natgillin/translations-raw huggingface dataset:
In the once every three weeks group, 72% of patients required dose reductions.
RAVIMPREPARAADI NIMETUS
This study supports 500 μ g once
Nespo 50 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
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
ud 2.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
en 3.
Two of the studies recruited patients who were being treated with chemotherapy.
lõ 4.
The lp
RAVIMVORM JA PAKENDI SUURUS
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
1 eeltäidetud süstal 4 eeltäidetud süstalt 5.
with recombinant human erythropoietin and controls.
MANUSTAMISVIIS JA - TEE
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
ba
associated with various common cancers who received recombinant human erythropoietin compared ed
lu Intravenoosne või subkutaanne gi
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
Enne ravimi kasutamist lugege pakendi infolehte üü
erythropoietin and those in the control group.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS m
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Hoida laste eest varjatud ja kättesaamatus kohas.
0.99, 1.18; 42 trials and 8167 patients).
7.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
8.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
KÕLBLIKKUSAEG il im
5.2 Pharmacokinetic properties
SÄILITAMISE ERITINGIMUSED av
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.
Hoida külmkapis.
Chronic renal failure patients
R
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
10.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
MÜÜGILOA HOIDJA NIMI JA AADRESS
or Bioavailability is 37% with subcutaneous administration.
Dompé Biotec S. p. A.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was
Via San Martino 12 I- 20122 Milan Itaalia
th 73 hours (SD 24).
12.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
MÜÜGILOA NUMBER( NUMBRID)
au accumulation was observed with either route of administration.
ud EU/ 1/ 01/ 184/ 012 4 süstalt pakis
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.
13.
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.
RAVIMI VÄLJASTAMISTINGIMUSED
Following intravenous administration, an approximate 25% difference between du
lõ 15.
pediatricpatients.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Half-life was also similar between adult and paediatric patients with lp
403 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
CRF following both intravenous and subcutaneous administration. a
1.
(SD 19.7).
MÜÜGILOA HOIDJA NIMI
Pharmacokinetic parameters did not M
en Dompé
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
3.
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
KÕLBLIKKUSAEG
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
pp EXP:
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.
PARTII NUMBER
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.
5.
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
0, 5 ml gi üü m on il im av R
Placental transfer was minimal.
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
ed is 6.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
th Sodium phosphate monobasic Sodium phosphate dibasic
MANUSTAMISVIIS
au Sodium chloride Polysorbate 80
en 3.
lo
PARTII NUMBER
ng
lõ Lot:
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
6.4 Special precautions for storage ro
MUU gi
Store in a refrigerator (2°C – 8°C) Do not freeze. lp
Dompé Biotec S. p. A. üü m on il im av R
Keep the container in the outer carton, in order to protect from light. a
405 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Package containing one or four pre-filled pens of a 50 µg Nespo solution for injection in 0.5 ml (100 µg/ ml).
RAVIMPREPARAADI NIMETUS
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
Nespo 50 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
See section 4.4.
ud 2.
The carton contains a package leaflet with the full instructions for use and handling.
ABIAINED
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
Nespo is a sterile but unpreserved product.
lõ 4.
Do not administer more than one dose per pen.
RAVIMVORM JA PAKENDI SUURUS
Any medicinal product remaining in the pre-filled pen should be disposed of.
1 eeltäidetud süstal
Before administration the Nespo solution should be inspected for visible particles.
5.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
Allow the pre- filled pen to reach room temperature before injecting.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
ed Rotate the injection sites to avoid discomfort at the site of injection.
KOHAS
MARKETING AUTHORISATION HOLDER
7.
Via San Martino 12
8.
MARKETING AUTHORISATION NUMBERS no
Kõlblik kuni: im
EU/ 1/ 01/ 184/ 050 1 pack EU/ 1/ 01/ 184/ 062 4 pack ct
9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
Hoida külmkapis.
Date of first authoristion:
Mitte külmutada.
Date of last renewal:
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
19 May 2006 lp
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
10.
MÜÜGILOA HOIDJA NIMI JA AADRESS
Detailed information on this medicinal product is available on the website of the European Medicines ed
Via San Martino 12 I- 20122 Milan Itaalia
Agency (EMEA) http: / /www. emea. europa. eu/ M
406 12.
NAME OF THE MEDICINAL PRODUCT
EU/ 1/ 01/ 184/ 038
Nespo 60 micrograms solution for injection in a pre-filled pen.
13.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Partii nr:
Each pre-filled pen contains 60 micrograms of darbepoetin alfa in 0.3 ml (200 µg/ ml).
14.
ed is 3.
KASUTUSJUHEND
or Solution for injection (injection) in a pre-filled pen.
lõ ba lu gi üü m on il im av R
th au 4.
407 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
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
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
4.2 Posology and method of administration ct
Nespo 50 µg süstelahus Darbepoetin alfa i. v. / s. c.
Nespo (SureClick) is supplied ready for use in a pre-filled pen.
ud 2.
The pre-filled pen is only for subcutaneous administration.
MANUSTAMISVIIS
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
KÕLBLIKKUSAEG
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
pp EXP:
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
4.
Nespo in
PARTII NUMBER
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
lõ Lot:
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and M
0, 5 ml lu 6.
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).
MUU gi
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Dompé Biotec S. p. A. üü m on il im av R
Treatment with Nespo is divided into two stages – correction and maintenance phase.
BLISTERÜMBRISES EELTÄIDETUD SÜSTALDE KARP
Guidance is given separately for adult and paediatric patients.
1.
Treatment of paediatric patients younger than 1 year of age has not been studied:
RAVIMPREPARAADI NIMETUS
278 Adult patients with chronic renal failure
Nespo 60 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
Correction Phase
ud 2.
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.
Iga 0, 3 ml eeltäidetud süstal sisaldab 60 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml)
Dose increases must not be made more frequently than once every four weeks.
en 3.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
ed considered.
lõ 4.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
RAVIMVORM JA PAKENDI SUURUS
or The haemoglobin should be measured every one or two weeks until it is stable.
MANUSTAMISVIIS JA - TEE
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
Enne ravimi kasutamist lugege pakendi infolehte üü
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS 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%. du
Hoida laste eest varjatud ja kättesaamatus kohas.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
7.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
8.
If the haemoglobin continues to increase, the lp
KÕLBLIKKUSAEG il im
dose should be reduced by approximately 25%.
Kõlblik kuni:
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
SÄILITAMISE ERITINGIMUSED av
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
Hoida külmkapis.
provide adequate control of the symptoms of anaemia. ed
R
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
10.
M
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
409 11.
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.
Via San Martino 12 I- 20122 Milan Itaalia
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.
12.
Because of
MÜÜGILOA NUMBER( NUMBRID)
279 individual variability, titration to optimal therapeutic doses is expected for individual patients.
EU/ 1/ 01/ 184/ 013 1 süstal pakis
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.
ud EU/ 1/ 01/ 184/ 014 4 süstalt pakis
Paediatric patients with chronic renal failure
PARTII NUMBER
Correction Phase
en Partii nr:
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.
pp 14.
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.
RAVIMI VÄLJASTAMISTINGIMUSED
Dose increases must not be made more frequently than once every four weeks.
lõ 15.
or approximately 25%, depending on the rate of increase.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
If the haemoglobin continues to increase,
410 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
th the dose should be reduced by approximately 25%.
1.
If after a dose reduction, haemoglobin continues
RAVIMPREPARAADI NIMETUS
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.
Nespo 60 µg süstelahus Darbepoetiin alfa
Maintenance Phase
MÜÜGILOA HOIDJA NIMI
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
en Dompé
administered as a single injection once weekly or once every two weeks.
3.
Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose du
KÕLBLIKKUSAEG
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Nespo may be administered ro
pp EXP:
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
lõ 4.
those receiving r-HuEPO once weekly may be converted to once every other week Nespo.
MUU ba lu i. v. / s. c.
The initial ic
0, 3 ml gi üü m on il im av R
Because of individual variability, titration to ed
411 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
optimal therapeutic doses is expected for individual patients.
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
should be used.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Dosing should be titrated as necessary to maintain the haemoglobin target.
Nespo 60 µg Darbepoetin alfa i. v. / s. c.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
ud 2.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
en 3.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
KÕLBLIKKUSAEG
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.
PARTII NUMBER
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
lõ Lot:
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
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
ed haemoglobin at the desired level.
0, 3 ml lu 6.
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
MUU gi
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.
412 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
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.
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
RAVIMPREPARAADI NIMETUS
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Nespo 60 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
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.
ud 2.
Appropriate dose titration between lp
TOIMEAINE( TE) SISALDUS
500 μ g, 300 μ g, and 150 μ g should be considered. a
Iga 0, 3 ml eeltäidetud süstal sisaldab 60 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml)
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
en 3.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
RAVIMVORM JA PAKENDI SUURUS
or below.
1 eeltäidetud süstal
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%.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
4.3 Contraindications
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
KOHAS
General
TEISED ERIHOIATUSED (VAJADUSEL) on
Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy.
8.
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).
KÕLBLIKKUSAEG il
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.
Kõlblik kuni: im
Non-response to therapy with Nespo should prompt a search for causative factors.
9.
Deficiencies of
SÄILITAMISE ERITINGIMUSED av
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
Hoida külmkapis.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis
Mitte külmutada.
or the evaluation.
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
11.
If the bone marrow is consistent with
MÜÜGILOA HOIDJA NIMI JA AADRESS
th PRCA, testing for anti-erythropoietin antibodies should be performed.
Dompé Biotec S. p. A.
This has been
413 12.
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.
EU/ 1/ 01/ 184/ 039
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
PARTII NUMBER
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
Partii nr:
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
14.
This du
RAVIMI VÄLJASTAMISTINGIMUSED
may be associated with life-threatening complications of the cardiovascular system. ro
ud Retseptiravim.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
en 15.
upper limit of the target haemoglobin concentration recommended in section 4.2.
lõ ba lu gi üü m on il im av R
Controlled clinical trials have not shown significant benefits attributable to the administration of M
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Nespo 60 µg süstelahus Darbepoetin alfa i. v. / s. c.
Chronic renal failure patients
MANUSTAMISVIIS
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
en 3.
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.
pp EXP:
Serum potassium levels should be monitored regularly during Nespo therapy.
4.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
PARTII NUMBER
ed Effect on tumour growth
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Epoetins are growth factors that primarily stimulate red blood cell production.
0, 3 ml lu 6.
is receptors may be expressed on the surface of a variety of tumour cells.
MUU gi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
415 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
th in patients with anaemia associated with cancer.
1.
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
TOIMEAINE( TE) SISALDUS
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
ud Iga 0, 4 ml eeltäidetud süstal sisaldab 80 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml)
• 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
en 3.
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.
pp polüsorbaat 80, süstevesi.
The decision to administer recombinant lp
4.
Factors that should be considered a
lõ 1 eeltäidetud süstal 4 eeltäidetud süstalt
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
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
Platelet counts and haemoglobin level should also be monitored at regular intervals.
6.