FrancophonIA/ELRC3.0 huggingface dataset:
English: Study Day 1) showed a significant reduction in pancreatitis attacks in volanesorsen-treated patients compared to placebo treated patients (p=0.0242).
Slovenian: 1. dnevom študije) je pokazala pomembno zmanjšanje števila napadov pankreatitisa pri bolnikih, zdravljenih z volanesorsenom, v primerjavi z bolniki, zdravljenimi s placebom (p = 0,0242).
English: The MAH shall ensure that in each Member State where Waylivra is marketed, all healthcare professionals, patients and carers who are expected to prescribe, dispense and use Waylivra have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Waylivra trži, vsi zdravstveni delavci, bolniki in skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo Waylivra, imeli dostop oziroma prejeli paket izobraževalnih gradiv, ki vključuje:
English: Following subcutaneous injection, peak plasma concentrations of volanesorsen are typically reached in 2 to 4 hours.
Slovenian: Po subkutani injekciji je najvišja plazemska koncentracija volanesorsena običajno dosežena v dveh do štirih urah.
English: Clean your chosen injection site with an alcohol pad (Figure G).
Slovenian: Izbrano mesto injiciranja očistite z alkoholnim zložencem (Slika G).
English: Volanesorsen has no or negligible influence on the ability to drive and use machines.
Slovenian: Volanesorsen nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Treatment should be discontinued if there is a single increase in ALT or AST > 8 x ULN, or an increase > 5 x ULN, which persists for ≥ 2 weeks, or lesser increases in ALT or AST that are associated with total bilirubin > 2 x ULN or INR > 1.5.
Slovenian: Zdravljenje je treba prekiniti ob enkratnem zvečanju ravni ALT ali AST > 8 x ZMN ali zvečanju > 5 x ZMN, ki traja ≥ 2 tedna, ali manjših zvečanjih ravni ALT ali AST, ki so povezana s celokupnim bilirubinom > 2 x ZMN ali INR > 1,5.
English: Relative Difference in Change vs Placebo
Slovenian: Relativna razlika v spremembi v primerjavi s placebom
English: FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood.
Slovenian: Sindrom FCS je genetska bolezen, ki povzroča nenormalno visoke ravni maščob, imenovanih trigliceridi, v krvi.
English: Prior to initiating Waylivra, secondary causes of hypertriglyceridemia (e.g. uncontrolled diabetes, hypothyroidism) should be excluded or appropriately addressed.
Slovenian: Pred uvedbo zdravila Waylivra je treba izključiti ali ustrezno obravnavati sekundarne vzroke hipertrigliceridemije (npr. nenadzorovani diabetes, hipotiroidizem).
English: Prior to launch of Waylivra in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Waylivra na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: The selective binding of volanesorsen to the apoC-III messenger ribonucleic acid (mRNA) within the 3′ untranslated region at base position 489-508 causes the degradation of the mRNA.
Slovenian: Selektivna vezava volanesorsena na informacijsko ribonukleinsko kislino (mRNA) za apoC-III v 3' neprevedeni regiji na baznih mestih od 489 do 508 povzroči razgradnjo mRNA.
English: They may change how often you use it, or may stop it for a period or permanently, depending on the results of your blood and urine tests or occurrence of side effects.
Slovenian: Pogostnost jemanja lahko spremeni ali zdravilo za določen čas ali trajno ukine, odvisno od rezultatov vaših preiskav krvi in urina ali pojava neželenih učinkov.
English: The absolute bioavailability of volanesorsen following a single subcutaneous administration is approximately 80% (most likely higher because an AUC of 0 to 24 hours was used and volanesorsen has a half-life of >2 weeks).
Slovenian: Absolutna biološka uporabnost volanesorsena po enkratnem subkutanem dajanju je približno 80-odstotna (najverjetneje je višja, ker je bila uporabljena AUC (Area Under Curvepovršina pod krivuljo) od 0 do 24 ur, volanesorsen pa ima razpolovni čas > 2 tednov).
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS.
Slovenian: Zdravljenje mora začeti in nadzorovati zdravnik z izkušnjami pri zdravljenju bolnikov s sindromom FCS.
English: In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Slovenian: Pri posameznih opicah je bila v 9-mesečnih študiji zdravljenih skupin pri klinično pomembnih izpostavljenostih ugotovljena huda trombocitopenija, prav tako pa so jo opazili v kliničnih študijah.
English: Treatment should also be discontinued for any clinical symptoms or signs of hepatic impairment or hepatitis.
Slovenian: Zdravljenje je treba prekiniti tudi pri vsakem kliničnem simptomu ali znaku okvare jeter ali hepatitisa.
English: • Physician educational material
Slovenian: • Izobraževalno gradivo za zdravnika,
English: Place the following items on a clean, flat surface in a well-lit area (Figure A).
Slovenian: Na čisto, ravno in dobro osvetljeno površino postavite naslednje predmete (slika A).
English: Most patients receiving volanesorsen experienced a clinically significant reduction in triglycerides.
Slovenian: Pri večini bolnikov, ki so prejemali volanesorsen, se je raven trigliceridov klinično pomembno zmanjšala.
English: Chronic or unexplained thrombocytopenia.
Slovenian: Kronična ali nepojasnjena trombocitopenija.
English: You may also apply ice to the injection site to reduce pain, redness, or discomfort (Figure P).
Slovenian: Mesto injiciranja lahko hladite z ledom, da zmanjšate bolečino, rdečino ali nelagodje (slika P).
English: Cardiac Electrophysiology
Slovenian: Srčna elektrofiziologija
English: Injection should be avoided at the waistline and other sites where pressure or rubbing may occur from clothing.
Slovenian: Izogibati se je treba injiciranju v predel pasu in druga mesta, kjer se lahko pojavi pritisk ali drgnjenje oblačil.
English: Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Slovenian: Zdravilo Waylivra je indicirano kot dodatek k prehrani pri odraslih bolnikih z genetsko potrjenim sindromom družinske hilomikronemije (FCS - Familial Chylomicronemia Syndrome) in zelo velikim tveganjem za pankreatitis, pri katerih sta bila odziv na dieto in zdravljenje za zniževanje ravni trigliceridov nezadostna.
English: There were no significant differences in treatment effect across the stratification factors of presence or absence of concurrent omega-3 fatty acids or fibrates.
Slovenian: V učinku zdravljenja ni bilo pomembnih razlik med stratifikacijskimi dejavniki prisotnosti ali odsotnosti sočasnega jemanja omega-3-maščobnih kislin ali fibratov.
English: Following subcutaneous administration, terminal elimination half-life is approximately 2 to 5 weeks.
Slovenian: Po subkutanem dajanju je končni razpolovni čas izločanja približno od 2 do 5 tednov.
English: In the case of a positive assessment, a broader assessment of renal function, including serum creatinine and a 24-hour collection to quantify the proteinuria and assess creatinine clearance, should be performed.
Slovenian: Ob pozitivni oceni je treba ledvično funkcijo oceniti z dodatnimi preiskavami, vključno z določitvijo ravni serumskega kreatinina in 24-urnim zbiranjem urina za kvantitativno določitev proteinurije in oceno očistka kreatinina.
English: The objective of the programme is to provide information on the risks of thrombocytopaenia and bleeding; advise on platelet monitoring and provide details about the dose frequency adjustment algorithm.
Slovenian: Cilj izobraževalnega programa je zagotavljanje informacij o tveganjih za trombocitopenijo in krvavitve, svetovanje o spremljanju števila trombocitov in zagotavljanje informacij o algoritmu prilagajanja pogostosti odmerjanja.
English: Time Point
Slovenian: Časovn a točka
English: Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen.
Slovenian: 1 ml vsebuje 200 mg natrijevega volanesorsenata, kar ustreza 190 mg volanesorsena.
English: In vitro studies indicate that volanesorsen is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 or inducer of CYP1A2, CYP2B6, or CYP3A4.
Slovenian: Študije in vitro kažejo, da volanesorsen ni zaviralec encimov CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4 ali induktor encimov CYP1A2, CYP2B6 ali CYP3A4.
English: - A low number of platelets, a type of cell in your blood that clump together to help it clot (thrombocytopenia); your doctor will do a blood test before you start using this medicine to check the number of platelets in your blood.
Slovenian: - Nizko število trombocitov, vrste krvnih celic, ki z medsebojnim zlepljanjem pomagajo pri strjevanju krvi (trombocitopenija); preden začnete uporabljati to zdravilo, bo zdravnik opravil preiskavo krvi, s katero bo preveril število trombocitov v vaši krvi.
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected and the medicinal product should be returned to the pharmacy.
Slovenian: Če je raztopina motna ali vsebuje vidne delce, se vsebina ne sme injicirati, zdravilo pa je treba vrniti v lekarno.
English: Main inclusion criteria were a diagnosis of FCS (Type 1 hyperlipoproteinemia) in combination with a history of chylomicronemia evidenced by documentation of lactescent serum or documentation of fasting TG measurement ≥ 880 mg/dl.
Slovenian: Glavni vključitveni kriteriji so bili diagnoza sindroma FCS (hiperlipoproteinemija tipa 1) v kombinaciji z anamnezo hilomikronemije, dokazane z dokumentacijo mlečnega seruma ali dokumentacijo meritve TG na tešče ≥ 880 mg/dl.
English: Do not attempt to remove the air bubble.
Slovenian: Zračnega mehurčka ne poskušajte odstraniti.
English: When you first receive Waylivra the pre-filled syringes should be stored in their packaging in the refrigerator (2 °C-8 °C).
Slovenian: Ko zdravilo Waylivra prvič prejmete, morate napolnjene injekcijske brizge shraniti v njihovi ovojnini v hladilniku (od 2 °C do 8 °C).
English: The CS7 study is an ongoing multicentre, open-label extension Phase 3 study designed to evaluate the safety and efficacy of dosing and extended dosing with volanesorsen in patients with FCS.
Slovenian: Študija CS7 je potekajoča multicentrična nezaslepljena podaljšana študija 3. faze, zasnovana za oceno varnosti in učinkovitosti odmerjanja in podaljšanega odmerjanja volanesorsena pri bolnikih s sindromom FCS.
English: It is unknown whether triglyceride lowering by volanesorsen and the potentially ensuing decrease in inflammation leads to normalisation of CYP enzyme expression.
Slovenian: Ni znano, ali se ob znižanju ravni trigliceridov z volanesorsenom in morebitnem posledičnem zmanjšanju vnetja normalizira izražanje encimov CYP.
English: What you need to know before you use Waylivra Do not use Waylivra if:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Waylivra Ne uporabljajte zdravila Waylivra:
English: In clinical studies, this medicinal product has been used in combination with fibrates and fish oils with no impact on the medicinal product pharmacodynamics or pharmacokinetics.
Slovenian: V kliničnih študijah kombiniranje tega zdravila s fibrati in ribjimi olji ni vplivalo na njegovo farmakodinamiko ali farmakokinetiko.
English: Using your free hand, pinch the skin around the injection site (Figure I).
Slovenian: S svojo prosto roko stisnite kožo okoli mesta injiciranja (slika I).
English: Your doctor may also do a blood test every 3 months to check for signs of damage to your liver.
Slovenian: Zdravnik lahko vsake 3 mesece opravi tudi preiskavo krvi za preverjanje znakov okvare jeter.
English: It is normal to see a large air bubble (Figure D).
Slovenian: Če vidite velik zračni mehurček, je to normalno (slika D).
English: It should be removed from refrigerated storage (2 ° to 8 °C) at least 30 minutes before use.
Slovenian: Iz hladilnika (pri temperaturi od 2 °C do 8 °C) jo morate vzeti najmanj 30 minut pred uporabo.
English: Before starting this medicine, you should be on a diet designed to help lower triglyceride levels in your blood.
Slovenian: Preden začnete uporabljati to zdravilo, morate biti na dieti, namenjeni znižanju ravni trigliceridov v krvi.
English: Table 5: Additional Results for Changes in Triglycerides in the APPROACH study (Primary endpoint at Month 3)
Slovenian: Preglednica 5: Dodatni izidi glede spremembe trigliceridov v študiji APPROACH (primarni izid po treh mesecih)
English: Haemodialysis is unlikely to be beneficial given that volanesorsen is rapidly distributed into cells.
Slovenian: Koristnost hemodialize je malo verjetna, saj se volanesorsen hitro porazdeli v celice.
English: Remove the syringe and inspect the medicine
Slovenian: Odstranite injekcijsko brizgo in preglejte zdravilo
English: The recommended starting dose is 285 mg in 1.5 ml injected subcutaneously once weekly for 3 months.
Slovenian: Priporočeni začetni odmerek je 285 mg v 1,5 ml, injiciran subkutano enkrat na teden 3 mesece.
English: Waylivra monitoring and treatment recommendations
Slovenian: Priporočila za spremljanje in zdravljenje z zdravilom Waylivra
English: Injection with cold liquid may cause injection site reactions such as pain, redness, or swelling.
Slovenian: Injiciranje hladne tekočine lahko povzroči reakcije na mestu injiciranja, kot so bolečina, rdečina ali oteklina.
English: The medicinal product is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment.
Slovenian: To zdravilo se ne presnavlja prek citokromskega encimskega sistema P450 v jetrih, zato pri bolnikih z okvaro jeter odmerka verjetno ni treba prilagajati.
English: Allow the injection to reach to room temperature
Slovenian: Pustite, da se injekcija segreje na sobno temperaturo
English: Patients must be reminded to read the patient leaflet and the patient/carer guide.
Slovenian: Bolnike je treba opomniti, naj preberejo navodilo za uporabo in vodnik za bolnike in skrbnike.
English: - Other medicines that may change how your blood clots, including non-steroidal antiinflammatory medicines like ibuprofen, medicines used to prevent heart attacks and strokes such as clopidogrel, ticagrelor and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce stomach acid), and quinine (used to treat malaria).
Slovenian: - druga zdravila, ki lahko vplivajo na strjevanje krvi, vključno z nesteroidnimi protivnetnimi zdravili, kot so ibuprofen, zdravili za preprečevanje srčnega infarkta in kapi, kot so klopidogrel, tikagrelor in prasugrel, antibiotiki, kot je penicilin, zdravili, kot sta ranitidin
English: +92 (-301, +486) mg/dL +1 (-3, +5) mmol/L
Slovenian: +92 (−301, +486) mg/dl +1 (−3, +5) mmol/l mg/dl
English: After a 6-week diet run-in period, the mean fasting triglyceride level at baseline was 2,209 mg/dL (25.0 mmol/L).
Slovenian: Po šesttedenskem uvajalnem prehranskem obdobju je bila povprečna vrednost trigliceridov na tešče 2.209 mg/dl (25,0 mmol/l).
English: The expiry date on the package refers to the life of the product when refrigerated.
Slovenian: Datum izteka roka uporabnosti na embalaži se nanaša na življenjsko dobo zdravila, če je shranjeno v hladilniku.
English: Daily a See section 4.4 for recommendations regarding use of antiplatelet agents/NSAIDs/anticoagulants b Consultation of a haematologist is needed to reconsider the benefit/risk for possible further treatment with volanesorsen.
Slovenian: Dnevno a Za priporočila o uporabi antitrombotikov/NSAID/antikoagulansov glejte poglavje 4.4. b Za ponovno oceno koristi/tveganja za morebitno nadaljnje zdravljenje z volanosorsenom se je treba posvetovati s hematologom.
English: Onset of the reduction was rapid with separation from placebo seen as early as 4 weeks and maximum response seen at 12 weeks, with clinically and statistically significant triglyceride reduction maintained over 52 weeks (Figure 1).
Slovenian: Začetek zmanjšanja je bil hiter; ločitev od placeba je bila vidna že po štirih tednih, največji odziv pa je bil viden po 12 tednih, s klinično in statistično pomembnim zmanjšanjem trigliceridov, ki se je ohranilo več kot 52 tednov (slika 1).
English: Storage Storage information
Slovenian: Podatki o skladiščenju
English: Hepatic impairment The pharmacokinetics of volanesorsen in patients with hepatic impairment is unknown.
Slovenian: Okvara jeter Farmakokinetika volanesorsena pri bolnikih z okvaro jeter ni znana.
English: Background lipid-lowering therapies remained consistent throughout the study.
Slovenian: Osnovna terapija za zniževanje ravni lipidov je v celotni študiji ostala nespremenjena.
English: A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of volanesorsen.
Slovenian: Analiza populacijske farmakokinetike kaže, da blaga ali zmerna okvara ledvic nima klinično pomembnega vpliva na sistemsko izpostavljenost volanesorsenu.
English: • Properly labeled to warn of hazardous waste inside the container.
Slovenian: • je odporna proti puščanju; • je označena z ustreznimi opozorili o tem, da vsebuje nevarne odpadke.
English: It is preferable to avoid the use of Waylivra during pregnancy.
Slovenian: Priporočljivo je, da se med nosečnostjo izogibate uporabi zdravila Waylivra.
English: All patients enrolled either had participated in the APPROACH Study, in the CS16 Study, or were new FCS patients and had completed qualification assessments prior to receiving volanesorsen 285 mg once per week or a reduced frequency for safety or tolerability reasons determined in their index study.
Slovenian: Vsi vključeni bolniki so sodelovali v študiji APPROACH, v študiji CS16 ali pa so bili novi bolniki s sindromom FCS in so zaradi razlogov varnosti in prenašanja zdravila, določenih v njihovi indeksni študiji, pred prejemom 285 mg volanesorsena enkrat na teden ali manj pogosto opravili kvalifikacijski pregled.
English: You can reduce the likelihood of having injection site reaction if you wait for Waylivra to reach room temperature before injecting, and by applying ice to the injection site after injecting.
Slovenian: Verjetnost pojava reakcije na mestu injiciranja lahko zmanjšate, če pred injiciranjem počakate, da zdravilo Waylivra doseže sobno temperaturo, in po injiciranju na mesto injiciranja nanesete led.
English: Due to the poor oral bioavailability of this medicinal product, it is considered unlikely that these low milk concentrations would result in systemic exposure from nursing.
Slovenian: Zaradi slabe peroralne biološke uporabnosti tega zdravila je malo verjetno, da bi te nizke koncentracije v mleku povzročile sistemsko izpostavljenost ob dojenju.
English: Immediately after the injection, dispose of the used syringe as instructed by your healthcare professional, usually into a sharps disposal container (Figure N) by following these steps.
Slovenian: Uporabljeno iglo takoj po injiciranju zavrzite po navodilih zdravstvenega delavca, običajno v vsebnik za ostre odpadke (slika N), tako da sledite naslednjim korakom.
English: - Severe tiredness (fatigue), weakness or lack of energy, fluid retention, chest pain unrelated to the heart o
Slovenian: - Huda utrujenost, šibkost ali pomanjkanje energije, zadrževanje tekočine, bolečine v prsnem košu, ki niso povezane s srcem.
English: For any patient dose paused or discontinued due to severe thrombocytopenia, the benefits and risks of returning to treatment once platelet count ≥100 x 109/L should be carefully considered.
Slovenian: Pri vsakem bolniku, ki je zaradi hude trombocitopenije uporabo zdravila ustavil ali prekinil, je treba natančno pretehtati koristi in tveganja ponovne uvedbe zdravljenja, ko je število trombocitov spet ≥ 100 x 109/l.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections.
Slovenian: Natrijev hidroksid (za prilagoditev pH) Klorovodikova kislina (za prilagoditev pH) Voda za injekcije.
English: The other ingredients are water for injections, sodium hydroxide and hydrochloric acid (to adjust acidity level, see section 2 under ‘Sodium').
Slovenian: Druge sestavine so voda za injekcije, natrijev hidroksid in klorovodikova kislina (za uravnavanje kislosti; glejte poglavje 2 pod „Natrij“).
English: Your doctor may do a urine and/or blood test every 3 months to check for signs of damage to your kidneys.
Slovenian: Zdravnik lahko vsake 3 mesece opravi preiskavo urina in/ali krvi za preverjanje znakov okvare ledvic.
English: Very common (N, %)
Slovenian: Zelo pogosti (n; %)
English: Inject the liquid by holding the syringe with your thumb on the plunger, and slowly push the plunger down as far as it will go, until the syringe is completely empty (Figure K and L).
Slovenian: Ob injiciranju tekočine držite brizgo s palcem na batu in bat počasi potisnite do konca navznoter, dokler ni brizga popolnoma prazna (sliki K in L).
English: Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the patient information leaflet.
Slovenian: Bolnike in/ali negovalce je treba usposobiti za uporabo tega zdravila skladno z navodilom za uporabo.
English: If not noticed within 48 hours, then the missed dose should be skipped and the next planned injection given.
Slovenian: Če tega niste opazili v 48 urah, je treba izpuščeni odmerek preskočiti in dati naslednjo načrtovano injekcijo.
English: Elimination involves both metabolism in tissues and excretion in urine.
Slovenian: Izločanje Izločanje vključuje tako presnovo v tkivih kot tudi izločanje v urin.
English: Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS).
Slovenian: Zdravilo Waylivra vsebuje učinkovino volanesorsen, ki pomaga pri zdravljenju bolezni, imenovane sindrom družinske hilomikronemije (FCS).
English: This binding prevents translation of the protein apoC-III, thus removing an inhibitor of triglyceride clearance and enabling metabolism through an LPL-independent pathway.
Slovenian: Ta vezava prepreči prevajanje beljakovine apoC-III, s čimer odstrani zaviralec očistka trigliceridov in omogoči presnovo po poti, neodvisni od LPL.
English: No starting dose adjustment is necessary for elderly patients.
Slovenian: Pri starejših bolnikih ni treba prilagajati začetnega odmerka.
English: None of these patients had any major bleeding events and all recovered to normal platelet count following drug discontinuation and administration of glucocorticosteroids where medically indicated.
Slovenian: Pri nobenem od teh bolnikov se ni pojavila večja krvavitev in pri vseh se je število trombocitov normaliziralo po ukinitvi zdravila in dajanju glukokortikosteroidov, kadar je bilo to medicinsko indicirano.
English: If formation of anti-drug antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Slovenian: Ob sumu na nastanek protiteles proti zdravilu s klinično pomembnim učinkom se obrnite na imetnika dovoljenja za promet z zdravilom za posvetovanje o preiskavah za protitelesa.
English: What Waylivra is and what it is used for
Slovenian: Kaj je zdravilo Waylivra in za kaj ga uporabljamo
English: Waylivra should be inspected visually prior to administration.
Slovenian: Zdravilo Waylivra je treba pred dajanjem vizualno pregledati.