FrancophonIA/ELRC3.0 huggingface dataset:
English: Doses up to 4 mL at a concentration of 108 PFU/mL every 2 weeks have been administered in clinical trials with no evidence of dose limiting toxicity.
Croatian: U kliničkim su ispitivanjima primjenjivane doze od najviše 4 ml u koncentraciji od 108 PFU/ml svaka dva tjedna bez dokaza o toksičnosti koja ograničava dozu.
English: Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
Croatian: Log-rang - p-vrijednost = 0,0511 Omjer rizika [95% CI] = 0,79 [0,62; 1,00]
English: Close contacts who are pregnant or immunocompromised should not change the patient's dressing or clean their injection site.
Croatian: Osobe iz neposredne blizine koje su imunokompromitirane ili su trudnice ne smiju mijenjati bolesnikove zavoje ili čistiti njegovo mjesto injiciranja.
English: Disseminated herpetic infection may also occur in immunocompromised patients (such as those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or who require chronic high-dose steroids or other immunosuppressive agents).
Croatian: Diseminirana infekcija herpes virusom se također može pojaviti u imunokompromitiranih bolesnika (poput onih s HIV-om/AIDS-om, leukemijom, limfomom, običnom varijabilnom imunodeficijencijom ili u kojih je potrebna kronična primjena visokih doza steroida ili drugih imunosupresiva).
English: No pharmacokinetic studies using talimogene laherparepvec have been conducted in special populations.
Croatian: Farmakokinetička ispitivanja virusa talimogene laherparepvec u posebnim populacijama nisu provedena.
English: Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a foetus or neonate contracts the wild type herpes infection.
Croatian: Infekcije divljim tipom HSV-1 povezuju se s ozbiljnim nuspojavama, uključujući višestruko zatajenje organa i smrt, ako se u fetusu ili u novorođenčeta razvije infekcija divljim tipom herpes virusa.
English: • Generally feeling unwell
Croatian: • Opće loše osjećanje
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti“ ili „EXP“.
English: As with other wild-type HSV-1 infections, a latent pool of talimogene laherparepvec DNA may persist in neuronal cell bodies innervating the injection sites; therefore, the occurrence of latent infection with talimogene laherparepvec cannot be excluded.
Croatian: Kao i u slučaju ostalih infekcija divljim tipom virusa HSV-1, u tijelima neurona koji inerviraju mjesta injiciranja mogu se zadržati latentne zalihe DNK virusa talimogene laherparepvec; prema tome, ne može se isključiti pojava latentnih infekcija virusom talimogene laherparepvec.
English: • Clean the lesion and surrounding areas with an alcohol swab and let dry.
Croatian: • Očistite leziju i okolna područja alkoholnom maramicom i pustite da se osuši.
English: Among patients with detectable talimogene laherparepvec DNA in the blood, urine, oral mucosa, and anogenital area, no samples had detectable talimogene laherparepvec DNA 30 days after the end of treatment.
Croatian: Kod bolesnika s detektabilnom razinom DNK virusa talimogene laherparepvec u krvi, urinu, oralnoj sluznici i anogenitalnom području, nijedan uzorak nije imao detektabilnu razinu DNK virusa talimogene laherparepvec 30 dana nakon završetka liječenja.
English: - The other ingredients are di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections (see section 2).
Croatian: - Ostale tvari su natrijevfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, mio-inozitol, sorbitol (E420), voda za injekcije (vidjeti dio 2).
English: The carcinogenic potential of talimogene laherparepvec has not been evaluated in long-term animal or human studies.
Croatian: Kancerogeni potencijal virusa talimogene laherparepvec nije procijenjen u dugotrajnim ispitivanjima na životinjama ili ljudima.
English: Accidental exposure may lead to transmission of Imlygic and herpetic infection.
Croatian: Slučajno izlaganje može dovesti do prijenosa lijeka Imlygic i infekcije herpes virusom.
English: In the event of exposure to broken skin or needle stick, clean the affected area thoroughly with soap and water and/or disinfectant.
Croatian: U slučaju izloženosti oštećenoj koži ili uboda iglom, temeljito očistite zahvaćeno područje sapunom i vodom i/ili dezinficijensom.
English: Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus.
Croatian: Virus talimogene laherparepvec je genetski modificiran i za replikaciju sposoban virus HSV-1.
English: What you need to know before and during Imlygic treatment You will not be given Imlygic: - if you are allergic to talimogene laherparepvec or any of the other ingredients of this medicine
Croatian: Što morate znati prije početka i tijekom primjene lijeka Imlygic Nećete dobiti Imlygic: - ako ste alergični na virus talimogene laherparepvec ili neki drugi sastojak ovog lijeka (naveden u djelu 6.). - ako Vam je Vaš zdravstveni radnik rekao da imate ozbiljno oslabljen imunološki sustav.
English: The genotoxic potential of talimogene laherparepvec has not been evaluated in long-term animal or human studies.
Croatian: Genotoksični potencijal virusa talimogene laherparepvec nije procijenjen u dugotrajnim ispitivanjima na životinjama ili ljudima.
English: Women who are able to become pregnant should use effective contraception to avoid pregnancy during treatment with Imlygic.
Croatian: Žene koje mogu postati trudne trebaju koristiti učinkovitu kontracepciju kako bi izbjegle trudnoću tijekom liječenja lijekom Imlygic.
English: • Herpetic infection occurring throughout the entire body (disseminated herpetic infection) in immunocompromised individuals (those with any congenital or acquired cellular and/or humoral immune deficiency, i.e. HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or those who require high-dose steroids or other immunosuppressive agents)
Croatian: • Infekcija herpes virusom u cijelom tijelu (diseminirana infekcija herpes virusom) u imunokompromitiranih osoba (oni s bilo kojom urođenom ili stečenom deficijencijom stanične i/ili humoralne imunosti npr. HIV/AIDS, leukemija, limfom, obična varijabilna imunodeficijencija ili oni u kojih su potrebne visoke doze steroida ili drugih imunosupresiva)
English: Confusional state, Anxiety, Depression, Dizziness, Insomnia
Croatian: Konfuzno stanje, anksioznost, depresija, omaglica, nesanica
English: • Confusion, anxiety, depression, dizziness, difficulty sleeping (insomnia)
Croatian: • Smetenost, tjeskoba, depresija, omaglica, poteškoće sa spavanjem (nesanica)
English: All patients should be advised to use a latex condom during sexual contact to prevent possible transmission of Imlygic (see section 4.4).
Croatian: Sve bolesnike treba savjetovati da koriste kondom od lateksa tijekom seksualnog kontakta kako bi se spriječio mogući prijenos lijeka Imlygic (vidjeti dio 4.4).
English: • Pain, redness, bleeding, swelling, inflammation, secretion, discharge, and warmth at the injection site
Croatian: • Bol, crvenilo, krvarenje, oticanje, upala, sekrecija, izlučivanje, iscjedak i toplina na mjestu injiciranja
English: Selection of Imlygic injection volume based on lesion size
Croatian: Odabir volumena injiciranja lijeka Imlygic na temelju veličine lezije
English: (vasculitis), inflammation of the lungs (pneumonitis), worsening scaling of the skin (worsening psoriasis), and inflammation of kidneys (glomerulonephritis)
Croatian: (vaskulitis), upale pluća (pneumonitis), ljuštenje kože koje se pogoršava (pogoršanje psorijaze) i upala bubrega (glomerulonefritis)
English: This medicine contains 80 mg sorbitol in each 4 mL dose.
Croatian: Ovaj lijek sadrži 80 mg sorbitola u jednoj dozi od 4 ml.
English: • Shortness of breath (dyspnoea), upper respiratory infection
Croatian: • Nedostatak zraka (dispneja), infekcija gornjih dišnih puteva
English: Median [95% CI] 23.3 [19.5, 29.6] months Median [95% CI] 18.9 [16.0, 23.7] months
Croatian: Medijan [95% CI] 23,3 [19,5; 29,6] mjeseci Medijan [95% CI] 18,9 [16,0; 23,7] mjeseci
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using IMLYGIC o Contact details of the IMLYGIC prescriber o Details about IMLYGIC treatment start date, batch number, date administered, product manufacturer and license holder o Information of herpetic lesions
Croatian: • Kartica s upozorenjima za bolesnika će sadržavati sljedeće ključne poruke: o Upozorenje za zdravstvenog radnika koji liječi bolesnika u bilo kojem trenutku, uključujući hitna stanja, da se bolesnik liječi lijekom IMLYGIC o Kontakt podatke propisivača lijeka IMLYGIC o Detalje o početnom datumu liječenja lijekom IMLYGIC, broju serije, datumu primjene, proizvođaču lijeka i nositelju dozvole o Informacije o herpetičkim lezijama
English: • Swab the injection site and surrounding area with alcohol, and cover the injected lesion with an absorbent pad and dry occlusive dressing.
Croatian: • Obrišite mjesto injiciranja i okolno područje alkoholom te prekrijte injiciranu leziju upijajućim jastučićem i suhim okluzivnim zavojem.
English: Summary of results from exploratory subgroup analysis from Imlygic study 005/05
Croatian: Tablica 5. Sažetak rezultata eksploratornih analiza podskupina iz ispitivanja 005/05 lijeka Imlygic
English: 8.2 months (95% CI: 6.5, 9.9)
Croatian: 8,2 mjeseca (95% CI: 6,5; 9,9)
English: Adverse reactions were determined based on clinical trials in patients with melanoma treated with Imlygic compared to GM-CSF and post-marketing experience.
Croatian: Nuspojave su određene na temelju kliničkih ispitivanja bolesnika s melanomom liječenih lijekom Imlygic u usporedbi s GM-CSF i razdoblja nakon stavljanja lijeka u promet.
English: Store and transport frozen at -90°C to -70°C.
Croatian: Čuvati i prevoziti zamrznuto na temperaturi od -90°C do -70°C.
English: The risks and benefits of Imlygic should be considered in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Croatian: Potrebno je razmotriti rizike i koristi lijeka Imlygic u bolesnika s multiplim mijelomom ili u kojih se plazmocitom razvije tijekom liječenja.
English: • If storing thawed Imlygic in the original vial followed by a syringe: o the same temperature range should be maintained throughout the duration of storage until administration.
Croatian: • Ako se odmrznuti Imlygic čuva u originalnoj bočici i zatim u štrcaljki: o tijekom cijelog perioda čuvanja treba se održavati isti raspon temperature, sve do primjene.
English: Initial
Croatian: Početni
English: 24 hours
Croatian: 24 sata
English: The total injection volume for each treatment session should be up to a maximum of 4 mL.
Croatian: Ukupni injicirani volumen za svaki posjet tijekom liječenja mora biti do najviše 4 ml.
English: Dispose of all materials that have come in contact with Imlygic (e.g. vial, syringe, needle, any cotton or gauze) in accordance with local institutional procedures (see section 6.6).
Croatian: Zbrinite sve materijale koji su došli u doticaj s lijekom Imlygic (npr. bočica, štrcaljka, igla, bilo kakva vata ili gaza) u skladu sa smjernicama lokalnih institucija (vidjeti dio 6.6).
English: For patients with detectable DNA in injected lesions, no samples had detectable talimogene laherparepvec DNA 60 days after end of treatment.
Croatian: Kod bolesnika s detektabilnom razinom DNK u injiciranim lezijama, nijedan uzorak nije imao detektabilnu razinu DNK virusa talimogene laherparepvec 60 dana nakon završetka liječenja.
English: GRH0116v1
Croatian: GRH0233HRv1
English: The following activities should be avoided: Sexual intercourse without a latex condom Kissing if either party has an open mouth sore Common usage of cutlery, crockery, and drinking vessels Common usage of injection needles, razorblades and toothbrushes;
Croatian: Sljedeće aktivnosti se moraju izbjegavati: Seksualni odnos bez korištenja kondoma od lateksa Ljubljenje ako jedna od osoba ima otvorenu ranu u ustima Zajedničko korištenje pribora za jelo, posuđa i čaša Zajedničko korištenje injekcijskih igli, brijaćih britvica i četkica za zube;
English: - The active substance is talimogene laherparepvec.
Croatian: - Djelatna tvar je virus talimogene laherparepvec.
English: In case suspected herpetic lesions occur, patients, close contacts or healthcare providers have the option of follow-up testing by the Marketing Authorisation Holder for further characterisation of the infection.
Croatian: U slučaju sumnje na herpetičke lezije, bolesnici, osobe u neposrednoj blizini ili zdravstveni radnici imaju mogućnost kontrolnog testiranja od strane nositelja odobrenja za stavljanje lijeka u promet za daljnju karakterizaciju infekcije.
English: This medicinal product contains 80 mg sorbitol (E420) per 4 mL dose.
Croatian: Ovaj lijek sadrži 80 mg sorbitola (E420) u jednoj dozi od 4 ml.
English: Accidental needle stick and splash-back have been reported in healthcare professionals during preparation and administration of Imlygic.
Croatian: Prijavljeni su slučajevi slučajnog uboda iglom i povratnog štrcanja lijeka u zdravstvenih radnika tijekom pripreme i primjene lijeka Imlygic.
English: • Faster heart rate at rest (tachycardia)
Croatian: • Ubrzani otkucaji srca u mirovanju (tahikardija)
English: The biodistribution and shedding of intralesionally administered talimogene laherparepvec were investigated in a clinical study that measured talimogene laherparepvec DNA in blood, urine, injection site, exterior of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Croatian: Biodistribucija i izlučivanje intralezijski primijenjenog virusa talimogene laherparepvec istraženi su u kliničkom ispitivanju koje je mjerilo DNK virusa talimogene laherparepvec u krvi, urinu, na mjestu injiciranja, na vanjskom dijelu okluzivnih zavoja, u oralnoj sluznici, anogenitalnom području i u sumnjivim herpetičkim lezijama.
English: • Trained HCPs to record batch number information in patient´s charts and on the patient´s alert card for all injections and to provide the batch number when reporting adverse drug reactions.
Croatian: • Educirani zdravstveni radnici koji će zabilježiti broj serije u bolesnikov karton i Karticu s upozorenjima za bolesnika za sva injiciranja i pružiti informaciju o broju serije prilikom prijave nuspojava.
English: Di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections.
Croatian: Natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, mio-inozitol, sorbitol (E420), voda za injekcije.
English: • Treat all Imlygic spills with a virucidal agent and absorbent materials.
Croatian: • Svako izlijevanje lijeka Imlygic tretirajte virucidom i upijajućim materijalima.
English: • Keep injection sites covered with airtight and watertight dressings at all times.
Croatian: • Mjesta injiciranja držite pokrivena zavojem nepropusnim za zrak i vodu cijelo vrijeme.
English: to 26-gauge needle is recommended.
Croatian: Preporučuje se igla od 22 do 26 G.
English: Imlygic is provided as a one ml preservative-free solution in a single-use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene) in two different presentations:
Croatian: Imlygic je dostupan kao otopina od jednog ml otopine bez konzervansa u bočici za jednokratnu primjenu (plastična smola od cikličkog olefinskog polimera) s čepom (klorobutilni elastomer) i zatvaračem (aluminij) s flip-off poklopcem (polipropilen) u dva različita pakiranja:
English: 6.4 Special precautions for storage Store and transport frozen (-90°C to -70°C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati i prevoziti zamrznuto (na temperaturi od -90°C do -70°C).
English: The risks and benefits of Imlygic should be considered before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immunemediated events.
Croatian: Potrebno je razmotriti rizike i koristi lijeka Imlygic prije početka liječenja u bolesnika koji imaju podležeću autoimunu bolest ili prije nastavka liječenja u bolesnika u kojih su se razvili imunološki posredovani događaji.
English: Metabolism and nutrition disorders Common
Croatian: Poremećaji metabolizma i prehrane Često
English: Second
Croatian: DRUGO
English: Wipe the exterior of occlusive dressing with an alcohol wipe.
Croatian: Obrišite vanjski dio okluzivnog zavoja alkoholnom maramicom.
English: † Immune mediated events include: uncommon terms of vasculitis, pneumonitis, worsening psoriasis and glomerulonephritis.
Croatian: † Imunološki posredovani događaji uključuju: manje česte pojave vaskulitisa, pneumonitisa, pogoršanja psorijaze i glomerulonefritisa.
English: • Patient information pack
Croatian: • Informacijski paket za bolesnika
English: o the maximum cumulative storage time (storage time in vial plus storage time in syringe) cannot exceed the durations in table 8.
Croatian: o maksimalno kumulativno vrijeme čuvanja (vrijeme čuvanja u bočici plus vrijeme čuvanja u štrcaljki) ne smije prekoračiti period naveden u tablici 8.
English: Cellulitis at the injection site
Croatian: Celulitis na mjestu injiciranja
English: Plasmacytoma at injection site* Blood and lymphatic system disorders Very common Oedema peripheral Common
Croatian: Plazmocitom na mjestu injiciranja* Poremećaji krvi i limfnog sustava Vrlo često
English: Recommended dosing schedule for Imlygic
Croatian: Preporučeni raspored doziranja lijeka Imlygic
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: The risks and benefits of treatment should be considered before administering Imlygic to these patients.
Croatian: Potrebno je razmotriti rizike i koristi liječenja prije primjene lijeka Imlygic u tih bolesnika.
English: If herpetic lesions (blisters or sores) are suspected, patients or close contacts have the option of follow-up testing by the Marketing Authorisation Holder for further characterisation of the infection.
Croatian: U slučaju sumnje na herpetičke lezije (mjehuriće ili rane), bolesnici ili osobe u neposrednoj blizini imaju mogućnost kontrolnog testiranja od strane nositelja odobrenja za stavljanje lijeka u promet za daljnju karakterizaciju infekcije.
English: • Dispose of all materials that have come in contact with Imlygic (e.g. vial, syringe, needle, any cotton or gauze) in accordance with local institutional procedures.
Croatian: • Uklonite sve materijale koji su bili u kontaktu s lijekom Imlygic (npr. bočica, štrcaljka, igla, bilo koja vata ili gaza) u skladu s propisima lokalnih institucija.
English: Cellular uptake of talimogene laherparepvec occurs through HSV-1 receptors on tumours and nontumour cells following local injection into tumours.
Croatian: Unos virusa talimogene laherparepvec u stanicu odvija se putem HSV-1 receptora na tumorskim i ne-tumorskim stanicama nakon lokalnog injiciranja u tumore.
English: 2.9 months (95% CI: 2.8, 4.0) HR: 0.42; (95% CI: 0.32, 0.54)
Croatian: 2,9 mjeseci (95% CI: 2,8; 4,0) HR: 0,42; (95% CI: 0,32; 0,54)
English: As talimogene laherparepvec is injected and replicates intratumourally, bioavailability and systemic concentration of talimogene laherparepvec are not predictive of drug substance activity and therefore have not been evaluated.
Croatian: S obzirom da se virus talimogene laherparepvec injicira i replicira unutar tumora, njegova bioraspoloživost i sistemska koncentracija ne mogu predvidjeti aktivnost djelatne tvari te stoga nisu procijenjene.
English: Thawed Imlygic may be stored prior to administration (see section 6.3).
Croatian: Odmrznuti Imlygic može se čuvati prije primjene (vidjeti dio 6.3).
English: Your healthcare professional will inject Imlygic directly into your tumour(s) with a needle and syringe.
Croatian: Vaš zdravstveni radnik će iglom i štrcaljkom injicirati lijek Imlygic izravno u Vaš/e tumor/e.
English: There were no impacts to male or female reproductive tissues following treatment of adult mice at doses up to 4 x 108 PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Croatian: Nije bilo učinka na reproduktivna tkiva mužjaka i ženki nakon liječenja odraslih miševa u dozama od najviše 4 x 108 PFU/kg (na temelju PFU/kg, doza 60 puta viša u odnosu na maksimalnu kliničku dozu).
English: In the event of an accidental exposure to Imlygic, exposed individuals should be advised to clean the affected area thoroughly with soap and water and/or a disinfectant.
Croatian: U slučaju slučajnog izlaganja lijeku Imlygic, izložene osobe treba savjetovati da temeljito očiste zahvaćeno područje sapunom i vodom i/ili dezinficijensom.
English: Single-use vial permanently inserted into a clear copolyester plastic sleeve
Croatian: Slika 6. Bočica za jednokratnu primjenu trajno umetnuta u prozirni kopoliesterski plastični omot
English: o the maximum cumulative storage time (storage time in vial plus storage time in syringe) cannot exceed the durations in table 2.
Croatian: o maksimalno kumulativno vrijeme čuvanja (vrijeme čuvanja u bočici plus vrijeme čuvanja u štrcaljki) ne smije prekoračiti period naveden u tablici 2.
English: The following activities should be avoided: Sexual intercourse without a latex condom Kissing if either party has an open mouth sore Common usage of cutlery, crockery, and drinking vessels Common usage of injection needles, razorblades and toothbrushes; o Adequate waste disposal and decontamination, following the recommendations for disposal of biohazardous waste.
Croatian: Sljedeće aktivnosti se moraju izbjegavati: Seksualni odnos bez korištenja kondoma od lateksa Ljubljenje ako jedna od osoba ima otvorenu ranu u ustima Zajedničko korištenje pribora za jelo, posuđa i čaša Zajedničko korištenje injekcijskih igli, brijaćih britvica i četkica za zube; o Odgovarajući način zbrinjavanja i dekontaminacije, u skladu s preporukama za zbrinjavanje biološkog otpada.
English: • Dehydration
Croatian: • Dehidracija
English: SPECIAL STORAGE CONDITIONS Store and transport frozen at -90° to -70°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati i prevoziti zamrznuto na temperaturi od -90° do -70°C.
English: • Eye infection caused by herpes (keratitis herpetic)
Croatian: • Infekcija oka uzrokovana herpes virusom (herpes keratitis)
English: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with Imlygic (see section 4.6).
Croatian: Žene reproduktivnog potencijala treba savjetovati da koriste učinkovitu metodu kontracepcije kako bi se spriječila trudnoća tijekom liječenja lijekom Imlygic (vidjeti dio 4.6).
English: At doses up to 4 x 108 PFU/kg or 107 PFU/dose (60-fold over the highest proposed clinical dose), single or repeated doses of talimogene laherparepvec administered by SC, IV, or intratumoural injection were well tolerated in immunocompetent mice, rats, and dogs.
Croatian: Jednostruke ili ponavljane doze virusa talimogene laherparepvec od najviše 4 x 108 PFU/kg ili 107 PFU/doza (60 puta više od najviše preporučene kliničke doze), primijenjene supkutanom ili intravenskom injekcijom ili injiciranjem u tumor bile su dobro podnošene u imunokompetentnih miševa, štakora i pasa.
English: Some people taking Imlygic have developed inflammation in the kidneys (glomerulonephritis), narrowing or blockage of blood vessels (vasculitis), swelling of the lungs (pneumonitis), worsening skin scaling (psoriasis), and areas of skin without any colour (vitiligo).
Croatian: U nekih osoba liječenih lijekom Imlygic razvila se upala u bubrezima (glomerulonefritis), sužavanje ili začepljenje krvnih žila (vaskulitis), oticanje pluća (pneumonitis), ljuštenje kože koje se pogoršava (psorijaza) te dijelovi kože bez imalo boje (vitiligo).