qanastek/EMEA-V3 huggingface dataset:
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
154 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.
143 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
155 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 300 µg Aranesp solution for injection in 0.6 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 '300 µg f' 0. 6 ml (500 µg/ ml).
144 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 021 1 Pack Blister EU/ 1/ 01/ 185/ 022 4 Pack Blister EU/ 1/ 01/ 185/ 043 1 Pack Unblistered
EU/ 1/ 01/ 185/ 021 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 022 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 043 Pakkett ta '1 (mhux ġo folja)
Aranesp 500 micrograms solution for injection in a pre-filled syringe.
Aranesp 500 mikrogramma soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
158 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
147 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.
148 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.
162 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.
150 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).
163 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).
151 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
152 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:
154 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.
167 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.
155 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
168 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled syringe(s) of a 500 µg Aranesp solution for injection in 1 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 '500 µg f' 1 ml (500 µg/ ml).
156 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 01/ 185/ 031 1 Pack Blister EU/ 1/ 01/ 185/ 032 4 Pack Blister EU/ 1/ 01/ 185/ 044 1 Pack Unblistered
EU/ 1/ 01/ 185/ 031 Pakkett Folja ta '1 EU/ 1/ 01/ 185/ 032 Pakkett Folja ta' 4 EU/ 1/ 01/ 185/ 044 Pakkett ta '1 (mhux ġo folja)
8 June 2001 Date of last renewal:
ISEM TAL- PRODOTT MEDIĊINALI
DATE OF REVISION OF THE TEXT
Aranesp 10 mikrogrammi soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Solution for injection (injection) in a pre-filled pen.
Soluzzjoni għall- injezzjoni (injezzjoni) ġo pinna mimlija għal- lest (SureClick).
Aranesp (SureClick) is supplied ready for use in a pre-filled pen.
Aranesp (SureClick) jiġi lest għall- użu ġo pinna mimlija għal- lest.
The instructions for use, handling and disposal are given in section 6.6.
L- istruzzjonijiet għall- użu, l - immaniġġjar u r- rimi huma mniżżla f’ sezzjoni 6. 6.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
171 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
159 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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.
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.
172 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
160 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.
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- biduf '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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
173 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
161 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.
162 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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 newtralizzanti ġiet irrappurtata b’ assoċazzjoni ma ’ kura bi proteini rikombinanti eritropojetiċi, inkluża darbepoetin alfa.
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have 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 newtralizzanti għal eritropojetin m’ għandiex tinbidlilhom il- kura għal darbapoetin alfa (ara sezzjoni 4. 8).
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
L- għatu tal- labra tal- pinna mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex), li jista 'jikkawża reazzjonijiet allerġiċi.
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.
175 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.
163 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).
176 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.
164 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
165 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:
167 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.
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.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
180 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.
168 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
181 6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C) Do not freeze.
Tagħmlux fil- friża.
Once a pre-filled pen 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 pinna mimlija għal- lest tkun tneħħiet mill- friġġ u tkun laħqet temperatura ambjentali (sa 25°C) din għandha tintuża fi żmien sebgħat ijiem jew tintrema.
Package containing one or four pre-filled pens of a 10 µg Aranesp solution for injection in 0.4 ml (25 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '10 µg f' 0. 4 ml (25 µg/ ml).
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
Is- siringi ġewwa il- pinen huma magħmula minn ħġieġ Tip I b 'labar ta' l- azzar li ma jissaddatx kejl 27.
169 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
The Aranesp (SureClick) pre-filled pen delivers the complete dose of each presentation.
Il- pinna mimlija għal- lest b 'Aranesp (SureClick) tagħti d- doza kompleta li msemmija fuq il- pakkett.
Any medicinal product remaining in the pre-filled pen should be disposed of.
Il- prodott mediċinali li jifdal ġewwa l- pinna mimlija għal- lest għandu jintrema.
Allow the pre- filled pen to reach room temperature before injecting.
Ħalli l- pinna mimlija għal- lest tilħaq temperatura ambjentali qabel ma tinjetta.
Rotate the injection sites to avoid discomfort at the site of injection.
Biddel is- sit ta 'l - injezzjoni u injetta bil- mod sabiex tevita l- iskumdità fis- sit ta' l- injezzjoni.
EU/ 1/ 01/ 185/ 045 1 pack EU/ 1/ 01/ 185/ 057 4 pack
EU/ 1/ 01/ 185/ 045 – 1 pack EU/ 1/ 01/ 185/ 057 – 4 pack
Aranesp 15 micrograms solution for injection in a pre-filled pen.
Aranesp 15- il mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
184 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
171 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
185 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
172 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
186 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
173 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.
4.3 Contraindications
187 4. 3 Kontra- indikazzjonijiet
174 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
188 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.
175 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).
189 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).
176 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
177 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:
179 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.
193 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.
180 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
194 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 15 µg Aranesp solution for injection in 0.375 ml (40 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '15 µg f' 0. 375 ml (40 µg/ ml).
181 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 046 1 pack EU/ 1/ 01/ 185/ 058 4 pack
EU/ 1/ 01/ 185/ 046 – Pakkett ta '1 EU/ 1/ 01/ 185/ 058 – Pakkett ta' 4
Aranesp 20 micrograms solution for injection in a pre-filled pen.
Aranesp 20 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
197 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
183 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
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 jizdiedid- 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.
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.
198 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
184 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
199 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
185 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.
4.3 Contraindications
200 4. 3 Kontra- indikazzjonijiet
186 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
201 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.
187 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.
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.
202 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.
188 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
189 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:
191 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.
206 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.
192 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
207 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 20 µg Aranesp solution for injection in 0.5 ml (40 µg/ ml).
5 ml (40 µg/ ml).
193 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 047 1 pack EU/ 1/ 01/ 185/ 059 4 pack
EU/ 1/ 01/ 185/ 047 – Pakkett ta '1 EU/ 1/ 01/ 185/ 059 – Pakkett ta' 4
Aranesp 30 micrograms solution for injection in a pre-filled pen.
Aranesp 30 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
210 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
195 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
211 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
196 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
212 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
197 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.
4.3 Contraindications
213 4. 3 Kontra- indikazzjonijiet
198 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
214 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.
199 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).
215 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).
200 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
201 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:
203 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.
219 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.
204 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 pens of a 30 µg Aranesp solution for injection in 0.3 ml (100 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '30 µg f' 0. 3 ml 100 µg/ ml).
205 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 048 1 pack EU/ 1/ 01/ 185/ 060 4 pack
EU/ 1/ 01/ 185/ 048 – Pakkett ta '1 EU/ 1/ 01/ 185/ 060 – Pakkett ta' 4
Aranesp 40 micrograms solution for injection in a pre-filled pen.
Aranesp 40 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ ml).
Kull pinna mimlija għal- lest fiha 40 mikrogramma ta 'darbepoetin alfa f' 0. 4 ml (100 µg/ ml).
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
223 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
207 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
224 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
208 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
225 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
209 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.
4.3 Contraindications
226 4. 3 Kontra- indikazzjonijiet
210 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
227 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.
211 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).
228 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).
212 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
213 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:
215 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.
232 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.
216 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
233 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 40 µg Aranesp solution for injection in 0.4 ml (100 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '10 µg f' 0. 4 ml (25 µg/ ml).
217 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 049 1 pack EU/ 1/ 01/ 185/ 061 4 pack
EU/ 1/ 01/ 185/ 049 – Pakkett ta '1 EU/ 1/ 01/ 185/ 061 – Pakkett ta' 4
Aranesp 50 micrograms solution for injection in a pre-filled pen.
Aranesp 50 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
236 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
219 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
237 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
220 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
238 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
221 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.
4.3 Contraindications
239 4. 3 Kontra- indikazzjonijiet
222 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
240 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.
223 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).
241 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).
224 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
225 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:
227 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.
245 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.
228 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
246 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 50 µg Aranesp solution for injection in 0.5 ml (100 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '50 µg f' 0. 5 ml (100 µg/ ml).
229 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 050 1 pack EU/ 1/ 01/ 185/ 062 4 pack
EU/ 1/ 01/ 185/ 050 – Pakkett ta '1 EU/ 1/ 01/ 185/ 062 – Pakkett ta' 4
Aranesp 60 micrograms solution for injection in a pre-filled pen.
Aranesp 60 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
249 Il- kura b’ Aranesp hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
231 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
250 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
232 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.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
251 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
233 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.
4.3 Contraindications
252 4. 3 Kontra- indikazzjonijiet
234 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
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.
253 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.
235 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).
254 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).
236 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
237 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:
239 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.
258 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.
240 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
259 6. 4 Prekawzjonijiet speċjali għall- ħażna
Package containing one or four pre-filled pens of a 60 µg Aranesp solution for injection in 0.3 ml (200 µg/ ml).
Pakkett li fih pinna waħda mimlija għal- lest jew erbgħa pinen mimlija għal- lest ta 'soluzzjoni għall - injezzjoni ta' Aranesp ta '60 µg f' 0. 3 ml (200 µg/ ml).
241 The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif b' istruzzjonijiet kollha għall- użu u l- immaniġġar.
EU/ 1/ 01/ 185/ 051 1 pack EU/ 1/ 01/ 185/ 063 4 pack
EU/ 1/ 01/ 185/ 051 – Pakkett ta '1 EU/ 1/ 01/ 185/ 063 – Pakkett ta' 4
Aranesp 80 micrograms solution for injection in a pre-filled pen.
Aranesp 80 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.