FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of donating blood, Silapo should be administered after the completion of the blood donation procedure.
Slovenian: Ko se daruje kri, moramo ob zaključku postopka dajanja krvi dati zdravilo Silapo.
English: If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40 000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
Slovenian: Če se po 4 tednih zdravljenja hemoglobin zviša za najmanj 1 g/dl (0,62 mmol/l) ali če se je število retikulocitov dvignilo ≥40 000 celic/µl nad osnovno vrednostjo, naj odmerek ostane pri 150 i.e./kg trikrat tedensko ali 450 i.e./kg enkrat tedensko.
English: Silapo should be given by the intravenous route.
Slovenian: Zdravilo Silapo je treba dajati intravensko.
English: 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,
Slovenian: V treh s placebom kontroliranih študijah je sodelovalo 721 bolnikov z rakom na kemoterapiji brez platine, 389 bolnikov s hematološkimi malignostmi (221 primerov multiplega mieloma, 144 neHodgkinovega limfoma, in 24 primerov drugih hematoloških malignosti) in 332 s čvrstimi tumorji (172 dojke, 64 ginekološki, 23 pljuč, 22 prostate, 21 gastro-intestinalni, in 30 s tumorji drugih vrst).
English: Anti-erythropoeitin antibody positive
Slovenian: Preiskave pozitivnost protiteles proti eritropoetinu redki
English: If you are on a more extended dosing interval (greater than once weekly) of Silapo, you may not maintain adequate haemoglobin levels and you may require an increase in Silapo dose or frequency of administration.
Slovenian: Če so vaši odmerni intervali daljši (daljši kot enkrat tedensko), morda ne boste obdržali utreznih ravni hemoglobina.
English: It could be shown with the aid of cell cultures of human bone marrow cells that erythropoietin stimulates erythropoiesis specifically and does not affect leukopoiesis.
Slovenian: 3H-timidina v eritroidne vranične celice z jedrom po inkubaciji z eritropoetinom.V raziskavah na celičnih kulturah človeškega kostnega mozga so ugotovili, da eritropoetin specifično stimulira eritropoezo in da na levkopoezo ne vpliva.
English: 30 000 IU/0.75 ml
Slovenian: 30 000 i.e./0,75 ml
English: Use in kidney disease patients
Slovenian: Uporaba pri bolnikih z boleznimi ledvic
English: 8 000 IU/0.8 ml
Slovenian: 8 000 i.e./0,8 ml
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dl
Slovenian: Vaš zdravnik bo po uvedbi terapije ohranjal vašo raven hemoglobina med 10 in 12 g/dl.
English: Silapo 40 000 IU
Slovenian: Silapo 40 000 i.e.
English: Your doctorwill monitor your blood pressure regularly while you are using Silapo.
Slovenian: Vaš zdravnik vam bo med uporabo zdravilaSilapo redno meril krvni tlak.
English: Vary the site from day to day.
Slovenian: Mesto injiciranja vsak dan spremenite.
English: Silapo is a biosimilar medicinal product.
Slovenian: Zdravilo Silapo je podobno biološko zdravilo.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o hudih kožnih neželenih učinkih (SCAR-severe cutaneous adverse reactions), vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN), ki so lahko življenje ogrožajoči ali smrtni (glejte poglavje 4.4).
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Slovenian: Če heparinizacija ni optimalna, se lahko zamaši dializna naprava.
English: Silapo is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Slovenian: Zdravilo Silapo je bistra in brezbarvna raztopina za injiciranje.
English: congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Slovenian: Analiza posameznih komponent sestavljenih opazovanih dogodkov je pokazala naslednje razmerje ogroženosti (95 % CI): smrt 1,05 (0,92, 1,21), kap 1,92 (1,38, 2,68), kongestivno srčno popuščanje 0,89 (0,74, 1,08), miokardni infarkt 0,96 (0,75, 1,23), hospitalizacija zaradi ishemije miokarda 0,84 (0,55, 1,27), končna ledvična odpoved 1,02 (0,87, 1,18).
English: Silapo 10 000 IU
Slovenian: Silapo 10 000 i.e.
English: 10 000 IU/1 ml
Slovenian: 10 000 i.e./1 ml
English: Silapo 6 000 IU
Slovenian: Silapo 6 000 i.e.
English: Silapo should be administered either subcutaneously or intravenously.
Slovenian: Zdravilo Silapo se lahko daje subkutano ali intravensko.
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Slovenian: Če prihaja do prekomerno visokih nivojev hemoglobina, bo morda potrebna potrebna flebotomija.
English: 40 000 IU/1 ml
Slovenian: 40 000 i.e./1 ml
English: Take special care with other products that stimulate red blood cell production: Silapo is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Slovenian: Silapo je eno izmed zdravil, ki spodbuja nastajanje rdečih krvnih celic, podobno kot humana beljakovina eritropoetin.
English: A haemoglobin concentration of greater than 12 g/dl (7.5 mmol/l) should be avoided.
Slovenian: Izogibajte se koncentraciji hemoglobina, ki presega 12 g/dl (7,5 mmol/l).
English: - raised blood pressure which may require treatment with medicinal products or adjustment of the dosage of medicinal products you already take for high blood pressure.
Slovenian: Ledvični bolnik - Zvišan krvni tlak bo morda treba zdraviti z zdravili oziroma bo treba odmerek zdravil, ki ji jemljete za zmanjšanje krvnega tlaka, prilagoditi.
English: If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
Slovenian: 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.
English: Depending on how the anaemia responds, the dose may be adjusted approximately every 4 weeks until the condition is controlled.
Slovenian: Odvisno od tega, kako se anemija odziva na zdravljenje, se bo odmerek popravljalo prilagajal vsake štiri tedne, dokler stanje ne bo pod nadzorom.
English: 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.
Slovenian: Če se je hemoglobina zvišal <1 g/dl (0,62 mmol/l) ali če se je število retikulocitov dvignilo <40 000 celic/µl nad osnovno vrednost, zvišamo odmerek na 300 i.e./kg trikrat tedensko.
English: Common in dialysis
Slovenian: Pogosto pri dializi.
English: Diarrhoea, Nausea, Vomiting
Slovenian: Bolezni prebavil driska, navzea, bruhanje zelo pogosti
English: If an elevated (or rising) serum potassium level is detected, your doctor may consider to stop the treatment with Silapo until the level is back to normal.
Slovenian: Če se med zdravljenjem pojavi povečana koncentracija kalija ali njeno naraščanje, moramo premisliti o prekinitvi, do vrnitve na normalne vrednosti.
English: The protective cap is removed from the injection needle and air is expelled from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
Slovenian: Odstranite zaščito za iglo in pazljivo odstranite zrak iz brizge tako, da jo držite navpično, bat pa počasi potiskate navzgor.
English: Silapo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l).
Slovenian: Zdravilo Silapo je treba dajati subkutano ali intravensko, da bi koncentracijo hemoglobina zvečali na vrednost, ki ne presega 12g/dl (7,5mmol/l).
English: Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Slovenian: Odmerek in odmerne intervale je treba ustrezno prilagoditi, da se vrednost hemoglobina (Hb) ohranja na želenem nivoju: (Hb med 10 in 12 g/dl (6,2-7,5 mmol/l).
English: in adult patients receiving chemotherapy for solid tumours, malignant lymphoma (cancer of the lymphatic system) or multiple myeloma (bone marrow cancer) to treat anaemia and reduce the need for a blood transfusion, if the doctor decides there may be a high risk for needing for a blood transfusion.
Slovenian: za zdravljenje anemije in zmanjšanje potrebe po krvnih transfuzijah pri odraslih bolnikih,ki prejemajo kemoterapijo zaradi čvrstih tumorjev, malignih limfomov (rak limfnega sistema) ali multiplega mieloma (rak kostnega mozga) in za katere je bil zdravnik mnenja, da bodo zaradi transfuzije krvi izpostavljeni velikemu tveganju.
English: 5 000 IU/0.5 ml
Slovenian: 5 000 i.e./0,5 ml
English: Silapo 4 000 IU
Slovenian: Silapo 4 000 i.e.
English: Silapo 2 000 IU
Slovenian: Silapo 2 000 i.e.
English: Alternatively, Silapo can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Slovenian: Zdravilo Silapo se lahko daje tudi enkrat tedensko subkutano z začetnim odmerkom 450 i.e./kg.
English: Maintenance phase: Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Slovenian: Vzdrževalna faza: prilagajanje odmerka, da se vrednost hemoglobina (Hb) ohranja na želenem nivoju: Hb med 10 in 12 g/dl (6,2-7,5 mmol/l).
English: Adult patients on haemodialysis
Slovenian: Odrasli bolniki na hemodializi
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Slovenian: • V spoju (šantu) za dializo lahko nastanejo krvni strdki (tromboza).
English: 20 000 IU/0.5 ml
Slovenian: 20 000 i.e./0,5 ml
English: Caution should be exercised with escalation of Silapodoses in patients with chronic renal failure.In patients with a poor haemoglobin response to Silapo,alternative explanations for the poor response should be considered (see sections4.4and 5.1).
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na zdravilo Silapo je treba razmisliti o možnih drugih razlagah za slab odziv na zdravljenje (glejte poglavje 4.4 in 5.1).
English: Silapo 30 000 IU
Slovenian: Silapo 30 000 i.e.
English: Pure red cell aplasia Thrombocythemia
Slovenian: Bolezni krvi in limfatičnega sistema čista aplazija rdečih krvnih celic redki trombocitemija
English: The solution contains 10 000 IU Epoetin zeta per ml.
Slovenian: Raztopina vsebuje 10 000 i.e. epoetina zeta na ml.
English: 3 000 IU/0.9 ml
Slovenian: 3 000 i.e./0,9 ml
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov.
English: Silapo 3 000 IU
Slovenian: Silapo 3 000 i.e.
English: The solution contains 40 000 IU Epoetin zeta per ml.
Slovenian: Raztopina vsebuje 40 000 i.e. epoetina zeta na ml.
English: Usual maintenance dose
Slovenian: Telesna masa (kg) mediana običajni vzdrževalni odmerek
English: Rare: may affect up to 1 in 1 000 people • Symptoms of pure red cell aplasia (PRCA)
Slovenian: • Simptomi čiste aplazije rdečih krvnih celic (PRCA)
English: Ask your doctor for advice before taking any medicine.
Slovenian: Preden vzamete katero koli zdravilo, se posvetujte s svojim zdravnikom.
English: Baseline Characteristics for Subjects with sEPO<200 mU/ml at Screening Randomised
Slovenian: Izhodiščne značilnosti preskušancev s sEPO < 200 mU/ml ob presejanju Randomizirani epoetin alfa placebo
English: An increase in heparin dose during haemodialysis is frequently required during the course of therapy with erythropoietin as a result of the increased packed cell volume.
Slovenian: Pri hemodializi je med zdravljenjem z zdravilom Silapo, zaradi povečanega hematokrita treba pogosto povečati odmerek heparina.
English: 1 000 IU/0.3 ml
Slovenian: 1 000 i.e./0,3 ml
English: Appropriate dose adjustments should be made to maintain haemoglobin concentrations within the target range of 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l).
Slovenian: Odmerek je treba ustrezno prilagajati za ohranjanje koncentracije hemoglobina znotraj ciljnega razpona med 10 g/dl in 12 g/dl (6,2 - 7,5 mmol/l).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe
Slovenian: Silapo 1 000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 2 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 3 000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 4 000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 5 000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 6 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 8 000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 10 000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 20 000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 30 000 i.e./0,75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 40 000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: 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).
Slovenian: 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 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).
English: Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o hudih kožnih izpuščajih, vključno s StevensJohnsonovim sindromom in toksično epidermalno nekrolizo.
English: Dose information
Slovenian: DRUGI PODATKI
English: Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route.
Slovenian: Pri bolnikih s kronično ledvično okvaro, ki se jih je zdravilo s subkutanimi injekcijami eritropoetina, so v zelo redkih primerih poročali o PRCA, do katere je prišlo zaradi protiteles.
English: - The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese
Slovenian: - Učinkovina je epoetin zeta (pridobljen iz celične linije jajčnika kitajskega hrčka (CHO
English: Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Slovenian: glicin levcin izolevcin treonin glutamatna kislina fenilalanin voda za injekcije natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
English: 4 000 IU/0.4 ml
Slovenian: 4 000 i.e./0,4 ml
English: Convulsion
Slovenian: Odmerjanje
English: A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Slovenian: V času štirih tednov se morate izogibati dvigu koncentracije hemoglobina, ki presega 2 g/dl (1,25 mmol/l).
English: 1 pre-filled syringe contains 8 000 IU Epoetin zeta
Slovenian: 1 napolnjena ijekcijska brizga vsebuje 8 000 i.e. epoetin zeta
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o hudih kožnih neželenih učinkih (SCAR-severe cutaneous adverse reactions), vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN), ki so lahko življenje ogrožajoči ali smrtni.
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov.
English: This regresses during the course of continued therapy.
Slovenian: Med nadaljevanjem zdravljenja se njihovo število zmanjša.
English: Solution for injection in pre-filled syringe.
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi bistra, brezbarvna raztopina
English: 6 000 IU/0.6 ml
Slovenian: 6 000 i.e./0,6 ml
English: • You may be given iron supplements before and during Silapo treatment to make it more effective.
Slovenian: • Med zdravljenjem z zdravilom Silapo in po njem boste morda prejemali tudi nadomestno železo za povečanje učinkovitosti zdravila.
English: Weight (kg)
Slovenian: 450i.e./kg
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe Epoetin zeta
Slovenian: Silapo 8 000 i.e./0,8 ml raztopine za injiciranje v napolnjeni injekcijski brizgi epoetin zeta
English: A slower injection is preferable in patients who react to the treatment with “flu-like” symptoms.
Slovenian: Pri bolnikih, ki na postopek reagirajo s simptomi podobnimi gripi, se priporoča počasneje iniciranje.
English: 1 pre-filled syringe contains 5 000 IU Epoetin zeta
Slovenian: 1 napolnjena ijekcijska brizga vsebuje 5 000 i.e. epoetin zeta
English: Use in adult patients receiving haemodialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl (6.2 - 7.5 mmol/l).
Slovenian: Vaš zdravnik bo vašo koncentracijo hemoglobina ohranjal na vrednosti med 10 in 12 g/dl (6,2-7,5 mmol/l).
English: Silapo 1 000 IU
Slovenian: Silapo 1 000 i.e.
English: Serum electrolytes (substances in your blood) should be monitored in chronic renal failure patients.
Slovenian: Pri bolnikih s kronično ledvično okvaro je treba meriti elektrolite v serumu (snovi v krvi).
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe Epoetin zeta
Slovenian: Silapo 30 000 i.e./0,75 ml raztopine za injiciranje v napolnjeni injekcijski brizgi epoetin zeta
English: 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).
Slovenian: Pri bolnikih z rakom, ki so prejemali zdravila z eritropoetinom (glejte poglavje 4.8), je bilo opaziti porast trombotičnih vaskularnih zapletov (TVE - thrombotic vascular event), tako da je treba pazljivo pretehtati koristi in tveganja terapije z zdravilom Silapo.
English: 2 000 IU/0.6 ml
Slovenian: 2 000 i.e./0,6 ml
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, bolečina v kosteh, mialgija, bolečina v okončinah pogosti
English: Hypertension, Venous and arterial thromboses
Slovenian: Žilne bolezni zvišan krvni tlak, venske in arterijske tromboze pogosti hipertenzivna kriza neznana
English: 1 pre-filled syringe contains 20 000 IU Epoetin zeta
Slovenian: 1 napolnjena ijekcijska brizga vsebuje 20 000 i.e. epoetin zeta
English: 1 pre-filled syringe of 0.75 ml solution for injection 4 pre-filled syringes of 0.75 ml solution for injection
Slovenian: 1 napolnjena injekcijska brizga z 0,75 ml raztopine za injiciranje 4 napolnjenih injekcijskih brizg z 0,75 ml raztopine za injiciranje
English: Severe cutaneous adverse reactions
Slovenian: Hudi kožni neželeni učinki
English: Serum electrolytes should be monitored in chronic renal failure patients.
Slovenian: Pri bolnikih s kronično ledvično okvaro je treba meriti elektrolite v serumu.
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Slovenian: V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.
English: 1 pre-filled syringe contains 6 000 IU Epoetin zeta
Slovenian: 1 napolnjena ijekcijska brizga vsebuje 6 000 i.e. epoetin zeta
English: • Diarrhoea
Slovenian: • Bruhanje.
English: • Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.
Slovenian: • Pri bolnikih z boleznijo ledvic, ki niso na dializi, so poročali o kongestiji dihal, kot je zamašen nos ali bolečine v grlu.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Slovenian: Silapo 8 000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,8 ml raztopine za injiciranje vsebuje 8 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija zelo pogosti mrzlica, gripi podobna bolezen, reakcija na mestu injiciranja, periferni edem pogosti neučinkovitost zdravila neznana
English: Kidney patients
Slovenian: Ledvični bolniki
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/432/013
Slovenian: Silapo 8 000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/432/013
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o hudih kožnih reakcijah, vključno s StevensJohnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN).
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 0.8 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Slovenian: Silapo 8 000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,8 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
English: Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
Slovenian: V študijah s podaljšanim odmernim intervalom pri odraslih bolnikih z zmanjšanim delovanjem ledvic, ki se še ne zdravijo z dializo, so poročali o kongestiji dihal z dogodki, pri katerih je prišlo do kongestije zgornjih dihalnih poti, nosne kongestije in nazofaringitisa.
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 0.75 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Slovenian: Silapo 30 000 i.e./0,75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,75 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.