qanastek/EMEA-V3 huggingface dataset:
General Disorders and Administration Site Conditions ed
Disturbi ġenerali u kondizzjonijiet
placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
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).
176 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
189 L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
Very Common (≥ 1/ 10)
t Komuni ħafna (≥1/ 10)
Oedema
za ta 'mnejn jingħata
ed Postmarketing Experience
riz Esperjenza wara t- tqegħid fuq is- suq
is The following adverse reactions have been identified during postmarketing use of Nespo:
to Ir- reazzjonijiet avversi li ġejjin ġew identifikati waqt l- użu wara t- tqegħid fuq is- suq ta ’ Nespo:
or th • Pure Red Cell Aplasia.
aw • Aplażja pura ta ’ ċelluli ħomor (PRCA).
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 b’ Aranaesp l- aktar f’ pazjenti b’ insuffiċjenza renali kronika (CRF) ikkurati minn taħt il- ġilda.
au patients with CRF treated subcutaneously.
x F’ każ li aplażja pura ta ’ ċelluli ħomor (PRCA) tiġi djanjostikata, il- kura, b’ Nespo għandha
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).
du titwaqqaf u l- pazjenti m’ għandhiex tinbidlilhom il- kura għal proteina rikombinanti eritropojetika
• 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. ’ g • Aċċessjonijiet. im
4.9 Overdose no
4. 9 Doża eċċessiva
Even at very high serum levels, no symptoms of overdose have been observed. ct du
sintomi ta ’ doża eċċessiva ma ġew osservati. al
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
Jekk klinikament in
If clinically indicated, phlebotomy may be performed. ro lp
indikat, tista ’ ssir flebotomija. iċ ed
5.1 Pharmacodynamic properties in
5. 1 Tagħrif farmakodinamiku m
B03XA02. ic ed
B03XA02. t ot
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
L- eritropojetina umana hija ormon glikoprotejiku endoġenu li hija r- regolatur ewlieni ta ’ l- eritropojeżi permezz ta ’ l- interazzjoni speċifika mar- riċettur ta ’ l- eritropojetina fuq iċ- ċelluli eritrojdi proġenituri od
The production of erythropoietin primarily occurs in and is regulated by the M
Il- produzzjoni ta ’ l- eritropojetina endoġena hija mnaqqsa Pr
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
f’ pazjenti b 'insuffiċjenza renali kronika u l- kawża ewlenija ta ’ l- anemija tagħhom hija minħabba nuqqas f' eritropojetina.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Darbepoetin alfa tistimola l- eritropojeżi bl- istess mekkaniżmu ta ’ l- ormon endoġenu.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Minħabba l- kontenut akbar ta ’ karboidrati, darbepoetin alfa
177 in vivo activity.
190 għandha half- life terminali itwal minn r- HuEPO, u għalhekk għandha attività in vivo akbar.
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
Fi studju prospettiv, randomised double- blind, ikkontrollat bil- plaċebo, li sar fuq 314- il pazjent b’ kanċer fil- pulmun li kienu qed jirċievu kimoterapija li fiha l- platinum, kien hemm tnaqqis sinifikattiv fil- ħtiġijiet ta ’ trasfużjoni (p < 0. 001).
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
t za Studji kliniċi wrew li darbepoetin alfa kellha effikaċja simili meta ngħatat bħala injezzjoni waħda darba kull tliet ġimgħat, darba kull ġimgħatejn, jew darba fil- ġimgħa mingħajr l- ebda żieda fil- ħtiġijiet tad- doża totali.
ed The safety and effectiveness of once every three weeks dosing of Nespo therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a
riz Is- sigurtà u l- effikaċja ta 'ddożar ta' Nespo darba kull tliet ġimgħat biex titnaqqas il- ħtieġa ta '
is randomised, double-blind, multinational study.
to trasfużjonijiet ta 'ċelluli ħomor tad- demm f' pazjenti li kienu qed jirċievu l- kimoterapija ġew assessjati fi studju randomized, double- blind, multi- nazzjonali.
This study was conducted in 705 anaemic patients with
Dan l- istudju sar f '705 pazjent anemiku b'
or non-myeloid malignancies receiving multi-cycle chemotherapy.
aw tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija ta 'bosta ċikli.
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
Il- pazjenti ġew randomised biex jirċievu Nespo b 'doża ta' 500 μg darba kull tliet ġimgħat jew 2. 25 μg / kg darba fil - ġimgħa.
In both groups, the dose was
Fiż- żewġ gruppi, id- doża ġiet mnaqqsa b '40% mid- doża ta' qabel (eżempju, l- ewwel tnaqqis
th reduced by 40% of the previous dose (e. g., for first dose reduction, to 300 μ g in the once every three weeks group and 1.35 μ g / kg in the once weekly group) if haemoglobin increased by more than 1 g/ dl
x fid- doża, tnaqqis għal 300 μg fil- grupp ta 'darba kull tliet ġimgħat u tnaqqis għal 1. 35 μg / kg fil- grupp
au in a 14-day period.
du ta 'darba fil- ġimgħa) jekk l- emoglobin żdiedet b' aktar minn 1 g/ dl f 'perijodu ta' 14- il ġurnata.
This study supports 500 μ g once
Fil- grupp ta 'darba fil- ġimgħa, 75% tal- pazjenti kellhom bżonn tnaqqis fid- doża.
er every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase. ng In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic lo patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001). no
Dan l- istudju jsostni li 500 μg darba kull ħa tliet ġimgħat huwa komparabbli għal għoti ta 'darba fil- ġimgħa, fl- aspett li l- inċidenza ta' individwi li rċevew mill- anqas trasfużjoni ta 'ċelluli ħomor tad- demm waħda mill- ħames ġimgħa sa l- aħħar fażi ’ g tal- kura. im
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
Ġie osservat ukoll titjib fl- għeja il
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
li ġie mkejjel bil- kejl Functional Assessment of Cancer Therapy- fatigue (FACT- fatigue). al
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Ir - in
Survival and tumour progression have been examined in five large controlled studies involving a total ro
riċetturi ta 'eritropojetina jistgħu jiġu esprimati fuq il- wiċċ ta' varjetà ta 'ċelluli ta' tumur. iċ
The lp
L- għejxien u l- progressjoni tat- tumur ġew eżaminati f ’ ħames studji kkontrollati kbar li involvew total ta ’ 2833 pazjent, liema minnhom erba ’ studji kieku studji double blind kkontrollati bil- placebo u l - ed
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Għal tnejn mill- istudji ntagħżlu pazjenti li kien qed jiġu kkurati bil- kimoterapija.
In the open-label study there was no difference in overall survival between patients treated a
Il- konċentrazzjoni targit ta ’ l- emoglobina f ’ żewġ studji kienet > 13 g/ dl; fit- tlitt m
with recombinant human erythropoietin and controls.
studji l- oħra kienet 12- 14 g/ dl.
In the four placebo-controlled studies the hazard in
F’ erba ’ studji t
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
kkontrollati bil- placebo r- ratio ta ’ periklu ta ’ l- għejxien kien bejn 1. 25 u 2. 47 favur dawk li rċevew il - ot
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
Dawn l- istudji wrew eċċess ta ’ mortalità statistikament sinnifikanti mhux spejgat f ’ pazjenti li għandhom anemija assoċjata ma ’ varji tipi ta ’ kanċer komuni li rċevew eritropoeitin rikombinanti od
associated with various common cancers who received recombinant human erythropoietin compared ed
uman meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human M
Ir- riżultat ta ’ l- għejxien fl- istudji ma setgħax jiġi spejgat b ’ suddisfazzjoni bid- differenzi ta ’ l- inċidenza tat- trombożi u kumplikazzjonijiet relatati bejn dawk li Pr
erythropoietin and those in the control group.
rċevew l- eritropoeitin rikombinanti uman u dawk fil- grupp ta ’ kontroll.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Analażi sistematika saret fuq 9000 pazjent bil- kancer li pparteċipaw f ’ 57 studji kliniċi.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Għalhekk hemm evidenża konsistenti li tissuġġerixxi li jista ’ jkun hemm ħsara sinnifikanti lil pazjenti bil- kanċer li qed jiġu
178 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Iċ- ċans li dawn l- affarijiet jseħħu jistgħu japplikaw għal pazjenti bil- kanċer, li jirċievu eritropeotin rikombinanti uman, li qed jiġu kkurati bil- kimoterapija biex jilħqu konċentrazzjoni ta ’ l- emoglobin ta ’ anqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b ’ dawn il- karatteristiċi ġew inklużi fit- tagħrif li ġie analiżżat.
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
riz Il- farmakokinetika ta ’ darbepoetin alfa ġiet studjata klinikament f’ pazjenti b 'insuffiċjenza renali
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg (SD
Il- clearance ta ’ darbepoetin alfa hija ta ’ 1. 9 ml/ siegħa/ kg (SD 0. 56) u
is 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
aw l- volum ta ’ distribuzzjoni (Vss) huwa bejn wieħed u ieħor l- istess bħall- volum tal- plażma (50 ml/ kg).
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was 73
Wara l- għoti ta 'darbepoetin alfa darba fix- xahar, b' dożi taħt il- ġilda li jvarjaw bejn 0. 6 u 2. 1 µg/ kg, il- half- life terminali kienet ta '73 siegħa
th hours (SD 24).
x (SD 24).
In clinical studies, minimal
Il- half- life terminali ta 'darbepoetin alfa hija itwal meta mogħti taħt il- ġilda milli meta mogħti
au accumulation was observed with either route of administration.
du ġol- vina minħabba l- kinetika ta 'l- assorbiment taħt il- ġilda.
In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Fl- istudji kliniċi, akkumulazzjoni minima ġiet osservata fiż- żewġ modi ta ’ teħid.
er Data from 809 patients receiving Nespo in European clinical studies were analysed to assess the dose ng required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection. lo
Fi studji qabel l- użu kliniku, intwera li l- clearance renali hija minima (sa 2% il- clearance totali), u ma teffettwax il- half life fis- serum. ħa Tagħrif miġbur minn 809 pazjenti li ngħataw Nespo fi studji kliniċi Ewropej ġie analizzat sabiex ’ g tinstab id- doża meħtieġa biex l- emoglobina tinżamm f’ livell stabbli; l- ebda differenza ma ġiet osservata bejn id- doża medja ta 'darba fil- ġimgħa mogħtija b' injezzjoni taħt il- ġilda u bejn dik im
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
Valutazzjoni ta 'farmokinetika ta' darbepoetin alfa f 'pazjenti tfal (3 sa 16- il sena) li għandhom CRF li il
who were either receiving or not receiving dialysis determined pharmacokinetic profiles for sampling periods up to 1 week (168 hours) after a single subcutaneous or intravenous dose.
Meta al
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
mqabbla ma 'tagħrif farmakokinetiku f' adulti li għandhom CRF fl- liema l- istess dewmien ta' sampling in
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
intuża, it- tqabbil wera li l- farmakokinetika ta 'darbepoetin alfa hija simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF.
Following intravenous administration, an approximate 25% difference between du
Wara għoti ġol- vina, ġiet osservata differenza ta '25% fl- erja taħt il- kurva minn iċ
pediatricpatients.
AUC[ 0- ∞] kienet simili f 'ed
Half-life was also similar between adult and paediatric patients with lp
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 m
CRF following both intravenous and subcutaneous administration. a
għoti taħt il- ġilda.
Cancer patients receiving chemotherapy in
Pazjenti bil- kanċer li jirċievu l- kimoterapija t ot
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
Wara l- għoti taħt il- ġilda ta ’ 2. 25 μg/ kg lil pazjenti adulti bil- kanċer, l- ogħla konċentrazzjoni medja ta ’ od
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
10. 6 ng/ ml (SD 5. 9) ta 'darbepoetin alfa ntlaħqet f ’ ħin medju ta ’ 91 siegħa (SD 19. 7).
These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/ kg weekly and 3 to 9 µg/ kg every two weeks).
Dawn il - parametri kienu konsistenti ma ’ farmakokinetiċi tad- doża linjari fuq medda wiesa ’ ta ’ dożi (0. 5 sa 8 Pr
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
μg/ kg kull ġimgħa u 3 sa 9 μg/ kg kull ġimagħtejn).
5.3 Preclinical safety data
192 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
In all studies in rats and dogs Nespo produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
Fl- istudji kollha li saru fuq klieb u firien, Nespo wassal għal żjidiet sostanzjali fl- emoglobina, l - ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
Effetti avversi b’ dożi għoljin ħafna kienu kollha meqjusa bħala relatati għall- effett farmakoloġiku eżaġerat (tnaqqis ta ’ perfużjoni fit- tessuti minħabba żjieda fil- viskożità tad- demm).
These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS complex in dogs but no dysrhythmia and no effect on the QT interval were observed.
Dawn kienu jinkludu majelofibrożi u ipertrofija tal- marrara kif ukoll twessigħ tal- kumpless ECG- QRS fil- klieb, imma ma kienux osservati la tibdil fir- rata ta ’ tħabbit tal- qalb u lanqas effett fuq l- intervall QT.
Nespo did not reveal any genotoxic potential nor did it have any effect on the proliferation of non- haematological cells in vitro or in vivo.
t za Nespo ma wera l- ebda potenzjal ġenotossiku u ma kellu l- ebda effett fuq il- proliferazzjoni ta ’ ċelluli mhux ematoloġiċi in vitro jew in vivo.
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
riz darbepoetin alfa ma ġiex evalwat fi studji fit- tul fuq l- annimali.
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
It -
Placental transfer was minimal.
aw trasferiment mill- plaċenta kien minimu.
No alteration of fertility was detected.
L- ebda bidla fil- fertilità ma ġiet osservata.
ed is 6.
x 6.
or 6.1 List of excipients
Lista ta ’ sustanzi mhux attivi
th Sodium phosphate monobasic Sodium phosphate dibasic
ħa
au Sodium chloride Polysorbate 80
Sodium phosphate monobasic Sodium phosphate dibasic ’ g Sodium chloride Polysorbate 80 im
er Water 6.2
6. 2 Inkompatibilitajiet il
for injections Incompatibilities
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux ma 'Nespo, dan il- prodott al
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
mediċinali m’ għandux jitħallat jew jingħata bħala infużjoni ma ’ prodotti mediċinali oħrajn. in
6.3 Shelf life ct
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali iċ
2 years. du
Sentejn ed
6.4 Special precautions for storage ro
6. 4 Prekawzjonijiet speċjali għall- ħażna m
Store in a refrigerator (2°C – 8°C) Do not freeze. lp
Tagħmlux fil- friża. t ot
Keep the container in the outer carton, in order to protect from light. a
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl. od
period of seven days at room temperature (up to 25°C).
La darba kunjett jkun tneħħa millfriġġ u Pr
refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
jkun laħaq temperatura ambjentali (sa 25°C) dan għandu jintuża fi żmien sebgħat ijiem jew jintrema.
6.5 Nature and contents of container M
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 25 µg Nespo solution for injection in 1 ml (25 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' 25 µg f '1 ml (25 µg/ ml).
180 6.6 Special precautions for disposal
193 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Nespo is a sterile but unpreserved product.
Nespo hija soluzzjoni sterili iżda mhux ppreservata.
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection.
t za Biddel is- sit ta 'l - injezzjoni u injetta bil- mod sabiex tevita l- iskumdità fis- sit ta' l- injezzjoni.
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
ed is 7.
to 7.
or Dompé Biotec S. p. A.
aw Dompé Biotec S. p. A.
th I-20122 Milan Italy
x I- 20122 Milan
au er 8.
du Italja ħa 8.
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ’ g EU/ 1/ 01/ 184/ 025 Pakkett ta '1 EU/ 1/ 01/ 184/ 026 Pakkett ta' 4 im
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI il
8 June 2001 ct
8 Ġunju 2001 al
19 May 2006 du
19 Mejju 2006 in iċ
DATE OF REVISION OF THE TEXT ro lp
DATA TA ’ META ĠIET RIVEDUTA L- KITBA ed m
Detailed information on this medicinal product is available on the website of the European Medicines a
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. t ot od Pr
181 1.
194 1.
Nespo 40 micrograms solution for injection in a vial.
Nespo 40 mikrogramma soluzzjoni għall- injezzjoni ġo kunjett
Each vial contains 40 micrograms of darbepoetin alfa in 1 ml (40 µg/ ml).
Kull kunjett fih 40 mikrogramma ta 'darbepoetin alfa f' 1 ml (40 µg/ ml).
182 Adult patients with chronic renal failure
195 Pazjenti adulti li għandhom insuffiċjenza renali kronika
If the haemoglobin continues to increase, the lp
Jekk l- emoglobina tkompli tiżdied, id - doża m
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
Jekk wara tnaqqis fid - doża il- livell ta ’ l - emoglobina jkompli jizdied, id- doża għandha tigi mnaqqsa bejn wieħed u ieħor b’ 25%.
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
Jekk wara tnaqqis fid - doża il- livell ta ’ l- emoglobina jkompli jizdied id- doża għandha titwaqqaf temporanjament t ot
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to ic
sa kemm l- emoglobina tibda tonqos, fl’ liema punt għandha terġa tinbeda l- kura b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel. od
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo.
196 Studji kliniċi wrew li pazjenti adulti li jirċievu r- HuEPO darba, darbtejn jew tliet darbiet fil- ġimgħa jistgħu jibdlu għal Nespo darba fil- ġimgħa jew darba kull ġimgħatejn.
183 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 individwali.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
197 Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid titnaqqas b 'bejn wieħed u ieħor 25%, skond ir- rata taż- żjieda.
184 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.
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 - doża ta ’ qabel.
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
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
x du Nespo għandu jingħata taħt il- ġilda lil pazjenti b 'anemija (eżempju: konċentrazzjoni ta ’ emoglobina ≤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.
Varjazzjoni fl- emoglobina għandha im
au Due to intra-patient variability, occasional individual haemoglobin values for a patient above and
tiġi ndirizzata permezz ta ’ immaniġjar tad- doża, b ’ kunsiderazzjoni għat- targit ta ’ l- emoglobina ta ’ 10g/ dl (6. 2 mmol/ l) għal 12 g/ dl (7. 5mmol/ l).
er below the desired haemoglobin level may be observed.
ta ’ l- emoglobina jaqbżu it- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt. al
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl ng (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Id- doża rakkomandata fil- bidu hija ta ’ 500 μg (6. 75 μg/ kg) mogħtija darba kull tliet ġimgħat, jew 2. 25 in
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.
μg/ kg piż tal- ġisem mogħtija darba fil- ġimgħa.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct du
Jekk ir- rispons kliniku tal- pazjent (għeja, rispons ta 'l - emoglobina) mhux adegwat wara disa' ġimgħat, aktar kura tista 'ma tkunx effettiva. iċ
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. ro
Il- kura b 'Nespo għandha titwaqqaf bejn wieħed u ieħor erba' ġimgħat wara tmiem il- kimoterapija. ed
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Nespo is used to maintain lp
La darba li l- għan tal- kura għal pazjent individwali jkun ntlaħaq, id- doża trid titnaqqas għal bejn 25% m
Appropriate dose titration between 500 μ g, 300 μ g, and 150 μ g should be considered. a in
Aġġustament xieraq fid- doża ta ’ bejn 500 μg, 300 μg, u 150 μg għandu jiġi kkunsidrat. t ot
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib, jekk l- emoglobina taqbeż it- 12g/ dl (7. 5mmol/ l), id - od
Therapy should be reinitiated at ed
Il- kura b ’ Nespo għandha titwaqqaf temporanjament jekk il- livell ta ’ l- emoglobina jaqbeż it- 13g/ dl (8. 1mmol/ l).
approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) or below.
Il- kura għandha terġa tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel wara li l- emoglobina tkun Pr
M
waqgħet għal 12 g/ dl (7. 5 mmol/ l) jew anqas.
Poorly controlled hypertension.
198 Pressjoni għolja mhux ikkontrollata tajjeb.
185 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
t za Sabiex tiġi assigurata eritropojeżi effettiva, il- qagħda tal- ħadid trid tiġi evalwata għal pazjenti kollha qabel u waqt il- kura u jista ’ jkun hemm l- bżonn ta ’ kura supplementari bil- ħadid.
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
to eritropojeżi u għalhekk għandhom jiġu kkoreġuti.
is may also compromise the erythropoietic response.
L- għadd tar- retikuloċiti għandu jiġi kkunsidrat bħala parti mill- evalwazzjoni.
A reticulocyte count should be considered as part of
Jekk il- kawżi tipiċi ta ’ nuqqas ta ’ rispons jiġu esklużi, u l- pazjent għandu
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
x retikuloċitopenija, eżami tal- mudullun għandu jiġi kkunsidrat.
If the bone marrow is consistent with
Jekk il- mudullun hu konsistenti ma ’
th PRCA, testing for anti-erythropoietin antibodies should be performed.
du aplażja pura ta ’ ċelluli ħomor (PRCA), għandhom jsiru testijiet għal anitkorpi anti- eritropojetiċi.
This has been
Aplażja pura ta ’ ċelluli ħomor ikkawżata minn anitkorpi anti- eritropojetin newtralizzanti ġiet ħa irrappurtata b’ assoċazzjoni ma ’ kura bi proteini rikombinanti eritropojetiċi, inkluża darbepoetin alfa.
er predominantly reported in patients with CRF treated subcutaneously.
Din ġiet irrapurtata l- aktar f’ pazjenti b ’ insuffiċjenza renali kronika (CRF) li ngħataw il- kura taħt il - ’ g ġilda.
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.
Dawn l- antikorpi ntwerew li jgħamlu cross- reaction mal- proteini eritropojetiċi kollha, u pażjenti b’ suspett jew b 'konferma li għandhom antikorpi newtralizzanti għal eritropojetin m’ għandiex im
Since the liver is thought to be the principal route of no
tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8).
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
Mard attiv tal- fwied kien kriterju ta ’ esklużjoni fl- istudji kollha ta ’ Nespo, għalhekk m' hemm l- ebda il
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
Minħabba li huwa maħsub li l- fwied huwa r- rotta ewlenija ta ’ tneħħija ta ’ Nespo u r- HuEPO, Nespo għandu jintuża b’ attenzjoni f’ pazjenti al
This du
Nespo għandu wkoll jintuża b’ attenzjoni f’ pazjenti b’ anemija tat- tip sickle cell jew epilessija. iċ
may be associated with life-threatening complications of the cardiovascular system. ro
Użu ħażin ta ’ Nespo minn persuni b’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum taċ - ed
In clinical studies, an lp
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li jistgħu jpoġġu l- ħajja f’ periklu. m
increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater a
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.
than 12 g/ dl (7.5 mmol/ l). in
Fi studji t ot
Controlled clinical trials have not shown significant benefits attributable to the administration of ic
kliniċi, riskju għola ta ’ mewt, avvenimenti kardjovaskulari serji u trombożi ta’ aċċess vaskulari ġew osservati meta aġenti li jistimolaw l- eritropojesi (ESAs) ġew mogħtija biex jintlaħaq targit ta ’ l - od
epoetins when haemoglobin concentration is increased beyond the level necessary to control ed
emoglobina ta ’ aktar minn 12g/ dl (7. 5 mmol/ l).
M
konċentrazzjoni ta ’ l- emoglobin tiżdied għal aktar mill- livell neċessarju biex tikkontrolla s- sintomi ta ’ l- anemija u biex tevita trasfużjoni tad- demm.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
199 Kura supplementari bil- ħadid hija rakkomandata għall- pazjenti kollha b 'livelli ta ’ ferritin fis- serum taħt 100 μg/ l jew li għandhom saturazzjoni ta ’ transferrin taħt 20%.
186 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.
Cancer patients
riz Pazjenti bil- kanċer
Effect on tumour growth
to Effett fuq it- tkabbir ta 'tumur
Epoetins are growth factors that primarily stimulate red blood cell production.
aw Epoetins huma fatturi ta 'tkabbir li primarjament jistimolaw il- produzzjoni taċ- ċelluli ħomor.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Ir - 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 in patients with anaemia associated with cancer.
x kliniċi kkontrollati, epoetins wrew titjib fl- għejxien jew tnaqqis fir- riskju ta ’ progress ta ’ tumur
is or In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
du f’ pazjenti b’ anemija assoċjata ma ’ kanċer.
au shortened time to tumour progression in patients with advanced head and neck cancer receiving 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.
Fi studji kliniċi kkontrollati, l- użu ta ’ Nespo u aġenti li jistimolaw l- eritropojesi (ESAs) wera: ħa • tnaqqis fil- ħin għal progress ta ’ tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed ’ g 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. im
• er shortened overall survival and increased deaths attributed to disease progression at 4 months in ng patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l) lo
• tnaqqis fit- tul ta ’ ħajja u żjieda fl- imwiet attribwiti ma ’ progressjoni tal- mard f ’ 4 xhur f ’ pazjenti b ’ kanċer metastastiku fis- sider, li qed jirċievu l- kimoterapija, meta ngħatalhom biex il
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in no
jintlaħaq targit ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 – 8. 7 mmol/ l) al
patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for use in this patient population. ct
• żjieda fir- riskju ta ’ mewt meta ngħatalhom biex jintlaħaq targit ta ’ emoglobina ta ’ 12 g/ dl in
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
(7. 5mmol/ l) f ’ pazjenti b ’ tumur mallinn attiv li mhux qed jirċievu la kimoterapija u l- anqas kura bir- raġġi.
The decision to administer recombinant du
ESAs mhux indikata għall- użu f ’ din il- popolazzjoni ta ’ pazjenti. iċ
Factors that should be considered ro
Minħabba dak li ntqal hawn fuq, f’ ċertu sitwazzjonijiet kliniċi l- aħjar kura għal anemija f’ pazjent bil - ed
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- lp
Id- deċiżjoni li jingħataw eritropojetins rikombinanti għandha tkun ibbażata fuq evalwazzjoni tal- benefiċju- riskju bil- parteċipazzjoni tal- pazjent, li għandha tikkunsidra l - m
expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1). a
Fatturi li għandhom jitqiesu f’ din l- evalwazzjoni għandhom jinkludu t- tip ta ’ 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). t ot
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds in
Jekk il- livell ta 'l- emoglobina jaqbeż it- 12 g/ dl (7. 5 mmol/ l), f ’ pazjenti b’ tumuri solidi jew od
12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in ic
L- għadd tal- plejtlits u l- livell ta ’ l - Pr
order to minimise the potential risk of thromboembolic events.
emoglobina għandhom jiġu mmonitorjati b 'intervalli regolari.
4.6 Pregnancy and lactation
200 4. 6 Tqala u treddigħ
187 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.
As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
t za Billi m’ hemm l- ebda esperjenza klinika relatata ma ’ nisa li qed ireddgħu, Nespo m’ għandux jingħata lil dawn in- nisa.
is General
x Ġenerali
or There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
du Kien hemm rapporti ta ’ reazzjonijiet ta ’ sensittività eċċessiva serji li jinkludu reazzjonijiet anafilattiċi, anġioedema, qtugħ ta 'nifs, raxx tal- ġilda u urtikarja, assoċjati ma ’ darbapoetin alfa. ħa Espenjenza fi prova klinika ’ g
Chronic renal failure patients
Pazjenti b 'insuffiċjenza renali kronika im
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. lo
Fil- grupp ta ’ Nespo, 83% kienu fuq dijaliżi u 17% ma kienux fuq il
Injection site pain was reported as attributable to treatment in studies where Nespo was administered no
Fi studji fl ’ liema Nespo ingħata bħala injezzjoni taħt il- ġilda, l- uġigħ fis- sit ta 'l- injezzjoni ġie in
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ct
L- iskumdità fis- sit ta 'l- injezzjoni kienet ġeneralment moderata u temporanja u nħasset l- aktar wara l- ewwel injezzjoni. iċ
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical du
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati mal- kura b’ Nespo fi studji kliniċi ed
studies are: ro
kontrollati huma dawn: m
< 1/ 100) ic
Pr
placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
201 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).
188 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.
202 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.
203 Analażi sistematika saret fuq 9000 pazjent bil- kancer li pparteċipaw f ’ 57 studji kliniċi.
190 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.
204 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.
191 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
205 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 40 µg Nespo solution for injection in 1 ml (40 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' 40 µg f '1 ml (40 µg/ ml).
192 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 184/ 027 1 Pack EU/ 1/ 01/ 184/ 028 4 pack lo no
EU/ 1/ 01/ 184/ 027 Pakkett ta '1 EU/ 1/ 01/ 184/ 028 Pakkett ta' 4 iċ ed
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI m
8 June 2001 ct
8 Ġunju 2001 Data ta 'l- aħħar tiġdid:
193 1.
206 1.
Nespo 60 micrograms solution for injection in a vial.
Nespo 60 mikrogramma soluzzjoni għall- injezzjoni ġo kunjett
Each vial contains 60 micrograms of darbepoetin alfa in 1 ml (60 µg/ ml).
Kull kunjett fih 60 mikrogramma ta 'darbepoetin alfa f' 1 ml (60 µg/ ml).
194 Adult patients with chronic renal failure
207 Pazjenti adulti li għandhom insuffiċjenza renali kronika
is approximately 25% lower than the previous dose.
to punt il- kura għandha terġa tinbeda b ’ doza ta ’ bejn wieħed u ieħor doża ta ’ 25% anqas mid- doża ta ’ qabel.
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
Jekk wara tnaqqis fid - doża il- livell ta ’ l- emoglobina jkompli jizdiedid- doża għandha titwaqqaf temporanjament t ot
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo.
208 Studji kliniċi wrew li pazjenti adulti li jirċievu r- HuEPO darba, darbtejn jew tliet darbiet fil- ġimgħa jistgħu jibdlu għal Nespo darba fil- ġimgħa jew darba kull ġimgħatejn.
195 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 individwali.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
209 Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid titnaqqas b 'bejn wieħed u ieħor 25%, skond ir- rata taż- żjieda.
196 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.
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 - doża ta ’ qabel.
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.
Id- doża rakkomandata fil- bidu hija ta ’ 500 μg (6. 75 μg/ kg) mogħtija darba kull tliet ġimgħat, jew 2. 25 in
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. ro
Jekk ir- rispons kliniku tal- pazjent (għeja, rispons ta 'l - emoglobina) mhux adegwat wara disa' ġimgħat, aktar kura tista 'ma tkunx effettiva. iċ
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Nespo is used to maintain lp
Il- kura b 'Nespo għandha titwaqqaf bejn wieħed u ieħor erba' ġimgħat wara tmiem il- kimoterapija. ed m
haemoglobin at a level that controls the symptoms of anaemia.
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 - sintomi ta ’ l- anemija.
Appropriate dose titration between 500 μ g, 300 μ g, and 150 μ g should be considered. a in
Aġġustament xieraq fid- doża ta ’ bejn 500 μg, 300 μg, u 150 μg għandu jiġi t ot
Treatment with Nespo should be temporarily ic
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%.
discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Il- kura b ’ Nespo għandha titwaqqaf temporanjament jekk il- livell ta ’ l- emoglobina jaqbeż it- 13g/ dl (8. 1mmol/ l).
Therapy should be reinitiated at ed
Il- kura għandha terġa Pr
M
tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel wara li l- emoglobina tkun waqgħet għal 12 g/ dl (7. 5 mmol/ l) jew anqas.
Poorly controlled hypertension.
210 Pressjoni għolja mhux ikkontrollata tajjeb.
197 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
Deficiencies of
riz Nuqqas ta ’ rispons għal kura b’ Nespo għandu jġiegħel li tinbeda tfittxija għal fatturi kawżattivi.
ed iron, folic acid or vitamin B12 reduce the effectiveness of erythropoiesis stimulating agents and should therefore be corrected.
to Nuqqas ta ’ ħadid, folic acid jew ta ’ vitamina B12 jnaqqsu l- effikaċja ta ’ l- aġenti li jistimolaw l - eritropojeżi u għalhekk għandhom jiġu kkoreġuti.
is may also compromise the erythropoietic response.
aw episodji ta ’ infjammazjoni jew trawma, telf ta ’ demm (li ma jidhirx waqt eżami mediku), emoliżi, tossiċità severa ta ’ aluminju, mard ematoloġiku moħbi, jew fibrożi fil- mudullun jistgħu wkoll jikkompromettu r- rispons eritropojetiku.
or the evaluation.
x mill- evalwazzjoni.
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
Jekk il- kawżi tipiċi ta ’ nuqqas ta ’ rispons jiġu esklużi, u l- pazjent għandu
th PRCA, testing for anti-erythropoietin antibodies should be performed.
du retikuloċitopenija, eżami tal- mudullun għandu jiġi kkunsidrat.
This has been
Dawn l- antikorpi ntwerew li jgħamlu cross- reaction mal- proteini eritropojetiċi kollha, u pażjenti im
er predominantly reported in patients with CRF treated subcutaneously.
b’ suspett jew b 'konferma li għandhom antikorpi newtralizzanti għal eritropojetin m’ għandiex tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8). il
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.
Mard attiv tal- fwied kien kriterju ta ’ esklużjoni fl- istudji kollha ta ’ Nespo, għalhekk m' hemm l- ebda tagħrif fuq pazjenti b 'indeboliment tal- funzjoni tal- fwied.
Since the liver is thought to be the principal route of no
Minħabba li huwa maħsub li l- fwied huwa al
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
r- rotta ewlenija ta ’ tneħħija ta ’ Nespo u r- HuEPO, Nespo għandu jintuża b’ attenzjoni f’ pazjenti in
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
b’ mard tal- fwied. iċ
This du
Nespo għandu wkoll jintuża b’ attenzjoni f’ pazjenti b’ anemija tat- tip sickle cell jew epilessija. ed
may be associated with life-threatening complications of the cardiovascular system. ro
Użu ħażin ta ’ Nespo minn persuni b’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum taċ - ċelluli ppakkjati.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li jistgħu m
In clinical studies, an lp
jpoġġu l- ħajja f’ periklu.
increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater a
F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina t ot
than 12 g/ dl (7.5 mmol/ l). in
m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
Controlled clinical trials have not shown significant benefits attributable to the administration of ic
Fi studji kliniċi, riskju għola ta ’ mewt, avvenimenti kardjovaskulari serji u trombożi ta’ aċċess vaskulari ġew od
epoetins when haemoglobin concentration is increased beyond the level necessary to control ed
Pr
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
211 Kura supplementari bil- ħadid hija rakkomandata għall- pazjenti kollha b 'livelli ta ’ ferritin fis- serum taħt 100 μg/ l jew li għandhom saturazzjoni ta ’ transferrin taħt 20%.