natgillin/translations-raw huggingface dataset:
Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL).
Aranesp 150 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 150 mikrograma darbepoetina alfa u 0,3 ml (500 μg/ml).
Aranesp 100 micrograms solution for injection pre-filled pen EU/1/01/185/053 - 1 pack
Aranesp 100 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/053 - pakiranje od 1
Aranesp 500 micrograms solution for injection in pre-filled syringe.
Aranesp 500 mikrograma otopina za injekciju u napunjenoj štrcaljki.
EU/1/01/185/109 4 pack
EU/1/01/185/109 pakiranje od 4
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled pen label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici napunjene brizgalice iza „Rok valjanosti“/EXP.
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.
Aranesp 200 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (200 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL).
Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 20 mikrograma darbepoetina alfa u 0,5 ml (40 μg/ml).
Aranesp 40 micrograms solution for injection in vial Each vial contains 40 micrograms of darbepoetin alfa in 1 mL (40 mcg/mL).
Aranesp 40 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 40 mikrograma darbepoetina alfa u 1 ml (40 µg/ml).
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,375 ml sadrži 15 mikrograma darbepoetina alfa (40 mikrograma/ml).
Aranesp 40 micrograms solution for injection vial EU/1/01/185/102 1 Pack
Aranesp 40 mikrograma otopina za injekciju u bočici EU/1/01/185/102 pakiranje od 1
Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL).
Aranesp 60 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 60 mikrograma darbepoetina alfa u 0,3 ml (200 μg/ml).
NAME OF THE MEDICINAL PRODUCT Aranesp 200 micrograms solution for injection in vial Darbepoetin alfa
Aranesp 200 mikrograma otopina za injekciju u bočici darbepoetin alfa
Aranesp 300 micrograms solution for injection vial EU/1/01/185/110 1 Pack
Aranesp 300 mikrograma otopina za injekciju u bočici EU/1/01/185/110 pakiranje od 1
Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL).
Aranesp 130 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 130 mikrograma darbepoetina alfa u 0,65 ml (200 μg/ml).
Oedemad
Edemd
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/039
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/039
Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL).
Aranesp 500 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 500 mikrograma darbepoetina alfa u 1 ml (500 μg/ml).
Aranesp 150 micrograms solution for injection in pre-filled syringe.
Aranesp 150 mikrograma otopina za injekciju u napunjenoj štrcaljki.
INFORMATION IN BRAILLE Aranesp 60 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 60 štrcaljka
INFORMATION IN BRAILLE Aranesp 80 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 80 brizgalica
EU/1/01/185/066 4 pack
EU/1/01/185/066 pakiranje od 4
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 100 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 100 mikrograma darbepoetina alfa.
EU/1/01/185/073 - 4 pack
EU/1/01/185/073 - pakiranje od 4
INFORMATION IN BRAILLE Aranesp 50 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 50 štrcaljka
EU/1/01/185/101 4 pack
EU/1/01/185/101 pakiranje od 4
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,4 ml sadrži 10 mikrograma darbepoetina alfa (25 mikrograma/ml).
Aranesp 15 micrograms solution for injection in pre-filled syringe.
Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki.
Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL).
Aranesp 10 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 10 mikrograma darbepoetina alfa u 0,4 ml (25 μg/ml).
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled pen contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica od 0,375 ml sadrži 15 mikrograma darbepoetina alfa (40 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/106 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/106 pakiranje od 1
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 300 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 300 mikrograma darbepoetina alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,4 ml sadrži 40 mikrograma darbepoetina alfa (100 mikrograma/ml).
Aranesp 60 micrograms solution for injection in pre-filled syringe.
Aranesp 60 mikrograma otopina za injekciju u napunjenoj štrcaljki.
EU/1/01/185/103 4 pack
EU/1/01/185/103 pakiranje od 4
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.
Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki 0,375 ml otopine za injekciju (40 μg/ml darbepoetina alfa) u napunjenoj štrcaljki od stakla tipa 1 s iglom od 27 gauge od nehrđajućeg čelika.
EU/1/01/185/014 4 Pack Blister
EU/1/01/185/014 pakiranje od 4
Aranesp 10 micrograms solution for injection in pre-filled syringe.
Aranesp 10 mikrograma otopina za injekciju u napunjenoj štrcaljki.
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.
Aranesp 40 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (40 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
EU/1/01/185/059 4 pack
EU/1/01/185/059 pakiranje od 4
NAME OF THE MEDICINAL PRODUCT Aranesp 150 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 150 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
EU/1/01/185/058 - 4 pack
EU/1/01/185/058 - pakiranje od 4
INFORMATION IN BRAILLE Aranesp 15 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 15 brizgalica
EU/1/01/185/059 - 4 pack
EU/1/01/185/059 - pakiranje od 4
INFORMATION IN BRAILLE Aranesp 20 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 20 brizgalica
INFORMATION IN BRAILLE Aranesp 500 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 500 brizgalica
EU/1/01/185/061 4 pack
EU/1/01/185/061 pakiranje od 4
EU/1/01/185/058 4 pack
EU/1/01/185/058 pakiranje od 4
NAME OF THE MEDICINAL PRODUCT Aranesp 500 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 500 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/043
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/043
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,3 ml sadrži 30 mikrograma darbepoetina alfa (100 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/072 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/072 pakiranje od 1
Aranesp 20 micrograms solution for injection in pre-filled syringe.
Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki.
Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Aranesp 150 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1,14 mg natrija u 0,3 ml.
Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1,52 mg natrija u 0,4 ml.
Aranesp 100 micrograms solution for injection in vial 1 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover.
Aranesp 100 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (100 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
Aranesp 60 micrograms solution for injection vial EU/1/01/185/104 1 Pack
Aranesp 60 mikrograma otopina za injekciju u bočici EU/1/01/185/104 pakiranje od 1
Aranesp 40 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Aranesp 40 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 3,79 mg natrija.
Aranesp 200 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Aranesp 200mikrograma otopina za injekciju u bočici Svaka bočica sadrži 3,79 mg natrija.
EU/1/01/185/066 - 4 pack
EU/1/01/185/066 - pakiranje od 4
EU/1/01/185/022 4 Pack Blister
EU/1/01/185/022 pakiranje od 4
INFORMATION IN BRAILLE Aranesp 30 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 30 brizgalica
Belly
Nuspojava
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.
Aranesp 300 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (300 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
Aranesp 80 micrograms solution for injection in pre-filled syringe.
Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki.
Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL).
Aranesp 50 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mikrograma darbepoetina alfa u 0,5 ml (100 μg/ml).
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.
Aranesp 60 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (60 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/102 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/102 pakiranje od 1
Aranesp 130 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 2.46 mg of sodium in 0.65 mL.
Aranesp 130 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 2,46 mg natrija u 0,65 ml.
Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL).
Aranesp 100 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 100 mikrograma darbepoetina alfa u 0,5 ml (200 μg/ml).
INFORMATION IN BRAILLE Aranesp 100 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 100 brizgalica
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.65 mL pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,65 ml sadrži 130 mikrograma darbepoetina alfa (200 mikrograma/ml).
Aranesp 40 micrograms solution for injection in pre-filled syringe.
Aranesp 40 mikrograma otopina za injekciju u napunjenoj štrcaljki.
Aranesp 50 micrograms solution for injection pre-filled pen EU/1/01/185/050 - 1 pack
Aranesp 50 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/050 - pakiranje od 1
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/108 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/108 pakiranje od 1
When your pen 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.
Jednom kad se brizgalica izvadi iz hladnjaka i ostavi prije injiciranja na sobnoj temperaturi približno 30 minuta, mora se ili primijeniti u roku 7 dana ili zbrinuti.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/038
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/038
Aranesp 60 micrograms solution for injection pre-filled pen EU/1/01/185/051 - 1 pack
Aranesp 60 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/051 - pakiranje od 1
NAME OF THE MEDICINAL PRODUCT Aranesp 15 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 20 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
EU/1/01/185/062 4 pack
EU/1/01/185/062 pakiranje od 4
Aranesp 300 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 2.27 mg of sodium in 0.6 mL.
Aranesp 300 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 2,27 mg natrija u 0,6 ml.
Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL).
Aranesp 300 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 300 mikrograma darbepoetina alfa u 0,6 ml (500 μg/ml).
For patients treated with Aranesp once every two weeks, after the target haemoglobin has been achieved, Aranesp may then be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Aranesp se tada može primjenjivati supkutano jednom mjesečno, uz početnu dozu koja je dvostruko veća od prethodne, primijenjene jednom svaka 2 tjedna.
Aranesp 60 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Aranesp 60 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 3,79 mg natrija.
Vascular disorders
Tromboembolijski događajic
SC
K
NAME OF THE MEDICINAL PRODUCT Aranesp 40 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 40 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/037
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/037
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,5 ml sadrži 20 mikrograma darbepoetina alfa (40 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/042
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/042
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 1 ml sadrži 500 mikrograma darbepoetina alfa (500 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/104 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/104 pakiranje od 1
Aranesp 100 micrograms solution for injection vial EU/1/01/185/106 1 Pack
Aranesp 100 mikrograma otopina za injekciju u bočici EU/1/01/185/106 pakiranje od 1
EU/1/01/185/073 4 pack
EU/1/01/185/073 pakiranje od 4
NAME OF THE MEDICINAL PRODUCT Aranesp 300 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 300 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
Do not use this medicine after the expiry date which is stated on the carton and on the vial label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza „Rok valjanosti“/EXP.
NAME OF THE MEDICINAL PRODUCT Aranesp 10 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 10 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
NAME OF THE MEDICINAL PRODUCT Aranesp 60 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 60 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/044
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/044
EU/1/01/185/067 4 pack
EU/1/01/185/067 pakiranje od 4
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/049 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/049 pakiranje od 1
INFORMATION IN BRAILLE Aranesp 100 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 100 štrcaljka
Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Aranesp 60 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1,14 mg natrija u 0,3 ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/047 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/047 pakiranje od 1
Aranesp 130 micrograms solution for injection in pre-filled syringe.
Aranesp 130 mikrograma otopina za injekciju u napunjenoj brizgalici.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/046 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/046 pakiranje od 1
Aranesp 300 micrograms solution for injection in pre-filled syringe.
Aranesp 300 mikrograma otopina za injekciju u napunjenoj brizgalici.
NAME OF THE MEDICINAL PRODUCT Aranesp 80 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
Aranesp 500 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL).
Aranesp 500 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 500 mikrograma darbepoetina alfa u 1 ml (500 µg/ml).
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.
Aranesp 10 mikrograma otopina za injekciju u napunjenoj štrcaljki 0,4 ml otopine za injekciju (25 μg/ml darbepoetina alfa) u napunjenoj štrcaljki od stakla tipa 1 s iglom od 27 gauge od nehrđajućeg čelika.
EU/1/01/185/068 - 4 pack
EU/1/01/185/068 - pakiranje od 4
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica od 0,4 ml sadrži 10 mikrograma darbepoetina alfa (25 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/036
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/036
NAME OF THE MEDICINAL PRODUCT Aranesp 30 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 30 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
Aranesp 50 micrograms solution for injection in pre-filled syringe.
Aranesp 50 mikrograma otopina za injekciju u napunjenoj štrcaljki.
Aranesp 100 micrograms solution for injection in pre-filled syringe.
Aranesp 100 mikrograma otopina za injekciju u napunjenoj štrcaljki.
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.
Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki 0,5 ml otopine za injekciju (40 μg/ml darbepoetina alfa) u napunjenoj štrcaljki od stakla tipa 1 s iglom od 27 gauge od nehrđajućeg čelika.
The frequency is estimated from clinical trial data as uncommon in CRF patients.
Učestalost je procijenjena iz podataka kliničkog ispitivanja kao manje često kod bolesnika s kroničnim zatajenjem bubrega.
NAME OF THE MEDICINAL PRODUCT Aranesp 130 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Aranesp 130 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
INFORMATION IN BRAILLE Aranesp 50 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 50 brizgalica
Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1,90 mg natrija u 0,5 ml.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
U redovitim razmacima mora se mjeriti broj trombocita i razinu hemoglobina.
Aranesp 100 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Aranesp 100 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 3,79 mg natrija.
EU/1/01/185/062 - 4 pack
EU/1/01/185/062 - pakiranje od 4
EU/1/01/185/105 4 pack
EU/1/01/185/105 pakiranje od 4
EU/1/01/185/057 - 4 pack
EU/1/01/185/057 - pakiranje od 4
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.
Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki 0,4 ml otopine za injekciju (200 μg/ml darbepoetina alfa) u napunjenoj štrcaljki od stakla tipa 1 s iglom od 27 gauge od nehrđajućeg čelika.
INFORMATION IN BRAILLE Aranesp 60 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 60 brizgalica
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,3 ml sadrži 150 mikrograma darbepoetina alfa (500 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/041
12. BROJ(EVI) odobrenja za stavljanje lijeka u promet EU/1/01/185/041
INFORMATION IN BRAILLE Aranesp 10 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 10 brizgalica
Finger grips Syringe label Syringe barrel
Etiketa na štrcaljki Spremnik štrcaljke
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/035
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/035
STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka od 0,3 ml sadrži 60 mikrograma darbepoetina alfa (200 mikrograma/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/033
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/033
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/048 1 pack
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/048 pakiranje od 1
EU/1/01/185/064 4 pack
EU/1/01/185/064 pakiranje od 4