natgillin/translations-raw huggingface dataset:
No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Raziskave na živalih niso pokazale škodljivih vplivov na brejost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Four randomized controlled studies were performed in dialysis patients currently treated with darbepoetin alfa or epoetin at the time of enrollment.
Pri dializnih bolnikih, ki so se v času vključevanja v raziskavo zdravili z darbepoetinom alfa ali epoetinom, so opravili štiri randomizirane kontrolirane klinične raziskave.
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Če se koncentracija hemoglobina še vedno povečuje, zdravljenje prekinite, dokler koncentracija hemoglobina ne začne padati.
Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, repeat dose toxicity and reproductive toxicity.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih raziskav o farmakološki varnosti za srce in ožilje, toksičnosti ob ponavljajočih se odmerkih in vplivu na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Do not move the needle while it is inserted in the skin
Medtem ko je igla zapičena v koži, je ne premikajte.
Treatment of symptomatic anaemia in adult chronic kidney disease patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni,
A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
V kliničnih preskušanjih so opazili rahel padec števila trombocitov, ki pa je ostal v mejah normale.
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Varnosti in učinkovitosti zdravljenja z zdravilom MIRCERA niso raziskali pri drugih indikacijah,
A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PRILOGA II A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA
Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
učinkovina zdravila MIRCERA, je stalni aktivator eritropoetinskega receptorja, ki ima v primerjavi z eritropoetinom drugačno delovanje na ravni receptorja.
Keep the syringe in the box to protect it from light and allow it to reach room temperature for at least 30 minutes.
Škatlo pustite zunaj hladilnika vsaj 30 minut, da se segreje na sobno temperaturo.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F).
Vedno shranjujte injekcijsko brizgo v hladilniku pri temperaturi od 2-8 °C.
Sterile cotton ball or gauze Puncture-resistant container or sharps container for safe disposal of needle and used syringe
Vsebnik za odpadni material, ki je odporen proti vbodom za varno odlaganje uporabljene injekcijske brizge in igle.
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).
Zdravljenje simptomatske anemije, povezane s kronično ledvično boleznijo pri odraslih bolnikih
In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
V primeru potrditve diagnoze zdravljenje z zdravilom MIRCERA ukinemo, bolnikov pa naj ne bi prevedli na druga zdravila za stimulacijo eritropoeze.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l).
Do not shake
Ne zamrzujte
If signs and symptoms suggestive of these reactions appear, Mircera should be withdrawn immediately and an alternative treatement considered.If the patient has developed a severe cutaneous skin reaction such as SJS orTEN due to the use of Mircera, treatment with ESA must not be restarted in this patient at any time.
Če se pojavijo znaki in simptomi, ki nakazujejo na te reakcije, je treba zdravilo Mircera takoj ukiniti in razmisliti o alternativnem zdravljenju.
The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month.
Če se je koncentracija hemoglobina v enem mesecu povečala za manj kot 1,0 g/dl (0,621 mmol/l),
INFORMATION IN BRAILLE mircera 75 mcg
PODATKI V BRAILLOVI PISAVI mircera 75 mcg
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
MIRCERA z odmerjanjem enkrat na mesec v eni intravenski ali subkutani injekciji.
INFORMATION IN BRAILLE mircera 120 mcg
PODATKI V BRAILLOVI PISAVI mircera 120 mcg
Tell your doctor if you are breast-feeding or intend to breast-feed.
Obvestite zdravnika, če dojite ali nameravate dojiti.
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/h per kg.
Po intravenskem dajanju pri dializnih bolnikih s kronično ledvično boleznijo je skupni sistemski očistek znašal 0,494 ml/h na kg. Razpolovni čas izločanja po intravenskem vnosu metoksipolietilenglikol epoetina beta znaša 134 ur.
Throw away used syringes in a puncture-resistant container.
Uporabljene injekcijske brizge zavrzite v vsebnik, odporen proti vbodom.
INFORMATION IN BRAILLE mircera 360 mcg
PODATKI V BRAILLOVI PISAVI mircera 360 mcg
Elderly population
Starejši
Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.
· Zdravi ljudje ne smejo prejemati zdravila MIRCERA, ker bi lahko pretirano povečalo njihovo koncentracijo hemoglobina in povzročilo težave s srcem ali krvnimi žilami, ki so lahko življenjsko nevarne.
Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained.
Dokler bolniki ne dosežejo svojih ciljnih koncentracij hemoglobina, lahko odmerek povečujete po približno 25 % v mesečnih presledkih.
In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
Število trombocitov v izhodišču pod 100 x 109/l je bilo prisotno pri 2,1 % bolnikov v skupini z zdravilom MIRCERA in 2,4 % bolnikov v skupini z drugimi zdravili za stimulacijo eritropoeze.
There have been reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting.
Po prihodu zdravila na trg so poročali o številu trombocitov, ki je bilo nižje od normalne ravni (trombocitopenija).
INFORMATION IN BRAILLE mircera 200 mcg
PODATKI V BRAILLOVI PISAVI mircera 200 mcg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 360 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 360 mikrogramov napolnjena injekcijska brizga
One pre-filled syringe contains: 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
Ena napolnjena injekcijska brizga vsebuje: 30, 40, 50, 60, 75, 100, 120, 150, 200 ali 250 mikrogramov učinkovine v 0,3 ml in 360 mikrogramov učinkovine v 0,6 ml. · Pomožne snovi so natrijev dihidrogenfosfat monohidrat, natrijev sulfat, manitol (E 421), metionin, poloksamer 188 in voda za injekcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 75 mikrogramov napolnjena injekcijska brizga
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 360 mcg/0.6 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 360 µg/0,6 ml
Attach the needle to the syringe by pushing it firmly onto the syringe.
Na injekcijsko brizgo pritrdite iglo, tako da ju trdno pritisnete skupaj.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 75 µg/0,3 ml
Immediately throw away the needle cap in the sharps/ puncture-resistant container or sharps container.
Pokrovček igle nemudoma zavrzite v vsebnik za odpadni material, ki je odporen proti vbodom.
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 833 micrograms/ml.
MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 833 mikrogramov/ml.
· Do not remove the needle shield that protects the needle.
· Zaščite na igli ne odstranite.
• hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).
zbadajoč glavobol podoben migreni, zmedenost, motnje govora, epileptični napad ali krče); · pljučni embolizem; · makulopapulozni izpuščaj (rdeča kožna reakcija, ki lahko vključuje mozolje ali pege); · vročinski oblivi; · preobčutljivost (alergična reakcija, ki lahko povzroči nenavadno piskanje ali težave z dihanjem; otekel jezik, obraz ali grlo ali oteklino okoli mesta injiciranja; ali pa se lahko počutite omotično, omedlite ali pa se zgrudite).
Attach the needle to the syringe
Korak 4: Pritrdite iglo na injekcijsko brizgo
Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles
Eno pakiranje vsebuje 3 napolnjene injekcijske brizge za enkratno uporabo po 0,3 ml in 3 igle
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micgrograms/ml
MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 667 mikrogramov/ml.
This leaflet was last revised in {MM/YYYY}..
Navodilo je bilo odobreno {MM/LLLL}
• It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count.
(motnja povezana z nenormalnim hemoglobinom), krvavitvijo v preteklosti ali sedanjosti,
INFORMATION IN BRAILLE mircera 250 mcg
PODATKI V BRAILLOVI PISAVI mircera 250 mcg
Do NOT use the syringe if: · You have accidentally dropped the syringe.
NE uporabite injekcijske brizge, če:
INFORMATION IN BRAILLE mircera 150 mcg
PODATKI V BRAILLOVI PISAVI mircera 150 mcg
(b) Tabulated list of adverse reactions
(b) Neželeni učinki, prikazani v preglednici
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml.
MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 500 mikrogramov/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 120 µg/0,3 ml
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml
MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 75 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 250 mikrogramov/ml.
PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection).
FARMACEVTSKA OBLIKA raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) Raztopina je bistra in brezbarvna do rahlo rumenkasta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 120 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 120 mikrogramov napolnjena injekcijska brizga
INFORMATION IN BRAILLE mircera 30 mcg
PODATKI V BRAILLOVI PISAVI mircera 30 mcg
• If you are a patient with chronic renal failure, and particularly if you do not respond properly to MIRCERA, your doctor will check your dose of MIRCERA because repeatedly increasing your dose of MIRCERA if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
· Če ste bolnik s kronično ledvično odpovedjo, in še posebej, če se ne odzivate ustrezno na zdravilo Mircera, bo zdravnik preveril vaš odmerek zdravila Mircera.
INFORMATION IN BRAILLE mircera 40 mcg
PODATKI V BRAILLOVI PISAVI mircera 40 mcg
INFORMATION IN BRAILLE mircera 60 mcg
PODATKI V BRAILLOVI PISAVI mircera 60 mcg
Each pack contains a pre-filled syringe of 0.6 ml and a needle
Pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,6 ml in iglo
A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.
Smernice za ustrezno prilagajanje odmerkov, ko koncentracija hemoglobina preseže 12 g/dl (7,45 mmol/l), so opisane spodaj.
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml.
MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 167 mikrogramov/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 µg/0,3 ml
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3).
porod ali postnatalni razvoj; reverzibilno zmanjšanje plodove teže (glejte poglavje 5.3) pa nakazuje povezavo s to skupino zdravil.
INFORMATION IN BRAILLE mircera 100 mcg
PODATKI V BRAILLOVI PISAVI mircera 100 mcg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 250 microgram pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 250 mikrogramov napolnjena injekcijska brizga
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 75 mikrogramov metoksipolietilenglikol epoetina beta.
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 400 micrograms/ml.
MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 120 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 400 mikrogramov/ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/008
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta*at a concentration of 600 micrograms/ml.
MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 360 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 600 mikrogramov/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 200 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 150 microgram pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 150 mikrogramov napolnjena injekcijska brizga
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 µg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 75 mikrogramov
How to store MIRCERA
Shranjevanje zdravila MIRCERA
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 360 mikrogramov metoksipolietilenglikol epoetina beta.
INFORMATION IN BRAILLE mircera 50 mcg
PODATKI V BRAILLOVI PISAVI mircera 50 mcg
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml.
MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 133 mikrogramov/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 µg/0,3 ml
Skin and subcutaneous disorders
Bolezni kože in podkožja redki makulopapulozni izpuščaj neznana
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov napolnjena injekcijska brizga
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/009
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 100 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov napolnjena injekcijska brizga
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 120 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 360 mg/0,6 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
Do not freeze
Ne stresajte
Step 6.
Korak 6: Injiciranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 40 mikrogramov napolnjena injekcijska brizga
NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ml
MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 100 mikrogramov/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 µg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 60 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ml.
MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 333 mikrogramov/ml.
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 200 micrograms/ml.
MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 200 mikrogramov/ml.
Only one dose should be administered per syringe.
Iz ene napolnjene injekcijske brizge lahko odvzamemo le en odmerek.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 120 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 120 mikrogramov
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 µg/0,3 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 75 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 µg/0,3 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 120 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Napolnjena injekcijska brizga je pripravljena za uporabo.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/023
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov metoksipolietilenglikol epoetina beta.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 150 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 150 mikrogramov
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov metoksipolietilenglikol epoetina beta.