natgillin/translations-raw huggingface dataset:
Bronchitis; gastroenteritis; viral infections; skin, eye and ear infections; pneumonia Bacterial meningitis 
Infekcijske in parazitske bolezni okužba zgornjih dihal; sinuzitis zelo pogosti bronhitis, gastroenteritis, virusne okužbe; okužbe kože, oči in očes; pljučnica pogosti bakterijski meningitis občasen
• 2 sterile, 3-ml disposable syringes 
• 2 sterilni trimililitrski brizgi za enkratno uporabo
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated-dose toxicity. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
What Rilonacept Regeneron is and what it is used for 
Kaj je zdravilo Rilonacept Regeneron in za kaj ga uporabljamo
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za rekonstitucijo
ADRs to Rilonacept Regeneron reported during the Phase 2/3 program in a total of 109 patients, some treated for longer than 2 years, are listed below using the following categories of frequency: very common (≥1/10); common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100). 
Uporabili smo naslednje kategorije pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100).
• Stomach/Intestinal infection 
• okužba želodca/črevesa;
No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving Rilonacept Regeneron. 
Pri bolnikih, ki prejemajo zdravilo Rilonacept Regeneron, ni na voljo nikakršnih podatkov niti o učinkih cepljenja z živim cepivom niti o sekundarnem prenosu okužbe z živimi cepivi.
Sites for subcutaneous injection, such as the abdomen, thigh, or upper arm, should be rotated. 
Mesta za subkutano injekcijo, na primer trebuh, stegno ali nadlaket, morate menjavati.
Do not use Rilonacept Regeneron: 
Ne uporabljajte zdravila Rilonacept Regeneron:
Results of a single-dose study in patients with end-stage renal disease (ESRD) indicate that the rate of elimination of rilonacept was not decreased. 
Rezultati študije enkratnih odmerkov pri bolnikih s končno ledvično odpovedjo (ESRD) kažejo, da se hitrost odstranjevanja rilonacepta iz telesa ni zmanjšala, zato velja eliminacija rilonacepta skozi ledvici za manj pomembno pot za očistek.
You must tell your doctor right away if any of the following serious side effects occur while you are using Rilonacept Regeneron: 
Takoj morate povedati svojemu zdravniku, če se med jemanjem zdravila Rilonacept Regeneron pojavi kateri od naslednjih resnih neželenih učinkov:
Uncommon side effects (affects 1 to up to 10 users in 1,000) 
Občasni neželeni učinki (pojavijo se pri od 1 do 10 bolnikih od 1.000 bolnikov)
Reconstitution and administration instructions 
Navodila za rekonstitucijo in uporabo
No dose adjustment is needed in patients with renal impairment. 
Pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerjanja.
• 8 sterile, 3-ml disposable syringes 
• 8 sterilnih 3-mililitrskih injekcijskih brizg za enkratno uporabo;
Attach the exposed top of the sterile water vial to the top of a syringe by twisting the syringe onto the vial of sterile water (solvent) (see Figure 2). 
Pritrdite razkriti vrh viale s sterilno vodo na vrh brizge, tako da privijete brizgo na vialo s sterilno vodo (vehiklom) (glejte sliko 2).
Rilonacept Regeneron is intended for subcutaneous use. 
Zdravilo Rilonacept Regeneron je namenjeno za subkutno uporabo.
Table 1: Rilonacept Regeneron dose volume (after reconstitution) by body weight for paediatric patients, aged 12-17 years 
Preglednica 1: Volumen odmerka (po rekonstituciji) zdravila Rilonacept Regeneron glede na telesno maso pri otrocih, starih 12-17 let
You should tell your doctor if you have: 
Če imate kaj od naslednjega, povejte zdravniku:
• 1 puncture-resistant container for disposal of used needles, syringes and vials 
• 1 vsebnik za odstranjevanje rabljenih igel, brizg in vial, odporen proti prebadanju
The average trough levels of rilonacept were approximately 24 µg/ml at steady state following weekly subcutaneous doses of 160 mg for up to 48 weeks in patients with CAPS. 
V stanju ravnovesja po vsakotedenskih subkutanih odmerkih po 160 mg do 48 tednov so bile pri bolnikih s CAPS povprečne minimalne koncentracije rilonacepta približno 24 µg/ml.
Headache Dizziness 
Okvare ledvic
• 1 vial of sterile water (solvent) 
• 1 vialo sterilne vode (vehikla)
Prior to injection, the reconstituted solution should be carefully inspected for any discolouration or particulate matter. 
Pred injiciranjem morate rekonstituirano raztopino skrbno pregledati, ali ni obarvana in ali niso prisotni delci.
• Physician information 
• informacije za zdravnike,
Clean the area in a circular motion with a new alcohol wipe. 
Predel očistite, tako da ga s krožnim gibom obrišete z novim alkoholnim zložencem.
No dose adjustment is required in patients with mild, moderate, or severe renal impairment, or end stage renal disease. 
Pri bolnikih z blago, zmerno ali težko ledvično okvaro ali končno ledvično odpovedjo ni potrebno prilagajanje odmerka.
Carefully turn the vial upside down. 
Previdno potegnite bat navzven.
Paediatric population (up to 12 years old) 
Otroci (stari do 12 let)
• Viral infection 
• Virusna okužba;
• A puncture-resistant container for disposal of used needles, syringes, and vials 
• vsebnik, odporen za vbode, za odstranjevanje uporabljenih igel, injekcijskih brizg in vial.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Table 3: Mean Symptom Scores in Adults (age 18 and older) 
Preglednica 3: Povprečni izidi simptomov pri odraslih (starih najmanj 18 let) Del A Placebo (n=24)
STEP 1: Setting up for an injection 
KORAK 1: Priprava na injiciranje
If you have questions, contact your doctor, nurse, or pharmacist. 
Če ste negotovi, se posvetujte s svojim zdravnikom, z medicinsko sestro ali s farmacevtom.
Push the syringe plunger down all the way so that the sterile water (solvent) in the syringe flows into the vial (see Figure 7). 
Bat brizge potisnite navzdol, da se sterilna voda (vehikel) pretoči v vialo (glejte sliko 7).
The MAH shall provide updates on the recruitment rates and any intermediary results with the PSURs. 
Imetnik dovoljenja za promet z zdravilom mora v PSUR vključiti posodobitve o deležu vključenih preskušancev in kakršne koli vmesne rezultate.
General guidelines when giving a Rilonacept Regeneron injection: 
Splošna navodila pri injiciranju zdravila Rilonacept Regeneron:
Table 2: Adverse reactions with Rilonacept Regeneron in CAPS patients MedDRA 
Preglednica 2: Neželeni učinki pri zdravilu Rilonacept Regeneron pri bolnikih s CAPS Organski sistem po
Reduction from Baseline 
Zmanjšanje od izhodišča
• 2 sterile, disposable needles (27-gauge, ½-inch) 
• 2 sterilni igli za enkratno uporabo (27-G, pol palca):
With the other hand gently pinch a fold of skin around the site that you cleaned for injection. 
Z drugo roko na predelu kože, ki ste ga očistili, nežno naredite kožno gubo za injiciranje.
Women should use effective contraceptives during treatment with Rilonacept Regeneron and for up to 6 weeks after the last dose. 
Med zdravljenjem z zdravilom Rilonacept Regeneron in še do 6 tednov po zadnjem odmerku morajo ženske uporabljati učinkovita kontracepcijska sredstva.
STEP 6: Giving the injection Rilonacept Regeneron is injected into the tissue directly below the layers of skin. 
Zdravilo Rilonacept Regeneron se injicira v tkivo neposredno pod plastmi kože.
• Patient Alert Card 
• opozorilne kartice za bolnike.
How to inject Rilonacept Regeneron 
Kako injicirati zdravilo Rilonacept Regeneron
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING POWDER VIAL LABEL 
PODATKI NA PRIMARNI OVOJNINI ETIKETA VIALE S PRAŠKOM
• Pneumonia 
• pljučnica;
Anxiety, insomnia 
Psihiatrične motnje anksioznost, nespečnost pogosti
As with other large proteins elimination of rilonacept is expected to be via proteolytic catabolism and target mediated clearance. 
Pričakovati je, da se bo rilonacept, podobno kot drugi veliki proteini, odstranjeval iz telesa s proteolitičnim katabolizmom in tarčno posredovanim očistkom, zato ni pričakovati, da bo okvarjeno delovanje jeter na klinično pomemben način vplivalo na farmakokinetiko rilonacepta.
The powder is white to off-white. 
Prašek je bel do belkast.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Regeneron UK Limited 
Imetnik dovoljenja za promet z zdravilom Regeneron UK Limited 40 Bank Street
After reconstitution, each ml of solution contains 80 mg rilonacept. 
Po rekonstituciji vsebuje en ml raztopine 80 mg rilonacepta.
Adolescents who entered in OLE 
Mladostniki, ki so se vključili v odprto podaljšanje
• 8 sterile, disposable needles (27-gauge, ½-inch) 
• 8 sterilnih igel za enkratno uporabo (27-G, polpalčnih);
Live vaccines should not be given concurrently with Rilonacept Regeneron (see section 4.5). 
Sočasno z zdravilom Rilonacept Regeneron bolnik ne sme prejeti živih cepiv (glejte poglavje 4.5).
The ability to drive and operate machines may be impaired by some symptoms associated with CAPS. 
Nekateri simptomi, povezani s CAPS, lahko poslabšajo sposobnost vožnje in upravljanja s stroji.
Open the wrapper that contains a syringe by pulling apart the tabs. 
Odprite ovoj, ki vsebuje brizgo, tako da s potegom ločite označena dela.
What Rilonacept Regeneron looks like and contents of the pack 
Izgled zdravila Rilonacept Regeneron in vsebina pakiranja
Also contains: glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate polyethylene glycol 3350, sucrose, and water for injections. 
Vsebuje tudi: glicin, argininijev klorid, histidin, histidinijev klorid monohidrat, polietilenglikol 3350, saharozo in vodo za injekcije.
Antibodies directed against the receptor domains of rilonacept were detected by an ELISA assay in patients with CAPS after treatment with Rilonacept Regeneron in clinical studies. 
V kliničnih študijah so pri bolnikih s CAPS po zdravljenju z zdravilom Rilonacept Regeneron s testom ELISA odkrili protitelesa proti receptorskim območjem rilonacepta.
The concomitant use of Rilonacept Regeneron with other IL-1 inhibitors is not recommended (see section 
Sočasne uporabe zdravila Rilonacept Regeneron z drugimi zaviralci IL-1 ne priporočajo (glejte poglavje 4.5).
Treatment in adults should be initiated with a loading dose of 320 mg. Dosing should be continued with a once-weekly injection of 160 mg. Rilonacept Regeneron should not be given more often than once weekly. 
Zdravljenje pri odraslih naj se uvede s polnitvenim odmerkom 320 mg. Odmerjanje naj se nadaljuje z injekcijo 160 mg enkrat tedensko.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
Supplies needed: 
Kaj potrebujete:
- fever lasting longer than 3 days, or any other symptoms possibly related to an infection, such as prolonged cough, prolonged headache or localised redness, warmth or swelling of your skin. 
Takoj se pogovorite z zdravnikom, če se med zdravljenjem z zdravilom Rilonacept Regeneron razvijejo simptomi okužbe, na primer: zvišana telesna temperatura, ki traja več kot 3 dni, ali kakšni drugi simptomi, ki bi utegnili biti povezani z okužbo, na primer dolgotrajen kašelj, dolgotrajen glavobol ali lokalna rdečina, zvišana temperatura ali oteklina kože.
Mean Change from Baseline to Endpoint 
Povprečna sprememba od izhodišča do končnega stanja
Open a wrapper containing a new, sterile, disposable needle. 
Odprite omot z novo sterilno iglo za enkratno uporabo.
The majority of the related adverse events in the clinical trials were classified as injection site reactions, experienced by approximately 50% of the patients in the Phase 3 study. 
Imelo jih je približno 50 % bolnikov v študiji 3. faze.
• been scheduled to receive any vaccines. 
• zgodovino okužb, ki se ponavljajo; • načrtovana kakršnakoli cepljenja.
Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml solvent (water for injections) prior to administration. 
Pred uporabo je treba zdravilo Rilonacept Regeneron v prašku z aseptično metodo rekonstituirati z 2,3 ml vehikla (voda za injekcije).
Rilonacept Regeneron should not be used with TNF inhibitors because of increased risk of serious infections (see section 4.5). 
Zaradi zvečanega tveganja resnih okužb se zdravilo Rilonacept Regeneron ne sme uporabljati skupaj z zaviralci TNF (glejte poglavje 4.5).
Rilonacept Regeneron is for subcutaneous use only. 
Zdravilo Rilonacept Regeneron je namenjeno samo za subkutano uporabo.
Remove the syringe and needle from the stopper and throw away the syringe attached to the needle and sterile water (solvent) vial in the puncture-resistant container. 
Potegnite brizgo in iglo iz zamaška in zavrzite brizgo s pritrjeno iglo, in vialo s sterilno vodo
Adults who entered in OLE 
Odrasli, ki so se vključili v odprto podaljšanje
The efficacy was not evaluated in patients without a confirmed NLRP3 gene mutation. 
Pri bolnikih brez potrjene mutacije gena NLRP3 učinkovitosti niso ugotavljali.
STEP 3: Filling a syringe with sterile water for injection (solvent) Snap off the plastic tab on the top of the vial containing sterile water for injection (solvent). 
KORAK 3: Polnjenje injekcijske brizge s sterilno vodo za injekcije (vehiklom) 1.
The dose of Rilonacept Regeneron may need to be adjusted as the child grows. 
Ko otrok raste, bo treba odmerek zdravila Rilonacept Regeneron mogoče prilagajati.
Treatment with Rilonacept Regeneron should not be initiated in patients with neutropenia. 
Pri bolnikih z nevtropenijo ne smemo uvesti zdravljenja z zdravilom Rilonacept Regeneron.
How to use Rilonacept Regeneron 
Kako uporabljati zdravilo Rilonacept Regeneron
STEP 4: Dissolving Rilonacept Regeneron powder with the sterile water for injection (solvent) With one hand, hold the Rilonacept Regeneron powder vial on a firm surface. 
Slika 6 KORAK 4: Raztapljanje praška zdravila Rilonacept Regeneron s sterilno vodo za injekcije (vehiklom) 1.
Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection rilonacept 
Rilonacept Regeneron 80 mg/ml prašek za raztopino za injiciranje rilonacept
Eosinophil count increased common 
Preiskave zvišana koncentracija eozinofilcev pogosti
Remove the needle, discard the syringe and needle. 
Potegnite iglo ven in brizgo z iglo zavrzite.
Common side effects (affects 1 to up to 10 users in 100) 
Pogosti neželeni učinki (pojavijo se pri od 1 do 10 bolnikih od 100 bolnikov)
Histidine hydrochloride monohydrate Polyethylene glycol 3350 
Prašek glicin argininijev klorid histidin histidinijev klorid monohidrat polietilenglikol 3350 saharoza
NAME OF THE MEDICINAL PRODUCT Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection. 
IME ZDRAVILA Rilonacept Regeneron 80 mg/ml prašek in vehikel za raztopino za injiciranje.
• 4 vials of Rilonacept Regeneron powder 
• 4 viale praška zdravila Rilonacept Regeneron;
The initial administration of Rilonacept Regeneron by a patient or caregiver should be under the guidance of a trained healthcare professional. 
Bolnik ali negovalec naj prvič injicira zdravilo Rilonacept Regeneron pod vodstvom usposobljenega zdravstvenega delavca.
• 1 vial of Rilonacept Regeneron powder 
• 1 vialo praška zdravila Rilonacept Regeneron
The reconstituted solution is viscous, clear and colourless to pale yellow. 
Rekonstituirana raztopina je viskozna, bistra in brezbarvna do bledorumena.
Figure 2 
Vrednost2
Prior to injection, the solution should be carefully inspected for any discolouration or particulate matter. 
Raztopino morate pred injiciranjem skrbno pregledati, ali ni obarvana in ali niso prisotni delci.
- The other ingredients in the powder are glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polyethylene glycol 3350 and sucrose. 
Pomožne snovi v prašku so glicin, argininijev klorid, histidin, histidinijev klorid monohidrat, polietilenglikol 3350 in saharoza.
You should not become pregnant and must use birth control while using Rilonacept Regeneron and for at least six weeks after your last dose. 
Med uporabo zdravila Rilonacept Regeneron in vsaj šest tednov po zadnjem odmerku ne smete zanositi in morate uporabljati ustrezno kontracepcijo.
If you are breast-feeding you should ask your doctor for advice before using Rilonacept Regeneron. 
Če dojite, se morate pred uporabo zdravila Rilonacept Regeneron posvetovati s svojim zdravnikom.
NOTE: Contact your pharmacy to report any dissolved Rilonacept Regeneron that is discoloured or contains particles. 
POZOR: Če je raztopljeno zdravilo Rilonacept Regeneron spremenjene barve ali vsebuje delce, obvestite o tem lekarno.
The solvent is a clear colourless solution. 
Vehikel je bistra, brezbarvna raztopina.
Talk with your doctor before making any dose adjustments. 
Pred vsako prilagoditvijo odmerka se pogovorite s svojim zdravnikom.
The following items are included in each Rilonacept Regeneron dose pack: 
V enem pakiranju zdravila Rilonacept Regeneron so:
1 Based on population PK modelling 2 Derived values are presented. 
Na podlagi modeliranja populacijske farmakokinetike.
Do not push down on the plunger while inserting the needle into the skin. 
Tačas ko potiskate iglo v kožo, ne pritiskajte bata.
Do not replace the needle cover. 
Po uporabi igle ne pokrivajte s pokrovčkom.
You will also need to obtain these items from your pharmacist, which are not included in the Rilonacept Regeneron dose pack: 
V pakiranje zdravila Rilonacept Regeneron niso vključene naslednje potrebščine, ki jih boste dobili v lekarni:
Point the syringe and needle straight upward. 
Injekcijsko brizgo in iglo obrnite popolnoma navzgor.
Antibodies directed against the receptor domains of rilonacept were detected by an ELISA assay in 35% of patients (19 out of 55) treated for at least 6 weeks in the clinical study. 
V klinični študiji so pri 35 % bolnikov (19 bolnikih od 55), zdravljenih vsaj 6 tednov, s testom ELISA odkrili protitelesa, usmerjena proti receptorskim območjem rilonacepta.
STEP 2: Preparing the vial of Rilonacept Regeneron powder Remove the plastic cap from the Rilonacept Regeneron vial. 
KORAK 2: Priprava viale s praškom zdravila Rilonacept Regeneron
Figure 12 
Slika 12 2.
• Sinus infection 
• okužba sinusov;
Hypertension, flushing 
Žilne bolezni hipertenzija, rdečica pogosti
Serious, life-threatening infections have been reported uncommonly in patients taking Rilonacept Regeneron. 
Pri bolnikih, ki so jemali zdravilo Rilonacept Regeneron, so občasno poročali o resnih, smrtno nevarnih okužbah.
8 disposable 3 ml syringes 8 disposable 27-gauge, 1/2-inch needles 
8 trimililitrskih brizg za enkratno uporabo 8 polpalčnih igel kalibra 27 za enkratno uporabo
• Anxiety 
• anksioznost;
Solvent vial 
ETIKETA VEHIKLA
Keep Rilonacept Regeneron away from light. 
Zdravilo Rilonacept Regeneron hranite na temnem.
Immune system disorders 
Bolezni imunskega sistema preobčutljivost pogosti
Open a wrapper containing a new, disposable syringe. 
Odprite omot z novo injekcijsko brizgo za enkratno uporabo.
Package leaflet: Information for the user Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection rilonacept 
Navodilo za uporabo Rilonacept Regeneron 80 mg/ml prašek in vehikel za raztopino za injiciranje rilonacept
Figure 5 
Slika 10 5.
Talk to your doctor before using Rilonacept Regeneron. 
Pred začetkom jemanja zdravila Rilonacept Regeneron se posvetujte s svojim zdravnikom.
Hepatic impairment Rilonacept Regeneron has not been studied in patients with hepatic impairment. 
Okvare jeter Pri bolnikih z okvarami jeter zdravila Rilonacept Regeneron niso proučevali.
Upper respiratory tract infection; sinusitis very common 
Bolezni živčevja glavobol zelo pogosti omotica pogosti
You must stop treatment with Rilonacept Regeneron if you develop a severe infection. 
Če se pri vas razvije težka okužba, morate prekiniti zdravljenje z zdravilom Rilonacept Regeneron.
• Headache 
• glavobol.
Pull the needle cap straight off. Do not twist the needle or the cap as you pull it off. Gently tap the syringe until air bubbles rise to the top of the syringe (see Figure 5). 
Nalahno potrkajte po brizgi, da se zračni mehurčki dvignejo na vrh brizge (glejte sliko 5).
Figure 8 
Slika 8 10.
It is best to move to the next step and inject the medicine immediately after dissolving the Rilonacept Regeneron powder in the sterile water (solvent). 
Najbolje je, da takoj po raztapljanju praška zdravila Rilonacept Regeneron v sterilni vodi (vehiklu) preidete na naslednji korak in injicirate zdravilo Če je potrebno, lahko zdravilo hranite obarvana ali motna bistra pri sobni temperaturi (20 do 25 C) največ 3 ure.
The dissolved Rilonacept Regeneron solution should be a thick, clear liquid, colourless to pale yellow. 
Raztopljena raztopina zdravila Rilonacept Regeneron mora biti gosta, bistra tekočina,
It is injected under the skin once a month. 
Injicira se pod kožo enkrat mesečno.
Details of the recommendations for patients and healthcare professionals are given below. 
Podrobnosti priporočil za bolnike in zdravstvene delavce so navedene spodaj.
• In addition, healthcare professionals are advised of the following measures to minimise risks: 
• Poleg tega se zdravstvenim delavcem za zmanjšanje tveganj svetujejo naslednji ukrepi:
• These recommendations update provisional measures introduced in July 2017 which were communicated directly to healthcare professionals in the EU. 
• Ta priporočila so posodobitev začasnih ukrepov, uvedenih julija 2017, ki so bili neposredno poslani zdravstvenim delavcem v EU.
More information can be found on the medicine's dedicated page on EMA's website. 
Več informacij je na voljo na posebni strani o zdravilih na spletišču agencije EMA.
The review of Zinbryta was initiated on 9 June 2017 at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004. 
Pregled zdravila Zinbryta se je pričel 9. junija 2017 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
A new written communication will be sent out to healthcare professionals with the updated recommendations. 
Zdravstveni delavci bodo prejeli novo pisno obvestilo, ki bo vsebovalo posodobljena priporočila.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 08/01/2018. 
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 08/01/2018 izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU.
• Contact your doctor immediately if you develop any signs and symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine. 
• Takoj se obrnite na zdravnika, če se pojavijo znaki in simptomi težav z jetri, kot so nepojasnjena navzeja (slabost), bruhanje, bolečine v trebuhu, utrujenost, izguba teka, rumeno obarvanje kože in oči ter temen urin.
An acknowledgement form for patients will be made available to confirm that patients have understood the risk. 
Na voljo bo obrazec za bolnike, s katerim bodo ti potrdili, da razumejo tveganje.
The Committee for Medicinal Products for Human Use (CHMP) then adopted EMA's final opinion, which was sent to the European Commission for adoption of a legally binding decision. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je nato sprejel končno mnenje agencije EMA, ki je bilo poslano Evropski komisiji za sprejetje pravno zavezujočega sklepa.
− Review all patients who are currently taking Zinbryta to assess whether the medicine is still appropriate for them. 
− preglejte vse bolnike, ki trenutno jemljejo zdravilo Zinbryta, in ocenite, ali je zdravilo še vedno primerno zanje;
Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016. 
Zdravilo Zinbryta vsebuje zdravilno učinkovino daklizumab in je bilo v EU odobreno julija 2016.