natgillin/translations-raw huggingface dataset:
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
V dodatnih študijah zdravila Insulatard, ki so jih opravili na 225 bolnikih, so injiciranje zdravila Insulatard z injekcijsko brizgo primerjali z injiciranjem tega zdravila z napolnjenim peresnikom (InnoLet ali FlexPen).
Insulatard is a long-acting insulin.
Zdravilo Insulatard je dolgodelujoči insulin.
How has Insulatard been studied?
Kako je bilo zdravilo Insulatard raziskano?
What is Insulatard used for?
Za kaj se zdravilo Insulatard uporablja?
How does Insulatard work?
Kako zdravilo Insulatard deluje?
This gives Insulatard a longer duration of action.
To podaljša čas delovanja zdravila Insulatard.
How is Insulatard used?
Kako se zdravilo Insulatard uporablja?
What is Insulatard?
Kaj je zdravilo Insulatard?
These other medicines may include:
Ta druga zdravila lahko vključujejo:
•Final report of study results: December 2038
• Končno poročilo o rezultatih študije: december 2038
Date of first authorisation: 23 August 2018
Datum prve odobritve: 23. avgust 2018
Other outcomes were consistent with those of the mITT population.
Ostali izidi so bili skladni z izidi pri populaciji mITT.
It will not be given to you again.
Ne boste ga prejeli ponovno.
This can take 3 to 6 hours and may need to be repeated.
To lahko traja od 3 do 6 ur; morda bo treba postopek ponoviti.
Annual safety reports and 5-yearly interim reports
Letno poročilo o varnosti in 5-letna vmesna poročila
If not improving, manage as Grade 4 (below).
Če ni izboljšanja, ravnajte kot pri 4. stopnji (spodaj).
Your doctor or nurse will check carefully that this medicine is yours.
Zdravnik ali medicinska sestra bo skrbno preveril/a, da je to zdravilo vaše.
• Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
• preveril, ali ste bili v predhodnih 6 tednih cepljeni in ali se nameravate cepiti v naslednjih nekaj mesecih.
HBV reactivation
Reaktivacija HBV
You may be given medicines to help prevent the condition.
Morda boste dobili zdravila za preprečevanje tega stanja.
An impact of these antibodies on efficacy or safety was not discernible.
Vpliv teh protiteles na učinkovitost ali varnost ni bil opazen.
As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product.
Ker vam bodo to zdravilo dali usposobljeni zdravstveni delavci, so za pravilno odstranitev zdravila odgovorni oni.
- have had a stem cell transplant in the last 4 months.
- če ste v zadnjih 4 mesecih imeli presaditev matičnih celic.
One out of 111 patients did not receive the product due to manufacturing failure.
Eden od 111 bolnikov zdravila ni prejel zaradi napake v izdelavi.
• Check your lungs, heart and blood pressure.
• pregledal vaša pljuča, srce in krvni tlak.
Do not try to treat your symptoms with other medicines on your own.
Simptomov ne poskušajte sami zdraviti z drugimi zdravili.
Verify patient ID.
Preverite ID bolnika.
Availability of tocilizumab and site qualification
Razpoložljivost tocilizumaba in usposobljenost mesta
Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Zdravnik bo redno preverjal vaša števila krvnih celic, saj se lahko število krvnih celic in drugih sestavin krvi zmanjša.
Efficacy was consistent with the overall treated patient population.
Učinkovitost je bila skladna z učinkovitostjo pri splošni populaciji zdravljenih bolnikov.
• You will be given a pregnancy test before treatment starts.
• Pred začetkom zdravljenja boste opravili test nosečnosti.
• After treatment while the immune system is recovering.
• Po zdravljenju, ko vaš imunski sistem okreva.
If this happens to you, do not drive or use heavy machines until at least 8 weeks after infusion or until your doctor tells you that you have completely recovered.
Če se vam to zgodi, ne vozite in ne upravljajte težkih strojev še vsaj 8 tednov po infundiranju ali dokler vam zdravnik ne pove, da ste povsem okrevali.
Median duration of response and median overall survival have not been reached (Table 5).
Mediana trajanja odziva in mediana celokupnega preživetja nista bili doseženi (preglednica 5).
Active uncontrolled infection.
Aktivna neobvladana okužba.
It is used to treat these conditions when other available medicines have stopped working for you.
Uporablja se za zdravljenje teh bolezni, ko druga razpoložljiva zdravila pri vas več ne učinkujejo.
A summary of the patient demographics is provided in Table 4.
Povzetek demografskih značilnosti bolnikov je v preglednici 4.
Serious adverse reactions occurred in 56% of patients.
Resni neželeni učinki so se pojavili pri 56 % bolnikov.
Patient Educational program
Izobraževalni program za bolnika
Hence, traditional toxicology studies used for drug development were not performed.
Zato tradicionalnih toksikoloških študij, ki se uporabljajo za razvoj zdravil, niso izvedli.
Response and survival after treatment with available standard-of-care therapy was evaluated.
Ocenili so odziv in preživetje po zdravljenju z razpoložljivo standardno oskrbo.
If the bag is compromised, follow the local guidelines (or immediately contact Kite).
Če je vreča poškodovana, upoštevajte lokalne smernice (ali pa takoj poklicati Kite).
If your temperature is high, see your doctor immediately.
Če je temperatura zvišana, pojdite takoj k zdravniku.
•Update reports:
• Posodobitev poročil:
CR rates were 75% and 56%, respectively.
Stopnja CR je bila 75 % oziroma 56 %.
Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS.
Omejitev na največ 3 odmerke v 24-urnem obdobju; skupaj največ 4 odmerki, če ni kliničnega izboljšanja znakov in simptomov CRS.
Effects on male and female fertility have not been evaluated in animal studies.
Učinkov na sposobnost razmnoževanja pri moških in ženskah niso ugotavljali v študijah na živalih.
• Place the infusion bag inside a second sterile bag or per local guidelines.
• Infuzijsko vrečo položite v drugo sterilno vrečo ali v skladu z lokalnimi smernicami.
YESCARTA is intended solely for autologous use and must not be administered to other patients.
Zdravilo YESCARTA je namenjeno izključno za avtologno uporabo in se ne sme dajati drugim bolnikom.
This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 15 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslo osebo.
Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen.
Po potrebi se dajanje tocilizumaba ponovi vsakih 8 ur, če ni odziva na intravenske tekočine ali povečano dodajanja kisika.
• Check if your cancer is getting worse.
• preveril, ali se vaša rakava bolezen slabša.
ORR (%) [95% CI] CR (%)
ORR (%) [95-% IZ] CR (%)
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Pogostnosti so opredeljene kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
Thawing should take approximately 3 to 5 minutes.
Odtajanje običajno traja od 3 do 5 minut.
In some cases, it might not be possible to go ahead with the planned treatment with YESCARTA.
V nekaterih primerih morda načrtovanega zdravljenja z zdravilom YESCARTA ne bo mogoče nadaljevati.
Age (range: 23 to 76 years) and sex had no significant impact on AUC and Cmax of YESCARTA.
Starost (razpon: od 23 do 76 let) in spol nista bistveno vplivala na vrednosti AUC in Cmax zdravila
It usually takes about 3 to 4 weeks to receive your YESCARTA therapy but the time may vary.
Običajno traja približno 3 do 4 tedne do zdravljenja z zdravilom YESCARTA, vendar se lahko čas razlikuje.
The primary endpoint was objective response rate (ORR).
Primarni opazovani dogodek je bila stopnja objektivnega odziva (ORR, objective response rate).
17.4 (11.6, NE) 17.4 (11.6, NE) NE (12.8, NE)
17,4 (11,6, NO) 17,4 (11,6, NO) NO (12,8, NO) NO (12,8, NO)
Most patients recovered from neurologic adverse reactions, with the exception of 4 patients who had ongoing neurologic adverse reactions at the time of death; the deaths were due to other causes.
Večina bolnikov je po nevroloških neželenih učinkih okrevala, z izjemo 4 bolnikov, ki so imeli ob smrti nevrološke neželene reakcije; smrti so bile posledica drugih vzrokov.
This will show if you are likely to develop a condition called tumour lysis syndrome.
To bo pokazalo, ali je verjetno, da bi se pri vas razvilo stanje, ki se imenuje sindrom tumorske lize.
Do not use this medicine after the expiry date which is stated on the container label and infusion bag.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki vsebnika in infuzijski vreči.
• Fits, shaking, or difficulty speaking or slurred speech, loss of consciousness or decreased level of consciousness, confusion and disorientation, loss of balance or coordination.
• Krče, tresenje, težave z govorom ali nerazločno govorjenje, izgubo zavesti ali zmanjšano raven zavesti, zmedenost in dezorientacijo, izgubo ravnotežja ali koordinacije.
Patients relapsed within 1 year of ASCT Patients with International Prognostic Index 3/4 Patients with disease stage III/IV
Bolniki z mednarodnim prognostičnim indeksom 3/4 Bolniki s fazo bolezni III/IV
- have an infection.
- če imate okužbo.
Secondary endpoints included duration of response (DOR), overall survival (OS), and severity of adverse events.
Sekundarni opazovani dogodki so vključevali trajanje odziva (DOR, duration of response), celokupno preživetje (OS, overall survival) in resnost neželenih učinkov.
The most common site of infection was in the respiratory tract.
Najpogostejše mesto okužbe so bila dihala.
YESCARTA will only be supplied to hospitals and associated centres that are qualified and only if the healthcare professionals involved in the treatment of a patient have completed the educational program.
Zdravilo YESCARTA se priskrbi le bolnišnicam in povezanim centrom, ki so usposobljeni, in le, če so zdravstveni delavci, ki sodelujejo pri zdravljenju bolnikov, končali izobraževalni program.
Of the 111 patients in the ITT population, the ORR was 66% and the CR was 47%.
Pri 111 bolnikih v populaciji ITT je bila stopnja ORR 66 % in stopnja CR 47 %.
12-month analysis
Analiza po 12 mesecih
Nearly all patients experienced some degree of CRS.
Pri skoraj vseh bolnikih se je pojavila določena stopnja CRS.
The number of anti-CD19 CAR T cells in the blood was positively associated with objective response (CR or PR).
Število anti-CD19 CAR T-celic v krvi je bilo pozitivno povezano z objektivnim odzivom (CR ali PR).
If you miss any appointments, call your doctor or the qualified clinical facility as soon as possible to reschedule your appointment.
Če izpustite termin za obisk, čim prej pokličite zdravnika ali usposobljeno klinično ustanovo, da termin prestavite.
• Prophylactic use of systemic corticosteroids is not recommended as it may interfere with the activity of YESCARTA.
• Profilaktične uporabe sistemskih kortikosteroidov se ne priporoča, saj lahko ovira aktivnost zdravila YESCARTA.
The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Do not donate blood, organs, tissues or cells for transplants.
Ne darujte krvi, organov, tkiva ali celic za presaditev.
Dysphagia is a recognised symptom of encephalopathy which is currently listed in the product information; however, dysphagia can lead to serious complications and may require specific clinical measures.
Disfagija je znan simptom encefalopatije, ki je trenutno naveden v informacijah o zdravilu; vendar pa lahko disfagija vodi do resnih zapletov, zaradi katerih so potrebni posebni klinični ukrepi.
Before you are given YESCARTA tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of YESCARTA.
Preden boste dobili zdravilo YESCARTA, povejte zdravniku ali medicinski sestri, če jemljete kakršna koli zdravila, ki slabijo vaš imunski sistem, kot so kortikosteroidi, saj lahko ta zdravila vplivajo na učinek zdravila YESCARTA.
Peak elevation was observed within the first 14 days after infusion, and levels generally returned to baseline within 28 days.
Največje zvišanje so opazili v prvih 14 dneh po infundiranju, ravni pa so se na izhodiščne običajno vrnile v 28 dneh.
The ORR was prespecified to be tested in the first 92 treated patients and was significantly higher than the prespecified rate of 20% (P < 0.0001).
ORR je bil določen vnaprej in testiran pri prvih 92 zdravljenih bolnikih; rezultat je bil značilno večji od vnaprej določene stopnje 20 % (P < 0,0001).
YESCARTA will always be given to you by a healthcare professional.
Zdravilo YESCARTA vam bo vedno dal zdravstveni delavec.
Non-interventional post-authorisation safety study (PASS): In order to assess the safety profile including long term safety in patients with B-lymphocyte malignancies treated with axicabtagene ciloleucel in the post marketing setting, the applicant should conduct and submit a study based on a registry.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za ocenitev profila varnosti, vključno z dolgotrajno varnostjo bolnikov z malignimi obolenji B-limfocitov, zdravljenih z aksicabtagen ciloleucelom v obdobju trženja, mora vlagatelj izvesti in predložiti študijo na podlagi registra.
These events were considered as syndromes of neurologic toxicity, an important identified risk of axicabtagene ciloleucel use.
Ti dogodki so bili obravnavani kot sindromi nevrološke toksičnosti, ki je pomembno ugotovljeno tveganje pri uporabi aksicabtagen ciloleucela.
- have low blood cell levels (blood counts).
- če imate nizke ravni krvnih celic (števila krvnih celic).
Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion.
Zdravnik vam bo priporočil, da se v bolnišnico vsak dan vračate vsaj 10 dni, in razmislil o tem, da vas prvih 10 dni po infundiranju hospitalizira.
24-month analysis
Analiza po 24 mesecih
Infections occurred in 39% of patients in ZUMA-1.
Okužbe so se pojavile pri 39 % bolnikov v študiji ZUMA-1.
Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Nekatere bele krvne celice se izločijo iz krvi, nato pa se preostanek krvi vrne v žilo.
One cryostorage bag is individually packed in a shipping cassette.
Vsaka vreča za krioshranjevanje je posamično pakirana v transportno kaseto.
Forty-seven patients were evaluable for MYC, BCL-2, and BCL-6 status.
Pri 47 bolnikih je bilo mogoče oceniti status MYC, BCL-2 in BCL-6.
Outcomes were consistent between patients with Eastern Cooperative Oncology Group (ECOG) of 0 and 1 and by sex.
Izidi med bolniki s statusom 0 in 1 po Eastern Cooperative Oncology Group (ECOG) in po spolu so bili skladni.
See section 2 “YESCARTA contains sodium”.
Glejte poglavje 2 »Zdravilo YESCARTA vsebuje natrij«.
YESCARTA should only be given if the results show you are not pregnant.
Zdravilo YESCARTA lahko dobite samo, če rezultat testa pokaže, da niste noseči.
The anticipated metabolic products are typical cellular degradation products resulting from normal cellular clearance mechanisms.
Pričakovani presnovni produkti so tipični produkti celične razgradnje z običajnimi mehanizmi celičnega očistka.
• Your doctor or nurse will give you a single infusion of YESCARTA into your vein for approximately 30 minutes.
• Zdravnik ali medicinska sestra vam bo dal/a eno infuzijo zdravila YESCARTA v veno, kar bo trajalo približno 30 minut.
This medicine contains 300 mg sodium (main component of cooking/table salt) in each infusion.
To zdravilo vsebuje 300 mg natrija (glavna sestavina soli za kuhanje/namizne soli) v eni infuziji.
YESCARTA has major influence on the ability to drive and use machines.
Zdravilo YESCARTA ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Precautions to be taken before handling or administering the medicinal product This medicinal product contains genetically modified human blood cells.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila To zdravilo vsebuje gensko spremenjene človeške krvne celice.
Of 111 patients who underwent leukapheresis, 101 received YESCARTA.
Od 111 bolnikov, pri katerih je bila opravljena levkafereza, je 101 prejel zdravilo YESCARTA.
Nine patients were not treated, primarily due to progressive disease or serious adverse events after enrolment and prior to cell delivery.
Devet bolnikov ni bilo zdravljenih, pretežno zaradi napredovanja bolezni ali resnega neželenega dogodka po vključitvi in pred vnosom celic.
Therefore, YESCARTA is not recommended for women who are pregnant, or for women of childbearing potential not using contraception.
Zdravila YESCARTA se zato ne priporoča pri ženskah, ki so noseče, ali pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection.
Pri postavljanju diagnoze CRS je treba izključiti druge možne vzroke sistemskega vnetnega odziva, vključno z okužbo.
In the phase 1 part of ZUMA-1, 7 patients were treated.
V 1. fazi študije ZUMA-1 je bilo zdravljenih 7 bolnikov.
Administer tocilizumab per Table 1 for management of Grade 2 CRS.
Dajanje tocilizumaba v skladu s preglednico 1 za obravnavo CRS 2. stopnje.
In phase 2 of ZUMA-1, after YESCARTA infusion, pharmacodynamic responses were evaluated over a 4-week interval by measuring transient elevation of cytokines, chemokines, and other molecules in blood.
V 2. fazi študije ZUMA-1 so bili po infundiranju zdravila YESCARTA farmakodinamični odzivi ocenjeni v 4-tedenskem intervalu z merjenjem prehodnega povišanja ravni citokinov, kemokinov in drugih molekul v krvi.
• Additional risk minimisation measures
• Dodatni ukrepi za zmanjševanje tveganj Ključni elementi:
Patients were not required to be followed after they progressed; thus, the majority of patients with evaluable samples were responders.
Bolnikov, pri katerih je prišlo do napredovanja bolezni, ni bilo treba spremljati, zato je bila večina bolnikov z vzorci, ki jih je bilo mogoče oceniti, odzivnih na zdravljenje.
Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, and IL2Rα were analyzed.
Analizirali so ravni citokinov in kemokinov, kot so IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ in IL2Rα.
- If YESCARTA infusion is delayed for more than 2 weeks after you have received preparatory chemotherapy you may have to receive more preparative chemotherapy.
Če se infundiranje zdravila YESCARTA odloži za več kot 2 tedna po pripravljalni kemoterapiji, boste morda morali prejeti dodatno pripravljalno kemoterapijo.
Duration of Responsea, median (range) in months
Trajanje odzivaa, mediana (razpon) v mesecih
• Your white blood cells are frozen and sent away to make YESCARTA.
• Vaše bele krvne celice se zamrznejo in pošljejo v izdelavo zdravila YESCARTA.
Your doctor may need to take special care of you during your treatment with YESCARTA.
Morda bo moral biti zdravnik pri vas posebno pozoren med zdravljenjem z zdravilom YESCARTA.
• Infuse the entire content of the YESCARTA bag within 30 minutes by either gravity or a peristaltic pump.
• Celotno vsebino vreče zdravila YESCARTA infundirajte v 30 minutah s težnostno infuzijo ali s peristaltično črpalko.
Administer tocilizumab (c) 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Dati je treba tocilizumab (c)8 mg/kg intravensko v obdobju 1 ure (ne več kot 800 mg).
You must receive YESCARTA infusion in a qualified clinical facility and be discharged only when your doctor thinks it is safe for you to go home.
Infuzijo zdravila YESCARTA morate prejeti v usposobljeni klinični ustanovi, iz katere boste odpuščeni, ko bo zdravnik menil, da lahko varno greste domov.
Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have.
V vašem tkivu se nakopiči preveč teh nenormalnih belih krvnih celic, kar je vzrok simptomov, ki jih imate.
• Look for signs of graft-versus-host disease that can happen after a transplant.
• preveril znake bolezni presadka proti gostitelju, ki se lahko pojavi po presaditvi.
- have any lung, heart or blood pressure (low or raised) problems.
- če imate kakršne koli težave s pljuči, srcem ali krvnim tlakom (znižan ali zvišan).
There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with YESCARTA.
Podatkov o izpostavljenosti ni dovolj, da bi lahko podali priporočilo glede dolžine uporabe kontracepcije po zdravljenju z zdravilom YESCARTA.
Therefore, the risk/benefit of YESCARTA has not been established in this population.
Zato razmerje med koristmi in tveganji zdravila YESCARTA za to populacijo ni bilo dokazano.
Summary of demographics for ZUMA-1 phase 2 (12 month analysis)
Preglednica 4: Povzetek demografskih značilnosti za 2. fazo ZUMA-1 (analiza po 12 mesecih) Kategorija
Patients should be monitored for signs and symptoms of neurologic adverse reactions (Table 2).
Bolnike je treba spremljati glede znakov in simptomov nevroloških neželenih učinkov (preglednica 2).
Age (years) Median (min, max)
Mediana (min, maks)
Tell your doctor immediately if you get any of the side effects listed above.
Zdravnika takoj obvestite, če opazite katerega od zgoraj navedenih neželenih učinkov.
However, YESCARTA infusion should begin within 30 minutes of thaw completion and the total YESCARTA infusion time should not exceed 30 minutes.
Vendar pa je z infundiranjem zdravila YESCARTA treba začeti v 30 minutah po koncu odtajanja, skupni čas infundiranja zdravila YESCARTA pa ne sme preseči 30 minut.
Pregnant women should be advised on the potential risks to the foetus.
Nosečnicam je treba svetovati o možnih tveganjih za plod.
Prior to receiving YESCARTA, you will be given other medicines such as preparative chemotherapy, which will allow your modified white blood cells in YESCARTA to multiply in your body when the medicine is given to you.
Preden boste prejeli zdravilo YESCARTA, boste dobili druga zdravila, kot je pripravljalna kemoterapija, ki bo omogočila, da se spremenjene bele krvne celice iz zdravila YESCARTA v vašem telesu namnožijo, ko prejmete zdravilo.
Do NOT use a leukodepleting filter.
NE uporabljajte filtra za odstranjevanje levkocitov.
A retrospective, patient-level, pooled analysis of outcomes in refractory aggressive NHL (N = 636) was conducted (Crump et al., 2017) to provide confirmation of the prespecified control response rate of 20% and historical context for interpreting the ZUMA-1 results.
Na ravni bolnikov so izvedli retrospektivno združeno analizo izidov neodzivnega, agresivnega NHL (N = 636) (Crump et al., 2017) za potrditev vnaprej določene kontrolne stopnje odziva 20 % in pridobitev zgodovinskega konteksta za razlago rezultatov ZUMA-1.
YESCARTA should not be used in children and adolescents below 18 years of age.
Zdravila YESCARTA ni dovoljeno uporabiti pri otrocih in mladostnikih, starih manj kot 18 let.
All treated (mITT) Cohort 1 + 2 (N = 101)
Vsi zdravljeni (mITT) Kohorta 1 + 2 (N = 101)
Additional Patient ID: Patient Name:
Kite ID št. bolnika: Dodatna ID št. bolnika: Ime bolnika:
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Znotraj vsake skupine pogostosti so neželeni učinki na zdravilo navedeni po padajoči resnosti.