qanastek/EMEA-V3 huggingface dataset:
Therapy should be reinitiated at ic
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) ed
Il- kura għandha terġa 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.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Jekk l- emoglobina tgħola b 'aktar minn 2 g/ dl (1. 25 mmol/ l) f' erba 'ġimgħat, id- doża trid titnaqqas b ’ bejn 25% u 50%.
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Sensittività eċċessiva għal darbepoetin alfa, r- HuEPO jew għal xi sustanzi mhux attivi.
Poorly controlled hypertension.
Pressjoni għolja mhux ikkontrollata tajjeb.
5 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
Blood pressure should be monitored in all patients, particularly during initiation of Nespo therapy.
t za Il- pressjoni tad- demm għandha tiġi mmonitorjata fil- pazjenti kollha, speċjalment fil- bidu tal- kura b’ Nespo.
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Nespo (see section 4.2).
Jekk il- pressjoni tkun diffiċli biex tiġi kkontrollata billi jinbdew miżuri xierqa, l- emoglobina tista ’ tiġi mnaqqsa billi titnaqqas jew titwaqqaf id- doża ta ’ Nespo (ara sezzjoni 4. 2).
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.
riz Sabiex tiġi assigurata eritropojeżi effettiva, il- qagħda tal- ħadid trid tiġi evalwata għal pazjenti kollha
Deficiencies of
to 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.
Nuqqas ta ’ ħadid, folic acid jew ta ’ vitamina B12 jnaqqsu l- effikaċja ta ’ l- aġenti li jistimolaw l - eritropojeżi u għalhekk għandhom jiġu kkoreġuti.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis
Infezzjonijiet li jitfaċċaw minn żmien għal ieħor,
A reticulocyte count should be considered as part of
x episodji ta ’ infjammazjoni jew trawma, telf ta ’ demm (li ma jidhirx waqt eżami mediku), emoliżi,
If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
du tossiċità severa ta ’ aluminju, mard ematoloġiku moħbi, jew fibrożi fil- mudullun jistgħu wkoll jikkompromettu r- rispons eritropojetiku.
If the bone marrow is consistent with
L- għadd tar- retikuloċiti għandu jiġi kkunsidrat bħala parti mill- evalwazzjoni.
th PRCA, testing for anti-erythropoietin antibodies should be performed.
Jekk il- mudullun hu konsistenti ma ’ aplażja pura ta ’ ċelluli ħomor (PRCA), għandhom jsiru testijiet għal anitkorpi anti- eritropojetiċi. ’ g
This has been
Aplażja pura ta ’ ċelluli ħomor ikkawżata minn anitkorpi anti- eritropojetin newtraliżanti ġiet im
er predominantly reported in patients with CRF treated subcutaneously.
irrappurtata b’ assoċazzjoni ma ’ kura bi proteini rikombinanti eritropojetiċi, inkluża darbepoetin alfa.
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 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 pażjenti il
elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.
b’ suspett jew b 'konferma li għandhom antikorpi newtraliżanti għal eritropojetin m’ għandiex tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8). al in
Nespo should also be used with caution in those patients with sickle cell anaemia or epilepsy. ct
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.
This du
r- rotta ewlenija ta ’ tneħħija ta ’ Nespo u r- HuEPO, Nespo għandu jintuża b’ attenzjoni f’ pazjenti b’ mard tal- fwied. ed
may be associated with life-threatening complications of the cardiovascular system. ro
Nespo għandu wkoll jintuża b’ attenzjoni f’ pazjenti b’ anemija tat- tip sickle cell jew epilessija. m
The needle cover of the pre-filled syringe 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.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the a
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li jistgħu t ot
In clinical studies, an in
jpoġġu l- ħajja f’ periklu. od
increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater ic
Pr
than 12 g/ dl (7.5 mmol/ l). ed
6 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.
Controlled clinical trials have not shown significant benefits attributable to the administration of M
Fi studji 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 - emoglobina ta ’ aktar minn 12g/ dl (7. 5 mmol/ l).
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Studji kliniċi kkontrollati ma ’ wrewx benefiċji sinnifikanti attribwiti għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobin tiżdied għal aktar mill- livell neċessarju biex tikkontrolla s- sintomi ta ’ l- anemija u biex tevita trasfużjoni tad- demm.
Nespo should be used with caution in patients with epilepsy.
t za Nespo għandu jintuża b 'attenzjoni f' pazjenti li għandhom epilessija.
Convulsions have been reported in patients receiving Nespo.
Aċċessjonijiet ġew rrappurtati f’ pazjenti li ngħataw Nespo.
Chronic renal failure patients
riz Pazjenti b 'insuffiċjenza renali kronika
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
to Kura supplementari bil- ħadid hija rakkomandata għal pazjenti kollha b 'livelli ta ’ ferritin fis- serum taħt
6 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta'
In these patients an upper limit of 12 g/ dl (7.5 mmol/ l) should be aimed for, unless severe symptoms (e. g. angina) dictate otherwise.
F ’
Serum potassium levels should be monitored regularly during Nespo therapy.
du dawn il- pazjenti, għandu jkun immirat li jintlaħaq l- ogħla limitu ta ’ 12- il g/ dl (7. 5mmol/ l), dejjem jekk sintomi serveri (eżempju: anġina) ma jiddettawx mod ieħor. ħa Il- livelli ta ’ potassium fis- serum għandhom jiġu mmonitorjati b’ mod regolari waqt kura b’ Nespo.
Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
Żjieda fil- potassium ġiet irrappurtata f’ xi pazjenti li ngħataw Nespo, għalkemm il- kawża għadha ma ’ g 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 li jitwaqqaf l- għoti ta ’ Nespo sakemm il- livell jiġi korrett. im
Cancer patients
Pazjenti bil- kanċer il
ed Effect on tumour growth
Effett fuq it- tkabbir ta 'tumur al
Epoetins are growth factors that primarily stimulate red blood cell production.
Epoetins huma fatturi ta 'tkabbir li primarjament jistimolaw il- produzzjoni taċ- ċelluli ħomor.
Erythropoietin
Ir - in
As with all growth factors,
riċetturi ta 'eritropojetina jistgħu jiġu esprimati fuq il- wiċċ ta' varjetà ta 'ċelluli ta' tumur.
or there is a concern that epoetins could stimulate the growth of tumours.
Bħal kull 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 iċ
th in patients with anaemia associated with cancer.
kliniċi kkontrollati, epoetins wrew titjib fl- għejxien jew tnaqqis fir- riskju ta ’ progress ta ’ tumur f’ pazjenti b’ anemija assoċjata ma ’ kanċer. ed
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
Fi studji kliniċi kkontrollati, l- użu ta ’ Nespo u aġenti li jistimolaw l- eritropojesi (ESAs) wera: m
• 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 t ot
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
mmol/ l), l- użu ta ’ ESAs mhux indikat f ’ din il- popolazzjoni ta ’ pazjenti. 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
• 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 jintlaħaq targit ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 – 8. 7 mmol/ l) Pr
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation du
• żjieda fir- riskju ta ’ mewt meta ngħatalhom biex jintlaħaq targit ta ’ emoglobina ta ’ 12 g/ dl (7. 5mmol/ l) f ’ pazjenti b ’ tumur mallinn attiv li mhux qed jirċievu la kimoterapija u l- anqas kura bir- raġġi.
therapy. ESAs are not indicated for use in this patient population. ro
ESAs mhux indikata għall- użu f ’ din il- popolazzjoni ta ’ pazjenti.
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.
Minħabba dak li ntqal hawn fuq, f’ ċertu sitwazzjonijiet kliniċi l- aħjar kura għal anemija f’ pazjent bil - kanċer hija trasfużjoni tad- demm.
Factors that should be considered a
Id- deċiżjoni li jingħataw eritropojetins rikombinanti għandha tkun ibbażata fuq evalwazzjoni tal- benefiċju- riskju bil- parteċipazzjoni tal- pazjent, li għandha tikkunsidra l - kuntest kliniku speċifiku.
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- in
Fatturi li għandhom jitqiesu f’ din l- evalwazzjoni għandhom jinkludu t- tip ta ’
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
7 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).
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.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
L- għadd tal- plejtlits u l- livell ta ’ l - emoglobina għandhom jiġu mmonitorjati b 'intervalli regolari.
The clinical results obtained so far do not indicate any interaction of Nespo with other substances.
t za Ir- riżultati kliniċi li nġabru s’ issa ma jindikaw l- ebda interazzjoni ta ’ Nespo ma ’ sustanzi oħra.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
riz ċelluli ħomor tad- demm eżempju, cyclosporin, tacrolimus.
If darbepoetin alfa is given concomitantly with any of these drugs, blood levels of these drugs should be monitored and the dosage adjusted as the haemoglobin rises.
Jekk darbepoetin alfa jingħata flimkien ma ’ xi waħda minn dawn il- mediċini, il- livell fid- demm ta ’ dawn is- sustanzi għandu jiġi mmonitorjat u d -
7 4.6 Pregnancy and lactation
to doża regolata hekk kif tiżdied l- emoglobina.
For Nespo no clinical data on exposed pregnancies are available.
aw 4. 6 Tqala u treddigħ
Caution should be exercised when prescribing to pregnant women.
M ’ hemm l- ebda tagħrif kliniku disponibbli dwar l- effett ta ’ Nespo fuq it- tqala.
As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
x du 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. ħa Nespo għandu jingħata b’ attenzjoni lill- nisa tqal. ’ g Billi m’ hemm l- ebda esperjenza klinika relatata ma ’ nisa li qed ireddgħu, Nespo m’ għandux jingħata lil dawn in- nisa.
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Meta l- kura b’ Nespo hija assolutament meħtieġa, il- mara għandha tieqaf mit - im
ed 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni il al
There have been no observed effects with Nespo on the ability to drive and use machines.
Ma ġewx osservati effetti b 'Nespo fuq il- ħila biex issuq jew tħaddem magni. in
is or 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa iċ
th General
Ġenerali ed
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
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. m
Clinical Trial Experience er ng Chronic renal failure patients lo
Pazjenti b 'insuffiċjenza renali kronika od
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
Tagħrif ippreżentat minn studji kkontrollati inkludew 1357 pazjenti, 766 li ngħataw Nespo u 591 pazjent li ngħataw r- HuEPO.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
Fil- grupp ta ’ Nespo, 83% kienu fuq dijaliżi u 17% ma kienux fuq Pr
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
Fi studji fl ’ liema Nespo ingħata bħala injezzjoni taħt il- ġilda, l- uġigħ fis- sit ta 'l- injezzjoni ġie attribwit għall- kura.
This was seen more frequently than with r-HuEPO.
Dan deher aktar ta ’ spiss milli b’ r- HuEPO.
discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ro
L- iskumdità fis- sit ta 'l- injezzjoni kienet ġeneralment moderata u temporanja u nħasset l- aktar wara l- ewwel injezzjoni.
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati mal- kura b’ Nespo fi studji kliniċi kontrollati huma dawn:
studies are: a
8
MedDRA system organ class in
Sistema tal- klassifika tal- organi MedDRA
Subject Incidence
Inċidenza fis- suġġett
Adverse Drug Reaction
Effetti mhux mixtieqa
Cardiac Disorders ic
Disturbi fil- qalb
Very Common (≥ 1/ 10)
Komuni ħafna (≥1/ 10)
Skin and Subcutaneous Tissue Disorders ed
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common (≥ 1/ 100 to < 1/ 10)
Komuni (> 1/ 100 to < 1/ 10)
Rash/ Erythema
Raxx/ ħmura
Vascular disorders M
Disturbi vaskulari
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Mhux komuni (≥1/ 1, 000 sa ≤1/ 100)
Thromboembolic Events
Avvenimenti tromboemboliċi
General Disorders and Administration Site Conditions
Disturbi ġenerali u kondizzjonijiet
Injection site pain
Uġigħ fis- sit ta 'l- injezzjoni
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
riz 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).
Patients with solid tumours (e. g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e. g., lymphoma, multiple myeloma) were enrolled in the clinical studies.
to Pazjenti b ’ tumuri solidi (eż. tumuri fil- pulmun, fis- sider, fil- kolon, fl- ovarji) u tumuri limfojdi malinni
8 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:
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Sistema tal- klassifika tal- organi MedDRA
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
Inċidenza fis- suġġett ħa
Adverse Drug Reaction Rash/ Erythema
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common (≥ 1/ 100 to < 1/ 10)
Komuni (> 1/ 100 to < 1/ 10) ’ g im
Thromboembolic events, including pulmonary embolism
Avvenimenti tromboemboliċi, inkluż emboliżmu pulmonari
General Disorders and Administration Site Conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Oedema
Edima
Common (≥ 1/ 100 to < 1/ 10)
Komuni (> 1/ 100 to < 1/ 10) il
ed Postmarketing Experience
Esperjenza wara t- tqegħid fuq is- suq al
is The following adverse reactions have been identified during postmarketing use of Nespo:
Ir- reazzjonijiet avversi li ġejjin ġew identifikati waqt l- użu wara t- tqegħid fuq is- suq ta ’ Nespo: in iċ
or th • Pure Red Cell Aplasia.
• 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 ’ ed
au patients with CRF treated subcutaneously.
F’ każ li aplażja pura ta ’ ċelluli ħomor (PRCA) tiġi djanjostikata, il- kura, b’ Nespo m
In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
għandha titwaqqaf u l- pazjenti m’ għandhiex tinbidlilhom il- kura għal proteina rikombinanti eritropojetika oħra (ara sezzjoni 4. 4). t
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
• Reazzjonijiet allerġiċi, inklużi reazzjonijiet anafilattiċi, anġioedema, raxx tal- ġilda u urtikarja. ot od
4.9 Overdose no
• Aċċessjonijiet.
The therapeutic margin of Nespo is very wide.
Il- marġni terapewtiku ta ’ Nespo huwa wiesa ’ ħafna.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
Anki b’ livelli għoljin ħafna fis- serum, l- ebda sintomi ta ’ doża eċċessiva ma ġew osservati.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
Fil- każ ta ’ poliċitemija, Nespo għandu jitwaqqaf temporanjament (ara sezzjoni 4. 2).
If clinically indicated, phlebotomy may be performed. ro lp
Jekk klinikament indikat, tista ’ ssir flebotomija.
PHARMACOLOGICAL PROPERTIES a
TAGĦRIF FARMAKOLOĠIKU
5.1 Pharmacodynamic properties in
5. 1 Tagħrif farmakodinamiku
Anti-anaemic ATC Code:
Anti- anemiku Kodiċi ATC:
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 fil- mudullun.
The production of erythropoietin primarily occurs in and is regulated by the M
Il- produzzjoni ta ’ l- eritropojetina endoġena hija mnaqqsa
kidney in response to changes in tissue oxygenation.
t za f’ pazjenti b 'insuffiċjenza renali kronika u l- kawża ewlenija ta ’ l- anemija tagħhom hija minħabba nuqqas f' eritropojetina.
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 bil- kanċer li qed jirċievu kimoterapija, l- kawża ta ’ l- anemija għandha ħafna fatturi.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
F’ dawn il- pazjenti, kemm in- nuqqas fl- eritropojetina kif ukoll ir- rispons
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
riz imnaqqas taċ- ċelluli eritrojdi proġenituri jikkontribwixxu b’ mod sinifikattiv għall- anemija.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
to Darbepoetin alfa tistimola l- eritropojeżi bl- istess mekkaniżmu ta ’ l- ormon endoġenu.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Darbepoetin alfa għandha ħames ktajjen ta ’ karboidrati N- linked, filwaqt li l- ormon endoġenu u l- eritropojetina umana
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Ir- residwi ta ’ zokkor żejda ma jingħarfux minn dawk ta ’ l - ormon endoġenu fuq livell molekolari.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Minkejja
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
x dawn il- bidliet molekolari, darbepoetin alfa għandha speċifiċità dejqa ħafna għar- riċettur ta ’ l -
Cancer patients receiving chemotherapy
du eritropojetina.
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).
Pazjenti bil- kanċer li jirċievu l- kimoterapija ħa Fi studju prospettiv, randomised double- blind, ikkontrollat bil- plaċebo, li sar fuq 314- il pazjent ’ g b’ kanċer fil- pulmun li kienu qed jirċievu kimoterapija li fiha l- platinum, kien hemm tnaqqis sinifikattiv fil- ħtiġijiet ta ’ trasfużjoni (p < 0. 001). im
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.
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 il
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
Is- sigurtà u l- effikaċja ta 'ddożar ta' Nespo darba kull tliet ġimgħat biex titnaqqas il- ħtieġa ta 'in
is randomised, double-blind, multinational study.
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' iċ
or non-myeloid malignancies receiving multi-cycle chemotherapy.
tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija ta 'bosta ċikli.
In both groups, the dose was
Il- pazjenti ġew randomised biex jirċievu Nespo b 'doża ta' 500 μg darba kull tliet ġimgħat jew 2. 25 μg / kg darba fil - ed
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
Fiż- żewġ gruppi, id- doża ġiet mnaqqsa b '40% mid- doża ta' qabel (eżempju, l- ewwel tnaqqis fid- doża, tnaqqis għal 300 μg fil- grupp ta 'darba kull tliet ġimgħat u tnaqqis għal 1. 35 μg / kg fil- grupp m
au in a 14-day period.
ta 'darba fil- ġimgħa) jekk l- emoglobin żdiedet b' aktar minn 1 g/ dl f 'perijodu ta' 14- il ġurnata.
In the once every three weeks group, 72% of patients required dose reductions.
Fil - grupp ta 'darba kull tliet ġimgħat, 72% tal- pazjenti kellhom bżonn tnaqqis fid- doża.
In the once weekly group, 75% of patients required dose reductions.
Fil- grupp ta 'darba fil- ġimgħa, 75% tal- pazjenti kellhom bżonn tnaqqis fid- doża.
This study supports 500 μ g once
Dan l- istudju jsostni li 500 μg darba kull t ot
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
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 od
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
Fi studju prospettiv, randomised double- blind, ikkontrollat bil- plaċebo, li sar fuq 344 pazjent anemiku Pr
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
b’ tumur malinn limfoproliferiku li kienu qed jirċievu kimoterapija, kien hemm tnaqqis sinifikattiv fil - ħtiġijiet ta ’ trasfużjoni u titjib fir- rispons ta 'l- emoglobina (p < 0. 001).
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Ġie osservat ukoll titjib fl- għeja li ġie mkejjel bil- kejl Functional Assessment of Cancer Therapy- fatigue (FACT- fatigue).
Survival and tumour progression have been examined in five large controlled studies involving a total ro
Eritropojetina huwa fattur ta 'tkabbir li primarjament jistimola l- produzzjoni taċ- ċelluli ħomor.
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 -
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
10 istudju l- ieħor kien studju open- label.
In the open-label study there was no difference in overall survival between patients treated a
Għal tnejn mill- istudji ntagħżlu pazjenti li kien qed jiġu kkurati bil- kimoterapija.
In the four placebo-controlled studies the hazard in
Il- konċentrazzjoni targit ta ’ l- emoglobina f ’ żewġ studji kienet > 13 g/ dl; fit- tlitt studji l- oħra kienet 12- 14 g/ dl.
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- istudju open- label ma kien hemm l- ebda differenza fl- għejxien bejn pazjenti li ġew kkurati b ’ eritropoetina rikombinanti umana u dawk li rċevew kontroll.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
F’ erba ’ studji kkontrollati bil- placebo r- ratio ta ’ periklu ta ’ l- għejxien kien bejn 1. 25 u 2. 47 favur dawk li rċevew il - kontroll.
associated with various common cancers who received recombinant human erythropoietin compared ed
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 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
erythropoietin and those in the control group.
t 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.
Meta- analiżi
0.99, 1.18; 42 trials and 8167 patients).
riz tat- tgħarif ta ’ l- għejxien pproduċa ratio tar- riskju ta ’ 1. 08 favur il- kontrolli (95% CI: 0. 99, 1. 18; 42 studji u 8167 pazjenti).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
to Riskju relattiv għola ta ’ avveniment thromboemboliċi (RR 1. 67, 95% CI:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
aw pazjent) ġew osservati f ’ pazjenti kkurati b ’ eritropoetin uman rikombinanti.
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 kkurati bl- eritropoetin rikombinanti uman.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Iċ- ċans li dawn l- affarijiet jseħħu jistgħu japplikaw għal pazjenti bil- kanċer, li jirċievu eritropeotin rikombinanti uman, li qed jiġu kkurati bil- kimoterapija biex
10 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 ’
5.2 Pharmacokinetic properties
du dawn il- karatteristiċi ġew inklużi fit- tagħrif li ġie analiżżat. ħa 5. 2 Tagħrif farmakokinetiku
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
B’ hekk darbepoetin alfa tkun tista ’ tingħata inqas ta ’ spiss im
Chronic renal failure patients
Pazjenti b 'insuffiċjenza renali kronika al
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Il- farmakokinetika ta ’ darbepoetin alfa ġiet studjata klinikament f’ pazjenti b 'insuffiċjenza renali kronika wara l- għoti ġol- vina u taħt il- ġilda.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Il- half- life terminali ta ’ darbepoetin alfa hija 21 siegħa in
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
Il- clearance ta ’ darbepoetin alfa hija ta ’ 1. 9 ml/ siegħa/ kg (SD 0. 56) u l- volum ta ’ distribuzzjoni (Vss) huwa bejn wieħed u ieħor l- istess bħall- volum tal- plażma (50 ml/ kg). iċ
or Bioavailability is 37% with subcutaneous administration.
Il- biodisponibilità fil- ġisem hija ta ’ 37% bl- għoti taħt il- ġilda.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was
Wara l- għoti ta 'darbepoetin alfa darba ed
th 73 hours (SD 24).
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 (SD 24).
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
Il- half- life terminali ta 'darbepoetin alfa hija itwal meta mogħti taħt il- ġilda milli meta mogħti ġol- vina minħabba l- kinetika ta' l- assorbiment taħt il- ġilda.
In clinical studies, minimal
Fl- istudji kliniċi, akkumulazzjoni minima m
au accumulation was observed with either route of administration.
ġiet osservata fiż- żewġ modi ta ’ teħid.
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.
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. t ot
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
Tagħrif miġbur minn 809 pazjenti li ngħataw Nespo fi studji kliniċi Ewropej ġie analizzat sabiex tinstab id- doża meħtieġa biex l- emoglobina tinżamm f’ livell stabbli; l- ebda differenza ma ġiet od
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
Pr
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
Valutazzjoni ta 'farmokinetika ta' darbepoetin alfa f 'pazjenti tfal (3 sa 16- il sena) li għandhom CRF li kienu qed jirċievu jew li ma kienux qed jirċievu dijalisi ddetermina profili farmakokinetiċi għal sampling ta' perijodi sa ġimgħa (168 siegħa) wara doża waħda taħt il- ġilda jew ġol- vina.
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.
paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0- ∞) observed for the ro
Wara għoti ġol- vina, ġiet osservata differenza ta '25% fl- erja taħt il- kurva minn ħin 0 sa l- infinità (AUC[ 0- ∞]) bejn pazjenti tfal u pazjenti adulti; madankollu, din id- differenza kienet anqas minn darbtejn il- medda f' AUC[ 0- ∞] osservata f 'pazjenti tfal.
pediatricpatients.
AUC[ 0- ∞] kienet simili f '
CRF following both intravenous and subcutaneous administration. a
11 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.
Cancer patients receiving chemotherapy in
Pazjenti bil- kanċer li jirċievu l- kimoterapija
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 ’ 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 μg/ kg kull ġimgħa u 3 sa 9 μg/ kg kull ġimagħtejn).
Pharmacokinetic parameters did not M
Il- parametri farmakokinetiċi ma tbiddlux
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
t za b’ dożaġġ multiplu fuq perijodu ta ’ 12- il ġimgħa (dożaġġ kull ġimgħa jew kull ġimagħtejn).
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Kien 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.
A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 µg/ kg darbepoetin alfa administered SC every 3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of the terminal half-life.
riz Sar studju farmakokinetiku f 'pazjenti b' anemija kkawżata mill- kimoterapija, dawn ngħataw 6. 75 µg/ kg darbepoetin alfa taħt il- ġilda darba kull tliet ġimgħat flimkien mal- kimoterapija, b 'hekk saret
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
F 'dan l- istudju, il- half- life terminali (SD) kienet 74 (SD 27) siegħa.
5.3 Preclinical safety data
aw 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.
x Fl- istudji kollha li saru fuq klieb u firien, Nespo wassal għal żjidiet sostanzjali fl- emoglobina, l -
11 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.
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.
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). ħa 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 ’ g QT. im
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.
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.
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
Fl- istudji dwar it- tossiċità kronika, l- ebda rispons tumuroġeniku jew mitoġeniku mhux mistenni ma ġie osservat fl- ebda tip ta ’ tessut.
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Fi studji li saru fuq fniek u firien, l- ebda evidenza ta ’ relevanza klinika ma wriet ħsara f’ dak li għandu in
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.
x ’ jaqsam ma ’ tqala, żvilupp ta ’ l- embriju jew tal- fetu, il- ħlas jew l- iżvilupp wara t- twelid.
Placental transfer was minimal.
It - trasferiment mill- plaċenta kien minimu.
No alteration of fertility was detected.
L- ebda bidla fil- fertilità ma ġiet osservata. iċ ed
PHARMACEUTICAL PARTICULARS
TAGĦRIF FARMAĊEWTIKU m
or 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
th Sodium phosphate monobasic Sodium phosphate dibasic
Sodium phosphate dibasic Sodium chloride od
au Sodium chloride Polysorbate 80
Polysorbate 80 Ilma għall- injezzjoni Pr
er Water 6.2
6. 2 Inkompatibilitajiet
In the absence of incompatibility studies, Nespo should not be mixed or administered as an infusion with other medicinal products. no
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux ma 'Nespo, dan il- prodott mediċinali m’ għandux jitħallat jew jingħata bħala infużjoni ma ’ prodotti mediċinali oħrajn.
6.3 Shelf life ct
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 years. du
Sentejn
6.4 Special precautions for storage ro
12 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not freeze. lp
Tagħmlux fil- friża.
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.
For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single in
Għall- iskop ta 'l- użu ambulatorju, Nespo jista ’ jitneħħa mill- friġġ darba għal perijodu wieħed ta' massimu ta 'sebgħat ijiem f' temperatura ambjentali (sa 25°C).
refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
La darba siringa tkun tneħħiet mill - friġġ u tkun laħqet temperatura ambjentali (sa 25°C) din għandha tintuża fi żmien sebgħat ijiem jew tintrema.
6.5 Nature and contents of container M
t za 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Package containing one or four pre-filled syringe(s) of a 10 µg Nespo solution for injection in 0.4 ml (25 µg/ ml).
riz Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Nespo ta '10 µg f' 0. 4 ml (25 µg/ ml).
The syringes may be presented in either blistered (1- & 4-pack) or non-blistered packaging (1-pack only).
to Is- siringi jinstabu jew ippakkjati ġo folja (pakkett ta '1 u ta' 4) jew mingħajr folja (pakkett ta '1 biss).
The syringes are made from type 1 glass with stainless steel 27 gauge needles.
aw Is- siringi huma magħmula minn ħġieġ Tip I b 'labar ta' l- azzar li ma jissaddatx kejl 27.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).
L- għatu tal - labra tas- siringa mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex).
Not all packs may be marketed.
x du Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
12 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema ħa Nespo hija soluzzjoni sterili iżda mhux ppreservata.
Any medicinal product remaining in the pre-filled syringe should be disposed of.
Tagħtix aktar minn doża waħda b' siringa waħda. ’ g Il- prodott mediċinali li jifdal ġewwa s- siringa mimlija għal- lest għandu jintrema. im
Before administration the Nespo solution should be inspected for visible particles.
Qabel l- għoti s- soluzzjoni ta 'Nespo għandha tiġi ispezzjonata għal frak viżibbli.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Għandhom jsiru biss injezzjonijiet b 'soluzzjoni mingħajr kulur, ċara jew kemm kemm tiddi b' ħafna lwien.
Allow the pre- filled syringe to reach room temperature before injecting.
Ħalli s- siringa mimlija għal- lest tilħaq temperatura ambjentali qabel ma tinjetta. il
Rotate the injection sites and inject slowly 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. al in
ed 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. iċ ed
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ m
th Via San Martino 12 I-20122 Milan
Via San Martino 12 I- 20122 Milan t ot
au Italy
Italja od
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 001 1 Pack Blister lo EU/ 1/ 01/ 184/ 002 4 Pack Blister EU/ 1/ 01/ 184/ 033 1 Pack Unblistered no
EU/ 1/ 01/ 184/ 001 Pakkett Folja ta '1 EU/ 1/ 01/ 184/ 002 Pakkett Folja ta' 4 EU/ 1/ 01/ 184/ 033 Pakkett ta '1 (mhux ġo folja)
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION ct
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Date of first authoristion:
Data ta 'l- ewwel awtorizzazzjoni:
8 June 2001 du
8 Ġunju 2001 Data ta 'l- aħħar tiġdid:
19 May 2006 ro
19 Mejju 2006
Detailed information on this medicinal product is available on the website of the European Medicines ic
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/ ed M
t za riz to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
Nespo 15 micrograms solution for injection in a pre-filled syringe.
Nespo 15- il mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ ml).
Kull siringa mimlija għal- lest fiha 15- il mikrogramma ta 'darbepoetin alfa f' 0. 375 ml (40 µg/ ml).
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Varjazzjoni fl- emoglobina għandha tiġi ndirizzatandirizzata 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).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell ta ’ l- emoglobina miżmum fit- tul għal aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwidagħal aġġustament fid- doża xierqa għal meta l- valuri ta ’ l- emoglobina jaqbżu t- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Għandhom jiġu evitati żjidiet fl- emoglobina ta ’ aktar minn 2g/ dl (1. 25 mmol/ l) fuq perijodu ta ’ erba ’ ġimgħat.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
15 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
14 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.
16 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.
15 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%.
17 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%.