FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Slovenian: Filmska obloga: polivinilalkohol titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) smukec makrogol 3000 (polietilenglikol)
English: Clopidogrel dura contains hydrogenated castor oil This may cause stomach upset and diarrhoea.
Slovenian: Zdravilo Klopidogrel dura vsebuje hidrogenirano ricinusovo olje, To lahko povzroči želodčne motnje ali drisko.
English: Blood and the lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija,
English: Do not stop the treatment unless your doctor tells you so.
Slovenian: Če ste prenehali jemati zdravilo Klopidogrel dura Ne prekinite zdravljenja razen, če tako odloči zdravnik.
English: It may be given with or without food.
Slovenian: Način uporabe peroralna uporaba Bolnik lahko zdravilo vzame s hrano ali brez nje.
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Slovenian: prostora bronhospazem, intersticijski pnevmonitis, eozinofilna pljučnica
English: Clopidogrel dura is unlikely to affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel dura vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Slovenian: hematomi (neobičajne krvavitve ali modrice pod kožo), krvavitev iz nosu, kri v seču.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel dura 75 mg film-coated tablets
Slovenian: IME ZDRAVILA Klopidogrel dura 75 mg filmsko obložene tablete
English: This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Slovenian: Pomožne snovi Zdravilo vsebuje hidrogenirano ricinusovo olje, ki lahko razdraži želodec in povzroči drisko.
English: If you forget to take Clopidogrel dura:
Slovenian: Če ste pozabili vzeti zdravilo Klopidogrel dura
English: Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Slovenian: Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Nemčija
English: Clopidogrel dura 75 mg film-coated tablets clopidogrel
Slovenian: Klopidogrel dura 75 mg filmsko obložene tablete klopidogrel
English: Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Slovenian: • Okvara ledvic Terapevtske izkušnje pri bolnikih z ledvično okvaro so omejene (glejte poglavje 4.4).
English: The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
Slovenian: Sočasno dajanje klopidogrela in peroralnih antikoagulantov se ne priporoča, ker se lahko okrepi krvavitev (glejte poglavje 4.5).
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Slovenian: nevtropenija, vključno s hudo nevtropenijo trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, pridobljena hemofilija A, granulocitopenija, anemija
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Slovenian: • če pri vas obstaja tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (rana na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa), - nedavna huda poškodba, - nedavni kirurški poseg (tudi na zobeh), - načrtovan kirurški poseg (tudi na zobeh) v naslednjih sedmih dneh;
English: The most common side effect reported is bleeding.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali med zdravljenjem z zdravilom Klopidogrel dura je krvavitev.
English: The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Slovenian: V študiji CAPRIE so primerjali klopidogrel in ASA, v študijah CURE, CLARITY in COMMIT pa klopidogrel in placebo; bolniki so oboje dobivali v kombinaciji z ASA in drugo standardno terapijo.
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Klopidogrel dura, kot bi smeli Zaradi povečanega tveganja za krvavitev se posvetujte s svojim zdravnikom ali z medicinskim osebjem na najbližjem oddelku nujne medicinske pomoči.
English: - heparin, or any other injectable medicine used to reduce blood clotting, - omeprazole, esomeprazole or cimetidine, medicines to treat for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and
Slovenian: • omeprazol, esomeprazol ali cimetidin, zdravila za zdravljenje težav z želodcem, • flukonazol, vorikonazol, ciprofloksacin ali klorampfenikol, zdravila za zdravljenje bakterijskih in
English: Clopidogrel dura 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel dura 75 mg
English: Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: • Odrasli in starejši bolniki Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Nemčija
English: If you get any side effects, talk to your doctor or pharmacist .
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: The active substance is clopidogrel.
Slovenian: Zdravilna učinkovina je klopidogrel.
English: While you are taking Clopidogrel dura:
Slovenian: Ko jemljete zdravilo Klopidogrel dura:
English: If you are breast-feeding or planning to breastfeed, talk to your doctor before taking this medicine.
Slovenian: Če dojite ali nameravate dojiti, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: Method of administration For oral use
Slovenian: NAVODILA ZA UPORABO
English: - Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Dura contains hydrogenated castor oil') - Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Slovenian: - Obloga tablete: polivinilalkohol, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), smukec ter makrogol 3000.
English: Marketing Authorisation Holder Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Slovenian: Imetnik dovoljenja za promet z zdravilom Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Nemčija.
English: The other ingredients are:
Slovenian: Druga zdravila:
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Slovenian: KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija.
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Slovenian: Pred vsakim načrtovanim kirurškim posegom in preden vzamejo katero koli novo zdravilo, morajo bolniki zdravnika in zobozdravnika obvestiti, da jemljejo klopidogrel.
English: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Slovenian: Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): glavobol, razjeda na želodcu, bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, občutek mravljinčenja in omrtvelosti.
English: If you forget to take a dose of Clopidogrel dura, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
English: Haematoma
Slovenian: Dojenje
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost, kar so znaki redkega zmanjšanja števila določenih krvnih celic; - znaki jetrnih težav, npr. porumenelost kože in/ali oči (zlatenica), ki so lahko povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 »Opozorila in previdnostni ukrepi«); - otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži kar so lahko znaki alergijske reakcije.
English: Tel: +33 4 37 25 75 00
Slovenian: Mylan SAS Tel: +33 4 37 25 75 00
English: Clopidogrel dura is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Slovenian: Proces je znan kot aterotromboza in lahko povzroči aterotrombotične dogodke (kot so kap, srčni napad ali smrt).
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Pri jemanju zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: If you stop taking Clopidogrel dura:
Slovenian: Ne jemljite zdravila Klopidogrel dura:
English: • Renal impairment
Slovenian: • Okvara jeter
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Slovenian: Pri manjših vrezninah ali poškodbah, npr. če se urežete ali brijete, navadno ni razloga za skrb, če pa ste glede krvavitve v kakršnihkoli dvomih, se morate takoj posvetovati s svojim zdravnikom, (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Taste disturbances
Slovenian: Jetrna okvara
English: Vascular disorders
Slovenian: Ledvična okvara
English: 6.6 Special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam imen, farmacevtska oblika, jakost zdravila, pot uporabe, imetniki dovoljenja za promet v državah članicah
English: Janssen Farmacêutica Portugal, Lda.
Slovenian: Portugalska Janssen Farmacêutica Portugal, Lda.
English: S.C.
Slovenian: A.C.
English: 2734-503 Barcarena Portugal
Slovenian: 2734-503 Barcarena
English: Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti
Slovenian: Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti România
English: 821 08 Bratislava
Slovenian: 821 08 Bratislava Slovak Republic
English: Arena Group S.A.
Slovenian: S.C. Arena Group S.A.
English: Slovak Republic Johnson & Johnson s.r.o.
Slovenian: Johnson & Johnson s.r.o.
English: Karla Engliše 3201/6
Slovenian: Karla Engliše 3201/6 15000 Praha 5
English: Luxembourg Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
Slovenian: Luksemburg Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
English: 1-10 Constantinoupoleos street 3505 Lemesos
Slovenian: Medochemie ltd 1-10 Constantinoupoleos street 3505 Lemesos
English: A.C. Helcor s.r.l.
Slovenian: Helcor s.r.l.
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
Slovenian: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom
English: Belgium Janssen-Cilag NV Antwerpseweg 15-17
Slovenian: Janssen-Cilag NV Antwerpseweg 15-17 2340 Beerse Belgium
English: The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150
Slovenian: Dr. Paul Janssenweg 150
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana pogostnost (pogostnostni ni mogoče oceniti iz razpoložljivih podatkov)
English: Recovery* > 21 days
Slovenian: Obnovitev* > 21 dni
English: Also contains mannitol.
Slovenian: Vsebuje tudi manitol.
English: Dose mg/m (% of recommended starting dose)
Slovenian: Odmerek mg/m (% priporočenega začetnega odmerka)
English: Total dose based on BSA value of 1.8 m
Slovenian: Celotni odmerek na podlagi vrednosti BSA 1,8 m
English: Children and adolescents Azacitidine Celgene is not recommended for use in children and adolescents below the age of 18.
Slovenian: Otroci in mladostniki Uporaba zdravila Azacitidine Celgene ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: The safety and efficacy of Azacitidine Celgene in children aged 0-17 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Azacitidine Celgene pri otrocih, starih 0 do 17 let, še nista bili dokazani.
English: The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m
Slovenian: Naslednja preglednica je prikazana samo kot primer izračuna za pripravo individualnih odmerkov azacitidina na podlagi povprečne vrednosti BSA, ki je 1,8 m
English: • The recommended dose is 75 mg per m body surface area.
Slovenian: • Priporočeni odmerek je 75 mg/m površine telesa.
English: They are also responsible for preparing and disposing of any unused Azacitidine Celgene correctly.
Slovenian: Odgovoren je tudi za pravilno pripravo in odstranitev neuporabljenega zdravila Azacitidine Celgene.
English: • Azacitidine Celgene is given every day for one week, followed by a rest period of 3 weeks.
Slovenian: • Zdravilo Azacitidine Celgene boste en teden prejemali vsak dan, nato sledi tritedensko obdobje mirovanja.
English: Health- Related Quality of Life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Slovenian: Z zdravjem povezano kakovost življenja (HRQoL - Health-Related Quality of Life) so ocenjevali z osnovnim vprašalnikom o kakovosti življenja Evropske organizacije za raziskovanje in zdravljenje raka (EORTC QLQ-C30 - European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire).
English: Number of vials required
Slovenian: Število potrebnih vial
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
Slovenian: • mielodisplastičnimi sindromi (MDS) z vmesno stopnjo 2 in visoko stopnjo tveganja po Mednarodnem prognostičnem sistemu ocenjevanja (IPSS - International Prognostic Scoring System),
English: While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with azacitidine.
Slovenian: Čeprav so v analizi nekatere omejitve, podatki, ki so na voljo, kažejo, da pri bolnikih med zdravljenjem z azacitidinom ne pride do pomembnega poslabšanja kakovosti življenja.
English: A survival benefit was also demonstrated in patients that had not achieved a complete response for azacitidine compared to CCR.
Slovenian: Korist za preživetje so dokazali tudi pri bolnikih, ki niso dosegli popolnega odziva na azacitidin v primerjavi s CCR.
English: The Azacitidine Celgene suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Slovenian: Suspenzijo zdravila Azacitidine Celgene lahko pripravite tik pred uporabo, rekonstituirano suspenzijo morate uporabiti v 45 minutah.
English: • Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
Slovenian: • okužba globljih plasti kože, ki se hitro širi, poškoduje kožo in tkiva in je lahko življenje ogrožajoča (nekrotizantni fasciitis).
English: You should not use Azacitidine Celgene during pregnancy as it may be harmful to the baby.
Slovenian: Med nosečnostjo ne uporabljajte zdravila Azacitidine Celgene, ker lahko škodi otroku.
English: Azacitidine plus BSC (n=241) was compared to CCR.
Slovenian: Azacitidin skupaj z BSC (n=241) so primerjali s CCR.
English: Azacitidine Celgene should be reconstituted with water for injections.
Slovenian: Zdravilo Azacitidine Celgene je treba rekonstituirati z vodo za injekcije.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Druga zdravila in zdravilo Azacitidine Celgene Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Azacitidine treatment was also associated with a reduction in cytopenias, and their related symptoms.
Slovenian: Zdravljenje z azacitidinom je bilo povezano tudi z zmanjšanjem citopenij in z njimi povezanih simptomov.
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval; HR = hazard ratio
Slovenian: LEGENDA: AZA = azacitidin; CCR = običajni režimi zdravljenja; IZ = interval zaupanja; RO = razmerje ogroženosti
English: The individual baseline parameters were comparable between the azacitidine and CCR groups.
Slovenian: Posamezni izhodiščni parametri so bili med skupino z azacitidinom in skupino s CCR primerljivi.
English: Investigations weight decreased * = rarely fatal cases have been reported
Slovenian: Preiskave zmanjšanje telesne mase *= redko so poročali o smrtnih primerih
English: Azacitidine Celgene treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents.
Slovenian: Zdravljenje z zdravilom Azacitidine Celgene mora uvesti in spremljati zdravnik, ki ima izkušnje z uporabo kemoterapevtskih zdravil.
English: The one-year survival rates were 46.5% in patients receiving azacitidine versus 34.3% in patients receiving CCR.
Slovenian: Pogostnosti enoletnega preživetja sta bili 46,5 % pri bolnikih, ki so prejemali azacitidin, proti 34,3 % pri bolnikih, ki so prejemali CCR.
English: In addition, although the study was not powered to demonstrate a statistically significant difference when comparing azacitidine to the preselection CCR treatment groups, the survival of azacitidine treated patients was longer when compared to CCR treatment options BSC alone, low-dose cytarabine plus BSC and were similar when compared to standard intensive chemotherapy plus BSC.
Slovenian: Poleg tega, čeprav študija ni bila zasnovana tako, da bi dokazala statistično signifikantno razliko pri primerjavi azacitidina z vnaprej izbranimi skupinami, zdravljenimi s CCR, je bilo preživetje bolnikov, zdravljenih z azacitidinom, daljše, ko so jih primerjali z opcijama zdravljenja CCR, samo BSC ali citarabin v majhnem odmerku skupaj z BSC, podobne pa so bile, če so jih primerjali s standardno intenzivno kemoterapijo skupaj z BSC.
English: The Cox PH model adjusted for pre-specified baseline prognostic factors defined a HR for azacitidine versus CCR of 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
Slovenian: Coxov PH model, prilagojen za vnaprej določene izhodiščne prognostične dejavnike, je definiral HR za azacitidin proti CCR 0,80 (95 % IZ= 0,66; 0,99; p = 0,0355).
English: VIAL LABEL
Slovenian: OZNAKA VIALE
English: The following supplies should be assembled:
Slovenian: Pripraviti je treba naslednje pripomočke:
English: 5 How to store Azacitidine Celgene Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Azacitidine Celgene Vsebina pakiranja in dodatne informacije
English: Also, some other medicines may affect the way Azacitidine Celgene works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na način delovanja zdravila Azacitidine Celgene.
English: Azacitidine Celgene is an anti-cancer agent which belongs to a group of medicines called ‘antimetabolites'.
Slovenian: Zdravilo Azacitidine Celgene je sredstvo proti raku, ki pripada skupini zdravil, ki se imenujejo 'antimetaboliti'.
English: This is because Azacitidine Celgene may affect the way some other medicines work.
Slovenian: Zdravilo Azacitidine Celgene lahko vpliva na način delovanja nekaterih drugih zdravil.
English: Area under the curve and maximum plasma concentration (Cmax) of subcutaneous admiminstration of azacitidine were approximately proportional within the 25 to 100 mg/m dose range.
Slovenian: Površina pod krivuljo in najvišja koncentracija v plazmi (Cmax) pri subkutanem dajanju azacitidina sta bili v razponu odmerkov 25 do 100 mg/m približno proporcionalni.
English: Before giving you Azacitidine Celgene, your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle.
Slovenian: Preden vam bo zdravnik predpisal zdravilo Azacitidine Celgene, vam bo predpisal druga zdravila za preprečevanje slabosti in bruhanja na začetku vsakega cikla,.
English: 9/L), baseline bone marrow blasts (≤ 50% & > 50%) and prior history of MDS] there was a trend in OS benefit in favour of azacitidine.
Slovenian: 9/l), izhodiščnimi blastnimi celicami v kostnem mozgu (≤ 50 % & > 50 %) in prejšnjo anamnezo MDS] se je pokazala tendenca v korist celokupnemu preživetju (OS) v prid azacitidinu.
English: The efficacy and safety of azacitidine was studied in an international, multicentre, controlled, openlabel, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Slovenian: Učinkovitost in varnost azacitidina so proučevali v mednarodni, multicentrični, kontrolirani, odprti študiji 3. faze s paralelnimi skupinami pri bolnikih, starih 65 let ali več, z novo diagnosticirano de novo ali sekundarno AML z >30 % blastnih celic v kostnem mozgu po klasifikaciji SZO, ki niso bili primerni za PKMC.
English: What Azacitidine Celgene is and what it is used for What you need to know before you use Azacitidine Celgene How to use Azacitidine Celgene Possible side effects
Slovenian: Kaj je zdravilo Azacitidine Celgene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Azacitidine Celgene Kako uporabljati zdravilo Azacitidin Celgene Možni neželeni učinki
English: Following subcutaneous administration of a single 75 mg/m dose, mean exposure values (AUC and Cmax) from subjects with mild, moderate and severe renal impairment were increased by 11-21%, 15-27%, and 41-66%, respectively, compared to normal renal function subjects.
Slovenian: Po subkutanem dajanju enkratnega odmerka 75 mg/m so se srednje vrednosti izpostavljenosti (AUC in Cmax) oseb z blago, zmerno in hudo okvaro ledvic zvečale za 11-21 %, 15-27 % oziroma 41-66 % v primerjavi z osebami z normalno ledvično funkcijo.
English: The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration (single 75 mg/m doses) was approximately 89% based on area under the curve (AUC).
Slovenian: Absolutna biološka razpoložljivost azacitidina, danega subkutano, v primerjavi z intravensko danim azacitidinom (enkratni odmerki po 75 mg/m2) je bila približno 89 %, na osnovi površine pod krivuljo (AUC - area under the curve).