natgillin/translations-raw huggingface dataset:
101 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Štiri ogljikovodikove verige so s tremi N- glikozidnimi vezmi in eno O- glikozidno vezjo pritrjene na protein.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
110 točke razmerja tveganja, ki je bila 1, 08 v prid kontrolam (95% CI:
102 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/ dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
103 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
111 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)
Each pre-filled syringe contains 1.0 ml solution for injection.
Vsaka napolnjena brizga vsebuje 1, 0 ml raztopine za injiciranje.
104 Any unused product or waste material should be disposed of in accordance with local requirements.
112 Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
Retacrit 20000 IU/ 0.5ml solution for injection in pre-filled syringe
Retacrit 20. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
The solution contains 40000 IU Epoetin zeta per ml.
Raztopina vsebuje 40. 000 i. e. epoetina zeta na ml.
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme.
− Zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih: o zdravljenje anemije pri odraslih in pediatričnih bolnikih s kronično odpovedjo ledvic na hemodializi ali odraslih bolnikov na peritonealni dializi (glejte poglavje 4. 4). o zdravljenje hude anemije ledvičnega izvora s spremljajočimi kliničnimi znaki, pri odraslih bolnikih z ledvično insuficienco, ki se jih še ne zdravi z dializo (glejte poglavje 4. 4). − zdravljenje anemije in zmanjšanje potrebe po transfuzijah pri odraslih bolnikih, ki prejemajo kemoterapijo zaradi čvrstih tumorje, malignega limfoma ali multiplega mieloma, in za katere je transfuzija glede na splošno stanje bolnika tvegana (npr. kardiovaskularni status, anemičnost ob začetku kemoterapije). − Zdravilo Retacrit se lahko uporablja za povečanje količine avtologne krvi pri bolnikih v programu avtologne transfuzije.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
114 − Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo Pri bolnikih s kronično odpovedjo ledvic je treba zdravilo dajati intravensko (glejte poglavje 4. 4).
106 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
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).
Dose (IU/ kg given 3x week)
115 Odmerek (i. e. / kg 3x na teden)
107 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
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).
If the haemoglobin increase is < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, increase the dose to 300 IU/ kg 3 times per week.
116 če se je število retikulocitov dvignilo < 40. 000 celic/ µl nad osnovno vrednost, zvišamo odmerek na 300 i. e. / kg trikrat tedensko.
Appropriate dose titration should be considered.
117 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg, enkrat na teden
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Retacrit therapy.
118 čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Retacrit bolnik imel visoke zaloge železa.
109 Method of administration
Način dajanja
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
120 odpovedjo lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
111 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Recepte za dializo je treba periodično prilagajati, da urea, kreatinin in kalij ostanejo v želenih mejah.
112 increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
121 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.
113 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Pri bolnikih, ki so prejemali epoetin alfa, so poročali tudi o redkih preobčutljivostnih reakcijah, vključno s posameznimi primeri angioedemov in anafilaktičnih reakcij.
The four
123 prispeva okoli 58% h končni molekularni masi, sestavlja pa ga 165 amino kislin.
114 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Štiri ogljikovodikove verige so s tremi N- glikozidnimi vezmi in eno O- glikozidno vezjo pritrjene na protein.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
124 točke razmerja tveganja, ki je bila 1, 08 v prid kontrolam (95% CI:
115 apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/ dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
116 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
125 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)
Each pack contains 1 or 4 or 6 pre-filled syringes.
Vsako pakiranje vsebuje 1 do 4 do 6 vnaprej napolnjenih brizg.
Do not shake.
126 Ne stresajte.
117 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
Retacrit 30000 IU/ 0.75ml solution for injection in pre-filled syringe
Retacrit 30. 000 i. e. / 0, 75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
1 napolnjena injekcijska brizga z 0, 75 ml raztopine za injiciranje vsebuje 30. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Each pre-filled syringe contains 0.38 mg phenylalanine.
Vsaka napolnjena brizga vsebuje 0, 38 mg fenilalanina.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
128 − Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo Pri bolnikih s kronično odpovedjo ledvic je treba zdravilo dajati intravensko (glejte poglavje 4. 4).
119 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
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).
Dose (IU/ kg given 3x week)
129 Odmerek (i. e. / kg 3x na teden)
120 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
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).
If the haemoglobin increase is < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, increase the dose to 300 IU/ kg 3 times per week.
130 če se je število retikulocitov dvignilo < 40. 000 celic/ µl nad osnovno vrednost, zvišamo odmerek na 300 i. e. / kg trikrat tedensko.
121 The recommended dosing regimen is described in the following diagram:
Priporočeni režim odmerjanja je opisan v spodnjem diagramu:
Appropriate dose titration should be considered.
131 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg, enkrat na teden
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Retacrit therapy.
132 čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Retacrit bolnik imel visoke zaloge železa.
122 Method of administration
Način dajanja
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
134 Priporoča se reden nadzor števila retikulocitov, ker se s tem pri bolnikih s kronično ledvično odpovedjo lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
124 electrolytes should be monitored in chronic renal failure patients.
Pri bolnikih s kronično ledvično odpovedjo je treba meriti elektrolite v serumu.
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.
135 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.
125 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.
126 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.
The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
137 prispeva okoli 58% h končni molekularni masi, sestavlja pa ga 165 amino kislin.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the
Štiri ogljikovodikove verige so s tremi N- glikozidnimi vezmi in eno O- glikozidno vezjo pritrjene na protein.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
138 točke razmerja tveganja, ki je bila 1, 08 v prid kontrolam (95% CI:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/ dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine
Natrijev fosfat dihidrat Natrijev dihidrogenfosfat dihidrat Natrijev klorid
129 Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
139 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)
Each pre-filled syringe contains 0.75 ml solution for injection.
Vsaka napolnjena brizga vsebuje 0, 75 ml raztopine za injiciranje.
130 Any unused product or waste material should be disposed of in accordance with local requirements.
140 Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
Retacrit 40000 IU/ 1.0ml solution for injection in pre-filled syringe
Retacrit 40. 000 i. e. / 1, 0 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
142 − Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo Pri bolnikih s kronično odpovedjo ledvic je treba zdravilo dajati intravensko (glejte poglavje 4. 4).
132 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Zdravilo Retacrit je treba dajati intravensko, da bi koncentracijo hemoglobina zvečali na vrednost, ki ne presega 12 g/ dl (7, 5 mmol/ l).
Dose (IU/ kg given 3x week)
143 Odmerek (i. e. / kg 3x na teden)
133 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Odrasli bolniki na peritonealni dializi Zdravljenje poteka v dveh stopnjah:
Appropriate dose titration should be considered.
145 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg, enkrat na teden
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Retacrit therapy.
146 čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Retacrit bolnik imel visoke zaloge železa.
135 Method of administration
Način dajanja
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously. In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično ledvično odpovedjo vzdrževalna koncentracija hemoglobina ne sme presegati zgornje meje priporočene ciljne koncentracije hemoglobina, ki je podana v poglavju 4. 2.
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
148 odpovedjo lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
137 potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
Če se med zdravljenjem pojavi povečana koncentracija kalija ali njeno naraščanje, moramo premisliti, če ne bi bilo bolje zdravljenja z eritropoetinom prekiniti, dokler je ne uravnamo.
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.
149 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.
138 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.
139 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.
The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
151 prispeva okoli 58% h končni molekularni masi, sestavlja pa ga 165 amino kislin.
140 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).
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
152 točke razmerja tveganja, ki je bila 1, 08 v prid kontrolam (95% CI:
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine
Natrijev fosfat dihidrat
142 Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
153 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)
Do not shake.
154 Ne stresajte.
144 ANNEX II
155 DODATEK II
Norbitec GmbH Pinnauallee 4 D-25436 Uetersen Germany
Norbitec GmbH Pinnauallee 4 D- 25436 Uetersen Nemčija
STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Nemčija
Prior to launch and as agreed with competent authorities in the Member States, the Marketing Authorisation Holder shall provide healthcare professionals in dialysis centres and retail pharmacies with the following: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
Pred lansiranjem zdravila na trg mora imetnik dovoljenja za promet z zdravilom zdravnikom v centrih za dializo in lekarnam predložiti naslednje: • izobraževalno brošuro; • povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • Loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Izobraževalna brošura mora vsebovati naslednje ključne elemente: • Uporaba zdravil z epoetinom alfa lahko povzroči imunogenost, ki lahko v redkih primerih povzroči čisto aplazijo rdečih krvnih celic (PRCA). • Pri drugih zdravilih, ki vsebujejo epotein, je tveganje za pojav imunogenosti pri kronični ledvični bolezni (CRF – ” Chronic Renal Failure “) povečano pri uporabi subkutane poti uporabe. • Podatkov o zdravilu Retacrit je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila. • Subkutana pot zato ni priporočena za bolnike s CRF. • Treba je raziskati izgubo učinkovitosti ali druge simptome pojava imunogenosti. • Vse primere suma čiste aplastične anemije ali pojava imunogenosti je treba sporočiti imetniku dovoljenja za promet z zdravilom.
146 • OTHER CONDITIONS
• DRUGI POGOJI