qanastek/EMEA-V3 huggingface dataset:
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
106 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
98 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),
107 urew mortalità eċċessiva mhux spjegabbli.
99 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.
100 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.
Additional supportive care should be provided as necessary.
109 fejn hu meħtieġ.
101 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.
110 studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
102 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.
Each pre-filled syringe contains 1.0 ml solution for injection.
Kull siringa mimlija minn qabel fiha 1. 0 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.
112 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
104 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 20000 IU/ 0.5ml solution for injection in pre-filled syringe
Retacrit 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.5 ml solution for injection contains 20000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni għandha 20000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
The solution contains 40000 IU Epoetin zeta per ml.
Is- soluzzjoni fiha 40000 IU Epoetin zeta kull ml.
− 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.
106 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).
114 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)
115 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
107 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.
116 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.
117 150 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 ta ’ demm għandhom jiġu ttratati b’ Retacrit b’ doża ta ’ 600 IU/ kg tal- piż tal- ġisem darbtejn fil ġimgħa 118 għal 3 ġimgħat qabel il- kirurġija.
109 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
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
120 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
111 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.
Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’
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),
121 tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider urew mortalità eċċessiva mhux spjegabbli.
112 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.
113 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.
114 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.
115 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.
There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
125 rapporti konflittwali fil- letteratura dwar jekk l- eritropojetin jistax ikollu rwol ewlieni bħala proliferatur ta ’ tumuri.
Each pack contains 1 or 4 or 6 pre-filled syringes.
Kull pakett għandu 1 jew 4 jew 6 siringi mimlija minn qabel.
117 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 30000 IU/ 0.75ml solution for injection in pre-filled syringe
Retacrit 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 75 ml soluzzjoni għall- injezzjoni għandha 30000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.38 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 38 mg p fenilalanin.
119 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).
128 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).
Patients should be monitored closely to ensure that the lowest approved dose of Retacrit is used to provide adequate control of the symptoms of anemia.
Pazjenti għandhom jiġu monitorati mill- qrib sabiex jiġi żgurat li tingħata biss l- anqas doża approvata ta ’ Retacrit sabiex ikun hemm kontroll adegwat għas- sintomi ta ’ l- anemija..
Dose (IU/ kg given 3x week)
129 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
120 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.
130 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.
121 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.
131 150 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 ta ’ demm għandhom jiġu ttratati b’ Retacrit b’ doża ta ’ 600 IU/ kg tal- piż tal- ġisem darbtejn fil ġimgħa 132 għal 3 ġimgħat qabel il- kirurġija.
122 Method of administration
Mod ta ’ kif jingħata
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
134 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
124 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.
135 tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider urew mortalità eċċessiva mhux spjegabbli.
126 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.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.
128 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.
There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
139 rapporti konflittwali fil- letteratura dwar jekk l- eritropojetin jistax ikollu rwol ewlieni bħala proliferatur ta ’ tumuri.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine
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 0.75 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 75 ml ta ’ soluzzjoni għall- injezzjoni.
130 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 40000 IU/ 1.0ml solution for injection in pre-filled syringe
Retacrit 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 1.0 ml solution for injection contains 40000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni għandha 40000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
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).
142 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).
132 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)
143 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
133 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.
144 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.
145 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
146 Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
135 Method of administration
Mod ta ’ kif jingħata
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
147 plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously. 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.
F’ pazjenti li għandhom insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manteniment tal - emoglobina m’ għandiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni tal- emoglobina mixtieqa rakkomandata f’ sezzjoni 4. 2.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
148 Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
137 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.
139 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.
151 fejn hu meħtieġ.
140 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.
152 studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
144 ANNEX II
155 ANNESS II
A.
U
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
L- AWTORIZZAZZJONI
B.
TA '
CONDITIONS OF THE MARKETING AUTHORISATION
L- AWTORIZZAZZJONI
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ LAWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TALLOTT
Name and address of the manufacturers of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
Norbitec GmbH Pinnauallee 4 D-25436 Uetersen Germany
Norbitec GmbH Pinnauallee 4 D- 25436 Uetersen Il- Ġermanja
STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Il- Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FISSUQ
Prior to launch and as agreed with competent authorities in the Member States, the Marketing Authorisation Holder shall provide healthcare professionals in dialysis centres and retail pharmacies with the following: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
Qabel jitpoġġa fuq is- suq u kif maqbul ma ’ l- awtoritajiet kompetenti fl- Istati Membri, l- MAH għandu jipprovdi lill- professjonisti fiċ- ċentri tad- dijalisi u spiżeriji kummerċjali b’ dawn li ġejjin: • Fuljett edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • Loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jistagħu jikkawżaw immunoġeniċità li f’ każijiet rari tista’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CRF) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Retacrit biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CRF • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ suspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
146 • OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
Pharmacovigilance system The Marketing Authorisation Holdet must ensure that the system of pharmacovigilance, as described in version 02 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 02, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jitpoġġa fuq is- suq..
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated Risk Management Plan should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
157 għall- użu uman, l- RMP aġġornat għandu jintbagħat fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jkun imiss.
147 ANNEX III
158 ANNEX III
149 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
160 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 1000 IU/ 0.3ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 1000 IU/ 0. 3 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 1000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 1000 IU ta ’ Epoetin zeta
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 (pH adjuster), hydrochloric acid (pH adjuster).
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).
Contains phenylalanine, see leaflet for further information.
Fih il- fenilalanin, ara l- fuljett għal aktar informazzjoni.
1 pre-filled syringe of 0.3 ml solution for injection 6 pre-filled syringes of 0.3 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 3 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 3 ml ta ’ soluzzjoni għall- injezzjoni
Read the package leaflet before use.
Użu għal taħt il- ġilda u għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu.
INFORMATION IN BRAILLE
INFORMAZJONI BIL- BRAILLE
151 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
162 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SYRINGE LABELS
TIKKETTI TAS- SIRINGA
Retacrit 1000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 1000 IU Epoetin zeta Użu IV u SC
1000 IU/ 0.3 ml
1000 IU/ 0. 3 ml
152 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
163 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 2000 IU/ 0.6ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 2000 IU/ 0. 6 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 2000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 2000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.6 ml solution for injection 6 pre-filled syringes of 0.6 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 6 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 6 ml ta ’ soluzzjoni għall- injezzjoni
154 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
165 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 2000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 2000 IU Epoetin zeta Użu IV u SC
2000 IU/ 0.6 ml
2000 IU/ 0. 6 ml
155 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
166 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 3000 IU/ 0.9ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 3000 IU/ 0. 9 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 3000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 3000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.9 ml solution for injection 6 pre-filled syringes of 0.9 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 9 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 9 ml ta ’ soluzzjoni għall- injezzjoni
157 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
168 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 3000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 3000 IU Epoetin zeta Użu IV u SC
3000 IU/ 0.9 ml
3000 IU/ 0. 9 ml
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
169 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 4000 IU/ 0.4ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 4000 IU/ 0. 4 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 4000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 4000 IU ta ‘ Epoetin zeta
1 pre-filled syringe of 0.4 ml solution for injection 6 pre-filled syringes of 0.4 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 4 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 4 ml ta ’ soluzzjoni għall- injezzjoni
Retacrit 4000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 4000 IU Epoetin zeta Użu IV u SC
4000 IU/ 0.4 ml
4000 IU/ 0. 4 ml
161 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
172 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 5000 IU/ 0.5ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 5000 IU/ 0. 5 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 5000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 5000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.5 ml solution for injection 6 pre-filled syringes of 0.5 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni
163 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
174 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 5000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 5000 IU Epoetin zeta Użu IV u SC
5000 IU/ 0.5 ml
5000 IU/ 0. 5 ml
164 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
175 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 6000 IU/ 0.6ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 6000 IU/ 0. 6 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 6000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 6000 IU ta ’ Epoetin zeta
166 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
177 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 6000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 6000 IU Epoetin zeta Użu IV u SC
6000 IU/ 0.6 ml
6000 IU/ 0. 6 ml
167 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
178 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 8000 IU/ 0.8ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 8000 IU/ 0. 8 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 8000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 8000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.8 ml solution for injection 6 pre-filled syringes of 0.8 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni
169 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
180 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 8000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 8000 IU Epoetin zeta Użu IV u SC
8000 IU/ 0.8 ml
8000 IU/ 0. 8 ml
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
181 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 10000 IU/ 1.0ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 10000 IU/ 1. 0 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 10000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 10000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 1.0 ml solution for injection 6 pre-filled syringes of 1.0 ml solution for injection
Siringa waħda mimlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni
172 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
183 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 10000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 10000 IU Epoetin zeta Użu IV u SC
10000 IU/ 1.0 ml
10000 IU/ 1. 0 ml
173 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
184 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 20000 IU/ 0.5ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 20000 IU/ 0. 5 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 20000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 20000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.5 ml solution for injection 4 pre-filled syringes of 0.5 ml solution for injection 6 pre-filled syringes of 0.5 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni 4 siringi momlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni
175 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
186 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 20000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 20000 IU Epoetin zeta Użu IV u SC
176 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
187 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 30000 IU/ 0.75ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 30000 IU/ 0. 75 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 30000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 30000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 0.75 ml solution for injection 4 pre-filled syringes of 0.75 ml solution for injection 6 pre-filled syringes of 0.75 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 75 ml ta ’ soluzzjoni għall- injezzjoni 4 siringi momlija minn qabel b’ 0. 75 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 0. 75 ml ta ’ soluzzjoni għall- injezzjoni
178 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
189 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Retacrit 30000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 30000 IU Epoetin zeta Użu IV u SC
30000 IU/ 0.75 ml
30000 IU/ 0. 75 ml
179 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
190 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Retacrit 40000 IU/ 1.0ml solution for injection in pre-filled syringe Epoetin zeta
Retacrit 40000 IU/ 1. 0 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe contains 40000 IU Epoetin zeta
Siringa waħda mimlija minn qabel fiha 40000 IU ta ’ Epoetin zeta
1 pre-filled syringe of 1.0 ml solution for injection 4 pre-filled syringes of 1.0 ml solution for injection 6 pre-filled syringes of 1.0 ml solution for injection
Siringa waħda mimlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni 4 siringi momlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni 6 siringi momlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni
Retacrit 40000 IU Injection Epoetin zeta iv/ sc use
Injezzjoni tas- Retacrit 40000 IU Epoetin zeta Użu IV u SC
183 PACKAGE LEAFLET:
194 FULJETT TA ’ TAGĦRIF:
Retacrit 1000 IU/ 0.3ml solution for injection in pre-filled syringe Retacrit 2000 IU/ 0.6ml solution for injection in pre-filled syringe Retacrit 3000 IU/ 0.9ml solution for injection in pre-filled syringe Retacrit 4000 IU/ 0.4ml solution for injection in pre-filled syringe Retacrit 5000 IU/ 0.5ml solution for injection in pre-filled syringe Retacrit 6000 IU/ 0.6ml solution for injection in pre-filled syringe Retacrit 8000 IU/ 0.8ml solution for injection in pre-filled syringe Retacrit 10000 IU/ 1.0ml solution for injection in pre-filled syringe Retacrit 20000 IU/ 0.5ml solution for injection in pre-filled syringe Retacrit 30000 IU/ 0.75ml solution for injection in pre-filled syringe Retacrit 40000 IU/ 1.0ml solution for injection in pre-filled syringe
Retacrit 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 2000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 10000UI/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Retacrit 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel ma tibda tuża l- mediċina. − Żomm dan il- fuljett.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Retacrit is and what it is used for 2.
X’ inhu Retacrit u għalxiex jintuża 2.
Before you use Retacrit 3.
Qabel ma tuża Retacrit 3.
How to use Retacrit 4.
Kif għandek tuża Retacrit 4.
Possible side effects 5.
Effetti oħra li jista ’ jkollu 5.
How to store Retacrit 6.
Kif taħżen Retacrit 6.
WHAT RETACRIT IS AND WHAT IT IS USED FOR
X’ INHU RETACRIT U GĦALXIEX JINTUŻA
Retacrit is a medicine that stimulates the bone marrow to produce more red blood cells.
Retacrit huwa mediċina li jistimola l- għadma tal- mudullun biex tipproduċi aktar ċelluli ħomor tad - demm.
Retacrit is used
Retacrit jintuża
− in adults, children and adolescents on haemodialysis to treat symptomatic anaemia associated with chronic renal failure (kidney disease). − in adult patients on peritoneal dialysis to treat symptomatic anaemia associated with chronic renal failure (kidney disease). − in adult patients with renal insufficiency not yet on dialysis to treat severe anaemia associated with kidney disease accompanied by clinical symptoms. − in adult patients receiving chemotherapy for solid tumours, malignant lymphoma (cancer of the lymphatic system) or multiple myeloma (bone marrow cancer) to treat anaemia and reduce the need for a blood transfusion, if the doctor decides there may be a high risk for needing for a blood transfusion. − in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous pre-donation).
− fl- adulti, fit- tfal, u fl- adolexxenti li qegħdin fuq l- emodijalisi biex jitratta anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (mard tal- kliewi). − f’ pazjenti adulti fuq dijalisi peritonjali biex jitratta anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (mard tal- kliewi). − f’ pazjenti adulti b’ insuffiċjenza renali mhux digà fuq id- dijalisi biex jitratta l- anemija assoċjata mal- mard tal- kliewi akkumpanjat minn sintomi kliniċi. − f’ pazjenti adulti jekk qegħdin jirċievu l- kimoterapija għat- tumuri sħaħ, limfoma malinn (kanċer fis- sistema limfatiku) jew majeloma multipla (kanċer fl- għadma tal- mudullun) u t- tabib tiegħek jiddeċiedi li jkollok bżonn ħtieġa għolja ta ’ trasfużjoni tad- demm. − f’ pazjenti b’ anemija moderata li ser ikollhom il- kirurġija u qabilha, jagħtu d- demm sabiex demmhom stess jista ’ jingħatalhom waqt jew wara l- kirurġija (donazzjoni awtologa minn qabel).
BEFORE YOU USE RETACRIT
QABEL MA TUŻA RETACRIT
Do not use Retacrit
Tużax Retacrit
− if you are allergic (hypersensitive) to erythropoietins or any of the other ingredients of Retacrit − if you have developed Pure Red Cell Aplasia (PRCA; reduced or stopped production of red blood cells) following treatment with any erythropoietin − if you have high blood pressure, which is not properly controlled with blood pressure-lowering medicines − if you cannot be given medicines to thin blood for the prevention of blood clots − if you are donating your own blood before surgery, and:
− jekk int allerġiku (sensittività eċċessiva) għall- eritropojetini jew kwalunkwe ingredjenti ta ’ Retacrit − jekk żviluppajt Pure Red Cell Aplasia (PRCA; in- nuqqas ta ’ ċelluli żgħar tad- demm ħomor) wara trattament b’ kwalunkwe eritropojetin − jekk għandek pressjoni għolja, li m’ hijiex ikkontrollata kif suppost bi prodotti li jnaqqsu l - pressjoni − jekk ma tistax tingħata mediċini li jraqqu d- demm għall- prevenzjoni tat- tagħqid tad- demm − jekk qed tagħti d- demm tiegħek stess qabel il- kirurġija, u:
you had a heart attack or stroke in the month before your treatment you have unstable angina pectoris (new or increasing chest pain) you are at risk of blood clots in the veins (deep venous thrombosis) – for example, if you have had clots before.
kellek attakk tal- qalb jew puplesija fix- xahar ta ’ qabel it- trattament għandek anġina pectoris (uġigħ fis- sider li ma kellekx qabel jew żieda fl - uġigħ fis- sider) għandek ir- riskju ta ’ demm magħqud fil- vini (trombożi fonda fil- vini) – per eżempju, jekk kellek demm magħqud qabel.
Take special care with Retacrit
Oqgħod attent ħafna b’ Retacrit
Please tell your doctor if you know you are suffering, or have suffered, from any of the following: − epileptic seizures − liver disease − cancer − anaemia from other causes − heart disease (such as angina) − disorders of blood circulation resulting in pins and needles or cold hands or feet or muscle cramps in the legs − blood clots/blood clotting disorders − phenylketonuria (genetic enzyme deficiency that increases excretion of a chemical (phenylketone) in urine and may cause nervous system disorders) − kidney disease.
Jekk jogħġbok staqsi lit- tabib tiegħek jekk taftx li qed tbati, jew kont tbati, minn dawn li ġejjin: − attakki epilettiċi − mard fil- fwied − kanċer − anemija minn kawżi oħra − mard tal- qalb (bħal anġina) − mard fiċ- ċirkolazzjoni tad- demm li jwassal għal tingiż jew idejn u saqajn kesħin jew bugħawwieġ tal- muskoli fis- saqajn − demm magħqud/ mard li jeffettwa it- tagħqid tad- demm − fenilketonurja (defiċjenza ġenetika ta ’ l- enzim li jżid l- eskrizzjoni ta ’ kimika (il- fenilketonurja) fl- urina u li jista ’ iwassal għal mard ħafif fis- sistema nervuża) − mard tal- kliewi.
General information Your doctor should try to keep your hemoglobin levels between 10 and 12 g/dL.
Tagħrif ġenerali It- tabib tiegħek għandu jipprova jżomm il- livelli tal- emoglobina bejn 10 u 12 g/ dL.
The haemoglobin values should not exceed a value of 12 g/dl.
Il- valur tal- emoglobina m’ għandux jaqbeż 12 g/ dL
Your doctor will monitor your blood pressure regularly while you are using Retacrit.
It- tabib tiegħek ser josserva l- pressjoni tiegħek spiss waqt li qed tuża Retacrit.
If you experience headaches, particularly sudden, stabbing migraine-like headaches or start to feel confused or have fits, tell your doctor or nursing staff immediately.
Jekk tbati mill- uġigħ ta ’ ras, speċjalment f’ daqqa waħda, uġigħ ta ’ ras qisu emigranja persistenti jew tibda tħossok konfuż jew jkollok xi aċċessjonijiet., għid lit- tabib tiegħek jew l- infermiera mill- ewwel.