qanastek/EMEA-V3 huggingface dataset:
Any medicinal product remaining in the pre-filled syringe should be disposed of.
Il- prodott mediċinali li jifdal ġewwa s- siringa mimlija għal- lest għandu jintrema.
Before administration the Aranesp solution should be inspected for visible particles.
Qabel l- għoti s- soluzzjoni ta 'Aranesp għandha tiġi ispezzjonata għal frak viżibbli.
Allow the pre- filled syringe to reach room temperature before injecting.
Ħalli s- siringa mimlija għal- lest tilħaq temperatura ambjentali qabel ma tinjetta.
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.
EU/ 1/ 01/ 185/ 001 1 Pack Blister EU/ 1/ 01/ 185/ 002 4 Pack Blister EU/ 1/ 01/ 185/ 033 1 Pack Unblistered
EU/ 1/ 01/ 185/ 001 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 002 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 033 Pakkett ta '1 (mhux ġo folja)
8 June 2001 Date of last renewal:
8 Ġunju 2001 Data ta 'l- aħħar tiġdid:
19 May 2006
19 Mejju 2006
Aranesp 15 micrograms solution for injection in a pre-filled syringe.
Aranesp 15- il mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
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.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
15 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
15 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.
16 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
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.
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- piż ta ’ mard fuq kolloxpiz ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent hija neċessarja.
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.
19 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
18 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
Fatturi li għandhom jitqiesu f’ din l- evalwazzjoni għandhom jinkludu t- tip ta ’ tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
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.
20 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.
19 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Vascular disorders
Disturbi Vaskulari
20 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:
22 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
24 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
23 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
25 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 15 µg Aranesp solution for injection in 0.375 ml (40 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '15 µg f' 0. 375 ml (40 µg/ ml).
EU/ 1/ 01/ 185/ 003 1 Pack Blister EU/ 1/ 01/ 185/ 004 4 Pack Blister EU/ 1/ 01/ 185/ 034 1 Pack Unblistered
EU/ 1/ 01/ 185/ 003 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 004 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 034 Pakkett ta '1 (mhux ġo folja)
Aranesp 20 micrograms solution for injection in a pre-filled syringe.
Aranesp 20 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
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.
Sintomi u problemi ta ’ anemija jistgħu jvarjaw skond l- età, is- sess, u l - piż ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent huma neċessarji.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
28 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
27 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.
28 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
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.
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.
32 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
30 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
33 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
32 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:
34 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
37 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
35 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
38 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 20 µg Aranesp solution for injection in 0.5 ml (40 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '20 µg f' 0. 5 ml (40 µg/ ml).
EU/ 1/ 01/ 185/ 005 1 Pack Blister EU/ 1/ 01/ 185/ 006 4 Pack Blister EU/ 1/ 01/ 185/ 035 1 Pack Unblistered
EU/ 1/ 01/ 185/ 005 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 006 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 035 Pakkett ta '1 (mhux ġo folja)
Aranesp 30 micrograms solution for injection in a pre-filled syringe.
Aranesp 30 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
41 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
39 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.
40 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
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.
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.
45 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
42 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
46 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
43 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
44 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:
46 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Iċ- ċans li dawn l- affarijiet jseħħu jistgħu japplikaw għal pazjenti bil- kanċer, li jirċievu eritropeotin rikombinanti umanuman, 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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
50 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
47 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
51 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 30 µg Aranesp solution for injection in 0.3 ml (100 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '30 µg f' 0. 3 ml (100 µg/ ml).
48 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 007 1 Pack Blister EU/ 1/ 01/ 185/ 008 4 Pack Blister EU/ 1/ 01/ 185/ 036 1 Pack Unblistered
EU/ 1/ 01/ 185/ 007 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 008 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 036 Pakkett ta '1 (mhux ġo folja)
Aranesp 40 micrograms solution for injection in a pre-filled syringe.
Aranesp 40 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
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.
Sintomi u problemi ta ’ anemija jistgħu jvarjaw skond l- età, is- sess, u l- livell ta ’ mard; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent huma neċessarji.
Aranesp should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Aranesp għandu jingħata bħala injezzjoni taħt il- ġilda jew ġol- vina sabiex tiżdied il- konċentrazzjoni ta ’ l- emoglobina għal mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
54 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
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 minn mid- doża ta ’ qabel.
51 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.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient’ s clinical course and condition is necessary.
Is- sintomi u kumplikazzjonijiet ta ’ l- anemija jvarjaw bl- eta, is- sess, u l- piz ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent hija neċessarja.
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.
58 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
54 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
59 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
56 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:
58 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Iċ- ċans li dawn l- affarijiet jseħħu jistgħu japplikaw għal pazjenti bil- kanċer, li jirċievu eritropeotin rikombinanti umanuman, 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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
63 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
59 effect (decreased tissue perfusion due to increased blood viscosity).
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).
Package containing one or four pre-filled syringe(s) of a 40 µg Aranesp solution for injection in 0.4 ml (100 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '40 µg f' 0. 4 ml (100 µg/ ml).
60 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 009 1 Pack Blister EU/ 1/ 01/ 185/ 010 4 Pack Blister EU/ 1/ 01/ 185/ 037 1 Pack Unblistered
EU/ 1/ 01/ 185/ 009 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 010 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 037 Pakkett ta '1 (mhux ġo folja)
Aranesp 50 micrograms solution for injection in a pre-filled syringe.
Aranesp 50 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
67 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
63 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.
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.
71 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.
66 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
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.
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).
72 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).
68 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:
70 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
76 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
71 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
77 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 50 µg Aranesp solution for injection in 0.5 ml (100 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '50 µg f' 0. 5 ml (100 µg/ ml).
72 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 011 1 Pack Blister EU/ 1/ 01/ 185/ 012 4 Pack Blister EU/ 1/ 01/ 185/ 038 1 Pack Unblistered
EU/ 1/ 01/ 185/ 011 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 012 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 038 Pakkett ta '1 (mhux ġo folja)
Aranesp 60 micrograms solution for injection in a pre-filled syringe.
Aranesp 60 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
80 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
75 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.
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.
84 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
78 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
85 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
79 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
80 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:
82 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
89 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
83 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
90 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 60 µg Aranesp solution for injection in 0.3 ml (200 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '60 µg f' 0. 3 ml (200 µg/ ml).
84 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 013 1 Pack Blister EU/ 1/ 01/ 185/ - 014 4 Pack Blister EU/ 1/ 01/ 185/ 039 1 Pack Unblistered
EU/ 1/ 01/ 185/ 013 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 014 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 039 Pakkett ta '1 (mhux ġo folja)
Aranesp 80 micrograms solution for injection in a pre-filled syringe.
Aranesp 80 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
93 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
87 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.
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.
97 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manutenzjoni ta ’ l- emoglobina m’ għandiex taqbeż l- għola livell tal- konċentrazzjoni targit rrakkomandata f ’ sezzjoni 4. 2.
90 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
F ’ pazjenti b 'insuffiċjenza renali kronika u b’ evidenza klinika ta ’ mard iskemiku tal- qalb jew ta' insuffiċjenza tal- qalb konġestiva, it- targit ta 'l- emoglobina jrid jiġi determinat individwalment.
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).
98 tumur u l- stadju tiegħu; il- gravità tal- anemija; it- tul tal- għejxien, l- ambjent li fih il- pazjent qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
91 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
92 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:
94 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
102 pazjenti adulti u f 'pazjenti tfal li għandhom CRF wara għoti taħt il- ġilda. Il- Half- life kienet ukoll simili f' pazjenti adulti u f 'pazjenti tfal li għandhom CRF kemm wara għoti ġol- vina kif ukoll wara għoti taħt il- ġilda.
95 effect (decreased tissue perfusion due to increased blood viscosity).
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).
6.4 Special precautions for storage
103 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 80 µg Aranesp solution for injection in 0.4 ml (200 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '80 µg f' 0. 4 ml (200 µg/ ml).
96 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 015 1 Pack Blister EU/ 1/ 01/ 185/ 016 4 Pack Blister EU/ 1/ 01/ 185/ 040 1 Pack Unblistered
EU/ 1/ 01/ 185/ 015 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 016 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 040 Pakkett ta '1 (mhux ġo folja)
Aranesp 100 micrograms solution for injection in a pre-filled syringe.
Aranesp 100 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
106 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
99 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.
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.
110 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.
102 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.
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).
111 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).
103 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
104 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:
106 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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
115 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.
107 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).
6.4 Special precautions for storage
116 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 100 µg Aranesp solution for injection in 0.5 ml (200 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '100 µg f' 0. 5 ml (200 µg/ ml).
108 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 017 1 Pack Blister EU/ 1/ 01/ 185/ 018 4 Pack Blister EU/ 1/ 01/ 185/ 041 1 Pack Unblistered
EU/ 1/ 01/ 185/ 017 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 018 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 041 Pakkett ta '1 (mhux ġo folja)
Aranesp 130 micrograms solution for injection in a pre-filled syringe.
Aranesp 130 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
119 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
111 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.
112 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.
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.
123 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.
114 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.
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).
124 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).
116 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:
118 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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
128 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.
119 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).
6.4 Special precautions for storage
129 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 130 µg Aranesp solution for injection in 0.65 ml (200 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '130 µg f' 0. 65 ml (200 µg/ ml).
120 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 069 1 Pack Blister EU/ 1/ 01/ 185/ 070 4 Pack Blister EU/ 1/ 01/ 185/ 071 1 Pack Unblistered
EU/ 1/ 01/ 185/ 069 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 070 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 071 Pakkett ta '1 (mhux ġo folja)
Aranesp 150 micrograms solution for injection in a pre-filled syringe.
Aranesp 150 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
132 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
123 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.
124 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.
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.
136 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.
126 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.
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).
137 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).
127 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
128 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:
130 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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
141 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.
131 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).
6.4 Special precautions for storage
142 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 150 µg Aranesp solution for injection in 0.3 ml (500 µg/ ml).
Pakkett li fih siringa waħda mimlija għal- lest jew erbgħa siringi mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '150 µg f' 0. 3 ml (500 µg/ ml).
132 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 019 1 Pack Blister EU/ 1/ 01/ 185/ 020 4 Pack Blister EU/ 1/ 01/ 185/ 042 1 Pack Unblistered
EU/ 1/ 01/ 185/ 019 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 020 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 042 Pakkett ta '1 (mhux ġo folja)
Aranesp 300 micrograms solution for injection in a pre-filled syringe.
Aranesp 300 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
145 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
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.
135 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.
136 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.
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.
149 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.
138 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.
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).
150 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).
139 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
140 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:
142 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.