qanastek/EMEA-V3 huggingface dataset:
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
2 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
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%.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Jekk l- emoglobina taqbeż it- 12 g/ dl (7. 5 mmol/ l), tnaqqis fid - doża għandha tiġi kkunsidrata.
If after a dose reduction, haemoglobin continues to 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 il- livell ta ’ l- emoglobina jkompli jiżdied, wara tnaqqis fid- doża, id- doża għandha titwaqqaf temporanjament sa kemm il- livell ta ’ l- emoglobina jibda jonqos, fl ’ liema punt il- kura għandha terġa tinbeda b ’ doza ta ’ bejn wieħed u ieħor doża ta ’ 25% anqas mid- doża ta ’ qabel.
The haemoglobin should be measured every one or two weeks until it is stable.
L- emoglobina għandha titkejjel kull ġimgħa jew ġimagħtejn sakemm tilħaq livell stabbli.
Thereafter the haemoglobin can be measured at longer intervals.
Minn hemm ‘ il quddiem, l- emoglobina tista ’ titkejjel f’ intervalli itwal.
Maintenance Phase
Fażi ta ’ manutenzjoni
In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
Fil- fażi ta ’ manutenzjoni, Aranesp jista 'jkompli jingħata bħala injezzjoni waħda darba fil- ġimgħa jew darba kull ġimgħatejn.
Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
Pazjenti fuq dijalisi li qed ibiddlu minn doża ta 'Aranesp ta' darba fil- ġimgħa għal doża ta 'darba kull ġimgħatejn, fil- bidu għandhom jingħataw doża ekwivalenti għal darbtejn id - doża li qabel kienet tingħata darba fil- ġimgħa.
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
F 'pazjenti mhux fuq dijalisi, la darba t- targit tal - konċentrazzjoni ta ’ emoglobina tkun ntlaħqet b' iddożar ta 'darba kull ġimgħatejn, Aranesp jista' jingħata darba fix- xahar bħala injezzjoni taħt il- ġilda b 'doża tal- bidu ekwivalenti għal darbtejn id - doża li qabel kienet tingħata darba kull ġimgħatejn.
Dosing should be titrated as necessary to maintain the haemoglobin target.
L - iddożar għandu jiġi kkalkulat skond il- bżonn biex tinżamm il- konċentrazzjoni ta ’ emoglobina mixtieqa.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Jekk aġġustament fid- doża hija meħtieġ biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Jekk l- emoglobina tkompli tiżdied, id- doża għandha tigi mnaqqsa bejn wieħed u ieħor b’ 25%.
If after a dose reduction, haemoglobin continues to 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 għandha terġa tinbeda l- kura b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel.
Patients should be monitored closely to ensure that the lowest approved dose of Aranesp is used to provide adequate control of the symptoms of anaemia.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib biex jiġi assigurat li l- anqas doża ta ’ Aranesp approvata tintuża biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Wara kull aġġustament fid- doża jew fl- iskeda l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimagħtejn.
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 Aranesp.
Studji kliniċi wrew li pazjenti adulti li jirċievu r- HuEPO darba, darbtejn jew tliet darbiet fil- ġimgħa jistgħu jibdlu għal Aranesp darba fil- ġimgħa jew darba kull ġimgħatejn.
The initial weekly dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
Id- doża tal- bidu ta ’ Aranesp ta 'kull ġimgħa (μg/ ġimgħa) tista ’ tiġi ddeterminata billi tiddividi d- doża totali fil- ġimgħa ta ’ r- HuEPO (IU/ ġimgħa) b ’ 200.
Because
Id- doża tal- bidu ta ’ Aranesp ta 'kull ġimgħatejn (μg/ ġimgħatejn) tista ’ tiġi ddeterminata billi tiddividi t- totali tad- dożi ta ’ r- HuEPO ta' perijodu ta 'ġimgħatejn b ’ 200.
3 of 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.
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Meta Aranesp jiġi sostitwit b’ r- HuEPO, l- emoglobina għandha tiġi mmonitorjata kull ġimgħa jew ġimgħatejn u għandu jintuża l- istess mod ta ’ teħid.
For patients ≥ 11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
F 'pazjenti ta' ≤ 11- il sena, id- doża tal- bidu mogħtija taħt il- ġilda jew ġol- vina hija ta ’ 0. 45 μg/ kg piż tal- ġisem, bħala injezzjoni waħda darba fil- ġimgħa.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
Jekk iż- żjieda fl- emoglobina mhix biżżejjed (inqas minn 1 g/ dl (0. 6 mmol/ l) f’ erba ’ ġimgħat), id- doża trid tiżdied b ’ bejn wieħed u ieħor 25%.
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.
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.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Jekk il- livell ta ’ l- emoglobina jkompli jiżdied, id- doża għandha titnaqqas b’ bejn wieħed u ieħor 25%.
If after a dose reduction, haemoglobin continues to 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, l- emoglobina tkompli tiżdied, id- doża għandha titwaqqaf temporanjament sa kemm l- emoglobina tibda tonqos, fl ’ liema punt il- kura għandha terġa tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel.
Thereafter the haemoglobin can be measured at longer intervals.
Minn hemm ‘ il quddiem, l- emoglobina tista ’ titkejjel f ’ intervalli itwal.
No guidance regarding the correction of haemoglobin is available for paediatric patients 1 to 10 years of age.
M' hemm l- ebda tmexxija dwar il- korrezzjoni ta 'l- emoglobina f' pazjenti tfal ta 'bejn sena u 10 snin.
For paediatric patients ≥ 11 years of age, in the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
F 'pazjenti tfal ta' ≤ 11- il sena, fil- fażi ta ’ manutenzjoni, Aranesp jista 'jkompli jingħata bħala injezzjoni waħda darba fil- ġimgħa jew darba kull ġimgħatejn.
Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
Pazjenti fuq dijalisi li qed ibiddlu minn doża ta 'Aranesp ta' darba fil- ġimgħa għal doża ta 'darba kull ġimgħatejn, fil- bidu għandhom jingħataw doża ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba fil- ġimgħa.
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
F 'pazjenti mhux fuq dijalisi, la darba t- targit tal- konċentrazzjoni ta’ emoglobina tkun ntlaħqet b' iddożar ta 'darba kull ġimgħatejn, Aranesp jista' jingħata darba fix- xahar bħala injezzjoni taħt il- ġilda b 'doża tal- bidu ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba kull ġimgħatejn.
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly may be converted to once every other week Aranesp.
F 'pazjenti tfal bejn sena u 18- il sena, tagħrif kliniku wera li pazjenti tfal li jirċievu r- HuEPO darbtejn jew tliet darbiet fil- ġimgħa jistgħu jibdlu għal Aranesp darba fil- ġimgħa, u dawk li jirċievu r- HuEPO darba fil- ġimgħa jistgħu jibdlu għal Aranesp darba kull ġimgħatejn.
The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.
Id- doża tal- bidu f 'pazjenti tfal ta ’ Aranesp ta' darba fil- ġimgħa jew ta 'darba kull ġimgħatejn (µg/ ġimgħa) tista' tiġi ddeterminata billi tiddividi d- doża totali ta 'ġimgħa ta' r- HuEPO (IU/ ġimgħa) b '240.
Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjoni bejn individwu u ieħor, kalkoli għal dożi terapewtiċi ottimali għandhom jsiru għal pazjenti individwali.
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Meta tibdel Aranesp għal r- HuEPO l- emoglobina għandha tiġi mmonitorjata darba fil- ġimgħa jew darba kull ġimgħatejn u għandu jintuża l- istess mod ta ’ teħid.
4 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.
Patients should be monitored closely to ensure that the lowest approved dose of Aranesp is used to provide adequate control of the symptoms of anaemia.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’ Aranesp approvata biex jiġi pprovdut kontroll fuq is- sintomi ta ’ l- anemija.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Wara kull aġġustament fid- doża jew fl- iskeda l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
Meta tibdel ir- rotta tal- amministrazzjoni, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimagħtejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
Treatment of symptomatic chemotherapy induced anaemia in cancer patients
Kura ta ’ l- anemija sintomatika minħabba l- kimoterapija f’ pazjenti bil- kanċer
Aranesp 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 (7.5 mmol/ l).
Aranesp 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.
Is- sintomi u kumplikazzjonijiet ta ’ l- anemija jvarjaw bl- eta, is- sess, u l - piz ta ’ mard fuq kolloxpiz ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent hija neċessarja.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Minħabba varjazzjonijiet bejn pazjent u ieħor, jistgħu okkażjonalment jiġu osservati f’ pazjenti valuri ta ’ l- emoglobina ‘ l fuq jew taħt il- livelli ta ’ emoglobina mixtieqa.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustments for when haemoglobin 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; tmexxija għall- aġġustament fid- doża xieraq għal meta l- valuri ta ’ l- emoglobina jaqbżu it- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt.
The recommended initial dose is 500 μ g (6.75μ 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 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.
Jekk ir- rispons kliniku tal- pazjent (għeja, rispons ta 'l - emoglobina) mhux adegwat wara disa' ġimgħat, aktar kura tista 'ma tkunx effettiva.
Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy.
Il- kura b 'Aranesp għandha titwaqqaf bejn wieħed u ieħor erba' ġimgħat wara tmiem il- kimoterapija.
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 Aranesp is used to maintain 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 ’ Aranesp 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.
Aġġustament xieraq fid- doża ta ’ bejn 500 μg, 300 μg, u 150 μg għandu jiġi kkunsidrat.
Treatment with Aranesp should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Il- kura b ’ Aranesp għandha titwaqqaf temporanjament jekk il- livell ta ’ l- emoglobina jaqbeż it- 13g/ dl (8. 1mmol/ l).
Therapy should be reinitiated at 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 waqgħet għal 12 g/ dl (7. 5 mmol/ l) jew anqas.
Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Il- pressjoni tad- demm għandha tiġi mmonitorjata fil- pazjenti kollha, speċjalment fil- bidu tal- kura b’ Aranesp.
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (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 ’ Aranesp (ara sezzjoni 4. 2).
Non-response to therapy with Aranesp should prompt a search for causative factors.
Nuqqas ta ’ rispons għal kura b’ Aranesp għandu jġiegħel li tinbeda tfittxija għal fatturi kawżattivi.
Deficiencies of 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 may also compromise the erythropoietic response.
Infezzjonijiet li jitfaċċaw minn żmien għal ieħor, 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.
A reticulocyte count should be considered as part of the evaluation.
L- għadd tar- retikuloċiti għandu jiġi kkunsidrat bħala parti 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 retikuloċitopenija, eżami tal- mudullun għandu jiġi kkunsidrat.
If the bone marrow is consistent with 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.
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
Aplażja pura ta ’ ċelluli ħomor ikkawżata minn anitkorpi anti- eritropojetin newtraliżanti ġiet irrappurtata b’ assoċazzjoni ma ’ kura bi proteini rikombinanti eritropojetiċi, inkluża darbepoetin alfa.
This has been 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 - ġilda.
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8).
Dawn l- antikorpi ntwerew li jgħamlu cross- reaction mal- proteini eritropojetiċi kollha, u pażjenti b’ suspett jew b 'konferma li għandhom antikorpi newtraliżanti għal eritropojetin m’ għandiex tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8).
Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
Mard attiv tal- fwied kien kriterju ta ’ esklużjoni fl- istudji kollha ta ’ Aranesp, 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 elimination of Aranesp and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Minħabba li huwa maħsub li l- fwied huwa r- rotta ewlenija ta ’ tneħħija ta ’ Aranesp u r- HuEPO, Aranesp għandu jintuża b’ attenzjoni f’ pazjenti b’ mard tal- fwied.
Aranesp should also be used with caution in those patients with sickle cell anaemia or epilepsy.
Aranesp għandu wkoll jintuża b’ attenzjoni f’ pazjenti b’ anemija tat- tip sickle cell jew epilessija.
Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Użu ħażin ta ’ Aranesp minn persuni b’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum taċ - ċelluli ppakkjati.
This may be associated with life-threatening complications of the cardiovascular system.
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li jistgħu jpoġġu l- ħajja f’ periklu.
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.
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.
In clinical studies, an 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 than 12 g/ dl (7.5 mmol/ l).
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).
Controlled clinical trials have not shown significant benefits attributable to the administration of 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.
Aranesp should be used with caution in patients with epilepsy.
Aranesp għandu jintuża b 'attenzjoni f' pazjenti li għandhom epilessija.
Convulsions have been reported in patients receiving Aranesp.
Aċċessjonijiet ġew rrappurtati f’ pazjenti li ngħataw Aranesp.
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' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
Serum potassium levels should be monitored regularly during Aranesp therapy.
Il- livelli ta ’ potassium fis- serum għandhom jiġu mmonitorjati b’ mod regolari waqt kura b’ Aranesp.
Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
Żjieda fil- potassium ġiet irrappurtata f’ xi pazjenti li ngħataw Aranesp, għalkemm il- kawża għadha ma ġietx stabbilita.
If an elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp 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 ’ Aranesp sakemm il- livell jiġi korrett.
As with all growth factors, 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 in patients with anaemia associated with cancer.
F ’ bosta studji kliniċi kkontrollati, epoetins wrew titjib fl- għejxien jew tnaqqis fir- riskju ta ’ progress ta ’ tumur f’ pazjenti b’ anemija assoċjata ma ’ kanċer.
In controlled clinical studies, use of Aranesp and other erythropoiesis-stimulating agents (ESAs) have shown:
Fi studji kliniċi kkontrollati, l- użu ta ’ Aranesp u aġenti li jistimolaw l- eritropojesi (ESAs) wera:
• 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.
• tnaqqis fil- ħin għal progress ta ’ tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed jirċievu kura bir- raġġi meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 mmol/ l), l- użu ta ’ ESAs mhux indikat f ’ din il- popolazzjoni ta ’ pazjenti.
• shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l)
• 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)
• 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 therapy. ESAs are not indicated for use in this patient population.
ESAs mhux indikata għall- użu f ’ din il- popolazzjoni ta ’ pazjenti.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
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.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
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 order to minimise the potential risk of thromboembolic events.
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.
The clinical results obtained so far do not indicate any interaction of Aranesp with other substances.
Ir- riżultati kliniċi li nġabru s’ issa ma jindikaw l- ebda interazzjoni ta ’ Aranesp ma ’ sustanzi oħra.
7 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
For Aranesp no clinical data on exposed pregnancies are available.
M ’ hemm l- ebda tagħrif kliniku disponibbli dwar l- effett ta ’ Aranesp fuq it- tqala.
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.
Caution should be exercised when prescribing to pregnant women.
Aranesp għandu jingħata b’ attenzjoni lill- nisa tqal.
As there is no clinical experience with lactating women Aranesp should not be administered to women who are breast-feeding.
Billi m’ hemm l- ebda esperjenza klinika relatata ma ’ nisa li qed ireddgħu, Aranesp m’ għandux jingħata lil dawn in- nisa.
When Aranesp therapy is absolutely indicated women must stop breast- feeding.
Meta l- kura b’ Aranesp hija assolutament meħtieġa, il- mara għandha tieqaf mit - treddiegħ.
There have been no observed effects with Aranesp on the ability to drive and use machines.
Ma ġewx osservati effetti b 'Aranesp fuq il- ħila biex issuq jew tħaddem magni.
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.
Clinical Trial Experience
Espenjenza fi prova klinika
Data presented from controlled studies included 1357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Tagħrif ippreżentat minn studji kkontrollati inkludew 1357 pazjenti, 766 li ngħataw Aranesp u 591 pazjent li ngħataw r- HuEPO.
In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
Fil- grupp ta ’ Aranesp, 83% kienu fuq dijaliżi u 17% ma kienux fuq dijaliżi.
Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection.
Fi studji fl ’ liema Aranesp ingħata bħala injezzjoni taħt il- ġilda, l- uġigħ fis- sit ta 'l- injezzjoni ġie attribwit għall- kura.
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
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 Aranesp from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati mal- kura b’ Aranesp fi studji kliniċi kontrollati huma dawn:
MedDRA system organ class Cardiac Disorders Skin and Subcutaneous Tissue Disorders
Sistema tal- klassifika tal- organi MedDRA
Subject Incidence Very Common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10)
Komuni ħafna (≥1/ 10)
Adverse Drug Reaction Hypertension Rash/ Erythema
Raxx/ ħmura
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
Reazzjonijiet avversi ġew determinati fuq l- informazzjoni li nġabret minn sebgħa studji, randomised, double- blind, kkontrollati bi plaċebo ta ’ Aranesp b ’ total ta ’ 2112- il pazjent (Aranesp 1200, plaċebo 912).
8 Incidence of undesirable effects considered related to treatment with Aranesp from controlled clinical studies are:
L- inċidenza ta ’ effetti mhux mixtieqa meqjusa bħala relatati ma ’ kura b’ Aranesp fi studji kliniċi kontrollati huma dawn:
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
Komuni (> 1/ 100 to < 1/ 10)
Adverse Drug Reaction Rash/ Erythema
Raxx/ ħmura
Postmarketing Experience
Esperjenza wara t- tqegħid fuq is- suq
The following adverse reactions have been identified during postmarketing use of Aranesp:
Ir- reazzjonijiet avversi li ġejjin ġew identifikati waqt l- użu wara t- tqegħid fuq is- suq ta ’ Aranesp:
• 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 Aranesp therapy have been reported predominantly in patients with CRF treated subcutaneously.
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.
In case PRCA is diagnosed, therapy with Aranesp must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
F’ każ li aplażja pura ta ’ ċelluli ħomor (PRCA) tiġi djanjostikata, il- kura, b’ Aranesp għandha titwaqqaf u l- pazjenti m’ għandhiex tinbidlilhom il- kura għal proteina rikombinanti eritropojetika oħra (ara sezzjoni 4. 4).
• Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.
• Reazzjonijiet allerġiċi, inklużi reazzjonijiet anafilattiċi, anġioedema, raxx tal- ġilda u urtikarja.
• Convulsions.
• Aċċessjonijiet.
The therapeutic margin of Aranesp is very wide.
Il- marġni terapewtiku ta ’ Aranesp huwa wiesa ’ ħafna.
Even at very high serum levels, no symptoms of overdose have been observed.
Anki b’ livelli għoljin ħafna fis- serum, l- ebda sintomi ta ’ doża eċċessiva ma ġew osservati.
In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
Fil- każ ta ’ poliċitemija, Aranesp għandu jitwaqqaf temporanjament (ara sezzjoni 4. 2).
If clinically indicated, phlebotomy may be performed.
Jekk klinikament indikat, tista ’ ssir flebotomija.
The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Il- produzzjoni ta ’ l- eritropojetina sseħħ primarjament u tiġi rregolata fil- kilwa b’ rispons għal bidliet fl- ossiġenazzjoni tat- tessuti.
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 tad- doża totali.
The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Is- sigurtà u l- effikaċja ta 'ddożar ta' Aranesp darba kull tliet ġimgħat biex titnaqqas il- ħtieġa ta '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 non-myeloid malignancies receiving multi-cycle chemotherapy.
Dan l- istudju sar f '705 pazjent anemiku b' tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija ta 'bosta ċikli.
Patients were randomized to receive Aranesp at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
Il- pazjenti ġew randomised biex jirċievu Aranesp b 'doża ta' 500 μg darba kull tliet ġimgħat jew 2. 25 μg / kg darba fil - ġimgħa.
In both groups, the dose was 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 in a 14-day period.
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 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 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.
Dan l- istudju jsostni li 500 μg darba kull 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 tal- kura.
In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).
Fi studju prospettiv, randomised double- blind, ikkontrollat bil- plaċebo, li sar fuq 344 pazjent anemiku 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).
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed.
Ġie osservat ukoll titjib fl- għeja li ġie mkejjel bil- kejl Functional Assessment of Cancer Therapy- fatigue (FACT- fatigue).
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
Eritropojetina huwa fattur ta 'tkabbir li primarjament jistimola l- produzzjoni taċ- ċelluli ħomor.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
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 -
Two of the studies recruited patients who were being treated with chemotherapy.
Għal tnejn mill- istudji ntagħżlu pazjenti li kien qed jiġu kkurati bil- kimoterapija.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Il- konċentrazzjoni targit ta ’ l- emoglobina f ’ żewġ studji kienet > 13 g/ dl; fit- tlitt studji l- oħra kienet 12- 14 g/ dl.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and 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.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
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.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
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 erythropoietin and those in the control group.
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 rċevew l- eritropoeitin rikombinanti uman u dawk fil- grupp ta ’ kontroll.
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.
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.
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 sabiex jintlaħaq l- istess rispons bijoloġiku.
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 (SD 7. 5) meta mogħti ġol- vina.
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg (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).
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 73 hours (SD 24).
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 (SD 24).
In clinical studies, minimal accumulation was observed with either route of administration.
Fl- istudji kliniċi, akkumulazzjoni minima 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.
Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
Tagħrif miġbur minn 809 pazjenti li ngħataw Aranesp fi studji kliniċi Ewropej ġie analizzat sabiex 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 mogħtija b 'injezzjoni ġol- vina.
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF 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.
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.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
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.
Following intravenous administration, an approximate 25% difference between 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 pediatricpatients.
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.
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
AUC[ 0- ∞] kienet simili f '
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
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.
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours (SD 19.7).
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).
Pharmacokinetic parameters did not change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Il- parametri farmakokinetiċi ma tbiddlux b’ dożaġġ multiplu fuq perijodu ta ’ 12- il ġimgħa (dożaġġ kull ġimgħa jew kull ġimagħtejn).
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
Fl- istudji kollha li saru fuq klieb u firien, Aranesp wassal għal żjidiet sostanzjali fl- emoglobina, l - ematokriti, l- għadd ta ’ ċelluli ħomor u r- retikuloċiti, li jikkorrispondu għall- effetti farmakoloġiċi mistennija.
11 effect (decreased tissue perfusion due to increased blood viscosity).
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).
Aranesp did not reveal any genotoxic potential nor did it have any effect on the proliferation of non- haematological cells in vitro or in vivo.
Aranesp 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.
Il- potenzjal karċenoġeniku ta ’ 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.
Fi studji li saru fuq fniek u firien, l- ebda evidenza ta ’ relevanza klinika ma wriet ħsara f’ dak li għandu x ’ jaqsam ma ’ tqala, żvilupp ta ’ l- embriju jew tal- fetu, il- ħlas jew l- iżvilupp wara t- twelid.
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Water for injections
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Ilma għall- injezzjoni
In the absence of incompatibility studies, Aranesp should not be mixed or administered as an infusion with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux ma 'Aranesp, dan il- prodott mediċinali m’ għandux jitħallat jew jingħata bħala infużjoni ma ’ prodotti mediċinali oħrajn.
Keep the container in the outer carton, in order to protect from light.
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
For the purpose of ambulatory use, Aranesp may be removed from storage once for a maximum single period of seven days at room temperature (up to 25°C).
Għall- iskop ta 'l- użu ambulatorju, Aranesp jista ’ jitneħħa mill- friġġ darba għal perijodu wieħed ta' massimu ta 'sebgħat ijiem f' temperatura ambjentali (sa 25°C).
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.
La darba siringa tkun tneħħiet mill - friġġ u tkun laħqet temperatura ambjentali (sa 25°C) din għandha tintuża fi żmien sebgħat ijiem jew tintrema.
Package containing one or four pre-filled syringe(s) of a 10 µg Aranesp solution for injection in 0.4 ml (25 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp 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).
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.
Is- siringi huma magħmula minn ħġieġ Tip I b 'labar ta' l- azzar li ma jissaddatx kejl 27.
Not all packs may be marketed.
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
Aranesp is a sterile but unpreserved product.
Aranesp hija soluzzjoni sterili iżda mhux ppreservata.
Do not administer more than one dose per syringe.
Tagħtix aktar minn doża waħda b' siringa waħda.