FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.65 mL pre-filled pen contains 130 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,65 ml áfylltur penni inniheldur 130 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,375 ml áfyllt sprauta inniheldur 15 míkrógrömm darbepoetin alfa (40 míkrógrömm/ml).
English: EU/1/01/185/069 1 pack EU/1/01/185/070 4 pack EU/1/01/185/092 1 pack with needle guard EU/1/01/185/093 4 pack with needle guard
Icelandic: EU/1/01/185/069 1 sprauta í pakkningu EU/1/01/185/070 4 sprautur í pakkningu EU/1/01/185/092 1 sprauta í pakkningu með nálarvörn EU/1/01/185/093 4 sprautur í pakkningu með nálarvörn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 25 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 25 míkrógrömm darbepoetin alfa.
English: Aranesp 25 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: Step 4: Finish L Dispose of the used pre-filled pen and grey cap.
Icelandic: Að lokum L Fargið notuðum áfylltum penna og grárri nálarhlíf.
English: Finger grips Syringe label Syringe barrel
Icelandic: Grip Merkimiði á sprautu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/044
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/044
English: NAME OF THE MEDICINAL PRODUCT Aranesp 500 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 500 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfylltur penni inniheldur 10 míkrógrömm darbepoetin alfa (25 míkrógrömm/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/042
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/042
English: EU/1/01/185/101 4 Pack
Icelandic: EU/1/01/185/101 4 hettuglös
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/039
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/039
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Icelandic: B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN Ávísun lyfsins er háð sérstökum takmörkunum (sjá viðauka I:
English: EU/1/01/185/105 4 pack
Icelandic: EU/1/01/185/105 4 hettuglös
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfyllt sprauta inniheldur 10 míkrógrömm darbepoetin alfa (25 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.65 mL pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,65 ml áfyllt sprauta inniheldur 130 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/038
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/038
English: EU/1/01/185/005 1 pack EU/1/01/185/006 4 pack EU/1/01/185/078 1 pack with needle guard EU/1/01/185/079 4 pack with needle guard
Icelandic: EU/1/01/185/005 1 sprauta í pakkningu EU/1/01/185/006 4 sprautur í pakkningu EU/1/01/185/078 1 sprauta í pakkningu með nálarvörn EU/1/01/185/079 4 sprautur í pakkningu með nálarvörn
English: Aranesp 40 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: Aranesp 15 micrograms solution for injection in pre-filled pen 0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 15 míkrógrömm stungulyf, lausn í áfylltum penna 0,375 ml stungulyf, lausn (40 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: • plan to get pregnant.
Icelandic: hyggst verða þunguð.
English: EU/1/01/185/003 1 pack EU/1/01/185/004 4 pack EU/1/01/185/076 1 pack with needle guard EU/1/01/185/077 4 pack with needle guard
Icelandic: EU/1/01/185/003 1 sprauta í pakkningu EU/1/01/185/004 4 sprautur í pakkningu EU/1/01/185/076 1 sprauta í pakkningu með nálarvörn EU/1/01/185/077 4 sprautur í pakkningu með nálarvörn
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/056 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/056
English: NAME OF THE MEDICINAL PRODUCT Aranesp 150 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 150 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: EU/1/01/185/011 1 pack EU/1/01/185/012 4 pack EU/1/01/185/084 1 pack with needle guard EU/1/01/185/085 4 pack with needle guard
Icelandic: EU/1/01/185/011 1 sprauta í pakkningu EU/1/01/185/012 4 sprautur í pakkningu EU/1/01/185/084 1 sprauta í pakkningu með nálarvörn EU/1/01/185/085 4 sprautur í pakkningu með nálarvörn
English: The frequency is estimated from clinical trial data as uncommon in cancer patients.
Icelandic: Í klínískum rannsóknum á krabbameinssjúklingum er aukaverkunin metin sem sjaldgæf.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfyllt sprauta inniheldur 30 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
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
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi Aranesp 40 míkrógrömm stungulyf, lausn í hettuglasi Aranesp 60 míkrógrömm stungulyf, lausn í hettuglasi Aranesp 100 míkrógrömm stungulyf, lausn í hettuglasi Aranesp 200 míkrógrömm stungulyf, lausn í hettuglasi Aranesp 300 míkrógrömm stungulyf, lausn í hettuglasi darbepoetin alfa
English: EU/1/01/185/031 1 pack EU/1/01/185/032 4 pack EU/1/01/185/098 1 pack with needle guard EU/1/01/185/099 4 pack with needle guard
Icelandic: EU/1/01/185/031 1 sprauta í pakkningu EU/1/01/185/032 4 sprautur í pakkningu EU/1/01/185/098 1 sprauta í pakkningu með nálarvörn EU/1/01/185/099 4 sprautur í pakkningu með nálarvörn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL pre-filled pen contains 500 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 1 ml áfylltur penni inniheldur 500 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled pen contains 80 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfylltur penni inniheldur 80 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled pen contains 40 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfylltur penni inniheldur 40 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
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).
Icelandic: Aranesp er gefið með einni inndælingu annaðhvort undir húð (s.c.) eða í bláæð (i.v.).
English: NAME OF THE MEDICINAL PRODUCT Aranesp 10 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 10 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfyllt sprauta inniheldur 80 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: EU/1/01/185/007 1 pack EU/1/01/185/008 4 pack EU/1/01/185/080 1 pack with needle guard EU/1/01/185/081 4 pack with needle guard
Icelandic: EU/1/01/185/007 1 sprauta í pakkningu EU/1/01/185/008 4 sprautur í pakkningu EU/1/01/185/080 1 sprauta í pakkningu með nálarvörn EU/1/01/185/081 4 sprautur í pakkningu með nálarvörn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,4 ml áfyllt sprauta inniheldur 40 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled pen contains 150 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfylltur penni inniheldur 150 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
Icelandic: Lengri helmingunartími darbepoetins alfa sem gefið er undir húð, samanborið við gjöf í bláæð, stafar af lyfjahvörfum í tengslum við frásog lyfsins eftir gjöf undir húð.
English: Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Icelandic: Læknar með reynslu af framangreindum ábendingum eiga að hefja meðferð með Aranesp.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 10 µg injection
Icelandic: Aranesp 10 µg stungulyf
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 1 ml áfyllt sprauta inniheldur 500 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled pen contains 20 micrograms darbepoetin alfa (40 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfylltur penni inniheldur 20 míkrógrömm darbepoetin alfa (40 míkrógrömm/ml).
English: EU/1/01/185/015 1 pack EU/1/01/185/016 4 pack EU/1/01/185/088 1 pack with needle guard EU/1/01/185/089 4 pack with needle guard
Icelandic: EU/1/01/185/015 1 sprauta í pakkningu EU/1/01/185/016 4 sprautur í pakkningu EU/1/01/185/088 1 sprauta í pakkningu með nálarvörn EU/1/01/185/089 4 sprautur í pakkningu með nálarvörn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled pen contains 30 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfylltur penni inniheldur 30 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
English: EU/1/01/185/019 1 pack EU/1/01/185/020 4 pack EU/1/01/185/094 1 pack with needle guard EU/1/01/185/095 4 pack with needle guard
Icelandic: EU/1/01/185/019 1 sprauta í pakkningu EU/1/01/185/020 4 sprautur í pakkningu EU/1/01/185/094 1 sprauta í pakkningu með nálarvörn EU/1/01/185/095 4 sprautur í pakkningu með nálarvörn
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/033
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/033
English: Do not store the pre-filled pen in extreme heat or cold. For example, avoid storing in your car glove box or boot.
Icelandic: Geymið áfylltan penna hvorki í miklum hita né miklum kulda.
English: Aranesp 60 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 60 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: Aranesp 10 micrograms solution for injection pre-filled syringe EU/1/01/185/001 1 Pack Blister EU/1/01/185/002 4 Pack Blister EU/1/01/185/033 1 Pack Unblistered EU/1/01/185/074 1 blister pack with needle guard EU/1/01/185/075 4 blister pack with needle guard Aranesp 15 micrograms solution for injection pre-filled syringe EU/1/01/185/003 1 Pack Blister EU/1/01/185/004 4 Pack Blister EU/1/01/185/034 1 Pack Unblistered EU/1/01/185/076 1 blister pack with needle guard EU/1/01/185/077 4 blister pack with needle guard Aranesp 20 micrograms solution for injection pre-filled syringe EU/1/01/185/005 1 Pack Blister EU/1/01/185/006 4 Pack Blister EU/1/01/185/035 1 Pack Unblistered EU/1/01/185/078 1 blister pack with needle guard EU/1/01/185/079 4 blister pack with needle guard Aranesp 30 micrograms solution for injection pre-filled syringe EU/1/01/185/007 1 Pack Blister EU/1/01/185/008 4 Pack Blister EU/1/01/185/036 1 Pack Unblistered EU/1/01/185/080 1 blister pack with needle guard EU/1/01/185/081 4 blister pack with needle guard Aranesp 40 micrograms solution for injection pre-filled syringe EU/1/01/185/009 1 Pack Blister EU/1/01/185/010 4 Pack Blister EU/1/01/185/037 1 Pack Unblistered EU/1/01/185/082 1 blister pack with needle guard EU/1/01/185/083 4 blister pack with needle guard Aranesp 50 micrograms solution for injection pre-filled syringe EU/1/01/185/011 1 Pack Blister EU/1/01/185/012 4 Pack Blister EU/1/01/185/038 1 Pack Unblistered EU/1/01/185/084 1 blister pack with needle guard EU/1/01/185/085 4 blister pack with needle guard
Icelandic: Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/091 Þynnupakkning með 4 sprautum með nálarvörn Aranesp 130 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/01/185/069 Þynnupakkning með 1 sprautu EU/1/01/185/070 Þynnupakkning með 4 sprautum EU/1/01/185/071 Pakkning, sem ekki er þynnupakkning, með 1 sprautu EU/1/01/185/092 Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/093 Þynnupakkning með 4 sprautum með nálarvörn Aranesp 150 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/01/185/019 Þynnupakkning með 1 sprautu EU/1/01/185/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/036
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/036
English: Aranesp 80 micrograms solution for injection in pre-filled pen 0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 80 míkrógrömm stungulyf, lausn í áfylltum penna 0,4 ml stungulyf, lausn (200 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Icelandic: Gerðar hafa verið klínískar rannsóknir á lyfjahvörfum darbepoetin alfa eftir gjöf undir húð og í bláæð hjá sjúklingum með langvarandi nýrnabilun.
English: EU/1/01/185/001 1 pack EU/1/01/185/002 4 pack EU/1/01/185/074 1 pack with needle guard EU/1/01/185/075 4 pack with needle guard
Icelandic: EU/1/01/185/001 1 sprauta í pakkningu EU/1/01/185/002 4 sprautur í pakkningu EU/1/01/185/074 1 sprauta í pakkningu með nálarvörn EU/1/01/185/075 4 sprautur í pakkningu með nálarvörn
English: Aranesp is supplied ready for use in a vial.
Icelandic: Aranesp er í hettuglasi sem er tilbúið til notkunar.
English: The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in cancer patients.
Icelandic: Í klínískum rannsóknum hjá krabbameinssjúklingum voru öll ofnæmisviðbrögð metin sem mjög algeng aukaverkun.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 80 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 80 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Aranesp 15 micrograms solution for injection in pre-filled syringe 0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 15 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,375 ml stungulyf, lausn (40 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 40 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 40 míkrógrömm darbepoetin alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/041
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/041
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/037
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/037
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfyllt sprauta inniheldur 150 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: Aranesp 40 micrograms solution for injection in pre-filled pen 0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í áfylltum penna 0,4 ml stungulyf, lausn (100 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: Aranesp 40 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,4 ml stungulyf, lausn (100 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: EU/1/01/185/013 1 pack EU/1/01/185/014 4 pack EU/1/01/185/086 1 pack with needle guard EU/1/01/185/087 4 pack with needle guard
Icelandic: EU/1/01/185/013 1 sprauta í pakkningu EU/1/01/185/014 4 sprautur í pakkningu EU/1/01/185/086 1 sprauta í pakkningu með nálarvörn EU/1/01/185/087 4 sprautur í pakkningu með nálarvörn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled pen contains 50 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfylltur penni inniheldur 50 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
English: Aranesp 60 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 60 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: 4 single use vials
Icelandic: 4 einnota hettuglös
English: Aranesp 10 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 10 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: You must stop breast-feeding if you use Aranesp.
Icelandic: Hætta verður brjóstagjöf þegar Aranesp er notað.
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.
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi 1 ml stungulyf, lausn (25 µg/ml darbepoetin alfa) í hettuglasi úr gleri af gerð 1 með tappa úr lagskiptri gúmmíkenndri flúorfjölliðu og álinnsigli með rykhlíf sem smellt er af.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/053 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/053
English: Aranesp 40 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: Aranesp 15 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 15 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 300 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 300 míkrógrömm darbepoetin alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/034
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/034
English: Aranesp 150 micrograms solution for injection in pre-filled pen 0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 150 míkrógrömm stungulyf, lausn í áfylltum penna 0,3 ml stungulyf, lausn (500 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: Aranesp 80 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 80 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,4 ml stungulyf, lausn (200 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: Aranesp 130 micrograms solution for injection in pre-filled syringe 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 130 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,65 ml stungulyf, lausn (200 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfyllt sprauta inniheldur 20 míkrógrömm darbepoetin alfa (40 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfyllt sprauta inniheldur 60 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: NAME OF THE MEDICINAL PRODUCT Aranesp 60 µg injection
Icelandic: Aranesp 60 µg stungulyf
English: Aranesp 20 micrograms solution for injection in pre-filled pen 0.5 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 20 míkrógrömm stungulyf, lausn í áfylltum penna 0,5 ml stungulyf, lausn (40 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: Aranesp 50 micrograms solution for injection in pre-filled pen 0.5 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 50 míkrógrömm stungulyf, lausn í áfylltum penna 0,5 ml stungulyf, lausn (100 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: Aranesp 10 micrograms solution for injection in pre-filled pen 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 10 míkrógrömm stungulyf, lausn í áfylltum penna 0,4 ml stungulyf, lausn (25 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: Aranesp 500 micrograms solution for injection pre-filled pen EU/1/01/185/056 - 1 pack
Icelandic: Pakkning með 4 pennum Aranesp 500 míkrógrömm stungulyf, lausn í áfylltum penna EU/1/01/185/056
English: EU/1/01/185/017 1 pack EU/1/01/185/018 4 pack EU/1/01/185/090 1 pack with needle guard EU/1/01/185/091 4 pack with needle guard
Icelandic: EU/1/01/185/017 1 sprauta í pakkningu EU/1/01/185/018 4 sprautur í pakkningu EU/1/01/185/090 1 sprauta í pakkningu með nálarvörn EU/1/01/185/091 4 sprautur í pakkningu með nálarvörn
English: Correction of anaemia in paediatric patients with once monthly Aranesp dosing frequency has not been studied.
Icelandic: á blóðleysi hjá börnum með því að gefa Aranesp einu sinni í mánuði.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 30 µg injection
Icelandic: Aranesp 30 µg stungulyf
English: Aranesp 60 micrograms solution for injection in pre-filled pen 0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Icelandic: Aranesp 60 míkrógrömm stungulyf, lausn í áfylltum penna 0,3 ml stungulyf, lausn (200 µg/ml darbepoetin alfa) í áfylltum penna með sprautu úr gleri af gerð 1 og 27 gauge nál úr ryðfríu stáli.
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Icelandic: Þrýstið bómullarhnoðra eða grisju á stungustaðinn ef þar er blóð.
English: Aranesp 500 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 500 míkrógrömm stungulyf, lausn í áfylltum penna.
English: Poorly controlled hypertension.
Icelandic: öryggishlífina af áfylltu sprautunni.