qanastek/EMEA-V3 huggingface dataset:
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi,
Silapo has no or negligible influence on the ability to drive and use machines.
87 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales:
F’ prova prospettiva, randomised, double- blind, plaċebo- kontrollata magħmula fi 375 pazjent anemiċi b’ kankri mallinni varji mhux myeloid li qed jirċievu l- kimoterapija mhux tal- platinu, kien hemm tnaqqis sinjifikanti ta ’ sequelae relatati ma ’ l- anemija (eż. l- għejja, nuqqas ta ’ enerġija, u nuqqas ta ’ attività), kif imkejjel mill- istrumenti u skali li ġejjin:
Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Functional Assessment of Cancer
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.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
F’ xi studji tossikoloġiċi ta ’ qabel l- użu kliniku fil- klieb u l- ġrieden, iżda mhux fix- xadini, it- terapija bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija
Not all pack sizes may be marketed.
91 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe
Silapo 10000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
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).
93 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)
94 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
A naemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ l- anemija u sequelae jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- marda; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal - pazjent hi meħtieġa.
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.
95 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.
General
97 Ġenerali
These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
98 Dawn jinkludu: deifiċjenza fil- ħadid, fil- folate, jew fil- Vitamina B12; intossikazzjoni bl- aluminju; infezzjonijiet interkurrenti; episodji ta ’ infjammazzjoni jew trawmatiċi; telf ta ’ demm moħbi; emolisi, fibrożi tal- muddullun ta ’ kwalunkwe oriġini.
Silapo has no or negligible influence on the ability to drive and use machines.
100 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
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 pack contains 1 or 6 pre-filled syringes.
104 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe
Silapo 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
− 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). − Silapo 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). − Silapo 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).
106 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).
A nemia 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)
107 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.
108 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.
109 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
General
110 Ġenerali
110 All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Dawn il- fatturi kollha flimkien tal- anemija għandhom jiġi kkunsidrati mill- qrib meta wieħed ikun qed jiddeċiedi d- doża ta ’ eritropojetin fil- pazjenti bil- kanċer.
Non response to erythropoietin therapy should prompt a search for causative factors.
111 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
111 electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
112 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Silapo has no or negligible influence on the ability to drive and use machines.
113 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
113 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.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
114 Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet osservata f’ pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
114 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).
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hemm riskju ogħla għal każijiet tromboemboliċi f’ pazjenti b’ kanċer ittrattati b’ eritropojetin rikombinanti uman u impatt negattiv fuq is- sopravivenza globali ma tistax tiġi eskluża.
115 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
116 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections
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 4 pre-filled syringes.
117 Kull pakett għandu 1 jew 4 siringi mimlija minn qabel.
117 Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Il- Ġermanja
Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe
Silapo 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
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).
119 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)
120 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.
121 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.
General
123 Ġenerali
Non response to erythropoietin therapy should prompt a search for causative factors.
124 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
125 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Silapo has no or negligible influence on the ability to drive and use machines.
126 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
127 Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet osservata f’ pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
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.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
129 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pack contains 1 or 4 pre-filled syringes.
130 Kull pakett għandu 1 jew 4 siringi mimlija minn qabel.
Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe
Silapo 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
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).
132 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)
133 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
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.
134 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.
General
136 Ġenerali
The refore, 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.
Non response to erythropoietin therapy should prompt a search for causative factors.
137 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
138 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Silapo has no or negligible influence on the ability to drive and use machines.
139 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
140 Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet osservata f’ pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
140 The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Il- massa molekulari apparenti ta ’ eritropojetin hija ta ’ 32000- 40000 Dalton.
141 thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hemm riskju ogħla għal każijiet tromboemboliċi f’ pazjenti b’ kanċer ittrattati b’ eritropojetin rikombinanti uman u impatt negattiv fuq is- sopravivenza globali ma tistax tiġi eskluża.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
142 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pack contains 1 or 4 pre-filled syringes.
143 Kull pakett għandu 1 jew 4 siringi mimlija minn qabel.
144 ANNEX II
144 ANNESS II
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 Silapo 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 Silapo 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
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).
146 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
147 ANNEX III
149 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
149 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 1000 IU/0.3ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 1000 IU/ 0. 3 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
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 Sitt siringi momlija minn qabel b’ 0. 3 ml ta ’ soluzzjoni għall- injezzjoni
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 61118 Bad Vilbel Il- Ġermanja
151 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
151 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 1000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
152 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 2000 IU/ 0. 6 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 0. 6 ml ta ’ soluzzjoni għall- injezzjoni
154 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
154 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 2000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
155 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 3000 IU/ 0. 9 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 0. 9 ml ta ’ soluzzjoni għall- injezzjoni
157 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
157 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 3000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
158 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 4000 IU/ 0. 4 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 0. 4 ml ta ’ soluzzjoni għall- injezzjoni
160 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
160 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 4000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
161 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 5000 IU/ 0. 5 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni
Silapo 5000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
164 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 6000 IU/0.6ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 6000 IU/ 0. 6 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
166 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
166 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 6000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
167 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 8000 IU/ 0. 8 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni
169 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
169 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 8000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
170 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 10000 IU/ 1. 0 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel 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 Sitt siringi momlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni
172 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
172 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 10000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 10000 IU Epoetin zeta Użu IV u SC
173 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
173 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 20000 IU/ 0. 5 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe of 0.5 ml solution for injection 4 pre-filled syringes of 0.5 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni Erbgħa siringi momlija minn qabel b’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni
Silapo 20000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 20000 IU Epoetin zeta Użu IV u SC
20000 IU/0.5 ml
20000 IU/ 0. 5 ml
176 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
176 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 30000 IU/ 0. 75 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe of 0.75 ml solution for injection 4 pre-filled syringes of 0.75 ml solution for injection
Siringa waħda mimlija minn qabel b’ 0. 75 ml ta ’ soluzzjoni għall- injezzjoni Erbgħa siringi momlija minn qabel b’ 0. 75 ml ta ’ soluzzjoni għall- injezzjoni
178 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
178 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 30000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 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
179 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 40000 IU/ 1. 0 ml Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Epoetin zeta
1 pre-filled syringe of 1.0 ml solution for injection 4 pre-filled syringes of 1.0 ml solution for injection
Siringa waħda mimlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni Erbgħa siringi momlija minn qabel b’ 1. 0 ml ta ’ soluzzjoni għall- injezzjoni
181 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
181 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Silapo 40000 IU Injection Epoetin zeta iv/sc use
Injezzjoni tas- Silapo 40000 IU Epoetin zeta Użu IV u SC
40000 IU/1.0 ml
40000 IU/ 1. 0 ml
183 PACKAGE LEAFLET:
183 FULJETT TA ’ TAGĦRIF:
Silapo 1000 IU/0.3ml solution for injection in pre-filled syringe Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe Silapo 6000 IU/0.6ml solution for injection in pre-filled syringe Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe
Silapo 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 2000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 10000UI/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Silapo 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
What Silapo is and what it is used for 2.
X’ inhu Silapo u għalxiex jintuża 2.
Before you use Silapo 3.
Qabel ma tuża Silapo 3.
How to use Silapo 4.
Kif għandek tuża Silapo 4.
How to store Silapo 6.
Kif taħżen Silapo 6.
WHAT SILAPO IS AND WHAT IT IS USED FOR
X’ INHU SILAPO U GĦALXIEX JINTUŻA
Silapo is a medicine that stimulates the bone marrow to produce more red blood cells.
Silapo huwa mediċina li jistimola l- għadma tal- mudullun biex tipproduċi aktar ċelluli ħomor tad - demm.
Silapo is used
Silapo jintuża
BEFORE YOU USE SILAPO
QABEL MA TUŻA SILAPO
Do not use Silapo
Tużax Silapo
− if you are allergic (hypersensitive) to erythropoietins or any of the other ingredients of Silapo − 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 ’ Silapo − 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:
Take special care with Silapo
Oqgħod attent ħafna b’ Silapo
Your doctor will monitor your blood pressure regularly while you are using Silapo.
It- tabib tiegħek ser josserva l- pressjoni tiegħek spiss waqt li qed tuża Silapo.
Remember to tell your doctor that you are receiving Silapo if you have to visit the hospital or family doctor for any treatmentincluding a blood test, as Silapo may affect the results.
Ftakar biex tgħid lit- tabib tiegħek li qed tieħu Silapo jekk ikollok bżonn iżżur l- isptar jew it- tabib tal - familja għal xi trattament, jew il- klinika għall- eżami tad- demm, peress li Silapo jista ’ jaffettwa ir - riżultati.
Kidney disease patients There is no experience with subcutaneous use (injection into the skin) of Silapo in kidney patients.
Pazjenti bil- mard tal- kliewi M’ hemmx wisq esperjenza fl- użu ta ’ taħt il- ġilda (injezzjoni taħt il- ġilda) ta ’ Silapo fil- pazjenti tal - kliewi.
Therefore, if you are being treated for anaemia associated with kidney disease, Silapo has to be given by injection into a vein (intravenously).
Għalhekk, jekk qiegħed tiġi ttrattat għal anemija assoċjata mal- mard tal- kliewi, Silapo għandu jingħata f’ vina (ġol- vina).
PRCA means the inability to produce enough red blood cells in the bone marrow.
Il- Pure Red Cell Aplasia (PRCA) ġiet irraportata rarament wara xhur sa snin ta ’ trattament mogħti taħt il- ġilda bi prodotti oħra li għandhom l- eritropojetini u ma tistax tiġi eskluża b’ Silapo.
PRCA
Il- PRCA
185 may be caused by the production to antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
185 iffisser in- nuqqas ta ’ abilità li tipproduċi biżżejjed ċelluli ħomor fil- mudullun.
If PRCA, a very rare condition, occurs, the Silapo therapy will be stopped and your doctor will determine the best course of action to treat the anaemia.
Jekk il- PRCA – kundizzjoni rari - tiġri, it- terapija b’ Silapo titwaqqaf u t- tabib tiegħek jidditermina l- aħjar mod ta ’ trattament għall- anemija.
Although this complication is very rare, you should be aware that if you develop it, you would need to have regular blood transfusions, possibly lifelong, to treat your anaemia and the Silapo therapy would have to be discontinued.
Għalkemm din il- kumplikazzjoni hija rari, għandek tkun taf li jekk tiżviluppaha, ikollok bżonn trasfużjonijiet tad - demm regolari, forsi għal kumplament ta ’ ħajtek, għat- trattament tal- anemija tiegħek u t- trattament b’ Silapo jkun irid jitwaqqaf.
Your doctor can decide whether Silapo is not working properly for you and will end the treatment, if necessary.
It- tabib tiegħek jista ’ jiddeċiedi jekk Silapo hux qed jaħdem tajjeb għalik u jwaqqaf it- trattament, jekk hemm bżonn.
If you are receiving dialysis treatment when you begin treatment with Silapo, your dialysis regimen may need to be adjusted to maintain urea, creatinine and potassium levels in the desired range.
Jekk qed tirċievi trattament ta ’ dijalisi meta tibda t- trattament b’ Silapo, ir- reġim ta- dijalisi tiegħek jista ’ jkollu bżonn li jiġi aġġustat sabiex jinżammu l- livelli tal- ureja, il- kreatinina u l- potassju f’ livelli mixtieqa.
If an elevated (or rising) serum potassium level is detected, your doctor may consider to stop the treatment with Silapo until the level is back to normal.
Jekk il- livell ta ’ potassju fis- serum għola (jew qed jogħla) jiġi osservat imbagħad kunsiderazzjoni għandha tingħata sabiex jingħataSilapo sakemm il- livell jiġi lura għan- normal.
An increase in the dose of a particular blood-thinning medicine (heparin) during haemodialysis is often needed during the course of therapy with Silapo to minimize the risk of blood clotting.
Spiss ikun hemm bżonn żieda fid- doża ta ’ mediċina partikulari li traqqaq id- demm (l- eparina) matul l - emodijalisi matul il- kors tat- terapija b’ Silapo sabiex jitnaqqas ir- riskju li d- demm jagħqad.
Cancer patients Cancer patients are more likely to suffer from blood clots if receiving erythropoietin medicines, like Silapo (see section 4).
Il- pazjenti tal- kanċer l- pazjenti tal- kanċer iżjed għandhom lok li jbatu mid- demm li jgħaqad jekk ikunu qegħdin jirċievu l - mediċini bl- eritropojetin, bħal Silapo (ara sezzjoni 4).
Therefore, you should discuss the benefits of Silapo with your doctor, particularly if you are obese or have a history of blood clots/blood clotting disorders.
Għalhekk, għandek tidisskuti l- benifiċċji ta ’ Silapo mat- tabib tiegħek, partikolarment jekk int oħxon jew jekk fil- passat kellek problemi biex jgħaqad id- demm/ mard biex jgħaqad id- demm.
If you are a cancer patient, you should be aware that Silapo may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Jekk int pazjent tal- kanċer, għandek tkun konxju li Silapo jista ’ jaġixxi bħala fattur ta’ żvilupp għaċ - ċellula tad- demm u f’ xi ċirkostanzi jista ’ jkollu impatt negattiv fuq il- kanċer tiegħek.
In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure ciclosporin levels while you are taking Silapo.
Partikolarment, jekk qed tieħu mediċina li fiha s- sustanza attiva ciclosporin sabiex trażżan is- sistema immunitarja tiegħek wara trapjant tal- kliewi, it- tabib tiegħek jista ’ jordna eżamijiet speċjali tad- demm
186 Pregnancy and breast-feeding
186 sabiex jitkejlu l- livelli taċ- ċiklosporin waqt li qed tieħu Silapo.
If you are pregnant or breast-feeding, Silapo should be used only if the potential benefit outweighs the potential risk to the foetus.
Jekk int tqila jew qed tredda ’, Silapo għandu jintuża biss jekk il- benefiċċju potenzjali huwa akbar mir - riskju għall- fetu.
Silapo has no or negligible effect on the ability to drive and use machines.
Silapo għandu ftit jew l- ebda effett fuq il- kapacità tas- sewqan jew it- tħaddim tal- magni.
Important information about some of the ingredients of Silapo
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Silapo
HOW TO USE SILAPO
KIF GĦANDEK TUŻA SILAPO
Silapo therapy is usually started under medical supervision.
It- terapija b’ Silapo normalmment tibda taħt superviżjoni medika.
The injections can then be given by a doctor, trained nurse or other health care professional.
L- injezzjonijiet b’ Silapo jistgħu imbagħad jingħataw minn tabib, infermiera mħarrġa jew professjonist ieħor.
In case Silapo is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Jekk Silapo jiġi injettat taħt il- ġilda, tista ’ tinjetta lilek nnifsek bis- soluzzjoni la darba jkunu wrewk kif.
Always use Silapo exactly as your doctor has told you.
Dejjem għandek tuża Silapo skond il- parir eżatt tat- tabib.
Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Silapo.
It- tabib tiegħek jagħmel l- investigazzjonijiet, per eżempju, testijiet tad- demm, biex jgħinuh jiddeċiedi jekk ikun hemmx bżonn li int tieħi Silapo.
He/she will work out the correct dose of Silapo for you to use, how long the treatment should continue and by what route the medicine will be given.
Hu/ Hi jaħdmu d- doża ta ’ Silapo li suppost int għandek tuża, kemm idum it- trattament u b’ liema mod il- prodott mediċinali għandu jingħata.
These decisions will be influenced by what is causing your anaemia.
Dawn id- deċiżjonijiet ikunu influwenzati minn dak li qiegħed jikkawża l- anemija tiegħek.
Silapo may be given during the dialysis session or after you have received a dialysis session.
Silapo jista ’ jingħata waqt is- sessjoni tad- dijalisi jew wara li tkun irċevejt sessjoni tad- dijalisi.
The usual starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Id- doża normali tal- bidu hija 50 IU/ kg (Units Intenazzjonali kull kilogramma).
When your condition has been brought under control, you will receive regular doses of Silapo, 2 or 3 times a week.
Meta l- kundizzjoni tiegħek tkun ġiet ikkontrollata, int tirċievi dożi regolari ta ’ Silapo, 2 jew 3 darbiet fil- ġimgħa.
Silapo should be given after the patient has received a dialysis session.
Silapo għandu jingħata wara li l- pazjent irċieva s- sessjoni ta ’ dijalisi.
The usual starting dose is 50 IU/ kg.
Id- doża normali tal - bidu hija ta ’ 50 IU kull kilogramma.
Use in adult patients with kidney disease but not receiving dialysis The usual starting dose is 50 IU/kg.
L- użu f’ pazjenti adulti b’ mard fil- kliewi imma li m’ humiex jirċievu d- dijalisi Id- doża normali tal- bidu hija ta ’ 50 IU/ kg.
After your condition has been brought under control, you will receive regular doses of Silapo, 3 times a week.
Wara li l- kundizzjoni tiegħek tkun ġiet taħt kontroll, int tierċievi dożi regolari ta ’ Silapo, 3 darbiet fil - ġimgħa.
Use in adult patients receiving chemotherapy Your doctor may initiate treatment with Silapo if your haemoglobin level is 10 g/dl or less.
L- użu fil- pazjenti adulti li qegħdin jirċievu l- kimoterapija It- tabib tiegħek jista ’ jibda t- trattament b’ Silapo jekk il- livell tal- emoglobina hu ta ’ 10 g/ dl jew inqas.
The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Silapo until 1 month after the end of chemotherapy.
Id- doża tal- bidu tista ’ tiġi aġġustata mit- tabib tiegħek skond kif tirrisspondi l- anemija tiegħek għat- trattament; normalment int ser tierċievi Silapo sa xahar wara t- tmiem tal- kimoterapija.
You will receive Silapo during the 3 weeks before your surgery.
Int ser tieċievi Silapo matul it- 3 ġimgħat qabel il- kirurġija tiegħek.
You will also take iron supplements before and during Silapo treatment to increase the effectiveness of Silapo.
Int ser tieħu wkoll supplimenti tal - ħadid qabel u waqt it- trattament b’ Silapo sabiex iżżid l- effikaċija ta ’ Silapo.
Information on administration
188 Informazzjoni ta ’ kif jingħata
The pre-filled syringe is ready for use.
Is- siringa mimlija minn qabel b’ Silapo hija lesta biex tintuża.
Silapo must not be shaken or mixed with any other liquid.
L- injezzjoni ta ’ Silapo m’ għandiex titħawwad jew titħallat ma ’ xi likwidu ieħor.
If Silapo is injected under the skin for anaemia not associated with kidney disease the amount injected in any one place should not exceed 1 ml.
Jekk Silapo huwa injettat taħt il- ġilda għall- anemija mhix assoċjata mal- mard tal- kliewi l- ammont injettat f’ post wieħed m’ għandux ikun ta ’ izjed minn 1 ml.
Always follow these instructions when using Silapo:
Dejjem segwi dawn l- isruzzjonijiet meta tuża Silapo:
• 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 • you know or think it may have been accidentally frozen
Tużax Silapo jekk: • Is- siġġill tal- pakkett hu mkisser jew is- siġġill għandu xi ħsara • il- likwidu huwa kkulurit jew tista ’ tara partiċelli jgħumu fil- wiċċ • kwalunke likwidu ħareġ mis- siringa mimlija minn qabel jew kondensazzjoni hija viżibbli mill - pakkett issiġġillat • taf jew taħseb li seta ’ ġie iffriżat bi żball
Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection) Once your condition is controlled you will receive regular doses of Silapo.
Bdil minn injezzjoni f’ vina għal injezzjoni taħt il- ġilda La darba l- kundizzjoni tiegħek hija kkontrollata int tirċievi dożi regolari ta ’ Silapo.
If your anaemia is not associated with kidney disease, your doctor may decide that it is better for you to receive Silapo by injection under the skin (subcutaneous) rather than into a vein (intravenous).
Jekk l- anemija mhix assocjata mal- mard tal- kliewi, it- tabib tiegħek jista ’ jiddeċiedi li huwa aħjar għalik li tirċievi Silapo bl- injezzjoni taħt il- ġilda minflok fil- vina.
Injecting Silapo under the skin yourself for anaemia not associated with kidney disease At the start of your therapy, Silapo is injected by medical or nursing staff.
L- Injezzjoni ta ’ Silapo taħt il- ġilda minnek stess għall- anemija mhix assocjata mal- mard tal- kliewi Fil- bidu tat- terapija tiegħek, Silapo jista ’ jiġi injettat min staff mediku jew infermiera.
However, your doctor may decide that it is right for you to learn how to inject Silapo under the skin (subcutaneously) yourself.
Iżda, t- tabib tiegħek jista ’ jiddeċiedi li huwa tajjeb li titgħallem int stess kif tinjetta Silapo taħt il- ġilda.
If you use more Silapo than you should
Jekk tuża ’ aktar Silapo milli suppost
Silapo has a wide safety margin and side effects due to an overdose of using Silapo are unlikely.
Silapo għandu marġini wiesa ’ ta ’ sigurtà u effetti sekondarji minħabba doża żejda mill- użu ta ’ Silapo huma remoti.
You should inform the doctor or nurse immediately if you think too much Silapo has been injected.
Għandek tinforma lit- tabib jew l- infermiera mil- ewwel jekk taħseb li wisq Silapo ġie injettat.
If you forget to use Silapo
Jekk tinsa tuża Silapo