natgillin/translations-raw huggingface dataset:
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.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
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.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
KOHAS
Placental transfer was minimal.
Hoida laste eest varjatud ja kättesaamatus kohas. m
ed is 6.
TEISED ERIHOIATUSED (VAJADUSEL) on
or 6.1 List of excipients
KÕLBLIKKUSAEG il
th Sodium phosphate monobasic Sodium phosphate dibasic
Kõlblik kuni: im
au Sodium chloride Polysorbate 80
9.
for injections Incompatibilities
Mitte külmutada.
ng
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
11.
2 years. du
Via San Martino 12 I- 20122 Milan Itaalia
6.4 Special precautions for storage ro
378 12.
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
PARTII NUMBER
period of seven days at room temperature (up to 25°C).
Partii nr:
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
RAVIMI VÄLJASTAMISTINGIMUSED
6.5 Nature and contents of container M
ud Retseptiravim.
Package containing one or four pre-filled pens of a 40 µg Nespo solution for injection in 0.4 ml (100 µg/ ml).
en 15.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
pp 16.
See section 4.4.
lõ ba lu gi üü m on il im av R
Not all packs may be marketed.
379 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
264 6.6 Special precautions for disposal
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
The carton contains a package leaflet with the full instructions for use and handling.
1.
Any medicinal product remaining in the pre-filled pen should be disposed of.
ud 2.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
en 3.
Do not shake.
KÕLBLIKKUSAEG
is Any unused product or waste material should be disposed of in accordance with local requirements.
PARTII NUMBER
or th 7.
lõ Lot:
au Dompé Biotec S. p. A.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
MARKETING AUTHORISATION NUMBERS no
MUU gi
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
380 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Date of first authoristion:
1.
8 June 2001 ro
RAVIMPREPARAADI NIMETUS
Date of last renewal:
Nespo 20 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
10.
TOIMEAINE( TE) SISALDUS
Agency (EMEA) http: / /www. emea. europa. eu/ M
ABIAINED
265 1.
Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid,
NAME OF THE MEDICINAL PRODUCT
pp polüsorbaat 80, süstevesi.
Nespo 50 micrograms solution for injection in a pre-filled pen.
RAVIMVORM JA PAKENDI SUURUS
2.
lõ 1 eeltäidetud süstal 4 eeltäidetud süstalt
For excipients, see section 6.1.
5.
ed is 3.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
or Solution for injection (injection) in a pre-filled pen.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
th au 4.
KOHAS
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
TEISED ERIHOIATUSED (VAJADUSEL) on
4.2 Posology and method of administration ct
8.
The pre-filled pen is only for subcutaneous administration.
9.
The instructions for use, handling and disposal are given in section 6.6. ro lp
SÄILITAMISE ERITINGIMUSED av
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Hoida külmkapis.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
Mitte külmutada.
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
10.
Nespo in
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
11.
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
Dompé Biotec S. p. A.
below the desired haemoglobin level may be observed.
MÜÜGILOA NUMBER( NUMBRID)
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.
EU/ 1/ 01/ 184/ 005 1 süstal pakis EU/ 1/ 01/ 184/ 006 4 süstalt pakis
If it occurs, appropriate dose adjustment should be made as provided.
13.
Guidance is given separately for adult and paediatric patients.
Partii nr:
266 Adult patients with chronic renal failure
RAVIMI VÄLJASTAMISTINGIMUSED
Correction Phase
Retseptiravim.
The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
en 15.
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.
KASUTUSJUHEND
Dose increases must not be made more frequently than once every four weeks.
pp 16.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be
382 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
ed considered.
1.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
RAVIMPREPARAADI NIMETUS
Thereafter the
ud 2.
er In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
KÕLBLIKKUSAEG
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
pp EXP:
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
PARTII NUMBER
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
Lot:
approximately 25%, depending on the rate of increase.
5.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
MUU ba lu i. v. / s. c.
If the haemoglobin continues to increase, the lp
0, 5 ml gi üü m on il im av R
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
383 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
1.
M
ud 2.
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 haemoglobin at the desired level.
KÕLBLIKKUSAEG
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.
pp EXP:
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.
4.
Because of
PARTII NUMBER
267 individual variability, titration to optimal therapeutic doses is expected for individual patients.
lõ Lot:
Paediatric patients with chronic renal failure
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Correction Phase
0, 5 ml lu 6.
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.
MUU gi
Dose increases must not be made more frequently than once every four weeks.
384 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
th the dose should be reduced by approximately 25%.
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
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.
RAVIMPREPARAADI NIMETUS
er The haemoglobin should be measured every one or two weeks until it is stable.
Nespo 20 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
Maintenance Phase
TOIMEAINE( TE) SISALDUS
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
Iga 0, 5 ml eeltäidetud süstal sisaldab 20 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml)
administered as a single injection once weekly or once every two weeks.
en 3.
Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose du
ABIAINED
equivalent to twice the previous once weekly dose.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
RAVIMVORM JA PAKENDI SUURUS
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that a
1 eeltäidetud süstal
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
5.
The initial ic
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
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.
KOHAS
optimal therapeutic doses is expected for individual patients.
Hoida laste eest varjatud ja kättesaamatus kohas. m
should be used.
TEISED ERIHOIATUSED (VAJADUSEL) on
Dosing should be titrated as necessary to maintain the haemoglobin target.
8.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
9.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
SÄILITAMISE ERITINGIMUSED av
268 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.
Mitte külmutada.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
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
MÜÜGILOA HOIDJA NIMI JA AADRESS
ed haemoglobin at the desired level.
Dompé Biotec S. p. A.
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
MÜÜGILOA NUMBER( NUMBRID)
th (7.5 mmol/ l).
EU/ 1/ 01/ 184/ 035
au Due to intra-patient variability, occasional individual haemoglobin values for a patient above and
PARTII NUMBER
er below the desired haemoglobin level may be observed.
Partii nr:
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
14.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
ud Retseptiravim.
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
en 15.
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.
lõ ba lu gi üü m on il im av R
Appropriate dose titration between lp
Dompé Biotec S. p. A. üü m on il im av R
should be reduced by approximately 25 to 50%.
MÜÜGILOA HOIDJA NIMI JA AADRESS
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Via San Martino 12 I- 20122 Milan Itaalia
Therapy should be reinitiated at ic
MÜÜGILOA NUMBER( NUMBRID)
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
lõ 15.
or below.
ud 2.
M
MÜÜGILOA HOIDJA NIMI
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%.
en Dompé
Poorly controlled hypertension.
PARTII NUMBER
269 4.4 Special warnings and precautions for use
Lot:
General
5.
Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy.
KÕLBLIKKUSAEG
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).
pp EXP:
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.
4.
Deficiencies of
Dompé Biotec S. p. A. üü m on il im av R
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
391 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
is may also compromise the erythropoietic response.
RAVIMPREPARAADI NIMETUS
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
ud 2.
If the bone marrow is consistent with
TOIMEAINE( TE) SISALDUS
th PRCA, testing for anti-erythropoietin antibodies should be performed.
Iga 0, 3 ml eeltäidetud süstal sisaldab 30 mikrogrammi darbepoetiin alfat (100 mikrogrammi/ ml)
au Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
en 3.
This has been
ABIAINED
er predominantly reported in patients with CRF treated subcutaneously.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
Since the liver is thought to be the principal route of no
lõ 4.
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
Hoida laste eest varjatud ja kättesaamatus kohas. m
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
MÜÜGILOA NUMBER( NUMBRID)
This du
EU/ 1/ 01/ 184/ 036
may be associated with life-threatening complications of the cardiovascular system. ro
Partii nr:
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
lõ ba lu gi üü m on il im av R
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
upper limit of the target haemoglobin concentration recommended in section 4.2.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
In clinical studies, an in
pp 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
KOHAS
Controlled clinical trials have not shown significant benefits attributable to the administration of M
TEISED ERIHOIATUSED (VAJADUSEL) on
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
8.
Convulsions have been reported in patients receiving Nespo.
Kõlblik kuni: im
Chronic renal failure patients
9.
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.
Mitte külmutada.
Serum potassium levels should be monitored regularly during Nespo therapy.
10.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Cancer patients
MÜÜGILOA HOIDJA NIMI JA AADRESS
ed Effect on tumour growth
Dompé Biotec S. p. A.
Erythropoietin
395 12.
As with all growth factors,
EU/ 1/ 01/ 184/ 009 1 süstal pakis EU/ 1/ 01/ 184/ 010 4 süstalt pakis
or there is a concern that epoetins could stimulate the growth of tumours.
13.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
PARTII NUMBER
th in patients with anaemia associated with cancer.
Partii nr:
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
ud 14.
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
KASUTUSJUHEND
• 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
pp 16.
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.
EELTÄIDETUD SÜSTLA BLISTERÜMBRIS
The decision to administer recombinant lp
1.
Factors that should be considered a
Nespo 40 µg süstelahus Darbepoetiin alfa
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
ud 2.
order to minimise the potential risk of thromboembolic events.
KÕLBLIKKUSAEG
4.5 Interaction with other medicinal products and other forms of interaction
pp EXP:
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
lõ 4.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
PARTII NUMBER
For Nespo no clinical data on exposed pregnancies are available.
MUU ba lu i. v. / s. c.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
0, 4 ml gi üü m on il im av R
Caution should be exercised when prescribing to pregnant women.
397 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
ed 4.7 Effects on ability to drive and use machines
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
There have been no observed effects with Nespo on the ability to drive and use machines.
Nespo 40 µg Darbepoetin alfa i. v. / s. c.
is or 4.8 Undesirable effects
ud 2.
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
KÕLBLIKKUSAEG
Clinical Trial Experience er ng Chronic renal failure patients lo
pp EXP:
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
4.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
lõ Lot:
This was seen more frequently than with r-HuEPO.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
MUU gi
studies are: a
Dompé Biotec S. p. A. üü m on il im av R
MedDRA system organ class in
398 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Very Common (≥ 1/ 10)
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
Hypertension
1.
Rash/ Erythema
TOIMEAINE( TE) SISALDUS
Vascular disorders M
Iga 0, 4 ml eeltäidetud süstal sisaldab 40 mikrogrammi darbepoetiin alfat (100 mikrogrammi/ ml)
Uncommon (≥ 1/ 1,000 to < 1/ 100)
en 3.
Common (≥ 1/ 100 to < 1/ 10)
RAVIMVORM JA PAKENDI SUURUS
Injection site pain
1 eeltäidetud süstal
Cancer patients
5.
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.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
272 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
KOHAS
Adverse Drug Reaction Rash/ Erythema
TEISED ERIHOIATUSED (VAJADUSEL) on
Vascular disorders
8.
General Disorders and Administration Site Conditions
SÄILITAMISE ERITINGIMUSED av
Very Common (≥ 1/ 10)
Hoida külmkapis.
Oedema
Mitte külmutada.
Common (≥ 1/ 100 to < 1/ 10)
10.
Injection site pain
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
ed Postmarketing Experience
MÜÜGILOA HOIDJA NIMI JA AADRESS
is The following adverse reactions have been identified during postmarketing use of Nespo:
Dompé Biotec S. p. A.
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
399 12.
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).
EU/ 1/ 01/ 184/ 037
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
13.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
14.
If clinically indicated, phlebotomy may be performed. ro lp
ud Retseptiravim.
5.
en 15.
PHARMACOLOGICAL PROPERTIES a
KASUTUSJUHEND
5.1 Pharmacodynamic properties in
pp 16.
Anti-anaemic ATC Code:
400 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
The production of erythropoietin primarily occurs in and is regulated by the M
1.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Nespo 40 µg süstelahus Darbepoetiin alfa i. v. / s. c.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
ud 2.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
MANUSTAMISVIIS
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
en 3.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
pp EXP:
Cancer patients receiving chemotherapy
4.
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
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
is randomised, double-blind, multinational study.
0, 4 ml lu 6.
or non-myeloid malignancies receiving multi-cycle chemotherapy.
MUU gi
In both groups, the dose was
Dompé Biotec S. p. A. üü m on il im av R
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
401 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
au in a 14-day period.
1.