natgillin/translations-raw huggingface dataset:
ed increase the dose by approximately 25%.
MÜÜGILOA HOIDJA NIMI JA AADRESS
is If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by
Via San Martino 12 I- 20122 Milan Itaalia
or approximately 25%, depending on the rate of increase.
455 12.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
MÜÜGILOA NUMBER( NUMBRID)
If after a dose reduction, haemoglobin continues
13.
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
14.
administered as a single injection once weekly or once every two weeks.
KASUTUSJUHEND
equivalent to twice the previous once weekly dose.
lõ ba lu gi üü m on il im av R
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
those receiving r-HuEPO once weekly may be converted to once every other week Nespo.
Nespo 500 µg süstelahus Darbepoetin alfa i. v. / s. c.
Because of individual variability, titration to ed
ud 2.
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration M
en 3.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
PARTII NUMBER
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.
lõ Lot:
If after a dose reduction, haemoglobin continues to
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
304 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.
1 ml lu 6.
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.
MUU gi
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Dompé Biotec S. p. A. üü m on il im av R
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
457 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
ed haemoglobin at the desired level.
1.
th (7.5 mmol/ l).
TOIMEAINE( TE) SISALDUS
er below the desired haemoglobin level may be observed.
ABIAINED
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
Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat
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.
4.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
RAVIMVORM JA PAKENDI SUURUS
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
lõ 1 ühekordselt kasutatav viaal 4 ühekordselt kasutatavat viaali
500 μ g, 300 μ g, and 150 μ g should be considered. a
5.
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
should be reduced by approximately 25 to 50%.
6.
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
M
7.
4.3 Contraindications
KÕLBLIKKUSAEG il
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Kõlblik kuni: im
Poorly controlled hypertension.
9.
General
Mitte külmutada.
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).
10.
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.
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Non-response to therapy with Nespo should prompt a search for causative factors.
MÜÜGILOA HOIDJA NIMI JA AADRESS
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
Via San Martino 12 I- 20122 Milan Itaalia
is may also compromise the erythropoietic response.
MÜÜGILOA NUMBER( NUMBRID)
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
13.
If the bone marrow is consistent with
PARTII NUMBER
th PRCA, testing for anti-erythropoietin antibodies should be performed.
Partii nr:
au Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
ud 14.
This has been
RAVIMI VÄLJASTAMISTINGIMUSED
er predominantly reported in patients with CRF treated subcutaneously.
Retseptiravim.
Since the liver is thought to be the principal route of no
en 15.
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
lõ ba lu gi üü m on il im av R
Misuse of Nespo by healthy persons may lead to an excessive increase in packed cell volume.
459 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
Nespo 15 µg süstelahus Darbepoetin alfa i. v. / s. c.
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
MANUSTAMISVIIS
Nespo should be used with caution in patients with epilepsy.
PARTII NUMBER
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
306 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
1 ml lu 6.
Serum potassium levels should be monitored regularly during Nespo therapy.
MUU gi
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
Dompé Biotec S. p. A. üü m on il im av R
Cancer patients
460 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
ed Effect on tumour growth
1.
Erythropoietin
Nespo 25 mikrogrammi süstelahus viaalis Darbepoetiin alfa
is receptors may be expressed on the surface of a variety of tumour cells.
ud 2.
As with all growth factors,
TOIMEAINE( TE) SISALDUS
or there is a concern that epoetins could stimulate the growth of tumours.
Iga 1 ml viaal sisaldab 25 mikrogrammi darbepoetiin alfat.
th in patients with anaemia associated with cancer.
ABIAINED
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
• er shortened time to tumour progression in patients with advanced head and neck cancer receiving ng radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), ESAs are not indicated for use in this patient population. lo
lõ 4.
• 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
MANUSTAMISVIIS JA - TEE
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.
ba
Factors that should be considered a
Enne ravimi kasutamist lugege pakendi infolehte üü
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
TEISED ERIHOIATUSED (VAJADUSEL) on
order to minimise the potential risk of thromboembolic events.
8.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
KÕLBLIKKUSAEG il im
4.5 Interaction with other medicinal products and other forms of interaction
Kõlblik kuni:
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
9.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
SÄILITAMISE ERITINGIMUSED av
307 4.6 Pregnancy and lactation
Mitte külmutada.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Caution should be exercised when prescribing to pregnant women.
461 11.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Dompé Biotec S. p. A.
There have been no observed effects with Nespo on the ability to drive and use machines.
MÜÜGILOA NUMBER( NUMBRID)
is or 4.8 Undesirable effects
EU/ 1/ 01/ 184/ 025 1 viaal pakis
th General
13.
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
RAVIMI VÄLJASTAMISTINGIMUSED
patients who received r-HuEPO.
Retseptiravim.
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
KASUTUSJUHEND
The injection site du
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
MedDRA system organ class in
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Subject Incidence
Nespo 25 µg süstelahus Darbepoetin alfa i. v. / s. c.
Cardiac Disorders ic
ud 2.
Hypertension
KÕLBLIKKUSAEG
Skin and Subcutaneous Tissue Disorders ed
pp EXP:
Common (≥ 1/ 100 to < 1/ 10)
4.
Uncommon (≥ 1/ 1,000 to < 1/ 100)
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Thromboembolic Events
1 ml lu 6.
General Disorders and Administration Site Conditions
MUU gi
Cancer patients
VIAALI KARP
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).
RAVIMPREPARAADI NIMETUS
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
TOIMEAINE( TE) SISALDUS
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
Iga 1 ml viaal sisaldab 40 mikrogrammi darbepoetiin alfat.
Adverse Drug Reaction Rash/ Erythema
en 3.
Thromboembolic events, including pulmonary embolism
RAVIMVORM JA PAKENDI SUURUS
Very Common (≥ 1/ 10)
1 ühekordselt kasutatav viaal 4 ühekordselt kasutatavat viaali 5.
is The following adverse reactions have been identified during postmarketing use of Nespo:
Enne ravimi kasutamist lugege pakendi infolehte üü
or th • Pure Red Cell Aplasia.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS m
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).
7.
4.9 Overdose no
KÕLBLIKKUSAEG il im
The therapeutic margin of Nespo is very wide.
Kõlblik kuni:
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
SÄILITAMISE ERITINGIMUSED av
5.
Mitte külmutada.
PHARMACOLOGICAL PROPERTIES a
R
5.1 Pharmacodynamic properties in
10.
Anti-anaemic ATC Code:
464 11.
B03XA02. ic ed
MÜÜGILOA HOIDJA NIMI JA AADRESS
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Dompé Biotec S. p. A.
The production of erythropoietin primarily occurs in and is regulated by the M
Via San Martino 12 I- 20122 Milan Itaalia
kidney in response to changes in tissue oxygenation.
12.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
MÜÜGILOA NUMBER( NUMBRID)
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
EU/ 1/ 01/ 184/ 027 1 viaal pakis
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
13.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
PARTII NUMBER
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
en Partii nr:
309 in vivo activity.
pp 14.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
RAVIMI VÄLJASTAMISTINGIMUSED
Cancer patients receiving chemotherapy
Retseptiravim.
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).
lõ 15.
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
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
is randomised, double-blind, multinational study.
465 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
1.
In both groups, the dose was
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
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
Nespo 40 µg süstelahus Darbepoetin alfa i. v. / s. c.
In the once weekly group, 75% of patients required dose reductions.
ud 2.
This study supports 500 μ g once
MANUSTAMISVIIS
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
en 3.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
4.
The lp
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
1 ml lu 6.
with recombinant human erythropoietin and controls.
MUU gi
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
466 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
associated with various common cancers who received recombinant human erythropoietin compared ed
1.
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
Nespo 60 mikrogrammi süstelahus viaalis Darbepoetiin alfa
erythropoietin and those in the control group.
ud 2.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Iga 1 ml viaal sisaldab 60 mikrogrammi darbepoetiin alfat.
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
ABIAINED
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
310 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
RAVIMVORM JA PAKENDI SUURUS
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
1 ühekordselt kasutatav viaal 4 ühekordselt kasutatavat viaali 5.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
ba
or Bioavailability is 37% with subcutaneous administration.
Enne ravimi kasutamist lugege pakendi infolehte üü
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
Hoida laste eest varjatud ja kättesaamatus kohas.
au accumulation was observed with either route of administration.
TEISED ERIHOIATUSED (VAJADUSEL) on
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
KÕLBLIKKUSAEG il im
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
Kõlblik kuni:
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.
9.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
SÄILITAMISE ERITINGIMUSED av
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
Hoida külmkapis.
Following intravenous administration, an approximate 25% difference between du
Mitte külmutada.
pediatricpatients.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Half-life was also similar between adult and paediatric patients with lp
467 11.
Cancer patients receiving chemotherapy in
Via San Martino 12 I- 20122 Milan Itaalia
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
12.
(SD 19.7).
ud EU/ 1/ 01/ 184/ 030 4 viaali pakis
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).
13.
Pharmacokinetic parameters did not M
PARTII NUMBER
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
en Partii nr:
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.
pp 14.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
RAVIMI VÄLJASTAMISTINGIMUSED
5.3 Preclinical safety data
Retseptiravim.
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.
lõ 15.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
KASUTUSJUHEND
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.
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
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.
468 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
VIAALI MÄRGISTUS
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
1.
Placental transfer was minimal.
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
or 6.1 List of excipients
ud 2.
au Sodium chloride Polysorbate 80
KÕLBLIKKUSAEG
er Water 6.2
pp EXP:
for injections Incompatibilities
4.
6.3 Shelf life ct
1 ml lu 6.
2 years. du
MUU gi
Keep the container in the outer carton, in order to protect from light. a
EELTÄIDETUD PENSÜSTELI KARP
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
RAVIMPREPARAADI NIMETUS
period of seven days at room temperature (up to 25°C).
Nespo 10 mikrogrammi süstelahus eeltäidetud pensüstelis Darbepoetiin alfa
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
TOIMEAINE( TE) SISALDUS
6.5 Nature and contents of container M
Iga 0, 4 ml eeltäidetud pensüstel sisaldab 10 mikrogrammi darbepoetiin alfat (40 mikrogrammi/ ml).
Package containing one or four pre-filled pens of a 100 µg Nespo solution for injection in 0.5 ml (200 µg/ ml).
en 3.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
pp Abiained: ühealuseline naatriumfosfaat, kahealuseline naatriumfosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
Not all packs may be marketed.
RAVIMVORM JA PAKENDI SUURUS
The carton contains a package leaflet with the full instructions for use and handling.
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
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
5.
Do not administer more than one dose per pen.
Enne ravimi kasutamist lugege pakendi infolehte. m
Any medicinal product remaining in the pre-filled pen should be disposed of.
6.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Hoida laste eest varjatud ja kättesaamatus kohas.
Allow the pre- filled pen to reach room temperature before injecting.
7.
is Any unused product or waste material should be disposed of in accordance with local requirements.
KÕLBLIKKUSAEG av
MARKETING AUTHORISATION HOLDER
Kõlblik kuni:
au Dompé Biotec S. p. A.
9.
Via San Martino 12
SÄILITAMISE ERITINGIMUSED R
er I-20122 Milan Italy ng lo 8.
Hoida külmkapis.
MARKETING AUTHORISATION NUMBERS no
Mitte külmutada.
EU/ 1/ 01/ 184/ 053 1 pack EU/ 1/ 01/ 184/ 065 4 pack ct
10.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
470 11.
8 June 2001 ro
Dompé Biotec S. p. A.
19 May 2006 lp
12.
DATE OF REVISION OF THE TEXT a in ic
EU/ 1/ 01/ 184/ 045 1- ne pakk
Detailed information on this medicinal product is available on the website of the European Medicines ed
13.
NAME OF THE MEDICINAL PRODUCT
pp 14.
QUALITATIVE AND QUANTITATIVE COMPOSITION
lõ 15.
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
For excipients, see section 6.1.
471 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
ed is 3.
1.
PHARMACEUTICAL FORM
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE