FrancophonIA/ELRC3.0 huggingface dataset:
English: For use in animals from the age of 2 weeks in the absence of maternally derived antibodies against IBR virus or from the age of 3 months in the presence of maternally derived antibodies.
Slovenian: Cepimo živali, starejše od 2 tednov, ki nimajo maternalnih protiteles proti virusu IBR ali od 3. meseca starosti dalje, če so maternalna protitelesa prisotna.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: NAČIN IN POT UPORABE Pred uporabo preberite priložena navodila.
English: The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila Bovalto Ibraxion je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.
Slovenian: Po vnosu čezmernega odmerka niso opazili nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju 4.6.
English: Bovalto Ibraxion can be used during pregnancy and lactation.
Slovenian: Bovalto Ibraxion se lahko uporablja v obdobju brejosti in laktacije.
English: EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
Slovenian: EU/2/99/017/001 5 odmerkov (10 ml) EU/2/99/017/004 10 x 5 odmerkov (10 x 10 ml) EU/2/99/017/002 10 odmerkov (20 ml) EU/2/99/017/005 10 x 10 odmerkov (10 x 20 ml) EU/2/99/017/003 25 odmerkov (50 ml) EU/2/99/017/006 10 x 25 odmerkov (10 x 50 ml)
English: Special precautions for use in animals: Vaccinate only healthy animals.
Slovenian: POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin).
English: Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
Slovenian: Bovalto Ibraxion je cepivo, ki ima delecijo specifičnega gena (gE) Je inaktivirano pomožno cepivo (o/v emulzija), ki aktivno imunizira govedo tako, da ustvarja vironevtralizirajoča protitelesa proti kužnemu govejemu rinotreheitisu (IBR).
English: Use sterile syringes and needles
Slovenian: Uporabite sterilne brizge in igle.
English: Manufacturer responsible for batch release MERIAL
Slovenian: Izdelovalec, odgovoren za sproščanje serij: MERIAL
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURRER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.
Slovenian: Po vnosu čezmernega odmerka ni opisanih nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju „Neželeni učinki“.
English: MERIAL,Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux-69007 Lyon FRANCE
Slovenian: Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON
English: Onset of immunity: 14 days
Slovenian: Nastop imunosti: 14. dan po cepljenju
English: Store and transport refrigerated (2°C- 8°C), Do not freeze.
Slovenian: Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku), zaščiteno pred svetlobo.
English: 4.2 Indications for use, specifying the target species Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in izločanja virusa v naravo.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession,sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo Bovalto Ibraxion, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom,
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Evropske agencije za zdravila http://www.ema.europa.eu/.
English: 5 doses (10 ml) 10 x 5 doses (10 x 10 ml) 10 doses (20 ml) 10 x 10 doses (10 x 20 ml) 25 doses (50 ml) 10 x 25 doses (10 x 50 ml)
Slovenian: 5 odmerkov (10 ml) 10 x 5 odmerkov (10 x 10 ml) 10 odmerkov (20ml) 10 x 10 odmerkov (10 x 20 ml) 25 odmerkov (50 ml) 10 x 25 odmerkov (10 x 50 ml)
English: Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Slovenian: Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in zmanjšanje izločanja
English: Store and transport refrigerated (2°C- 8°C).
Slovenian: Shranjujte in prevažajte pri temperaturi 2 °C - 8 °C.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
English: Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)
Slovenian: Kartonska škatla z 1 ali 10 stekleničkami s 5 odmerki (1 x 10 ml ali 10 x 10 ml) Kartonska škatla z 1 ali 10 stekleničkami z 10 odmerki (1 x 20 ml ali 10 x 20 ml) Kartonska škatla z 1 ali 10 stekleničkami s 25 odmerki (1 x 50 ml ali 10 x 50 ml)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................ 0.75 VN.U
Slovenian: V 1 odmerku po 2 ml: inaktivirani virus IBR z delecijo gE, najmanj .................................... 0,75 VN.U*
English: Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03
Slovenian: IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: imunološka zdravila, virus govejega rinotraheitisa (IBR)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e):
English: Shelf life after first opening the container: 6 hours Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: dravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP..
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovalto Ibraxion emulsion for injection Cattle
Slovenian: Bovalto Ibraxion emulzija za injiciranje Govedo
English: Light paraffin oil Benzyl alcohol
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Parafinsko olje, lahko Benzilalkohol
English: Polyoxyethylene oleate Polyoxyethylene oleic alcohol Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride, Calcium chloride
Slovenian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat
English: PACKAGE LEAFLET FOR Bovalto Ibraxion emulsion for injection
Slovenian: Bovalto Ibraxion emulzija za injiciranje
English: Each dose (2 ml) contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* adjuvant: light paraffin oil ........................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Slovenian: inaktivirani virus IBR z delecijo gE, najmanj ........................................................................ 0,75 VN.U* adjuvans: lahko parafinsko olje .................................................................................... 449,6 do 488,2 mg
English: Marketing authorisation holder MERIAL
Slovenian: Imetnik dovoljenja za promet z zdravilom: MERIAL
English: Triethanolamine
Slovenian: Trietanolamin Polioksietilen oleat
English: EXPIRY DATE EXP {month/year} Once broached use by: 6 hours
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 6 ur.
English: Zero days
Slovenian: Karenca: Nič dni.
English: SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
English: 29 avenue Tony Garnier 69007 LYON FRANCE
Slovenian: 29 avenue Tony Garnier 69007 LYON Francija
English: 29 avenue Tony Garnier 69007 LYON France
Slovenian: 29 avenue Tony Garnier 69007 LYON FRANCIJA
English: a booster injection should be administered at 6 month intervals.
Slovenian: Odprto zdravilo uporabite v 6 urah.
English: Each dose of 2 ml contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Slovenian: inaktivirani virus IBR z delecijo gE, najmanj ..................................................................... 0,75 VN.U* .
English: ROUTE(S) OF ADMINISTRATION
Slovenian: POTI(I) UPORABE ZDRAVILA
English: ADVICE ON CORRECT ADMINISTRATION See above.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA
English: 4.11 Withdrawal period(s)
Slovenian: 4.11 Karenca(e) Nič dni.
English: 4.5 Special precautions for use
Slovenian: NAVODILO ZA UPORABO ZA
English: SPECIAL WARNING(S)
Slovenian: Adjuvans(i):
English: Adjuvant light paraffin oil .......................................................................................................... 449.6 to 488.2 mg
Slovenian: lahko parafinsko olje .................................................................................................. 449,6 do 488,2 mg
English: Vaccinate only healthy animals.
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
English: WITHDRAWAL PERIOD Zero days
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Lot
Slovenian: FRANCIJA
English: The European Commission granted a marketing authorisation valid throughout the EU for Retacrit on 18 December 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Retacrit, veljavno po vsej Evropski uniji, odobrila dne 18. decembra 2007.
English: After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Slovenian: Nato so skupinama zamenjali zdravili za nadaljnjih 12 tednov.
English: This means that Retacrit is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine.
Slovenian: To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU) in vsebuje podobno zdravilno učinkovino kot referenčno zdravilo.
English: The full EPAR for Retacrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Retacrit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Retacrit:
Slovenian: Druge informacije o zdravilu Retacrit:
English: Retacrit is used in the following situations:
Slovenian: Zdravilo Retacrit se uporablja v naslednjih primerih:
English: It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin zeta.
Slovenian: Proizvajajo jo z metodo, znano kot „tehnologija rekombinantne DNK“, proizvede jo celica, ki je prejela gen (DNK), s katerim lahko tvori epoetin zeta.
English: In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
Slovenian: V teh primerih se eritropoetin uporablja za nadomestitev manjkajočega hormona ali za povečanje števila rdečih krvnih celic.
English: In both studies, the dose of epoetin received was similar with both medicines.
Slovenian: V obeh študijah je bil odmerek prejetega epoetina pri obeh zdravilih podoben.
English: This document is a summary of the European Public Assessment Report (EPAR) for Retacrit.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Retacrit.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Retacrit.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Retacrit, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: • to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
Slovenian: • za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in za zmanjšanje potrebe po transfuziji krvi;
English: For more information about treatment with Retacrit, read the Package Leaflet (also part of the EPAR).
Slovenian: Za več informacij o zdravljenju z zdravilom Retacrit preberite navodilo za uporabo (ki je prav tako del EPAR).
English: What benefit has Retacrit shown during the studies?
Slovenian: Kakšne koristi je zdravilo Retacrit izkazalo med študijami?
English: For patients with chronic renal failure 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).
Slovenian: Pri bolnikih s kronično odpovedjo ledvic 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).
English: Treatment with Retacrit must be started under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
Slovenian: Zdravljenje z zdravilom Retacrit je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov, katerih bolezenska stanja se zdravijo s tem zdravilom.
English: What is the risk associated with Retacrit?
Slovenian: Kakšna tveganja so povezana z zdravilom Retacrit?
English: The dose, the frequency of injection and how long Retacrit is used for depend on why it is being used, and are adjusted according to the patient's response.
Slovenian: Odmerek, pogostnost injiciranja in trajanje zdravljenja z zdravilom Retacrit so odvisni od namena uporabe zdravila in jih je treba prilagoditi bolnikovemu odzivu.
English: The Committee recommended that Retacrit be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Retacrit odobri dovoljenje za promet.
English: It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Slovenian: Na voljo je v obliki napolnjene injekcijske brizge, ki vsebuje od 1 000 do 40 000 mednarodnih enot (i.e.) zdravilne učinkovine epoetin zeta.
English: Retacrit should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Slovenian: Zdravila Retacrit ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin zeta ali katero koli drugo sestavino zdravila.
English: The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Slovenian: Pred zdravljenjem je treba pri vseh bolnikih preveriti raven železa in s tem zagotoviti, da njihove vrednosti niso prenizke, med zdravljenjem pa morajo bolniki jemati dodatke, ki vsebujejo železo.
English: The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa.
Slovenian: Referenčno zdravilo za zdravilo Retacrit je Eprex/Erypo, ki vsebuje epoetin alfa.
English: 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.
Slovenian: V zadnjih štirih tednih študije popravljanja so se ravni hemoglobina zvišale na okoli 11,6 g/dl s približno 8,0 g/dl pred zdravljenjem.
English: The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Retacrit primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
English: The study in patients receiving chemotherapy showed that Retacrit brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
Slovenian: V študiji pri bolnikih, ki so prejemali kemoterapijo, so dokazali, da je zdravilo Retacrit zagotovilo podobno izboljšanje ravni hemoglobina, kot je opisano v strokovni literaturi za druge epoetine.
English: In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received.
Slovenian: V obeh študijah sta bili glavni merili učinkovitosti ravni hemoglobina med zdravljenjem in prejeti odmerek epoetina.
English: 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.
Slovenian: Kot pri drugih zdravilih, ki vsebujejo epoetin, je najpogostejši neželeni učinek zdravila Retacrit zvišan krvni tlak, ki lahko v posameznih primerih povzroči simptome encefalopatije (možganskih zapletov), kot sta nenaden, migreni podoben, glavobol z zbadanjem in zmedenost.
English: It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.
Slovenian: Zdravilo se ne sme uporabljati pri bolnikih, pri katerih se je pojavila čista aplazija rdečih krvnih celic (zmanjšano ali prekinjeno nastajanje rdečih krvnih celic) po zdravljenju s katerim koli eritropoetinom, bolnikih s hipertenzijo (visokim krvnim tlakom), ki ni nadzorovana, bolnikih pred operacijo, ki imajo hude kardiovaskularne težave (težave s srcem in ožiljem), vključno z nedavnim miokardnim infarktom ali kapjo, ali pri bolnikih, ki ne smejo jemati zdravil za preprečevanje nastanka krvnih strdkov.
English: Retacrit must not be used prior to major bone surgery in patients who have a severe disease affecting their arteries or their blood vessels in the heart, neck or brain, including patients who have recently had a heart attack or stroke.
Slovenian: Zdravilo Retacrit se ne sme uporabljati pred velikim operativnim posegom na kosteh pri osebah z resno boleznijo, ki je prizadela arterije ali krvne žile v srcu, vratu ali možganih, vključno z bolniki, ki so pred nedavnim utrpeli srčni napad ali kap.
English: 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.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo ali imajo ledvične težave, lahko anemijo povzroči pomanjkanje eritropoetina ali premajhna odzivnost telesa na naravno prisotni eritropoetin.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Slovenian: • za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim zmanjševanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
English: Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood).
Slovenian: Zdravilo Retacrit, injicirano v veno, so z referenčnim zdravilom primerjali 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 (tehniki odstranjevanja odpadnih snovi iz krvi).
English: Retacrit is a ‘biosimilar' medicine.
Slovenian: Zdravilo Retacrit je „biološko podobno“ zdravilo.
English: The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Slovenian: Družba je predstavila tudi rezultate dveh študij, v katerih so ugotavljali učinke podkožno injiciranega zdravila Retacrit: ena študija je vključevala 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi pa so primerjali zdravilo Retacrit z zdravilom Eprex/Erypo pri 462 bolnikih z anemijo kot posledico težav z ledvicami.
English: In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo.
Slovenian: V študiji pri bolnikih, ki so se že zdravili z epoetinom, so ravni hemoglobina ostale na ravni približno 11,4 g/dl pri bolnikih, ki so prejemali zdravilo Retacrit ali zdravilo Eprex/Erypo.
English: For the full list of all side effects reported with Retacrit, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Retacrit, glejte navodilo za uporabo.
English: Retacrit is a solution for injection.
Slovenian: Zdravilo Retacrit je raztopina za injiciranje.
English: Why has Retacrit been approved?
Slovenian: Zakaj je bilo zdravilo Retacrit odobreno?
English: 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.
Slovenian: Zdravilna učinkovina v zdravilu Retacrit, epoetin zeta, je kopija človeškega eritropoetina in spodbuja tvorjenje rdečih krvnih celic povsem enako kot naravni hormon.
English: • to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
Slovenian: • za povečanje količine krvi, ki jo lahko bolniki z zmerno slabokrvnostjo dajo pred operacijo in jo nato prejmejo med operacijo ali po njej;