaneous administration. a
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
Cancer patients receiving chemotherapy in
1.
(SD 19.7).
TOIMEAINE( TE) SISALDUS
Pharmacokinetic parameters did not M
Iga 0, 375 ml eeltäidetud süstal sisaldab 15 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml)
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
en 3.
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
ABIAINED
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
5.3 Preclinical safety data
lõ 4.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
1 eeltäidetud süstal
263 effect (decreased tissue perfusion due to increased blood viscosity).
5.