FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data on the effects of Strimvelis on human fertility.
Croatian: Nema podataka o učincima lijeka Strimvelis na plodnost ljudi.
English: This medicine contains approximately 3.5 mg sodium per millilitre.
Croatian: Ovaj lijek sadrži približno 3,5 mg natrija po mililitru.
English: Healthcare professionals handling Strimvelis should therefore take appropriate precautions to avoid potential transmission of infectious diseases.
Croatian: Strimvelis moraju poduzeti odgovarajuće mjere opreza kako bi izbjegli mogući prijenos zaraznih bolesti.
English: Elderly Strimvelis is not intended for use in patients >65 years of age, and has not been studied in this age group.
Croatian: Strimvelis nije namijenjen za primjenu u bolesnika u dobi od > 65 godina i nije se ispitivao u toj dobnoj skupini.
English: Results at 3 years for patients treated within the pivotal study are presented in Table 1.
Croatian: Rezultati zabilježeni nakon 3 godine u bolesnika liječenih u sklopu pivotalnog ispitivanja prikazani su u Tablici 1.
English: This should be harvested from the patient at least 3 weeks prior to treatment with Strimvelis.
Croatian: Taj uzorak treba uzeti od bolesnika najmanje 3 tjedna prije liječenja lijekom Strimvelis.
English: In such cases, the doctor will give you (or your child) replacement stem cells, using the backup sample that was collected and stored before treatment started (see also section 3, How Strimvelis is given).
Croatian: U tim će slučajevima liječnik Vama (ili Vašem djetetu) dati nadomjesne matične stanice, koristeći rezervni uzorak koji je uzet i pohranjen prije početka liječenja (pogledajte i dio
English: dAXP results are based on a responder analysis of the percentage of patients following gene therapy who met the definition of adequate metabolic detoxification, therefore baseline value is not applicable.
Croatian: Rezultati za dAXP temelje se na analizi onog postotka bolesnika s odgovorom na gensku terapiju koji su zadovoljili definiciju odgovarajuće metaboličke detoksikacije i stoga početna vrijednost nije primjenjiva.
English: Patients treated with Strimvelis should not donate blood, organs, tissues and cells for transplantation, at any time in the future.
Croatian: Bolesnici liječeni lijekom Strimvelis nikada u budućnosti ne smiju darovati krv, organe, tkiva ni stanice za presađivanje.
English: Low levels of human cells and vector sequences were also detected in non-haematopoietic organs consistent with the presence of blood containing transduced human cells.
Croatian: Niske razine humanih stanica i vektorskih sekvenci pronađene su i u nehematopoetskim organima, što je u skladu s prisutnosti krvi koja sadrži transducirane humane stanice.
English: Table 2 Rate of severe infections per person year of exposure (pivotal population)* Pre treatment
Croatian: Tablica 2 Stopa teških infekcija po osoba-godini izloženosti (populacija iz pivotalnog ispitivanja)*
English: Asthma, rhinitis allergic
Croatian: prsišta i sredoprsja astma, alergijski rinitis
English: As Strimvelis will be administered following busulfan conditioning, patients of childbearing potential must use reliable barrier contraception during administration of Strimvelis and for at least 6 months afterwards.
Croatian: Budući da će se Strimvelis primijeniti nakon kondicioniranja busulfanom, bolesnice reproduktivne dobi moraju koristiti pouzdanu mehaničku metodu kontracepcije u vrijeme primjene lijeka Strimvelis i još najmanje 6 mjeseci nakon toga.
English: Interventionfree survival in this pivotal population (defined as survival without the requirement for long-term (≥3 month) re-introduction of PEG-ADA, or stem cell transplant) was 92% (11/12 subjects) (82% (14/17 subjects) for integrated population).
Croatian: Preživljenje bez intervencije u toj populaciji iz pivotalnog ispitivanja (koje se definiralo kao preživljenje bez potrebe za dugoročnim [≥ 3 mjeseca] ponovnim uvođenjem PEG-ADA ili presađivanjem matičnih stanica) iznosilo je 92% (11/12 ispitanika) (82% [14/17 ispitanika] u populaciji uključenoj u integriranu analizu).
English: After notification, the treating physician may need to modify the treatment program of the patient accordingly (i.e. terminating the busulfan conditioning and/or administration of the stem cell back up treatment if appropriate).
Croatian: Nakon primitka obavijesti, nadležni će liječnik možda morati prilagoditi bolesnikov program liječenja u skladu s time (npr. prekinuti kondicioniranje busulfanom i/ili primijeniti rezervne matične stanice,
English: Strimvelis is intended solely for autologous use.
Croatian: Strimvelis je namijenjen isključivo za autolognu primjenu.
English: The efficacy of Strimvelis was evaluated in a 3-year open-label, prospective study in children who lacked a sibling HLA matched stem cell donor and were either failing to respond adequately to PEG-ADA, were intolerant or did not have access to it.
Croatian: Djelotvornost lijeka Strimvelis ocjenjivala se u 3-godišnjem otvorenom, prospektivnom ispitivanju provedenom u djece koja nisu imala HLA-podudarnog brata ili sestru koji bi bili davatelji matičnih stanica i koji nisu uspješno odgovorili na PEG-ADA ili ga nisu podnosili ili im nije bio dostupan.
English: This medicine contains genetically-modified cells.
Croatian: Ovaj lijek sadrži genetski modificirane stanice.
English: Strimvelis is used to treat ADA-SCID when there is no suitable match from a family member to donate stem cells from their bone marrow for a transplant.
Croatian: Strimvelis se koristi za liječenje ADA-SCID-a kada ne postoji podudaran član obitelji koji bi darovao matične stanice iz svoje koštane srži za presađivanje.
English: Non-interventional PASS: In order to investigate the long term safety and efficacy of Strimvelis gene therapy, the MAH should conduct and submit the results of a long term prospective, non-interventional follow up study using data from a registry of patients with adenosine deaminase severe combined immunodeficiency (ADA-SCID) treated with Strimvelis.
Croatian: PASS): Radi ispitivanja dugoročne sigurnosti i djelotvornosti genske terapije lijekom Strimvelis, nositelj odobrenja treba provesti i dostaviti rezultate dugoročnog prospektivnog neintervencijskog ispitivanja praćenja koristeći podatke iz registra bolesnika s teškom kombiniranom imunodeficijencijom uzrokovanom nedostatkom adenozin deaminaze (ADA-SCID) liječenih lijekom Strimvelis.
English: Successful generation of T cells after Strimvelis is also likely to be affected by residual thymic function which can become impaired in older children.
Croatian: T stanica nakon primjene lijeka Strimvelis vjerojatno će utjecati i rezidualna funkcija timusa, koja se u starije djece može narušiti.
English: This medicinal product contains 0.15 mmol sodium per ml (see section 4.4).
Croatian: Ovaj lijek sadrži 0,15 mmol natrija po ml (vidjeti dio 4.4).
English: • the backup sample, at least 3 weeks before.
Croatian: • rezervni uzorak, najmanje 3 tjedna prije primjene lijeka.
English: Strimvelis should not be used during pregnancy.
Croatian: Strimvelis se ne smije primijeniti u trudnoći.
English: The concentration is 1-10 million CD34+ cells/ml.
Croatian: Koncentracija iznosi 1-10 milijuna CD34+ stanica/ml.
English: A total of 18 patients with ADA-SCID were treated with Strimvelis as part of one open-label pivotal trial (AD1115611; N=12), two early open-label pilot studies (AD1117054/AD1117056; N=3), and a compassionate use program (AD1117064; N=3).
Croatian: Ukupno je 18 bolesnika s ADA-SCID-om bilo liječeno lijekom Strimvelis u sklopu jednog otvorenog pivotalnog ispitivanja (AD1115611; N=12), dva rana otvorena pilot ispitivanja (AD1117054/AD1117056; N=3) i programa milosrdne primjene lijeka (AD1117064; N=3).
English: to make the bone marrow ready for Strimvelis
Croatian: kako bi se koštana srž pripremila za Strimvelis
English: Strimvelis should be used with caution in patients with hypersensitivity to aminoglycosides or bovine serum albumin.
Croatian: Strimvelis treba primjenjivati uz oprez u bolesnika s preosjetljivošću na aminoglikozide ili goveđi serumski albumin.
English: CD34+ cells/kg:
Croatian: CD34+ stanica/kg:
English: PHARMACEUTICAL FORM Dispersion for infusion.
Croatian: OBLIK Disperzija za infuziju.
English: It is recommended that patients be monitored long term with at least annual visits for the first eleven years and then at 13 and 15 years post treatment with Strimvelis, to include a complete blood count with differential, biochemistry and thyroid stimulating hormone.
Croatian: Preporučuje se dugoročan nadzor bolesnika uz najmanje jedan posjet godišnje tijekom prvih jedanaest godina i zatim u 13. i 15. godini nakon liječenja lijekom Strimvelis, koji mora obuhvatiti kompletnu krvnu sliku i diferencijalnu krvnu sliku, biokemijske pretrage krvi i određivanje vrijednosti tireostimulirajućeg hormona.
English: A cloudy to clear, colourless to pink dispersion of cells.
Croatian: Mutna do bistra, bezbojna do ružičasta disperzija stanica.
English: Strimvelis contains sodium
Croatian: Strimvelis sadrži natrij
English: Strimvelis is for intravenous infusion.
Croatian: Strimvelis se primjenjuje intravenskom infuzijom.
English: No. of infusion bags:
Croatian: Broj infuzijskih vrećica:
English: Older patients are typically less able to donate high numbers of CD34+ cells which may mean that older patients cannot be treated.
Croatian: U starijih je bolesnika mogućnost uzimanja velikih količina CD34+ stanica u načelu manja, što može značiti da se stariji bolesnici neće moći liječiti.
English: These autoimmune adverse reactions were reported for subjects post-gene therapy.
Croatian: Te autoimune nuspojave prijavljene su u ispitanika nakon genske terapije.
English: No cases of leukaemia or myelodysplasia have been reported following treatment with Strimvelis.
Croatian: Nisu prijavljeni slučajevi leukemije ni mijelodisplazije nakon liječenja lijekom Strimvelis.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot:
Croatian: 13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Lot:
English: Any unused medicinal product or waste material should be disposed of in accordance with local biosafety requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima o biosigurnosti.
English: It will be used to make the Strimvelis, by putting a new gene into the cells.
Croatian: On će se upotrijebiti za proizvodnju lijeka Strimvelis, pri čemu će se u stanice ubaciti novi gen.
English: - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to your doctor or nurse when you see them or if you go to hospital.
Croatian: - Uvijek pokažite Karticu s upozorenjima za bolesnika svom liječniku ili medicinskoj sestri kada ih posjetite ili kada odete u bolnicu.
English: Very common > 1/10 Common ≥1/100 to <1/10
Croatian: ≥ 1/100 i < 1/10
English: Rate of severe infections per person-year of observation (95% confidence
Croatian: Stopa teških infekcija po osoba-godini promatranja (interval pouzdanosti od
English: Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)matched related stem cell donor is available (see section 4.2 and section 4.4).
Croatian: Strimvelis je indiciran za liječenje bolesnika s teškom kombiniranom imunodeficijencijom uzrokovanom nedostatkom adenozin deaminaze (engl. severe combined immunodeficiency due to adenosine deaminase deficiency, ADA-SCID), za koje nije dostupan prikladan davatelj matičnih stanica s podudarnim humanim leukocitnim antigenom (HLA) (vidjeti dio 4.2 i dio 4.4).
English: The stem cell back-up is collected for use as rescue treatment should there be a failure during product manufacture, transplant failure, or prolonged bone marrow aplasia after treatment with Strimvelis.
Croatian: Rezervne matične stanice prikupljaju se za spasonosno liječenje u slučaju neuspjeha tijekom proizvodnje lijeka, neuspješnog presađivanja ili dugotrajne aplazije koštane srži nakon liječenja lijekom Strimvelis.
English: The median percentages of genetically modified cells in peripheral blood at one year and 3 years after treatment were 28% (range 6%-92%) and 30% (range 8%-101%) of CD19+, and 73% (range 20%-100%) and 67% (range 39%-82%) of CD3+ cells, respectively.
Croatian: Medijani postotaka genetski modificiranih stanica u perifernoj krvi godinu dana i 3 godine nakon liječenja iznosili su 28% (raspon: 6%-92%) odnosno 30% (raspon: 8%-101%) za CD19+ stanice te 73% (raspon: 20%-100%) odnosno 67% (raspon: 39%-82%) za CD3+ stanice.
English: • runny or blocked nose (allergic rhinitis)
Croatian: • curenje iz nosa ili začepljen nos (alergijski rinitis)
English: If clinically relevant quality issues, such as out of specification results, are identified after Strimvelis has been infused, the treating physician will be notified.
Croatian: Ako se nakon infuzije lijeka Strimvelis utvrde klinički značajni problemi s kakvoćom, poput rezultata koji nisu u skladu sa specifikacijama, nadležni će liječnik biti obaviješten o tome.
English: Stage two quality control results will only be available after the product has been infused.
Croatian: Rezultati kontrole kakvoće druge faze bit će dostupni tek nakon infuzije lijeka.
English: It works by putting a new gene into stem cells in the bone marrow so they can make ADA.
Croatian: Djeluje tako da usađuje novi gen u matične stanice u koštanoj srži, tako da one mogu stvarati enzim ADA.
English: The patient must be able to donate adequate CD34+ cells to deliver the minimum 4 million purified CD34+ cells/kg, required for manufacture of Strimvelis.
Croatian: Od bolesnika se mora moći prikupiti dovoljno CD34+ stanica kako bi se dobilo najmanje 4 milijuna pročišćenih CD34+ stanica/kg potrebnih za proizvodnju lijeka Strimvelis.
English: A medicine called busulfan is given four times a day for two days (total of 8 doses)
Croatian: 3 dana prije i 2 dana prije liječenja primjenjuje se lijek koji se zove busulfan četiri puta na dan tijekom 2 dana (ukupno 8 doza)
English: Four subjects had previously received an unsuccessful stem cell transplant from a haploidentical donor and 15 of 18 subjects had previously received prior enzyme replacement therapy with polyethylene-glycol-modified bovine adenosine deaminase (PEG-ADA).
Croatian: Četiri ispitanika prethodno su neuspješno bila podvrgnuta presađivanju matičnih stanica od haploidentičnog davatelja, dok je 15 od 18 ispitanika prethodno primalo nadomjesnu enzimsku terapiju goveđom adenozin deaminazom modificiranom polietilenglikolom
English: This is because Strimvelis is a gene therapy product.
Croatian: Razlog tome jest činjenica da je Strimvelis lijek za gensku terapiju.
English: A completed product consent form is required prior to initiating treatment.
Croatian: Prije početka liječenja mora se pribaviti ispunjen obrazac pristanka za primjenu lijeka.
English: It is recommended that 0.5 mg/kg intravenous busulfan be administered every 6 hours on two consecutive days starting three days before administration of Strimvelis.
Croatian: Kondicioniranje prije liječenja Preporučuje se primijeniti intravenski busulfan u dozi od 0,5 mg/kg svakih 6 sati tijekom dva uzastopna dana, počevši tri dana prije primjene lijeka Strimvelis.
English: Long-term PEG-ADA (exceeding 3 months of continuous duration) was used by three subjects; two of these subjects subsequently received a sibling-matched stem cell transplant and one subject remained on chronic PEG-ADA treatment.
Croatian: PEG-ADA se primjenjivao dugoročno (više od 3 mjeseca neprekidnog liječenja) u tri ispitanika; dva od ta tri ispitanika naknadno su primila presadak matičnih stanica od podudarnog brata ili sestre, dok je jedan nastavio primati kroničnu terapiju PEG-ADA-om.
English: Two samples are collected The doctor will collect two samples of bone marrow stem cells before the planned treatment:
Croatian: Liječnik će prije planiranog liječenja uzeti dva uzorka matičnih stanica iz koštane srži:
English: There are several reasons why this might happen, for example:
Croatian: Postoji nekoliko razloga zbog kojih bi se to moglo dogoditi, primjerice: • ako je došlo do problema u trenutku uzimanja stanica za proizvodnju lijeka
English: Serious adverse reactions include autoimmunity (e.g. autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune hepatitis, autoimmune thrombocytopenia and Guillain-Barré syndrome).
Croatian: Ozbiljne nuspojave uključuju autoimunost (npr. autoimunu hemolitičku anemiju, autoimunu aplastičnu anemiju, autoimuni hepatitis, autoimunu trombocitopeniju i Guillain-Barréov sindrom).
English: Strimvelis is made specially for each patient, using the patient's own bone marrow cells.
Croatian: Strimvelis se izrađuje za svakog bolesnika posebno, korištenjem njegovih vlastitih stanica koštane srži.
English: CD34+ cells derived from healthy human umbilical cord blood, transduced with the vector used for the production of Strimvelis, were administered intravenously to busulfan-conditioned mice.
Croatian: CD34+ stanice iz krvi pupkovine zdravih ljudi, transducirane vektorom koji se koristi u proizvodnji lijeka Strimvelis, intravenski su se primjenjivale miševima koji su prethodno bili kondicionirani busulfanom.
English: Reproductive and developmental studies have not been conducted.
Croatian: Nisu provedena ispitivanja utjecaja na reprodukciju i razvoj.
English: 67% (12 of 18) of Strimvelis treated patients had either autoimmune antibodies or other manifestations (e.g. autoimmune thrombocytopenia, autoimmune aplastic anaemia, autoimmune hepatitis and Guillain-Barré syndrome) (see section 4.8).
Croatian: Šezdeset i sedam posto (12 od 18) bolesnika liječenih lijekom Strimvelis imalo je ili autoimuna protutijela ili neke druge manifestacije (npr. autoimunu trombocitopeniju, autoimunu aplastičnu anemiju, autoimuni hepatitis i Guillain-Barréov sindrom)
English: The quantitative information regarding CD34+ cells/kg and total cells in the product is presented in the labelling for each batch.
Croatian: Kvantitativne informacije o broju CD34+ stanica/kg i ukupnom broju stanica u lijeku navedene su na pakiranju svake serije lijeka.
English: All patients received busulfan conditioning prior to gene therapy, with most receiving a total dose of 4 mg/kg intravenously over 2 consecutive days prior to CD34+ infusion.
Croatian: U svih se bolesnika prije genske terapije provelo kondicioniranje busulfanom, pri čemu je većina primila ukupnu dozu od 4 mg/kg intravenski tijekom 2 uzastopna dana prije infuzije
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Strimvelis Lijek čuvajte izvan pogleda i dohvata djece.
English: The MAH will follow up on the risk of immunogenicity, insertional mutagenesis and oncogenesis as well as hepatic toxicity.
Croatian: Nositelj odobrenja prikupljat će podatke o riziku od imunogenosti, insercijske mutageneze i onkogeneze te o hepatotoksičnosti.
English: Treatment with Strimvelis resulted in a 100% survival rate at 3 years post therapy, a decrease in the severe infection rate, an increase in T-lymphocytes (CD3+) and all subjects having post-baseline venous red blood cell deoxyadenosine nucleotide (RBC dAXP) levels below pathological levels (>100 nmol/ml).
Croatian: Liječenje lijekom Strimvelis rezultiralo je stopom preživljenja od 100% 3 godine nakon terapije, smanjenjem stope teških infekcija i povećanjem broja T-limfocita (CD3+), te je u svih ispitanika nakon početka ispitvanja dovelo do vrijednosti deoksiadenozin nukleotida u eritrocitima u venskoj krvi (engl. red blood cell deoxyadenosine nucleotide, RBC dAXP) koje su bile ispod patoloških vrijednosti (> 100 nmol/ml).
English: - are allergic to any of the ingredients of this medicine (listed in section 6) - have or have had a type of cancer called leukaemia or myelodysplasia - have tested positive for HIV or some other infections (your doctor will advise you about this) - have already been treated with gene therapy
Croatian: Vi (ili Vaše dijete) ne smijete primiti Strimvelis: - ako ste alergični na bilo koji sastojak ovog lijeka (naveden u dijelu 6.) - ako imate ili ste nekada imali jednu vrstu raka koji se zove leukemija ili mijelodisplazija - ako imate pozitivan nalaz testa na HIV ili neku drugu infekciju (liječnik će Vas savjetovati o tome)
English: One year post treatment, median ADA activity (mononuclear cells adenosine deaminase) in peripheral blood lymphocytes was 181.2 (range 42.11678.2) nmol/h/mg protein, compared to a baseline median (range) of 80.6 (30.5-92.3) nmol/h/mg protein.
Croatian: medijan aktivnosti enzima ADA (adenozin deaminaza u mononuklearnim stanicama) u limfocitima iz periferne krvi iznosio je 181,2 (raspon: 42,1 - 1678,2) nmol/h/mg proteina, u usporedbi s početnim medijanom koji je iznosio 80,6 (raspon: 30,5 - 92,3) nmol/h/mg proteina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number:
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Ukupan broj stanica: x 106
English: Exp.: {DD MMM YY} {hh:mm} SPECIAL STORAGE CONDITIONS
Croatian: ROK VALJANOSTI EXP: {DD MM GG} {hh:mm}
English: A 100% survival rate was observed for all 12 subjects treated within the pivotal study and also for the 18 subjects in the integrated analysis, with a median follow up duration of approximately 7 years.
Croatian: U svih 12 ispitanika liječenih u pivotalnim ispitivanjima, kao i u 18 ispitanika uključenih u integriranu analizu, primijećena je stopa preživljenja od 100%, uz medijan praćenja od približno 7 godina.
English: Strimvelis has no or negligible long term influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Strimvelis ne utječe ili ima zanemariv dugotrajan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: T cell function: In the patients treated in the pivotal study, T cell proliferation was demonstrated in response to stimulation with anti-CD3 antibodies (median 62629 cpm, range 4531 to 252173) and phytohemaglutinin (median 140642 cpm, range 11119 to 505607) at 1 year post gene therapy, and these responses were sustained through Year 3.
Croatian: Funkcija T stanica: U bolesnika liječenih u pivotalnom ispitivanju je godinu dana nakon genske terapije zabilježena proliferacija T stanica kao odgovor na stimulaciju anti-CD3 protutijelima (medijan: 62 629 cpm, raspon: od 4531 do 252 173) i fitohemaglutininom (medijan: 140 642 cpm, raspon: od 11 119 do 505 607), a ti su se odgovori održali do 3. godine.
English: Studies evaluated the use of Strimvelis with a range of 0.9 million - 18.2 million CD34+ cells/kg.
Croatian: U ispitivanjima se ocjenjivala primjena lijeka Strimvelis u rasponu od 0,9 milijuna do 18,2 milijuna CD34+ stanica/kg.
English: 50 ml ethylene vinyl acetate (EVA) infusion bag, with a luer spike interconnector closed with a luer lock cap, packed in a re-usable outer container.
Croatian: Etilenvinilacetatna (EVA) infuzijska vrećica volumena 50 ml s luer priključkom sa šiljkom zatvorenim luer lock zatvaračem, zapakirana u vanjski spremnik za višekratnu uporabu.
English: A CD34+ stem cell back-up containing at least 1 million CD34+ cells per kg is required.
Croatian: Potreban je rezervni uzorak CD34+ matičnih stanica koji sadrži najmanje 1 milijun CD34+ stanica po kilogramu.
English: All the identified adverse reactions in the table (apart from those potentially related to busulfan) are considered to be related to immune reconstitution, due to their nature and timing.
Croatian: Zbog svoje se prirode i vremena nastupa sve identificirane nuspojave navedene u tablici (osim onih koje bi mogle biti povezane s primjenom busulfana) smatraju povezanima s imunološkom rekonstitucijom.
English: After infusion, CD34+ cells engraft in the bone marrow where they repopulate the haematopoetic system with a proportion of cells that express pharmacologically active levels of the ADA enzyme.
Croatian: Nakon infuzije, CD34+ stanice usađuju se u koštanu srž, gdje regeneriraju hematopoetski sustav udjelom stanica koje eksprimiraju farmakološki aktivne razine enzima ADA.