natgillin/translations-raw huggingface dataset:
Patients who are taking ethinyloestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax with or without dasabuvir therapy (see sections 4.3 and 4.5). 
kontracepcija samo progestinom ili nehormonske metode) prije započinjanja liječenja lijekom Viekirax s dasabuvirom ili bez njega (vidjeti dijelove 4.3 i 4.5).
Disopyramide 
dezmetilcitalopram
Co-administration of Viekirax with or without dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine). 
povećava koncentracije tih lijekova u plazmi; preporuča se rutinsko kliničko praćenje za lijekove s uskim terapijskim indeksom (tj. levotiroksin).
Target 
Ciljno mjesto
CONTRACEPTIVES 
Lijek/
↑ salmeterol 
Očekuje se: ↑ salmeterol
The SVR12 rates in HCV/HIV-1 co-infected subjects were thus consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects. 
om tipa 1 odgovarala je stopi SVR12 u ispitivanjima faze III u ispitanika s infekcijom samo HCV-om.
Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir 
Očekuje se: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Medicinal products transported by BCRP 
Lijekovi koji se prenose putem P-gp-a u crijevima
A 
U
ANTITPLATELET AGENTS Ticagrelor 
ANTITROMBOTICI tikagrelor
Tacrolimus 
Metformin
The activity of paritaprevir in genotype 1a was not significantly affected (less than or equal to 3-fold) by single substitutions V36A/M, V55I, Y56H, Q80K or E357K. 
Pojedinačne supstitucije V36A/M, V55I, Y56H, Q80K i E357K nisu značajno utjecale na aktivnost paritaprevira protiv genotipa 1a (trostruko ili manje).
DIURETICS Furosemide 
↑ dabigatraneteksilat
Mechanism: CYP3A4 inhibition by ritonavir. 
Mehanizam: CYP3A4 inhibicija ritonavirom.
Mechanism: CYP3A4 induction by carbamazepine 
Mehanizam : Indukcija CYP3A4 karbamazep inom.
Viekirax without dasabuvir ciclosporin ombitasvir 
Viekirax bez dasabuvira ciklosporin ombitasvir
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection. 
Kod bolesnika s transplantiranom jetrom s infekcijom HCV-om genotipa 1 preporučuje se kombinacija lijeka Viekirax i dasabuvira s ribavirinom tijekom 24 tjedna.
Esomeprazole Lansoprazole Mechanism: CYP2C19 induction by ritonavir. 
Mehanizam : Indukcija CYP2C19 ritonavirom.
Viekirax without dasabuvir duloxetine 
Viekirax bez dasabuvira duloksetin
CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin. 
Kliničke napomene inhibicije OATPa/BCRPa/P-gp-a uzrokovane primjenom ciklosporina
Clinical Comments raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir. 
: Povećanje izloženosti raltegraviru moglo bi biti posljedica inhibicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
NA If clinically indicated higher doses of omeprazole should be used. 
NP Primijeniti veće doze omeprazola, ako je to klinički indicirano.
CYP3A4/Pgp inhibition. 
Mehanizam : Inhibicija CYP3A4 /P-gp.
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir. 
Nije potrebno prilagođavati dozu metadona niti lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega.
↑ norbu 
↑ kinidin
Viekirax + dasabuvir dolutegravir 
Viekirax + dasabuvir buprenorfin
CYP3A4 induction by St. John's Wort 
Mehanizam: CYP3A4 indukcija gospinom travom
Viekirax and dasabuvir for 8 weeks 
GT1b Viekirax i dasabuvir (8 tjedana)
No dose adjustment needed for dolutegravir when coadministered with Viekirax with or without dasabuvir. 
Nije potrebno prilagođavati dozu dolutegravira kada se primjenjuje s lijekom Viekirax s dasabuvirom ili bez njega.
Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg. 
godišnjem istraživanju na štakorima ni pri najvišoj ispitivanoj dozi (300 mg/30 mg/kg/dan), koja je dovela do približno 8 puta veće izloženosti paritapreviru (određene na temelju AUC-a) od izloženosti koja se postiže u ljudi nakon primjene doze od 150 mg.
Mechanism: CYP3A inhibition by ritonavir 
CYP3A inhibicija ritonavirom
↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir. 
Jačina interakcije bila je slična onoj primijećenoj kod kombinacije Viekirax +
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir 
Mehanizam ritonavir inducira CYP2C19 i inhibira CYP3A4
Durability of response 
Trajanje liječenja
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3). 
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,7% imalo je početne razine
↑ digoxin 
↑ pimozid
Caution should be used when Viekirax with or without dasabuvir is coadministered with fexofenadine. 
Potreban je oprez kod istodobne primjene lijeka Viekirax s dasabuvirom ili bez njega i feksofenadina.
The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively. 
U testu replikona HCV-a u staničnoj kulturi, srednja vrijednost EC50 ombitasvira protiv replikona koji sadrže NS5A iz palete izolata genotipa 1a odnosno 1b prikupljenih u prethodno neliječenih ispitanika iznosila je 0,66 pM (raspon:
↑ encorafenib 
↑ kvetiapin
Clinical Comments inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir. 
CYP3A koju uzrokuje atazanavir i CYP3A uzrokuje dodatna doza ritonavira.
Duration 
Dojenje
ANTIFUNGALS Ketoconazole 400 mg once daily 
KONTRACEPTIVI etinilestradiol/ norgestimat mg jedanput na dan
Apalutamide 
pitavastatin
Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders, and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection. 
Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,1% imalo je početnu razinu
General disorders and administration and administration site conditions Very common 
Opći poremećaji i reakcije na mjestu primjene vrlo često astenija umor
Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL; 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection). 
HCV RNK od najmanje 6 000 000 IU po ml; 9% imalo je uznapredovalu fibrozu (F3), a 98,2% imalo je infekciju HCV-om genotipa 1b (po jedan ispitanik imao je infekciju HCV-om genotipa 1a, 1d i 6).
No dose adjustment needed for Viekirax with dasabuvir ombitasvir paritaprevir 
Nije potrebna prilagodba doze lijeka Viekirax u ombitasvir dasabuvir
Mechanism of action 
Mehanizam
OPIOIDS Methadone 
NARKOTIČKI ANALGETICI
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir paritaprevir 
Mehanizam ketokonazol i paritaprevir/ ritonavir/o mbitasvir inhibiraju CYP3A4/Pgp.
ANTICANCER AGENTS Encorafenib 
ANTITUMORSKI LIJEKOVI enkorafenib
Mechanism: CYP3A4 induction by rifampicin. 
CYP3A4 indukcija rifampicino m.
Trazodone Mechanism: CYP3A4 inhibition by ritonavir. 
Mehanizam : CYP3A4 inhibicija ritonavirom.
Mechanism: CYP3A4 inhibition by ritonavir ombitasvir 
Mehanizam : Inhibicija CYP3A4 ritonavirom
No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir. 
Nije potrebno prilagođavati dozu buprenorfina/ naloksona niti lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega.
Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL. 
28% nisu odgovarali na prethodno liječenje pegIFN/RBV, 10% su djelomično odgovarali na prethodno liječenje pegIFN/RBV, 13% je imalo relaps nakon prethodnog liječenja pegIFN/RBV; 70% bili su muškarci; 17% bili su crnci; 73% imalo je početnu razinu HCV RNK od najmanje 800 000
5 days after completion of Viekirax + dasabuvir treatment, the sirolimus dose and dosing frequency prior to receiving Viekirax should be resumed, along with routine monitoring of sirolimus blood concentrations. 
+ dasabuvirom, treba se vratiti na dozu i učestalost primjene sirolimusa kao prije liječenja lijekom
Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection. 
HCV-om; 14% bilo je prethodno neuspješno liječeno pegIFN/RBV-om; 68% imalo je infekciju HCVom genotipa 1a.
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis 
Klinička ispitivanja u prethodno neliječenih odraslih ispitanika SAPPHIRE-I - prethodno neliječeni ispitanici s infekcijom genotipom 1, bez ciroze
No dose adjustment of Viekirax is required in patients with mild hepatic impairment (Child-Pugh A). 
Nije potrebno prilagođavati dozu lijeka Viekirax u bolesnika s blagim oštećenjem funkcije jetre
Mechanism: OATP1B/BC RP inhibition by paritaprevir 
Mehanizam paritaprevir inhibira OATP1B/ BCRP
No dose adjustment is necessary for raltegravir or Viekirax with or without dasabuvir. 
Nije potrebno prilagođavati dozu raltegravira niti lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega.
• cobicistat 
• konivaptan
paritaprevir ANTIBIOTICS (SYSTEMIC ADMINISTRATION) 
ANTIBIOTICI (SISTEMSKA PRIMJENA) klaritromici n telitromicin
PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis 
Klinička ispitivanja u ispitanika s kroničnim hepatitisom C genotipa 4 PEARL- I - ispitanici s infekcijom genotipom 4, prethodno neliječeni ili prethodno liječeni pegIFN i RBV bez ciroze
There is also a potential risk of autoimmune disease. 
Postoji i mogući rizik od autoimune bolesti.
As a result, patients lack the ADA enzyme. 
Kao rezultat toga, bolesnicima nedostaje enzim ADA.
Other information about Strimvelis 
Ostale informacije o lijeku Strimvelis
What is Strimvelis and what is it used for? 
Što je Strimvelis i za što se koristi?
Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied. 
U pogledu sigurnosti, pokazalo se da se lijek Strimvelis relativno dobro podnosi iako su podaci ograničeni zbog malog broja ispitanih bolesnika.
The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years. 
Učestalost ozbiljnih infekcija smanjila se nakon liječenja i nastavila se smanjivati u okviru dugoročnog praćenja nakon tri godine.
It is not intended to provide practical advice on how to use Strimvelis. 
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Strimvelis.
Why is Strimvelis approved? 
Zašto je Strimvelis odobren?
The effects are expected to last for the patient's lifetime. 
Očekuje se da će učinci trajati tijekom cijelog bolesnikova života.
All patients were treated with Strimvelis and were still alive 3 years after treatment. 
Svi bolesnici liječeni su lijekom Strimvelis te su bili i dalje živi tri godine nakon liječenja.
Patients are also given an antihistamine injection just before treatment to reduce the risk of allergic reactions. 
Bolesnicima se također daje injekcija s antihistaminom netom prije davanja terapije kako bi se smanjio rizik od alergijskih reakcija.
What measures are being taken to ensure the safe and effective use of Strimvelis? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Strimvelis?
The dose depends on the bodyweight of the patient. 
Doza ovisi o tjelesnoj težini bolesnika.
This is a summary of the European public assessment report (EPAR) for Strimvelis. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Strimvelis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Strimvelis's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Strimvelis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
Because Strimvelis is produced using a retrovirus, there could be a potential risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far. 
Budući da se lijek Strimvelis proizvodi s pomoću retrovirusa, postoji mogući rizik od raka uzrokovanog nenamjernim promjenama u genetskom materijalu, iako do sada nisu zabilježeni takvi slučajevi.
The full EPAR for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Strimvelis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This type of medicine works by delivering genes into the body. 
Ta vrsta lijeka djeluje tako da unosi gene u tijelo.
Strimvelis is a type of advanced therapy medicine called a ‘gene therapy product'. 
Strimvelis je vrsta lijeka za napredno liječenje koji se naziva „lijek za gensku terapiju”.
Serious side effects with Strimvelis may include effects linked to autoimmunity (when the immune system attacks the body's own cells) such as haemolytic anaemia (low red blood cell counts due to their too rapid breakdown), aplastic anaemia (low blood cell counts due to damaged bone marrow), hepatitis (liver inflammation), thrombocytopenia (low blood platelet count) and Guillain-Barré syndrome (damage to nerves that can result in pain, numbness, muscle weakness and difficulty walking). 
Teške nuspojave lijeka Strimvelis mogu uključivati učinke povezane s autoimunošću (kada imunološki sustav napadne vlastite stanice u tijelu) kao što su hemolitička anemija (smanjeni broj crvenih krvnih stanica zbog njihova brzog raspada), aplastična anemija (smanjen broj krvnih stanica zbog oštećene koštane srži), hepatitis (upala jetre), trombocitopenija (smanjen broj trombocita) i Guillain-Barréov sindrom (oštećenje živaca koje može prouzročiti bol, utrnulost, slabost u mišićima i teškoće pri hodanju).
In addition, the company that makes Strimvelis will provide educational materials for patients and healthcare professionals with information on the medicine, and patients will have to sign a consent form before treatment is started. 
Osim toga, tvrtka koja proizvodi lijek Strimvelis osigurat će bolesnicima i zdravstvenim djelatnicima edukativne materijale s informacijama o lijeku, a bolesnici će morati potpisati suglasnost prije početka liječenja.
Strimvelis is given as an infusion (drip) into a vein over about 20 minutes. 
Lijek Strimvelis daje se intravenskom infuzijom (drip) u trajanju od otprilike 20 minuta.
The most common side effect with Strimvelis (which may affect up to 1 in 10 people) is pyrexia (fever). 
Najčešća je nuspojava lijeka Strimvelis (može se javiti u do 1 na 10 osoba) pireksija (vrućica).
A risk management plan has been developed to ensure that Strimvelis is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Strimvelis.
The company will also maintain a registry of patients treated with Strimvelis and monitor their progress regularly after treatment to study the long-term safety of the medicine. 
Tvrtka će također voditi registar bolesnika liječenih lijekom Strimvelis te će redovito pratiti njihov napredak nakon liječenja radi ispitivanja dugoročne sigurnosti lijeka.
The summary of the opinion of the Committee for Orphan Medicinal Products for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Strimvelis dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
These lymphocytes improve the patient's ability to fight infection, and so overcome the symptoms of the condition related to the immune system. 
Ti limfociti poboljšavaju sposobnost bolesnika da se bori protiv infekcije i tako prevlada simptome stanja povezanog s imunosnim sustavom.
However, measures are in place to monitor such events once the medicine is in use by using a registry of patients to study their long-term progress. 
Međutim, postoje mjere za praćenje takvih slučajeva čim počne primjene lijeka s pomoću registra bolesnika radi praćenja njihova dugoročnog napretka.
Patients in the study had no appropriate bone marrow donor and alternative treatment had not worked or was not available. 
Bolesnici koji su sudjelovali u ispitivanju nisu imali odgovarajućeg davatelja koštane srži, a alternativno liječenje nije bilo uspješno ili nije bilo dostupno.
Because the number of patients with ADA-SCID is low, the disease is considered ‘rare', and Strimvelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005. 
Budući da postoji mali broj bolesnika s bolešću ADA-SCID, bolest se smatra „rijetkom” te se Strimvelis označava kao lijek za liječenje rijetkih bolesti od 26. kolovoza 2005.
Before Strimvelis is given, patients receive conditioning (preparatory) treatment with another medicine, busulfan, to get rid of their abnormal bone marrow cells. 
Prije primjene lijeka Strimvelis bolesnici primaju kondicioniranu (pripremnu) terapiju drugim lijekom, busulfanom, kako bi se uklonile njihove abnormalne stanice koštane srži.
To prepare Strimvelis, two samples of the patient's bone marrow are collected, one to make Strimvelis and one that is kept as a back-up in case Strimvelis cannot be given or does not work. 
Za pripremu lijeka Strimvelis uzimaju se dva uzorka koštane srži bolesnika, jedan za pripravljanje lijeka i drugi koji se čuva kao pričuva u slučaju da se lijek ne može primijeniti ili ne djeluje.
What are the risks associated with Strimvelis? 
Koji su rizici povezani s lijekom Strimvelis?
Strimvelis can only be used to treat the same patient whose bone marrow was used to make the medicine. 
Lijek Strimvelis može se koristiti samo za liječenje onog bolesnika čija je koštana srž upotrijebljena za pripravljanje lijeka.
The benefits of Strimvelis have been shown in one main study involving 12 patients from 6 months to around 6 years old with ADA-SCID. 
Koristi lijeka Strimvelis utvrđene su u jednom glavnom ispitivanju koje je obuhvaćalo 12 bolesnika u dobi od 6 mjeseci do otprilike 6 godina koji boluju od bolesti ADA-SCID.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Strimvelis, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Strimvelis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Because ADA is essential for maintaining healthy lymphocytes (white blood cells that fight off infections), the immune system of patients with ADA-SCID does not work properly and without effective treatment they rarely survive more than 2 years. 
Budući da je enzim ADA ključan za održavanje limfocita (bijelih krvnih stanica koje štite od infekcija) zdravima, imunosni sustav bolesnika koji boluju od bolesti ADASCID ne funkcionira ispravno i stoga oni rijetko žive dulje od dvije godine bez učinkovitog liječenja.
Strimvelis must not be used in patients who have leukaemia (cancer of white blood cells) or myelodysplasia (a type of bone marrow disorder) or have had these conditions in the past. 
Lijek Strimvelis ne smije se primjenjivati u bolesnika koji boluju od leukemije (rak bijelih krvnih stanica) ili mijelodisplazije (vrsta poremećaja koštane srži) ili u bolesnika koji su u prošlosti bolovali od tih bolesti.
Once given back to the patient into a vein, Strimvelis is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal lymphocytes that can produce ADA. 
Nakon što se ubrizga u venu bolesnika, lijek Strimvelis krvotokom se prenosi u koštanu srž gdje CD34+ stanice počnu rasti i stvarati normalne limfocite koji mogu proizvesti enzim ADA.
For more information about treatment with Strimvelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Strimvelis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine deaminase (ADA). 
ADA-SCID rijetka je nasljedna bolest kod koje dolazi do promjene (mutacije) gena koji je potreban za proizvodnju enzima adenozin deaminaze (ADA).
How is Strimvelis used? 
Kako se Strimvelis koristi?
Some of the cells (called CD34+ cells) have been genetically modified to contain a working gene for ADA. 
Neke od stanica (koje se nazivaju CD34+ stanice) genetski su modificirane kako bi sadržavale radni gen za enzim ADA.
Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence 
Stanična frakcija obogaćena autolognim CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane adenoza deaminaze (ADA)
A working gene for ADA is inserted into the CD34+ cells using a type of virus called a retrovirus, which has been altered genetically so that it can carry the ADA gene into cells and does not cause viral disease in humans. 
U CD34+ stanice unosi se radni gen za enzim ADA s pomoću vrste virusa koji se naziva retrovirus, a koji je genetski izmijenjen kako bi mogao prenositi gen za enzim ADA u stanice i koji ne uzrokuje virusnu bolest u ljudi.