natgillin/translations-raw huggingface dataset:
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 40 mikrograma metoksi polietilenglikol-epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/020
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/010
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/011
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 100 mikrograma metoksi polietilenglikol-epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 150 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/019
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 100 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 40 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
Peel back the protective film from the plastic tray and remove the needle and the syringe, holding the syringe by the middle of the body without touching the release clips.
Odlijepite zaštitnu foliju s plastične plitice te izvadite iglu i štrcaljku.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 50 mikrograma metoksi polietilenglikol-epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 60 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
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.
Ukoliko je mjesečni porast hemoglobina manji od 1,0 g/dl (0,621 mmol/l) doza se smije povećati za otprilike 25% prethodne doze.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 30 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 50 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
thrombocytopenia thrombosis
• tromboza (začepljenje krvne žile krvnim ugruškom)
Step5.
PRILOG I.
1/1,000 to < 1/100), not known (cannot be estimated from available data).
< 1/100), te nepoznato (ne može se procijeniti iz dostupnih podataka).
RT-PCR for PML/ RARα
RT-PCR za PML/ RARα
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego što primite ovaj lijek jer sadrži Vama važne podatke.
Lutomierska 50, 95-200 Pabianice, Poland
Lutomierska 50, 95-200 Pabianice, Poljska
Conventional Cytogenetics [t(15;17)]
standardna citogenetika [t(15;17)]
The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Sigurnost i djelotvornost arsenovog trioksida u djece u dobi do 17 godina nisu ustanovljene.
*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
*U ispitivanju CALGB C9710, 2 slučaja stupnja ≥ 3 povećane GGT prijavljena su između 200
From a microbiological point of view, the product must be used immediately.
S mikrobiološkog stajališta, lijek se mora primijeniti odmah.
You may experience convulsions, muscle weakness and confusion.
Možete osjetiti konvulzije, slabost u mišićima i smetenost.
If you are not sure, show the bottle or pack to your doctor.
Ako niste sigurni, pokažite svom liječniku bocu lijeka ili njegovo pakiranje.
Ask your doctor or pharmacist for advice before taking any medicine.
Obratite se liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions:
Dok se liječite lijekom Arsenov trioksid Accord, možete osjetiti neke od sljedećih reakcija:
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX27 Mehanizam djelovanja
Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population.
Ozbiljne nuspojave bile su česte (1-10%) i nisu bile neočekivane za populaciju u fazi relapsa/refraktornoj na liječenje.
Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Osoblje mora biti obučeno za rukovanje i razrjeđivanje arsenovog trioksida te mora nositi odgovarajuću zaštitnu odjeću.
Arsenic trioxide Accord is normally given by a doctor or a nurse.
Lijek Arsenov trioksid Accord obično daje liječnik ili medicinska sestra.
Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord.
Vaš će liječnik poduzeti sljedeće mjere opreza: - Provest će se testovi kako bi se provjerila količina kalija, magnezija, kalcija i kreatinina u Vašoj krvi prije prve doze lijeka Arsenov trioksid Accord.
Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.
Arsenov trioksid također uzrokuje oštećenje ili degradaciju fuzijskog proteina PML/RAR alfa.
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:
Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava jer one mogu biti znakovi ozbiljnog stanja zvanog „sindrom diferencijacije” koji može biti smrtonosan:
The daily dose can be escalated back to 100% of the original dose if no prolongation occurs.
Dnevna doza može se ponovno povisiti na 100% prvobitne doze ako ne nastupi produljenje.
APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
Učestalosti se definiraju kao: (vrlo često ≥ 1/10), (često ≥ 1/100 i < 1/10), (manje često ≥ 1/1000 i
There are no data on the effect of arsenic trioxide on the QTc interval during the infusion.
Nema podataka o učinku arsenovog trioksida na interval QTc tijekom infuzije.
is large (>400 L) indicating significant distribution into the tissues with negligible protein binding.
Volumen distribucije (Vd) za AsIII je velik (> 400 l) što ukazuje na značajnu raspodjelu u tkiva sa zanemarivim vezivanjem na proteine.
It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.
Daje se kao drip (infuzija) u venu tijekom 1-2 sata, ali infuzija može trajati dulje ako se pojave nuspojave poput navale crvenila i omaglice.
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Trajanje infuzije može se produljiti do 4 sata ako se primijete vazomotoričke reakcije.
Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/µl) during induction, 4 of whom had values above 100,000/µl.
Dvadeset i sedam bolesnika je imalo leukocitozu (leukociti ≥ 10 x 103/µl) tijekom indukcije, a od njih su 4 imala vrijednosti iznad 100 000/µl.
Arsenic trioxide dose, mg/kg/day (median, range) Complete remission
Doza arsenovog trioksida, mg/kg/dan (medijan, raspon) Potpuna remisija
Each pack contains 1, 5 or 10 vials.
Pakiranje sadrži 1, 5 ili 10 bočica.
- If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously.
Ako ste pod rizikom od određenih tipova poremećenog srčanog ritma (primjerice, torsade de pointes ili produljenje QTc intervala), Vaše će srce biti pod stalnim nadzorom.
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.
Lijekovi koji se koriste za snižavanje leukocita često pojačaju toksičnosti povezane s leukocitozom, te se nijedan standardni pristup nije pokazao učinkovitim.
Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Ukupni arsen akumulira se uglavnom u jetri, bubrezima i srcu te u manjem opsegu u plućima, kosi i noktima.
Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide.
Ne očekuje se da će tvari koje su supstrati za ove enzime P450 stupiti u interakciju s arsenovim trioksidom.
Must be diluted before use.
Razrijediti prije uporabe.
For patients with severe, acute arsenic overdose, dialysis should be considered.
Za bolesnike s teškim, akutnim predoziranjem arsenom potrebno je uzeti u obzir dijalizu.
If you are pregnant or you become pregnant during the treatment with Arsenic trioxide Accord, you must ask your doctor for advice.
Ako ste trudni ili zatrudnite tijekom liječenja lijekom Arsenov trioksid Accord, obratite se svom liječniku za savjet.
Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord.
Liječnik će točno odrediti koliko dugo morate nastaviti liječenje lijekom Arsenov trioksid Accord.
Arsenic trioxide Accord with food and drink
Arsenov trioksid Accord s hranom i pićem
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.
Bolesnici koji primaju, ili koji su primali, lijekove za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju, poput diuretika ili amfotericina B, mogu biti pod većim rizikom od torsade de pointes.
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:
Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava jer one mogu biti znakovi alergijskih reakcija:
Patients with complete remission received consolidation therapy with arsenic trioxide for 25 additional doses over a 5 weeks period.
Bolesnici s potpunom remisijom primili su konsolidacijsku terapiju arsenovim trioksidom od 25 dodatnih doza u razdoblju od 5 tjedana.
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 otopinu za infuziju 1 bočica s 10 ml (10 mg/10 ml) 5 bočica s 10 ml (10 mg/10 ml) 10 bočica s 10 ml (10 mg/10 ml)
PVC-free plastic bags should be used.
Potrebno je upotrebljavati plastične vrećice za infuziju koje ne sadrže PVC.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
Uvjete čuvanja nakon razrjeđivanja ili prvog otvaranja lijeka vidjeti u dijelu 6.3.
If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose.
Ako se toksični događaj ne pojavi unutar 7 dana od ponovnog početka liječenja pri smanjenoj dozi, dnevna doza može se ponovno povećati na 100% početne doze.
Approximately 15% of the administered arsenic trioxide dose is excreted in the urine as unchanged AsIII.
Približno 15% primijenjene doze arsenovog trioksida izlučuje se u mokraći kao nepromijenjeni AsIII.
- Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with Arsenic trioxide Accord.
- Krvne pretrage (kalij, kalcij, magnezija i funkcija jetre) moraju se ponoviti tijekom liječenja lijekom Arsenov trioksid Accord.
In these studies, leukocytosis was not treated with chemotherapeutic medicinal products.
U ovim ispitivanjima, leukocitoza se nije liječila kemoterapeuticima.
Patients who experience such reactions that are considered arsenic trioxide related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption.
Bolesnici koji osjete takve reakcije koje se smatraju povezane s arsenovim trioksidom moraju nastaviti liječenje samo nakon rješavanja toksičnih događaja ili nakon oporavka na početno stanje abnormalnosti koje je uzrokovalo prekid liječenja.
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 bolesnika mlađih od 18 godina (raspon od 5 do 16 godina) koji su liječeni arsenovim trioksidom pri preporučenoj dozi od 0,15 mg/kg/dan, 5 bolesnika postiglo je potpuni odgovor (vidjeti dio 4.2).
The majority of patients do not require permanent termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome.
Većina bolesnika ne zahtijeva trajan prekid liječenja arsenovim trioksidom tijekom liječenja sindroma diferencijacije APL-a.
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
Arsenov trioksid indiciran je za indukciju remisije i konsolidaciju u odraslih bolesnika s:
Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given.
Nakon toga se može davati dnevna doza penicilamina ≤ 1 mg po danu.
- fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
- iznenadni porast tjelesne težine - zadržavanje vode - nesvjestica - palpitacije (snažni otkucaji srca koje možete osjetiti u prsima)
The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord.
Učinak tih lijekova na Vaše otkucaje srca može se pogoršati uzimanjem lijeka Arsenov trioksid
You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Nužno je da svaki put kada posjetite liječnika prijavite sve nove i izvanredne simptome i okolnosti.
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/1/19/1398/002 (pakiranje od 5 bočica) EU/1/19/1398/003 (pakiranje od 10 bočica)
What Arsenic trioxide Accord is and what it is used for
Što je Arsenov trioksid Accord i za što se koristi
It is recommended that chemotherapy not be added to treatment with steroids since there is no experience with administration of both steroids and chemotherapy during treatment of the leukocyte activation syndrome due to arsenic trioxide.
Preporučuje se da se kemoterapija ne dodaje liječenju steroidima jer nema iskustva s primjenom i steroida i kemoterapije tijekom liječenja sindroma aktivacije leukocita izazvanog arsenovim trioksidom.
Dilution: Carefully insert the needle of a syringe into the vial through the rubber stopper and draw up all of the content.
Razrjeđivanje: Pažljivo umetnite iglu štrcaljke u bočicu kroz gumeni čep te povucite nagore sav sadržaj.
Hepatotoxicity (grade 3-4)
Hepatotoksičnost (3.-4. stupnja)
Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i na kutiji.
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.
Koristi se u odraslih bolesnika s novodijagnosticiranom akutnom promijelocitnom leukemijom (APL) niskog do srednjeg rizika te u odraslih bolesnika čija bolest ne reagira na druga liječenja.
The key efficacy results are summarised in table 3 below:
Ključni rezultati djelotvornosti sažeti su u tablici 3 u nastavku Tablica 3
No data are available on patient with variant translocations like t(11;17) (PLZF/RAR alpha).
Nema dostupnih podataka o bolesniku s drugačijim translokacijama poput t(11;17) (PLZF/RAR alfa).
During therapy with arsenic trioxide, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Tijekom liječenja arsenovim trioksidom moraju se držati koncentracije kalija iznad 4 mEq/l, a magnezija iznad 1,8 mg/dl.
Induction treatment schedule
Raspored indukcijskog liječenja
Hydrochloric acid, concentrated (for pH adjustment) Water for injections
Kloridna kiselina, koncentrirana (za podešavanje pH) Voda za injekcije
What you need to know before you use Arsenic trioxide Accord
Što morate znati prije nego što primite Arsenov trioksid Accord
QT/QTc prolongation is expected during treatment with arsenic trioxide, and Torsade de pointes and complete heart block have been reported.
Produljenje intervala QT/QTc očekuje se tijekom liječenja arsenovim trioksidom, a prijavljeni su i torsade de pointes te potpuni srčani blok.
In such cases, treatment must resume at 50% of the preceding daily dose.
U takvim se slučajevima liječenje mora nastaviti s 50% prethodne dnevne doze.
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.
Arsenov trioksid primjenjivan je intravenski tijekom 1 do 2 sata sve dok koštana srž nije bila bez leukemičnih stanica, a maksimalno do 60 dana.
Arsenic trioxide Accord is supplied in glass vials as a concentrated, sterile, clear, colourless, aqueous solution .
Lijek Arsenov trioksid Accord dostupan je u staklenim bočicama u obliku koncentrirane, sterilne, bistre, bezbojne, vodene otopine.
If your doctor gives you more Arsenic trioxide Accord than he/she should
Ako primite više lijeka Arsenov trioksid Accord nego što ste trebali
AsIII is the pharmacologically active species of arsenic trioxide.
AsIII je farmakološki aktivni oblik arsenovog trioksida.
Contents of the pack and other information What Arsenic trioxide Accord contains
Sadržaj pakiranja i druge informacije Što lijek Arsenov trioksid Accord sadrži
Each course of consolidation was initiated at hematological recovery from the previous course defined as absolute neutrophil count >1.5×109/L and platelets >100×109/L.
Svaki ciklus konsolidacije započeo je pri hematološkom oporavku od prethodnog ciklusa definiranom kao apsolutni broj neutrofila > 1,5 × 10
Peripheral neuropathy, characterised by paresthesia/dysesthesia, is a common and well known effect of environmental arsenic.
Periferna neuropatija koju karakterizira parestezija/dizestezija čest je i dobro poznati učinak arsena iz okoliša.
Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia
Lijekovi za koje je poznato da uzrokuju produljenje QT/QTc intervala, hipokalemiju ili hipomagnezijemiju
After first opening: Once opened the product should be used immediately.
Nakon prvog otvaranja: Lijek se mora upotrijebiti odmah nakon otvaranja.
Only 2 relapsed/refractory APL patients discontinued treatment early due to this adverse event and one went on to receive additional arsenic trioxide on a subsequent protocol.
Samo su 2 bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje prekinula liječenje ranije zbog ovog štetnog događaja, a jedan je primio dodatni arsenov trioksid tijekom naknadnog protokola.
No formal assessments of pharmacokinetic interactions between arsenic trioxide and other therapeutic medicinal products have been conducted.
Nisu provedena službena ispitivanja farmakokinetičkih interakcija između arsenovog trioksida i drugih lijekova.
See section 2, “Arsenic trioxide Accord contains sodium”.
Pogledajte dio 2, „Lijek Arsenov trioksid Accord sadrži natrij“.
95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide
95% CI za razliku, 2-22 postotnih bodova p < 0,001 za neinferiornost p = 0,02 za superiornost kombinacije ATRA+ arsenov trioksid potpuna hematološka remisija (engl. hematologic complete remission, HCR)
There is no experience on the effect of arsenic trioxide on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Nema iskustva s učinkom arsenovog trioksida na varijante APL-a s kromosomskim translokacijama t(11;17) i t(5;17).
There are no restrictions on your food or drink while you are receiving Arsenic trioxide Accord.
Nema ograničenja vezanih uz uzimanje hrane i pića dok ste na terapiji lijekom Arsenov trioksid
200 patients who received arsenic trioxide consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.
bolesnika koji su primali konsolidacijske cikluse arsenovog trioksida (ciklus 1 i ciklus 2) dok u kontrolnoj skupini nije bilo nijednog slučaja.
Patients with acute promyelocytic leukaemia, whose disease has not responded to other therapies Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Bolesnici s akutnom promijelocitnom leukemijom čija bolest ne reagira na druge terapije Liječnik će Vam svakog dana jedanput dnevno davati lijek Arsenov trioksid Accord kao infuziju.
It is for single use only, and any unused portions of each vial must be discarded properly.
Lijek je namijenjen samo za jednokratnu primjenu i neiskorišteni dio svake bočice mora se odložiti na ispravan način.
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).
Plazmatski klirens AsIII u bolesnika s teškim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) bio je 40% niži u usporedbi s bolesnicima normalne bubrežne funkcije (vidjeti dio 4.4).