natgillin/translations-raw huggingface dataset:
Patients with TDT treated with Zynteglo who achieved platelet engraftment had a median (min, max) platelet engraftment on Day 41.0 (19, 191) in clinical trials (N=39). 
Bolniki s TDT, zdravljeni z zdravilom Zynteglo, ki so dosegli vsaditev trombocitov, je v kliničnih preskušanjih (N=39) do vsaditve trombocitov prišlo mediano (min.; maks.)
Mobilisation medicine is given To move the blood stem cells from your bone marrow into your blood stream. 
Za premik krvnih matičnih celic iz kostnega mozga v krvni obtok
It is unknown whether Zynteglo is excreted in human milk. 
Ni znano, ali se zdravilo Zynteglo izloča v materino mleko.
All patients were administered Zynteglo with a median (min, max) dose of 7.80 × 106 (5.0, 19.4) CD34+ cells/kg as an intravenous infusion (N=32). 
odmerka 7,80 × 106 (5,0; 19,4) celic CD34+/kg kot intravensko infuzijo (N=32).
Zynteglo, therefore the likelihood that an offspring would have general somatic expression of the βA-T87Q-globin gene is considered negligible. 
Ni priložnosti za prenos gena za βA-T87Q-globin po zdravljenju z zdravilom Zynteglo, zato je verjetnost, da bi imel otrok splošni somatski izraz gena za βA-T87Q-globin, zanemarljiva.
cell/mL. 
{DD/MM/LLLL
Bag ID 
ID COI
Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended. 
Priporočamo profilakso za jetrno venookluzivno bolezen.
No cases of leukaemia or lymphoma have been reported in clinical studies with Zynteglo in patients with TDT. 
V kliničnih študijah z zdravilom Zynteglo pri bolnikih s TDT niso poročali o primerih levkemije ali limfoma.
Baseline characteristics for non-β0/β0 patients with TDT ≥12 years of age treated with Zynteglo (Studies HGB-204, HGB-205, HGB-207, HGB-212, LTF-303) 
Preglednica 4 Izhodiščne značilnosti za bolnike z ne-β0/β0 s TDT ≥ 12 let, zdravljene z zdravilom Zynteglo (študije HGB-204, HGB-205, HGB-207, HGB-212, LTF-303) Bolniki z ne-β0/β0
• dry, itchy skin 
• suha, srbeča koža
All patients who have achieved TI have maintained TI with a min, max duration of TI of 12.0+, 18.2+ months (N=4). 
trajanjem TI 12,0+, 18,2+ mesecev (N=4).
Local biosafety guidelines should be followed for unused medicinal products or waste material. 
Za neuporabljeno zdravilo ali odpadni material je treba upoštevati lokalne smernice za biološko varnost.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INFUSION BAG 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• spots on skin from bleeding under the skin 
• pikčasta koža zaradi podkožnih krvavitev
Hypocalcaemia, Hypokalaemia, Metabolic acidosis, Fluid overload, Fluid retention, Hypomagnesaemia, Hyponatraemia, Hypophosphataemia 
metabolna acidoza, tekočinska preobremenjenost, zastajanje tekočine, hipomagneziemija,
Citrate toxicity, Contusion, Procedural pain 
Poškodbe, zastrupitve in zapleti pri posegih citratna toksičnost, kontuzija, bolečina ob postopku
Cryostor CS5 Sodium chloride 
Cryostor CS5.
• tingling or numbness of the hands, feet, or mouth 
• mravljinčenje ali odrevenelost rok, nog ali ust
After Zynteglo infusion, patient iron levels were managed at physician discretion. 
Po infuziji zdravila Zynteglo so zdravniki po lastni presoji uravnavali ravni železa pri bolnikih.
(g/dL) at 6 months n median (min, max) 
(g/dl) pri 6. mesecih n mediana (min, maks)
Atrial fibrillation 
Srčne bolezni atrijska fibrilacija
• weight decreased 
• zmanjšan tek
After Zynteglo infusion patient iron chelation was managed at physician discretion. 
Po infuziji zdravila Zynteglo so kelacijo železa pri bolnikih uravnavali zdravniki po lastni presoji.
Preparation for the infusion 
Priprava na infuzijo
Zynteglo has not been studied in patients with hepatic impairment. 
Zdravila Zynteglo niso preučili pri bolnikih z okvaro ledvic.
All patients with TDT with a non-β0/β0 genotype who received Zynteglo with at least 3 months of follow-up produced HbAT87Q (N=10, HGB-204; N=4, HGB-205; N=14, HGB-207; N=1, HGB-212). 
Vsi bolniki s TDT z genotipom, ki ni genotip β0/β0, ki so prejeli zdravilo Zynteglo in bili deležni vsaj 3-mesečnega nadaljnjega spremljanja, so proizvedli HbAT87Q (N=10, HGB-204; N=4, HGB-205;
n median (min, max) 
n mediana (min, maks)
• inflamed skin lesions 
• srbeča koža
• swelling of the face 
• otekanje obraza
Non-β0/β0 patients 
Število bolnikov
Efficacy was based on 32 adult and adolescent patients with TDT and a non-β0/β0 genotype treated with Zynteglo (N=10, HGB-204; N=4, HGB-205; N=15, HGB-207; N=3, HGB-212) (see Table 4). 
Učinkovitost temelji na 32 odraslih bolnikih in mladostnikih s TDT in genotipom, ki ni genotip β0/β0, zdravljenih z zdravilom Zynteglo (N=10, HGB-204; N=4, HBG-205, N=15, HGB-207; N=3,
A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene with a strength of 1.2-20 × 106 
Gensko spremenjena obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin, z jakostjo 1,2-20 × 106 celic/m.
Hypotension, Haematoma 
Žilne bolezni hipotenzija, hematom
No correlation was observed between incidence of bleeding and delayed platelet engraftment. 
Med incidenco neželenih učinkov krvavitev in časom do vsaditve trombocitov niso opazili korelacije.
Study HGB-207 
Študija HGB-207
Administer each infusion bag via intravenous infusion over a period of less than 30 minutes. 
Vsako infuzijsko vrečko je treba kot intravensko infuzijo dati v manj kot 30 minutah.
• inflammation of the gallbladder 
• vnetje žolčnika
This medicine contains genetically-modified cells. 
To zdravilo vsebuje gensko spremenjene celice.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v okončinah
It may no longer be possible for you to become pregnant or father a child after receiving chemotherapy medicine. 
Morda po prejemu zdravila za kemoterapijo ne boste več mogli zanositi ali zaploditi otroka.
Study HGB-205 
Študija HGB-205
CD34+ cells) 
(× 106 celic CD34+)
Study HGB-204 
Študija HGB-204
• Confirm that patient identity matches the unique patient identification information located on the Zynteglo infusion bag(s). 
• Preverite, ali se identiteta bolnika ujema z edinstvenimi informacijami o bolniku na infuzijski/-ih vrečki/-ah zdravila Zynteglo.
• stomach pain 
• bolezen dlesni
Contraindications to the mobilisation agents and the myeloablative conditioning agent must be considered. 
Upoštevati je treba kontraindikacije na učinkovine, uporabljene za mobilizacijo, in učinkovino za mieloablativni postopek.
Anal haemorrhage, Gastritis, Gastrointestinal inflammation, Abdominal distension, Abdominal pain upper, Anal fissure, Dyspepsia, Dysphagia, Oesophagitis, Haemorrhoids, Proctalgia. 
konstipacija, bolečine v trebuhu, analno vnetje analna krvavitev, gastritis, vnetje prebavil, abdominalna distenzija, bolečine v zgornjem delu trebuha, analna fisura, dispepsija, disfagija, ezofagitis, hemoroidi, proktalgija, suhe ustnice
BATCH NUMBER, CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT, AND EXPIRY DATE 
ŠTEVILKA SERIJE, VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI
All patients who have achieved TI at any time have maintained TI at Month 30 with a min, max duration of TI of 21.2+, 56.3+ months (N=11). 
trajanjem TI 21,2+ oz. 56,3+ mesecev (N=11).
After you have been treated with Zynteglo, you will not be able to donate blood, organs, or tissues in the future. 
Po zdravljenju z zdravilom Zynteglo v prihodnosti ne boste mogli darovati krvi, organov ali tkiva, ker je zdravilo Zynteglo zdravilo za gensko zdravljenje.
In the clincal studies, patients received a median (min, max) RBC transfusion volume of 175.7 (139, 251) mL/kg/year and a median (min, max) number of 14.8 (10, 40) RBC transfusions per year. 
količine transfuzije celic RBC 175,7 (139; 251) ml/kg/leto in mediano (min.; maks.)
• Confirm that Zynteglo is printed on the infusion bag(s). 
• Preverite, ali je na infuzijski(h) vrečki(vrečkah) natisnjeno ime Zynteglo.
Reproductive and developmental toxicity studies with Zynteglo were not performed. 
Študije vpliva zdravila Zynteglo na sposobnost razmnoževanja in razvoja niso bile izvedene.
Talk to your doctor if you need to have any vaccinations. 
Če potrebujete kakršno koli cepljenje, se posvetujte z zdravnikom.
• chest pain or discomfort 
• nelagodje ali bolečina v prsnem košu
Engraftment failure as measured by neutrophil engraftment 
Odpoved presadka, merjena z vsaditvijo nevtrofilcev
You should not take hydroxyurea (a medicine for blood disorders) or any medicines for HIV infection from at least one month before you undergo mobilisation until at least 7 days after Zynteglo infusion (see also section 3, How Zynteglo is given). 
Vsaj en mesec pred izvajanjem mobilizacije in najmanj 7 dni po infuziji zdravila Zynteglo ne smete jemati hidroksisečnine (zdravilo za bolezni krvi) ali katerega koli zdravila za okužbo z virusom HIV (glejte tudi poglavje 3, Kako uporabljati zdravilo Zynteglo).
• head discomfort 
• nelagodje v glavi
• soreness of the mouth 
• bolečina v ustih
Confirm that Zynteglo is printed on the infusion bag(s). 
Preverite, ali je na infuzijski(h) vrečki(ah) natisnjeno ime Zynteglo.
Keep infusion bag(s) in the metal cassette(s). 
vrečki(vrečkah) in kovinski(h) kaseti(kasetah).
The Summary of Product Characteristics (SmPC) for the iron chelator and the myeloablative conditioning agent must be consulted for the recommendations regarding co-administration with CYP3A substrates. 
Za priporočila glede sočasne uporabe s substrati CYP3A je treba upoštevati povzetek glavnih značilnosti zdravila (SmPC) za železov kelat in sredstva za mieloablativni postopek.
The medicinal product contains genetically-modified cells. 
Zdravilo vsebuje gensko spremenjene celice.
Ovarian failure, Menstruation irregular, Premature menopause, Blood follicle stimulating hormone increased, Blood testosterone decreased 
folikle stimulirajočega hormona v krvi, zmanjšana raven testosterona v krvi
Psychiatric disorders 
Psihiatrične motnje agitacija
Total Hb remained stable at Month 24 with a median (min, max) of 10.60 (8.8, 13.7) g/dL (N=12) and at Month 36 with a median (min, max) of 11.30 (7.8, 13.5) g/dL (N=11). 
10,60 (8,8; 13.7) g/dL (N=12), v 36. mesecu pa je bila mediana (min.; maks.)
Petechiae, Ecchymosis, Pain of skin, Palpable purpura, Petechiae, Pruritus generalised, Purpura, Sweat gland disorder, Urticaria, Dry skin 
hiperpigmentacija kože petehije, ekhimoza, bolečine kože, tipna purpura, petehije,
There is no clinical experience with the use of erythropoiesis-stimulating agents in patients treated with Zynteglo. 
Kliničnih izkušenj z zdravili za spodbujanje eritropoeze pri bolnikih, zdravljenih z zdravilom
Age median (min, max) 
Starost mediana (min, maks)
Figure 1 Median total haemoglobin over time in non-β0/β0 TDT patients treated with Zynteglo who have achieved transfusion independence (Studies HGB-204, 
Slika 1 Mediana skupne koncentracije hemoglobina v odvisnosti od časa za bolnike s TDT in genotipom, ki ni genotip β0/β0, ki so se zdravili z zdravilom Zynteglo in so dosegli neodvisnost od transfuzije (študije HGB-204, HGB-205, HGB-207, LTF-303)
Zynteglo is a genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene. 
Zdravilo Zynteglo je gensko modificirana obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin.
Talk to your doctor before you are given Zynteglo. 
Pred začetkom uporabe zdravila Zynteglo se posvetujte z zdravnikom.
Healthcare professionals handling Zynteglo should take appropriate precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases. 
zaščitnih oblačil in zaščite za oči), da se prepreči morebitni prenos kužnih bolezni.
Last Name First Name: Date of Birth: DIN: 
Datum rojstva:
Driving and using machines 
Odtajanje in uporaba
Eighteen adults and adolescents with TDT with a non-β0/β0 genotype have been treated with Zynteglo in Phase 3 studies (N=15, HGB-207; N=3, HGB-212) and their median (min, max) duration of follow-up was 10.0 (1.3, 22.2) months. 
18 odraslih in mladostnikov s TDT in genotipom, ki ni β0/β0 genotip, se je zdravilo z zdravilom Zynteglo v študijah faze III (N=15, HGB-207; N=3, HGB-212), mediano (min.; maks.)
Expose the sterile port on the infusion bag by tearing off the protective wrap covering the port. Access the infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products. 
Vzemite infuzijsko vrečko z zdravilom in jo infundirajte v skladu s standardnimi postopki na mestaza dajanje zdravil pri celičnem zdravljenju.
HGB-207 and HGB-212 are ongoing Phase 3 open-label, single-arm 24-month studies that are planned to include approximately 39 adults, adolescents, and children with TDT (N=23, HGB-207; 
HGB-207 in HGB-212 sta potekajoči, nezaslepljeni 24-mesečni študiji faze III z eno skupino bolnikov, v kateri naj bi se vključilo približno 39 odraslih bolnikov, mladostnikov in otrok s TDT (N=23, HGB-207; N=16, HGB-212), od katerih je 29 bolnikov z genotipom, ki ni β0/β0 genotip (N=23, HGB-207; N=6, HGB-212), in 10 bolnikov z genotipom β0/β0 v študiji HGB-212.
• inflammation of the throat 
• bolečina v grlu (glasilkah)
Package leaflet: Information for the patient or carer Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion 
Navodilo za uporabo Zynteglo 1,2-20 × 106 celic/ml disperzija za infundiranje
Neutropenic sepsis, Systemic infection, Staphylococcal infection, Pneumonia, Lower respiratory tract infection, Urinary tract infection, Mucosal infection, Cellulitis, Vaginal infection, Rash pustular, Folliculitis, Gingivitis 
infekcija sluznice, celulitis, vaginalna infekcija, pustularni izpuščaj, folikulitis, gingivitis
Back pain, Musculoskeletal discomfort 
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v kosteh bolečine v hrbtu, mišično skeletno nelagodje
Cardiac disorders 
Srčne bolezni srčna undulacija
Efficacy outcomes for non-β0/β0 TDT patients treated with Zynteglo (Studies 
Preglednica 3 Neželeni učinki, ki so pripisani zdravilu Zynteglo Organski sistem
Consult the SmPC of the myeloablative conditioning agent for information on the need for effective contraception in patients who undergo conditioning. 
Za informacije o potrebi po učinkoviti kontracepciji pri bolnikih, ki so opravili mieloablativni postopek, je treba upoštevati SmPC mieloablativnega zdravila.
Hypoxia, Dyspnoea, Pleural effusion, Rales, Upper-airway cough syndrome, Cough, Laryngeal pain, Hiccups 
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa, faringealno vnetje hipoksija, dispneja, plevralna efuzija, piskanje, sindrom kašlja zgornjih dihal, kašelj,
A negative serology test for HIV is necessary to ensure acceptance of apheresis material for Zynteglo manufacturing. 
Za zagotovitev sprejetja afereznega materiala za izdelavo zdravila Zynteglo je potreben negativen serološki test za
Transfusion reaction, Skin abrasion 
Poškodbe in zastrupitve in zapleti pri posegih reakcija na transfuzijo, kožna abrazija
Stomatitis, Vomiting, Nausea, Diarrhoea, Gingival bleeding, Constipation, Abdominal pain, Anal inflammation, 
Bolezni prebavil stomatitis, bruhanje, navzea, driska, krvavitev dlesni,
• dry lips 
• otekanje ustnic
Delayed platelet engraftment 
Zapoznela vsaditev trombocitov
Mucosal inflammation, Face oedema, Hypothermia, Feeling cold, Pain, Xerosis 
hipotermija, občutek mrazenja, bolečina, kseroza
A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells (HSC) transduced with lentiviral vector (LVV) encoding the βA-T87Q-globin gene. 
Gensko modificirana obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin.
Zynteglo must not be administered to women who are breast-feeding. 
Zdravila Zynteglo ni dovoljeno dajati doječim materam.
After Zynteglo infusion 
Po uporabi zdravila Zynteglo
• tiredness 
• kolcanje
• Obligation to conduct post-authorisation measures 
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
• inflammation in the digestive tract 
• vnetje prebavnega trakta
Zynteglo administration 
Uporaba zdravila Zynteglo
How to store Zynteglo 
Shranjevanje zdravila Zynteglo
Lip dry 
Okvara jeter
Inspect each infusion bag for any breaches of integrity before thawing and infusion. 
Pred odtajanjem in infundiranjem preglejte vsako infuzijsko vrečko za morebitne poškodbe.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI Seznam pomožnih snovi
Veno-occlusive liver disease, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased 
Bolezni jeter, žolčnika in žolčevodov veno-okluzivna jetrna bolezen, zvišanje ravni alaninaminotransferaze, zvišanje ravni aspartataminotransferaze, zvišanje ravni bilirubina v krvi holecistitis, holelitiaza, hepatomegalija, zlatenica, zvišanje ravni transaminaze, zvišanje ravni gamaglutamiltransferaze
Keep the infusion bag(s) in the metal cassette(s). 
Infuzijske vrečke pustite v kovinski kaseti.
Adverse reactions attributed to mobilisation/apheresis System Organ Class (SOC) Very Common (≥10%) 
Preglednica 1 Neželeni učinki, ki so pripisani mobilizaciji/aferezi Organski sistem
• excessive sweating 
• težave z znojnicami
Headache 
HIV.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja izpuščaj, hiperhidroza
Final results: Q4 
Končni rezultati:
• fever 
• hemeroidi
Nederland bluebird bio (Netherlands) B.V. Tel: +31 (0) 303 100 450 
Tel.: +31 (0) 303 100 450
You should not be given Zynteglo if you are breast-feeding. 
Če dojite, ne smete prejeti zdravila Zynteglo.
N=16, HGB-212), of whom 29 have a non-β0/β0 genotype (N=23, HGB-207; N=6, HGB-212) and 10 have a β0/β0 genotype in HGB-212. 
N=14, HGB-207; N=1, HGB-212).
This is because Zynteglo is a gene therapy medicine. 
zaradi zdravila Zynteglo.
• gallstones 
• žolčni kamni
GENERAL CLASSIFICATION FOR SUPPLY 
INFORMACIJE O DOBAVLJENIH SERIJAH
genotype, the MAH should submit interim and final data from patients with a severe non-β0/β0 genotype such as IVS-I-110 included in Study HGB-212. 
Za potrditev učinkovitosti in varnosti zdravila Zynteglo pri bolnikih, starih 12 let in več, z β-talasemijo, odvisno od transfuzije (TDT), ki nimajo genotipa β0/β0, mora imetnik dovoljenja za promet predložiti vmesne in končne podatke za bolnike z resno, ki ni genotipa-β0/β0, kot je IVS-I-110, vključene v študijo HGB
Haematuria 
Celice
HGB-204, HGB-205, HGB-207, LTF-303) 
(N=10, HGB-204; N=4, HGB-205; N=15, HGB-207; N=3, HGB-212).
Alopecia, Pruritus, Skin hyperpigmentation 
Bolezni kože in podkožja alopecija, pruritus,
Dizziness, Lethargy, Dysgeusia 
generalizirani pruritus, purpura,
Splenomegaly, Leukocytosis 
Bolezni krvi in limfatičnega sistema trombocitopenija splenomegalija, levkocitoza
Adverse reactions attributed to myeloablative conditioning 
Preglednica 2 Neželeni učinki, ki so pripisani mieloablativnem postopku Organski sistem
Nervous system disorders 
Žilne bolezni hipotenzija
It must also not be used in women who are breast-feeding. 
Prav tako ga ne smejo uporabljati ženske, ki dojijo.
Treatment is continued for as long as the patient benefits from it. 
Zdravljenje se nadaljuje tako dolgo, dokler je za bolnika koristno.
The European Commission granted a marketing authorisation valid throughout the European Union for Caprelsa on 17 February 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Caprelsa, veljavno po vsej Evropski uniji, izdala 17. februarja 2012.
The main measure of effectiveness was ‘overall response rate' (ORR) which considers several features of the disease. 
Glavno merilo učinkovitosti je bil celotna stopnja odziva (ORR), ki upošteva številne značilnosti bolezni.
The study involved 331 patients and the main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse). 
V študijo je bilo vključenih 331 bolnikov, glavno merilo učinkovitosti pa je bil čas preživetja bolnikov brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se jim bolezen poslabšala).
The Committee noted the potential risk for QTc interval prolongation, and measures were introduced to minimise this risk. 
Odbor je opozoril na možno tveganje podaljšanja intervala QTc in uvedel ukrepe za zmanjšanje tega tveganja.
What measures are being taken to ensure the safe and effective use of Caprelsa? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Caprelsa?
The full EPAR for Caprelsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Caprelsa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This means that there is more evidence to come about the medicine, in particular on the size of the benefit in patients without the RET mutation. 
To pomeni, da se pričakujejo dodatni dokazi o zdravilu, zlasti o obsegu koristi pri bolnikih brez mutacije RET.
This is a summary of the European public assessment report (EPAR) for Caprelsa. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Caprelsa.
Of the 16 children treated with Caprelsa, 7 (44%) had partial response on the ORR scale, which was comparable to the response rate in adults. 
Od 16 otrok, ki so bili zdravljeni z zdravilom Caprelsa, se jih je sedem (44 %) delno odzvalo na lestvici ORR, kar je primerljivo s stopnjo odziva pri odraslih.
By blocking the activity of EGF receptors, the cancer cells no longer receive the messages needed for growth and multiplication. 
Z zaviranjem aktivnosti receptorjev EGF rakave celice več ne sprejemajo sporočil, potrebnih za rast in razmnoževanje.
On average, patients taking Caprelsa lived for 30.5 months without their disease getting worse, compared with 19.3 months for patients taking placebo. 
Povprečno so bolniki, ki so jemali zdravilo Caprelsa , živeli 30,5 meseca brez poslabšanja bolezni, v primerjavi z 19,3 meseca pri bolnikih, ki so jemali placebo.
On average children taking Caprelsa lived for 46 months without their disease getting worse. 
V povprečju so otroci, ki so jemali zdravilo Caprelsa, živeli 46 mesecev brez poslabšanja bolezni.
These enzymes are needed by certain receptors (such as VEGF, EGF and RET receptors) on the surface of cancer cells, where they activate several processes including cell division and the growth of new blood vessels. 
Te encime potrebujejo nekateri receptorji (kot so receptorji VEGF, EGF in RET) na površini rakavih celic, kjer spodbujajo številne procese, vključno z delitvijo celic in rastjo novih žil.
The medicine is used when the disease is spreading quickly and causes symptoms, and when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body. 
Uporablja se, ko se bolezen hitro širi in povzroča simptome ter ko raka ni mogoče odstraniti operativno in je napredoval ali se je razširil na druge dele telesa.
The dose for children aged 5 years or older is calculated using the child's weight and height. 
Odmerek za otroke, starejše od pet let, se izračuna na podlagi otrokove telesne mase in višine.
Patients who cannot swallow tablets can mix the tablet in plain (non-sparkling) water. 
Bolniki, ki ne morejo pogoltniti tablet, lahko tableto razpustijo v navadni (negazirani) vodi.
By blocking the activity of VEGF receptors, the medicine reduces the blood supply to the cancer cells, slowing down the cancer's growth. 
Z zaviranjem aktivnosti receptorjev VEGF zdravilo zmanjša oskrbo rakavih celic s krvjo in upočasni rast raka.
Caprelsa must not be used with other medicines that can prolong the QTc interval. 
Zdravilo Caprelsa se ne sme uporabljati skupaj z drugimi zdravili, ki lahko podaljšajo interval QTc.
This means that it blocks the activity of enzymes known as tyrosine kinases. 
To pomeni, da zavira delovanje encimov, imenovanih tirozin-kinaze.