FrancophonIA/ELRC3.0 huggingface dataset:
English: In CRF patients on haemodialysis, events of vascular access thrombosis (such as vascular access complication, arteriovenous fistula thrombosis, graft thrombosis, shunt thrombosis, arteriovenous fistula site complication, etc.) have been reported in post-marketing data.
Slovenian: Pri bolnikih s kronično odpovedjo ledvic na hemodializi so v podatkih iz obdobja trženja zdravila poročali o dogodkih v povezavi s trombozo žilnega pristopa (kot so zaplet v povezavi z žilnim pristopom, tromboza arteriovenske fistule, tromboza presadka, tromboza šanta, zaplet v povezavi z mestom arteriovenske fistule ipd.).
English: In patients ≥ 11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Slovenian: Ko je z odmerjanjem enkrat na dva tedna dosežen ciljni hemoglobin, lahko bolniki, stari ≥ 11 let, ki niso na dializi, zdravilo Aranesp dobivajo subkutano enkrat na mesec; začetni odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival enkrat na dva tedna.
English: In dialysis patients, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
Slovenian: Pri bolnikih na dializi je mogoče zdravilo Aranesp še naprej uporabljati v eni injekciji na teden ali na dva tedna.
English: Aranesp is supplied ready for use in a pre-filled syringe.
Slovenian: Zdravilo Aranesp je pripravljeno za uporabo v napolnjeni injekcijski brizgi.
English: Skin and subcutaneous tissue disorders
Slovenian: tromboza dializnega žilnega pristopad
English: Do not use this medicine if you notice the pre-filled syringe contents are cloudy or there are particles in it.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je raztopina v viali motna ali so v njej delci.
English: • Upper part of your thigh
Slovenian: • zgornji del stegna
English: Aranesp 25 micrograms solution for injection in vial Aranesp 40 micrograms solution for injection in vial Aranesp 60 micrograms solution for injection in vial Aranesp 100 micrograms solution for injection in vial Aranesp 200 micrograms solution for injection in vial Aranesp 300 micrograms solution for injection in vial darbepoetin alfa
Slovenian: Aranesp 25 mikrogramov raztopina za injiciranje v viali Aranesp 40 mikrogramov raztopina za injiciranje v viali Aranesp 60 mikrogramov raztopina za injiciranje v viali Aranesp 100 mikrogramov raztopina za injiciranje v viali Aranesp 200 mikrogramov raztopina za injiciranje v viali Aranesp 300 mikrogramov raztopina za injiciranje v viali darbepoetin alfa
English: Aranesp 25 micrograms solution for injection in vial Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL).
Slovenian: Aranesp 25 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 25 mikrogramov darbepoetina alfa v 1 ml (25 µg/ml).
English: A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 mcg/kg darbepoetin alfa administered SC every
Slovenian: Farmakokinetična študija, opravljena pri bolnikih z anemijo zaradi kemoterapije, ki so v kombinaciji s kemoterapijo dobivali 6,75 µg/kg darbepoetina alfa subkutano na 3 tedne, je omogočila popolno opredelitev terminalnega razpolovnega časa.
English: 4 single use pre-filled syringes.
Slovenian: 4 napolnjene injekcijske brizge za enkratno uporabo.
English: Do not use the pre-filled pen after the expiry date on the label.
Slovenian: Ne uporabljajte napolnjenega injekcijskega peresnika po datumu izteka roka uporabnosti, ki je naveden na nalepki.
English: • Hives (urticaria)
Slovenian: • koprivnica (urtikarija)
English: The median TTP based on IRCdetermined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI: 0.924, 1.156).
Slovenian: Mediani TTP, ki temelji na oceni napredovanja bolezni s strani neodvisnega pregledovalnega odbora, je bil 8,0 meseca v skupini z epoetinom alfa in standardno oskrbo ter 8,3 meseca v skupini s samo standardno oskrbo (razmerje ogroženosti 1,033; 95 % IZ:
English: The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240.
Slovenian: Začetni odmerek zdravila Aranesp vsak drugi teden (μg/vsak drugi teden) lahko določite tako, da celotni kumulativni odmerek r-HuEPO, uporabljen v obdobju dveh tednov, delite z 240.
English: If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
Slovenian: Če se hemoglobin v štirih tednih zviša za več kot 20 g/l (1,25 mmol/l), zmanjšajte odmerek za približno 25 %, odvisno od hitrosti zvišanja.
English: Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
Slovenian: Nato kožo primite med palec in kazalec, ne da bi jo stiskali.
English: The initial weekly dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
Slovenian: Začetni tedenski odmerek zdravila Aranesp (µg/teden) lahko določite tako, da celotni tedenski odmerek r-HuEPO (i.e./teden) delite z 200.
English: A Remove one pre-filled pen from the carton.
Slovenian: A Vzemite en napolnjen injekcijski peresnik iz škatle.
English: For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a single injection by a healthcare professional, either under your skin (subcutaneous) or into a vein (intravenous).
Slovenian: Vsem odraslim in pediatričnim bolnikom, starim ≥ 1 leto, s kronično odpovedjo ledvic bo zdravilo Aranesp vbrizgal zdravstveni delavec v eni injekciji, in sicer pod kožo (subkutano) ali v veno (intravensko).
English: Aranesp 25 micrograms solution for injection in vial.
Slovenian: Aranesp 25 mikrogramov raztopina za injiciranje v viali
English: c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations.
Slovenian: c Neželeni učinek izpuščaj vključuje naslednje PT: izpuščaj, pruritični izpuščaj, generalizirani izpuščaj, papulozni izpuščaj, eritem, eksfoliativni izpuščaj, makulopapulozni izpuščaj, vezikulozni izpuščaj ter tudi pustulozni izpuščaj za organski sistem “infekcijske in parazitske bolezni”.
English: You should contact your doctor, nurse or pharmacist if this does happen.
Slovenian: Če se to zgodi, se morate posvetovati z zdravnikom, medicinsko sestro ali farmacevtom.
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex).
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa).
English: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Slovenian: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen
Slovenian: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi
English: For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp pre-filled pen is given as a single injection, under your skin (subcutaneous).
Slovenian: Vsem odraslim in pediatričnim bolnikom, starim ≥ 1 leto, s kronično odpovedjo ledvic se zdravilo Aranesp daje v napolnjenem injekcijskem peresniku kot eno injekcijo, in sicer pod kožo (subkutano).
English: For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a single injection, either under your skin (subcutaneous) or into a vein (intravenous).
Slovenian: Vsem odraslim in pediatričnim bolnikom, starim ≥ 1 leto, s kronično odpovedjo ledvic se zdravilo Aranesp daje v eni injekciji, in sicer pod kožo (subkutano) ali v veno (intravensko).
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake »EXP«.
English: • Pain around the area injected
Slovenian: • bolečina v predelu mesta injiciranja
English: The pre-filled pen is designed to inject the area under your skin only.
Slovenian: Napolnjeni injekcijski peresnik je namenjen samo za podkožno injiciranje.
English: The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Slovenian: Pokrovček igle na napolnjenem injekcijskem peresniku vsebuje suho naravno gumo (derivat lateksa).
English: Nervous system disorders
Slovenian: Bolezni živčevja občasni1
English: If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in 4 weeks, the dose should be reduced by 25 to 50%.
Slovenian: Če se koncentracija hemoglobina v 4 tednih zviša za več kot 20 g/l (1,25 mmol/l), je odmerek treba zmanjšati za 25 do 50 %.
English: Aranesp 10 micrograms solution for injection in pre-filled syringe Aranesp 15 micrograms solution for injection in pre-filled syringe Aranesp 20 micrograms solution for injection in pre-filled syringe Aranesp 30 micrograms solution for injection in pre-filled syringe Aranesp 40 micrograms solution for injection in pre-filled syringe Aranesp 50 micrograms solution for injection in pre-filled syringe Aranesp 60 micrograms solution for injection in pre-filled syringe Aranesp 80 micrograms solution for injection in pre-filled syringe Aranesp 100 micrograms solution for injection in pre-filled syringe Aranesp 130 micrograms solution for injection in pre-filled syringe Aranesp 150 micrograms solution for injection in pre-filled syringe Aranesp 300 micrograms solution for injection in pre-filled syringe Aranesp 500 micrograms solution for injection in pre-filled syringe darbepoetin alfa
Slovenian: Aranesp 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 15 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 20 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 30 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 40 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 50 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 60 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 80 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 100 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 130 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 150 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 300 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Aranesp 500 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi darbepoetin alfa
English: Aranesp in a pre-filled pen is only for subcutaneous administration.
Slovenian: Zdravilo Aranesp v napolnjenem injekcijskem peresniku se uporablja samo subkutano.
English: Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick) darbepoetin alfa
Slovenian: Aranesp 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 15 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 20 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 40 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 50 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 80 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 130 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 150 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) Aranesp 500 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) darbepoetin alfa
English: Stroke was reported as common in CRF patients in TREAT (see section 5.1).
Slovenian: Možganska kap je bila med bolniki s kronično odpovedjo ledvic v študiji TREAT poročana kot pogosta (glejte poglavje 5.1).
English: Aranesp is available in packs of 1 or 4 pre-filled syringes.
Slovenian: Zdravilo Aranesp je na voljo v pakiranjih po 1 ali 4 napolnjenimi injekcijskimi brizgami.
English: - Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Slovenian: - V zvezi z zdravljenjem z epoetinom so poročali o resnih kožnih reakcijah, med njimi o StevensJohnsonovem sindromu (SJS - Stevens-Johnson syndrome) in toksični epidermalni nekrolizi (TEN - Toxic Epidermal Necrolysis).
English: Adverse reactions were determined based on pooled data from eight randomised, double-blind,
Slovenian: Neželene učinke so ugotavljali na podlagi kumulativnih podatkov osmih randomiziranih, dvojno slepih, s placebom kontroliranih študij zdravila Aranesp pri skupaj 4.630 bolnikih (zdravilo
English: This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4
Slovenian: 1 napolnjen injekcijski peresnik za enkratno uporabo Ta škatla z 1 napolnjenim injekcijskim peresnikom je del pakiranja po 4.
English: Do not grasp the plunger Do not grasp the grey needle cap
Slovenian: Ne primite brizge za sivi pokrovček igle.
English: • Plaster
Slovenian: • obliž
English: Talk to your doctor, pharmacist or nurse before using Aranesp.
Slovenian: Pred začetkom uporabe zdravila Aranesp se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Slovenian: V povezavi z zdravljenjem z epoetinom so poročali o hudih kožnih neželenih učinkih, vključno s Stevens-Johnsonovim sindromom (SJS - Stevens-Johnson syndrome) in toksično epidermalno nekrolizo (TEN - Toxic Epidermal Necrolysis), ki so lahko življenjsko nevarni ali smrtni.
English: The initial weekly paediatric dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240.
Slovenian: Začetni pediatrični odmerek zdravila Aranesp (µg/teden) enkrat na teden lahko določite tako, da celotni tedenski odmerek r-HuEPO (i.e./teden)
English: INFORMATION IN BRAILLE Aranesp 130 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Aranesp 130 brizga
English: IV/SC 0.375 ml
Slovenian: 0,375 ml
English: In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
Slovenian: V skupini, ki je dobivala zdravilo Aranesp, je bilo 83 % bolnikov na dializi, 17 % pa ne. Možganska kap je bila ugotovljena kot neželen učinek v dodatni klinični študiji (TREAT, glejte poglavje 5.1).
English: Aranesp 200 micrograms solution for injection in vial Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL).
Slovenian: Aranesp 200 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 200 mikrogramov darbepoetina alfa v 1 ml (200 µg/ml).
English: The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.
Slovenian: Začetni odmerek zdravila Aranesp na dva tedna (µg/vsak drugi teden) lahko določite tako, da celotni kumulativni odmerek r-HuEPO, apliciran v dveh tednih, delite z 200.
English: Solution for injection (injection) in pre-filled pen (SureClick).
Slovenian: raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku (SureClick) raztopina za injiciranje (injekcija) v viali bistra, brezbarvna raztopina
English: Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na napolnjeni injekcijski brizgi poleg oznake »EXP«.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 25 micrograms solution for injection in vial Darbepoetin alfa
Slovenian: Aranesp 25 mikrogramov raztopina za injiciranje v viali darbepoetin alfa
English: Aranesp 60 micrograms solution for injection in vial Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL).
Slovenian: Aranesp 60 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 60 mikrogramov darbepoetina alfa v 1 ml (60 µg/ml).
English: Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the skin.
Slovenian: Zdravnik vam je predpisal injiciranje zdravila Aranesp v podkožno tkivo.
English: Aranesp 100 micrograms solution for injection in vial Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL).
Slovenian: Aranesp 100 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 100 mikrogramov darbepoetina alfa v 1 ml (100 µg/ml).
English: Aranesp 300 micrograms solution for injection in vial Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL).
Slovenian: Aranesp 300 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 300 mikrogramov darbepoetina alfa v 1 ml (300 µg/ml).
English: The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
Slovenian: Napolnjena injekcijska brizga vsebuje 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 ali 500 mikrogramov darbepoetina alfa.
English: Solution for injection (injection) in pre-filled syringe.
Slovenian: ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO V PRETISNEM OMOTU
English: Aranesp 40 micrograms solution for injection in vial Each vial contains 40 micrograms of darbepoetin alfa in 1 mL (40 mcg/mL).
Slovenian: Aranesp 40 mikrogramov raztopina za injiciranje v viali Ena viala vsebuje 40 mikrogramov darbepoetina alfa v 1 ml (40 µg/ml).
English: Aranesp 15 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.42 mg of sodium in 0.375 mL.
Slovenian: Aranesp 15 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 1,42 mg natrija v 0,375 ml.
English: Aranesp 200 micrograms solution for injection in vial.
Slovenian: Aranesp 200 mikrogramov raztopina za injiciranje v viali
English: Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 3.79 mg of sodium in 1 mL.
Slovenian: Aranesp 500 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 3,79 mg natrija v 1 ml.
English: INFORMATION IN BRAILLE Aranesp 80 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Aranesp 80 brizga
English: INFORMATION IN BRAILLE Aranesp 20 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Aranesp 20 brizga
English: Aranesp 25 micrograms solution for injection in vial 1 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover.
Slovenian: Aranesp 25 mikrogramov raztopina za injiciranje v viali 1 ml raztopine za injiciranje (25 µg/ml darbepoetina alfa) v viali iz stekla tipa 1 z elastomernim zamaškom, plastificirani s fluoropolimerom, in z aluminijasto zaporo in snemno zaporko proti prahu.
English: Injection site pain
Slovenian: ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK
English: Aranesp 60 micrograms solution for injection in vial.
Slovenian: Aranesp 60 mikrogramov raztopina za injiciranje v viali
English: Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled pen label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na napolnjenem injekcijskem peresniku poleg oznake »EXP«.
English: Aranesp 40 micrograms solution for injection in vial.
Slovenian: Aranesp 40 mikrogramov raztopina za injiciranje v viali
English: Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 2.27 mg of sodium in 0.6 mL.
Slovenian: Aranesp 300 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 2,27 mg natrija v 0,6 ml.
English: INFORMATION IN BRAILLE Aranesp 150 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Aranesp 150 brizga
English: Polysorbate 80
Slovenian: SureClick x 4
English: Do not put the grey cap back onto the pre-filled pen.
Slovenian: Ne nameščajte sivega pokrovčka igle nazaj na napolnjen injekcijski peresnik.
English: Aranesp 300 micrograms solution for injection in vial.
Slovenian: Aranesp 300 mikrogramov raztopina za injiciranje v viali
English: Plunger
Slovenian: Okence
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 25 micrograms darbepoetin alfa.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena 1-ml viala vsebuje 25 mikrogramov darbepoetina alfa.
English: Patients should be monitored closely, if the haemoglobin exceeds 12 g/dL (7.5 mmol/L), the dose should be reduced by approximately 25 to 50%.
Slovenian: Če hemoglobin preseže 120 g/l (7,5 mmol/l), morate odmerek zmanjšati za približno 25 do 50 %.
English: Aranesp 100 micrograms solution for injection in vial.
Slovenian: Aranesp 100 mikrogramov raztopina za injiciranje v viali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON WITHOUT TRAY
Slovenian: ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO BREZ PRETISNEGA OMOTA
English: EU/1/01/185/111 4 pack
Slovenian: EU/1/01/185/111 - pakiranje po 4
English: INFORMATION IN BRAILLE Aranesp 100 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Aranesp 100 brizga
English: Aranesp 500 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 3.79 mg of sodium in 1 mL.
Slovenian: Aranesp 500 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 3,79 mg natrija v 1 ml.
English: Aranesp 20 micrograms solution for injection pre-filled pen EU/1/01/185/047 - 1 pack
Slovenian: Aranesp 20 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/01/185/047 - pakiranje po 1
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
Slovenian: V povezavi z ESA (vključno z zdravilom Aranesp) je opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles.