natgillin/translations-raw huggingface dataset:
200-300 mg/day orally (100-200 mg/day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ml − oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose transferrin saturation is below 20%.
200- 300 mg na dan peroralno (100- 200 mg na dan za pediatrične bolnike) se priporoča za bolnike s kronično odpovedjo ledvic, ki imajo nivoje feritina v serumu pod 100 ng/ ml. − peroralno nadomeščanje železa z 200- 300 mg/ dan se priporoča za vse bolnike z rakom, pri katerih je nasičenost transferina pod 20%.
19 All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Vse te dodatne faktorje pri anemiji je treba skrbno pretehtati pri bolnikih z rakom, ko se odloča o zvišanju odmerka eritropoetina.
Immunogenicity data for subcutaneous use of Silapo in patients at risk for antibody-induced Pure Red Cell Aplasia (PRCA), i.e. patients with renal anaemia, are not sufficient.
Imunogenski podatki za subkutano uporabo zdravila Silapo pri bolnikih, s tveganjem za s protitelesi povzročene čiste aplazije rdečih krvnih celic (PRCA), t. j. pri bolnikih z ledvično anemijo, so nezadostni.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
V kliničnih preskušanjih so opazili povečano tveganje za smrt in resne kardiovaskularne dogodke, kadar so zdravila za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agents) dajali, da bi dosegli ciljno koncentracijo hemoglobina, ki presega 12 g/ dl (7, 5 mmol/ l).
The rate of increase in haemoglobin should be approximately 1 g/dl (0.62 mmol/l) per month and should not exceed 2 g/dl (1.25 mmol/l) per month to minimize the risk of developing or worsening of hypertension.
Hitrost, s katero se dviga hemoglobin, naj bi bila približno 1g/ dl (0, 62 mmol/ l) na mesec in naj ne bi presegala 2g/ dl (1, 25 mmol/ l) na mesec, da se zmanjša tveganje za razvoj ali poslabšanje hipertenzije.
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Pri bolnikih, pri katerih pride nenadoma do zmanjšanja učinkovitosti, definiranega kot zvišanje hemoglobina (1- 2 g/ dl na mesec) ob povečani potrebi po transfuzijah, je treba izmeriti število retikulocitov in raziskati tipične vzroke za zmanjšanje učinkovitosti (npr. pomanjkanje železa, folata, vitamina B12, zastrupitev z aluminijem, okužbe ali vnetja, izguba krvi in hemoliza).
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
20 Če pride do diagnoze PRCA, je treba zdravljenje z zdravilom Silapo takoj prekiniti in razmisliti o testiranju na protitelesa za eritropoetin.
20 electrolytes should be monitored in chronic renal failure patients.
Pri bolnikih s kronično ledvično odpovedjo je treba meriti elektrolite v serumu.
If the rate of increase in haemoglobin exceeds 2 g/dl (1.25 mmol/l) per month or the haemoglobin level exceeds 12 g/dl (7,5 mmol/l), the dose adjustment detailed in section 4.2 should be thoroughly performed to minimise the risk of thrombotic events (see section 4.2).
Če hitrost naraščanja hemoglobina presega 2 g/ dl (1, 25 mmol/ l) na mesec ali če nivo hemoglobina presega 12 g/ dl (7, 5 mmol/ l), je potrebno opraviti korenito spremembo odmerka, kot je navedeno v poglavju 4. 2, da bi se zmanjšalo riziko tveganja za trombotične zaplete (glejte poglavje 4. 2)
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Silapo) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e.g. deep venous thrombosis or pulmonary embolism).
Posebna pozornost je potrebna pri bolnikih z rakom, pri katerih je prisoto povečano tveganje ta trombotične vaskularne zaplete, na primer zaradi debelosti, ali pa zaradi trombotičnih vaskularnih zapletov v anamnezi (npr. globoka venozna tromboza ali pljučna embolija):
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l), • increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
21 V kontroliranih kliničnih študijah je prišlo pri uporabi epoetina alfa in drugih zdravil za stimulacijo eritropoeze (ESA) do: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/ dl (8, 7 mmol/ l), • skrajšanega časa skupnega preživetja in povečanja števila smrti, ki jih pripisujejo napredovanju bolezni po 4 mesecih pri bolnikih z metastaznim rakom dojk na kemoterapiji, pri katerih so z uporabo sredstev za stimulacijo eritropoeze želeli doseči ciljne koncentracije hemoglobina od 12– 14 g/ dl (7, 5– 8, 7 mmol/ l), • povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/ dl (7, 5 mmol/ l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
21 In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Z vidika zgoraj omenjenega bi morala biti transfuzija krvi v nekaterih kliničnih situacijah zdravljenje izbire za obvladovanje anemije pri bolnikih z rakom.
"Flu-like" symptoms such as headaches, joint pains, feelings of weakness, dizziness, and tiredness may occur, especially at the start of treatment.
22 Zlasti na začetku zdravljenja se lahko pojavijo » gripi podobni « simptomi, kot so glavobol, bolečine v sklepih, občutek šibkosti, omotica in utrujenost.
22 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Poročali so o pojavu eritroblastopenije (PRCA), povzročene s protitelesi, po več mesecih ali letih zdravljenja z epoetinom alfa.
Pharmacotherapeutic group:
23 Farmakoterapevtska skupina:
23 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Biološko uspešnost eritropoetina so dokazali na različnih živalskih modelih in vivo (normalne in slabokrvne podgane, policitemične miši).
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1, 35, 2, 06, 35 preskušanj in 6769 bolnikov) so opazili pri bolnikih, ki so jih zdravili z rekombinantnim humanim eritropoetinom.
The re 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.
Pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin, obstaja povečano tveganje za tromboembolijske dogodke, negativnega vpliva na skupno preživetje pa ni mogoče izključiti.
24 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine
Natrijev fosfat dihidrat Natrijev dihidrogenfosfat dihidrat Natrijev klorid Kalcijev klorid dihidrat Polisorbat 20 Glicin Levcin Izolevcin Treonin Glutamatna kislina Fenilalanin Voda za injekcije Natrijev hidroksid (za prilagoditev pH) Klorovodikova kislina (za prilagoditev pH)
26 STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Nemčija
Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe
Silapo 3. 000 i. e. / 0, 9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
28 The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
28 Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
29 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
The recommended dosing regimen is described in the following diagram:
30 verjetno ni in je treba zdravljenje prekiniti.
31 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Intravensko injiciranje Odmerek je treba injicirati najmanj 1 do 5 minut, odvisno od celotnega odmerka.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
32 V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.
32 All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Vse te dodatne faktorje pri anemiji je treba skrbno pretehtati pri bolnikih z rakom, ko se odloča o zvišanju odmerka eritropoetina.
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Če vzroka ni najti,
If no cause is identified, a bone marrow examination should be considered for diagnosis of PRCA.
33 je treba premisliti o preiskavi kostnega mozga za diagnosticiranje PRCA.
33 electrolytes should be monitored in chronic renal failure patients.
Pri bolnikih s kronično ledvično odpovedjo je treba meriti elektrolite v serumu.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
V večjem številu kontroliranih kliničnih študij, pri katerih so epoetine dajali bolnikom z različnimi vrstami raka, vključno z rakom glave in vratu, pljučnim rakom ter rakom dojke, so ugotovili
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l), • increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
V kontroliranih kliničnih študijah je prišlo pri uporabi epoetina alfa in drugih zdravil za stimulacijo eritropoeze (ESA) do: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/ dl (8, 7 mmol/ l), • skrajšanega časa skupnega preživetja in povečanja števila smrti, ki jih pripisujejo napredovanju bolezni po 4 mesecih pri bolnikih z metastaznim rakom dojk na kemoterapiji, pri katerih so z uporabo sredstev za stimulacijo eritropoeze želeli doseči ciljne koncentracije hemoglobina od 12– 14 g/ dl (7, 5– 8, 7 mmol/ l), • povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/ dl (7, 5 mmol/ l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
34 In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Z vidika zgoraj omenjenega bi morala biti transfuzija krvi v nekaterih kliničnih situacijah zdravljenje izbire za obvladovanje anemije pri bolnikih z rakom.
General Non-specific skin rashes have been described with epoetin alfa.
35 Splošni V povezavi z epoetinom alfa so poročali o nespecifičnih kožnih izpuščajih.
35 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Poročali so o pojavu eritroblastopenije (PRCA), povzročene s protitelesi, po več mesecih ali letih zdravljenja z epoetinom alfa.
5.1 Pharmacodynamic properties
36 5. 1 Farmakodinamične lastnosti
36 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Biološko uspešnost eritropoetina so dokazali na različnih živalskih modelih in vivo (normalne in slabokrvne podgane, policitemične miši).
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
37 so bila razmerja tveganj za skupno preživetje v razponu od 1, 25 in 2, 47 v prid kontrolam.
37 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Silapo must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
39 • če je tekočina obarvana ali če je videti v njej plavati delce • če je iz vnaprej napolnjene brizge iztekla tekočina ali če je v zavarjenem blistru videti kondenzacijo. • če je bila po nesreči zamrznjena
Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe
Silapo 4. 000 i. e. / 0, 4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 pre-filled syringe with 0.4 ml solution for injection contains 4000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
1 napolnjena injekcijska brizga z 0, 4 ml raztopine za injiciranje vsebuje 4. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
41 The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
41 Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
42 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
− Adult patients with renal insufficiency not yet undergoing dialysis
Odrasli bolniki z ledvično insuficienco, ki se še ne zdravijo z dializo
The recommended dosing regimen is described in the following diagram:
43 verjetno ni in je treba zdravljenje prekiniti.
In travenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Intravensko injiciranje Odmerek je treba injicirati najmanj 1 do 5 minut, odvisno od celotnega odmerka.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
45 V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.
200-300 mg/day orally (100-200 mg/day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ml − oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose
200- 300 mg na dan peroralno (100- 200 mg na dan za pediatrične bolnike) se priporoča za bolnike s kronično odpovedjo ledvic, ki imajo nivoje feritina v serumu pod 100 ng/ ml. − peroralno nadomeščanje železa z 200- 300 mg/ dan se priporoča za vse bolnike z rakom, pri katerih je nasičenost transferina pod 20%.
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
46 Če pride do diagnoze PRCA, je treba zdravljenje z zdravilom Silapo takoj prekiniti in razmisliti o testiranju na protitelesa za eritropoetin.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l), • increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
47 V kontroliranih kliničnih študijah je prišlo pri uporabi epoetina alfa in drugih zdravil za stimulacijo eritropoeze (ESA) do: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/ dl (8, 7 mmol/ l), • skrajšanega časa skupnega preživetja in povečanja števila smrti, ki jih pripisujejo napredovanju bolezni po 4 mesecih pri bolnikih z metastaznim rakom dojk na kemoterapiji, pri katerih so z uporabo sredstev za stimulacijo eritropoeze želeli doseči ciljne koncentracije hemoglobina od 12– 14 g/ dl (7, 5– 8, 7 mmol/ l), • povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/ dl (7, 5 mmol/ l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
"Flu-like" symptoms such as headaches, joint pains, feelings of weakness, dizziness, and tiredness may occur, especially at the start of treatment.
48 Zlasti na začetku zdravljenja se lahko pojavijo » gripi podobni « simptomi, kot so glavobol, bolečine v sklepih, občutek šibkosti, omotica in utrujenost.
Pharmacotherapeutic group:
49 Farmakoterapevtska skupina:
52 Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Nemčija
Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe
Silapo 5. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 pre-filled syringe with 0.5 ml solution for injection contains 5000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
1 napolnjena injekcijska brizga z 0, 5 ml raztopine za injiciranje vsebuje 5. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
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).
54 Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
54 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Zdravnik mora opraviti ocenjevanje poteka bolezni in stanja bolnika.
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).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
The recommended dosing regimen is described in the following diagram:
56 verjetno ni in je treba zdravljenje prekiniti.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
58 V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
59 Če pride do diagnoze PRCA, je treba zdravljenje z zdravilom Silapo takoj prekiniti in razmisliti o testiranju na protitelesa za eritropoetin.
Tumour growth potential Epoetins are growth factors that primarily stimulate red blood cell production.
Epoetini so rastni dejavniki, ki primarno stimulirajo nastajanje rdečih krvničk.