natgillin/translations-raw huggingface dataset:
The PRAC considers that the product information of axicabtagene ciloleucel containing products should be amended to reflect the risk of dysphagia associated with axicabtagene ciloleucel therapy.
Odbor PRAC meni, da je treba informacije o zdravilih, ki vsebujejo aksicabtagen ciloleucel, spremeniti tako, da bodo odražale tveganje za disfagijo, povezano z zdravljenjem z aksicabtagen ciloleucelom.
Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
Vreča iz etilenvinil acetata za krioshranjevanje z zatesnjeno cevko za dodajanje in dvema razpoložljivima vbodnima priključkoma, ki vsebuje približno 68 ml celične disperzije.
Based on the mechanism of action, if the transduced cells cross the placenta, they may cause foetal toxicity, including B-cell lymphocytopenia.
Na podlagi mehanizma delovanja lahko transducirane celice povzročijo toksičnost za plod, vključno z B-celično limfocitopenijo, če prehajajo skozi placento.
Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient.
Zdravila YESCARTA ne infundirajte, če se podatki na nalepki, specifični za bolnika, ne ujemajo s podatki bolnika, ki mu je zdravilo namenjeno.
The immunogenicity of YESCARTA has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR.
Imunogenost zdravila YESCARTA so ocenili z uporabo encimsko-imunskega testa (ELISA) za zaznavanje vezave protiteles proti FMC63, protiteles, ki nastanejo iz anti-CD19 CAR.
One sterile infusion bag.
INFUZIJSKA VREČA
Severe neurologic adverse reactions have been very commonly observed in patients treated with YESCARTA, which could be life-threatening or fatal (see section 4.8).
Nevrološki neželeni učinki Pri bolnikih, zdravljenih z zdravilom YESCARTA, so zelo pogosto opazili hude nevrološke neželene učinke, ki so lahko smrtno nevarni ali smrtni (glejte poglavje 4.8).
What YESCARTA looks like and contents of the pack
Izgled zdravila YESCARTA in vsebina pakiranja
See section 4.4 for management guidance.
Za navodila za ukrepanje glejte poglavje 4.4.
These reactions are presented by system organ class and by frequency.
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
Eligible patients were ≥ 18 years of age with refractory disease defined as progressive disease (PD) or stable disease (SD) as best response to last line of therapy, or disease progression within 12 months after autologous stem cell transplant (ASCT).
(PB) ali stabilna bolezen (SB) kot najboljši odgovor na zadnjo vrsto zdravljenja, ali napredovanje bolezni v 12 mesecih po avtologni presaditvi matičnih celic (ASCT, autologous stem cell transplant).
Each bag of YESCARTA contains 300 mg sodium.
Pomožne snovi z znanim učinkom Ena vreča zdravila YESCARTA vsebuje 300 mg natrija.
Pre-treatment (lymphodepleting chemotherapy)
Predzdravljenje (kemoterapija za uničenje limfocitov)
Tumour necrosis factor (TNF) antagonists are not recommended for management of YESCARTA-associated CRS.
Uporabe antagonistov tumorje nekrotizirajočega faktorja (TNF) se ne priporoča za obravnavo CRS zaradi zdravila YESCARTA.
Note: The 12-month analysis had a median follow-up of 15.1 months.
Opombe: Mediano spremljanje v analizi po 12 mesecih je bilo 15,1 meseca.Mediano spremljanje v analizi po 24 mesecih je bilo 27,1 meseca.
The most common serious adverse reactions included encephalopathy (22%), unspecified pathogen infections (16%), bacterial infections (6%), febrile neutropenia (6%), viral infections (5%), and pyrexia (5%).
Najpogostejši resni neželeni učinki so vključevali encefalopatijo (22 %), okužbe z neugotovljenimi povzročitelji (16 %), bakterijske okužbe (6 %), febrilno nevtropenijo (6 %), virusne okužbe (5 %) in pireksijo (5 %).
- notice the symptoms of your cancer are getting worse.
- če opazite simptome slabšanja svoje rakave bolezni.
Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Neporabljeno zdravilo morate odstraniti v skladu z lokalnimi smernicami za zagotavljanje biološke varnosti.
A single dose of YESCARTA contains 2 x 106 CAR-positive viable T cells per kg of body weight (or maximum of 2 x 108 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL dispersion in an infusion bag.
Enkratni odmerek zdravila YESCARTA vsebuje 2 x 106 CAR-pozitivnih viabilnih T-celic na kg telesne mase (ali največ 2 x 108 CAR- pozitivnih viabilnih T-celic za bolnika s 100 kg in več) v približno 68 ml disperzije v vreči za infundiranje.
The most significant and frequently occurring adverse reactions were CRS (93%), encephalopathy (58%), and infections (39%).
Najpomembnejši in najpogostejši neželeni učinki so bili CRS (93 %), encefalopatija (58 %) in okužbe
Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days.
Nadaljevati je treba z deksametazonom, dokler dogodek ne izzveni do 1. stopnje ali manj, nato pa sledi postopno 3-dnevno zmanjševanje.
Of these, 49 patients had GCB-type and 17 patients had ABC-type.
49 od teh bolnikov je imelo tip GCB in
To minimise risk of TLS, patients with elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, prior to YESCARTA infusion.
Za zmanjšanje tveganja za TLS morajo bolniki s povečanimi vrednostmi sečne kisline ali velikim tumorskim bremenom pred infundiranjem zdravila YESCARTA dobiti alopurinol ali drugo profilakso.
Continue corticosteroids use until the event is Grade 1 or less, then taper over 3 days.
Nadaljevati je treba s kortikosteroidi, dokler dogodek ne izzveni do 1. stopnje ali manj,
A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome (CRS) and emergency equipment must be available prior to infusion of YESCARTA.
YESCARTA morajo biti na voljo vsaj štirje odmerki tocilizumaba za uporabo v primeru sindroma sproščanja citokinov (CRS, cytokine release syndrome) in oprema za ukrepanje v nujnih primerih.
Median AUCDay 0-28 in responding patients (N = 71) was 253% of the corresponding level in nonresponders (N = 25) (562.0 days x cells/μL versus 222.0 days x cells/μL).
- 28. dan pri odzivnih bolnikih (N = 71) je bila 253 % pripadajoče ravni pri neodzivnih bolnikih (N = 25) (562,0 dneva × celic/μl v primerjavi z 222,0 dneva × celic/μl).
At the 12-month follow-up analysis, 3 patients remained in CR 24 months after YESCARTA infusion.
Ob analizi spremljanja po 12 mesecih so 3 bolniki ohranili CR 24 mesecev po infundiranju zdravila YESCARTA.
There are no available data with YESCARTA use in pregnant women.
Podatkov o uporabi zdravila YESCARTA pri nosečnicah ni.
Prolonged (still present at Day 30 or with an onset at Day 30 or beyond) Grade 3 or higher neutropenia, thrombocytopenia, and anaemia occurred in 26%, 24%, and 10% of patients, respectively.
Dolgotrajna (ki je še vedno vztrajala na 30. dan ali je nastopila na 30. dan ali po tem) nevtropenija, trombocitopenija in anemija 3. ali višje stopnje se je pojavila pri 26 %, 24 % oz. 10 % bolnikov.
YESCARTA should not be washed, spun down, and/or re-suspended in new media prior to infusion.
Pred infundiranjem zdravila YESCARTA ni dovoljeno izpirati, centrifugirati in/ali ponovno suspendirati v novem mediju.
Taking into account the PRAC Assessment Report on the PSUR(s) for axicabtagene ciloleucel, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za aksicabtagen ciloleucel je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Pregnancy after YESCARTA therapy should be discussed with the treating physician.
O nosečnosti po zdravljenju z zdravilom YESCARTA se je treba posvetovati z zdravnikom, ki vodi zdravljenje.
Thawed product should not be refrozen.
Odtajanega zdravila ni dovoljeno ponovno zamrzniti.
YESCARTA was administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg after lymphodepleting chemotherapy regimen of 500 mg/m2 intravenous cyclophosphamide and 30 mg/m2 intravenous fludarabine on the 5th, 4th, and 3rd day before YESCARTA.
Zdravilo YESCARTA so dali v obliki enkratne infuzije s ciljnim odmerkom 2 x 106 anti-CD19 CAR T-celic/kg po kemoterapiji za uničenje limfocitov po režimu intravenskega ciklofosfamida 500 mg/m2 in intravenskega fludarabina 30 mg/m2 na 5., 4. in 3. dan pred infundiranjem zdravila YESCARTA.
The PRAC considers that the product information of axicabtagene ciloleucel should be amended to reflect the risk of spinal cord oedema, myelitis and quadriplegia associated with axicabtagene ciloleucel therapy.
Odbor PRAC meni, da je treba informacije o zdravilu za aksicabtagen ciloleucel spremeniti tako, da bodo odražale tveganja za edem hrbtenjače, mielitis in kvadriplegijo, ki so povezani z zdravljenjem z aksicabtagen ciloleucelom.
- have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- če ste imeli okužbo s hepatitisom B, hepatitisom C ali virusom humane imunske pomanjkljivosti (HIV).
This medicine contains genetically modified human blood cells.
To zdravilo vsebuje gensko spremenjene človeške krvne celice.
YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Zdravilo YESCARTA je indicirano za zdravljenje odraslih bolnikov z difuznim velikoceličnim B-limfomom (DLBCL, diffuse large B-cell lymphoma) in primarnim mediastinalnim velikoceličnim B-limfomom (PMBCL, primary mediastinal large B-cell lymphoma), ki se je ponovil po dveh ali več vrstah sistemskega zdravljenja ali se ni odzival nanje.
The median peak level of anti-CD19 CAR T cells in the blood (Cmax) was 38.3 cells/µL (range: 0.8 to 1513.7 cells/μL), which decreased to a median of 2.1 cells/µL by 1 month (range: 0 to 167.4 cells/μL) and to a median of 0.4 cells/µL by 3 months (range: 0 to 28.4 cells/μL) after YESCARTA infusion.
Mediana največjih ravni anti-CD19 CAR T-celic v krvi (Cmax) po infundiranju zdravila YESCARTA je bila 38,3 celic/µl (razpon: od 0,8 do 1513,7 celice/μl), ki se je do 1. meseca zmanjšala na mediano 2,1 celice/µl (razpon: od 0 do 167,4 celice/μl), in do 3. meseca na mediano
Your doctor will take some of your blood using a catheter placed in your vein (a procedure call leukapheresis).
Zdravnik vam bo odvzel nekaj krvi s katetrom, nameščenim v vašo žilo
If visible cell clumps remain, continue to gently mix the contents of the bag.
Če so v vsebini vreče še vedno vidne celične grudice, nadaljujte z nežnim mešanjem.
N/A = not available/not applicable (a) Lee et al 2014.
(a) Lee et al 2014.
Before infusion, the patient's identity must match the patient identifiers on the YESCARTA infusion bag and cassette.
Pred infundiranjem je treba potrditi ujemanje bolnikove identitete z identifikacijskimi informacijami o bolniku na infuzijski vreči in kaseti zdravila YESCARTA.
There are no data regarding the signs of overdose with YESCARTA.
Podatkov o znakih prevelikega odmerjanja zdravila YESCARTA ni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CONTAINER (CASSETTE)
PODATKI NA ZUNANJI OVOJNINI ZUNANJI VSEBNIK (KASETA)
In the primary analysis, based on the mITT population (minimum follow up of 6 months) the ORR was 72% and the complete response (CR) rate was 51%, as determined by an independent review committee.
V primarni analizi, ki je temeljila na populaciji mITT (najkrajše spremljanje 6 mesecev), je bila po ugotovitvah neodvisne ocenjevalne komisije stopnja ORR 72 % in stopnja celovitega odziva (CR, complete response) 51 %.
Ensure that a minimum of 4 doses of tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, are available for each patient prior to infusion of YESCARTA.
Pred infundiranjem zdravila YESCARTA se prepričajte, da so za vsakega bolnika na voljo vsaj 4 odmerki tocilizumaba, zaviralca receptorja interlevkina-6 (IL-6).
STOP confirm patient ID prior to infusion.
STOP - pred infundiranjem potrdite identiteto bolnika.
ITT was defined as all patients who underwent leukapheresis; mITT was defined as all patients who received YESCARTA.
Populacija, ki so jo nameravali zdraviti (ITT, intention-to-treat), je opredeljena kot vsi bolniki, ki so jim opravili levkaferezo; modificirana populacija, ki so jo nameravali zdraviti (mITT, modified intent-to-treat), je bila opredeljena kot vsi bolniki, ki so prejeli zdravilo YESCARTA.
Allergic reactions may occur with the infusion of YESCARTA.
Pri infundiranju zdravila YESCARTA se lahko pojavijo alergijske reakcije.
The most common Grade 3 or higher adverse reactions included encephalopathy (31%), unspecified pathogen infections (19%), CRS (11%), bacterial infection (9%), aphasia (7%), viral infection (6%), delirium (6%), hypotension (6%), and hypertension (6%).
Najpogostejši neželeni učinki 3. ali višje stopnje so vključevali encefalopatijo (31 %), okužbe z neugotovljenimi povzročitelji (19 %), CRS (11 %), bakterijsko okužbo (9 %), afazijo (7 %), virusno okužbo (6 %), delirij (6 %), hipotenzijo (6 %) in hipertenzijo (6 %).
Grade 3 or higher neutropenia (including febrile neutropenia), anaemia, and thrombocytopenia occurred in 80%, 45%, and 40% of patients, respectively.
Nevtropenija (vključno s febrilno nevtropenijo), anemija in trombocitopenija 3. ali višje stopnje so se pojavile pri 80 %, 45 % oz. 40 % bolnikov.
Hypotension Hypertension
Zelo pogosti hipotenzija hipertenzija
What you need to know before you are given YESCARTA
Kaj morate vedeti, preden boste dobili zdravilo YESCARTA Kako se daje zdravilo YESCARTA
Provide intensive-care supportive therapy for severe or lifethreatening neurologic toxicities.
Pri resnih ali življenje ogrožajočih nevroloških toksičnostih je treba uvesti podporno zdravljenje z intenzivno nego.
The most common signs or symptoms associated with CRS included pyrexia (83%), hypotension (44%), tachycardia (24%), hypoxia (23%), and chills (20%).
Najpogostejši znaki ali simptomi, povezani s CRS, so vključevali pireksijo (83 %), hipotenzijo (44 %), tahikardijo (24 %), hipoksijo (23 %) in mrzlico (20 %).
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion.
Pri bolnikih lahko citopenija vztraja več tednov po kemoterapiji za uničenje limfocitov ter infundiranju zdravila YESCARTA.
To prepare YESCARTA, patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.
Za pripravo zdravila YESCARTA se bolniku odvzamejo T-celice, ki se gensko spremenijo ex vivo z retrovirusno transdukcijo, da izražajo himerni antigenski receptor (CAR, chimeric antigen receptor), ki ga sestavlja murini anti-CD19 enoverižni fragment variabilnih regij, povezan s kostimulativno domeno CD28 in signalno domeno CD3-zeta.
YESCARTA contains sodium
Zdravilo YESCARTA vsebuje natrij
Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
Velika Britanija Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
No dose adjustment is required in patients ≥ 65 years of age.
Pri bolnikih, starih ≥ 65 let, odmerka ni treba prilagajati.
YESCARTA is a type of medicine called a “genetically modified cell therapy”.
Kaj je zdravilo YESCARTA in za kaj ga uporabljamo Zdravilo YESCARTA je vrsta zdravila, ki se imenuje »zdravljenje z gensko spremenjenimi celicami«.
Secondary malignancies
Sekundarna maligna obolenja
Contraindications of the lymphodepleting chemotherapy must be considered.
Upoštevati je treba kontraindikacije za kemoterapijo za uničenje limfocitov.
Take your temperature twice a day for 3-4 weeks after treatment with YESCARTA.
Po zdravljenju z zdravilom YESCARTA si 3 do 4 tedne dvakrat na dan merite telesno temperaturo.
To minimise the risks associated with the treatment of YESCARTA, the MAH must ensure that hospitals and their associated centres that dispense YESCARTA are specially qualified in accordance with the agreed control distribution program.
Za zmanjšanje tveganj, povezanih z zdravljenjem z zdravilom YESCARTA, mora imetnik dovoljenja za promet z zdravilom zagotoviti, da so bolnišnice in njihovi povezani centri, ki izdajajo zdravilo
YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy.
Zdravilo YESCARTA (aksicabtagen ciloleucel) je proti CD19 usmerjena, gensko spremenjena avtologna T-celična imunoterapija.
• Check that the patient information on the cassette label matches that on the bag label.
• Preverite, ali se informacije o bolniku na nalepki na kaseti ujemajo s tistimi na nalepki na vreči.
Some people may feel tired, dizzy or have some shaking after being given YESCARTA.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje so lahko utrujeni, omotični ali se po dajanju zdravila YESCARTA tresejo.
The median time to onset was 5 days (range: 1 to 17 days).
Mediani čas do pojava je bil 5 dni (razpon od 1 do 17 dni).
Do not refreeze.
Ne obsevajte.
Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above.
3 dni naj se daje metilprednizolon 1.000 mg intravensko na dan; pri izboljšanju obravnava kot zgoraj.
YESCARTA 0.4 - 2 x 108 cells dispersion for infusion
YESCARTA 0,4-2 × 108 celic disperzija za infundiranje
The most common signs or symptoms associated with neurologic adverse reactions included encephalopathy (58%), headache (40%), tremor (31%), dizziness (21%), aphasia (18%), and delirium (17%).
Najpogostejši znaki ali simptomi, povezani z nevrološkimi neželenimi učinki, so vključevali encefalopatijo (58 %), glavobol (40 %), tremor (31 %), omotico (21 %), afazijo (18 %) in delirij (17 %).
Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity (b).
FiO2 ali hipotenzivni odziv na tekočine ali majhni odmerki enega od vazopresorjev ali toksičnost organov 2. stopnje (b).
Any unused medicine or waste material must be disposed of in accordance with local biosafety guidelines.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi smernicami za zagotavljanje biološke varnosti.
YESCARTA comprises human autologous T cells.
Zdravilo YESCARTA vsebuje človeške avtologne T-celice.
The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je pred zdravljenjem bolnika na kraju samem zagotovljen takojšnji dostop do najmanj 4 odmerkov tocilizumaba za vsakega bolnika kot zdravilo za obravnavo CRS.
Grade 3 or higher neutropenia, thrombocytopenia, and anaemia present after Day 93 occurred in 11%, 7%, and 3% of patients, respectively.
Nevtropenija, trombocitopenija in anemija 3. ali višje stopnje, ki je vztrajala tudi po 93. dnevu, se je pojavila pri 11 %, 7 % oz. 3 % bolnikov.
Duration of Responsea, CR, median (range) in months
Trajanje odzivaa, CR, mediana
Monitor patients life-long for secondary malignancies.
Potrebno je doživljenjsko spremljanje bolnikov glede pojava sekundarnih malignih obolenj.
Severe CRS, including life-threatening and fatal reactions, was very commonly observed with YESCARTA with a time to onset of 1 to 12 days (see section 4.8).
Hud CRS, vključno s smrtno nevarnimi in smrtnimi reakcijami, so pri zdravilu YESCARTA opazili zelo pogosto, s časom do pojava od 1 do
Preparation of YESCARTA
Priprava zdravila YESCARTA
• Central venous access is recommended for the administration of YESCARTA.
• Pri dajanju zdravila YESCARTA se priporoča centralni venski dostop.
YESCARTA is to be administered via intravenous infusion.
Zdravilo YESCARTA se daje z intravensko infuzijo.
YESCARTA is made specially for you as a single administration of your own modified white blood cells.
Zdravilo YESCARTA je izdelano posebej za vas za enkratno dajanje vaših lastnih belih krvnih celic,
There is limited experience with YESCARTA in patients exposed to prior CD19-directed therapy.
Izkušnje z zdravljenjem z zdravilom YESCARTA pri bolnikih, izpostavljenih predhodni terapiji, usmerjeni proti CD19, so omejene.
Neurologic adverse reaction grading and management guidance
Preglednica 2: Stopnje nevroloških neželenih učinkov in navodila za obravnavo
It is unknown whether YESCARTA is excreted in human milk or transferred to the breast-feeding child. Breast-feeding women should be advised of the potential risk to the breast-fed child.
Ni znano, ali se zdravilo YESCARTA izloča v materino mleko ali prenaša na dojenega otroka.
YESCARTA contains genetically modified human blood cells.
Zdravilo YESCARTA vsebuje gensko spremenjene človeške krvne celice.
Each patient specific single infusion bag of YESCARTA contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 x 106 - 2 x 106 cells/kg), with a maximum of 2 x 108 anti-CD19 CAR T cells.
Ena vreča za enkratno infundiranje zdravila YESCARTA, specifična za bolnika, vsebuje disperzijo anti-CD19 CAR T-celic v približno 68 ml za ciljni odmerek 2 x 106 anti-CD19 CAR-pozitivnih viabilnih T-celic/kg telesne mase (razpon: 1 x 106 - 2 x 106 celic/kg), z največ 2 x 108 anti-CD19 CAR T-celic.
Motor dysfunction Pain in extremity Back pain Arthralgia Muscle pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti motorična disfunkcija bolečine v okončinah bolečine v hrbtu artralgija bolečina v mišicah
• Prime the tubing with 0.9% sodium chloride solution (0.154 mmol sodium per mL) prior to infusion.
• Cevje pred infundiranjem napolnite z 0,9 % raztopino natrijevega klorida (0,154 mmol natrija na ml).
Gently mix the contents of the bag while thawing.
Med odtajanjem nežno mešajte vsebino vreče.
Renal insufficiency
Pogosti ledvična insuficienca
Manage per Grade 3 if no improvement within 24 hours after starting tocilizumab.
Če v 24 urah po uvedbi tocilizumaba ni izboljšanja, ravnajte v skladu z navodili za
After you have been given YESCARTA Tell your doctor or nurse immediately if you have any of the following:
Zdravniku ali medicinski sestri takoj povejte, če opazite kaj od naslednjega:
• An antihistamine such as diphenhydramine.
• paracetamol • antihistaminik, na primer difenhidramin.
Neurologic adverse reactions
Nevrološki neželeni učinki
The stability of YESCARTA upon completion of thawing is up to 3 hours at room temperature (20 ˚C to 25 °C).
Zdravilo YESCARTA je po končanem odtajanju stabilno do 3 ure pri sobni temperaturi (20 °C do 25 °C).
- have kidney problems.
- če imate težave z ledvicami.
Screening for HBV, HCV, and HIV should be performed in accordance with clinical guidelines before collection of cells for manufacturing of YESCARTA.
Pred odvzemom celic za izdelavo zdravila YESCARTA je treba izvesti presejalne teste za HBV, HCV in HIV v skladu s kliničnimi smernicami.
The median time to response was 1.0 months (range: 0.8 to 12.2 months).
1,0 meseca (razpon: 0,8 do 12,2 meseca).
Administer dexamethasone 10 mg intravenously every 6 hours.
Vsakih 6 ur naj se daje deksametazon 10 mg intravensko.
Counsel patients to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion and to seek immediate medical attention should signs or symptoms of neurologic toxicity occur.
Bolnikom je treba svetovati, da naj se vsaj 4 tedne po infundiranju zadržujejo blizu usposobljene klinične ustanove in da naj takoj poiščejo zdravniško pomoč, če se pojavijo znaki ali simptomi nevrološke toksičnosti.
Unspecified pathogen infections Viral infections
Zelo pogosti okužbe z neugotovljenimi povzročitelji virusne okužbe bakterijske okužbe
Cytokine Release Syndrome Hypogammaglobulinaemia
Zelo pogosti sindrom sproščanja citokinov hipogamaglobulinemija
Store frozen in vapour phase of liquid nitrogen ≤ -150 °C until thawed for use.
Shranjujte zamrznjeno v parni fazi tekočega dušika pri temperaturi ≤ -150 °C do odtajanja pred uporabo.