natgillin/translations-raw huggingface dataset:
The majority of adverse reactions presented in Table 3 were of grade 1 severity in Viekirax and dasabuvir-containing regimens. 
predstavljenih v preglednici 3, je bila v shemah, ki so vključevale zdravilo Viekirax in dasabuvir, 1.
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. 
UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively. 
V preizkusu z replikonsko celično kulturo HCV je bila EC50 paritaprevirja proti sevu genotipa 1a-H77 1,0
Viekirax + dasabuvir ciclosporin 
Viekirax + dasabuvir escitalopram
Angioedema 
takrolimus
Ribavirin was dosed based on weight (1000 mg - 1200 mg per day). 
Odmerki paritaprevirja so bili 100 mg in 200 mg ter ombitasvirja 25 mg. Odmerjanje ribavirina je bilo odvisno od telesne mase (1000 mg - 1200 mg na dan).
(≤25% difference in the Least Square Means ratio) for Viekirax with or without dasabuvir, unless otherwise noted. 
Izrazitost interakcije med uporabo z zdravili, navedenimi v preglednici 2, je podobna (≤ 25 % razlika v razmerju povprečij po metodi najmanjših kvadratov) za zdravilo Viekirax z dasabuvirjem ali brez njega,
CONTRACEPTIVES 
ZDRAVILOM
Clinical monitoring and dose reduction is recommended for angiotensin receptor blockers when coadministered with Viekirax with or without dasabuvir. 
Pri sočasni uporabi blokatorjev angiotenzinskih receptorjev in zdravila Viekirax z ali brez dasabuvirja je priporočljivo klinično spremljanje in zmanjšanje odmerka.
Thus, for these medicinal products, results and dosing recommendations of the Viekirax and dasabuvir regimen can be extrapolated to Viekirax without dasabuvir. 
Viekirax in dasabuvirjem ekstrapolirati na shemo z zdravilom Viekirax brez dasabuvirja.
Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir 
CYP3A4 in/ali P-gp z itrakonazolom, posakonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem.
↑ pravastatin The magnitude of interaction was similar to that observed with Viekirax + dasabuvir. 
↑ ketokonazol Izrazitost interakcije je bila podobna kot s kombinacijo Viekirax + dasabuvir.
No dose adjustment is necessary for raltegravir or Viekirax with or without dasabuvir. 
Prilagoditev odmerka dolutegravirja ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
NA No dose adjustment necessary for paracetamol when administered with Viekirax with or without dasabuvir. 
NP Prilagoditev odmerka paracetamola ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection. 
Zdravljeni preiskovanci (N = 380) so bili mediano stari 58 let (razpon: od 21 do 71); 42,1 % jih še ni bilo zdravljenih, 36,1 % jih predhodno ni imelo odziva na pegIFN/RBV; 8,2 % jih je predhodno imelo delen odziv na pegIFN/RBV in 13,7 % jih je predhodno imelo recidiv ob pegIFN/RBV; 70,3 % je bilo moških; 3,2 % je bilo črncev; 14,7 % jih je imelo število trombocitov manj kot 90 x 109/l; 49,7 % jih je imelo albumin manj kot 40 g/l; 86,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml;
While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is ombitasvir 
priporočljivo pa je ustrezno kontrolirati koncentracijo digoksina v serumu.
− Notice swelling of your stomach area 
− zmedenost; − opazite oteklino v predelu trebuha.
Viekirax and dasabuvir with weight-based ribavirin for 12 weeks Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection. 
Zdravljenje: Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 tednov Zdravljeni preiskovanci (N = 631) so bili mediano stari 52 let (razpon: od 18 do 70); 54,5 % je bilo moških; 5,4 % je bilo črncev; 15,2 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 79,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 15,4 % jih je imelo portalno fibrozo (F2)
ANTIPSYCHOTICS 
Psihiatrične motnje
Astemizole Terfenadine Mechanism: CYP3A4 inhibition by ritonavir. 
Učinek na sirolimus je posledica CYP3A4 inhibicije z ritonavirjem.
↓ voriconazole ↑ paritaprevir ↑ dasabuvir 
Pričakovano: ↑ ombitasvir ↑ paritaprevir ↑ dasabuvir
Viekirax and dasabuvir with RBV 12-week arm 
Viekirax in dasabuvir z RBV 12-tedenska skupina
↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir. 
↓ escitalopram Izrazitost interakcije je bila podobna kot s kombinacijo Viekirax + dasabuvir.
↑conivaptan ↑ paritaprevir ↑ dasabuvir 
↑ paritaprevir ↔ dasabuvir
Darunavir, dosed 800 mg once daily, if administered at the same time as Viekirax and dasabuvir, can be used in the absence of extensive PI resistance (darunavir exposure lowered). 
Darunavir v odmerku 800 mg enkrat na dan, če se ga da ob istem času kot zdravilo Viekirax in dasabuvir,
Digoxin 0.5 mg single 
↑ kinidin ↑ ranolazin digoksin enkraten odmerek 0,5 mg
Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir. 
Zavrtje BCRP s paritaprevirjem, ritonavirjem in dasabuvirjem.
Clinical Comments ritonavir. 
Klinične opombe fenobarbital
NA No dose adjustment needed for sofosbuvir when administered with Viekirax with or without dasabuvir. 
NP Prilagoditev odmerka sofosbuvirja ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
Viekirax with or without dasabuvir ethinyloestra diol 
Odmerka zdravila Viekirax z dasabuvirjem ali brez ombitasvir paritaprevir dasabuvir duloksetin
The magnitude of interaction was similar 
Pričakovan podoben učinek kot s kombinacijo
Clinical monitoring and dose adjustment maybe needed for s-mephenytoin. 
Morda bo potrebno klinično spremljanje in prilagoditev odmerka za druge substrate CYP1A2
Caution should be used when administering Viekirax with fluticasone or other glucocorticoids that are metabolised by CYP3A4. 
Uporaba z glukokortikoidi, ki se presnavljajo s CYP3A4 (npr. flutikazon) Med uporabo zdravila Viekirax hkrati s flutikazonom ali drugimi glukokortikoidi, ki se presnavljajo s
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3). 
Zdravljeni preiskovanci (N = 305) so bili mediano stari 54 let (razpon: od 19 do 70); 65,2 % je bilo moških; 11,8 % je bilo črncev; 20,7 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 86,6 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 18,4 % jih je imelo portalno fibrozo (F2) in 17,7 % jih je imelo fibrozo z mostiči (F3).
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir paritaprevir 
CYP3A4/P-gp s ketokonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem.
Buprenorphine / naloxone 
buprenorfin/nal okson
No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir. 
Prilagoditev odmerka buprenorfina/nalokso na in zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
CYP3A4 inhibition by ritonavir 
CYP3A4 z ritonavirjem;
The EC50 of ombitasvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 14.1 and 5 pM, respectively. 
V preizkusih z replikonsko celično kulturo HCV je bila EC50 ombitasvirja proti sevu genotipa 1a-H77
Clinical Comments and throughout coadministration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed. 
Koncentracije takrolimusa v polni krvi je potrebno spremljati na začetku in vseskozi med sočasno uporabo z zdravilom Viekirax in dasabuvirjem, odmerek in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
Expected: ↑ sildenafil 
Pričakovano: ↑ primozid
Psychiatric disorders Very common 
Zelo pogosti nespečnost
ERGOT ALKALOIDS Ergotamine 
ERGOT ALKALOIDI ergotamin dihidroergotami n ergonovin metilergometrin
Paritaprevir/ritonavir had no effects on embryo-foetal viability or on fertility when evaluated in rats at exposures 2- to 8-fold higher than the exposure in humans at the recommended clinical dose. 
ocenjeno pri podganah ob izpostavljenostih, ki so bile od 2- do 8-krat večje kot je izpostavljenost človeka ob priporočenih kliničnih odmerkih.
Fexofenadine 
feksofenadin
HERBAL PRODUCTS 
PODATKI NA ZUNANJI OVOJNINI
↑ imatinib 
↑ enkorafenib
Mechanism: CYP3A4 inhibition by ritonavir. 
Mehanizem: Zavrtje CYP3A4 z ritonavirjem.
Mechanism: OATP1B1 inhibition by paritaprevir. 
OATP1B1 z gemfibrozilom.
Tablet core 
dezmetilcitalo pram
Increase in dasabuvir exposure is possibly due to CYP2C8 inhibition and increase in paritaprevir possibly due to OATP1B1 inhibition by gemfibrozil. 
CYP2C8 in zvišanje ravni paritaprevirja je morda posledica zavrtja
↔ dasabuvir medications. 
Klinične opombe in dasabuvirjem.
Oral midazolam Triazolam 
midazolam, ki se jemlje peroralno, triazolam
paritaprevir ombitasvir 
↑ paritaprevir pravastatin
− Confusion 
Zavrtje
Clinical trial in subjects with compensated cirrhosis TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design: 
Klinična preskušanja pri odraslih, že zdravljenih s peginterferonom + ribavirinom SAPPHIRE-II - genotip 1, že zdravljeni s pegIFN + RBV, brez ciroze
Telithromycin 
↑ furosemid
Caution should be used when Viekirax with or without dasabuvir is coadministered with fexofenadine. 
Pri sočasni uporabi sulfasalazina z zdravilom Viekirax z ali brez dasabuvirja je potrebna previdnost.
Similar effect is expected as observed with Viekirax + dasabuvir. 
Pričakovan je podoben učinek kot s kombinacijo Viekirax +
Use of colchicine is contraindicated with Viekirax with or without dasabuvir in patients with renal or hepatic impairment (see sections 4.3 and 4.4). 
preden začnejo zdravljenje z zdravilom Viekirax z ali brez dasabuvirja (glejte poglavji 4.3 in 4.5).
No dose adjustment of Viekirax with and without dasabuvir is required for patients with mild, moderate or severe renal impairment , or end-stage-renal disease on dialysis (see section 4.2). 
Bolnikom, ki imajo blago, zmerno ali hudo okvaro ledvic ali končno ledvično odpoved in so na dializi, odmerka zdravila Viekirax z dasabuvirjem ali brez njega ni potrebno prilagoditi (glejte poglavje 4.2).
↓ dasabuvir ↓ ombitasvir ↓ paritaprevir 
Pričakovano: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
No dose adjustment needed for Viekirax with or without dasabuvir. 
Odmerka zdravila Viekirax z dasabuvirjem ali brez njega ni treba prilagoditi.
No dose adjustment needed for metformin when co-administered with Viekirax with and without dasabuvir. 
NP Prilagoditev odmerka metformina ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
Voriconazole 
↑ vorikonazol
Expected in CYP2C19 Poor Metabolisers: 
Pričakovano pri učinkovinah, ki se v manjši meri presnavljajo preko CYP2C19:
Subjects with liver transplant and GT4 infection were dosed with Viekirax with RBV (non-cirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1]. 
Preiskovanci s presajenimi jetri in GT4 okužbo so prejemali zdravilo Viekirax z RBV (brez ciroze 12
Medicinal products that inhibit CYP3A4 
Zdravila, ki zavrejo CYP3A4 in prenašalne proteine
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. 
Posamične substitucije V36A/M, V55I, Y56H, Q80K ali E357K niso bistveno vplivale na aktivnost paritaprevirja pri genotipu 1a
Viekirax + dasabuvir dolutegravir 
Viekirax + dasabuvir emtricitabin
Mechanism: CYP3A4 inhibition by 
Mehanizem: Zavrtje CYP3A4/P-gp
↑ dabigatran etexilate 
Pričakovano: ↑ dabigatran eteksilat
Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine). 
(npr. ciprofloksacin, ciklobenzaprin, teofilin in kofein).
HCV GT1- or 4-infected subjects with HIV-1 coinfection were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir, raltegravir, dolutegravir (Part 2 only), or darunavir (Part 1b and Part 2 GT4 only)-, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine. 
(ART) za HIV1, ki je vključevala z ritonavirjem okrepljeni atazanavir, raltegravir, dolutegravir (samo del
In subjects with moderate hepatic impairment, ombitasvir and ritonavir mean Cmax and AUC values decreased by 29% to 30% and 30 to 33%, respectively, while paritaprevir mean Cmax and AUC values increased by 26% to 62% compared to subjects with normal hepatic function. 
Cmax in AUC ritonavirja za 30 do 33 % manjši, povprečna Cmax in AUC paritaprevirja pa za 26 do 62 % večji (glejte poglavja 4.2, 4.4 in 4.8).
B. PACKAGE LEAFLET 
Mehanizem: Zavrtje črevesnega P
• Vomiting 
• kobicistat
Pitavastatin Mechanism: OATP1B inhibition by paritaprevir 
OATP1B/BCR P s paritaprevirjem pitavastatin Mehanizem:
Dose decrease and clinical monitoring of calcium channel blockers is recommended when coadministered with Viekirax with and without dasabuvir. 
Pri sočasnem dajanju zdravila Viekirax z dasabuvirjem ali brez njega in zaviralcev kalcijevih kanalčkov je priporočljivo zmanjšanje odmerka zaviralcev kalcijevih kanalčkov in klinično spremljanje.
↔ ombitasvir paritaprevir ↔ dasabuvir 
↓ paritaprevir ↔ dasabuvir
Similar effect expected as observed with Viekirax + dasabuvir. 
Pričakovan podoben učinek kot pri kombinaciji Viekirax +
There is also a potential risk of autoimmune disease. 
Obstaja tudi tveganje za avtoimunske bolezni.
Other information about Strimvelis 
Druge informacije o zdravilu Strimvelis
What measures are being taken to ensure the safe and effective use of Strimvelis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Strimvelis?
The effects are expected to last for the patient's lifetime. 
Pričakovano je, da učinki trajajo vse življenje.
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 zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Strimvelis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied. 
Kar zadeva varnost, so bolniki zdravilo Strimvelis prenašali sorazmerno dobro, čeprav so podatki omejeni zaradi majhnega števila preiskovanih bolnikov.
The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years. 
Delež hudih okužb se je po zdravljenju zmanjšal in se je v dolgoročnem spremljanju po obdobju treh let še zmanjševal.
This is a summary of the European public assessment report (EPAR) for Strimvelis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Strimvelis.
A risk management plan has been developed to ensure that Strimvelis is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Strimvelis je bil pripravljen načrt obvladovanja tveganj.
What is Strimvelis and what is it used for? 
Kaj je zdravilo Strimvelis in za kaj se uporablja?
All patients were treated with Strimvelis and were still alive 3 years after treatment. 
Vsi bolniki so se zdravili z zdravilom Strimvelis in so tri leta po zdravljenju še živeli.
As a result, patients lack the ADA enzyme. 
Zato imajo bolniki pomanjkanje encima ADA.
It is not intended to provide practical advice on how to use Strimvelis. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Patients in the study had no appropriate bone marrow donor and alternative treatment had not worked or was not available. 
Bolniki v študiji niso imeli primernega dajalca kostnega mozga in alternativno zdravljenje ni delovalo oziroma ni bilo na voljo.
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. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Strimvelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Patients are also given an antihistamine injection just before treatment to reduce the risk of allergic reactions. 
Bolniki bodo tik pred začetkom zdravljenja prejeli tudi intravenski antihistaminik, da se zmanjša tveganje za alergijske reakcije.
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. 
Družba bo prav tako vodila register bolnikov, zdravljenih z zdravilom Strimvelis, in redno spremljala njihov napredek po zdravljenju, da bi proučila dolgoročno varnost zdravila.
The most common side effect with Strimvelis (which may affect up to 1 in 10 people) is pyrexia (fever). 
Najpogostejši neželeni učinek zdravila Strimvelis (ki lahko prizadene največ 1 osebo od 10) je povišana telesna temperatura (pireksija).
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). 
Resni neželeni učinki zdravila Strimvelis so lahko povezani z avtoimunskimi motnjami (ko imunski sistem napade celice lastnega telesa), kot so hemolitična anemija (nizka raven rdečih krvnih celic zaradi njihove prehitre razgradnje), aplastična anemija (nizka raven krvnih celic zaradi okvare kostnega mozga), hepatitis (vnetje jeter), trombocitopenija (nizka raven trombocitov) in Guillain-Barréjev sindrom (poškodba živcev, ki lahko povzroči bolečino, odrevenelost, mišično oslabelost in težave pri hoji).
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. 
Ker se zdravilo Strimvelis izdela z uporabo retrovirusa, obstaja potencialno tveganje za raka zaradi nenačrtovanih sprememb genskega materiala, čeprav do zdaj niso opazili takih primerov.
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. 
Poleg tega bo družba, ki izdeluje zdravilo Strimvelis, priskrbela izobraževalna gradiva za bolnike in zdravstvene delavce z informacijami o zdravilu, bolniki pa bodo morali pred začetkom zdravljenja podpisati obrazec o soglasju.
It must not be used in patients who have tested positive for human immunodeficiency virus (HIV, the virus that causes AIDS) or some other infections, or in patients who have previously had gene therapy treatment. 
Ne sme se uporabljati pri bolnikih, ki imajo pozitiven izvid testiranja za okužbo z virusom humane imunske pomanjkljivosti (virusom HIV, ki povzroča aids) ali kakšno drugo okužbo, in bolnikih, ki so v preteklosti že bili zdravljeni z genskim zdravljenjem.
What benefits of Strimvelis have been shown in studies? 
Kakšne koristi je zdravilo Strimvelis izkazalo v študijah?
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. 
Vzpostavljeni so ukrepi za spremljanje takih dogodkov po uporabi zdravila, in sicer z vključitvijo bolnikov v register za proučevanje njihovega dolgoročnega napredka.
What are the risks associated with Strimvelis? 
Kakšna tveganja so povezana z zdravilom Strimvelis?
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. 
Ker je bolnikov z ADA-SCID malo, velja ta bolezen za redko, zato je bilo zdravilo Strimvelis 26. avgusta 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Why is Strimvelis approved? 
Zakaj je bilo zdravilo Strimvelis odobreno?
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. 
Ker je ADA ključen za ohranjanje zdravih limfocitov (belih krvnih celic, ki premagujejo okužbe), imunski sistem bolnikov z ADA-SCID ne deluje pravilno in bolniki brez učinkovitega zdravljenja redko preživijo dlje kot dve leti.
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 zdravila Strimvelis so se izkazale v eni glavni študiji z 12 bolniki z ADA-SCID, starimi od 6 mesecev do približno 6 let.
Strimvelis is given as an infusion (drip) into a vein over about 20 minutes. 
Zdravilo Strimvelis se daje v infuziji (kapalni) v veno, ki traja približno 20 minut.
For more information about treatment with Strimvelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Strimvelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The full EPAR for Strimvelis 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 Strimvelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 pripravo zdravila Strimvelis se odvzameta dva vzorca bolnikovega kostnega mozga, eden za izdelavo zdravila Strimvelis in drugi kot rezervni vzorec v primeru, če zdravila Strimvelis ni mogoče dati ali če ne deluje.
This type of medicine works by delivering genes into the body. 
Gre za skupino zdravil, ki delujejo tako, da prenesejo gene v telo.
For the full list of restrictions and side effects reported with Strimvelis, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Strimvelis, glejte navodilo za uporabo.
Results from the main study show that Strimvelis is effective at improving survival of ADA-SCID patients. 
Rezultati glavne študije kažejo, da je zdravilo Strimvelis učinkovito pri izboljševanju preživetja pri bolnikih z ADA-SCID.