FrancophonIA/ELRC3.0 huggingface dataset:
English: • Malignant diseases including multiple myeloma and myelodysplastic syndrome
Slovenian: • maligne bolezni, vključno z multiplim mielomom in mielodisplastičnim sindromom
English: Dynepo may be administered intravenously or subcutaneously.
Slovenian: Dynepo se lahko uporablja intravensko ali subkutano.
English: If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Due to limited experience, the efficacy and safety of Dynepo could not be assessed in patients with impaired liver function.
Slovenian: Zaradi omejenih izkušenj učinkovitosti in varnosti Dynepa ni mogoče oceniti pri bolnikih z
English: Dynepo may be used in patients on dialysis (a blood clearance technique) or in patients not on dialysis.
Slovenian: Dynepo se lahko uporablja pri bolnikih, ki so na dializi (postopek za čiščenje krvi), in pri tistih, ki niso.
English: Even patients with normal blood pressure may have a marked rise in their blood pressure and existing high blood pressure can get worse (See 2.
Slovenian: Celo bolnikom z normalnim krvnim tlakom se lahko krvni tlak izrazito zviša, obstoječ visok krvni tlak pa se lahko poslabša (glejte poglavje 2, Kaj morate vedeti, preden boste uporabili Dynepo).
English: For subcutaneous injection, the whole length of the needle should be inserted perpendicularly into a skin fold held between thumb and forefinger, the skin fold should be held throughout the injection.
Slovenian: Pri subkutani uporabi je treba v kožno gubo, ki se jo naredi s palcem in kazalcem, navpično vbosti celotno dolžino igle, kožno gubo pa je treba držati med celotnim postopkom injeciranja.
English: Clean your skin and then pinch the skin between your thumb and forefinger, without squeezing it.
Slovenian: Očistite kožo in s palcem in kazalcem napravite kožno gubo, ne da bi kožo pri tem stiskali.
English: Corso Italia, 29
Slovenian: Shire Italia S.p.A Corso Italia, 29
English: After injecting the liquid, remove the needle and let go of your skin.
Slovenian: Po končanem injiciranju odstranite iglo in spustite kožno gubo.
English: Dynepo should not be used by healthy persons.
Slovenian: Zdrave osebe ne smejo uporabljati Dynepa.
English: Mainly because of the time required for the production of new red blood cells, an interval of approximately 4 weeks may occur between the dose and an improvement in your anaemia.
Slovenian: Zlasti zaradi časa, potrebnega za nastanek novih eritrocitov, lahko od odmerka do izboljšanja anemije minejo približno 4 tedni.
English: Like all medicines, Dynepo can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Dynepo neželene učinke, ki pa se ne pojavijo pri vseh
English: An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use except that routine updates of the Risk Management Plan should be provided yearly until the start of the three-yearly PSUR cycle.
Slovenian: Do začetka 3-letnega cikla oddajanja PSUR-ov je treba letno predložiti dopolnjen Načrt upravljanja tveganja v skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP).
English: When given subcutaneously, the site of injection should be changed with each injection.
Slovenian: Pri subkutani uporabi je treba injekcijsko mesto za vsako injiciranje izmenično menjati.
English: Hypersensitivity to the active substance or to any of the excipients.
Slovenian: Preobčutljivost na zdravilno učinkovino ali na katerokoli pomožno snov.
English: After any dose adjustment, the haemoglobin should also be determined once weekly until it has stabilised in the target range.
Slovenian: Tudi po vsaki prilagoditvi odmerka je treba hemoglobin določati enkrat na teden, dokler se ne ustali v ciljnem območju.
English: Epoetin delta is a hormone which stimulates the production of red blood cells in the bone marrow.
Slovenian: Epoetin delta je hormon, ki spodbuja nastajanje rdečih krvnih celic (eritrocitov) v kostnem mozgu.
English: How do I give my injection?
Slovenian: Kako si boste injicirali zdravilo?
English: Patients with homozygous sickle cell disease and renal failure should where possible be maintained at a total haemoglobin concentration between 7 and 9 g/dl.
Slovenian: Pri bolnikih, ki imajo homozigotno bolezen s srpastimi eritrociti in odpoved ledvic, je treba celotno koncentracijo hemoglobina vzdrževati med 7 in 9 g/dl, če je mogoče.
English: Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from precursors of the stem cell compartment.
Slovenian: Eritropoetin je glikoprotein, ki stimulira nastajanje eritrocitov iz celic-predhodnic v razdelku matičnih celic.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (Glej Dodatek I: Povzetek glavnih značilnosti
English: After administration of epoetin delta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Feincorporation rate.
Slovenian: Po uporabi epoetina delta se zvečajo število eritrocitov, koncentracija hemoglobina, število retikulocitov in hitrost vgradnje 59Fe.
English: Do not take a double dose to make up for a forgotten individual dose.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnjega.
English: Take your next dose at the normal time.
Slovenian: Naslednji odmerek uporabite ob
English: Date of last renewal: 18 March 2007
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 18. marec 2007
English: Ensure that you only inject the amount as instructed by your doctor or nurse.
Slovenian: Prepričajte se, da ste si vbrizgali samo odmerek, ki sta vam ga predpisala zdravnik ali medicinska sestra.
English: Increases in serum chemistry values including creatinine and potassium have been observed (see section 4.4).
Slovenian: Opazili so tudi, da se serumske biokemične vrednosti, vključno s kreatininom in kalijem, med zdravljenjem z Dynepom zvečajo (glejte poglavje 4.4).
English: Dynepo is provided with a needle guard for your protection and you will be shown how to use this by your doctor or nurse.
Slovenian: Zdravilo Dynepo dobite skupaj z zaščitnim pokrovčkom za injekcijsko iglo, zdravnik ali sestra pa vam bosta pokazala, kako ga uporabljati.
English: Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe Dynepo 2,000 IU/0.5ml solution for injection in a pre-filled syringe Dynepo 3,000 IU/0.3ml solution for injection in a pre-filled syringe Dynepo 4,000 IU/0.4ml solution for injection in a pre-filled syringe Dynepo 5,000 IU/0.5 ml solution for injection in a pre-filled syringe Dynepo 6,000 IU/0.3 ml solution for injection in a pre-filled syringe Dynepo 8,000 IU/0.4 ml solution for injection in a pre-filled syringe Dynepo 10,000 IU/0.5ml solution for injection in a pre-filled syringe Epoetin delta
Slovenian: Dynepo 1.000 i.e./0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 2.000 i.e./0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 3.000 i.e./0,3 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 4.000 i.e./0,4 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 5.000 i.e./0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 6.000 i.e./0,3 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 8.000 i.e./0,4 ml raztopine za injiciranje v napolnjeni injekcijski brizgi Dynepo 10.000 i.e./0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi
English: If it is cloudy or there are particles in it, you
Slovenian: Če je zdravilo motno ali če vsebuje
English: There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Slovenian: To pomeni, da obstajajo trdni dokazi, ki kažejo, da je lahko zdravljenje z rekombinantnim humanim eritropoetinom zelo škodljivo za bolnike z rakom.
English: Dynepo is a clear, colourless and waterlike solution for injection containing epoetin delta.
Slovenian: Dynepo je bistra, brezbarvna, vodi podobna raztopina za injiciranje, ki vsebuje epoetin delta.
English: Animal studies conducted with both Dynepo and epoetin alfa in pregnant female rats and rabbits did not show any teratogenic effect, but indicated class-related reversible effects on growth and haematopoiesis in the offspring.
Slovenian: Pri študijah na živalih z zdravilom Dynepo in epoetinom na brejih samicah podgan in kuncev niso ugotovili nobenih teratogenih učinkov, je pa prišlo do negativnih učinkov pri rasti in razvoju hematopoetskih celic pri potomcih.
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Slovenian: V odprti študiji ni bilo razlik med celokupnim preživetjem med bolniki, ki so prejemali rekombinantni humanim eritropoetin, in kontrolno skupino.
English: Store in a refrigerator (2 C - 8 C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: No accumulation of epoetin delta was observed after repeated intravenous administration three times weekly.
Slovenian: Po ponavljajoči se intravenski uporabi trikrat na teden niso opazili kopičenja epoetina delta.
English: Polycythaemia Thrombocytosis
Slovenian: policitemija, trombocitoza
English: Your doctor should maintain your haemoglobin level within the target range of 10 to 12 g/dl.
Slovenian: Vaš zdravnik mora pri vas ohranjati raven hemoglobina v ciljnem območju od 10 do 12 g/dl.
English: Your doctor or nurse will tell you how much Dynepo you need and how frequently it should be injected.
Slovenian: Zdravnik ali medicinska sestra vam bosta povedala, kakšen odmerek zdravila potrebujete in kako
English: Dose should be increased by 25 % - 50 % if: - Haemoglobin falls below < 10 g/dl and - The rate of increase of haemoglobin is below 0.7 g/dl in any 4 week period.
Slovenian: Odmerek je treba zvečati za 25% - 50%, če: - se koncentracija hemoglobina zmanjša pod <10 g/dl in - hemoglobin v 4 tednih poraste za manj kot 0,7 g/dl.
English: Survival outcomes and tumour progression in cancer patients that are being treated with Dynepo for anaemia associated with chronic renal failure have not been investigated.
Slovenian: Preživetje in napredovanje tumorja pri bolnikih z rakom, ki se zdravijo z Dynepom zaradi anemije, ki je povezana s kronično ledvično odpovedjo, nista bila raziskana.
English: The extent to which the outcomes observed in the clinical studies discussed above may apply to this patient population is unclear, specifically considering that the dosages administered in the renal indication are lower than in the cancer indication.
Slovenian: V kakšni meri rezultati iz zgoraj opisanih kliničnih preskušanj veljajo za to populacijo bolnikov ni jasno, zlasti če upoštevamo, da so odmerki, ki se uporabljajo za ledvično indikacijo, nižji od odmerkov, ki so indicirani pri raku.
English: You will be monitored closely to ensure the lowest dose of Dynepo is used to provide adequate control of your symptoms of anaemia.
Slovenian: Natančno vas bodo spremljali, da bodo zagotovili uporabo najmanjšega odmerka Dynepa, ki omogoča zadosten nadzor simptomov anemije.
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dL (7.5 mmol/l).
Slovenian: V kliničnih preskušanjih so ugotovili povečano tveganje za smrt in resne srčno-žilne dogodke, če je bila ciljna raven hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/dl (7,5 mmol/l).
English: This does not affect normal operation of the syringe and the syringe can be rotated in the device.
Slovenian: To ne vpliva na uporabo brizge, brizgo pa lahko v pripravi vrtite.
English: Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/dl.
Slovenian: Klinične raziskave z epoetinom kažejo, da je tveganje v zvezi s zvišanim krvnim tlakom in trombozo mogoče zmanjšati s titracijo odmerka, da raven hemoglobina ohranimo med 10 in 12 g/dl.
English: If blood pressure values remain high, a transient interruption of Dynepo therapy may be required.
Slovenian: Če krvni tlak ostane zvišan, utegne biti potrebna začasna prekinitev zdravljenja z
English: Do not shake the syringe before use.
Slovenian: Brizge pred uporabo ne smete pretresati.
English: - The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International Units) (2,000 IU/ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ml), 0.3 ml of the solution containing 3,000 IU (10,000 IU/ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ml), 0.3 ml of the solution containing 6,000 IU (20,000 IU/ml), 0.4 ml of the solution containing 8,000 IU (20,000 IU/ml), or 0.5 ml of the solution containing 10,000 IU/ml (20,000 IU/ml) of epoetin
Slovenian: Zdravilna učinkovina je epoetin delta; 0,5 ml raztopine, vsebuje 1.000 i.e. (mednarodnih enot) (2.000 i.e./ml), 0,5 ml raztopine, vsebuje 2.000 i.e. (4.000 i.e./ml), 0,3 ml raztopine, ki vsebuje 3.000 i.e. (10.000 i.e./ml), 0,4 ml raztopine, vsebuje 4.000 i.e. (10.000 i.e./ml), 0,5 ml raztopine, vsebuje 5.000 i.e. (10.000 i.e./ml), 0,3 ml raztopine, vsebuje 6.000 i.e. (20.000 i.e./ml), 0,4 ml raztopine, vsebuje 8.000 i.e. (20.000 i.e./ml), ali 0,5 ml raztopine, vsebuje 10.000 i.e. (20.000 i.e./ml) epoetina delta.
English: Patients on Dynepo therapy can experience increase in blood pressure or aggravation of existing hypertension.
Slovenian: Bolnikom, ki dobivajo Dynepo, se lahko zviša krvni tlak ali se jim poslabša obstoječa hipertenzija.
English: To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.
Slovenian: Da si boste lahko subkutano injicirali zdravilo, boste potrebovali novo, z zdravilom Dynepo napolnjeno injekcijsko brizgo z zaščitnim pokrovčkom za iglo.
English: Depress the plunger slowly and evenly while holding the syringe barrel, always keeping your skin pinched.
Slovenian: Med držanjem brizge počasi in enakomerno pritiskajte na bat, pri tem pa držite kožno gubo.
English: The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
Slovenian: Koncentracijo hemoglobina je treba določiti vsak teden, dokler se ne ustali v priporočenem ciljnem območju in ni določen vzdrževalni odmerek.
English: The frequency of adverse events that were experienced during Dynepo therapy is tabulated below.
Slovenian: Pogostost neželenih učinkov, ki so se pojavili pri bolnikih med zdravljenjem z zdravilom Dynepo, je navedena spodaj.
English: Check the expiry date on the pre-filled syringe label (EXP:).
Slovenian: Preverite datum izteka roka uporabnosti na napolnjeni injekcijski brizgi (EXP.).
English: Since many compounds are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding women.
Slovenian: Številne spojine se izločajo v materinem mleku, zato je treba Dynepo pri doječih ženskah uporabljati previdno.
English: Once hypertension is controlled with more intensified therapy, Dynepo therapy should be re-started at a reduced dose.
Slovenian: Ko je hipertenzija z intenzivirano terapijo urejena, je mogoče zdravljenje z Dynepom začeti znova, z
English: Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line.
Slovenian: Epoetin delta je človeški eritropoetin, pridobljen iz linije človeških celic s posebnim tehnološkim postopkom, gensko aktivacijo.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Slovenian: Pri bolnikih, ki so se zdravili z rekombinantnim humanim eritropoetinom, so ugotovili zvišano relativno tveganje za tromboembolične dogodke (RR 1,67; 95-% IZ: 1,35, 2,06, 35 preskušanj in 6.769 bolnikov).
English: Occasionally, your individual haemoglobin values may be above and below this recommended target level.
Slovenian: Občasno so lahko posamezne vrednosti hemoglobina nad ali pod to priporočeno ciljno koncentracijo.
English: In addition, a reduction of the administered dose of Dynepo needs to be considered.
Slovenian: Razmisliti je treba tudi o zmanjšanju odmerka Dynepa.
English: • Haemoglobinopathies such as thalassaemia or sickle cell anaemia
Slovenian: • hemoglobinopatije, npr. talasemija ali anemija s srpastimi celicami
English: Hold the syringe assembly by the sides of the device and gently remove the plastic cover and rubber guard from the needle without twisting.
Slovenian: Rahlo držite injekcijsko brizgo na obeh straneh priprave in odstranite plastičen pokrovček in gumijasto zaščito z igle ter pazite, da je ne zvijete.
English: The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O.
Slovenian: Izdelovalec je: Shire Human Genetic Therapies AB Åldermansgatan 2, P.O. Box 1117, SE-221 04
English: Pharmacotherapeutic group: Antianaemic - ATC code: B03XA.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje slabokrvnosti - oznaka ATC: B03XA.
English: It may be used in patients on dialysis and in patients not on dialysis.
Slovenian: Uporablja se lahko pri bolnikih, ki so na dializi, in pri tistih,
English: Available in packs of 6 pre-filled syringes.
Slovenian: Na voljo so pakiranja s 6 napolnjenimi injekcijskimi brizgami.
English: In the iron-replete patient with an inadequate response to Dynepo therapy, the following conditions should be evaluated and treated, if appropriated:
Slovenian: Pri bolnikih, ki imajo zaloge železa napolnjene, a se na zdravljenje z Dynepom ne odzovejo ustrezno, je treba raziskati možnost naslednjih bolezni in jih po potrebi zdraviti:
English: A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
Slovenian: Izogniti se moramo zvišanju ravni hemoglobina za več kot 2 g/dl (1,25 mmol/l) v štirih tednih.
English: Peak serum concentrations for subcutaneously administered epoetin delta occur between 8 and 36 hours following injection.
Slovenian: Po subkutani uporabi doseže epoetin delta največjo koncentracijo v serumu od 8 do 36 ur po injekciji.
English: Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard.
Slovenian: Napolnjene injekcijske brizge iz stekla tipa I z gumijastim zamaškom iz bromobutila, igla dimenzije 27 (gauge) iz nerjavnega jekla, ki je zaščitena z naravno trdo gumo in polistirenom, bat iz polistirena in zaščitni pokrovček za iglo.
English: Do not use after the expiry date stated on the carton and on the label of the syringe after “EXP”.
Slovenian: Zdravila Dynepo ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na nalepki brizge poleg oznake »EXP«.
English: Do not warm Dynepo in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Injekcijske brizge z zdravilom Dynepo ne segrevajte na noben drug način (npr. ne segrevajte v
English: Subcutaneous administration results in a similar pattern of erythropoietic stimulation as after intravenous administration.
Slovenian: Subkutana uporaba vpliva na stimulacijo eritropoeze podobno kot intravenska.
English: If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če niste prepričani glede samoinjiciranja zdravila ali če imate kakršno koli vprašanje, se posvetujte z zdravnikom ali farmacevtom.
English: Packs of 6 pre-filled syringes are available.
Slovenian: Na voljo so škatle s šestimi napolnjenimi injekcijskimi brizgami.
English: Dynepo is not approved for use in cancer patients.
Slovenian: Zdravilo Dynepo ni odobreno za zdravljenje bolnikov, obolelih za rakom.
English: The maintenance dose will be then decided by your doctor to maintain the level of your haemoglobin within the target range.
Slovenian: Vzdrževalni odmerek bo zdravnik nato določil tako, da bo vašo koncentracijo hemoglobina vzdrževal
English: Information on how to give yourself an injection of Dynepo This section contains information on how to give yourself an injection of Dynepo.
Slovenian: Podatki o tem, kako si sami injicirate zdravilo Dynepo V naslednjih navodilih je razloženo, kako si sami injicirate zdravilo Dynepo.
English: Before you inject Dynepo you must do the following:
Slovenian: Pred injiciranjem zdravila storite naslednje:
English: It is recommended that a complete blood count and platelet count is performed regularly.
Slovenian: Priporočljivo je redno spremljanje celotne krvne slike in števila trombocitov.
English: Your Dynepo syringe is provided with a needle guard to prevent needle stick injuries after use, so no special disposal precautions are required.
Slovenian: Injekcijska brizga Dynepo ima varnostni zamašek, ki preprečuje vbode po uporabi, tako da za odlaganje igel niso potrebni posebni previdnostni ukrepi.
English: The 5 day period must end before the expiry date stated on the carton and label of the syringe after ‘EXP'.
Slovenian: Obdobje petih dni ne sme preseči roka uporabnosti, ki je naveden na pretisnem omotu in injekcijski brizgi za oznako 'EXP'.
English: Pull straight.
Slovenian: PRETISNI OMOTI
English: Do not use it if the date has passed
Slovenian: Zdravila ne smete uporabljati če je datum že pretekel zadnji dan navedenega meseca.
English: Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 and water for injections.
Slovenian: Pomožne snovi: natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, polisorbat 20 in voda za injekcije.
English: You may notice a small air bubble in the pre-filled syringe.
Slovenian: V injekcijski brizgi lahko opazite majhen zračni mehurček.
English: During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
Slovenian: V kliničnih preskušanjih pri ljudeh glede na klinični odziv ni bilo znakov razvoja nevtralizirajočih protiteles proti epoetinu delta.
English: The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Slovenian: Injekcijska brizga je opremljena z zaščitnim pokrovčkom za iglo, ki preprečuje vbode z iglo.
English: The solution is clear, colourless and waterlike with no visible particles.
Slovenian: Raztopina ie bistra, brezbarvna, podobna vodi in ne vsebuje vidnih delcev.
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Slovenian: Izida za celokupno preživetje v preskušanjih se med tistimi, ki so prejemali rekombinantni humani eritropoetin, in tistimi v kontrolni skupini, ni dalo zadovoljivo razložiti s pomočjo razlik v incidenci tromboze in sorodnih
English: The revised expiry date for storage at below 25oC must not exceed the expiry date set in accordance with the 24 month shelf-life.
Slovenian: Spremenjeni rok uporabnosti za shranjevanje brizg izven hladilnika, pri temperaturi, nižji od 25°C, ne sme preseči roka uporabnosti, ki naveden na ovojnini.
English: There may be also changes in the chemistry of your blood, including increase of creatinine, potassium levels.
Slovenian: Spremenijo se lahko biokemične vrednosti v krvi, z zvečanjem koncentracije kreatinina in kalija vred.