natgillin/translations-raw huggingface dataset:
Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.
S cepivom Fendrix se ne sme cepiti oseb, ki so preobčutljive za aktivne sestavine ali katerokoli pomožno snov cepiva Fendrix.
• Make sure you finish the complete course of four injections.
• Preverite, ali ste prejeli vse štiri načrtovane odmerke cepiva.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/0299/001 - pack of 1 with separate needle EU/1/04/0299/002 - pack of 1 without needle EU/1/04/0299/003 - pack of 10 without needles
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/0299/001 - pakiranje po 1 s priloženo injekcijsko iglo
• stomach and digestion problems.
• težave z želodcem ali s prebavo.
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
2adsorbiran na aluminijev fosfat (skupno 0,5 miligramov Al3+) 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case basis by the physician.
Cepljenje je lahko primerno, saj je pri teh bolnikih možna huda okužba z virusom hepatitisa B. Odločitev o cepljenju proti hepatitisu B mora torej zdravnik pretehtati od primera do primera.
• You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine.
• Med cepljenjem s cepivom Fendrix in katerimkoli drugim cepivom mora biti presledek vsaj 2 do 3
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated.
Podatki o cepljenju s cepivom Fendrix in sočasnem dajanju specifičnih imunoglobulinov proti hepatitisu B (HBIg) niso bili pridobljeni.
These make the vaccine work quicker, better and last for longer.
Ti sestavini dosežeta, da cepivo deluje hitreje,
It cannot protect you against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis B virus.
• Cepivo Fendrix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa B. Ne more vas zaščititi pred drugimi okužbami, ki lahko prizadenejo jetra - tudi če imajo te okužbe podobne znake, kot jih povzroča virus hepatitisa B.
General disorders and administration site conditions: Very common: injection site swelling, fatigue, pain, redness Common: fever
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: oteklost na mestu injiciranja, utrujenost, bolečine, pordelost
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients.
Predhemodializni in hemodializni bolniki: Dokazano je bilo, da pri predhemodializnih in hemodializnih bolnikih protitelesa proti-HBs persistirajo vsaj 36 mesecev po osnovnem cepljenju (0, 1, 2, 6 mesec) s cepivom Fendrix.
• Store in the original package in order to protect from light.
• Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
How much is given
Koliko cepiva boste prejeli
Rare: vertigo
Redki: vrtoglavica
The presence of a minor infection such as a cold, is not a contraindication for immunisation.
prehlad, ni kontraindikacija za cepljenje.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki morata biti v takšnem primeru nemudoma na voljo.
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.
En mesec po prejemu tretjega odmerka (npr. v 3. mesecu) je bil opažen zaščitni titer specifičnih humoralnih protiteles (titer proti-HBs ≥10 i.e./l) pri 74,4 % s cepivom Fendrix cepljenih bolnikov (N = 82), v primerjavi z 52,4 % bolnikov v kontrolni skupini, ki so bili cepljeni z dvema odmerkoma za to populacijo komercialno dostopnega cepiva proti hepatitisu B (N = 83).
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po imunizaciji s cepivom Fendrix pričakuje tudi preventiva hepatitisa D.
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines.
Zelo redko so bile s cepivi proti hepatitisu B opisane tudi anafilaksija, alergijske reakcije, vključno z anafilaktoidnimi reakcijami, in podobne serumski bolezni.
Nervous system disorders: Common: headache
Bolezni živčevja: Pogosti: glavobol
Very common (these may occur with more than 1 in 10 doses of the vaccine)
Zelo pogosti (pojavijo se lahko pri več kot 1 na 10 odmerkov cepiva):
SPECIAL STORAGE CONDITIONS Store in a refrigerator
POSEBNA NAVODILA ZA SHRANJEVANJE
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Fendrix suspenzija za injiciranje Adsorbirano cepivo proti hepatitisu B (rDNA) z adjuvansom
Booster dose:
Obnovitveni odmerek:
Muskuloskeletal and connective tissue disorders: Rare: tendinitis, back pain
Redki: tendinitis, bolečine v hrbtu
1 pre-filled syringe 1 separate needle 1 dose (0.5 ml)
1 napolnjena injekcijska brizga 1priložena injekcijska igla 1 odmerek (0,5 ml)
• back pain, swelling of your tendons.
• bolečine v hrbtu, otekanje kit
Store in the original package in order to protect from light
Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini
• pain or discomfort where the injection was given.
• občutek utrujenosti, • bolečina ali neugodje na mestu injiciranja.
Infections and infestations: Rare: viral infection
Redki: virusne okužbe
• The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice).
občutek hude utrujenosti, temen urin, bledo blato in porumenelost kože ali oči (zlatenica).
• hot flushes
• vročinski oblivi,
No increase in the incidence or severity of these adverse reactions was seen with subsequent doses of the primary vaccination schedule.
Po prejemu nadaljnjih odmerkov po shemi osnovnega cepljenja ni bilo opaženo povečanje pojavnosti ali resnosti teh neželenih reakcij.
Additional doses may need to be considered for subjects who do not respond or have a sub-optimal response to a course of vaccinations.
Pri osebah brez ali s suboptimalnim odzivom na cepljenje bo morda potrebno razmisliti o dodatnih odmerkih.
- Second injection - 1 month after the first injection.
• Dobili jih boste v 6 mesecih: - prva injekcija - na datum, ki se ga boste dogovorili z zdravnikom - druga injekcija - 1 mesec po prvi injekciji - tretja injekcija - 2 meseca po prvi injekciji - četrta injekcija - 6 mesecev po prvi injekciji
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Redki (pojavijo se lahko pri največ 1 na 1.000 odmerkov cepiva):
How to store Fendrix
Shranjevanje cepiva Fendrix
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Fendrix.
Pri osebah, pri katerih obstaja tveganje, da serozaščita po končanem cepljenju s cepivom Fendrix ne bo dosežena, je potrebno razmisliti o serološkem testiranju.
Hepatitis B surface antigen1, 2, 3
1 odmerek (0,5 ml): površinski antigen virusa hepatitisa B1, 2, 3
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika; • če ste kdaj imeli alergijsko reakcijo na katerokoli cepivo proti hepatitisu B;
Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine.
Po končanem osnovnem cepljenju s cepivom Fendrix ali katerimkoli drugim komercialno dostopnim rekombinantnim cepivom proti hepatitisu B, se cepivo Fendrix lahko uporabi za obnovitveni odmerek.
1 pre-filled syringe 1 dose (0.5 ml)
1 odmerek (0,5 ml)
Uncommon: other injection site reaction Rare: rigors, hot flushes, thirst, asthenia
Redki: mrzlica, valovi vročine, žeja, astenija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fendrix suspension for injection
Navodilo za uporabo Fendrix suspenzija za injiciranje
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
V 3. mesecu so bili v kontrolni skupini geometrični srednji titri 50,1 i.e./l, titre protiteles proti-HBs ≥100 i.e./l pa je imelo
PREFILLED SYRINGE
• Navodilo shranite.
Hypersensitivity after previous administration of other hepatitis B vaccines.
Preobčutljivost po predhodnem cepljenju z drugimi cepivi proti hepatitisu B. Pri osebah s hudimi akutnimi vročinskimi boleznimi je treba cepljenje preložiti.
At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
3559,2 i.e./l, titre protiteles proti-HBs ≥100 i.e./l pa je imelo 83,1 % bolnikov.
Talk to your doctor or pharmacist before you are given Fendrix:
Preden prejmete cepivo Fendrix, se posvetujte z zdravnikom ali farmacevtom:
Fendrix is a vaccine which prevents hepatitis B.
Kaj je cepivo Fendrix in za kaj ga uporabljamo Fendrix je cepivo, ki se uporablja za preprečevanje hepatitisa B. Uporablja se za bolnike, ki imajo težave z ledvicami:
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
2adsorbiran na aluminijev fosfat (skupno 0,5 miligramov Al3+)
Common (these may occur with up to 1 in 10 doses of the vaccine)
Pogosti (pojavijo se lahko pri največ 1 na 10 odmerkov cepiva):
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Občasni (pojavijo se lahko pri največ 1 na 100 odmerkov cepiva):
At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
V 36. mesecu so bili v kontrolni skupini geometrični srednji titri 111,9 i.e./l, titre protiteles proti-HBs ≥100 i.e./l pa je imelo
• redness or swelling where the injection was given
• rdečina ali oteklina na mestu injiciranja, • povišana telesna temperatura,
It is used for patients with kidney problems:
Podatki iz kliničnih študij Bolezni živčevja:
- Third injection
NAPOLNJENA INJEKCIJSKA BRIZGA
GlaxoSmithKline (Malta) Ltd Tel: + 356 21 238131
GlaxoSmithKline (Malta) Ltd
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Zelo redki (pojavijo se lahko pri največ 1 na 10.000 odmerkov cepiva): • napadi krčev,
EU (MA) number Invented name
EU (Številka dovoljenja za promet)
This means that Abseamed 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.
Flu-like illness may occur especially at the start of treatment.
Pojavijo se lahko gripi podobni simptomi, zlasti ob začetku zdravljenja.
Further information on Abseamed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije o zdravilu Abseamed so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Abseamed received a marketing authorisation valid throughout the EU on 28 August 2007.
Za zdravilo Abseamed je bilo 28. avgusta 2007 izdano dovoljenje za promet, veljavno po vsej EU.
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Pri teh bolnikih je treba uporabiti najnižji odmerek, ki še zagotavlja ustrezni nadzor nad simptomi.
What measures are being taken to ensure the safe and effective use of Abseamed?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Abseamed?
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Glavno merilo učinkovitosti je bila razlika med ravnjo hemoglobina na začetku študije in ravnjo v obdobju ocenjevanja, ki je potekalo med 25. in 29. tednom.
An overview of Abseamed and why it is authorised in the EU
Pregled zdravila Abseamed in zakaj je odobreno v EU
The iron levels of all patients should be checked to make sure that they are not too low, and iron supplements given if necessary.
Pri vseh bolnikih je treba preveriti raven železa in s tem zagotoviti, da njihove vrednosti niso prenizke, ter po potrebi dajati dodatke, ki vsebujejo železo.
Abseamed is a medicine used for the following:
Abseamed je zdravilo, ki se uporablja v naslednjih primerih:
What benefits of Abseamed have been shown in studies?
Kakšne koristi zdravila Abseamed so se pokazale v študijah?
When Abseamed is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Kadar se zdravilo Abseamed uporablja za avtologno transfuzijo krvi, je treba upoštevati omejitve, ki so običajno povezane s to vrsto transfuzije.
• patients with high blood pressure that is not controlled;
• bolnikih z nenadzorovanim visokim krvnim tlakom;
Other information about Abseamed
Druge informacije o zdravilu Abseamed
As for all medicines, data on the use of Abseamed are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Abseamed stalno spremljajo.
For patients with chronic kidney failure, myelodysplastic syndromes, or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Pri bolnikih s kronično odpovedjo ledvic, mielodisplastičnimi sindromom ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
Side effects reported with Abseamed are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Abseamed, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Abseamed authorised in the EU?
Zakaj je bilo zdravilo Abseamed odobreno v EU?
The most common side effects with Abseamed (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, vomiting, fever and headache.
Najpogostejši neželeni učinki zdravila Abseamed (ki se lahko pojavijo pri več kot 1 bolniku od 10) so navzeja (slabost), driska, bruhanje, povišana telesna temperatura in glavobol.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abseamed 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 Abseamed upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Abseamed?
Kakšna tveganja so povezana z zdravilom Abseamed?
Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Epoetin alfa se uporablja tudi pred kirurškimi posegi za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjšanju posledic izgube krvi.
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 ml do 1 800 ml;
• patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
• bolnikih, pri katerih bo izveden kirurški poseg in ne morejo prejemati zdravil za preprečevanje nastajanja krvnih strdkov;
For more information about using Abseamed, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Abseamed glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
• bolnikih, ki so tik pred zahtevnejšim ortopedskim kirurškim posegom in imajo resne kardiovaskularne (srčno-žilne) težave, vključno z nedavnim srčnim napadom ali možgansko kapjo.
What is Abseamed and what is it used for?
Kaj je zdravilo Abseamed in za kaj se uporablja?
In these cases, epoetin alfa is used to increase red blood cell counts.
V teh primerih se za povečanje števila rdečih krvnih celic uporablja epoetin alfa.
The dose, the frequency of injection and how long it is used for also depend on why Abseamed 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 Abseamed so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
Abseamed must not be used in the following groups:
Zdravilo se ne sme uporabljati pri naslednjih skupinah bolnikov:
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
• za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in za zmanjšanje potrebe po transfuziji krvi;
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
• za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim upadanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
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 anemijo povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisotni eritropoetin.
The active substance in Abseamed, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Učinkovina v zdravilu Abseamed, epoetin alfa, je kopija hormona eritropoetina in deluje popolnoma enako kot naravni hormon pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu.
Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Zdravilo Abseamed vsebuje učinkovino epoetin alfa in je „podobno biološko zdravilo“.
• to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
• za povečanje količine krvi, ki jo je mogoče odvzeti odraslim bolnikom z zmerno anemijo in normalno ravnjo železa v krvi, ki bodo imeli kirurški poseg in pred tem darujejo lastno kri (avtologna transfuzija krvi);
Abseamed 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 Abseamed is used for.
Predpisovanje in izdaja zdravila Abseamed 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 se to zdravilo uporablja.
Because Abseamed is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Abseamed.
Ker je zdravilo Abseamed podobno biološko zdravilo, študij o učinkovitosti in varnosti učinkovine epoetin alfa, ki so že bile izvedene z zdravilom Eprex/Erypo, za zdravilo Abseamed ni treba ponavljati.
Abseamed 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 Abseamed se uporablja pri bolnikih, pri katerih obstaja majhno ali srednje tveganje za pojav akutne mieloične levkemije in ki imajo nizke ravni naravnega hormona eritropoetina.
The reference medicine for Abseamed is Eprex/Erypo.
Referenčno zdravilo za zdravilo Abseamed je zdravilo Eprex/Erypo.
All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Abseamed or remained on Eprex/Erypo.
Vsem bolnikom so zdravilo Eprex/Erypo najmanj osem tednov injicirali v veno, preden so bodisi začeli prejemati zdravilo Abseamed bodisi so še naprej prejemali zdravilo Eprex/Erypo.
Abseamed is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Zdravilo Abseamed je na voljo v napolnjenih injekcijskih brizgah različnih jakosti in se daje z injiciranjem v veno ali podkožje, kar je odvisno od bolezenskega stanja bolnika, ki se zdravi.
• to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
• za zdravljenje anemije pri odraslih z mielodisplastičnimi sindromi (obolenji, pri katerih je okvarjeno nastajanje zdravih krvnih celic).
The injection under the skin may be given by the patient or their carer if they have been appropriately trained.
Bolnik si zdravilo lahko v podkožje injicira sam ali mu ga injicira negovalec, če sta bila za to ustrezno usposobljena.
Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Abseamed outweighs the identified risk and it can be authorised.
Agencija je zato menila, da koristi zdravila Abseamed enako kot pri zdravilu Eprex/Erypo odtehtajo znana tveganja in da se zdravilo lahko odobri.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abseamed 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 Abseamed po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Eprex/Erypo in da se po telesu enako prenaša.