FrancophonIA/ELRC3.0 huggingface dataset:
English: Aranesp 150 micrograms solution for injection in pre-filled syringe 0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 150 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,3 ml stungulyf, lausn (500 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: Aranesp 200 micrograms solution for injection in vial Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL).
Icelandic: Aranesp 200 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 200 míkrógrömm darbepoetin alfa í 1 ml (200 μg/ml).
English: Aranesp 30 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 130 míkrógrömm stungulyf, lausn í áfylltum penna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.6 mL pre-filled syringe contains 300 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,6 ml áfyllt sprauta inniheldur 300 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/035
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/035
English: Aranesp 20 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 20 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Icelandic: Sérlyfjaheiti þeirra rauðkornavaka (erythropoiesis-stimulating agents) sem notaðir eru á að skrá nákvæmlega í sjúkraskýrslu sjúklings til að bæta rekjanleika.
English: Aranesp 30 micrograms solution for injection in pre-filled pen 0.3 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 30 míkrógrömm stungulyf, lausn í áfylltum penna 0,3 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 60 micrograms solution for injection in pre-filled syringe 0.3 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 60 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,3 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 0.3 mL pre-filled pen contains 60 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,3 ml áfylltur penni inniheldur 60 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.6 mL pre-filled pen contains 300 micrograms darbepoetin alfa (500 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,6 ml áfylltur penni inniheldur 300 míkrógrömm darbepoetin alfa (500 míkrógrömm/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/040
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/040
English: Aranesp 100 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 100 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: EU/1/01/185/039 1 Pack Unblistered EU/1/01/185/086 1 blister pack with needle guard EU/1/01/185/087 4 blister pack with needle guard Aranesp 80 micrograms solution for injection pre-filled syringe EU/1/01/185/015 1 Pack Blister
Icelandic: Þynnupakkning með 4 sprautum EU/1/01/185/039 Pakkning, sem ekki er þynnupakkning, með 1 sprautu EU/1/01/185/086 Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/087 Þynnupakkning með 4 sprautum með nálarvörn Aranesp 80 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/01/185/015
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/055 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/055
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfyllt sprauta inniheldur 50 míkrógrömm darbepoetin alfa (100 míkrógrömm/ml).
English: • Pain around the area injected
Icelandic: 5 cm svæði í kringum naflann
English: EU/1/01/185/040 1 Pack Unblistered EU/1/01/185/088 1 blister pack with needle guard EU/1/01/185/089 4 blister pack with needle guard Aranesp 100 micrograms solution for injection pre-filled syringe EU/1/01/185/017 1 Pack Blister
Icelandic: Þynnupakkning með 4 sprautum EU/1/01/185/040 Pakkning, sem ekki er þynnupakkning, með 1 sprautu EU/1/01/185/088 Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/089 Þynnupakkning með 4 sprautum með nálarvörn Aranesp 100 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/01/185/017 Þynnupakkning með 1 sprautu EU/1/01/185/018
English: Aranesp 150 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 150 míkrógrömm stungulyf, lausn í áfylltum penna.
English: Aranesp 200 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 200 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: Aranesp 60 micrograms solution for injection in vial Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL).
Icelandic: Hvert hettuglas inniheldur 60 míkrógrömm darbepoetin alfa í 1 ml (60 μg/ml).
English: Aranesp 100 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 100 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: Aranesp 500 micrograms solution for injection in pre-filled pen 1 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 500 míkrógrömm stungulyf, lausn í áfylltum penna 1 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: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled pen contains 100 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfylltur penni inniheldur 100 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: NAME OF THE MEDICINAL PRODUCT Aranesp 60 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 60 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Aranesp 100 micrograms solution for injection in vial Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL).
Icelandic: Aranesp 100 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 100 míkrógrömm darbepoetin alfa í 1 ml (100 μg/ml).
English: Aranesp 80 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 80 míkrógrömm stungulyf, lausn í áfylltum penna.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 300 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 300 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Aranesp 30 micrograms solution for injection pre-filled pen EU/1/01/185/048 - 1 pack
Icelandic: Pakkning með 4 pennum Aranesp 15 míkrógrömm stungulyf, lausn í áfylltum penna EU/1/01/185/046 Pakkning með 1 penna EU/1/01/185/058
English: Aranesp 100 micrograms solution for injection in pre-filled pen 0.5 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 100 míkrógrömm stungulyf, lausn í áfylltum penna 0,5 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: • Keep used syringes out of the reach and sight of children.
Icelandic: Geymið notaðar sprautur þar sem börn hvorki ná til né sjá.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 20 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 20 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Aranesp 130 micrograms solution for injection in pre-filled pen 0.65 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 130 míkrógrömm stungulyf, lausn í áfylltum penna 0,65 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: NAME OF THE MEDICINAL PRODUCT Aranesp 15 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 15 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 40 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 500 µg injection
Icelandic: Aranesp 500 μg stungulyf
English: Aranesp 300 micrograms solution for injection in pre-filled pen 0.6 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 300 míkrógrömm stungulyf, lausn í áfylltum penna 0,6 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 30 micrograms solution for injection in pre-filled syringe 0.3 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 30 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,3 ml stungulyf, lausn (100 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Icelandic: Sprittþurrkur, bómullarhnoðra eða grisju, plástur og nálabox (fylgir ekki).
English: Aranesp 300 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 300 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: Aranesp 20 micrograms solution for injection in pre-filled syringe 0.5 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 20 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,5 ml stungulyf, lausn (40 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: Aranesp 60 micrograms solution for injection in vial 1 mL solution for injection (60 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 60 míkrógrömm stungulyf, lausn í hettuglasi 1 ml stungulyf, lausn (60 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/1/01/185/047 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/047
English: How do I prepare my Aranesp injection?
Icelandic: Hvernig á að undirbúa inndælingu
English: Aranesp 50 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 50 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: Aranesp 50 micrograms solution for injection in pre-filled syringe 0.5 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 50 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,5 ml stungulyf, lausn (100 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 25 micrograms solution for injection in vial Darbepoetin alfa
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi Darbepoetin alfa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON WITH TRAY
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ÁFYLLTRI SPRAUTU Í BAKKA
English: Aranesp 300 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Icelandic: Aranesp 300 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 3,79 mg af natríum.
English: Step 2: Get ready E Pull the grey cap straight off, only when you are ready to inject.
Icelandic: E Dragið gráu nálarhlífina beint af þegar allt er tilbúið til inndælingar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/048 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/048
English: The frequency is estimated from clinical trial data as common in cancer patients and was also common in the placebo groups.
Icelandic: Í klínískum rannsóknum hjá krabbameinssjúklingum er aukaverkunin metin sem algeng og einnig hjá lyfleysuhópunum.
English: Aranesp 200 micrograms solution for injection in vial 1 mL solution for injection (200 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 200 míkrógrömm stungulyf, lausn í hettuglasi 1 ml stungulyf, lausn (200 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: NAME OF THE MEDICINAL PRODUCT Aranesp 30 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 30 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY
Icelandic: Leiðbeiningar um einstaka hluti sprautunnar Fyrir notkun
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,5 ml áfyllt sprauta inniheldur 100 míkrógrömm darbepoetin alfa (200 míkrógrömm/ml).
English: NAME OF THE MEDICINAL PRODUCT Aranesp 50 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 50 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Aranesp 30 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 30 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 100 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 100 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Icelandic: Notkun epóetína til meðferðar á blóðleysi í tengslum við lifrarbólgu
English: 1 ADRs identified in the post marketing environment.
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis:
English: Keep the vial in the outer carton in order to protect from light.
Icelandic: Geymið hettuglasið í upprunalegum umbúðum til varnar gegn ljósi.
English: Aranesp 10 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 10 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,4 ml stungulyf, lausn (25 µg/ml darbepoetin alfa) í áfylltri sprautu úr gleri af gerð 1 með 27 gauge nál úr ryðfríu stáli.
English: Aranesp 500 micrograms solution for injection in pre-filled syringe 1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 500 míkrógrömm stungulyf, lausn í áfylltri sprautu 1 ml stungulyf, lausn (500 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 200 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 200 míkrógrömm darbepoetin alfa.
English: • Plaster
Icelandic: Plástur
English: EU/1/01/185/044 1 Pack Unblistered EU/1/01/185/098 1 blister pack with needle guard EU/1/01/185/099 4 blister pack with needle guard Aranesp 10 micrograms solution for injection pre-filled pen EU/1/01/185/045 - 1 pack
Icelandic: Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/099 Þynnupakkning með 4 sprautum með nálarvörn Aranesp 10 míkrógrömm stungulyf, lausn í áfylltum penna EU/1/01/185/045 Pakkning með 1 penna EU/1/01/185/057
English: Aranesp 300 micrograms solution for injection in pre-filled syringe 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Icelandic: Aranesp 300 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,6 ml stungulyf, lausn (500 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 100 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 100 míkrógrömm darbepoetin alfa.
English: Please tell your doctor if you are suffering or have suffered from: - high blood pressure which is being controlled with medicines prescribed by your doctor; - sickle cell anaemia; - epileptic fits (seizures); - convulsions (fits or seizures); - liver disease; - significant lack of response to medicines used to treat anaemia; or - hepatitis C.
Icelandic: - háan blóðþrýsting sem náðst hefur stjórn á með öðrum lyfjum sem læknirinn hefur ávísað, - sigðkornablóðleysi, - flogaköst, - krampa, - lifrarsjúkdóm, - ófullnægjandi svörun við lyfjum sem notuð eru við blóðleysi eða - lifrarbólgu C.
English: Aranesp 60 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 60 míkrógrömm stungulyf, lausn í áfylltum penna.
English: Aranesp 300 micrograms solution for injection in vial Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL).
Icelandic: Hvert hettuglas inniheldur 300 míkrógrömm darbepoetin alfa í 1 ml (300 μg/ml).
English: Upper arm Stomach area (abdomen)
Icelandic: Upphandleggur Magasvæði (kviður)
English: Aranesp 15 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 15 míkrógrömm stungulyf, lausn í áfylltum penna
English: Aranesp 130 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 130 míkrógrömm stungulyf, lausn í áfylltum penna
English: Aranesp 15 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Icelandic: Hver áfylltur penni inniheldur 15 míkrógrömm darbepoetin alfa í 0,375 ml (40 μg/ml).
English: Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
Icelandic: Leitast var við að ná blóðrauðagildi sem var > 13 g/dl í tveimur rannsóknum, í hinum þremur var leitast við að ná blóðrauðagildum sem voru 12-14 g/dl. Í opnu rannsókninni var enginn munur á heildarlifun sjúklinga sem voru meðhöndlaðir með raðbrigða manna erýtrópóetíni og viðmiðunarhópi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/050 1 pack
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/050
English: What Aranesp contains
Icelandic: Aranesp inniheldur
English: Aranesp 100 micrograms solution for injection in pre-filled syringe 0.5 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 100 míkrógrömm stungulyf, lausn í áfylltri sprautu 0,5 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 10 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 10 míkrógrömm stungulyf, lausn í áfylltum penna
English: d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, Face oedema e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, infusion site pain and vessel puncture site pain.
Icelandic: b Aukaverkunin blóðsegarek nær til kjörheitanna segarek, segamyndun, segamyndun í djúpum bláæðum, segarek í hóstarbláæð, bláæðasegarek, slagæðasegarek, segarek í bláæð í grindarholi, segamyndun í útlim, lungnasegarek svo og segarek vegna lækningatækis til hefðbundinnar meðferðar.
English: Pinch method
Icelandic: Amgen Technology
English: EU/1/01/185/042 1 Pack Unblistered EU/1/01/185/094 1 blister pack with needle guard EU/1/01/185/095 4 blister pack with needle guard Aranesp 300 micrograms solution for injection pre-filled syringe EU/1/01/185/021 1 Pack Blister
Icelandic: Þynnupakkning með 4 sprautum EU/1/01/185/042 Pakkning, sem ekki er þynnupakkning, með 1 sprautu EU/1/01/185/094 Þynnupakkning með 1 sprautu með nálarvörn EU/1/01/185/095 Þynnupakkning með 4 sprautum með nálarvörn
English: Aranesp 20 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 20 míkrógrömm stungulyf, lausn í áfylltum penna.
English: Aranesp 300 micrograms solution for injection in vial 1 mL solution for injection (300 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 300 míkrógrömm stungulyf, lausn í hettuglasi 1 ml stungulyf, lausn (300 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: LIST OF EXCIPIENTS
Icelandic: Ofanvert læri
English: Aranesp 40 micrograms solution for injection in pre-filled pen.
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í áfylltum penna.
English: Aranesp 40 micrograms solution for injection in vial 1 mL solution for injection (40 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 40 míkrógrömm stungulyf, lausn í hettuglasi 1 ml stungulyf, lausn (40 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: 0.6 ml (10 mg/ml)
Icelandic: Til notkunar undir húð áfyllt sprauta (gler) 0,6 ml (10 mg/ml)
English: EU Number
Icelandic: ESB númer
English: Solution for injection
Icelandic: Stungulyf, lausn
English: PC: {number} SN: {number} < NN: {number} >
Icelandic: PC: {númer} SN: {númer} < NN: {númer} >
English: - You should take only one tablet each time.
Icelandic: - Taktu aðeins eina töflu í hvert skipti.
English: FI-02200 Espoo Finland
Icelandic: FI-02200 Espoo Finnland
English: Your doctor may need to review your treatments.
Icelandic: Læknirinn gæti þurft að endurskoða meðferðina.
English: After that carry on as normal.
Icelandic: Þaðan í frá skaltu halda áfram samkvæmt venju.
English: This corresponded to an 8.3% increase in the proportion of daily ON time.
Icelandic: Þetta svaraði til 8,3% lengingar á hlutfalli daglegs ON tíma.
English: To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks.
Icelandic: Þegar glasið er opnað í fyrsta skipti: opnið lokið, og þrýstið á innsiglið með þumlinum þangað til það rofnar.
English: Not known (cannot be estimated from the available data)
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum):
English: Dose reduction may be needed (see section 5.2).
Icelandic: Verið getur að minnka þurfi skammta (sjá kafla 5.2).
English: [carton only]:
Icelandic: [einungis á öskju]:
English: Picture 1
Icelandic: Mynd 1
English: See picture 1.
Icelandic: Sjá mynd 1.
English: See section c.
Icelandic: Sjá kafla c.
English: In individual cases, only some of these symptoms and/or findings may be evident.
Icelandic: Í einstöku tilvikum kann að vera að einungis sum þessara einkenna og/eða mæligilda komi fram.
English: Each tablet is to be taken orally either with or without food (see section 5.2).
Icelandic: Taka á hverja töflu inn með eða án matar (sjá kafla 5.2).