qanastek/EMEA-V3 huggingface dataset:
198 Serum potassium levels should be monitored regularly during Nespo therapy.
Il- livelli ta ’ potassium fis- serum għandhom jiġu mmonitorjati b’ mod regolari waqt kura b’ Nespo.
4.6 Pregnancy and lactation
212 4. 6 Tqala u treddigħ
199 Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
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.
placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
213 Reazzjonijiet avversi ġew determinati fuq l- informazzjoni li nġabret minn sebgħa studji, randomised, double- blind, kkontrollati bi plaċebo ta ’ Nespo b ’ total ta ’ 2112- il pazjent (Nespo 1200, plaċebo 912).
200 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:
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
214 Darbepoetin alfa tistimola l- eritropojeżi bl- istess mekkaniżmu ta ’ l- ormon endoġenu.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
215 Analażi sistematika saret fuq 9000 pazjent bil- kancer li pparteċipaw f ’ 57 studji kliniċi.
202 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
t jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
216 hemm żjieda moderata mistennija (< darbtejn) fil- konċentrazzjoni fis- serum hekk kif qagħda stabbli kienet avviċinata, iżda l- ebda akkumulazzjoni mhux mistennija ma seħħet meta ngħataw aktar dożi.
203 effect (decreased tissue perfusion due to increased blood viscosity).
t za ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
6.5 Nature and contents of container M
217 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Package containing one or four clear glass vial(s) with rubber stopper(s) of 60 µg Nespo solution for injection in 1 ml (60 µg/ ml).
Pakkett li fih kunjett wieħed jew erba 'kunjetti ta' ħġieġ ċar b 'tapp( ijiet) tal- lastiku b' soluzzjoni għall - injezzjoni ta 'Nespo ta' 60 µg f '1 ml (60 µg/ ml).
204 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 184/ 029 1 Pack EU/ 1/ 01/ 184/ 030 4 pack lo no
EU/ 1/ 01/ 184/ 029 Pakkett ta '1 EU/ 1/ 01/ 184/ 030 Pakkett ta' 4 iċ ed
205 1.
218 1.
Nespo 10 micrograms solution for injection in a pre-filled pen.
Nespo 10 mikrogrammi soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ ml).
Kull pinna mimlija għal- lest fiha 10 mikrogrammi ta 'darbepoetin alfa f' 0. 4 ml (25 µg/ ml).
or Solution for injection (injection) in a pre-filled pen.
aw Soluzzjoni għall- injezzjoni (injezzjoni) ġo pinna mimlija għal- lest (SureClick).
Nespo (SureClick) is supplied ready for use in a pre-filled pen.
imsemmija hawn fuq. in
The pre-filled pen is only for subcutaneous administration.
Nespo (SureClick) jiġi lest għall- użu ġo pinna mimlija għal- lest.
The instructions for use, handling and disposal are given in section 6.6. ro lp
L- istruzzjonijiet għall- użu, l - iċ
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
immaniġġjar u r- rimi huma mniżżla f’ sezzjoni 6. 6. ed
Treatment with Nespo is divided into two stages – correction and maintenance phase.
219 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
206 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
F 'pazjenti mhux fuq dijalisi, la darba t- targit tal- konċentrazzjoni ta ’ emoglobina tkun ntlaħqet b' iddożar ta 'darba kull ġimgħatejn, Nespo il
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
jista 'jingħata darba fix- xahar bħala injezzjoni taħt il- ġilda b' doża tal- bidu ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba kull ġimgħatejn. al in
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.
220 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.
207 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
Because of individual variability, titration to ed
Id- doża tal- biduf 'pazjenti tfal ta ’ Nespo ta' darba fil- ġimgħa jew ta 'darba kull ġimgħatejn (µg/ ġimgħa) tista' tiġi ddeterminata billi tiddividi d- doża totali ta 'ġimgħa ta' r- HuEPO (IU/ ġimgħa) b '240.
Dosing should be titrated as necessary to maintain the haemoglobin target.
L - iddożar għandu jiġi kkalkulat skond il- bżonn biex tinżamm it- targit ta ’ emoglobina
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
221 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%.
208 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
222 4. 3 Kontra- indikazzjonijiet
209 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have ng neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8). lo Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function.
Din ġiet irrapurtata l- aktar f’ pazjenti b ’ insuffiċjenza renali kronika (CRF) li ngħataw il- kura minn taħt il- ġilda.
Since the liver is thought to be the principal route of no
Dawn l- antikorpi ntwerew li jgħamlu cross- reaction mal- proteini eritropojetiċi kollha, u il
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
pażjenti b’ suspett jew b 'konferma li għandhom antikorpi newtralizzanti għal eritropojetin m’ għandiex tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8). al in
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions. lp
Użu ħażin ta ’ Nespo minn persuni b’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum taċ - ċelluli ppakkjati.
Nespo should be used with caution in patients with epilepsy.
223 Nespo għandu jintuża b 'attenzjoni f' pazjenti li għandhom epilessija.
210 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 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
Jekk il- livell ta 'l- emoglobina jaqbeż it- 12 g/ dl (7. 5 mmol/ l) f ’ pazjenti b’ tumuri solidi jew limfoproliferattivi, l- addattament tad- doża kif deskritt f’ sezzjoni 4. 2 għandu jiġi rispettat b’ attenzjoni, sabiex jitnaqqas ir- riskju potenzjali ta ’ episodji tromboemboliċi.
4.5 Interaction with other medicinal products and other forms of interaction
224 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
211 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
studies are: a
225
Cancer patients
za Pazjenti bil- kanċer
212 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.
227 istudju l- ieħor kien studju open- label.
214 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 ’
Following intravenous administration, an approximate 25% difference between du
Meta mqabbla ma 'tagħrif farmakokinetiku f' adulti li għandhom CRF fl’ liema l- istess dewmien ta' sampling intuża, it- tqabbil wera li l- farmakokinetika ta 'darbepoetin alfa hija simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF.
CRF following both intravenous and subcutaneous administration. a
228 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.
215 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
229 6. 4 Prekawzjonijiet speċjali għall- ħażna
Once a pre-filled pen has been removed from ic
La darba pinna mimlija għal- lest tkun tneħħiet mill- friġġ u tkun laħqet temperatura ambjentali (sa 25°C) din għandha tintuża fi żmien sebgħat ijiem jew tintrema.
Package containing one or four pre-filled pens of a 10 µg Nespo solution for injection in 0.4 ml (25 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '10 µg f' 0. 4 ml (25 µg/ ml).
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
to Is- siringi ġewwa il- pinen huma magħmula minn ħġieġ Tip I b 'labar ta' l- azzar li ma jissaddatx kejl 27.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
aw L- għatu tal- labra tal- pinna mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex).
The carton contains a package leaflet with the full instructions for use and handling.
x du Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar. ’ g Il- pinna mimlija għal- lest b 'Nespo (SureClick) tagħti d- doza kompleta li msemmija fuq il- pakkett. im
Do not administer more than one dose per pen.
Tagħtix aktar minn doża waħda b 'pinna waħda.
Each pen may only be used once.
Kull pinna tista 'tintuża darba biss.
Any medicinal product remaining in the pre-filled pen should be disposed of.
Il- prodott mediċinali li jifdal ġewwa l- pinna mimlija għal- lest għandu jintrema. il
Only solutions which are colourless, clear or slightly opalescent, should be injected.
injezzjonijiet b 'soluzzjoni mingħajr kulur, ċara jew kemm kemm tiddi b' ħafna lwien.
Do not shake.
Tħawwadx. in
Allow the pre- filled pen to reach room temperature before injecting.
Ħalli l- pinna mimlija għal- lest tilħaq temperatura ambjentali qabel ma tinjetta. iċ
ed Rotate the injection sites to avoid discomfort at the site of injection.
Biddel is- sit ta 'l - injezzjoni u injetta bil- mod sabiex tevita l- iskumdità fis- sit ta' l- injezzjoni. ed
is Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali. m t
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ot
au Dompé Biotec S. p. A.
Dompé Biotec S. p. A. od
Via San Martino 12
Via San Martino 12 I- 20122 Milan Pr
MARKETING AUTHORISATION NUMBERS no
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 01/ 184/ 045 1 pack EU/ 1/ 01/ 184/ 057 4 pack ct
EU/ 1/ 01/ 184/ 045 – 1 pack EU/ 1/ 01/ 184/ 057 – 4 pack
9.
230 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
8 June 2001 ro
8 Ġunju 2001 Data ta 'l- aħħar tiġdid:
19 May 2006 lp
19 Mejju 2006
DATE OF REVISION OF THE TEXT a in ic
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
Detailed information on this medicinal product is available on the website of the European Medicines ed
t za Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Agency (EMEA) http: / /www. emea. europa. eu/ M
riz to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
217 1.
231 1.
Nespo 15 micrograms solution for injection in a pre-filled pen.
Nespo 15- il mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ ml).
Kull pinna mimlija għal- lest fiha 15- il mikrogramma ta 'darbepoetin alfa f' 0. 375 ml (40 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
232 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
218 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.
233 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.
219 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%.
234 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%.
220 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
235 4. 3 Kontra- indikazzjonijiet
221 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
Nespo should be used with caution in patients with epilepsy.
236 Nespo għandu jintuża b 'attenzjoni f' pazjenti li għandhom epilessija.
222 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.
4.5 Interaction with other medicinal products and other forms of interaction
237 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
223 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
studies are: a
238
224 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:
5.
239 5.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
240 istudju l- ieħor kien studju open- label.
226 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
241 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.
227 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
242 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 15 µg Nespo solution for injection in 0.375 ml (40 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '15 µg f' 0. 375 ml (40 µg/ ml).
EU/ 1/ 01/ 184/ 046 1 pack EU/ 1/ 01/ 184/ 058 4 pack ct
EU/ 1/ 01/ 184/ 046 – Pakkett ta '1 EU/ 1/ 01/ 184/ 058 – Pakkett ta' 4
229 1.
244 1.
Nespo 20 micrograms solution for injection in a pre-filled pen.
Nespo 20 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 20 micrograms of darbepoetin alfa in 0.5 ml (40 µg/ ml).
Kull pinna mimlija għal- lest fiha 20 mikrogramma ta 'darbepoetin alfa f' 0. 5 ml (40 µg/ ml).
For excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1..
Treatment with Nespo is divided into two stages – correction and maintenance phase.
245 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
230 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.
246 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.
231 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%.
247 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%.
232 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
248 4. 3 Kontra- indikazzjonijiet
233 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
249 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.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
to 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%.
234 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 ’
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.
x dawn il- pazjenti, għandu jkun immirat li jintlaħaq l- ogħla limitu ta ’ 12- il g/ dl (7. 5mmol/ l), dejjem jekk
Serum potassium levels should be monitored regularly during Nespo therapy.
du sintomi serveri (eżempju: anġina) ma jiddettawx mod ieħor.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
Il- livelli ta ’ potassium fis- serum għandhom jiġu mmonitorjati b’ mod regolari waqt kura b’ Nespo. ħa 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 ’ g li jitwaqqaf l- għoti ta ’ Nespo sakemm il- livell jiġi korrett. im
ed Effect on tumour growth
Effett fuq it- tkabbir ta 'tumur il
Erythropoietin
Ir - al
is receptors may be expressed on the surface of a variety of tumour cells.
riċetturi ta 'eritropojetina jistgħu jiġu esprimati fuq il- wiċċ ta' varjetà ta 'ċelluli ta' tumur.
As with all growth factors,
Bħal kull in
or there is a concern that epoetins could stimulate the growth of tumours.
fattur ta 'tkabbir, hemm tħassib li l- epoetins jistgħu jistimolaw it- tkabbir ta' tumuri.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
F ’ bosta studji kliniċi kkontrollati, epoetins wrew titjib fl- għejxien jew tnaqqis fir- riskju ta ’ progress ta ’ tumur iċ
th in patients with anaemia associated with cancer.
f’ pazjenti b’ anemija assoċjata ma ’ kanċer. ed
• 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
• 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 mmol/ l), l- użu ta ’ ESAs mhux indikat f ’ din il- popolazzjoni ta ’ pazjenti. t ot
• 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 ’ od
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) Pr
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
250 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).
235 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
251
236 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.
253 istudju l- ieħor kien studju open- label.
238 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
254 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.
239 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
255 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 20 µg Nespo solution for injection in 0.5 ml (40 µg/ ml).
5 ml (40 µg/ ml).
EU/ 1/ 01/ 184/ 047 1 pack EU/ 1/ 01/ 184/ 059 4 pack ct
EU/ 1/ 01/ 184/ 047 – Pakkett ta '1 EU/ 1/ 01/ 184/ 059 – Pakkett ta' 4
Nespo 30 micrograms solution for injection in a pre-filled pen.
Nespo 30 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 30 micrograms of darbepoetin alfa in 0.3 ml (100 µg/ ml).
Kull pinna 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.
258 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
242 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.
259 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.
243 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%.
260 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 wara tnaqqis fid - doża il- livell ta ’ l - emoglobina jkompli jizdied 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 -
244 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
261 4. 3 Kontra- indikazzjonijiet
245 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
262 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.
246 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 ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
263 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).
247 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
264
248 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:
5.
265 5.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
266 istudju l- ieħor kien studju open- label.
250 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
267 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.
251 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
268 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 30 µg Nespo solution for injection in 0.3 ml (100 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '30 µg f' 0. 3 ml 100 µg/ ml).
EU/ 1/ 01/ 184/ 048 1 pack EU/ 1/ 01/ 184/ 060 4 pack ct
EU/ 1/ 01/ 184/ 048 – Pakkett ta '1 EU/ 1/ 01/ 184/ 060 – Pakkett ta' 4
Date of first authoristion:
269 Data ta 'l- ewwel awtorizzazzjoni:
Detailed information on this medicinal product is available on the website of the European Medicines ed
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Agency (EMEA) http: / /www. emea. europa. eu/ M
t za riz to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
253 1.
270 1.
Nespo 40 micrograms solution for injection in a pre-filled pen.
Nespo 10 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ ml).
Kull pinna mimlija għal- lest fiha 10 mikrogramma ta 'darbepoetin alfa f' 0. 4 ml (25 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
271 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
254 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.
272 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.
255 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%.
273 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%.
256 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
274 4. 3 Kontra- indikazzjonijiet
257 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
275 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.
258 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 ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
276 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).
259 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
277
260 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.
279 istudju l- ieħor kien studju open- label.
262 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
280 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.
263 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
281 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 40 µg Nespo solution for injection in 0.4 ml (100 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '10 µg f' 0. 4 ml (25 µg/ ml).
EU/ 1/ 01/ 184/ 049 1 pack EU/ 1/ 01/ 184/ 061 4 pack ct
EU/ 1/ 01/ 184/ 045 – Pakkett ta '1 EU/ 1/ 01/ 184/ 057 – Pakkett ta' 4
265 1.
283 1.
Nespo 50 micrograms solution for injection in a pre-filled pen.
Nespo 50 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 50 micrograms of darbepoetin alfa in 0.5 ml (100 µg/ ml).
Kull pinna 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.
284 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
266 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.
285 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.
267 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%.
286 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%.
268 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
287 4. 3 Kontra- indikazzjonijiet
269 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
288 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.
270 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 ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
289 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).
271 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
290
272 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:
5.
291 5.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
292 istudju l- ieħor kien studju open- label.
274 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
293 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.
275 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
294 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 50 µg Nespo solution for injection in 0.5 ml (100 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '50 µg f' 0. 5 ml (100 µg/ ml).
EU/ 1/ 01/ 184/ 050 1 pack EU/ 1/ 01/ 184/ 062 4 pack ct
EU/ 1/ 01/ 184/ 050 – Pakkett ta '1 EU/ 1/ 01/ 184/ 062 – Pakkett ta' 4
9.
295 9.
277 1.
296 1.
Nespo 60 micrograms solution for injection in a pre-filled pen.
Nespo 60 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 60 micrograms of darbepoetin alfa in 0.3 ml (200 µg/ ml).
Kull pinna 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.
297 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
278 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.
298 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.
279 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%.
299 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%.
280 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
300 4. 3 Kontra- indikazzjonijiet
281 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
301 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.
282 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 ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
302 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).
283 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
303
284 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:
5.
304 5.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
305 istudju l- ieħor kien studju open- label.
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.
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
306 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.
287 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
307 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 60 µg Nespo solution for injection in 0.3 ml (200 µg/ ml).
riz Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '60 µg f' 0. 3 ml (200 µg/ ml).
EU/ 1/ 01/ 184/ 051 1 pack EU/ 1/ 01/ 184/ 063 4 pack ct
EU/ 1/ 01/ 184/ 051 – Pakkett ta '1 EU/ 1/ 01/ 184/ 063 – Pakkett ta' 4
289 1.
309 1.
Nespo 80 micrograms solution for injection in a pre-filled pen.
Nespo 80 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ ml).
Kull pinna mimlija għal- lest fiha 80 mikrogramma ta 'darbepoetin alfa f' 0. 4 ml (200 µg/ ml).
Treatment with Nespo is divided into two stages – correction and maintenance phase.
310 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
290 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.
311 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.
291 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%.
312 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%.
292 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
313 4. 3 Kontra- indikazzjonijiet
293 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
314 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.
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.
F ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
315 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).
295 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
studies are: a
316
296 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:
5.
317 5.