natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Each pack of KOGENATE Bayer 250 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 250 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 250 IU. 
Pred začetkom uporabe zdravila KOGENATE Bayer 250 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 500 IU. 
Pred začetkom uporabe zdravila KOGENATE Bayer 500 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/007 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/007
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/009 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/009
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KOGENATE Bayer 1000 IU powder for solution for injection Recombinant coagulation factor VIII (octocog alfa) Intravenous use. 
IME ZDRAVILA IN POT(I) UPORABE KOGENATE Bayer 1000 i.e. prašek za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
How much KOGENATE Bayer 2000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed. 
Koliko zdravila KOGENATE Bayer 2000 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/011 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/011
Package Leaflet: Information for the user KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
Navodilo za uporabo KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/013 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/013
If you want to stop using KOGENATE Bayer 2000 IU Do not stop using KOGENATE Bayer without consulting your doctor. 
Ne prenehajte uporabljati zdravila KOGENATE Bayer, ne da bi se prej posvetovali z vašim zdravnikom.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/010 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/010
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/004 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/004
PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below 
predhodno nezdravljenih bolnikih in 23 minimalno zdravljenih pediatričnih bolnikih (MTP
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
Navodilo za uporabo KOGENATE Bayer 2000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
How much KOGENATE Bayer 1000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed. 
Koliko zdravila KOGENATE Bayer 1000 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
KOGENATE Bayer 1000 IU contains sodium This medicinal product contains less than 23 mg sodium per vial, i.e. essentially “sodium-free”. 
Zdravilo KOGENATE Bayer 1000 i.e. vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na vialo, kar v bistvu pomeni "brez natrija".
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 2000 IU. 
Pred začetkom uporabe zdravila KOGENATE Bayer 2000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Each pack of KOGENATE Bayer 3000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 3000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Package Leaflet: Information for the user KOGENATE Bayer 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
Navodilo za uporabo KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 1000 IU. 
Pred začetkom uporabe zdravila KOGENATE Bayer 1000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Each pack of KOGENATE Bayer 1000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 1000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 2000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 2000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany 
Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 2000 i.e.. Imetnik dovoljenja za promet Bayer Pharma AG 13342 Berlin
Package Leaflet: Information for the user KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
Navodilo za uporabo KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Only the provided components (powder vial with Bio-Set device, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment. 
Če se uporabi drug pribor, je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.
Do not pass it on to others. 
Ne uporabljajte po tem datumu.
1 vial with Bio-Set device with powder for solution for injection. 
Bio-Set, z vehiklom napolnjeno injekcijsko brizgo in pribor za vensko punkcijo).
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 1000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa) 
Navodilo za uporabo KOGENATE Bayer 1000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
How to store KOGENATE Bayer 3000 IU 
Shranjevanje zdravila KOGENATE Bayer 3000 i.e.
How to store KOGENATE Bayer 500 IU 
Shranjevanje zdravila KOGENATE Bayer 500 i.e.
Do not use KOGENATE Bayer 2000 IU 
Če želite prenehati uporabljati zdravilo KOGENATE Bayer 2000 i.e.
How to store KOGENATE Bayer 1000 IU 
Shranjevanje zdravila KOGENATE Bayer 1000 i.e.
The speed of administration should be based on the patient's comfort, but should not be faster than 2 ml/min maximum rate of injection. 
Hitrost vbrizgavanja naj bo prilagojena bolnikovemu počutju, vendar naj injiciranje ne bo hitrejše kot
How to store KOGENATE Bayer 250 IU 
Shranjevanje zdravila KOGENATE Bayer 250 i.e.
Each pack of KOGENATE Bayer 3000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 3000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 500 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 500 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Other medicines and KOGENATE Bayer 3000 IU Interactions with other medicines are not known. 
Druga zdravila in zdravilo KOGENATE Bayer 3000 i.e.
Each pack of KOGENATE Bayer 2000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 2000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 250 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 250 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 3000 IU. 
Pred začetkom uporabe zdravila KOGENATE Bayer 3000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Each pack of KOGENATE Bayer 1000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer 1000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment. 
Za rekonstitucijo in dajanje zdravila se sme uporabiti samo priloženi pribor (vialo s praškom, z vehiklom napolnjeno injekcijsko brizgo, adapter za vialo in pribor za vensko punkcijo).
This summary was last updated in 02-2019. 
Povzetek je bil nazadnje posodobljen 02-2019.
This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Silapo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silapo?
Silapo received a marketing authorisation valid throughout the EU on 18 December 2007. 
Za zdravilo Silapo je bilo 18. decembra 2007 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
The iron levels of all patients should be checked and iron supplements given if necessary. 
Pri vseh bolnikih je treba preveriti raven železa in jim po potrebi predpisati dodatke železa.
After that, the two groups switched to receiving the other medicine for a further 12 weeks. 
Zatem sta obe skupini bolnikov za nadaljnjih 12 tednov prešli na zdravljenje z drugim zdravilom.
Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo 
Nadaljnje informacije o zdravilu Silapo so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/Silapo
• patients who cannot receive medicines to prevent blood clots; 
bolnikih, ki ne morejo prejemati zdravil za preprečevanje krvnih strdkov;
An overview of Silapo and why it is authorised in the EU 
Pregled zdravila Silapo in zakaj je odobreno v EU
What is Silapo and what is it used for? 
Kaj je zdravilo Silapo in za kaj se uporablja?
Haemoglobin levels were maintained at around 11.4 g/dl in both groups. 
Ravni hemoglobina so bile v obeh skupinah bolnikov ohranjene na približno 11,4 g/dl.
For these patients, the lowest dose that controls the symptoms well enough should be used. 
Pri teh bolnikih je treba uporabiti najnižji odmerek, ki še zagotavlja dovolj dober nadzor nad simptomi.
During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment. 
V zadnjih štirih tednih študije so bile ravni hemoglobina okoli 11,6 g/dl, kar pomeni, da so narasle z ravni okoli 8,0 g/dl pred zdravljenjem.
The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure. 
Najpogostejša neželena učinka zdravila Silapo (ki se lahko pojavita pri več kot 1 bolniku od 100) sta glavobol in povišan krvni tlak.
Why is Silapo authorised in the EU? 
Zakaj je zdravilo Silapo odobreno v EU?
What benefits of Silapo have been shown in studies? 
Kakšne koristi je zdravilo Silapo izkazalo v študijah?
Silapo must not be used in the following groups: 
Zdravilo Silapo se ne sme uporabljati pri naslednjih skupinah bolnikov:
As for all medicines, data on the use of Silapo are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Silapo stalno spremljajo.
Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Silapo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Silapo? 
Kakšna tveganja so povezana z zdravilom Silapo?
For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Silapo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• patients with hypertension (high blood pressure) that is not controlled; 
bolnikih z nenadzorovano hipertenzijo (visokim krvnim tlakom);
Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss. 
Epoetin zeta se uporablja tudi pred kirurškimi posegi za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjšanju posledic izgube krvi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Silapo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
• patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke. 
bolnikih, ki so tik pred kirurškim posegom, vključno pred zahtevnejšim ortopedskim kirurškim posegom, in imajo resne kardiovaskularne (srčnožilne) težave, vključno z nedavnim srčnim napadom ali možgansko kapjo.
In these cases, epoetin zeta is used to increase red blood cell counts. 
V teh primerih se za povečanje števila rdečih krvnih celic uporablja epoetin zeta.
The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working. 
Odmerek, pogostost injiciranja in trajanje uporabe zdravila Silapo so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range. 
Pri bolnikih z odpovedjo ledvic ali mielodisplastičnimi sindromi ali pri tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati znotraj priporočenega območja.
All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks. 
Vsi bolniki v drugi študiji so bili vsaj tri mesece zdravljeni z zdravilom Eprex/Erypo, preden so za 12 tednov bodisi prešli na zdravilo Silapo bodisi ostali pri zdravljenju z zdravilom Eprex/Erypo.
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.
The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems. 
Podjetje je predstavilo tudi rezultate dveh študij, ki sta pokazali, da je zdravilo Silapo, injicirano v podkožje, enako učinkovito kot druga zdravila, ki vsebujejo epoetin: v eni študiji je sodelovalo 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi študiji pa so zdravilo Silapo primerjali z zdravilom Eprex/Erypo pri 462 bolnikih s slabokrvnostjo kot posledico težav z ledvicami.
• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) 
bolnikih, pri katerih se je po zdravljenju z epoetinom razvila aplazija rdečih krvnih celic (zmanjšano ali zaustavljeno tvorjenje rdečih krvnih celic);
Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for. 
Predpisovanje in izdaja zdravila Silapo je le na recept, zdravljenje z njim pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z boleznimi, za katere je to zdravilo odobreno.
Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin. 
Zdravilo Silapo se uporablja pri bolnikih, pri katerih obstaja majhno ali srednje tveganje za pojav akutne mieloične levkemije in ki imajo nizke ravni naravnega hormona eritropoetina.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin. 
Pri bolnikih, ki prejemajo kemoterapijo, ali tistih z ledvičnimi težavami lahko slabokrvnost povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisotni eritropoetin.
The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. 
Učinkovina v zdravilu Silapo, epoetin zeta, je kopija hormona eritropoetina in deluje popolnoma enako kot naravni hormon pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu.
Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo. 
Ker je zdravilo Silapo podobno biološko zdravilo, študij o učinkovitosti in varnosti epoetina, ki so že bile izvedene z zdravilom Eprex/Erypo, za zdravilo Silapo ni treba ponavljati.
It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood; 
Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih lahko pride do zapletov pri transfuziji krvi, če pred kirurškim posegom ne darujejo lastne krvi, pričakovane izgube pa znašajo od 900 do 1 800 ml; za zdravljenje slabokrvnosti pri odraslih z mielodisplastičnimi sindromi (obolenji, pri katerih je okvarjeno nastajanje zdravih krvnih celic).
Other information about Silapo: 
Druge informacije o zdravilu Silapo:
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Silapo po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Eprex/Erypo in da se po telesu enako porazdeli.
All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Silapo pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Eprex/Erypo.
How does Silapo work? 
Kako zdravilo Silapo deluje?
Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised. 
Agencija je zato menila, da koristi zdravila Silapo enako kot pri zdravilu Eprex/Erypo odtehtajo znana tveganja in da se zdravilo lahko odobri.
The injection under the skin may be given by the patient or a carer if they have been trained. 
Bolnik si zdravilo lahko v podkožje injicira sam ali mu ga injicira negovalec, če sta bila za to ustrezno usposobljena.
Silapo is available in pre-filled syringes and is injected either into a vein or under the skin, depending on the condition for which the patient is being treated. 
Zdravilo Silapo je na voljo v napolnjenih injekcijskih brizgah, daje pa se z injiciranjem v veno ali podkožje, kar je odvisno od bolezni, ki se zdravi.