FrancophonIA/ELRC3.0 huggingface dataset:
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
Slovenian: V povezavi z rekombinantnimi eritropoetičnimi beljakovinami (vključno z darbepoetinom alfa) je opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA VIAL
English: Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between
Slovenian: Nato kožo primite med palec in kazalec, ne da bi jo
English: Nespo is supplied ready for use in a pre-filled syringe.
Slovenian: Nespo je na voljo pripravljen za uporabo v napolnjeni injekcijski brizgi.
English: Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary.
Slovenian: Zdravnik vam bo redno jemal kri za meritve, ki bodo pokazale, kako dobro se anemija odziva, in bo odmerek morda prilagodil, kot bo potrebno.
English: • Pain around the area injected
Slovenian: • Bolečina v predelu mesta injiciranja
English: In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Nespo may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Slovenian: Ko je z uporabo Nespa enkrat na teden ali enkrat na dva tedna ciljni hemoglobin dosežen, je pri bolnikih, ki niso na dializi, druga možnost subkutana uporaba zdravila enkrat na mesec; začetni odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival na dva tedna.
English: When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Slovenian: Ko brizgo vzamete iz hladilnika in jo pustite na sobni temperaturi približno 30 minut pred injiciranjem, jo morate uporabiti v 7 dneh, sicer jo morate zavreči.
English: Pull off the grey needle cap.
Slovenian: ∅ Ne upogibajte sivega pokrovčka.
English: Subject Incidence
Slovenian: pritisnjenega na
English: Nespo 80 µg injection Darbepoetin alfa
Slovenian: Nespo 80 µg Darbepoetin alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS UNBLISTERED PRE-FILLED SYRINGE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH NALEPKA NAPOLNJENE INJEKCIJSKE BRIZGE BREZ PRETISNEGA OMOTA
English: The syringes may be presented in either blistered (1- & 4-pack) or non-blistered packaging (1-pack only).
Slovenian: Injekcijske brizge so lahko v pakiranju s pretisnimi omoti (pakiranje z 1 oz. 4) ali brez pretisnih
English: ∅ Do not move the pre-filled pen during the injection.
Slovenian: ∅ Napolnjenega injekcijskega peresnika med injiciranjem ne smete premikati.
English: Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80
Slovenian: natrijev hidrogenfosfat natrijev dihidrogenfosfat natrijev klorid polisorbat 80 voda za injekcije
English: Allow the prefilled syringe to reach room temperature before injecting.
Slovenian: Pred injiciranjem morate vialo pustiti, da doseže sobno temperaturo.
English: Your doctor has prescribed an Nespo pre-filled syringe for injection into the tissue just under the skin.
Slovenian: Zdravnik vam je predpisal injiciranje zdravila Nespo v podkožno tkivo.
English: EU/1/01/184/013 1 Pack Blister EU/1/01/184/- 014 4 Pack Blister EU/1/01/184/039 1 Pack Unblistered
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/184/013 - pakiranje po 1 v pretisnem omotu EU/1/01/184/014 - pakiranje po 4 v pretisnem omotu EU/1/01/184/039 - pakiranje po 1 brez pretisnega omota
English: The preferred injection site for using the Nespo pre-filled pen is the front of the thigh.
Slovenian: Najprimernejše mesto za injiciranje z napolnjenim injekcijskim peresnikom Nespo je sprednji del
English: Nespo 30 µg injection Darbepoetin alfa
Slovenian: Nespo 30 µg Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Nespo 25 micrograms solution for injection in a vial.
Slovenian: IME ZDRAVILA Nespo 25 mikrogramov raztopina za injiciranje v viali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 60 micrograms of darbepoetin alfa in 1 ml (60 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 60 mikrogramov darbepoetina alfa v 1 ml (60 µg/ml).
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: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PRE-FILLED SYRINGE BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI PRETISNI OMOT NAPOLNJENE INJEKCIJSKE BRIZGE
English: Package containing one or four pre-filled pens of a 15 µg Nespo solution for injection in 0.375 ml (40 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 15 µg Nespa v 0,375 ml (40 µg/ml).
English: Instructions for injecting with the Nespo pre-filled syringe
Slovenian: Navodila za injiciranje z napolnjeno injekcijsko brizgo Nespo
English: Do not administer more than one dose per syringe.
Slovenian: Z eno injekcijsko brizgo ne aplicirajte več kot enega odmerka.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 micrograms of darbepoetin alfa in 1 ml (40 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 40 mikrogramov darbepoetina alfa v 1 ml (40 µg/ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING UNBLISTERED PRE-FILLED SYRINGE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA NAPOLNJENE INJEKCIJSKE BRIZGE BREZ PRETISNEGA OMOTA
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 25 micrograms of darbepoetin alfa in 1 ml (25 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 25 mikrogramov darbepoetina alfa v 1 ml (25 µg/ml).
English: Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l).
Slovenian: Če hemoglobin preseže 14 g/dl (8,7 mmol/l), zdravljenje prekinite, dokler ne pade pod 13 g/dl (8,1 mmol/l).
English: Nespo 50 µg injection Darbepoetin alfa
Slovenian: Nespo 50 µg Darbepoetin alfa
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Nespo 15 micrograms solution for injection in a vial Nespo 25 micrograms solution for injection in a vial Nespo 40 micrograms solution for injection in a vial Nespo 60 micrograms solution for injection in a vial darbepoetin alfa Please read this leaflet carefully before you start using this medicine.
Slovenian: Nespo 15 mikrogramov raztopina za injiciranje v viali Nespo 25 mikrogramov raztopina za injiciranje v viali Nespo 40 mikrogramov raztopina za injiciranje v viali Nespo 60 mikrogramov raztopina za injiciranje v viali darbepoetin alfa
English: Nespo is available in packs of 1 or 4 pre-filled syringes (not all pack sizes may be marketed).
Slovenian: Nespo je na voljo v pakiranjih z 1 ali 4 napolnjenimi injekcijskimi brizgami (na trgu morda ni vseh velikosti pakiranj).
English: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
Slovenian: Zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic pri odraslih in pri
English: In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic
Slovenian: Če je diagnosticirana čista aplazija rdečih celic, morate terapijo z Nespom prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4.4).
English: Package containing one or four clear glass vial(s) with rubber stopper(s) of 25 µg Nespo solution for injection in 1 ml (25 µg/ml).
Slovenian: Pakiranje z eno vialo/štirimi vialami iz prozornega stekla z gumijastim zamaškom/gumijastimi zamaški, v katerih je raztopina za injiciranje Nespo s 25 µg Nespa v 1 ml (25 µg/ml).
English: Once a vial has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.
Slovenian: Ko vialo vzamete iz hladilnika in doseže sobno temperaturo (do 25ºC), jo morate uporabiti v 7 dneh, sicer jo morate zavreči.
English: If the increase in haemoglobin is inadequate (less than 1 g/dl (0.6 mmol/l) in four weeks) increase the dose by approximately 25%.
Slovenian: Če se hemoglobin ne zviša dovolj (manj kot 1 g/dl (0,6 mmol/l) v štirih tednih), odmerek povečajte za približno 25%.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.
Slovenian: Ko brizgo vzamete iz hladilnika in doseže sobno temperaturo (do 25ºC), jo morate uporabiti v 7 dneh, sicer jo morate zavreči.
English: Do not use it if the date has passed the
Slovenian: Zdravila ne uporabite, če je že pretekel zadnji dan navedenega meseca.
English: • Rash and/or redness of the skin
Slovenian: • Izpuščaj, pordelost kože ali oboje
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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 micrograms of darbepoetin alfa in 1 ml (15 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 15 mikrogramov darbepoetina alfa v 1 ml (15 µg/ml).
English: • increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.ESAs are not indicated for use in this patient population.
Slovenian: • povečala tveganje smrti pri bolnikih z aktivno maligno boleznijo, ki niso dobivali ne kemoterapije ne obsevanja, če je bila ciljna vrednost hemoglobina 120 g/l (7,5 mmol/l).
English: You can use the abdomen, except for the 2 inch/5 cm area around the belly button (navel).
Slovenian: Injicirate lahko v trebuh, vendar vsaj 5 cm od popka.
English: Nespo 130 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 130 µg Darbepoetin alfa i.v./s.c.
English: If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
Slovenian: Če imate vprašanja o injiciranju zdravila, se za pomoč obrnite na zdravnika, medicinsko sestro ali
English: Nespo 150 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 150 µg Darbepoetin alfa i.v./s.c.
English: Package containing one or four pre-filled pens of a 500 µg Nespo solution for injection in 1 ml (500 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 500 µg Nespa v 1 ml (500 µg/ml).
English: Store in a refrigerator (2°C - 8°C) Do not freeze.
Slovenian: Shranjujte pri temperaturi med 2ºC in 8ºC (v hladilniku).
English: Package containing one or four clear glass vial(s) with rubber stopper(s) of 60 µg Nespo solution for injection in 1 ml (60 µg/ml).
Slovenian: Pakiranje z eno vialo/štirimi vialami iz prozornega stekla z gumijastim zamaškom/gumijastimi zamaški, v katerih je raztopina za injiciranje Nespo s 60 µg Nespa v 1 ml (60 µg/ml).
English: However, you should contact your doctor, nurse or pharmacist if this does happen.
Slovenian: A če se to zgodi, se kljub temu posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 60 micrograms darbepoetin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 1-ml viala vsebuje 60 mikrogramov darbepoetina alfa.
English: Package containing one or four clear glass vial(s) with rubber stopper(s) of 15 µg Nespo solution for injection in 1 ml (15 µg/ml).
Slovenian: Pakiranje z eno vialo/štirimi vialami iz prozornega stekla z gumijastim zamaškom/gumijastimi zamaški, v katerih je raztopina za injiciranje Nespo s 15 µg Nespa v 1 ml (15 µg/ml).
English: NAME OF THE MEDICINAL PRODUCT Nespo 60 micrograms solution for injection in a vial.
Slovenian: IME ZDRAVILA Nespo 60 mikrogramov raztopina za injiciranje v viali.
English: The needle cover 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: INSTRUCTIONS FOR INJECTING WITH THE NESPO PRE-FILLED SYRINGE
Slovenian: Navodila za injiciranje z napolnjenim injekcijskim peresnikom Nespo
English: Once a pre-filled pen has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.
Slovenian: Ko napolnjeni injekcijski peresnik vzamete iz hladilnika in doseže sobno temperaturo (do 25ºC), ga morate uporabiti v 7 dneh, sicer ga morate
English: Package containing one or four clear glass vial(s) with rubber stopper(s) of 40 µg Nespo solution for injection in 1 ml (40 µg/ml).
Slovenian: Pakiranje z eno vialo/štirimi vialami iz prozornega stekla z gumijastim zamaškom/gumijastimi zamaški, v katerih je raztopina za injiciranje Nespo s 40 µg Nespa v 1 ml (40 µg/ml).
English: NAME OF THE MEDICINAL PRODUCT Nespo 40 micrograms solution for injection in a vial.
Slovenian: IME ZDRAVILA Nespo 40 mikrogramov raztopina za injiciranje v viali.
English: 1 single use pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga za enkratno uporabo
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 15 mikrogramov darbepoetina alfa v 0,375 ml (40 µg/ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTERED PRE-FILLED SYRINGE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA NAPOLNJENE INJEKCIJSKE BRIZGE V PRETISNEM OMOTU
English: Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
Slovenian: V študijah, v katerih so Nespo uporabljali subkutano, so kot z zdravljenjem povezani učinek opisovali bolečino na mestu injiciranja.
English: This leaflet was last approved in .
Slovenian: Navodilo je bilo odobreno:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH NALEPKA NAPOLNJENEGA INJEKCIJSKEGA PERESNIKA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 40 micrograms darbepoetin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 1-ml viala vsebuje 40 mikrogramov darbepoetina alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 15 micrograms darbepoetin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 1-ml viala vsebuje 15 mikrogramov darbepoetina alfa.
English: Nespo 500 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 500 µg Darbepoetin alfa i.v./s.c.
English: NAME OF THE MEDICINAL PRODUCT Nespo 15 micrograms solution for injection in a vial.
Slovenian: IME ZDRAVILA Nespo 15 mikrogramov raztopina za injiciranje v viali.
English: 4 single use pre-filled pens
Slovenian: 4 napolnjeni injekcijski peresniki za enkratno uporabo
English: The needle cover 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: Package containing one or four pre-filled pens of a 20 µg Nespo solution for injection in 0.5 ml (40 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 20 µg Nespa v 0,5 ml (40 µg/ml).
English: EU/1/01/184/001 1 pack EU/1/01/184/002 4 pack
Slovenian: EU/1/01/184/002 pakiranje po 4
English: Package containing one or four pre-filled pens of a 130 µg Nespo solution for injection in 0.65 ml (200 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 130 µg Nespa v 0,65 ml (200 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 25 micrograms darbepoetin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 1-ml viala vsebuje 25 mikrogramov darbepoetina alfa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 ml (500 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 500 mikrogramov darbepoetina alfa v 1 ml (500 µg/ml).
English: Prepare the site
Slovenian: Navodilo shranite.
English: Package containing one or four pre-filled syringe(s) of a 40 µg Nespo solution for injection in 0.4 ml (100 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 40 µg Nespa v 0,4 ml (100 µg/ml).
English: Package containing one or four pre-filled syringe(s) of a 30 µg Nespo solution for injection in 0.3 ml (100 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 30 µg Nespa v 0,3 ml (100 µg/ml).
English: Nespo 60 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 60 µg Darbepoetin alfa i.v./s.c.
English: Package containing one or four pre-filled syringe(s) of a 80 µg Nespo solution for injection in 0.4 ml (200 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 80 µg Nespa v 0,4 ml (200 µg/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/035
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/035
English: NAME OF THE MEDICINAL PRODUCT Nespo 150 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 150 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: Package containing one or four pre-filled pens of a 300 µg Nespo solution for injection in 0.6 ml (500 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 300 µg Nespa v 0,6 ml (500 µg/ml).
English: Before administration the Nespo solution should be inspected for visible particles.
Slovenian: Pred aplikacijo morate raztopino Nespa pregledati in se tako prepričati, da ne vsebuje vidnih delcev.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov darbepoetina alfa v 0,4 ml (100 µg/ml).
English: Package containing one or four pre-filled syringe(s) of a 60 µg Nespo solution for injection in 0.3 ml (200 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 60 µg Nespa v 0,3 ml (200 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 ml (200 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov darbepoetina alfa v 0,3 ml (200 µg/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/037
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/037
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/071
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/071
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 ml (100 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov darbepoetina alfa v 0,3 ml (100 µg/ml).
English: Nespo 150 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 150 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: Package containing one or four pre-filled syringe(s) of a 150 µg Nespo solution for injection in 0.3 ml (500 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 150 µg Nespa v 0,3 ml (500 µg/ml).
English: Nespo 15 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 15 µg Darbepoetin alfa i.v./s.c.
English: Nespo 500 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 500 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 10 mikrogramov darbepoetina alfa v 0,4 ml (25 µg/ml).
English: NAME OF THE MEDICINAL PRODUCT Nespo 130 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 130 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti
English: NAME OF THE MEDICINAL PRODUCT Nespo 500 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 500 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 40 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 40 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko
English: Nespo 40 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 40 µg Darbepoetin alfa i.v./s.c.
English: Nespo 300 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 300 µg Darbepoetin alfa i.v./s.c.
English: Adverse Drug Reaction
Slovenian: Samoinjiciranje zdravila Nespo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/040
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/040
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 ml (40 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 20 mikrogramov darbepoetina alfa v 0,5 ml (40 µg/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/044
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/044
English: You must stop breast-feeding if you use Nespo.
Slovenian: Če uporabljate Nespo, morate nehati
English: Nespo 100 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 100 µg Darbepoetin alfa i.v./s.c.
English: Nespo 50 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 50 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/036
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/036
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 ml (500 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 300 mikrogramov darbepoetina alfa v 0,6 ml (500 µg/ml).
English: NAME OF THE MEDICINAL PRODUCT Nespo 80 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 80 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.