natgillin/translations-raw huggingface dataset:
or Solution for injection (injection) in a pre-filled pen.
Nespo 10 µg süstelahus Darbepoetin alfa s. c.
4.1 Therapeutic indications
MANUSTAMISVIIS
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
en 3.
Nespo (SureClick) is supplied ready for use in a pre-filled pen.
PARTII NUMBER
The instructions for use, handling and disposal are given in section 6.6. ro lp
lõ Lot:
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Nespo in
MUU gi
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
472 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and M
1.
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).
Nespo 15 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
ud 2.
If it occurs, appropriate dose adjustment should be made as provided.
TOIMEAINE( TE) SISALDUS
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Iga 0, 375 ml eeltäidetud pensüstel sisaldab 15 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml).
Treatment of paediatric patients younger than 1 year of age has not been studied:
en 3.
The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
RAVIMVORM JA PAKENDI SUURUS
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be
5.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Enne ravimi kasutamist lugege pakendi infolehte. m
is approximately 25% lower than the previous dose.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS on
or The haemoglobin should be measured every one or two weeks until it is stable.
Hoida laste eest varjatud ja kättesaamatus kohas.
th haemoglobin can be measured at longer intervals.
TEISED ERIHOIATUSED (VAJADUSEL) il im
au Maintenance Phase
8.
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
Kõlblik kuni:
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
9.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
Mitte külmutada.
approximately 25%, depending on the rate of increase.
10.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
dose should be reduced by approximately 25%.
MÜÜGILOA HOIDJA NIMI JA AADRESS
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
Via San Martino 12 I- 20122 Milan Itaalia
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
12.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
ud EU/ 1/ 01/ 184/ 058 4- ne pakk
M
13.
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.
RAVIMI VÄLJASTAMISTINGIMUSED
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.
Retseptiravim.
315 individual variability, titration to optimal therapeutic doses is expected for individual patients.
KASUTUSJUHEND
Paediatric patients with chronic renal failure
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Correction Phase
474 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
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.
1.
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.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
is If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by
ud 2.
If the haemoglobin continues to increase,
KÕLBLIKKUSAEG
th the dose should be reduced by approximately 25%.
pp EXP:
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.
PARTII NUMBER
er The haemoglobin should be measured every one or two weeks until it is stable.
lõ Lot:
Maintenance Phase
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
0, 375 ml lu 6.
Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose du
MUU gi
equivalent to twice the previous once weekly dose.
Dompé Biotec S. p. A. üü m on il im av R
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
EELTÄIDETUD PENSÜSTELI KARP
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that a
RAVIMPREPARAADI NIMETUS
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
Nespo 20 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
those receiving r-HuEPO once weekly may be converted to once every other week Nespo.
ud 2.
The initial ic
TOIMEAINE( TE) SISALDUS
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.
en Iga 0, 5 ml eeltäidetud pensüstel sisaldab 20 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml).
optimal therapeutic doses is expected for individual patients.
ABIAINED
Dosing should be titrated as necessary to maintain the haemoglobin target.
RAVIMVORM JA PAKENDI SUURUS
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
SureClick x1
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.
1 ühekordselt kasutatav eeltäidetud pensüstel See pakend, milles on 1 eeltäidetud pensüstel, on osa 4 pakendiga hulgipakist lu SureClick x4 4 ühekordselt kasutatavat eeltäidetud pensüstelit gi
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
5.
If after a dose reduction, haemoglobin continues to
MANUSTAMISVIIS JA - TEE üü
316 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.
Enne ravimi kasutamist lugege pakendi infolehte. m
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.
6.
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Hoida laste eest varjatud ja kättesaamatus kohas. il
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
7.
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
KÕLBLIKKUSAEG av
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
Kõlblik kuni:
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.
9.
er below the desired haemoglobin level may be observed.
Mitte külmutada.
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
10.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
476 11.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Via San Martino 12 I- 20122 Milan Itaalia
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.
12.
Appropriate dose titration between lp
MÜÜGILOA NUMBER( NUMBRID)
500 μ g, 300 μ g, and 150 μ g should be considered. a
EU/ 1/ 01/ 184/ 047 1- ne pakk
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
13.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
en Partii nr:
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
RAVIMI VÄLJASTAMISTINGIMUSED
or below.
Retseptiravim.
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%.
KASUTUSJUHEND
4.3 Contraindications
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Poorly controlled hypertension.
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
317 4.4 Special warnings and precautions for use
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
General
Nespo 20 µg süstelahus Darbepoetin alfa s. c.
th PRCA, testing for anti-erythropoietin antibodies should be performed.
0, 5 ml lu 6.
Since the liver is thought to be the principal route of no
478 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
1.
This du
ud 2.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
ABIAINED
upper limit of the target haemoglobin concentration recommended in section 4.2.
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
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
RAVIMVORM JA PAKENDI SUURUS
Controlled clinical trials have not shown significant benefits attributable to the administration of M
SureClick x1 ba 1 ühekordselt kasutatav eeltäidetud pensüstel See pakend, milles on 1 eeltäidetud pensüstel, on osa 4 pakendiga hulgipakist SureClick x4 lu 4 ühekordselt kasutatavat eeltäidetud pensüstelit gi
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
5.
Convulsions have been reported in patients receiving Nespo.
Enne ravimi kasutamist lugege pakendi infolehte. m
Chronic renal failure patients
6.
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.
7.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
8.
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
KÕLBLIKKUSAEG av
Cancer patients
Kõlblik kuni:
Epoetins are growth factors that primarily stimulate red blood cell production.
SÄILITAMISE ERITINGIMUSED R
is receptors may be expressed on the surface of a variety of tumour cells.
Mitte külmutada.
or there is a concern that epoetins could stimulate the growth of tumours.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
th in patients with anaemia associated with cancer.
MÜÜGILOA HOIDJA NIMI JA AADRESS
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
Dompé Biotec S. p. A.
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
MÜÜGILOA NUMBER( NUMBRID)
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
EU/ 1/ 01/ 184/ 048 1- ne pakk
• 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
13.
The decision to administer recombinant lp
pp 14.
Factors that should be considered a
Retseptiravim.
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- in
lõ 15.
5.1). ed
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
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
480 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
order to minimise the potential risk of thromboembolic events.
1.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
4.5 Interaction with other medicinal products and other forms of interaction
Nespo 30 µg süstelahus Darbepoetin alfa s. c.
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.
ud 2.
For Nespo no clinical data on exposed pregnancies are available.
KÕLBLIKKUSAEG
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
pp EXP:
Caution should be exercised when prescribing to pregnant women.
4.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
lõ Lot:
ed 4.7 Effects on ability to drive and use machines
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
th General
MUU gi
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
Dompé Biotec S. p. A. üü m on il im av R
Clinical Trial Experience er ng Chronic renal failure patients lo
481 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
1.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
Nespo 40 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
ud 2.
This was seen more frequently than with r-HuEPO.
TOIMEAINE( TE) SISALDUS
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
ABIAINED
studies are: a
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
MedDRA system organ class in
lõ 4.
Very Common (≥ 1/ 10)
MANUSTAMISVIIS JA - TEE üü
Hypertension
Enne ravimi kasutamist lugege pakendi infolehte. m
Skin and Subcutaneous Tissue Disorders ed
6.
Vascular disorders M
TEISED ERIHOIATUSED (VAJADUSEL) il im
Uncommon (≥ 1/ 1,000 to < 1/ 100)
8.
General Disorders and Administration Site Conditions
Kõlblik kuni:
Common (≥ 1/ 100 to < 1/ 10)
9.
Cancer patients
Mitte külmutada.
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).
10.
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.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
320 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
482 11.
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
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Adverse Drug Reaction Rash/ Erythema
12.
Common (≥ 1/ 100 to < 1/ 10)
ud EU/ 1/ 01/ 184/ 061 4- ne pakk
Thromboembolic events, including pulmonary embolism
PARTII NUMBER
General Disorders and Administration Site Conditions
en Partii nr:
Very Common (≥ 1/ 10)
pp 14.
Injection site pain
KASUTUSJUHEND
ed Postmarketing Experience
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
or th • Pure Red Cell Aplasia.
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
1.
In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Nespo 40 µg süstelahus Darbepoetin alfa s. c.
4.9 Overdose no
ud 2.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
en 3.
If clinically indicated, phlebotomy may be performed. ro lp
pp EXP:
PHARMACOLOGICAL PROPERTIES a
PARTII NUMBER
5.1 Pharmacodynamic properties in
lõ Lot:
Anti-anaemic ATC Code:
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
The production of erythropoietin primarily occurs in and is regulated by the M
MUU gi
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Dompé Biotec S. p. A. üü m on il im av R
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
484 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
1.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
RAVIMPREPARAADI NIMETUS
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Nespo 50 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
321 in vivo activity.
ud 2.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
TOIMEAINE( TE) SISALDUS
Cancer patients receiving chemotherapy
Iga 0, 5 ml eeltäidetud pensüstel sisaldab 50 mikrogrammi darbepoetiin alfat (100 mikrogrammi/ ml).
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).
en 3.
is randomised, double-blind, multinational study.
RAVIMVORM JA PAKENDI SUURUS
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
SureClick x1 ba 1 ühekordselt kasutatav eeltäidetud pensüstel See pakend, milles on 1 eeltäidetud pensüstel, on osa 4 pakendiga hulgipakist SureClick x4 lu 4 ühekordselt kasutatavat eeltäidetud pensüstelit gi
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
MANUSTAMISVIIS JA - TEE üü
au in a 14-day period.
Enne ravimi kasutamist lugege pakendi infolehte. m
In the once weekly group, 75% of patients required dose reductions.
6.
This study supports 500 μ g once
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS on
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
Hoida laste eest varjatud ja kättesaamatus kohas. il
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
7.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
8.
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
R
The lp
9.
In the open-label study there was no difference in overall survival between patients treated a
Hoida külmkapis.
In the four placebo-controlled studies the hazard in
10.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
485 11.
to controls.
Via San Martino 12 I- 20122 Milan Itaalia
erythropoietin and those in the control group.
MÜÜGILOA NUMBER( NUMBRID)
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
EU/ 1/ 01/ 184/ 050 1- ne pakk
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
ud EU/ 1/ 01/ 184/ 062 4- ne pakk
0.99, 1.18; 42 trials and 8167 patients).
13.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
en Partii nr:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
pp 14.
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.
KASUTUSJUHEND
Chronic renal failure patients
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
486 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
or Bioavailability is 37% with subcutaneous administration.
Nespo 50 µg süstelahus Darbepoetin alfa s. c.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
ud 2.
In clinical studies, minimal
MANUSTAMISVIIS
au accumulation was observed with either route of administration.
en 3.
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.
KÕLBLIKKUSAEG
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
pp EXP:
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
4.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
lõ Lot: