natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE, ČE JE POTREBNO
What Replagal is and what it is used for 2.
Kaj je zdravilo Replagal za kaj ga uporabljamo 2.
Before you take Replagal 3.
Kaj morate vedeti, preden boste vzeli zdravilo Replagal 3.
How to take Replagal 4.
Kako jemati zdravilo Replagal 4.
How to store Replagal 6.
Shranjevanje zdravila Replagal 6.
WHAT REPLAGAL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO REPLAGAL IN ZA KAJ GA UPORABLJAMO
The active substance in Replagal is agalsidase alfa (1mg/ ml).
Zdravilna učinkovina v zdravilu Replagal je agalzidaza alfa (1 mg/ ml).
Agalsidase alfa is a form of the human enzyme α -galactosidase.
Agalzidaza alfa je oblika človeškega encima α- galaktozidaze.
It is produced by switching on the gene for α -galactosidase A in cells.
Pridobiva se z vklopom gena za α- galaktozidazo v celicah.
Replagal is used to treat Fabry Disease.
Zdravilo Replagal je namenjeno zdravljenju Fabryjeve bolezni.
It is used as enzyme replacement therapy when the level of enzyme in the body is lower than normal as in Fabry Disease.
Uporabljamo ga kot encimsko nadomestno zdravljenje, ko je koncentracija encima v telesu manjša od normalne kot pri Fabryjevi bolezni.
BEFORE YOU TAKE REPLAGAL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO REPLAGAL
Do not take Replagal If you are allergic (hypersensitive) to agalsidase alfa or any of the other ingredients of Replagal.
Ne jemljite zdravila Replagal če ste alergični na (preobčutljivi za) algazidazo alfa ali katerokoli sestavino zdravila Replagal:
Take special care with Replagal If you notice any of these effects during or after an infusion you should tell your doctor immediately:
Bodite posebno pozorni pri uporabi zdravila Replagal Če med infundiranjem ali po njem opazite katere koli izmed navedenih učinkov, takoj obvestite zdravnika:
- high fever, chills, sweating, fast heart rate;
- visoka telesna temperatura, mrzlica, potenje, hiter srčni utrip;
- vomiting;
- bruhanje;
- light-headedness;
- omotica;
- hives, itching or rash;
- koprivnica, srbenje ali izpuščaj;
- swelling in your hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in
- otekanje dlani, podplatov, gležnjev, obraza, ustnic, ust ali grla, ki lahko povzroča težave pri
swallowing or breathing;
požiranju ali dihanju;
- pain or tenderness in chest, muscles or joints.
- bolečina v prsnem košu, mišicah ali sklepih ali njihova občutljivost.
Your doctor may stop the infusion temporarily (5 – 10 min) until the symptoms go away and then begin the infusion again.
Zdravnik lahko začasno prekine infundiranje (5 – 10 min), dokler simptomi ne izginejo, nato pa infundiranje nadaljuje.
22 If treatment with Replagal makes your body produce antibodies this will not stop Replagal working and the antibodies may disappear with time.
22 Če zaradi zdravljenja z zdravilom Replagal začne vaše telo proizvajati protitelesa, to delovanja zdravila ne bo preprečilo, protitelesa pa lahko s časom izginejo.
Use in Children Replagal has not yet been studied in children less than 6 years old and there is only limited clinical data in children 7-18 years old.
Uporaba pri otrocih Zdravila Replagal še niso preskušali pri otrocih, mlajših od 6 let, klinični podatki pri otrocih, starih od 7 do 18 let, pa so omejeni.
No unexpected safety issues were encountered in the studies with Replagal in children 7-18 years of age.
Pri študijah zdravila Replagal pri otrocih, starih od 7 do 18 let, niso opazili nikakršnih nepričakovanih varnostnih težav.
Using other medicines There is no known interaction of Replagal with other medicines.
Jemanje drugih zdravil Ni znano nobeno medsebojno delovanje zdravila Replagal z drugimi zdravili.
Taking Replagal with food and drink Interactions with food or drink are unlikely.
Jemanje zdravila Replagal s hrano in pijačo Medsebojno delovanja zdravila Replagal s hrano ali pijačo je malo verjetno.
Pregnancy and breast feeding Very limited clinical data on pregnancies exposed to Replagal (n=4) have shown no adverse effects on the mother and newborn child.
Zelo omejeni podatki o nosečnicah, izpostavljenih zdravilu Replagal (n=4), so pokazali, da ni neželenih učinkov na mater in novorojenca.
Driving and using machines You may drive and operate machinery whilst on Replagal.
V času ko prejemate zdravilo Replagal, lahko vozite in upravljate s stroji.
HOW TO TAKE REPLAGAL
KAKO JEMATI ZDRAVILO REPLAGAL
Replagal has to be diluted in 9 mg/ ml (0.9%) sodium chloride solution before use.
Pred uporabo je treba zdravilo Replagal razredčiti z 9 mg/ ml (0, 9 -%) raztopino natrijevega klorida.
This will usually be in your arm.
Po redčenju boste prejeli Replagal v veno, običajno na roki.
The usual dose is an infusion of 0.2 mg for every kg you weigh.
Običajni odmerek je infuzija 0, 2 mg na vsak kilogram telesne mase.
If you forget to have Replagal If you have missed a Replagal infusion, please contact your doctor.
Če ste pozabili uporabiti zdravilo Replagal Če ste izpustili infuzijo zdravila Replagal, povejte svojemu zdravniku.
Like all medicines, Replagal can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Replagal neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
About 1 out of 7 patients may have a reaction during or following an infusion of Replagal.
Približno 1 od 7 bolnikov ima lahko reakcijo med infuzijo zdravila Replagal ali po njej.
These effects include chills, headache, nausea, fever, facial flushing (redness) and tiredness.
Ti učinki obsegajo mrzlico, glavobol, slabost, povečano telesno temperaturo, pordelost obraza (rdečico) in utrujenost.
Very common side effects (occurring in more than 1 in 10 treated patients) include the following:
Med zelo pogostimi neželenimi učinki (ki se pojavijo pri več kot 1 bolniku od 10), so:
- flushing (redness)
- vročinski oblivi (rdečica)
- nausea
- slabost
- chills, fever
- mrzlica, zvišana telesna temperatura
- general pain or discomfort, tiredness.
- splošna bolečina ali občutek nelagodja, utrujenost.
23 Common side effects (occurring in less than 1 in 10 treated patients) include the following:
Med pogostimi neželenimi učinki (ki se pojavijo pri manj kot 1 bolniku od 10), so:
- tingling or numbness or pain in fingers or toes, change in the taste of food, eyes tearing, ears
- ščemenje ali otrplost ali bolečina v prstih na rokah ali nogah, spremembe okusa hrane, solzenje
ringing, shakes, unsteadiness, prolonged sleep
oči, zvenenje v ušesih, tresenje, nestabilnost, podaljšano spanje
- palpitations, increased heart rate, increased blood pressure
- palpitacije, zvišan srčni utrip, zvišan krvni tlak
- cough, chest pain or tightness, hoarseness, sore or tight throat, sticky throat secretions, runny
- kašelj, bolečina ali stiskanje v prsnem košu, hripavost, bolečina ali stiskanje v grlu, vlažen
nose
izloček iz grla, izcedek iz nosu
- vomiting, abdominal pain or discomfort, diarrhoea
- bruhanje, bolečina ali neprijeten občutek v trebuhu, driska
- acne, red or itchy or mottled skin, rash at the infusion site
- akne, rdeča, srbeča ali lisasta koža, izpuščaj na mestu infundiranja
- back or limb pain, swelling of the extremities or joints
- bolečina v hrbtu ali okončinah, otekanje okončin ali sklepov
- feeling cold or hot, flu-like symptoms, malaise
- občutek vročine ali mraza, simptomi, podobni gripi, občutek nelagodja
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta..
HOW TO STORE REPLAGAL
SHRANJEVANJE ZDRAVILA REPLAGAL
Do not use Replagal after the expiry date which is stated on the label after the letters EXP.
Zdravila Replagal ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake Upor. do.
Do not use Replagal if you notice that there is discolouration or other foreign particles present.
Ne uporabljajte Replagala če opazite, da je razbarvan ali če vsebuje tuje delce.
What Replagal contains
Kaj vsebuje zdravilo Replagal
- The active substance is agalsidase alfa
- Zdravilna učinkovina je agalzidaza alfa.
- The other ingredients are:
Pomožne snovi so:
Polysorbate 20 Sodium chloride Sodium hydroxide Water for injections
monohidrat natrijevega dihidrogenfosfata, polisorbat 20, natrijev klorid, natrijev hidroksid, voda za injekcije.
Replagal is a concentrate for solution for infusion.
Replagal je koncentrat za pripravo raztopine za infundiranje.
Your medicine is available in vials containing either 1 mg/ 1 ml or 3.5 mg/ 3.5 ml of agalsidase alfa.
Zdravilo je na voljo v vialah po 1 mg/ 1 ml ali 3, 5 mg/ 3, 5 ml agalzidaze alfa.
Marketing Authorisation Holder
Imetnik dovoljenja za promet z zdravilom in
24 This leaflet was last approved in:
24 Izdelovalec
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu There are also links to other websites about rare diseases and treatments.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
--------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ ml sodium chloride solution for infusion (0.9%w/ v).
Vso potrebno količino koncentrata zdravila Replagal razredčite s 100 ml raztopine natrijevega klorida za intravensko infundiranje 9 mg/ ml (0, 9 -% m/ v).
Do not infuse Replagal concomitantly in the same intravenous line with other agents.
Skozi isti intravenski kanal ne smete infundirati hkrati zdravila Replagal in zdravil.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UPOŠTEVATI DRŽAVE ČLANICE
The Member States shall ensure that prior to launch the Marketing Authorisation Holder provides health care professionals in dialysis centres and retail pharmacies with:
Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom pred lansiranjem zdravila zdravnikom v centrih za dializo in maloprodajnim lekarnam predloži naslednje:
• Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
• izobraževalno brošuro; • povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on 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 Retacrit je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila. • Subkutana pot zato ni priporočena za bolnike s CRF. • Treba je raziskati izgubo učinkovitosti ali druge simptome pojava imunogenosti. • Vse primere suma čiste aplastične anemije ali pojava imunogenosti je treba sporočiti imetniku dovoljenja za promet z zdravilom.
It is available in pre-filled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Na voljo je v obliki napolnjenih injekcijskih brizg s 1000 do 40. 000 mednarodnih enot (i. e.) zdravilne učinkovine, ki je epoetin zeta.
Retacrit is a ‘ biosimilar’ medicine.
Zdravilo Retacrit je „ biološko podobno “ zdravilo.
This means that Retacrit 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 Retacrit podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebuje podobno zdravilno učinkovino (imenovanemu tudi „ referenčno zdravilo “).
The reference medicine for Retacrit is EPREX/ ERYPO, which contains epoetin alfa.
Referenčno zdravilo za zdravilo Retacrit je zdravilo EPREX/ ERYPO, ki vsebuje epoetin alfa.
For more information on biosimilar medicines, see the question-and-answer document here.
Za več informacij o biološko podobni zdravilih glejte dokument z vprašanji in odgovori tukaj.
Retacrit 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 Retacrit 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 Retacrit 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 Retacrit 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, Retacrit must be injected intravenously (into a vein), while patients receiving chemotherapy receive it subcutaneously (under the skin).
Zdravilo Retacrit 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 Retacrit 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 Retacrit in se lahko prilagajajo glede na odziv bolnika.
The iron levels of all patients should be checked before treatment to make sure that they are not deficient, and iron supplements should be used throughout treatment.
Med zdravljenjem morajo bolniki jemati dodatke železa.
For full details, see the Package Leaflet.
Za več podrobnosti glejte Navodilo za uporabo.
A hormone called erythropoietin, which is produced by the kidneys, stimulates the production of red blood cells from the bone marrow.
Hormon eritropoetin, ki ga tvorijo ledvice, stimulira nastajanje rdečih krvnih celic v kostnem mozgu.
(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 Pri bolnikih, ki prejemajo kemoterapijo ali imajo bolezni ledvic, anemijo lahko povzroči pomanjkanje eritropoetina ali premajhna odzivnost telesa na naravno prisotni eritropoetin.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
V teh primerih uporabimo eritropoetin, da nadomesti manjkajoči hormon ali zviša ravni rdečih krvnih celic.
Erythropoietin can also be used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation.
Eritropoetin lahko uporabimo tudi pred kirurškim posegom, da zviša ravni rdečih krvnih celic in tako pripomore k tvorbi več krvi, ki jo bolnik nato prejema med posegom.
The active substance in Retacrit, 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 Retacrit, epoetin zeta, je kopija človeškega eritropoetina in deluje natančno tako kot naravni hormon za stimuliranje nastajanja rdečih krvnih celic.
The active substance in Retacrit, 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 Retacrit je epoetin zeta, ki je izdelan s „ tehnologijo rekombinantne DNA “: izdela ga celica, ki je prejela gen (DNA), s katerim lahko tvori eritropoetin.
Retacrit was studied to show that it is comparable with the reference medicine, EPREX/ ERYPO, in experimental models and in humans.
Za zdravilo Retacrit so s pomočjo poskusnih modelov in pri ljudeh dokazovali, da je primerljivo z referenčnim zdravilom EPREX/ ERYPO.
Retacrit, 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 Retacrit, 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 Retacrit with those of EPREX/ ERYPO in correcting red blood cell counts in 609 patients over 24 weeks.
V prvi študiji so primerjali učinke zdravila Retacrit z učinki zdravila EPREX/ ERYPO na popravljanje ravni rdečih krvnih celic pri 609 bolnikih v 24 tednih.
The second study compared the effects of Retacrit with those of EPREX/ ERYPO in maintaining red blood cell counts in 313 patients.
V drugi študiji so primerjali učinke zdravila Retacrit 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 Retacrit 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 Retacrit bodisi ohranili uporabo zdravila EPREX/ ERYPO.
After that the two groups switched to receiving the other medicine for a further 12 weeks.
Po tem obdobju so skupini zamenjali zdravili za nadaljnjih 12 tednov.
In both studies, the main measures of effectiveness were the levels of haemoglobin (a protein in red blood cells that carries oxygen around the body) during treatment, as well as the dose of epoetin received.
V obeh študijah sta bili glavna kazalca učinkovitosti raven hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik po telesu) med zdravljenjem in prejeti odmerek epoetina.
The company also presented the results of a study looking at the effects of Retacrit injected subcutaneously in 261 cancer patients taking chemotherapy.
Družba je predstavila tudi podatke o študiji, kjer so ugotavljali učinke podkožno injiciranega zdravila Retacrit pri 261 bolnikih, ki so prejemali kemoterapijo.
Retacrit was as effective as EPREX/ ERYPO in correcting and maintaining red blood cell counts.
Zdravilo Retacrit je bilo vsaj enako učinkovito kot zdravilo EPREX/ ERYPO pri popravljanju in ohranjanju ravni rdečih krvnih celic.
In the correction study, haemoglobin levels were around 11.6 g/ dl during the last four weeks of the study, having risen from around 8.0 g/ dl before treatment.
V študiji popravljanja ravni so bile v zadnjih štirih tednih ravni hemoglobina okoli 11, 6 g/ dl in so med zdravljenjem zrasle s približno 8, 0 g/ dl.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained to the same extent when the patients were receiving Retacrit 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 Retacrit ali zdravilom EPREX/ ERYPO z enako učinkovitostjo ohranjali ravni hemoglobina na približno 11, 4 g/ dl.
In both studies, the dose of epoetin received was similar with both medicines.
V obeh študijah je bil odmerek prejetega epoetina podoben pri obeh zdravilih podoben.
The study in patients receiving chemotherapy showed that Retacrit 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 Retacrit 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 Retacrit 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 Retacrit zvišan krvni tlak, ki lahko v posameznih primerih povzroči simptome encefalopatije (bolezni možganov), kot sta nenaden, migreni podoben glavobol z zbadanjem in zmedenost.
Retacrit can also lead to skin rash and flu-like symptoms.
Zdravilo Retacrit lahko povzroči tudi kožni izpuščaj in gripi podobne simptome.
For the full list of all side effects reported with Retacrit, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Retacrit, glejte Navodilo za uporabo.