qanastek/EMEA-V3 huggingface dataset:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
94 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
88 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
95 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
89 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
96 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
90 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Id- doża rakkomandata hi 600 IU/ kg epoetin alfa, mogħtija kull ġimgħa għal tliet ġimgħat (jum 21, 14 u 7) qabel l- operazzjoni u fil- jum ta ’ l- operazzjoni (jum 0).
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.
98 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ l- emoglobina mantenuta m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina mmirata rakkomandata f’ sezzjoni 4. 2.
92 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Ir- rata taż- żieda fl- emoglobina għandha tkun madwar 1 g/ dl (0. 62 mmol/ l) fix- xahar u m’ għandhiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar sabiex jitnaqqsu r- riskji ta ’ żieda fil- pressjoni għolja.
In that study the incidence of fatal thromboembolic events was higher in patients receiving epoetin alfa than in those receiving placebo (see section 5.1).
99 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
93 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
100 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
101 Pazjenti adulti u pedjatriċi fuq l- emodijalisi, pazjenti adulti fuq l- emodijalisi peritonali u pazjenti adulti b’ insuffiċjenza tal- kliewi li għadhom mhux qegħdin fuq id- dijalisi
95 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 osservata f’ pazjenti li kienu qed jirċievu mediċini eritropoetiċi.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
102 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
96 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
103 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
98 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.7 ml (7000 IU) of solution.
Is- siringi fihom 0. 7 ml (7000 IU) ta ’ soluzzjoni.
Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe
Binocrit 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.8 ml contains 8000 international units (IU) corresponding to 67.2 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 8 ml fiha 8000 unità internazzjonali (IU) li jikkorrispondu għal 67. 2 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
107 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
100 Posology
Pożoloġija
Paediatric haemodialysis patients:
108 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
109 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
102 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
110 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
103 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
111 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
104 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Id- doża rakkomandata hi 600 IU/ kg epoetin alfa, mogħtija kull ġimgħa għal tliet ġimgħat (jum 21, 14 u 7) qabel l- operazzjoni u fil- jum ta ’ l- operazzjoni (jum 0).
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.
113 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ l- emoglobina mantenuta m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina mmirata rakkomandata f’ sezzjoni 4. 2.
106 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Ir- rata taż- żieda fl- emoglobina għandha tkun madwar 1 g/ dl (0. 62 mmol/ l) fix- xahar u m’ għandhiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar sabiex jitnaqqsu r- riskji ta ’ żieda fil- pressjoni għolja.
In that study the incidence of fatal thromboembolic events was higher in patients receiving epoetin alfa than in those receiving placebo (see section 5.1).
114 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
107 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
115 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
116 Pazjenti adulti u pedjatriċi fuq l- emodijalisi, pazjenti adulti fuq l- emodijalisi peritonali u pazjenti adulti b’ insuffiċjenza tal- kliewi li għadhom mhux qegħdin fuq id- dijalisi
109 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 osservata f’ pazjenti li kienu qed jirċievu mediċini eritropoetiċi.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
117 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
110 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
118 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
112 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.8 ml (8000 IU) of solution.
Is- siringi fihom 0. 8 ml (8000 IU) ta ’ soluzzjoni.
Binocrit 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe
Binocrit 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.9 ml contains 9000 international units (IU) corresponding to 75.6 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 9 ml fiha 9000 unità internazzjonali (IU) li jikkorrispondu għal 75. 6 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
122 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
114 Posology
Pożoloġija
Paediatric haemodialysis patients:
123 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
124 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
116 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
125 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
117 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
126 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
118 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Id- doża rakkomandata hi 600 IU/ kg epoetin alfa, mogħtija kull ġimgħa għal tliet ġimgħat (jum 21, 14 u 7) qabel l- operazzjoni u fil- jum ta ’ l- operazzjoni (jum 0).
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.
128 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ l- emoglobina mantenuta m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina mmirata rakkomandata f’ sezzjoni 4. 2.
120 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Ir- rata taż- żieda fl- emoglobina għandha tkun madwar 1 g/ dl (0. 62 mmol/ l) fix- xahar u m’ għandhiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar sabiex jitnaqqsu r- riskji ta ’ żieda fil- pressjoni għolja.
In that study the incidence of fatal thromboembolic events was higher in patients receiving epoetin alfa than in those receiving placebo (see section 5.1).
129 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
121 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
130 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
131 Pazjenti adulti u pedjatriċi fuq l- emodijalisi, pazjenti adulti fuq l- emodijalisi peritonali u pazjenti adulti b’ insuffiċjenza tal- kliewi li għadhom mhux qegħdin fuq id- dijalisi
123 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 osservata f’ pazjenti li kienu qed jirċievu mediċini eritropoetiċi.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
132 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
124 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
133 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
126 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.9 ml (9000 IU) of solution.
Is- siringi fihom 0. 9 ml (9000 IU) ta ’ soluzzjoni.
Binocrit 10 000 IU/ 1 ml solution for injection in a pre-filled syringe
Binocrit 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 1 ml contains 10 000 international units (IU) corresponding to 84.0 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 1 ml fiha 10, 000 unità internazzjonali (IU) li jikkorrispondu għal 84. 0 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
137 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
128 Posology
Pożoloġija
Paediatric haemodialysis patients:
138 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
139 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
130 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
140 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
131 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
141 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
132 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Id- doża rakkomandata hi 600 IU/ kg epoetin alfa, mogħtija kull ġimgħa għal tliet ġimgħat (jum 21, 14 u 7) qabel l- operazzjoni u fil- jum ta ’ l- operazzjoni (jum 0).
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.
143 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ l- emoglobina mantenuta m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina mmirata rakkomandata f’ sezzjoni 4. 2.
134 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Ir- rata taż- żieda fl- emoglobina għandha tkun madwar 1 g/ dl (0. 62 mmol/ l) fix- xahar u m’ għandhiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar sabiex jitnaqqsu r- riskji ta ’ żieda fil- pressjoni għolja.
In that study the incidence of fatal thromboembolic events was higher in patients receiving epoetin alfa than in those receiving placebo (see section 5.1).
144 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
135 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
145 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
146 Pazjenti adulti u pedjatriċi fuq l- emodijalisi, pazjenti adulti fuq l- emodijalisi peritonali u pazjenti adulti b’ insuffiċjenza tal- kliewi li għadhom mhux qegħdin fuq id- dijalisi
137 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 osservata f’ pazjenti li kienu qed jirċievu mediċini eritropoetiċi.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
147 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
138 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
148 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
140 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 1 ml (10 000 IU) of solution.
Is- siringi fihom 1 ml (10, 000 IU) ta ’ soluzzjoni.
141 ANNEX II
151 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
Rentschler Biotechnologie GmbH Erwin-Rentschler-Strasse 21 D-88471 Laupheim Germany
Rentschler Biotechnologie GmbH Erwin- Rentschler- Strasse 21 D- 88471 Laupheim Il- Ġermanja
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
Hexal AG Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• 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 FIS - SUQ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (ara Anness I:
Summary of Product Characterisitics, Section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Prior to launch and as agreed with competent authorities in the Member States, the MAH 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 • Cool boxes for patients clearly labelled with a visual aid indicating correct use of product.
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 • Kaxxi għal pazjenti, li jkunu mmarkati b’ mod ċar b’ għajnuna viżwali li tindika b’ mod ċar l- użu korrett tal- prodott.
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 Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Binocrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CKD • The 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 jista ’ jikkawża 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 (CKD) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Binocrit 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 CKD • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ issuspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
• OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
Pharmacovigilance system
Sistema ta ’ farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 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.
153 L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 3. 0, 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..
143 Risk Management plan
Pjan dwar l- Immaniġġar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
L- MAH irid jikkommetti ruħu li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 5 tal- Pjan dwar l- Immaniġġar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHPM dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jintbagħat fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jintbagħat • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifikazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jnaqqsu ir- riskju. • Fi żmien 60 jum minn meta jintlaħaq pass importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba tal- EMEA
144 ANNEX III
154 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA ’ TAGĦRIF
LABELLING
TIKKETTA
146 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
156 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Binocrit 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Binocrit 1000 IU/ 0. 5 ml IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 5 ml fiha 1000 unità internazzjonali (IU) li jikkorrispondu għal 8. 4 mikrogrammi ta ’ epoetin alfa
10, A-6250 Kundl, Austria
10, A- 6250 Kundl, l- Awstrija
Binocrit 1000 IU/ 0.5 ml
Binocrit 1000 IU/ 0. 5 ml
148 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
158 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
149 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
159 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Binocrit 1000 IU/ 0.5 ml injection
Binocrit 1000 IU/ 0. 5 ml injezzjoni
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
160 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 1 ml contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 1 ml fiha 2000 unità internazzjonali (IU) li jikkorrispondu għal 16. 8 mikrogrammi ta ’ epoetin alfa
152 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
162 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
153 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
163 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Binocrit 2000 IU/ 1 ml injection
Binocrit 2000 IU/ 1 ml injezzjoni
154 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
164 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 3 ml fiha 3000 unità internazzjonali (IU) li jikkorrispondu għal 25. 2 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.3 ml 6 pre-filled syringes of 0.3 ml
Siringa 1 mimlija għal- lest ta ’ 0. 3 ml 6 siringi mimlija għal- lest ta ’ 0. 3 ml
Binocrit 3000 IU/ 0.3 ml
Binocrit 3000 IU/ 0. 3 ml
156 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
166 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
157 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
167 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Binocrit 3000 IU/ 0.3 ml injection
Binocrit 3000 IU/ 0. 3 ml injezzjoni
Binocrit 4000 IU/ 0.4 ml
Binocrit 4000 IU/ 0. 4 ml
Binocrit 4000 IU/ 0.4 ml injection
Binocrit 4000 IU/ 0. 4 ml injezzjoni
Binocrit 5000 IU/ 0.5 ml
Binocrit 5000 IU/ 0. 5 ml
Binocrit 5000 IU/ 0.5 ml injection
Binocrit 5000 IU/ 0. 5 ml injezzjoni
Binocrit 6000 IU/ 0.6 ml
Binocrit 6000 IU/ 0. 6 ml
Binocrit 6000 IU/ 0.6 ml injection
Binocrit 6000 IU/ 0. 6 ml injezzjoni
Binocrit 7000 IU/ 0.7 ml
Binocrit 7000 IU/ 0. 7 ml
Binocrit 7000 IU/ 0.7 ml injection
Binocrit 7000 IU/ 0. 7 ml injezzjoni
Binocrit 8000 IU/ 0.8 ml
Binocrit 8000 IU/ 0. 8 ml
Binocrit 8000 IU/ 0.8 ml injection
Binocrit 8000 IU/ 0. 8 ml injezzjoni
Binocrit 9000 IU/ 0.9 ml
Binocrit 9000 IU/ 0. 9 ml
Binocrit 9000 IU/ 0.9 ml injection
Binocrit 9000 IU/ 0. 9 ml injezzjoni
Binocrit 10 000 IU/ 1 ml
Binocrit 10, 000 IU/ 1 ml
Binocrit 10 000 IU/ 1 ml injection
Binocrit 10, 000 IU/ 1 ml injezzjoni
Binocrit 10 000 IU/ 1 ml solution for injection in a pre-filled syringe Epoetin alfa
Binocrit 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin alfa
What Binocrit is and what it is used for 2.
X’ inhu Binocrit u għalxiex jintuża 2.
Before you use Binocrit 3.
Qabel ma tuża Binocrit 3.
How to use Binocrit 4.
Kif għandek tuża Binocrit 4.
How to store Binocrit 6.
Kif taħżen Binocrit 6.
WHAT BINOCRIT IS AND WHAT IT IS USED FOR
X’ INHU BINOCRIT U GĦALXIEX JINTUŻA
Binocrit contains a hormone called epoetin alfa, which stimulates the production of red blood cells.
Binocrit fih ormon imsejjaħ epoetin alfa, li jistimula l- produzzjoni taċ- ċelluli l- ħomor tad- demm.
Binocrit is used: for treating symptomatic anaemia associated with kidney disease (given by injection into a vein) in children and adults on dialysis in adults on peritoneal dialysis for treating severe symptomatic anaemia caused by kidney disease in adults not yet undergoing dialysis (given by injection into a vein) for treating anaemia and reducing the need for a blood transfusion in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the doctor 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 predonation) as an alternative to a blood transfusion in adult patients about to undergo major orthopaedic (bone) surgery where there is a potentially high risk from blood transfusion complications
Binocrit jintuża: biex tiġi kkurata anemija sintomatika assoċjata ma ’ mard tal- kliewi (mogħti permezz ta ’ injezzjoni ġo vina) fi tfal u adulti fuq id- dijalisi f’ adulti fuq dijalisi peritonali biex tiġi kkurata anemija sintomatika severa kkawżata minn mard tal- kliewi f’ persuni adulti li jkunu għadhom mhux qegħdin fuq id- dijalisi (mogħti permezz ta ’ injezzjoni ġo vina) biex tiġi kkurata anemija u titnaqqas il- ħtieġa għal trasfużjoni tad- demm f’ persuni adulti li jkunu qegħdin jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla, u f’ riskju ta ’ trasfużjoni kif evalwat mit- tabib f’ pazjenti li jkunu moderatament anemiċi li jkun ser ikollhom operazzjoni, u qabel din issir, jagħtu d - demm biex id- demm tagħhom stess ikun jista ’ jingħatalhom waqt jew wara l- operazzjoni (predonazzjoni awtologa)
BEFORE YOU USE BINOCRIT
QABEL MA TUŻA BINOCRIT
Do not use Binocrit:
Tużax Binocrit:
- if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of Binocrit
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal epoetin alfa jew sustanzi oħra ta ’
Take special care with Binocrit:
Oqgħod attent ħafna b’ Binocrit:
In all patients treated with Binocrit blood pressure should be closely monitored and treated, if necessary.
Il- pressjoni tad- demm fil- pazjenti kollha kkurati b’ Binocrit għandha tiġi mmonitorjata mill- qrib u kkurata, jekk ikun meħtieġ.
Binocrit should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Binocrit għandu jintuża b’ attenzjoni fil- preżenza ta ’ pressjoni għolja mhux ikkurata, ikkurata b’ mod inadegwat jew li ma tistax tiġi kkontrollata tajjeb.
If blood pressure cannot be controlled, Binocrit treatment should be discontinued.
Jekk il- pressjoni tad- demm ma tkunx tista ’ tiġi kkontrollata, il- kura b’ Binocrit għandha titwaqqaf.
Take special care with Binocrit if you have epilepsy or chronic liver disease.
Oqgħod attent ħafna b’ Binocrit jekk għandek epilessija jew mard kroniku tal- fwied.
There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Binocrit, which gradually regresses during the course of continued therapy.
Jista ’ jkun hemm żieda moderata dipendenti fuq id- doża fl- għadd ta ’ plejtlits fil- medda normali waqt kura b’ Binocrit, li gradwalment tmur lura matul il- kors tat- terapija kontinwa.
All other causes of anaemia, e. g. iron deficiency, damage of red blood cells (haemolysis), blood loss, vitamin B12 or folate deficiency, should be taken into account and treated prior to initiating therapy with Binocrit.
Il- kawżi l- oħra kollha ta ’ anemija, eż. defiċjenza ta ’ ħadid, ħsara fiċ- ċelluli l- ħomor tad- demm (emodijalisi), telf ta ’ demm, defiċjenza ta ’ vitamina B12 jew ta ’ folate, għandhom jiġu kkunsidrati u kkurati qabel tinbeda t- terapija b’ Binocrit.
In order to ensure optimum response to Binocrit adequate iron stores should be ensured.
Sabiex jiġi assigurat l- aħjar respons għal Binocrit għandhom ikunu żgurati ħażniet adegwati ta ’ ħadid.
Pure Red Cell Aplasia (PRCA)
Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA)
Antibody-mediated PRCA has been very rarely reported in patients after months to years of subcutaneous (injection under the skin) erythropoietin treatment.
PRCA medjata mill- antikorpi kienet irrappurtata b’ mod rari ħafna fil- pazjenti wara perijodu ta ’ minn xhur għal snin ta ’ kura minn taħt il- ġilda (injezzjoni taħt il- ġilda) bl- eritropoetin.
PRCA means the inability to produce enough red blood cells in the bone marrow.
PRCA tfisser in - nuqqas ta ’ kapaċità tal- ġisem li jipproduċi biżżejjed ċelluli l- ħomor tad- demm fil- mudullun.
PRCA can result in sudden and severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
PRCA tista ’ tirriżulta f’ anemija f’ daqqa u severa, li s- sintomi tagħha huma għeja mhux tas- soltu, sensazzjoni
If you experience these symptoms you should talk to your doctor at once.
Inti għandek titkellem mat- tabib tiegħek minnufih jekk ikollok dawn is- sintomi.
Your doctor can decide whether Binocrit is not working properly for you.
It- tabib tiegħek jista ’ jiddeċiedi jekk Binocrit hux qiegħed jaħdem sewwa għalik.
If you develop PRCA your Binocrit therapy will be discontinued and your doctor will decide how best to treat your anaemia.
Jekk tiżviluppa PRCA, it- terapija tiegħek b’ Binocrit ser titwaqqaf u t- tabib tiegħek ser jiddeċiedi kif l- aħjar li tiġi kkurata l- anemija tiegħek.
189 Kidney patients
Pazjenti morda bil- kliewi
There is not much experience with subcutaneous use (injection into the skin) of Binocrit in kidney patients.
M’ hemmx wisq esperjenza bl- użu minn taħt il- ġilda (injezzjoni ġol- ġilda) ta ’ Binocrit f’ pazjenti b’ mard tal- kliewi.
Therefore, if you are being treated for anaemia associated with kidney disease, Binocrit has to be given by injection into a vein (intravenously).
Għalhekk, jekk inti qed tkun ikkurat/ a għal anemija assoċjata ma ’ mard tal- kliewi, Binocrit għandu jingħata permezz ta ’ injezzjoni ġo vina.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly
It- tabib tiegħek ser jiċċekkja l- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek b’ mod regolari biex jiżgura li l- emoglobina tiegħek ma taqbiżx ċertu livell, għax livell għoli ta ’ emoglobina
you at risk of having a problem of the heart or the blood vessels and could increase risk of death
jista ’ jpoġġik f’ riskju li jkollok xi problema tal- qalb jew tal- vini jew arterji, u jista ’ jżid ir- riskju li tmut biex jitnaqqas ir- riskju ta ’ żieda fil- pressjoni tad- demm.
Increased levels of potassium (hyperkalaemia) have been observed in isolated cases.
Livelli ogħla ta ’ potassju (iperkalimja) kienu osservati f’ każijiet iżolati.
The correction of your anaemia may lead to increased appetite, and thus increased potassium and protein intake.
Il- korrezzjoni ta ’ l- anemija tiegħek tista ’ twassal għal żieda fl- aptit, u għalhekk teħid akbar ta ’ potassju u proteini.
Therefore dialysis procedures may have to be adjusted to maintain urea, creatinine and potassium in the desired range.
Għalhekk jista ’ jkun hemm bżonn ta ’ aġġustament fil- proċeduri tad- dijalisi sabiex l- urea, il- krejatinina u l- potassju jinżammu fil- medda mixtieqa.
Serum electrolytes should be monitored.
L- elettroliti fis- serum għandhom jiġu mmonitorjati.
If an elevated or increasing serum potassium level is detected, your doctor may consider to discontinue the treatment with Binocrit until the potassium level has returned to the normal range.
Jekk jiġi osservat livell ta ’ potassju fis- serum għoli jew qiegħed jogħla, it- tabib tiegħek jista ’ jikkunsidra li jwaqqaf il- kura b’ Binocrit sakemm il - livell tal- potassju jkun reġa ’ lura għall- medda normali.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Binocrit.
Żieda fid- doża ta ’ mediċina partikulari li traqqaq id- demm (heparin) waqt l- emodijalisi ta ’ sikwit tkun meħtieġa matul il- kors tat- terapija b’ Binocrit.
Inadequate thinning of the blood by heparin (heparinisation) may lead to occlusion of the dialysis system.
Traqqiq inadegwat tad- demm mill- heparin (eparinizzazzjoni) jista ’ jwassal għal okklużjoni tas- sistema tad- dijalisi.
If you have chronic kidney failure and clinically evident coronary heart disease or signs of congestion due to inadequate heart output, your doctor will make sure that your haemoglobin levels do not exceed a certain level.
Jekk għandek insuffiċjenza tal- kliewi kronika u mard tal- qalb koronarju klinikament evidenti jew sinjali ta ’ konġestjoni minħabba li l- qalb ma taħdimx kif suppost, it- tabib tiegħek ser jiżgura li l- livelli ta ’ l- emoglobina tiegħek ma jaqbżux ċertu livell.
Based on information available to date, treatment of anaemia with Binocrit in adult patients with chronic kidney failure (renal insufficiency) who do not yet require dialysis, does not accelerate the rate of progression of renal insufficiency.
Fuq il- bażi ta ’ l- informazzjoni disponibbli sa issa, il- kura ta ’ l- anemija b’ Binocrit f’ pazjenti adulti b’ insuffiċjenza tal- kliewi kronika (insuffiċjenza renali) li jkun għad m’ għandhomx bżonn dijalisi, ma żżidx ir- rata tal- progressjoni ta ’ l- insuffiċjenza renali.
Cancer patients
Pazjenti morda bil- kanċer
The 2-3 week delay between epoetin alfa administration and the appearance of desired effects should be taken into account when assessing the efficacy of Binocrit.
Id- dewmien ta ’ 2- 3 ġimgħat bejn l- għoti ta ’ epoetin alfa u d- dehra ta ’ l- effetti mixtieqa għandu jiġi kkunsidrat meta tkun evalwata l- effikaċja ta ’ Binocrit.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly and adjust your dose of Binocrit accordingly to minimise the risk of blood clotting (thrombotic events).
It- tabib tiegħek ser jiċċekkja l- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek b’ mod regolari u jaġġusta d- doża tiegħek ta ’ Binocrit kif meħtieġ sabiex inaqqas ir- riskju ta ’ tagħqid tad - demm (episodji trombotiċi).
Cancer patients receiving treatment with erythropoietin have an increased risk of blood clots/ blood clotting disorders (thrombotic vascular events).
Pazjenti morda bil- kanċer li jkunu qed jingħataw kura bl- eritropoetin għandhom riskju akbar ta ’ emboli/ disturbi tat- tagħqid tad- demm (episodji trombotiċi vaskulari).
This risk should be carefully weighted against the benefit to be derived from treatment with epoetin alfa, particularly if you have an increased risk of thrombotic vascular events, e. g. if you are obese or have a history of thrombotic vascular events (e. g. deep vein thrombosis or pulmonary embolism).
Dan ir- riskju għandu jiġi evalwat bir- reqqa kontra l- benefiċċju li jista ’ jinkiseb minn kura b’ epoetin alfa, b’ mod partikulari jekk għandek riskju akbar ta ’ episodji trombotiċi vaskulari, eż. jekk int obeż jew għandek passat mediku ta ’ episodji trombotiċi vaskulari (eż. trombożi fonda fil- vini jew emboliżmu pulmonari).
If you are a cancer patient you should be aware that Binocrit may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Jekk inti pazjent marid bil- kanċer, għandek tkun taf li Binocrit jista ’ jaġixxi bħala fattur tat- tkabbir taċ- ċelluli tad- demm u f’ xi ċirkustanzi jista ’ jkollu impatt negattiv fuq il- kanċer tiegħek.
Depending on your individual situation a blood transfusion may be preferable.
Skond is - sitwazzjoni individwali tiegħek, trasfużjoni tad- demm tista ’ tkun preferibbli.
Please discuss this with your doctor.
Jekk jogħġbok iddiskuti dan mat- tabib tiegħek.
Patients donating their own blood before surgery
200 Pazjenti li jagħtu d- demm tagħhom stess qabel l- operazzjoni
Your doctor will consider warnings and precautions associated with autologous blood predonation, especially volume replacement.
It- tabib tiegħek ser jikkunsidra t- twissijiet u l- prekawzjonijiet marbuta ma ’ predonazzjoni awtologa tad- demm, speċjalment is- sostituzzjoni tal- volum.
Patients scheduled for orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika
If you are due to have major orthopaedic surgery, the cause of anaemia should be established and treated, if possible, before the start of Binocrit treatment.
Jekk wasalt biex tagħmel operazzjoni ortopedika maġġuri, il- kawża ta ’ l- anemija għandha tiġi stabbilita u kkurata, jekk jista ’ jkun, qabel il- bidu tal- kura b’ Binocrit.
Blood clots (thrombotic events) can be a risk.
L- emboli (episodji trombotiċi) jistgħu jkunu ta ’ riskju.
190 Your doctor will weight this risk carefully against the benefits to be derived from treatment with epoetin alfa.
It- tabib tiegħek ser jevalwa sewwa dan ir- riskju kontra l- benefiċċji li jistgħu jinkisbu minn kura b’ epoetin alfa.
You should receive adequate measures in order to prevent blood clots (thrombotic prophylaxis), particularly if you have cardiovascular disorders.
Inti għandek tirċievi miżuri adegwati biex jiġu evitati l- emboli (profilassi trombotika), b’ mod partikulari jekk għandek disturbi kardjovaskulari.
If your levels of the red blood pigment (haemoglobin) are too high you should not receive Binocrit, since you have an increased risk of blood clotting after the surgery.
Inti m’ għandekx tingħata Binocrit jekk il- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek ikunu għoljin iżżejjed, billi ser ikollok riskju akbar ta ’ tagħqid tad- demm wara l- operazzjoni.
If you are a cancer patient be aware that erythropoietins may act as growth factor.
Jekk inti pazjent/ a marid/ a bil- kanċer għandek tkun taf li l- eritropoetins jistgħu jaġixxu bħala fattur tat - tkabbir.
Taking other medicines
Meta tieħu mediċini oħra
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you are taking cyclosporin (medicine to suppress your immune system) during therapy with Binocrit, your doctor may order special blood tests to measure cyclosporin levels.
Jekk qiegħed tieħu cyclosporin (mediċina biex trażżan is- sistema immuni tiegħek) matul it- terapija b’ Binocrit, it- tabib tiegħek jista ’ jordna testijiet speċjali tad- demm biex ikejjel il- livelli ta ’ cyclosporin.