natgillin/translations-raw huggingface dataset:
Abseamed 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe
Abseamed 3. 000 i. e. / 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa
Ena 0, 3 ml napolnjena injekcijska brizga vsebuje 3. 000 mednarodnih enot (i. e.), kar ustreza 25, 2 mikrograma epoetina alfa.
4.2 Posology and method of administration
32 4. 2 Odmerjanje in način uporabe
30 Posology
Odmerjanje
Paediatric haemodialysis patients:
33 Otroci, ki se zdravijo s hemodializo:
31 Correction phase:
Korekcijska faza:
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 34 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
32 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
33 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
35 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
36 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
34 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).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
37 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
38 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
36 (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.
Da bi zmanjšali tveganje za poslabšanje hipertenzije, je treba koncentracijo hemoglobina povečevati za približno 1 g/ dl (0, 62 mmol/ l) na mesec in ne hitreje kot za 2 g/ dl (1, 25 mmol/ l) na mesec.
Adult surgery patients in an autologous predonation programme
39 Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu:
37 Patients scheduled for major elective orthopaedic surgery
Odrasli bolniki, naročeni na večji elektivni ortopedski kirurški poseg
4.6 Pregnancy and lactation
40 4. 6 Nosečnost in dojenje
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
41 Pri teh bolnikih je priporočena zgodnja revizija šanta in antiagregacijska profilaksa z uporabo acetilsalicilne kisline.
39 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetična zdravila, so opazili zvečano incidenco trombotičnih žilnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
42 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
40 721 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).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
5.2 Pharmacokinetic properties
43 5. 2 Farmakokinetične lastnosti
41 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
6.2 Incompatibilities
44 6. 2 Inkompatibilnosti
42 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
The syringes contain 0.3 ml (3000 IU) of solution.
Brizge vsebujejo 0, 3 ml (3. 000 i. e.) raztopine.
Abseamed 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe
Abseamed 4. 000 i. e. / 0, 4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.4 ml contains 4000 international units (IU) corresponding to 33.6 micrograms epoetin alfa
Ena 0, 4 ml napolnjena injekcijska brizga vsebuje 4. 000 mednarodnih enot (i. e.), kar ustreza 33, 6 mikrograma epoetina alfa.
4.2 Posology and method of administration
47 4. 2 Odmerjanje in način uporabe
44 Posology
Odmerjanje
Paediatric haemodialysis patients:
48 Otroci, ki se zdravijo s hemodializo:
45 Correction phase:
Korekcijska faza:
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 49 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
46 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
47 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
50 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
51 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
48 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).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
52 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
53 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
50 (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.
Da bi zmanjšali tveganje za poslabšanje hipertenzije, je treba koncentracijo hemoglobina povečevati za približno 1 g/ dl (0, 62 mmol/ l) na mesec in ne hitreje kot za 2 g/ dl (1, 25 mmol/ l) na mesec.
Adult surgery patients in an autologous predonation programme
54 Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu:
51 Patients scheduled for major elective orthopaedic surgery
Odrasli bolniki, naročeni na večji elektivni ortopedski kirurški poseg
4.6 Pregnancy and lactation
55 4. 6 Nosečnost in dojenje
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
56 Pri teh bolnikih je priporočena zgodnja revizija šanta in antiagregacijska profilaksa z uporabo acetilsalicilne kisline.
53 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetična zdravila, so opazili zvečano incidenco trombotičnih žilnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
57 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
54 721 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).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
5.2 Pharmacokinetic properties
58 5. 2 Farmakokinetične lastnosti
55 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
6.2 Incompatibilities
59 6. 2 Inkompatibilnosti
56 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
The syringes contain 0.4 ml (4000 IU) of solution.
Brizge vsebujejo 0, 4 ml (4. 000 i. e.) raztopine.
Abseamed 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Abseamed 5. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.5 ml contains 5000 international units (IU) corresponding to 42.0 micrograms epoetin alfa
Ena 0, 5 ml napolnjena injekcijska brizga vsebuje 5. 000 mednarodnih enot (i. e.), kar ustreza 42, 0 mikrograma epoetina alfa.
4.2 Posology and method of administration
62 4. 2 Odmerjanje in način uporabe
58 Posology
Odmerjanje
Paediatric haemodialysis patients:
63 Otroci, ki se zdravijo s hemodializo:
59 Correction phase:
Korekcijska faza:
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 64 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
60 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
61 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
65 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
66 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
62 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).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
67 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
68 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
64 (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.
Da bi zmanjšali tveganje za poslabšanje hipertenzije, je treba koncentracijo hemoglobina povečevati za približno 1 g/ dl (0, 62 mmol/ l) na mesec in ne hitreje kot za 2 g/ dl (1, 25 mmol/ l) na mesec.
Adult surgery patients in an autologous predonation programme
69 Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu:
65 Patients scheduled for major elective orthopaedic surgery
Odrasli bolniki, naročeni na večji elektivni ortopedski kirurški poseg
4.6 Pregnancy and lactation
70 4. 6 Nosečnost in dojenje
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
71 Pri teh bolnikih je priporočena zgodnja revizija šanta in antiagregacijska profilaksa z uporabo acetilsalicilne kisline.
67 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetična zdravila, so opazili zvečano incidenco trombotičnih žilnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
72 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
68 721 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).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
5.2 Pharmacokinetic properties
73 5. 2 Farmakokinetične lastnosti
69 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
6.2 Incompatibilities
74 6. 2 Inkompatibilnosti
70 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
The syringes contain 0.5 ml (5000 IU) of solution.
Brizge vsebujejo 0, 5 ml (5. 000 i. e.) raztopine.
Abseamed 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe
Abseamed 6. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.6 ml contains 6000 international units (IU) corresponding to 50.4 micrograms epoetin alfa
Ena 0, 6 ml napolnjena injekcijska brizga vsebuje 6. 000 mednarodnih enot (i. e.), kar ustreza 50, 4 mikrograma epoetina alfa.
4.2 Posology and method of administration
77 4. 2 Odmerjanje in način uporabe
72 Posology
Odmerjanje
Paediatric haemodialysis patients:
78 Otroci, ki se zdravijo s hemodializo:
73 Correction phase:
Korekcijska faza:
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 79 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
74 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
75 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
80 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
81 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
76 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).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
82 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
83 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
78 (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.
Da bi zmanjšali tveganje za poslabšanje hipertenzije, je treba koncentracijo hemoglobina povečevati za približno 1 g/ dl (0, 62 mmol/ l) na mesec in ne hitreje kot za 2 g/ dl (1, 25 mmol/ l) na mesec.
Adult surgery patients in an autologous predonation programme
84 Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu:
79 Patients scheduled for major elective orthopaedic surgery
Odrasli bolniki, naročeni na večji elektivni ortopedski kirurški poseg
4.6 Pregnancy and lactation
85 4. 6 Nosečnost in dojenje
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
86 Pri teh bolnikih je priporočena zgodnja revizija šanta in antiagregacijska profilaksa z uporabo acetilsalicilne kisline.
81 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetična zdravila, so opazili zvečano incidenco trombotičnih žilnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
87 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
82 721 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).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
5.2 Pharmacokinetic properties
88 5. 2 Farmakokinetične lastnosti
83 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
6.2 Incompatibilities
89 6. 2 Inkompatibilnosti
84 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
The syringes contain 0.6 ml (6000 IU) of solution.
Brizge vsebujejo 0, 6 ml (6. 000 i. e.) raztopine.
Abseamed 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe
Abseamed 7. 000 i. e. / 0, 7 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.7 ml contains 7000 international units (IU) corresponding to 58.8 micrograms epoetin alfa
Ena 0, 7 ml napolnjena injekcijska brizga vsebuje 7. 000 mednarodnih enot (i. e.), kar ustreza 58, 8 mikrograma epoetina alfa.
4.2 Posology and method of administration
92 4. 2 Odmerjanje in način uporabe
86 Posology
Odmerjanje
Paediatric haemodialysis patients:
93 Otroci, ki se zdravijo s hemodializo:
87 Correction phase:
Korekcijska faza:
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 94 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
88 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
89 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
95 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
96 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
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).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
97 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
98 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).