qanastek/EMEA-V3 huggingface dataset:
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
L- istudji jew inkludew pazjenti li kienu qed jiġu trattati b’ kimoterapija (żewġ studji) jew użaw popolazzjonijiet ta ’ pazjenti fejn sustanzi li jistimulaw l- eritropojesi ma kienux indikati: anemija f’ pazjenti bil- kanser li ma kienux qed jirċievu kimoterapija, u pazjenti b’ kanser fir ras u fil- għonq li kienu qed jirċievu radjoterapija.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji bi plaċebo bħala kontroll il- proporzjonijiet ta ’ ħsara
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l- istudji wrew mortalità eċċessiva konsistenti statistikament sinifikanti u bla spjegazzjoni f’ pazjenti li għandhom anemija assoċjata ma diversi kansers komuni li rċevew eritropojetin rikombinanti uman meta mqabbel ma ’ kontrolli.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Reviżjoni sistematika ġiet mwettqa wkoll fuq aktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
The extent to which these outcomes might
Hemm riskju ogħla għal każijiet tromboemboliċi f’ pazjenti b’ kanser ittrattati b’ eritropojetin rikombinanti uman u impatt negattiv fuq is- sopravivenza globali ma tistax tiġi eskluża.
24 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
L- eritropojetin ma wera l- ebda tibdil fit- testijiet mutaġenetiċi fil- kultura taċ- ċelluli batterjali u mammiferi u studji mikronukleji in vivo fi- ġrieden.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH)
Each pack contains 1 or 6 pre-filled syringes.
Kull siringa mimlija minn qabel fiha 0. 6 ml ta ’ soluzzjoni għall- injezzjoni.
Not all pack sizes may be marketed.
Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
The protective cap is removed from the injection needle and air is expelled from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
It- tapp protettiv jitneħħa mil- labra tas- siringa and l- arja titneħħa mis- siringa u l- labra billi żżomm is- siringa vertikali u tagħfas bil- mod it- tap ‘ il fuq.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar 28 • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
26 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Retacrit 3000 IU/ 0.9ml solution for injection in pre-filled syringe
Retacrit 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.9 ml solution for injection contains 3000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 9 ml soluzzjoni għall- injezzjoni għandha 3000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.45 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 45 mg p fenilalanin.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
− Trattament għal anemija sintomatika f’ pazjenti adulti u tfal b’ falliment renali kroniku.
28 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
30 F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4) Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
Dose (IU/ kg given 3x week)
Doża (UI/ kg mogħtija 3x fil- ġimgħa)
29 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150
Appropriate dose titration should be considered.
33 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti b’ anemija ħafifa (ematokrit ta ’ 33- 39%) li għandhom bzonn depozitu minn qabel ta ’ ≥ 4 unità 34 ta ’ demm għandhom jiġu ttratati b’ Retacrit b’ doża ta ’ 600 IU/ kg tal- piż tal- ġisem darbtejn fil ġimgħa għal 3 ġimgħat qabel il- kirurġija.
31 Method of administration
Mod ta ’ kif jingħata
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
35 Jista ’ ikun hemm żieda moderata, li tiddependi mid- doża, fl- għadd tal- plejtlits fil- limiti normali matul it- trattament bl- eritropojetin.
If no cause is identified, a bone marrow examination should be considered for diagnosis of PRCA.
Jekk l- ebda kawża ma tiġi identifikata, għandha tiġi kkunsidrata 36 eżaminazzjoni tal- mudullun għad- dijanjosi tal- PRCA.
33 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
37 Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’ tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider urew mortalità eċċessiva mhux spjegabbli.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l),
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
38 attenzjoni għal uġigħ ta ’ ras qawwi f’ daqqa li jixbah lill- emigranja, bħala sinjal possibbli ta ’ twissija.
35 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
36 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
40 indikati: anemija f’ pazjenti bil- kanser li ma kienux qed jirċievu kimoterapija, u pazjenti b’ kanser fir ras u fil- għonq li kienu qed jirċievu radjoterapija.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji bi plaċebo bħala kontroll il- proporzjonijiet ta ’ ħsara għal sopravivenza globali kienet tvarja bejn 1. 25 u 2. 47 favur il- kontrolli.
37 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
41 mammiferi u studji mikronukleji in vivo fi- ġrieden.
Each pre-filled syringe contains 0.9 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 9 ml ta ’ soluzzjoni għall- injezzjoni.
Retacrit 4000 IU/ 0.4ml solution for injection in pre-filled syringe
Retacrit 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.4 ml solution for injection contains 4000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 4 ml soluzzjoni għall- injezzjoni għandha 4000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
The solution contains 10000 IU Epoetin zeta per ml.
Is- soluzzjoni fiha 10000 IU Epoetin zeta kull ml.
Each pre-filled syringe contains 0.20 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 20 mg p fenilalanin.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
44 − Trattament għal anemija sintomatika f’ pazjenti adulti u tfal b’ falliment renali kroniku.
41 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4) Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
42 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
43 The recommended dosing regimen is described in the following diagram:
Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
Appropriate dose titration should be considered.
47 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Retacrit should be given by the intravenous route.
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ μl jew żieda fl- Hb ≥ 1 g/ d
At the time of donating blood, Retacrit should be administered after the completion of the blood donation procedure.
Aġġustament fid- doża F’ rata ta ’ żieda fl- emoglobina ta ’ > 2 g/ dl (> 1. 25 mmol/ l) fix- xahar id- doża ta ’ ’ Retacrit għanda tonqos b’ xi 25- 50%.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Fil- mument ta ’ donazzjoni tad- demm, Retacrit għandu jingħata wara t- tlestija tal- proċedura tad - donazzjoni tad- demm.
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
48 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
44 Method of administration
Mod ta ’ kif jingħata
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Jista ’ ikun hemm żieda moderata, li tiddependi mid- doża, fl- għadd tal- plejtlits fil- limiti normali matul it- trattament bl- eritropojetin.
This regresses during the course of continued therapy.
Huwa rrakomandat li l- għadd tal -
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
49 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
50 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
Serum
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
46 electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’ tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l), increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
48 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Eritroblastopenja medjata mill- antikorpi (PRCA) ġiet irrappurtata wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ epoetin alfa.
Additional supportive care should be provided as necessary.
Għajnuna addizzjonali supportiva għandha tingħata
49 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
l- efikaċija bijoloġika tal- eritropojetin intweriet f’ diversi mudelli ta ’ l- annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
Il- konċentrazzjoni ta ’ emoglobina immirata f’ żewġ
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
54 studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
50 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
Hemm rapporti konflittwali fil- letteratura dwar jekk l- eritropojetin jistax ikollu rwol ewlieni bħala proliferatur
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH)
Each pre-filled syringe contains 0.4 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 4 ml ta ’ soluzzjoni għall- injezzjoni.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
56 Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
Retacrit 5000 IU/ 0.5ml solution for injection in pre-filled syringe
Retacrit 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.5 ml solution for injection contains 5000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni għandha 5000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.25 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 25 mg p fenilalanin.
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
58 Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
54 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Dose (IU/ kg given 3x week)
59 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
55 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
60 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
Appropriate dose titration should be considered.
61 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
62 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
57 Method of administration
Mod ta ’ kif jingħata
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
63 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
64 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
If an elevated (or rising) serum
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
59 potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
Jekk livell elevat (jew qed qed jogħla) ta ’ potassju fis- serum jiġi osservat imbagħad għandha tingħata kunsiderazzjoni sabiex titwaqqaf l- amministrazzjoni tal- eritropojetin sakemm l- iperkalemija tkun ġiet irranġata.
61 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Eritroblastopenja medjata mill- antikorpi (PRCA) ġiet irrappurtata wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ epoetin alfa.
62 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
l- efikaċija bijoloġika tal- eritropojetin intweriet f’ diversi mudelli ta ’ l- annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
68 studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
63 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Each pre-filled syringe contains 0.5 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
70 Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
Retacrit 6000 IU/ 0.6ml solution for injection in pre-filled syringe
Retacrit 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.6 ml solution for injection contains 6000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni għandha 6000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
The solution contains 10000 IU Epoetin zeta per ml. *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Is- soluzzjoni fiha 10000 IU Epoetin zeta kull ml.
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
72 F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4) Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
67 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Dose (IU/ kg given 3x week)
73 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
68 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
74 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
Appropriate dose titration should be considered.
75 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
76 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
70 Method of administration
Mod ta ’ kif jingħata
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
77 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
78 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
72 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l),
79 urew mortalità eċċessiva mhux spjegabbli.
73 increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
74 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
75 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
82 studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
76 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
84 Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
Retacrit 8000 IU/ 0.8ml solution for injection in pre-filled syringe
Retacrit 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.8 ml solution for injection contains 8000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 8 ml soluzzjoni għall- injezzjoni għandha 8000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.40 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 40 mg p fenilalanin.
4.1 Therapeutic indications − Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme.
− Trattament għal anemija sintomatika assoċjata ma ’ falliment renali kroniku (CRF) f’ pazjenti adulti u tfal: o Trattament għal anemija assoċjata ma ’ falliment renali kroniku f’ pazjenti adulti u tfal fuq emodijalisi u pazjenti adulti fuq dijalisi peritoneali (Ara sezzjoni 4. 4). o Trattament għal anemija severa li ġejja mill- kliewi akkumpanjata minn sintomi kliniċi f’ pazjenti adulti b’ insuffiċjenza tal- kliewi li għad mhux ikollhom dijalisi (Ara sezzjoni 4. 4). − Trattament ta ’ anemija u nuqqas ta ’ bżonnijiet ta ’ trasfużjoni f’ pazjenti adulti li qegħdin jirċievu l- kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multiplu, u f’ riskju ta ’ trasfużjoni kif assessjat mill- istatus ġenerali tal- pazjent (e. g. status kardjovaskulari, anemija pre - eżistenti fil- bidu tal- kimoterapija). − Retacrit jista ’ jintuża sabiex tiżdied il- ġabra ta ’ demm awtologu minn pazjenti li qegħdin f’ programm ta ’ qabel id- donazzjoni.
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
86 Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
80 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Dose (IU/ kg given 3x week)
87 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
81 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
88 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
Appropriate dose titration should be considered.
89 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
90 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
83 Method of administration
Mod ta ’ kif jingħata
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
91 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
92 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
85 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l),
93 urew mortalità eċċessiva mhux spjegabbli.
86 increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
87 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
Phlebotomy may be performed if excessively high haemoglobin levels occur.
Il- flebotomija tista ’ issir
88 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
L- istudji jew inkludew pazjenti li kienu qed jiġu trattati b’ kimoterapija (żewġ studji) jew użaw popolazzjonijiet ta ’ pazjenti fejn sustanzi li jistimulaw l- eritropojesi ma kienux indikati: anemija f’ pazjenti bil- kanser li ma kienux qed jirċievu kimoterapija, u pazjenti b’ kanser fir
89 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
Long-term carcinogenicity studies have not been carried out.
Hemm
There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
97 rapporti konflittwali fil- letteratura dwar jekk l- eritropojetin jistax ikollu rwol ewlieni bħala proliferatur ta ’ tumuri.
Each pre-filled syringe contains 0.8 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 8 ml ta ’ soluzzjoni għall- injezzjoni.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
98 Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
91 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Retacrit 10000 IU/ 1.0ml solution for injection in pre-filled syringe
Retacrit 10000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 1.0 ml solution for injection contains 10000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni għandha 10000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.50 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 50 mg p fenilalanin.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
100 4. 4) Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
93 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Dose (IU/ kg given 3x week)
101 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
94 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
102 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
Appropriate dose titration should be considered.
103 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
104 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
96 Method of administration
Mod ta ’ kif jingħata
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
105 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.