natgillin/translations-raw huggingface dataset:
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
Hoida laste eest varjatud ja kättesaamatus kohas. m
283 4.6 Pregnancy and lactation
TEISED ERIHOIATUSED (VAJADUSEL) on
For Nespo no clinical data on exposed pregnancies are available.
8.
As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
SÄILITAMISE ERITINGIMUSED av
ed 4.7 Effects on ability to drive and use machines
Mitte külmutada.
is or 4.8 Undesirable effects
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
th General
11.
Clinical Trial Experience er ng Chronic renal failure patients lo
Via San Martino 12 I- 20122 Milan Itaalia
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
416 12.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
EU/ 1/ 01/ 184/ 015 1 süstal pakis EU/ 1/ 01/ 184/ 016 4 süstalt pakis
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
13.
This was seen more frequently than with r-HuEPO.
PARTII NUMBER
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
RAVIMI VÄLJASTAMISTINGIMUSED
studies are: a
Retseptiravim.
MedDRA system organ class in
en 15.
Adverse Drug Reaction
lõ ba lu gi üü m on il im av R
Cardiac Disorders ic
417 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
Very Common (≥ 1/ 10)
1.
Rash/ Erythema
MÜÜGILOA HOIDJA NIMI
Vascular disorders M
en Dompé
Uncommon (≥ 1/ 1,000 to < 1/ 100)
3.
General Disorders and Administration Site Conditions
pp EXP:
Common (≥ 1/ 100 to < 1/ 10)
lõ 4.
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 ba lu i. v. / s. c.
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.
0, 4 ml gi üü m on il im av R
Adverse Drug Reaction Rash/ Erythema
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Vascular disorders
Nespo 80 µg Darbepoetin alfa i. v. / s. c.
Common (≥ 1/ 100 to < 1/ 10)
ud 2.
General Disorders and Administration Site Conditions
KÕLBLIKKUSAEG
Very Common (≥ 1/ 10)
pp EXP:
Oedema
4.
ed Postmarketing Experience
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
is The following adverse reactions have been identified during postmarketing use of Nespo:
0, 4 ml lu 6.
or th • Pure Red Cell Aplasia.
KOHAS
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
TEISED ERIHOIATUSED (VAJADUSEL) on
au patients with CRF treated subcutaneously.
Via San Martino 12 I- 20122 Milan Itaalia
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/ 040
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
Partii nr:
4.9 Overdose no
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
The therapeutic margin of Nespo is very wide.
pp EXP:
Even at very high serum levels, no symptoms of overdose have been observed. ct du
4.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
422 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
If clinically indicated, phlebotomy may be performed. ro lp
BLISTERÜMBRISES EELTÄIDETUD SÜSTALDE KARP
5.
RAVIMPREPARAADI NIMETUS
Pharmacotherapeutic group:
TOIMEAINE( TE) SISALDUS
B03XA02. ic ed
ud Iga 0, 5 ml eeltäidetud süstal sisaldab 100 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml)
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.
en 3.
The production of erythropoietin primarily occurs in and is regulated by the M
ABIAINED
kidney in response to changes in tissue oxygenation.
Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid,
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
pp polüsorbaat 80, süstevesi.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
4.
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
RAVIMVORM JA PAKENDI SUURUS
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
lõ 1 eeltäidetud süstal 4 eeltäidetud süstalt
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
5.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
285 in vivo activity.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
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).
Hoida laste eest varjatud ja kättesaamatus kohas. m
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
7.
is randomised, double-blind, multinational study.
KÕLBLIKKUSAEG il
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
9.
In both groups, the dose was
SÄILITAMISE ERITINGIMUSED av
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
Hoida külmkapis.
au in a 14-day period.
Mitte külmutada.
In the once weekly group, 75% of patients required dose reductions.
10.
This study supports 500 μ g once
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
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
11.
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
Via San Martino 12 I- 20122 Milan Itaalia
Survival and tumour progression have been examined in five large controlled studies involving a total ro
MÜÜGILOA NUMBER( NUMBRID)
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
EU/ 1/ 01/ 184/ 017 1 süstal pakis EU/ 1/ 01/ 184/ 018 4 süstalt pakis
The lp
13.
In the open-label study there was no difference in overall survival between patients treated a
Partii nr:
with recombinant human erythropoietin and controls.
ud 14.
In the four placebo-controlled studies the hazard in
RAVIMI VÄLJASTAMISTINGIMUSED
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Retseptiravim.
associated with various common cancers who received recombinant human erythropoietin compared ed
KASUTUSJUHEND
to controls.
pp 16.
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
lõ ba lu gi üü m on il im av R
erythropoietin and those in the control group.
424 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
EELTÄIDETUD SÜSTLA BLISTERÜMBRIS
0.99, 1.18; 42 trials and 8167 patients).
1.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Nespo 100 µg süstelahus Darbepoetiin alfa
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Lot:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
MUU ba lu i. v. / s. c.
286 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
ud 2.
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.
KÕLBLIKKUSAEG
Chronic renal failure patients
pp EXP:
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
4.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
PARTII NUMBER
or Bioavailability is 37% with subcutaneous administration.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
In clinical studies, minimal
MUU gi
au accumulation was observed with either route of administration.
Dompé Biotec S. p. A. üü m on il im av R
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
BLISTERÜMBRISETA EELTÄIDETUD SÜSTLA KARP
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
RAVIMPREPARAADI NIMETUS
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.
Nespo 100 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
TOIMEAINE( TE) SISALDUS
pediatricpatients.
ABIAINED
Half-life was also similar between adult and paediatric patients with lp
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
CRF following both intravenous and subcutaneous administration. a
lõ 4.
Pharmacokinetic parameters did not M
5.
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
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.
6.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
5.3 Preclinical safety data
KOHAS
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.
Hoida laste eest varjatud ja kättesaamatus kohas. m
287 effect (decreased tissue perfusion due to increased blood viscosity).
TEISED ERIHOIATUSED (VAJADUSEL) on
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.
KÕLBLIKKUSAEG il
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Kõlblik kuni: im
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.
9.
Placental transfer was minimal.
SÄILITAMISE ERITINGIMUSED av
PHARMACEUTICAL PARTICULARS
Mitte külmutada.
or 6.1 List of excipients
10.
th Sodium phosphate monobasic Sodium phosphate dibasic
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
au Sodium chloride Polysorbate 80
MÜÜGILOA HOIDJA NIMI JA AADRESS
er Water 6.2
Dompé Biotec S. p. A.
lo
MÜÜGILOA NUMBER( NUMBRID)
ng
EU/ 1/ 01/ 184/ 041
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
13.
6.4 Special precautions for storage ro
RAVIMI VÄLJASTAMISTINGIMUSED
Store in a refrigerator (2°C – 8°C) Do not freeze. lp
ud Retseptiravim.
Keep the container in the outer carton, in order to protect from light. a
en 15.
period of seven days at room temperature (up to 25°C).
lõ ba lu gi üü m on il im av R
the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
6.5 Nature and contents of container M
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Package containing one or four pre-filled pens of a 60 µg Nespo solution for injection in 0.3 ml (200 µg/ ml).
Nespo 100 µg süstelahus Darbepoetin alfa i. v. / s. c.
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
PARTII NUMBER
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
Nespo 130 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
See section 4.4.
2.
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
pp polüsorbaat 80, süstevesi.
Do not administer more than one dose per pen.
4.
Each pen may only be used once.
PARTII NUMBER
Before administration the Nespo solution should be inspected for visible particles.
Retseptiravim.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
en 15.
Do not shake.
pp 16.
Allow the pre- filled pen to reach room temperature before injecting.
INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS)
MARKETING AUTHORISATION HOLDER
1.
Via San Martino 12
Nespo 130 µg süstelahus Darbepoetiin alfa
er I-20122 Milan Italy ng lo 8.
ud 2.
MARKETING AUTHORISATION NUMBERS no
MÜÜGILOA HOIDJA NIMI
EU/ 1/ 01/ 184/ 051 1 pack EU/ 1/ 01/ 184/ 063 4 pack ct
en Dompé
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
pp EXP:
Date of first authoristion:
lõ 4.
8 June 2001 ro
PARTII NUMBER
Date of last renewal:
Lot:
10.
MUU ba lu i. v. / s. c.
DATE OF REVISION OF THE TEXT a in ic
0, 65 ml gi üü m on il im av R
Detailed information on this medicinal product is available on the website of the European Medicines ed
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
Agency (EMEA) http: / /www. emea. europa. eu/ M
ud 2.
289 1.
KÕLBLIKKUSAEG
2.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
QUALITATIVE AND QUANTITATIVE COMPOSITION
MUU gi
Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ ml).
Dompé Biotec S. p. A. üü m on il im av R
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
433 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
For excipients, see section 6.1.
1.
PHARMACEUTICAL FORM
Nespo 130 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
or Solution for injection (injection) in a pre-filled pen.
ud 2.
CLINICAL PARTICULARS
Iga 0, 65 ml eeltäidetud süstal sisaldab 150 mikrogrammi darbepoetiin alfat (200 mikrogrammi/ ml)
4.1 Therapeutic indications
en 3.
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. du
RAVIMVORM JA PAKENDI SUURUS
Nespo (SureClick) is supplied ready for use in a pre-filled pen.
1 eeltäidetud süstal
The instructions for use, handling and disposal are given in section 6.6. ro lp
5.
greater than 12 g/ dl (7.5 mmol/ l).
TEISED ERIHOIATUSED (VAJADUSEL) on
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and M
KÕLBLIKKUSAEG il
below the desired haemoglobin level may be observed.
Kõlblik kuni: im
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.
9.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
SÄILITAMISE ERITINGIMUSED av
Guidance is given separately for adult and paediatric patients.
Mitte külmutada.
290 Adult patients with chronic renal failure
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
Correction Phase
11.
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.
Dompé Biotec S. p. A.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
Via San Martino 12 I- 20122 Milan Itaalia
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
MÜÜGILOA NUMBER( NUMBRID)
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
13.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at
PARTII NUMBER
is approximately 25% lower than the previous dose.
Partii nr:
or The haemoglobin should be measured every one or two weeks until it is stable.
14.
Thereafter the
RAVIMI VÄLJASTAMISTINGIMUSED
th haemoglobin can be measured at longer intervals.
ud Retseptiravim.
au Maintenance Phase
en 15.
Dialysis patients converting from once weekly to once every other week dosing ng with Nespo should initially receive a dose equivalent to twice the previous once weekly dose.
pp 16.
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 ba lu gi üü m on il im av R
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
435 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
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
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
1.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Nespo 130 µg Darbepoetin alfa i. v. / s. c.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
ud 2.
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
KÕLBLIKKUSAEG
provide adequate control of the symptoms of anaemia. ed
pp EXP:
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
4.
M
PARTII NUMBER
Dose changes in the maintenance phase of treatment should not be made more frequently than every 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 haemoglobin at the desired level.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
0, 65 ml lu 6.
Because of
MUU gi
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.
Dompé Biotec S. p. A. üü m on il im av R
Paediatric patients with chronic renal failure
436 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
Correction Phase
1.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Nespo 150 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
ed increase the dose by approximately 25%.
TOIMEAINE( TE) SISALDUS
or approximately 25%, depending on the rate of increase.
ABIAINED
If the haemoglobin continues to increase,
Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid,
th the dose should be reduced by approximately 25%.
4.
If after a dose reduction, haemoglobin continues
RAVIMVORM JA PAKENDI SUURUS
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.
lõ 1 eeltäidetud süstal 4 eeltäidetud süstalt
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
5.
administered as a single injection once weekly or once every two weeks.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
equivalent to twice the previous once weekly dose.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
TEISED ERIHOIATUSED (VAJADUSEL) on
those receiving r-HuEPO once weekly may be converted to once every other week Nespo.
8.
The initial ic
KÕLBLIKKUSAEG il
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.
Kõlblik kuni: im
optimal therapeutic doses is expected for individual patients.
SÄILITAMISE ERITINGIMUSED av
should be used.
Mitte külmutada.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI 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.
11.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
MÜÜGILOA HOIDJA NIMI JA AADRESS
If after a dose reduction, haemoglobin continues to
Dompé Biotec S. p. A.
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.
MÜÜGILOA NUMBER( NUMBRID)
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
EU/ 1/ 01/ 184/ 019 1 süstal pakis EU/ 1/ 01/ 184/ 020 4 süstalt pakis
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
PARTII NUMBER
ed haemoglobin at the desired level.
Partii nr:
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
ud 14.
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.
en 15.
er below the desired haemoglobin level may be observed.
lõ ba lu gi üü m on il im av R
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
438 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL