natgillin/translations-raw huggingface dataset:
Each pack contains a pre-filled syringe of 0.3 ml and a needle
Eno pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,3 ml in iglo
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/018
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 µg/0,3 ml
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/012
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/024
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/017
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov metoksipolietilenglikol epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/022
NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 µg/0,3 ml
To remove air bubbles from the prefilled syringe, hold the syringe with the needle pointing up.
Držite injekcijsko brizgo z iglo obrnjeno navzgor, da boste odstranili zračne mehurčke iz injekcijske brizge.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov metoksipolietilenglikol epoetina beta.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/013
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 75 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 75 mikrogramov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 250 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 250 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/011
NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 200 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 250 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/020
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 100 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/019
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 200 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/021
NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
The median time to response was 43 days in the MIRCERA arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 0.2 g/dl/week and 0.3 g/dl/week, respectively.
V primerjalni skupini je mediana znašala 29 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 150 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL
NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 40 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/010
Water for injections
Odstranjevanje injekcijske brizge
NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 100 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
Cleansing alcohol swabs
alkoholni zloženci sterilna vata ali gaza
NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 60 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 60 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 40 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
• A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with erythropoiesis stimulating agents (ESAs), including MIRCERA.
Pred zdravljenjem z zdravilom MIRCERA · Pri nekaterih bolnikih, zdravljenih z zdravili za spodbujanje eritropoeze (ESA), vključno z zdravilom MIRCERA, so opazili stanje - imenovano čista aplazija rdečih krvnih celic (prekinjeno ali zmanjšano nastajanje rdečih krvnih celic), ki nastane zaradi protiteles proti eritropoetinu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 30 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 30 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 30 mikrogramov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 360 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 360 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 50 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 50 mikrogramov
Vascular access thrombosis
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
EU/1/19/1398/001 (pack of 1 vial) EU/1/19/1398/002 (pack of 5 vials) EU/1/19/1398/003 (pack of 10 vials)
EU/1/19/1398/001 (pakiranje z 1 vialo) EU/1/19/1398/002 (pakiranje s 5 vialami) EU/1/19/1398/003 (pakiranje z 10 vialami)
Hematologic complete remission (HCR)
Popolna hematološka remisija (HCR)
Absent Present Not evaluable
odsotna prisotna ni mogoče vrednotiti
95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide
95-% IZ za razliko, 2-22 odstotnih točk p < 0,001 za neinferiornost p = 0,02 za superiornost ATRA + arzenov trioksid
The results are summarised in the table 4 below.
Rezultati so povzeti v preglednici 4 spodaj.
Conventional Cytogenetics [t(15;17)]
Navadna citogenetika [t(15;17)]
The daily dose can be escalated back to 100% of the original dose if no prolongation occurs.
Dnevni odmerek lahko zvečate na 100 % prvotnega odmerka, če ne pride do podaljšanja.
1/1,000 to < 1/100), not known (cannot be estimated from available data).
≥ 1/100 do < 1/10), (občasni ≥1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Negative Positive Not evaluable
negativna pozitivna ni mogoče vrednotiti
- if you are taking or have recently taken any medicine which may affect your liver.
- če jemljete ali ste pred kratkim jemali katero koli zdravilo, ki lahko vpliva na jetra.
Kaplan-Meier estimates of 18-month survival for each study are shown below.
Ocena 18-mesečnega preživetja po metodi Kaplan-Meier za obe študiji je prikazana spodaj.
You must be sure to tell your doctor about all medicines you are taking.
Zdravnika morate obvezno obvestiti o vseh zdravilih, ki jih uporabljate.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leukocytosis, and no standard approach has proven effective.
Zdravila za zmanjševanje števila belih krvnih celic pogosto poslabšajo toksične učinke, povezane z levkocitozo, in nobena izmed standardnih metod se ni pokazala kot učinkovita.
If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section
- če ste alergični na arzenov trioksid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Each pack contains 1, 5 or 10 vials.
Eno pakiranje vsebuje 1, 5 ali 10 vial.
Concentrate for solution for infusion 1 vial of 10 ml (10 mg/10 ml) 5 vials of 10 ml (10 mg/10 ml) 10 vials of 10 ml (10 mg/10 ml)
koncentrat za raztopino za infundiranje 1 viala z 10 ml (10 mg/10 ml) 5 vial z 10 ml (10 mg/10 ml) 10 vial z 10 ml (10 mg/10 ml)
The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Varnost in učinkovitost arzenovega trioksida pri otrocih, mlajših od 17 let, nista bili dokazani.
In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
In vitro encimske študije človeških jetrnih mikrosomov so razkrile, da arzenov trioksid ne vpliva zaviralno na substrate večjih encimov citokroma P450 kot so 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
is large (>400 L) indicating significant distribution into the tissues with negligible protein binding.
Volumen porazdelitve (Vd) za AsIII je velik (> 400 l), kar kaže na značilno porazdelitev v tkivu z zanemarljivo vezavo na beljakovine.
It is for single use only, and any unused portions of each vial must be discarded properly.
Namenjeno je samo za enkratno uporabo in vso neuporabljeno zdravilo iz vsake viale morate ustrezno zavreči.
Peripheral neuropathy, characterised by paresthesia/dysesthesia, is a common and well known effect of environmental arsenic.
Periferna nevropatija, za katero je značilna parestezija/disestezija, je pogost in dobro znan učinek arzena v okolju.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX27.
Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction:
Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če opazite enega ali več od naslednjih neželenih učinkov, saj so lahko znak alergične reakcije:
Approximately 15% of the administered arsenic trioxide dose is excreted in the urine as unchanged AsIII.
Približno 15 % apliciranega odmerka arzenovega trioksida se izloči v seču kot nespremenjen AsIII.
Arsenic trioxide Accord is normally given by a doctor or a nurse.
Zdravilo Arzenov trioksid Accord vam bo običajno dal zdravnik ali medicinska sestra.
After first opening: Once opened the product should be used immediately.
Po prvem odprtju: po odprtju je treba zdravilo porabiti takoj.
RT-PCR for PML/ RARα
RT-PCR za PML/
Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Sistemska izpostavljenost MMAV in DMAV je bila večja pri bolnikih z okvarjenim delovanjem ledvic; klinične posledice tega niso znane, vendar zvečane toksičnosti niso opazili.
PVC-free plastic bags should be used.
Uporabljajte plastične vrečke brez PVC.
Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide.
Za učinkovine, ki so substrati encimov P450, se ne pričakuje, da bodo medsebojno delovale z arzenovim trioksidom.
If you experience discomfort or if you feel unwell after a Arsenic trioxide Accord injection, you should wait until the symptoms go away before driving or using machines.
Če čutite neugodje ali če se ne počutite dobro po injekciji zdravila Arzenov trioksid Accord, morate pred vožnjo ali upravljanjem strojev počakati, da simptomi izginejo.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
Za pogoje shranjevanja po redčenju ali prvem odprtju zdravila glejte poglavje 6.3.
- difficulty in breathing
- težko dihanje
In these studies, leukocytosis was not treated with chemotherapeutic medicinal products.
Levkocitoze v teh študijah niso zdravili s kemoterapevtiki.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
Arzenov trioksid je indiciran za indukcijo remisije in konsolidacijo pri odraslih bolnikih z:
Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called “differentiation syndrome”, which might be fatal:
Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če opazite naslednje neželene učinke, saj so lahko ti znaki resnega bolezenskega stanja, ki se imenuje 'sindrom diferenciacije'
Arsenic trioxide Accord is not recommended in children and adolescents below 18 years of age.
Zdravilo Arzenov trioksid Accord ni primerno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Each carton contains 1, 5 or 10 vials.
Ena škatla vsebuje 1, 5 ali 10 vial.
Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
Od 7 bolnikov, mlajših od 18 let (razpon od 5 do 16 let), ki so prejemali arzenov trioksid v priporočenem odmerku 0,15 mg/kg/dan, so pri 5 dosegli popoln odziv (glejte poglavje 4.2).
Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Neuporabljeno zdravilo, vse predmete, ki pridejo v stik z zdravilom, in odpadni material zavrzite v skladu z lokalnimi predpisi.
Arsenic trioxide Accord is supplied in glass vials as a concentrated, sterile, clear, colourless, aqueous solution .
Zdravilo Arzenov trioksid Accord je na voljo v steklenih vialah kot koncentrirana, sterilna, čista, brezbarvna, vodna raztopina.
Arsenic trioxide was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
Arzenov trioksid so dajali intravensko v trajanju 1-2 uri, dokler kostni mozeg ni bil brez levkemičnih celic, vendar največ 60 dni.
After first opening Once opened the product should be used immediately.
Po prvem odprtju Po odprtju je treba zdravilo porabiti takoj.
- Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in Arsenic trioxide Accord, may cause other cancers.
- Zdravnik bo tako med zdravljenjem kot po njem morda nadzoroval vaše zdravje, saj lahko arzenov trioksid, učinkovina v zdravilu Arzenov trioksid Accord, povzroči druge oblike raka.
It is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies.
Uporablja se pri odraslih bolnikih z na novo diagnosticirano akutno promielocitno levkemijo (APL) z nizkim do srednjim tveganjem in pri odraslih bolnikih, pri katerih druge oblike zdravljenja niso pomagale.
If you are pregnant or you become pregnant during the treatment with Arsenic trioxide Accord, you must ask your doctor for advice.
Če ste noseči ali med zdravljenjem z zdravilom Arzenov trioksid Accord zanosite, se morate posvetovati z zdravnikom.
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/min) was 40% lower when compared with patients with normal renal function (see section 4.4).
Očistek AsIII v plazmi bolnikov s hudo okvaro delovanja ledvic (očistek kreatinina pod 30 ml/min) je bil 40 % nižji v primerjavi z bolniki z normalnim delovanjem ledvic (glejte poglavje 4.4).
Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed.
Arzenov trioksid morate uporabljati pod nadzorom zdravnikov, izkušenih v zdravljenju akutnih levkemij in treba je upoštevati posebne nadzorne postopke, opisane v poglavju 4.4.
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3.
koncentrat za raztopino za infundiranje sterilna, bistra, brezbarvna vodna raztopina brez vidnih delcev z razponom pH 7,7-8,3
Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given.
Nato lahko uporabite penicilamin v odmerkih po ≤ 1 gram na dan.
Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.
Arzenov trioksid povzroča tudi poškodbe in razgradnjo fuzijske beljakovine receptorja za PML/RAR-alfa.
In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with arsenic trioxide.
V nadaljevalnem zdravljenju po konsolidaciji so 7 bolnikom iz enocentrične študije in 18 bolnikom iz multicentrične študije odredili nadaljnje zdravljenje z arzenovim trioksidom.
No formal assessments of pharmacokinetic interactions between arsenic trioxide and other therapeutic medicinal products have been conducted.
Uradne ocene farmakokinetičnih interakcij med arzenovim trioksidom in drugimi zdravili niso izvedli.
If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Če se podaljšanje intervala Q-Tc ne ponovi v 7 dneh po vnovičnem začetku zdravljenja z zmanjšanim odmerkom, lahko nadaljujete zdravljenje z arzenovim trioksidom z odmerkom 0,11 mg/kg telesne mase na dan še en teden.
While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions:
Med zdravljenjem z zdravilom Arzenov trioksid Accord boste morda imeli nekatere od naštetih učinkov:
Arsenic trioxide has no or negligible influence on the ability to drive and use machines.
Arzenov trioksid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/min) or moderate renal impairment (creatinine clearance of 30-49 mL/min).
Očistek AsIII v plazmi ni bil spremenjen pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50-80 ml/min) ali zmerno okvaro delovanja ledvic (očistek kreatinina 30-49 ml/min).
Type I transparent colorless glass vial sealed with a silicon-oil free, elastomer type, grey rubber stopper made of bromobutyl and aluminium seal with a plastic flip off cap containing 10 ml of concentrate.
Prosojna brezbarvna steklena viala tipa I s sivim elastomernim gumijastim zamaškom brez silikonskega olja, ki je narejen iz bromobutila, in aluminijasto zaporko s plastičnim snemljivim pokrovčkom, ki vsebuje 10 ml koncentrata.
The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
Vpliv arzenovega trioksida na učinkovitost drugih zdravil za levkemijo ni znan.
If this happens, treatment with Arsenic trioxide Accord must be stopped immediately and your doctor will treat the arsenic overdose.
Če se to zgodi, morate nemudoma prekiniti zdravljenje z zdravilom Arzenov trioksid Accord in zdravnik vas bo zdravil zaradi prevelikega odmerka arzena.
Arsenic trioxide Accord with food and drink
Zdravilo Arzenov trioksid Accord skupaj s hrano in pijačo
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes.
Pri bolnikih, ki prejemajo ali so prejemali zdravila, za katera je znano, da povzročajo hipokaliemijo ali hipomagneziemijo, kot so diuretiki ali amfotericin B, je večje tveganje nastanka aritmije Torsade de pointes.
The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord.
Učinek teh zdravil na vaš srčni ritem se lahko z uporabo zdravila Arzenov trioksid Accord še okrepi.