natgillin/translations-raw huggingface dataset:
Following intravenous administration, an approximate 25% difference between du
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0- ∞) observed for the ro
0, 5 ml lu 6.
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
MUU gi
Cancer patients receiving chemotherapy in
EELTÄIDETUD PENSÜSTELI KARP
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
RAVIMPREPARAADI NIMETUS
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
Nespo 60 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
(SD 19.7).
ud 2.
These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/ kg weekly and 3 to 9 µg/ kg every two weeks).
TOIMEAINE( TE) SISALDUS
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
en 3.
A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 µg/ kg darbepoetin alfa administered SC every 3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of the terminal half-life.
ABIAINED
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.
RAVIMVORM JA PAKENDI SUURUS
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.
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
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.
5.
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
MANUSTAMISVIIS JA - TEE üü
Placental transfer was minimal.
6.
No alteration of fertility was detected.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS on
ed is 6.
Hoida laste eest varjatud ja kättesaamatus kohas.
or 6.1 List of excipients
TEISED ERIHOIATUSED (VAJADUSEL) il im
th Sodium phosphate monobasic Sodium phosphate dibasic
8.
er Water 6.2
Kõlblik kuni:
for injections Incompatibilities
9.
ng
Mitte külmutada.
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
10.
2 years. du
MÜÜGILOA HOIDJA NIMI JA AADRESS
6.4 Special precautions for storage ro
Dompé Biotec S. p. A.
Keep the container in the outer carton, in order to protect from light. a
MÜÜGILOA NUMBER( NUMBRID)
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
EU/ 1/ 01/ 184/ 051 1- ne pakk
period of seven days at room temperature (up to 25°C).
13.
Once a pre-filled pen has been removed from ic
PARTII NUMBER
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
en Partii nr:
6.5 Nature and contents of container M
pp 14.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
lõ 15.
See section 4.4.
KASUTUSJUHEND
Not all packs may be marketed.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
The carton contains a package leaflet with the full instructions for use and handling.
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Nespo is a sterile but unpreserved product.
Nespo 60 µg süstelahus Darbepoetin alfa s. c.
Before administration the Nespo solution should be inspected for visible particles.
MANUSTAMISVIIS
Do not shake.
en 3.
Allow the pre- filled pen to reach room temperature before injecting.
KÕLBLIKKUSAEG
ed Rotate the injection sites to avoid discomfort at the site of injection.
pp EXP:
is Any unused product or waste material should be disposed of in accordance with local requirements.
4.
MARKETING AUTHORISATION HOLDER
lõ Lot:
Via San Martino 12
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
er I-20122 Milan Italy ng lo 8.
0, 3 ml lu 6.
EU/ 1/ 01/ 184/ 072 1 pack EU/ 1/ 01/ 184/ 073 4 pack ct
MUU gi
9.
Dompé Biotec S. p. A. üü m on il im av R
Date of first authoristion:
EELTÄIDETUD PENSÜSTELI KARP
8 June 2001 ro
1.
19 May 2006 lp
Nespo 80 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
10.
ud 2.
DATE OF REVISION OF THE TEXT a in ic
TOIMEAINE( TE) SISALDUS
Detailed information on this medicinal product is available on the website of the European Medicines ed
Iga 0, 4 ml eeltäidetud pensüstel sisaldab 80 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml).
Agency (EMEA) http: / /www. emea. europa. eu/ M
en 3.
NAME OF THE MEDICINAL PRODUCT
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
Nespo 150 micrograms solution for injection in a pre-filled pen.
lõ 4.
Each pre-filled pen contains 150 micrograms of darbepoetin alfa in 0.3 ml (500 µg/ ml).
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
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
5.
PHARMACEUTICAL FORM
6.
CLINICAL PARTICULARS
7.
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
KÕLBLIKKUSAEG av
4.2 Posology and method of administration ct
Kõlblik kuni:
Nespo (SureClick) is supplied ready for use in a pre-filled pen.
SÄILITAMISE ERITINGIMUSED R
The instructions for use, handling and disposal are given in section 6.6. ro lp
Hoida külmkapis.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
491 11.
Nespo in
MÜÜGILOA HOIDJA NIMI JA AADRESS
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
Dompé Biotec S. p. A.
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
12.
below the desired haemoglobin level may be observed.
ud EU/ 1/ 01/ 184/ 064 4- ne pakk
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).
13.
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.
PARTII NUMBER
If it occurs, appropriate dose adjustment should be made as provided.
en Partii nr:
Treatment with Nespo is divided into two stages – correction and maintenance phase.
pp 14.
Guidance is given separately for adult and paediatric patients.
RAVIMI VÄLJASTAMISTINGIMUSED
Correction Phase
KASUTUSJUHEND
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.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Dose increases must not be made more frequently than once every four weeks.
492 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
1.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
ed considered.
Nespo 80 µg süstelahus Darbepoetin alfa s. c.
is approximately 25% lower than the previous dose.
ud 2.
Thereafter the
en 3.
er In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
PARTII NUMBER
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
lõ Lot:
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
approximately 25%, depending on the rate of increase.
MUU gi
If the haemoglobin continues to increase, the lp
Dompé Biotec S. p. A. üü m on il im av R
dose should be reduced by approximately 25%.
493 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
EELTÄIDETUD PENSÜSTELI KARP
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
RAVIMPREPARAADI NIMETUS
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
Nespo 100 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
provide adequate control of the symptoms of anaemia. ed
ud 2.
M
Iga 0, 5 ml eeltäidetud pensüstel sisaldab 100 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml).
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
en 3.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
lõ 4.
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.
RAVIMVORM JA PAKENDI SUURUS
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.
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
Paediatric patients with chronic renal failure
5.
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.
6.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks)
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS on
ed increase the dose by approximately 25%.
Hoida laste eest varjatud ja kättesaamatus kohas.
is If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by
TEISED ERIHOIATUSED (VAJADUSEL) il im
or approximately 25%, depending on the rate of increase.
8.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
KÕLBLIKKUSAEG av
th the dose should be reduced by approximately 25%.
Kõlblik kuni:
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.
SÄILITAMISE ERITINGIMUSED R
er The haemoglobin should be measured every one or two weeks until it is stable.
Hoida külmkapis.
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
Mitte külmutada.
Maintenance Phase
10.
administered as a single injection once weekly or once every two weeks.
MÜÜGILOA HOIDJA NIMI JA AADRESS
equivalent to twice the previous once weekly dose.
Via San Martino 12 I- 20122 Milan Itaalia
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
MÜÜGILOA NUMBER( NUMBRID)
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that a
EU/ 1/ 01/ 184/ 053 1- ne pakk
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
13.
The initial ic
en Partii nr:
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.
pp 14.
Because of individual variability, titration to ed
RAVIMI VÄLJASTAMISTINGIMUSED
optimal therapeutic doses is expected for individual patients.
Retseptiravim.
should be used.
KASUTUSJUHEND
Dosing should be titrated as necessary to maintain the haemoglobin target.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
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.
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
1.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
MANUSTAMISVIIS
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
KÕLBLIKKUSAEG
ed haemoglobin at the desired level.
pp EXP:
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
4.
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.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
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
MUU 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.
Dompé Biotec S. p. A. üü m on il im av R
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
EELTÄIDETUD PENSÜSTELI KARP
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
RAVIMPREPARAADI NIMETUS
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.
Nespo 130 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
500 μ g, 300 μ g, and 150 μ g should be considered. a
TOIMEAINE( TE) SISALDUS
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
Iga 0, 65 ml eeltäidetud pensüstel sisaldab 130 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml).
should be reduced by approximately 25 to 50%.
en 3.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
ABIAINED
or below.
RAVIMVORM JA PAKENDI SUURUS
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
MANUSTAMISVIIS JA - TEE üü
Poorly controlled hypertension.
Enne ravimi kasutamist lugege pakendi infolehte. m
329 4.4 Special warnings and precautions for use
6.
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).
7.
Non-response to therapy with Nespo should prompt a search for causative factors.
KÕLBLIKKUSAEG av
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
Kõlblik kuni:
is may also compromise the erythropoietic response.
SÄILITAMISE ERITINGIMUSED R
or the evaluation.
Mitte külmutada.
If the bone marrow is consistent with
10.
au Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
MÜÜGILOA HOIDJA NIMI JA AADRESS
er predominantly reported in patients with CRF treated subcutaneously.
Via San Martino 12 I- 20122 Milan Itaalia
Since the liver is thought to be the principal route of no
12.
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
ud EU/ 1/ 01/ 184/ 073 4- ne pakk
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
PARTII NUMBER
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
RAVIMI VÄLJASTAMISTINGIMUSED
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
Retseptiravim.
upper limit of the target haemoglobin concentration recommended in section 4.2.
lõ 15.
In clinical studies, an in
KASUTUSJUHEND
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
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Controlled clinical trials have not shown significant benefits attributable to the administration of M
EELTÄIDETUD PENSÜSTELI MÄRGISTUS
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Nespo should be used with caution in patients with epilepsy.
Nespo 130 µg süstelahus Darbepoetin alfa 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%.
MANUSTAMISVIIS
330 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
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.
KÕLBLIKKUSAEG
Serum potassium levels should be monitored regularly during Nespo therapy.
pp EXP:
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
4.
Epoetins are growth factors that primarily stimulate red blood cell production.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
As with all growth factors,
MUU gi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
Dompé Biotec S. p. A. üü m on il im av R
th in patients with anaemia associated with cancer.
499 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
1.
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
TOIMEAINE( TE) SISALDUS
• 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
Iga 0, 3 ml eeltäidetud pensüstel sisaldab 150 mikrogrammi darbepoetiin alfat (500 mikrogrammi/ ml).
therapy. ESAs are not indicated for use in this patient population. ro
en 3.
The decision to administer recombinant lp
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
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.
lõ 4.
Factors that should be considered a
RAVIMVORM JA PAKENDI SUURUS
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
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
5.1). ed
5.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
7.
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.
TEISED ERIHOIATUSED (VAJADUSEL) il im
331 4.6 Pregnancy and lactation
8.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Kõlblik kuni:
Caution should be exercised when prescribing to pregnant women.
9.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Hoida külmkapis.
There have been no observed effects with Nespo on the ability to drive and use machines.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
is or 4.8 Undesirable effects
500 11.
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
Via San Martino 12 I- 20122 Milan Itaalia
Clinical Trial Experience er ng Chronic renal failure patients lo
12.
patients who received r-HuEPO.
ud EU/ 1/ 01/ 184/ 066 4- ne pakk
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
13.
This was seen more frequently than with r-HuEPO.
en Partii nr:
discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ro
RAVIMI VÄLJASTAMISTINGIMUSED
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
Retseptiravim.
studies are: a
lõ 15.
Subject Incidence
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Adverse Drug Reaction
501 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Cardiac Disorders ic
1.
Common (≥ 1/ 100 to < 1/ 10)
MANUSTAMISVIIS
Rash/ Erythema
en 3.
Thromboembolic Events
PARTII NUMBER
General Disorders and Administration Site Conditions
lõ Lot:
Common (≥ 1/ 100 to < 1/ 10)
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
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).
MUU gi
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
EELTÄIDETUD PENSÜSTELI KARP
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
RAVIMPREPARAADI NIMETUS
Adverse Drug Reaction Rash/ Erythema
Nespo 300 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
Vascular disorders
ud 2.
General Disorders and Administration Site Conditions
ABIAINED
Very Common (≥ 1/ 10)
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
Oedema
lõ 4.
is The following adverse reactions have been identified during postmarketing use of Nespo:
MANUSTAMISVIIS JA - TEE üü
or th • Pure Red Cell Aplasia.
Enne ravimi kasutamist lugege pakendi infolehte. m
au patients with CRF treated subcutaneously.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS on
4.9 Overdose no
TEISED ERIHOIATUSED (VAJADUSEL) il im
The therapeutic margin of Nespo is very wide.
8.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
KÕLBLIKKUSAEG av
If clinically indicated, phlebotomy may be performed. ro lp
Kõlblik kuni:
PHARMACOLOGICAL PROPERTIES a
SÄILITAMISE ERITINGIMUSED R
5.1 Pharmacodynamic properties in
Hoida külmkapis.
Anti-anaemic ATC Code:
10.