natgillin/translations-raw huggingface dataset:
Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Ena filmsko obložena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required.
Pri bolnikih z normalnim delovanjem jeter ali ledvic, ki potrebujejo zdravljenje z zdravilom Viekirax z dasabuvirjem ali brez njega, je priporočljivo zmanjšanje odmerka kolhicina ali prekinitev zdravljenja s kolhicinom.
Double variants including combinations of V36LM, F43L, Y56H, Q80K or E357K with R155K or with a D168 substitution reduced the activity of paritaprevir by an additional 2 to 3-fold relative to the single R155K or D168 substitution.
R155K ali s substitucijo D168, so zmanjšale aktivnost paritaprevirja za dodatno 2- do 3-krat glede na eno samo substitucijo R155K ali D168.
Viekirax and dasabuvir for 12 weeks With RBV
Viekirax in dasabuvir 12 tednov Z RBV
Genotype 4
Tarčni gen
↑ naloxone
↑ digoksin
Following administration of Viekirax and dasabuvir
Po uporabi zdravila Viekirax in dasabuvirja
A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Med zdravljenjem z zdravilom Viekirax je priporočljivo začasno opustiti fluvastatin in pitavastatin.
How to store Viekirax
Shranjevanje zdravila Viekirax
No dose adjustment of Viekirax is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 5.2).
Bolnikom z blago, zmerno ali hudo okvaro ledvic ali bolnikom s končno ledvično odpovedjo, ki so na dializi, odmerka zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
The safety summary is based on pooled data from phase 2 and 3 clinical trials in subjects who received Viekirax and dasabuvir with or without ribavirin.
Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri preiskovancih,
400 mg twice daily
raltegravir 400 mg dvakrat na dan
Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Zdravljenje: zdravilo Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 ali 24 tednov
Increase in paritaprevir exposures may be due to inhibition of OATP1B1/B3 and CYP3A by atazanavir.
OATP1B1/B3 in CYP3A z atazanavirjem.
Viekirax and dasabuvir with RBV 24-week arm
Viekirax in dasabuvir z RBV 24-tedenska skupina
No dose adjustment is necessary for norethindrone or Viekirax with or without dasabuvir.
Prilagoditev odmerka noretindrona ali zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
Treatment-naïve pegIFN + RBV experienced Prior relapse Prior partial response Prior null response 100% (32/32) Other pegIFN/RBV failures TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
+Druge vrste neuspehov s pegIFN/RBV vključuje slabše dokumentirane neodzive, recidive/preboje ali druge neuspehe s pegIFN.
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Če je zdravilo Viekirax uporabljeno v kombinaciji z ribavirinom, je potrebna skrajna previdnost, da bi preprečili nosečnost bolnic in partnerk bolnikov.
PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
PEARL-III - genotip 1b, še nezdravljeni, brez ciroze
All clinical trials with ombitasvir, paritaprevir and ritonavir have been conducted following administration with food.
paritaprevirjem in ritonavirjem in dasabuvirjem so bila izvedena po uporabi s hrano.
↑ trazodone
konivaptan
Mechanism: CYP3A4 inhibition by protease inhibitors.
Mehanizem: Zavrtje CYP3A4 z zaviralci proteaz.
NA
SERIJ
Nausea, Diarrhoea
Bolezni prebavil Zelo pogosti navzea, diareja
SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis
Preglednica 10: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, brez ciroze
Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Bolniki, sočasno okuženi s HIV in HCV Celotne varnostne značilnosti pri preiskovancih sočasno okuženih s HCV in HIV-1 so bile podobne, kot so jih opažali pri preiskovancih, okuženih samo s HCV. Prehodna zvišanja celokupnega bilirubina (v glavnem indirektnega) na > 3-kratno ZNM so se pojavila pri 17 (27,0 %) preiskovancih; 15 teh preiskovancev je prejemalo atazanavir.
The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Izrazitost interakcije je bila podobna kot s kombinacijo Viekirax + dasabuvir.
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Prilagoditev odmerka metadona in zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
Viekirax dasabuvir
Viekirax brez dasabuvirja
↑ tacrolimus ombitasvir
karbamazepin epoksid ombitasvir
Viekirax with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Zdravljenje: Zdravilo Viekirax z ali brez dasabuvirja z ali brez ribavirina, odmerjenega glede na telesno maso, 12 ali 24 tednov
NA No dose adjustment needed for abacavir or lamivudine when coadministered with Viekirax with or without dasabuvir.
NP Prilagoditev odmerka abakavirja ali lamivudina ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively
19, 0,09 oziroma 0,68 nM proti replikonskim celičnim linijam, ki so vsebovale NS3 iz posamičnih izolatov genotipov 3a, 4a oziroma 6a.
25 mg once daily administered in the
25 mg enkrat na dan, zjutraj s hrano
Do not pass it on to others.
njega ni treba prilagoditi.
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).