natgillin/translations-raw huggingface dataset:
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.
1.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
RAVIMPREPARAADI NIMETUS
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
Nespo 150 µg süstelahus Darbepoetiin alfa
Appropriate dose titration between lp
MÜÜGILOA HOIDJA NIMI
500 μ g, 300 μ g, and 150 μ g should be considered. a
en Dompé
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
3.
Therapy should be reinitiated at ic
pp EXP:
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) ed
lõ 4.
M
Lot:
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%.
5.
4.3 Contraindications
0, 3 ml gi üü m on il im av R
General
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy.
Nespo 150 µg Darbepoetin alfa i. v. / s. c.
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.
MANUSTAMISVIIS
Deficiencies of
KÕLBLIKKUSAEG
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
pp EXP:
is may also compromise the erythropoietic response.
PARTII NUMBER
If the bone marrow is consistent with
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
th PRCA, testing for anti-erythropoietin antibodies should be performed.
0, 3 ml lu 6.
This has been
MUU gi
er predominantly reported in patients with CRF treated subcutaneously.
Dompé Biotec S. p. A. üü m on il im av R
Since the liver is thought to be the principal route of no
440 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
RAVIMPREPARAADI NIMETUS
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
Nespo 150 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
upper limit of the target haemoglobin concentration recommended in section 4.2.
ud 2.
In clinical studies, an in
TOIMEAINE( TE) SISALDUS
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
Iga 0, 3 ml eeltäidetud süstal sisaldab 150 mikrogrammi darbepoetiin alfat (500 mikrogrammi/ ml)
Nespo should be used with caution in patients with epilepsy.
RAVIMVORM JA PAKENDI SUURUS
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
294 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS üü
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
Hoida laste eest varjatud ja kättesaamatus kohas. m
Cancer patients
7.
Epoetins are growth factors that primarily stimulate red blood cell production.
KÕLBLIKKUSAEG il
As with all growth factors,
9.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
Hoida külmkapis.
th in patients with anaemia associated with cancer.
Mitte külmutada.
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
10.
• 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
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
MÜÜGILOA HOIDJA NIMI JA AADRESS
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
Dompé Biotec S. p. A.
therapy. ESAs are not indicated for use in this patient population. ro
MÜÜGILOA NUMBER( NUMBRID)
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.
EU/ 1/ 01/ 184/ 042
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.
PARTII NUMBER
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
RAVIMI VÄLJASTAMISTINGIMUSED
5.1). ed
ud Retseptiravim.
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
en 15.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
pp 16.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
295 4.6 Pregnancy and lactation
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
For Nespo no clinical data on exposed pregnancies are available.
Nespo 150 µg süstelahus Darbepoetin alfa i. v. / s. c.
Caution should be exercised when prescribing to pregnant women.
ud 2.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
en 3.
is or 4.8 Undesirable effects
PARTII NUMBER
th General
lõ Lot:
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
patients who received r-HuEPO.
MUU gi
This was seen more frequently than with r-HuEPO.
443 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
The injection site du
BLISTERÜMBRISES EELTÄIDETUD SÜSTALDE KARP
discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ro
RAVIMPREPARAADI NIMETUS
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
Nespo 300 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
studies are: a
2.
Adverse Drug Reaction
ABIAINED
Cardiac Disorders ic
Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid,
Very Common (≥ 1/ 10)
4.
Vascular disorders M
5.
Uncommon (≥ 1/ 1,000 to < 1/ 100)
MANUSTAMISVIIS JA - TEE ba lu Intravenoosne või subkutaanne Enne ravimi kasutamist lugege pakendi infolehte gi
Thromboembolic Events
6.
Cancer patients
TEISED ERIHOIATUSED (VAJADUSEL) on
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).
8.
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.
KÕLBLIKKUSAEG il
296 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Kõlblik kuni: im
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
9.
Adverse Drug Reaction Rash/ Erythema
Mitte külmutada.
Common (≥ 1/ 100 to < 1/ 10)
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
Thromboembolic events, including pulmonary embolism
11.
Very Common (≥ 1/ 10)
Via San Martino 12 I- 20122 Milan Itaalia
Oedema
444 12.
ed Postmarketing Experience
PARTII NUMBER
is The following adverse reactions have been identified during postmarketing use of Nespo:
Partii nr:
or th • Pure Red Cell Aplasia.
ud 14.
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
RAVIMI VÄLJASTAMISTINGIMUSED
au patients with CRF treated subcutaneously.
Retseptiravim.
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
KASUTUSJUHEND
4.9 Overdose no
pp 16.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
445 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
1.
If clinically indicated, phlebotomy may be performed. ro lp
RAVIMPREPARAADI NIMETUS
5.
Nespo 300 µg süstelahus Darbepoetiin alfa
Pharmacotherapeutic group:
MÜÜGILOA HOIDJA NIMI
B03XA02. ic ed
en Dompé
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.
3.
The production of erythropoietin primarily occurs in and is regulated by the M
KÕLBLIKKUSAEG
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 EXP:
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
lõ 4.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Lot:
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
5.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
0, 6 ml gi üü m on il im av R
Cancer patients receiving chemotherapy
446 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
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).
BLISTERÜMBRISES SÜSTLA MÄRGISTUS
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.
1.
This study was conducted in 705 anaemic patients with
ud 2.
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
en 3.
In both groups, the dose was
KÕLBLIKKUSAEG
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
pp EXP:
au in a 14-day period.
4.
In the once every three weeks group, 72% of patients required dose reductions.
PARTII NUMBER
This study supports 500 μ g once
lõ Lot:
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
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
MUU gi
Two of the studies recruited patients who were being treated with chemotherapy.
447 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
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
ud 2.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
en 3.
0.99, 1.18; 42 trials and 8167 patients).
ABIAINED
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
lõ 4.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
RAVIMVORM JA PAKENDI SUURUS
298 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
1 eeltäidetud süstal
5.2 Pharmacokinetic properties
5.
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg
Hoida laste eest varjatud ja kättesaamatus kohas. m
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
7.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was
8.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
Kõlblik kuni: im
au accumulation was observed with either route of administration.
SÄILITAMISE ERITINGIMUSED av
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
Mitte külmutada.
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.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
MÜÜGILOA HOIDJA NIMI JA AADRESS
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
Via San Martino 12 I- 20122 Milan Itaalia
pediatricpatients.
448 12.
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
MÜÜGILOA NUMBER( NUMBRID)
Cancer patients receiving chemotherapy in
PARTII NUMBER
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
Partii nr:
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
14.
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).
ud Retseptiravim.
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
KASUTUSJUHEND
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 16.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
lõ ba lu gi üü m on il im av R
5.3 Preclinical safety data
449 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
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.
BLISTERÜMBRISETA SÜSTLA MÄRGISTUS
299 effect (decreased tissue perfusion due to increased blood viscosity).
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
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.
MANUSTAMISVIIS
No alteration of fertility was detected.
en 3.
PHARMACEUTICAL PARTICULARS
pp EXP:
or 6.1 List of excipients
4.
er Water 6.2
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
for injections Incompatibilities
0, 6 ml lu 6.
lo
MUU gi
6.3 Shelf life ct
BLISTERÜMBRISES EELTÄIDETUD SÜSTALDE KARP
2 years. du
RAVIMPREPARAADI NIMETUS
6.4 Special precautions for storage ro
Nespo 500 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
Store in a refrigerator (2°C – 8°C) Do not freeze. lp
ud 2.
period of seven days at room temperature (up to 25°C).
ABIAINED
6.5 Nature and contents of container M
RAVIMVORM JA PAKENDI SUURUS
Package containing one or four pre-filled pens of a 80 µg Nespo solution for injection in 0.4 ml (200 µg/ ml).
1 eeltäidetud süstal 4 eeltäidetud süstalt 5.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
MANUSTAMISVIIS JA - TEE
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
Enne ravimi kasutamist lugege pakendi infolehte üü
Nespo is a sterile but unpreserved product.
ERIHOIATUS, ET RAVIMIT TULEB HOIDA LASTE EEST KÄTTESAAMATUS KOHAS m
Each pen may only be used once.
Hoida laste eest varjatud ja kättesaamatus kohas.
Before administration the Nespo solution should be inspected for visible particles.
TEISED ERIHOIATUSED (VAJADUSEL) on
Do not shake.
8.
Allow the pre- filled pen to reach room temperature before injecting.
KÕLBLIKKUSAEG il im
ed Rotate the injection sites to avoid discomfort at the site of injection.
Kõlblik kuni:
is Any unused product or waste material should be disposed of in accordance with local requirements.
9.
MARKETING AUTHORISATION HOLDER
Hoida külmkapis.
au Dompé Biotec S. p. A.
R
er I-20122 Milan Italy ng lo 8.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
EU/ 1/ 01/ 184/ 052 1 pack EU/ 1/ 01/ 184/ 064 4 pack ct
MÜÜGILOA HOIDJA NIMI JA AADRESS
9.
Dompé Biotec S. p. A.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
Via San Martino 12 I- 20122 Milan Itaalia
Date of first authoristion:
12.
8 June 2001 ro
MÜÜGILOA NUMBER( NUMBRID)
Date of last renewal:
EU/ 1/ 01/ 184/ 031 1 süstal pakis
19 May 2006 lp
ud EU/ 1/ 01/ 184/ 032 4 süstalt pakis
10.
PARTII NUMBER
Agency (EMEA) http: / /www. emea. europa. eu/ M
RAVIMI VÄLJASTAMISTINGIMUSED
301 1.
Retseptiravim.
Nespo 100 micrograms solution for injection in a pre-filled pen.
KASUTUSJUHEND
QUALITATIVE AND QUANTITATIVE COMPOSITION
16. ba INFORMATSIOON BRAILLE ’ KIRJAS (PUNKTKIRJAS) lu gi üü m on il im av R
Each pre-filled pen contains 100 micrograms of darbepoetin alfa in 0.5 ml (200 µg/ ml).
452 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER - VÕI RIBAPAKENDIL
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
1.
PHARMACEUTICAL FORM
Nespo 500 µg süstelahus Darbepoetiin alfa
CLINICAL PARTICULARS
en Dompé
4.1 Therapeutic indications
3.
4.2 Posology and method of administration ct
pp EXP:
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. du
lõ 4.
The pre-filled pen is only for subcutaneous administration.
Lot:
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
MUU ba lu i. v. / s. c.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
1 ml gi üü m on il im av R
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
453 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
greater than 12 g/ dl (7.5 mmol/ l).
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
below the desired haemoglobin level may be observed.
MANUSTAMISVIIS
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.
en 3.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
KÕLBLIKKUSAEG
Guidance is given separately for adult and paediatric patients.
4.
Treatment of paediatric patients younger than 1 year of age has not been studied:
PARTII NUMBER
302 Adult patients with chronic renal failure
lõ Lot:
Correction Phase
5. ba PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI
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.
1 ml lu 6.
Dose increases must not be made more frequently than once every four weeks.
MUU gi
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be
Dompé Biotec S. p. A. üü m on il im av R
ed considered.
454 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
au Maintenance Phase
RAVIMPREPARAADI NIMETUS
er In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
Nespo 500 mikrogrammi süstelahus eeltäidetud süstlas Darbepoetiin alfa
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
ud 2.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
ABIAINED
approximately 25%, depending on the rate of increase.
pp Abiained: ühealuseline naatriummonofosfaat, kahealuseline naatriummonofosfaat, naatriumkloriid, polüsorbaat 80, süstevesi.
If the haemoglobin continues to increase, the lp
lõ 4.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
1 eeltäidetud süstal
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
5.
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.
TEISED ERIHOIATUSED (VAJADUSEL) on
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.
8.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
KÕLBLIKKUSAEG il
Because of
Kõlblik kuni: im
303 individual variability, titration to optimal therapeutic doses is expected for individual patients.
9.
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.
SÄILITAMISE ERITINGIMUSED av
Paediatric patients with chronic renal failure
Hoida külmkapis.
Correction Phase
Mitte külmutada.
For patients ≥ 11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
10.
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.
VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI R
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks)
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE