natgillin/translations-raw huggingface dataset:
The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events, including constipation (41.9%), nausea (39.8%), and diarrhoea (36.9%), (usually Grade 1-2), general disorders and administration site conditions including pyrexia (37.7%; usually Grade 1-2) and haematological events, including febrile neutropenia (32.2%) and neutropenia (30.1%), (usually Grade 3-4).
Najpogostejši neželeni učinki, o katerih so poročali (≥ 30 %) pri zdravljenju z azacitidinom, so bili gastrointestinalni dogodki, vključno z zaprtjem (41,9 %), navzeo (39,8 %) in drisko (36,9 %), (navadno 1.-2. stopnje), splošne težave in spremembe na mestu aplikacije, vključno s pireksijo (37,7 %; navadno 1.-2. stopnje) in hematološki dogodki, vključno s febrilno nevtropenijo (32,2 %) in nevtropenijo (30,1 %), (navadno 3.-4. stopnje).
Grounds for the variation to the terms of the marketing authorisation(s)
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• A type of anaemia where your red and white blood cells and platelets are reduced.
• vrsta anemije, pri kateri je število eritrocitov, levkocitov in trombocitov zmanjšano
The most commonly reported adverse reactions with azacitidine treatment were haematological reactions (71.4 %) including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events (60.6 %) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
Neželeni učinki, o katerih so najpogosteje poročali v zvezi z zdravljenjem z azacitidinom, so bile hematološke reakcije (71,4 %), vključno s trombocitopenijo, nevtropenijo in levkopenijo (običajno 3.-4. stopnje), prebavni dogodki (60,6 %), vključno z navzeo, bruhanjem (običajno 1.-2. stopnje), ali reakcije na mestu injiciranja (77,1 %; običajno 1.-2. stopnje).
If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
Če poteče več kot 45 minut, morate rekonstituirano suspenzijo ustrezno zavreči in pripraviti nov odmerek.
Blood and lymphatic system disorders febrile neutropenia*, neutropenia, leukopenia, thrombocytopenia, anaemia pancytopenia*, bone marrow failure
Bolezni krvi in limfatičnega sistema febrilna nevtropenija*, nevtropenija, levkopenija, trombocitopenij a, anemija pancitopenija*, odpoved kostnega mozga
Psychiatric disorders insomnia confusional state, anxiety
Psihiatrične motnje nespečnost stanje zmedenosti, tesnoba
What Vidaza is used for
Za kaj zdravilo Vidaza uporabljamo
Table 1: ADRs reported in patients with MDS or AML treated with azacitidine (clinical studies and post- marketing)
Preglednica 1: Neželeni učinki, o katerih so poročali pri bolnikih z MDS ali AML, zdravljenih z azacitidinom (klinične študije in opažanja po prihodu zdravila na trg) Organski sistem Zelo pogosti
MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Imetnik dovoljenja za promet z zdravilom Celgene Europe B.V.
Shake the suspension vigorously before administration.
Suspenzijo pred odmerjanjem močno pretresite.
• chronic myelomonocytic leukaemia (CMML).
• kronične mielomonocitne levkemije (KMMoL);
The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2 °C to 8 °C) water for injections.
Rok uporabnosti rekonstituiranega zdravila se lahko podaljša, če se za rekonstitucijo uporabi voda za injekcije, ki je bila v hladilniku (2 °C do 8 °C).
Vidaza 25 mg/mL powder for suspension for injection Azacitidine
Vidaza 25 mg/ml prašek za suspenzijo za injiciranje azacitidin
PHARMACEUTICAL FORM Powder for suspension for injection.
FARMACEVTSKA OBLIKA Prašek za suspenzijo za injiciranje Bel liofiliziran prašek.
• intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International
• mielodisplastičnimi sindromi (MDS) z vmesno stopnjo 2 in visoko stopnjo tveganja po
Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle.
Kompletno krvno sliko je treba pridobiti pred začetkom zdravljenja in po potrebi za spremljanje odziva in toksičnosti, najmanj pa pred vsakim ciklom zdravljenja.
Not known (frequency cannot be estimated from the available data) Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
• okužba globljih plasti kože, ki se hitro širi, poškoduje kožo in tkiva in je lahko življenje ogrožajoča (nekrotizantni fasciitis).
In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the Vidaza group and 19.2 months in the CCR group.
Pri bolnikih, ki so bili v izhodišču odvisni od transfuzij trombocitov in so ob zdravljenju dosegli neodvisnost od transfuzij, je bilo mediano trajanje neodvisnosti od transfuzij trombocitov v skupini z zdravilom Vidaza 10,8 meseca, v skupini s CCR pa 19,2 meseca.
In patients who were RBC transfusion dependent at baseline and became independent, the median duration of RBC transfusion independence was 13 months in the azacitidine group.
Pri bolnikih, ki so bili na izhodišču odvisni od transfuzije eritrocitov in so nato postali od nje neodvisni, je bila mediana trajanja neodvisnosti od transfuzije eritrocitov 13 mesecev v skupini z azacitidinom.
• A disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis).
• črevesna bolezen, ki lahko povzroči zvišano telesno temperaturo, bruhanje in bolečine v trebuhu
• acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to
• akutno mieloično levkemijo (AML) z 20-30 % blastnih celic in displazijo več celičnih linij po razvrstitvi Svetovne zdravstvene organizacije (SZO),
If it comes into contact with mucous membranes, flush thoroughly with water.
Če pride zdravilo v stik s sluznico, jo temeljito sperite z vodo.
• Low levels of potassium in your blood.
• izguba telesne mase • nizka raven kalija v krvi
Musculoskeletal and connective tissue disorders arthralgia, musculoskeletal pain (includes back, bone and pain in extremity)
Bolezni mišično-skeletne ga sistema in vezivnega tkiva artralgija, bolečine v mišicah in kosteh (vključuje bolečine v križu, kosteh in udih)
Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
Pri bolnikih z razširjeno tumorsko boleznijo zaradi metastatskega obolenja so med zdravljenjem z azacitidinom poročali o odpovedi jeter, progresivni jetrni komi in smrti (glejte poglavje 4.4).
• Large plum-coloured, raised painful patches on the skin with fever.
• velike izbokle boleče zaplate na koži temno modre barve z zvišano telesno temperaturo
Vidaza is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Zdravilo Vidaza je kontraindicirano pri bolnikih z napredovalo obliko malignih jetrnih tumorjev (glejte poglavji 4.3 in 4.4).
• Sore or runny nose or sinuses (sinusitis)..
• vnetje nosu, izcedek iz nosu ali sinuzitis
Platelets (x 109/l) *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count])
Trombociti (x 109/l) *Obnovitev = število ≥ število v najnižji točki + (0,5 x [izhodiščno število - število v najnižji točki])
Deaths: AZA = 82, CCR = 113
RO 0,58 [95 % IZ: 0,43 - 0,77] Smrti: AZA = 82, CCR = 113
If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
Če zdravilo shranjujete v hladilniku več kot 8 ur, morate suspenzijo ustrezno zavreči in pripraviti nov odmerek.
What Vidaza contains
Kaj vsebuje zdravilo Vidaza
Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) ≥ 3.0 x 109/l and ANC ≥ 1.5 x 109/l, and platelets ≥ 75.0 x 109/l) prior to the first treatment
število levkocitov (WBC - White Blood Cells) ≥ 3,0 x 109/l in ANC ≥ 1,5 x 109/l in trombocitov ≥ 75,0 x 109/l)
If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Če poteče več kot 30 minut, morate suspenzijo ustrezno zavreči in pripraviti nov odmerek.
When using immediately
Kadar zdravilo uporabite takoj
Use an effective method of contraception during and up to 3 months after treatment with this medicine.
Med zdravljenjem s tem zdravilom in do 3 mesece po njem uporabljajte zanesljivo kontracepcijsko metodo.
• Raised itchy rash on the skin (urticaria).
• izbočen srbeč izpuščaj na koži (koprivnica, urtikarija)
Serious adverse reactions such as gastrointestinal haemorrhage and intracranial haemorrhage have been reported.
Poročali so o resnih neželenih učinkih, kot sta krvavitev v prebavila in intrakranialna krvavitev.
NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection Azacitidine STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains100 mg azacitidine.
IME ZDRAVILA Vidaza 25 mg/ml prašek za suspenzijo za injiciranje azacitidin NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 100 mg azacitidina.
In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the Vidaza group and was not reached in the CCR group.
Pri bolnikih, ki so bili v izhodišču odvisni od transfuzij eritrocitov in so ob zdravljenju dosegli neodvisnost od transfuzij, je bilo mediano trajanje neodvisnosti od transfuzij eritrocitov v skupini z zdravilom Vidaza 13,9 meseca, v skupini s CCR pa neodvisnosti niso dosegli.
Skin and subcutaneous tissue adverse reactions
S kožo in podkožjem povezani neželeni učinki
Of the patients in the Vidaza group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Od bolnikov v skupini z zdravilom Vidaza, ki so bili v izhodišču odvisni od transfuzij trombocitov, jih je 40,6 % (95 % IZ = 30,9; 50,8) v obdobju zdravljenja postalo neodvisnih od transfuzij trombocitov, v primerjavi z 29,3 % (95 % IZ = 19,7; 40,4) bolnikov v skupinah s kombiniranimi CCR.
• Pain in your throat and voicebox.
• bolečine v žrelu in grlu
bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage (at injection site), malaise, chills, catheter site hemorrhage injection site necrosis (at injection site)
modrice, hematom, induracija, osip, srbenje, vnetje, razbarvanje, vozli in krvavitev (na mestu injiciranja), splošno slabo počutje, mrzlica, krvavitev na mestu kateteriziranja nekroza injekcijske ga mesta (na mestu injiciranja)
• Bleeding.
• Krvavitev.
Developmental abnormalities in the brain have been detected in mice given azacitidine on or before closure of the hard palate.
Pri miših, ki so dobivale azacitidin med ali pred zapiranjem trdega neba, so opazili razvojne abnormalnosti v možganih.
• Redness of your skin.
• pordelost kože
• Feeling generally unwell.
• splošno slabo počutje
General disorders and administration site conditions pyrexia*, fatigue, asthenia, chest pain, injection site erythema, injection site pain, injection site reaction (unspecified)
Splošne težave in spremembe na mestu aplikacije pireksija*, utrujenost, astenija, bolečine v prsih, eritem na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja (nedoločena)
Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle.
Pred začetkom zdravljenja in pred vsakim ciklom zdravljenja je treba izvesti teste delovanja jeter in določiti vrednost serumskega kreatinina in serumskega hidrogenkarbonata.
• Inflammation of the lining around the heart (pericarditis).
• vnetje osrčnika, mrene, ki obdaja srce (perikarditis)
APPROPRIATE
ocenjeno
• An infection of the blood caused by bacteria (sepsis).
• okužba krvi, ki jo povzroči bakterija (sepsa) - vzrok je lahko majhno število levkocitov v krvi
Patients should be premedicated with anti-emetics for nausea and vomiting.
Bolnikom je treba pred začetkom kemoterapije dati antiemetike proti navzei in bruhanju.
Of the patients in the Vidaza group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Od bolnikov v skupini z zdravilom Vidaza, ki so bili v izhodišču odvisni od transfuzij eritrocitov, jih je 38,5 % (95 % IZ = 31,1; 46,2) v obdobju zdravljenja postalo neodvisnih od transfuzij eritrocitov, v primerjavi s 27,6 % (95 % IZ = 20,9; 35,1) bolnikov v skupinah s kombiniranimi CCR.
These may be symptoms of liver failure and can be life-threatening.
To utegnejo biti simptomi odpovedi ledvic in so lahko smrtno nevarni.
When Vidaza is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Pri rekonstituciji zdravila Vidaza z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C), je rekonstituirano zdravilo kemijsko in fizikalno stabilno 22 ur pri 2 °C do 8 °C.
• Sore nose and throat.
• vnetje nosu in žrela
Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza.
Pri bolnikih, zdravljenih z zdravilom Vidaza, so poročali o nekrotizantnem fasciitisu, vključno s smrtnimi primeri.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
Renal and urinary disorders renal failure*, haematuria, elevated serum creatinine renal tubular acidosis
Bolezni sečil odpoved ledvic*, hematurija, povečanje serumskega kreatinina ledvična tubularna acidoza
An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce CYP 1A2, 2C19, or 3A4 or 3A5.
do približno 30-krat višje kot klinično dosegljive koncentracije) azacitadin ne inducira CYP 1A2, 2C19, 3A4 ali 3A5.
Very common side effects (may affect more than 1 in 10 people)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Gastrointestinal disorders diarrhoea, vomiting, constipation, nausea, abdominal pain (includes upper and abdominal discomfort)
Bolezni prebavil diareja, bruhanje, obstipacija, navzea, bolečine v trebuhu (vključuje bolečine v zgornjem delu trebuha in trebuhu)
Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
Po zdravljenju z zdravilom Vidaza naslednjega cikla ni treba prestaviti in prilagajati odmerka, če je zmanjšanje števila levkocitov ali ANC ali trombocitov ≤ 50 % od stanja pred zdravljenjem ali večje kot 50 % z izboljšanjem v diferenciaciji katerekoli celične linije.
If the elapsed time in the refrigerator is greater than 22 hours, the suspension should be discarded appropriately and a new dose prepared.
Če zdravilo shranjujete v hladilniku več kot 22 ur, morate suspenzijo zavreči in pripraviti nov odmerek.
Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
število levkocitov < 3,0 x 109/l ali ANC < 1,5 x 109/l ali trombocitov < 75,0 x 109/l)
After reconstitution, each mL suspension contains 25 mg azacitidine.
Po rekonstituciji vsebuje vsak ml suspenzije 25 mg azacitidina.
Talk to your doctor, pharmacist or nurse before using Vidaza:
Pred začetkom uporabe zdravila Vidaza se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
• if you have decreased counts of platelets, red or white blood cells.
• če imate zmanjšano število trombocitov, eritrocitov ali levkocitov;
• higher-risk myelodysplastic syndromes (MDS).
• mielodisplastičnih sindromov (MDS) z večjim tveganjem;
The most commonly reported (≥ 10%) haematological adverse reactions associated with azacitidine treatment include anaemia, thrombocytopenia, neutropenia, febrile neutropenia and leukopenia, and were usually Grade 3 or 4.
Hematološki neželeni učinki, o katerih so najpogosteje (≥ 10 %) poročali v zvezi z zdravljenjem z azacitidinom, vključujejo anemijo, trombocitopenijo, nevtropenijo, febrilno nevtropenijo in levkopenijo.
UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
• Collection of fluid around the heart (pericardial effusion)..
• nabiranje tekočine okrog srca (perikardialni izliv)
Patients with hepatic impairment
Bolniki z okvaro jeter
Serious hypersensitivity reactions have been reported in patients receiving azacitidine.
Pri bolnikih, ki so se zdravili z azacitidinom, so poročali o resnih preobčutljivostnih reakcijah.
Reconstituted Vidaza should be injected subcutaneously into the upper arm, thigh or abdomen.
Rekonstituirano zdravilo Vidaza je treba injicirati pod kožo v nadlaket, stegno ali trebuh.
Rare side effects (may affect up to 1 in 1,000 people)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
• Constipation, diarrhoea, nausea, vomiting.
• zapeka, driska, slabost, bruhanje
1 vial - 100 mg METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
FARMACEVTSKA OBLIKA IN VSEBINA prašek za suspenzijo za injiciranje 1 viala - 100 mg POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Advanced malignant hepatic tumours (see section 4.4).
Napredovala oblika malignih jetrnih tumorjev (glejte poglavje 4.4).
Haematologic adverse reactions
Hematološki neželeni učinki
Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i.e. blood count at recovery ≥ nadir count + (0.5 x [baseline count - nadir count]).
Obnovitev je opredeljena kot porast celične linije/celičnih linij, pri katerih so opazili hematološko toksičnost, za vsaj polovico razlike med številom v najnižji točki in izhodiščnim številom plus število v najnižji točki (t.j.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
• Dizziness.
• izpuščaj
• Drowsiness, shaking, jaundice, abdominal bloating and easy bruising.
• Zaspanost, tresenje, zlatenica, napihnjen trebuh in nagnjenje k nastajanju modric.
gastrointestinal haemorrhage* (includes mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
krvavitev v prebavila* (vključuje krvavitve v ustih), hemoroidna krvavitev, stomatitis, krvavitev dlesni, dispepsija
Eye disorders eye haemorrhage, conjunctival haemorrhage
Očesne bolezni očesna krvavitev, krvavitev očesne veznice
Use an effective method of contraception during and up to 3 months after treatment.
Med zdravljenjem z zdravilom Vidaza in do 3 mesece po njem uporabljajte zanesljivo kontracepcijsko metodo.
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m2, almost 4 times the recommended starting dose.
Po enem intravenskem odmerku s približno 290 mg/m2, kar je skoraj 4-kratni priporočeni začetni odmerek, je bolnik dobil diarejo, občutil je navzeo ter je bruhal.
You should not breast-feed when using Vidaza.
Dojenje Če uporabljate zdravilo Vidaza, ne smete dojiti.
bleeding into your skin (haematoma), rash, itching and changes in the skin colour.
• spremembe kože na mestu injiciranja - to vključuje oteklost, zatrdelost, modrice, krvavitve v kožo (hematom), izpuščaj, srbenje in spremembe barve kože
• Chest pain, being short of breath.
• bolečine v prsih, kratka sapa
Soft tissue infections, including cellulitis and necrotising fasciitis in rare cases leading to death, have been reported with azacitidine in the post marketing setting.
Po prihodu zdravila na trg so v povezavi z azacitidinom poročali o okužbah mehkih tkiv, vključno s celulitisom in nekrotizantnim fasciitisom, kar se je v redkih primerih končalo s smrtjo.
Fatigue has been reported with the use of azacitidine.
Pri uporabi azacitidina so poročali o utrujenosti.
Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tubular acidosis, renal failure and death were reported in patients treated with azacitidine (see section 4.4).
Pri bolnikih, zdravljenih z azacitidinom, so poročali o ledvičnih nenormalnostih, ki so obsegale zvišan serumski kreatinin, hematurijo, ledvično tubularno acidozo, odpoved ledvic in smrt (glejte poglavje 4.4).
How Vidaza works
Kako zdravilo Vidaza deluje
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
Če imate kakšna vprašanja o tem, kako zdravilo Vidaza deluje, ali o tem, zakaj so vam predpisali to zdravilo, se posvetujte s svojim zdravnikom ali medicinsko sestro.
When reconstituting using refrigerated (2 °C to 8 °C) water for injections, the reconstituted suspension must be placed in a refrigerator (2 °C to 8 °C) immediately after reconstitution, and kept in a refrigerator for a maximum of 22 hours.
Pri rekonstituiranju z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C), morate rekonstituirano suspenzijo takoj po rekonstituciji shraniti v hladilnik (2 °C do 8 °C) in jo v hladilniku shranjujte največ 22 ur.
If the Vidaza suspension is prepared using water for injections that has been stored in the refrigerator (2 °C - 8 °C), the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
Če suspenzijo zdravila Vidaza pripravite z vodo za injekcije, ki je bila v hladilniku (2 °C - 8 °C), morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 22 ur.
Vidaza treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Zdravljenje z zdravilom Vidaza je povzročilo manjšo potrebo po transfuzijah eritrocitov in trombocitov.
- If you get any side effects talk to your doctor, pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
When reconstituting using water for injections that has not been refrigerated, the reconstituted suspension must be placed in a refrigerator (2 °C to 8 °C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours.
Pri rekonstituiranju z vodo za injekcije, ki ni bila v hladilniku, morate rekonstituirano suspenzijo takoj po rekonstituciji shraniti v hladilnik (2 °C do 8 °C) in jo v hladilniku shranjujte največ 8 ur.
• Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).
krvavitev v očesu, krvavitev pod ali v kožo (hematom)
• Fainting.
• omedlevica
• Tiredness (fatigue).
• oslabelost (astenija)