natgillin/translations-raw huggingface dataset:
Do not use Siklos after the expiry date which is stated on the carton and the blisters.
Zdravila Siklos ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
Unused broken tablets must be replaced in the blister and the blister itself must be put back in its box.
Neporabljene zlomljene tablete je treba namestiti nazaj v pretisni omot, ki ga je treba dati nazaj v škatlo.
What Siklos contains
Kaj vsebuje zdravilo Siklos
22 The active substance is hydroxycarbamide.
Zdravilna učinkovina je hidroksikarbamid.
Each film-coated tablet contains 1000 mg hydroxycarbamide.
Vsaka filmsko obložena tableta vsebuje 1000 mg hidroksikarbamida.
The other ingredients are sodium stearyl fumarate and silicified microcrystalline cellulose and methacrylate copolymer.
Pomožne snovi so natrijev stearil fumarat, silificirana mikrokristalna celuloza in metakrilatni kopolimer.
Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
1000 mg filmsko obložene tablete zdravila Siklos so sivobele tablete v obliki kapsul, označene s tremi zarezami na obeh straneh.
Siklos is supplied in blisters packed in cartons containing 30 tablets.
Zdravilo Siklos je dobavljeno v pretisnih omotih, zapakiranih v škatlah, ki vsebujejo 30 tablet.
Marketing Authorisation Holder Addmedica 84 rue d'Amsterdam 75009 Paris France
Imetnik dovoljenja za promet z zdravilom Addmedica 84 rue d' Amsterdam 75009 PARIZ Francija
Manufacturer Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Izdelovalec Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Les Bouillides - Sophia Antipolis 06560 Valbonne France
Les Bouillides - Sophia Antipolis 06560 Valbonne Francija
This leaflet was last approved in ….
Navodilo je bilo odobreno....
23
23 Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
ANNEX IV
DODATEK
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJA DRŽAVA ČLANICA
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI SE NASLOVIJO NA DRŽAVO ČLANICO
The Member States shall ensure that the MAH, prior to launch, provides all physicians who are expected to prescribe Siklos with a physician information pack containing the following: • Treatment guide for physicians • Patient information pack
Država članica bo zagotovila, da bo imetnik dovoljenja za promet ob začetku trženja oskrbel vse zdravnike, za katere se pričakuje, da bodo zdravilo Siklos predpisovali, z informativnim kompletom z naslednjo vsebino: • Vodnik za zdravljenje za zdravnika • Informativni komplet za bolnika
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 Silapo/ 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 Silapo 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.
Silapo is a ‘ biosimilar’ medicine.
Zdravilo Silapo je „ biološko podobno “ zdravilo.
This means that Silapo is similar to a biological medicine that is already authorised in the European Union (EU) and contains a similar active substance (also known as the ‘ reference medicine’).
To pomeni, da je zdravilo Silapo podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebuje podobno zdravilno učinkovino (imenovanemu tudi „ referenčno zdravilo “).
The reference medicine for Silapo is EPREX/ ERYPO, which contains epoetin alfa.
Referenčno zdravilo za zdravilo Silapo je zdravilo EPREX/ ERYPO, ki vsebuje epoetin alfa.
Silapo is used to stimulate red blood cell production in the following situations: • to treat anaemia (low red blood cell counts) caused by chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems, • to treat anaemia and reduce the need for blood transfusions in adults receiving chemotherapy for certain types of cancer, • to increase the amount of blood that patients with moderate anaemia can donate before surgery, so that their own blood can be given back to them during or after surgery.
Zdravilo Silapo se uporablja za stimuliranje nastajanja rdečih krvnih celic v naslednjih situacijah: • zdravljenje anemije (nizke ravni rdečih krvnih celic), ki je posledica kronične ledvične odpovedi (dolgotrajnega, napredujočega zmanjševanja sposobnosti pravilnega delovanja ledvic) ali drugih težav z ledvicami, • zdravljenje anemije in zmanjšanje potrebe po krvnih transfuzijah pri odraslih bolnikih, ki prejemajo kemoterapijo zaradi določenih vrst raka, • povečanje količine krvi, ki jo zmerno slabokrvni bolniki lahko dajo pred operacijo in jo nato med ali po operacijo prejmejo nazaj.
Treatment with Silapo must be initiated under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
Zdravljenje z zdravilom Silapo se treba uvesti pod nadzorom zdravnika, ki ima izkušnje z obravnavo bolnikov z boleznimi, za katere se zdravilo uporablja.
For patients with kidney problems or about to undergo surgery, Silapo must be injected intravenously (into a vein), while patients receiving chemotherapy receive it subcutaneously (under the skin).
Zdravilo Silapo je treba pri bolnikih z boleznimi ledvic in bolnikih pred kirurškim posegom injicirati intravensko (v veno), pri bolnikih, ki prejemajo kemoterapijo, pa subkutano (podkožno).
The dose, the frequency of injection and how long it is used for depend on why Silapo is being used, and are adjusted according to the patient’ s response.
Odmerek in pogostnost injiciranja ter trajanje zdravljenja so odvisni od namena uporabe zdravila Silapo in se lahko prilagajajo glede na odziv bolnika.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V teh primerih 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged uporabimo eritropoetin, da nadomesti manjkajoči hormon ali zviša ravni rdečih krvnih celic.
The active substance in Silapo, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Zdravilna učinkovina zdravila Silapo, epoetin zeta, je kopija človeškega eritropoetina in deluje natančno tako kot naravni hormon za stimuliranje nastajanja rdečih krvnih celic.
The active substance in Silapo, epoetin zeta, is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce erythropoietin.
Zdravilna učinkovina zdravila Silapo je epoetin zeta, ki je izdelan s „ tehnologijo rekombinantne DNA “: izdela ga celica, ki je prejela gen (DNA), s katerim lahko tvori eritropoetin.
Silapo was studied to show that it is comparable with the reference medicine, EPREX/ ERYPO, in experimental models and in humans.
Za zdravilo Silapo so s pomočjo poskusnih modelov in pri ljudeh dokazovali, da je primerljivo z referenčnim zdravilom EPREX/ ERYPO.
Silapo, injected intravenously, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a blood clearance technique).
Zdravilo Silapo, uporabljeno intravensko, so primerjali z referenčnim zdravilom v dveh glavnih študijah, v kateri je bilo vključenih 922 bolnikov z anemijo, ki je bila povezana s kronično ledvično odpovedjo s potrebo po hemodializi (tehnika čiščenja krvi).
The first study compared the effects of Silapo with those of EPREX/ ERYPO in correcting red blood cell counts in 609 patients over 24 weeks.
V prvi študiji so primerjali učinke zdravila Silapo z učinki zdravila EPREX/ ERYPO na popravljanje ravni rdečih krvnih celic pri 609 bolnikih v 24 tednih.
The second study compared the effects of Silapo with those of EPREX/ ERYPO in maintaining red blood cell counts in 313 patients.
V drugi študiji so primerjali učinke zdravila Silapo z učinki zdravila EPREX/ ERYPO na ohranjanje ravni rdečih krvnih celic pri 313 bolnikih.
All of the patients in the second study had been receiving treatment with EPREX/ ERYPO for at least three months before they were either switched to Silapo or remained on EPREX/ ERYPO for 12 weeks.
V drugi študiji so vse bolnike najmanj tri mesece zdravili z zdravilom EPREX/ ERYPO, nato pa so za 12 tednov bodisi zamenjali zdravilo z zdravilom Silapo bodisi ohranili uporabo zdravila EPREX/ ERYPO.
The company also presented the results of a study looking at the effects of Silapo injected subcutaneously in 261 cancer patients taking chemotherapy.
Družba je predstavila tudi podatke o študiji, kjer so ugotavljali učinke podkožno injiciranega zdravila Silapo pri 261 bolnikih, ki so prejemali kemoterapijo.
Silapo was as effective as EPREX/ ERYPO in correcting and maintaining red blood cell counts.
Zdravilo Silapo je bilo vsaj enako učinkovito kot zdravilo EPREX/ ERYPO pri popravljanju in ohranjanju ravni rdečih krvnih celic.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained to the same extent when the patients were receiving Silapo and when they were receiving EPREX/ ERYPO, at around 11.4 g/ dl.
V drugi študiji pri bolnikih, ki so že prejemali epoetin, so z zdravilom Silapo ali zdravilom EPREX/ ERYPO z enako učinkovitostjo ohranjali ravni hemoglobina na približno 11, 4 g/ dl.
The study in patients receiving chemotherapy showed that Silapo was also effective when it was injected subcutaneously, with similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
V študiji pri bolnikih, ki prejemajo kemoterapijo, so dokazali, da je zdravilo Silapo učinkovito tudi ob podkožnem injiciranju, pri čemer doseže podobno izboljšanje ravni hemoglobina, kakor je opisano v strokovni literaturi za druge epoetine.
As with other medicines containing an epoetin, the most common side effect with Silapo is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
Kot pri drugih zdravilih, ki vsebujejo epoetin, je najpogostejši neželeni učinek zdravila Silapo zvišan krvni tlak, ki lahko v posameznih primerih povzroči simptome encefalopatije (bolezni možganov), kot sta nenaden, migreni podoben glavobol z zbadanjem in zmedenost.
Silapo can also lead to skin rash and flu-like symptoms.
Zdravilo Silapo lahko povzroči tudi kožni izpuščaj in gripi podobne simptome.
For the full list of all side effects reported with Silapo, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Silapo, glejte Navodilo za uporabo.
Silapo should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Zdravila Silapo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin zeta ali katero koli drugo sestavino zdravila.
Silapo is not recommended for subcutaneous injection in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Zdravilo Silapo ni priporočljivo za podkožno injiciranje pri zdravljenju bolezni ledvic, ker so potrebne dodatne študije, s katerimi bi izključili možnost alergijskih reakcij zaradi takšnega injiciranja.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Silapo has been shown to have a comparable quality, safety and efficacy profile to
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je bilo za zdravilo Silapo v skladu z zahtevami EU dokazano, da ima primerljivo kakovost, varnost in učinkovitost kot zdravilo
EPREX/ ERYPO.
EPREX/ ERYPO.
Therefore, the CHMP’ s view was that, as for EPREX/ ERYPO, the benefit outweighs the identified risks.
Zato je CHMP mnenja, da so koristi zdravila Silapo kot tudi zdravila EPREX/ ERYPO večje od z njima povezanega znanega tveganja.
The Committee recommended that Silapo be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Silapo.
Which measures are being taken to ensure the safe use of Silapo?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Silapo?
The company that makes Silapo will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Podjetje, ki izdekuje zdravilo Silapo bo zdravstvenim delavcem v vseh državah članicah zagotovilo informacijsko gradivo, ki vključuje podatke o varnosti zdravila.
The European Commission granted a marketing authorisation valid throughout the EU for Silapo to STADA Arzneimittel AG on 18 December 2007.
Evropska Komisija je dovoljenje za promet z zdravilom Silapo, veljavno po vsej Evropski uniji, odobrila družbi STADA Arzneimittel AG dne 18. decembra 2007.
The full EPAR for Silapo can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Silapo je na voljo tukaj.
1000 IU/ 0.3 ml
1000 i. e. /
2000 IU/ 0.6 ml
2000 i. e. /
3000 IU/ 0.9 ml
3000 i. e. /
10000 IU / 1.0 ml
10000 i. e. /
20000 IU/ 0.5 ml
20000 i. e. /
30000 IU/ 0.75 ml
30000 i. e. /
40000 IU/ 1.0 ml
40000 i. e. /
Silapo 1000 IU/ 0.3ml solution for injection in pre-filled syringe
Silapo 1. 000 i. e. / 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
− 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). − Silapo 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 Silapo 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)
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).
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).
2 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).
2 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.
Simptomi anemije in posledična bolezenska stanja se lahko spreminjajo glede na starost, spol in skupno bolezensko breme.
Silapo should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L) Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi razlik med posameznimi bolniki je pri bolnikih občasno mogoče opaziti individualne vrednosti hemoglobina, ki so nad ali pod želeno koncentracijo hemoglobina.
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).
Izogibajte se trajni koncentraciji hemoglobina, ki presega 12 g/ dl.
Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anemia.
Bolnike morate skrbno nadzorovati, da bi zagotovili uporabo najnižjega odobrenega odmerka zdravila Silapo za primeren nadzor simptomov anemije.
At each step, the increase or reduction in dose should be of 25 IU/ kg 3 times per week.
Pri vsakem koraku je treba odmerek zvečati ali zmanjšati za 25 i. e/ kg trikrat na teden.
3 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Odrasli bolniki na peritonealni dializi Zdravljenje poteka v dveh stopnjah:
Silapo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Bolnikom z anemijo (npr. koncentracije hemoglobina ≤ 10 g/ dl (6, 2 mmol/ l)) je treba zdravilo Silapo dajati subkutano.
Alternatively, Silapo can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Zdravilo Silapo se lahko daje tudi enkrat tedensko subkutano z začetnim odmerkom 450 i. e. / kg.
However, if the haemoglobin has increased < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, response is unlikely and treatment should be discontinued.
Če pa 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, odziva
The recommended dosing regimen is described in the following diagram:
4 verjetno ni in je treba zdravljenje prekiniti.
Appropriate dose titration should be considered.
Priporočeni režim odmerjanja je opisan v spodnjem diagramu:
Dose adjustment At a rate of rise in haemoglobin of > 2 g/ dl (> 1.25 mmol/ l) per month the Silapo dose should be reduced by about 25-50%.
150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg, enkrat na teden
Silapo should be given by the intravenous route.
Razmisliti morate o primerni titraciji odmerka.
At the time of donating blood, Silapo should be administered after the completion of the blood donation procedure.
Če je koncentracija hemoglobina nad 12 g/ dl (7, 5 mmol/ l), zdravljenje prekinemo, dokler ne pade na 12 g/ dl (7, 5 mmol/ l) ali nižje, potem pa nadaljujemo s terapijo z zdravilom Silapo z odmerkom, ki je 25% nižji od predhodnega.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
5 Blago anemičnim bolnikom (hematokrit 33- 39%), ki potrebujejo zalogo ≥ 4 enot krvi, je treba dajati zdravilo Silapo v odmerku 600 i. e. / kg telesne mase dvakrat tedensko, 3 tedne pred operacijo.
All patients being treated with Silapo should receive adequate iron supplementation (e. g.
Vsem bolnikom, ki dobivajo zdravilo Silapo, je treba ves čas zdravljenja dodajati ustrezn dodatek z železom (npr.
5 Method of administration
Način dajanja
Silapo should not be administered by intravenous infusion.
Zdravilo Silapo se ne sme dajati z intravenozno infuzijo.
Silapo must not be mixed with other medicinal products (see section 6.2).
Zdravilo Silapo se ne sme mešati z drugimi zdravili (glej poglavje 6. 2).
In chronic renal failure patients Silapo has not to be administered subcutaneously.
Pri bolnikih, ki imajo kronično ledvično odpoved, Silapa ni dovoljeno dajati subkutano.
− Hypersensitivity to the active substance or to any of the excipients. − Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4). − Uncontrolled hypertension. − In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease. − Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
− Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. − Bolniki, pri katerih po zdravljenju s katerimkoli eritropoetinom pride do čiste aplazije rdečih krvnih celic (PRCA - "Pure Red Cell Aplasia"), zdravila Silapo ali kateregakoli drugega eritropoetina ne smejo dobivati (glejte poglavje 4. 4). − Nekontrolirana hipertenzija. − Pri indikaciji "povečanje količine avtologne krvi": miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska tromboembolična bolezen v anamnezi. − Bolniki, ki iz kakršnegakoli razloga ne morejo prejemati ustrezne profilakse proti trombozi.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
6 V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.