qanastek/EMEA-V3 huggingface dataset:
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Jekk l- emoglobina tkompli tiżdied, id - doża għandha tigi mnaqqsa bejn wieħed u ieħor b’ 25%.
16 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.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’
17 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
19 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
18 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
20 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
19 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
21
20 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
fis- suġġett ħa
Adverse Drug Reaction Rash/ Erythema
Effetti mhux mixtieqa
Vascular disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common (≥ 1/ 100 to < 1/ 10)
Komuni (>
Thromboembolic events, including pulmonary embolism
1/ 100 to < 1/ 10)
General Disorders and Administration Site Conditions
Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet
Very Common (≥ 1/ 10)
Komuni (> im
Oedema
Edima Komuni ħafna (≥1/ 10) ta 'mnejn jingħata
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
F’ każijiet iżolati, aplażja pura ta ’ ċelluli ħomor ikkawżata minn anitkorpi anti- eritropojetin newtraliżanti ġiet irrappurtata b’ assoċazzjoni ma ’ kura ed
au patients with CRF treated subcutaneously.
F’ każ li aplażja pura ta ’ ċelluli ħomor (PRCA) tiġi djanjostikata, il- kura, b’ Nespo għandha 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).
titwaqqaf u l- pazjenti m’ għandhiex tinbidlilhom il- kura għal proteina rikombinanti eritropojetika oħra (ara sezzjoni 4. 4). t
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
Reazzjonijiet allerġiċi, inklużi reazzjonijiet anafilattiċi, anġioedema, raxx tal- ġilda u urtikarja. od
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
23 istudju l- ieħor kien studju open- label.
22 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
CRF following both intravenous and subcutaneous administration. a
24 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
23 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
25 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 15 µg Nespo solution for injection in 0.375 ml (40 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '15 µg f' 0. 375 ml (40 µg/ ml).
24 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 003 1 Pack Blister lo EU/ 1/ 01/ 184/ 004 4 Pack Blister EU/ 1/ 01/ 184/ 034 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 005 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 006 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 035 Pakkett ta '1 (mhux ġo folja)
Nespo 20 micrograms solution for injection in a pre-filled syringe.
Nespo 20 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 ml (40 µg/ ml).
Kull siringa mimlija għal- lest fiha 20 mikrogramma ta 'darbepoetin alfa f' 0. 5 ml (40 µg/ ml).
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
Sintomi u problemi ta ’ anemija jistgħu jvarjaw skond l- età, is- sess, u l - piż ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent huma neċessarji.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
28 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
26 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
29 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
27 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
30 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
28 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.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’
4.3 Contraindications
31 4. 3 Kontra- indikazzjonijiet
29 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
32 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
30 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
33 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
31 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
34
32 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
36 istudju l- ieħor kien studju open- label.
34 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
CRF following both intravenous and subcutaneous administration. a
37 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
35 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
38 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 20 µg Nespo solution for injection in 0.5 ml (40 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '20 µg f' 0. 5 ml (40 µg/ ml).
36 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 005 1 Pack Blister lo EU/ 1/ 01/ 184/ 006 4 Pack Blister EU/ 1/ 01/ 184/ 035 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 005 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 006 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 035 Pakkett ta '1 (mhux ġo folja)
Nespo 30 micrograms solution for injection in a pre-filled syringe.
Nespo 30 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 ml (100 µg/ ml).
Kull siringa mimlija għal- lest fiha 30 mikrogramma ta 'darbepoetin alfa f' 0. 3 ml (100 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
41 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
38 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
42 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
39 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
43 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
40 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.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’
4.3 Contraindications
44 4. 3 Kontra- indikazzjonijiet
41 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
45 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
42 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
46 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
43 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
47
44 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
49 istudju l- ieħor kien studju open- label.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Iċ- ċans li dawn l- affarijiet jseħħu jistgħu japplikaw għal pazjenti bil- kanċer, li jirċievu eritropeotin rikombinanti umanuman, li qed jiġu kkurati bil- kimoterapija
46 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x biex jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti
5.2 Pharmacokinetic properties
du b ’ dawn il- karatteristiċi ġew inklużi fit- tagħrif li ġie analiżżat. ħa 5. 2 Tagħrif farmakokinetiku
CRF following both intravenous and subcutaneous administration. a
50 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
47 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
51 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 30 µg Nespo solution for injection in 0.3 ml (100 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '30 µg f' 0. 3 ml (100 µg/ ml).
48 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 007 1 Pack Blister lo EU/ 1/ 01/ 184/ 008 4 Pack Blister EU/ 1/ 01/ 184/ 036 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 007 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 008 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 036 Pakkett ta '1 (mhux ġo folja)
Nespo 40 micrograms solution for injection in a pre-filled syringe.
Nespo 40 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ ml).
Kull siringa mimlija għal- lest fiha 40 mikrogramma ta 'darbepoetin alfa f' 0. 4 ml (100 µg/ ml).
Nespo in
Nespo għandu jingħata bħala t ot
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
injezzjoni taħt il- ġilda jew ġol- vina sabiex tiżdied il- konċentrazzjoni ta ’ l- emoglobina għal mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
L- użu taħt il- ġilda huwa aħjar f’ pazjenti li mhux qegħdin fuq dijalisi tad - od
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.
Livell ta ’ l- emoglobina miżmum fit- tul għal aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għal aġġustament fid- doża xieraq għal meta l- valuri ta ’ l- emoglobina jaqbżu t- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
54 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
50 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
is approximately 25% lower than the previous dose.
aw id- doża għandha titwaqqaf temporanjament sa kemm il- livell ta ’ l- emoglobina jibda jonqos, fl ’ liema punt il- kura għandha terġa tinbeda b ’ doza ta ’ bejn wieħed u ieħor doża ta ’ 25% anqas minn mid- doża ta ’ qabel.
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.
55 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
51 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
56 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
If after a dose reduction, haemoglobin continues to
Jekk l- emoglobina tkompli tiżdied, id- doża għandha titwaqqaf temporanjament sa kemm l- emoglobina tibda tonqos, fl ’ liema punt il- kura għandha terġa tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel.
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.
t za Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’ Nespo approvata biex jiġi pprovdut kontroll fuq is- sintomi ta ’ l- anemija.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
riz Wara kull aġġustament fid- doża jew fl- iskeda l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn.
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
aw Meta tibdel ir- rotta tal- amministrazzjoni, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimagħtejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
x du Kura ta ’ l- anemija sintomatika minħabba l- kimoterapija f’ pazjenti bil- kanċer
or Nespo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l)) in order to increase haemoglobin to not greater than 12 g/ dl
Nespo għandu jingħata taħt il- ġilda lil pazjenti b 'anemija (eżempju: konċentrazzjoni ta ’ emoglobina ħa ≤10 g/ dl (6. 2 mmol/ l) sa biex l- emoglobina tiżdied b ’ mhux aktar minn 12g/ dl (7. 5 mmol/ l).
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.
Is- sintomi u kumplikazzjonijiet ta ’ l- anemija jvarjaw bl- eta, is- sess, u l- piz ta ’ mard fuq kollox; evalwazzjoni ’ g minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent hija neċessarja. im
au Due to intra-patient variability, occasional individual haemoglobin values for a patient above and
Minħabba varjazzjonijiet bejn pazjent u ieħor, jistgħu okkażjonalment jiġu osservati f’ pazjenti valuri ta ’ l- emoglobina ‘ l fuq jew taħt il- livelli ta ’ emoglobina mixtieqa.
er below the desired haemoglobin level may be observed.
10g/ dl (6. 2 mmol/ l) għal 12 g/ dl (7. 5mmol/ l).
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
Livell ta ’ l- emoglobina miżmum fit- tul għal aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; tmexxija għall- aġġustament fid- doża xieraq għal meta l- valuri al
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.
ta ’ l- emoglobina jaqbżu it- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt. in
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
Id- doża rakkomandata fil- bidu hija ta ’ 500 μg (6. 75 μg/ kg) mogħtija darba kull tliet ġimgħat, jew 2. 25 iċ
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
Jekk ir- rispons kliniku tal- pazjent (għeja, rispons ta 'l - emoglobina) mhux adegwat wara disa' ġimgħat, aktar kura tista 'ma tkunx effettiva. ed
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Il- kura b 'Nespo għandha titwaqqaf bejn wieħed u ieħor erba' ġimgħat wara tmiem il- kimoterapija. m
Appropriate dose titration between lp
La darba li l- għan tal- kura għal pazjent individwali jkun ntlaħaq, id- doża trid titnaqqas għal bejn 25% u 50% tintuża l- anqas doża approvata ta ’ Nespo sabiex tinżamm l- emoglobina fl- livell li jikkontrolla s - t ot
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
Aġġustament xieraq fid- doża ta ’ bejn 500 μg, 300 μg, u 150 μg għandu jiġi kkunsidrat. od
Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib, jekk l- emoglobina taqbeż it- 12g/ dl (7. 5mmol/ l), id - doża għandha titnaqqas b’ bejn wieħed u ieħor 25 u 50%.
Therapy should be reinitiated at ic
Il- kura b ’ Nespo għandha titwaqqaf Pr
4.3 Contraindications
57 4. 3 Kontra- indikazzjonijiet
53 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
58 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
54 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
59 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
55 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
60
56 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
62 istudju l- ieħor kien studju open- label.
58 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x biex jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti
CRF following both intravenous and subcutaneous administration. a
63 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
59 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
64 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 40 µg Nespo solution for injection in 0.4 ml (100 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '40 µg f' 0. 4 ml (100 µg/ ml).
60 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 009 1 Pack Blister lo EU/ 1/ 01/ 184/ 010 4 Pack Blister EU/ 1/ 01/ 184/ 037 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 009 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 010 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 037 Pakkett ta '1 (mhux ġo folja)
Nespo 50 micrograms solution for injection in a pre-filled syringe.
Nespo 50 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 ml (100 µg/ ml).
Kull siringa mimlija għal- lest fiha 50 mikrogramma ta 'darbepoetin alfa f' 0. 5 ml (100 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
67 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
62 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
68 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
63 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
69 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
4.3 Contraindications
70 4. 3 Kontra- indikazzjonijiet
65 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
Nespo should be used with caution in patients with epilepsy.
71 Nespo għandu jintuża b 'attenzjoni f' pazjenti li għandhom epilessija.
Chronic renal failure patients
Pazjenti b 'insuffiċjenza renali kronika
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
Kura supplementari bil- ħadid hija rakkomandata għal pazjenti kollha b 'livelli ta ’ ferritin fis- serum taħt 100 μg/ l jew li għandhom saturazzjoni ta ’ transferrin taħt 20%.
66 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
t za insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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.
F ’ dawn il- pazjenti, għandu jkun immirat li jintlaħaq l- ogħla limitu ta ’ 12- il g/ dl (7. 5mmol/ l), dejjem jekk sintomi serveri (eżempju: anġina) ma jiddettawx mod ieħor.
Serum potassium levels should be monitored regularly during Nespo therapy.
riz Il- livelli ta ’ potassium fis- serum għandhom jiġu mmonitorjati b’ mod regolari waqt kura b’ Nespo.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
to Żjieda fil- potassium ġiet irrappurtata f’ xi pazjenti li ngħataw Nespo, għalkemm il- kawża għadha ma ġietx stabbilita.
If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
Jekk ikun osservat livell ta ’ potassium għoli jew li qed jiżdied, għandu jiġi kkunsidrat
Cancer patients
Pazjenti bil- kanċer
ed Effect on tumour growth
x du Effett fuq it- tkabbir ta 'tumur
Erythropoietin
Epoetins huma fatturi ta 'tkabbir li primarjament jistimolaw il- produzzjoni taċ- ċelluli ħomor.
As with all growth factors,
Ir - ħa riċetturi ta 'eritropojetina jistgħu jiġu esprimati fuq il- wiċċ ta' varjetà ta 'ċelluli ta' tumur.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
F ’ bosta studji ’ g kliniċi kkontrollati, epoetins wrew titjib fl- għejxien jew tnaqqis fir- riskju ta ’ progress ta ’ tumur f’ pazjenti b’ anemija assoċjata ma ’ kanċer. im
th in patients with anaemia associated with cancer.
Fi studji kliniċi kkontrollati, l- użu ta ’ Nespo u aġenti li jistimolaw l- eritropojesi (ESAs) wera: il
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
• tnaqqis fil- ħin għal progress ta ’ tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed jirċievu kura bir- raġġi meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 al
• 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
mmol/ l), l- użu ta ’ ESAs mhux indikat f ’ din il- popolazzjoni ta ’ pazjenti. in
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
• tnaqqis fit- tul ta ’ ħajja u żjieda fl- imwiet attribwiti ma ’ progressjoni tal- mard f ’ 4 xhur f ’ iċ
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
pazjenti b ’ kanċer metastastiku fis- sider, li qed jirċievu l- kimoterapija, meta ngħatalhom biex jintlaħaq targit ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 – 8. 7 mmol/ l) ed
• 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
• żjieda fir- riskju ta ’ mewt meta ngħatalhom biex jintlaħaq targit ta ’ emoglobina ta ’ 12 g/ dl m
therapy. ESAs are not indicated for use in this patient population. ro
ESAs mhux indikata għall- użu f ’ din il- popolazzjoni ta ’ pazjenti. t ot
The decision to administer recombinant lp
Id- deċiżjoni li jingħataw eritropojetins rikombinanti għandha tkun od
Factors that should be considered a
ibbażata fuq evalwazzjoni tal- benefiċju- riskju bil- parteċipazzjoni tal- pazjent, li għandha tikkunsidra l - kuntest kliniku speċifiku.
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- in
Fatturi li għandhom jitqiesu f’ din l- evalwazzjoni għandhom jinkludu t- tip ta ’ Pr
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
4.5 Interaction with other medicinal products and other forms of interaction
72 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
Ir- riżultati kliniċi li nġabru s’ issa ma jindikaw l- ebda interazzjoni ta ’ Nespo ma ’ sustanzi oħra.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
Madankollu, jista ’ jkun hemm potenzjal għal interazzjoni ma ’ mediċini li jeħlu b’ mod qawwi maċ - ċelluli ħomor tad- demm eżempju, cyclosporin, tacrolimus.
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.
Jekk darbepoetin alfa jingħata flimkien ma ’ xi waħda minn dawn il- mediċini, il- livell fid- demm ta ’ dawn is- sustanzi għandu jiġi mmonitorjat u d - doża regolata hekk kif tiżdied l- emoglobina.
67 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
For Nespo no clinical data on exposed pregnancies are available.
t za M ’ hemm l- ebda tagħrif kliniku disponibbli dwar l- effett ta ’ Nespo fuq it- tqala.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
riz Studji fuq l- annimali ma jindikawx effetti ta ’ ħsara diretta f’ dak li għandu x ’ jaqsam mat- tqala, l - iżvilupp ta ’ l- embriju u tal- fetu, il- ħlas jew l- iżvilupp ta ’ wara t- twelid.
Caution should be exercised when prescribing to pregnant women.
to Nespo għandu jingħata b’ attenzjoni lill- nisa tqal.
As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
aw Billi m’ hemm l- ebda esperjenza klinika relatata ma ’ nisa li qed ireddgħu, Nespo m’ għandux jingħata lil dawn in- nisa.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Meta l- kura b’ Nespo hija assolutament meħtieġa, il- mara għandha tieqaf mit -
ed 4.7 Effects on ability to drive and use machines
x treddiegħ.
There have been no observed effects with Nespo on the ability to drive and use machines.
du Effetti fuq il- ħila biex issuq u tħaddem magni 4. 7 ħa Ma ġewx osservati effetti b 'Nespo fuq il- ħila biex issuq jew tħaddem magni. ’ g 4. 8 Effetti mhux mixtieqa im
is or 4.8 Undesirable effects
Ġenerali
th General
Kien hemm rapporti ta ’ reazzjonijiet ta ’ sensittività eċċessiva serji li jinkludu reazzjonijiet anafilattiċi, il
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
anġioedema, qtugħ ta 'nifs, raxx tal- ġilda u urtikarja, assoċjati ma ’ darbapoetin alfa. al
Clinical Trial Experience er ng Chronic renal failure patients lo
Pazjenti b 'insuffiċjenza renali kronika iċ
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
Tagħrif ippreżentat minn studji kkontrollati inkludew 1357 pazjenti, 766 li ngħataw Nespo u 591 ed
patients who received r-HuEPO.
pazjent li ngħataw r- HuEPO.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
Fil- grupp ta ’ Nespo, 83% kienu fuq dijaliżi u 17% ma kienux fuq dijaliżi. m
The injection site du
L- iskumdità fis- sit ta 'l- injezzjoni t ot
discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ro
kienet ġeneralment moderata u temporanja u nħasset l- aktar wara l- ewwel injezzjoni. od
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
Pr
studies are: a
73
68 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
75 istudju l- ieħor kien studju open- label.
70 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
CRF following both intravenous and subcutaneous administration. a
76 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
71 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
77 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 50 µg Nespo solution for injection in 0.5 ml (100 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '50 µg f' 0. 5 ml (100 µg/ ml).
72 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 011 1 Pack Blister lo EU/ 1/ 01/ 184/ 012 4 Pack Blister EU/ 1/ 01/ 184/ 038 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 011 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 012 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 038 Pakkett ta '1 (mhux ġo folja)
Nespo 60 micrograms solution for injection in a pre-filled syringe.
Nespo 60 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 ml (200 µg/ ml).
Kull siringa mimlija għal- lest fiha 60 mikrogramma ta 'darbepoetin alfa f' 0. 3 ml (200 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
80 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
74 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
81 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
75 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
82 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
4.3 Contraindications
83 4. 3 Kontra- indikazzjonijiet
77 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
84 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
78 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
85 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
79 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
86
80 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
88 istudju l- ieħor kien studju open- label.
82 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
CRF following both intravenous and subcutaneous administration. a
89 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
83 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
90 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 60 µg Nespo solution for injection in 0.3 ml (200 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '60 µg f' 0. 3 ml (200 µg/ ml).
84 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 013 1 Pack Blister lo EU/ 1/ 01/ 184/ - 014 4 Pack Blister EU/ 1/ 01/ 184/ 039 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 013 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 014 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 039 Pakkett ta '1 (mhux ġo folja)
Nespo 80 micrograms solution for injection in a pre-filled syringe.
Nespo 80 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ ml).
Kull siringa mimlija għal- lest fiha 80 mikrogramma ta 'darbepoetin alfa f' 0. 4 ml (200 µg/ ml).
If it occurs, appropriate dose adjustment should be made as provided.
Jekk dan jseħħ, għandu sir aġġustament fid- doża kif meħtieġ.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
93 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
86 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
94 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
87 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
95 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
4.3 Contraindications
96 4. 3 Kontra- indikazzjonijiet
89 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
than 12 g/ dl (7.5 mmol/ l). ed
97 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
90 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
98 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
91 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
99
92 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
101 istudju l- ieħor kien studju open- label.
94 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
x jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
CRF following both intravenous and subcutaneous administration. a
102 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
95 effect (decreased tissue perfusion due to increased blood viscosity).
du ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.4 Special precautions for storage ro
103 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 80 µg Nespo solution for injection in 0.4 ml (200 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '80 µg f' 0. 4 ml (200 µg/ ml).
96 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 015 1 Pack Blister lo EU/ 1/ 01/ 184/ 016 4 Pack Blister EU/ 1/ 01/ 184/ 040 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 015 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 016 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 040 Pakkett ta '1 (mhux ġo folja)
Nespo 100 micrograms solution for injection in a pre-filled syringe.
Nespo 100 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 ml (200 µg/ ml).
Kull siringa mimlija għal- lest fiha 100 mikrogramma ta 'darbepoetin alfa f' 0. 5 ml (200 µg/ ml).