natgillin/translations-raw huggingface dataset:
• Patients who are severely immunocompromised (e.g. patients with severe congenital or acquired cellular and/or humoral immune deficiency) (see section 4.4).
• Bolniki, ki so zelo imunokompromitirani (npr. bolnikih s hudo prirojeno ali pridobljeno celično in/ali humoralno imunsko pomanjkljivostjo) (glejte poglavje 4.4).
• Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in your household waste.
• Ves porabljeni material za obvezovanje in čiščenje dajte v zapečateno plastično vrečko in ga zavrzite v gospodinjske odpadke.
If you have a tumour in your neck, your healthcare professional may warn you that you might experience compression of your airways during treatment with Imlygic.
Če imate tumor v vratu, vas bo zdravstveni delavec morda opozoril, da se vam lahko med zdravljenjem z zdravilom Imlygic pojavi stisnjenje (kompresija) dihalnih poti.
Healthcare professionals and close contacts (e.g. household members, caregivers, sex partners or persons sharing the same bed) should avoid direct contact with injected lesions or body fluids of treated patients during the entirety of the treatment period and up to 30 days after the last treatment administration (see section 6.6).
Zdravstveni delavci in osebe, ki so v tesnem stiku z bolnikom (npr. člani gospodinjstva, negovalci, spolni partnerji ali osebe, ki z njim delijo posteljo) se morajo izogibati neposrednemu stiku s spremembo, v katero je bilo injicirano zdravilo, in telesnim tekočinam zdravljenega bolnika med celotnim obdobjem zdravljenja in do 30 dni po zadnji uporabi zdravila (glejte poglavje 6.6).
• Patients with a weakened immune system (immunocompromised patients) treated with IMLYGIC and suffering from concomitant infection
• Bolniki z oslabljenim imunskim sistemom (imunokompromitirani bolniki), ki so zdravljeni z zdravilom IMLYGIC, in imajo sočasno okužbo.
Summary of safety profile
Povzetek varnostnih značilnosti
It is not known whether Imlygic is excreted in breast milk.
Ni znano, ali se zdravilo Imlygic izloča v materino mleko.
Talimogene laherparepvec causes the death of tumour cells and the release of tumour-derived antigens.
Talimogen laherparepvek povzroči smrt tumorskih celic in sproščanje tumorskih antigenov.
• Advise patients to place used dressings and cleaning materials in a sealed plastic bag as they may be potentially contaminated, and to dispose of the bag in household waste.
• Bolnikom naročite, naj uporabljene povoje in materiale za čiščenje dajo v zapečateno plastično vrečko, ker so lahko kontaminirani, in vrečko vržejo v gospodinjske odpadke.
Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF.
Talimogen laherparepvek je spremenjen tako, da se razmnožuje v tumorjih in izdeluje imunostimulacijsko beljakovino, človeški GM-CSF.
This medicine contains approximately 30 mg sodium (main component of cooking/table salt) in each 4 mL dose.
To zdravilo vsebuje približno 30 mg natrija (glavna sestavina kuhinjske/namizne soli) v vsakem 4 ml odmerku.
You should do the following to avoid spreading Imlygic to other areas of your body or to your close contacts (close contacts include household members, caregivers, sex partners, or someone you share a bed with):
Upoštevajte sledeče, da boste preprečili prenos zdravila Imlygic na druge dele telesa in na osebe, s katerimi ste v tesnem stiku (med osebe, s katerimi ste v tesnem stiku, spadajo člani vašega gospodinjstva, negovalci, spolni partnerji ali osebe, s katerimi delite posteljo):
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Stage§ IIIB/IIIC/ stage IVM1a (Imlygic, n = 163; GM-CSF, n = 86)
Stadij§ IIIB/IIIC/stadij IVM1a (Imlygic, n = 163; GM-CSF, n = 86)
PHARMACEUTICAL FORM AND CONTENTS Solution for injection
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje
Healthcare professionals should ensure that patients are able to comply with the requirement to cover injection sites with occlusive dressings (see section 6.6).
Zdravstveni delavci morajo poskrbeti, da bodo bolniki lahko upoštevali zahtevo, da morajo biti mesta injiciranja prekrita z okluzivnim povojem (glejte poglavje 6.6).
Accidental exposure may lead to transmission of Imlygic and herpetic infection.
Nenamerna izpostavljenost lahko povzroči prenos zdravila Imlygic in herpetično okužbo.
Patients were randomised in a 2:1 ratio to receive either Imlygic or GM-CSF (N = 436; 295 Imlygic, 141 GM-CSF).
Bolnike so v razmerju 2:1 randomizirali na prejemanje bodisi zdravila Imlygic bodisi GM-CSF (n = 436; 295 zdravilo Imlygic, 141 GM-CSF).
Do not exceed the storage times specified in table 7 and table 8.
Ne prekoračite časov shranjevanja, opisanih v preglednici 7 in preglednici 8.
Please discuss with your Healthcare Professional.
Prosimo, posvetujte se z zdravstvenim delavcem.
Incidence of adverse reactions are presented by system organ class and by frequency.
Incidenca neželenih učinkov je prikazana po organskih sistemih in pogostnosti.
The MAH shall ensure that in each Member State where IMLYGIC is marketed, a system aimed to control distribution to IMLYGIC beyond the level of control ensured by routine risk minimisation measures.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vseh državah članicah, kjer se zdravilo IMLYGIC trži, vzpostavljen sistem nadzorovane distribucije zdravila IMLYGIC, ki presega raven nadzora, ki je zagotovljena z rednimi ukrepi za zmanjševanje tveganj.
Individuals with wild-type HSV-1 infection are known to be at a lifelong risk for symptomatic herpetic infection due to reactivation of latent wild-type HSV-1.
Znano je, da imajo osebe z okužbo z divjim tipom HSV-1 vseživljenjsko tveganje za simptomatsko herpetično okužbo zaradi reaktivacije latentnega divjega tipa HSV-1.
Overall 3 of 19 patients with lesions of suspected herpetic origin had talimogene laherparepvec DNA present at any time during the study.
Skupno so 3 od 19 bolnikov s spremembami, pri katerih obstaja sum na herpetični izvor, imeli prisotno DNA talimogena laherparepveka kadar koli v času študije.
Symptoms of a local or systemic infection possibly related to Imlygic are anticipated to be similar to symptoms caused by wild-type HSV-1 infections.
Simptomi lokalne ali sistemske okužbe, ki bi lahko bila povezana z zdravilom Imlygic, so predvidoma podobni simptomom, ki jih povzročajo okužbe z divjim tipom HSV-1.
Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission.
Bolnikom, ki se jim pojavi herpetična okužba, je treba naročiti, naj upoštevajo standardne higienske ukrepe za preprečitev prenosa virusa.
Imlygic may increase the risk of impaired healing in patients with underlying risk factors (e.g. previous radiation at the injection site, or lesions in poorly vascularised areas).
Zdravilo Imlygic lahko poveča tveganje za slabše celjenje pri bolnikih z osnovnimi dejavniki tveganja (npr. s predhodnim obsevanjem mesta injiciranja ali s spremembami v slabo prekrvljenih predelih).
Dose concentrations
Koncentracija odmerkov
The mean (SD) treatment duration for the intent-to-treat (ITT) population was 15.76 weeks (15.79) in the GM-CSF arm and 26.83 weeks (18.39) in the Imlygic arm.
Povprečno trajanje zdravljenja (standardni odklon) v populaciji z-namenom-zdravljenja je bilo v skupini z GM-CSF 15,76 tedna (15,79) in v skupini z zdravilom Imlygic 26,83 tedna (18,39).
Excipient with known effect
Pomožni snovi z znanim učinkom
• Trained HCPs and support personnel regarding safe and appropriate storage, handling, and administration of IMLYGIC, and clinical follow-up for patients treated with IMLYGIC;
• Zdravstveni delavci in podporno osebje morajo biti usposobljeni v zvezi z varnim in ustreznim shranjevanjem, ravnanjem in dajanjem zdravila IMLYGIC ter nadaljnjim kliničnim spremljanjem bolnikov, zdravljenih z zdravilom IMLYGIC.
To minimise the risk of viral transmission, patients should keep their injection site covered for at least 8 days from the last treatment or longer if the injection site is weeping or oozing.
Da bi se zmanjšalo tveganje za prenos virusa, naj imajo bolniki mesto injiciranja pokrito vsaj 8 dni po zadnjem zdravljenju ali dlje, če je na mestu injiciranja opazno izcejanje ali mezenje.
Therefore, its pharmacokinetics and biodistribution are driven by the site of intralesional injection, tumour-selective replication, and release from tumour tissue.
Zato sta njegova farmakokinetika in bioporazdelitev odvisna od mesta intralezijskega injiciranja, tumorsko selektivnega razmnoževanja in sproščanja iz tumorskega tkiva.
If a pregnant woman has an infection with wild type HSV-1 (primary or reactivation), there is potential for the virus to cross the placental barrier, and also a risk of transmission during birth due to viral shedding.
Če ima nosečnica okužbo z divjim tipom HSV-1 (primarno ali reaktivirano), obstaja možnost prehoda virusa skozi placentno bariero; zaradi izločanja novih virusov po njihovem razmnoževanju obstaja tudi možnost prenosa med porodom.
No adjustment of the dose is required in patients ≥ 65 years old (see section 5.1).
Bolnikom, starim ≥ 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.1).
Injectable anaesthetic may be injected around the periphery of the lesion but should not be injected directly into the lesion.
Injektabilni anestetik lahko injicirate okrog periferije spremembe, ne smete pa ga injicirati neposredno vanjo.
Name and address of the manufacturer of the biological active substance BioVex Inc. - Subsidiary of Amgen, Inc.
Ime in naslov izdelovalca biološke učinkovine BioVex Inc. - Subsidiary of Amgen, Inc. 34 Commerce Way
While there are no clinical data to date on talimogene laherparepvec infections in pregnant women, there could be a risk to the foetus or neonate if talimogene laherparepvec were to act in the same manner.
Ker kliničnih podatkov o okužbah s talimogenom laherparepvekom pri nosečnicah do zdaj ni, bi lahko obstajalo tveganje za plod ali novorojenčke, če bi talimogen laherparepvek deloval enako.
Ensure that your close contacts who are pregnant or who have a weakened immune system do not touch injection sites, used dressings and cleaning materials.
Poskrbite, da se osebe, ki so z vami v tesnem stiku in so noseče ali imajo oslabljen imunski sistem, ne bodo dotikale vaših mest injiciranja, uporabljenih povojev in materiala za čiščenje.
Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.
Neporabljeno zdravilo je treba zavreči v skladu s smernicami ustanove za genetsko spremenjene organizme ali biološko nevarne odpadke, kot je primerno.
Of the responders, 42 (54%) experienced a ≥ 25% increase in overall size of existing lesion(s) and/or developed a new lesion(s) prior to ultimately achieving a response.
Od bolnikov, ki so se odzvali, se je pri 42 (54 %) pojavilo ≥ 25 % povečanje skupne velikosti obstoječe spremembe/obstoječih sprememb in/ali se jim je pojavila nova sprememba/nove spremembe, preden so končno dosegli odziv.
Talimogene laherparepvec was also quantified in selected patient samples in clinical studies using viral infectivity assays at the injection sites and in some cases of potential herpetic lesions.
Prav tako so talimogen laherparepvek kvantificirali v izbranih vzorcih bolnikov v kliničnih študijah z uporabo preizkusov virusne infektivnosti na mestih injiciranja in v nekaterih primerih možnih herpetičnih sprememb.
Kaplan-Meier estimate of overall survival by randomised treatment arm for disease stage IIIB/IIIC/ stage IVM1a (exploratory subgroup analysis)
Slika 5: Kaplan-Meierjeva ocena celokupnega preživetja po randomizirani terapevtski skupini in stadiju bolezni IIIB/IIIC/ stadiju IVM1a (analiza eksplorativnih podskupin)
Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste.
Neporabljeno zdravilo je treba zavreči v skladu s smernicami ustanove za genetsko spremenjene organizme ali biološko nevarne odpadke.
• Determine injection volume for each lesion using table 2 above.
• Za vsako spremembo določite količino za injiciranje na podlagi zgornje preglednice 2.
Because wild-type HSV-1 does not integrate into the host genome, the risk of insertional mutagenesis with talimogene laherparepvec is negligible.
Divji tip HSV-1 se ne integrira v genom gostitelja, zato je tveganje za insercijsko mutagenost s talimogenom laherparepvekom zanemarljivo.
Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus.
Talimogen laherparepvek je gensko spremenjen in za razmnoževanje sposoben virus HSV-1.
This may impair your ability to drive or operate machinery.
To lahko poslabša vašo sposobnost upravljanja vozil in strojev.
Wipe the exterior of occlusive dressing with an alcohol wipe.
Zunanjost okluzivnega povoja obrišite z alkoholnim zložencem.
• Avoid direct contact with your body fluids or injection sites.
• se izognejo neposrednemu stiku z vašimi telesnimi tekočinami in mesti injiciranja.
• Tissue swelling (peripheral oedema)
• otekanje tkiva (periferni edemi),
• Patient alert card
• Opozorilno kartico za bolnika
• Thawed Imlygic is stable when stored at temperatures of 2°C up to 25°C protected from light in its original vial, in a syringe, or in the original vial followed by a syringe.
• Odtajano zdravilo Imlygic je stabilno, kadar ga shranjujete pri temperaturi od 2°C do 25°C, zaščiteno pred svetlobo v originalni viali, v injekcijski brizgi, ali v originalni viali in nato v injekcijski brizgi.
Whereas anti-viral immune responses defend normal cells following infection by talimogene laherparepvec, tumours have been shown to be susceptible to injury and cell death from ICP34.5deficient HSV-1 viruses, including talimogene laherparepvec.
Medtem ko protivirusni imunski odzivi po okužbi s talimogenom laherparepvekom branijo normalne celice, so tumorji dokazano občutljivi za poškodbo in celično smrt zaradi virusov HSV-1 brez ICP34.5, vključno s talimogenom laherparepvekom.
Do not exceed the storage times specified in table 1 and table 2.
Ne prekoračite časov shranjevanja, opisanih v preglednici 1 in preglednici 2.
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).
Zdravilo Imlygic je indicirano za zdravljenje odraslih bolnikov z inoperabilnim melanomom, ki imajo regionalne ali oddaljene zasevke (stopenj IIIB, IIIC in IVM1a) in nimajo kostne, možganske, pljučne ali druge visceralne bolezni (glejte poglavji 4.4 in 5.1).
Censor indicated by Vertical Bar I.
Krnjenje je označeno z navpičnimi črticami I.
There is no clinical experience with overdose with Imlygic.
Kliničnih izkušenj s prevelikim odmerjanjem zdravila Imlygic ni.
• Adequately trained and experienced HCPs in order to minimise the risk of occurrence of specified adverse drug reactions in patients, HCPs, and close contacts of the patients;
• Zdravstveni delavci morajo biti ustrezno usposobljeni in izkušeni, da bi zmanjšali tveganje za pojav določenih neželenih reakcij zdravila pri bolnikih, zdravstvenih delavcih in osebah, ki so v tesnem stiku z bolnikom.
• Apply pressure to the injection site with a sterile gauze for at least 30 seconds.
• Na mesto injiciranja vsaj 30 sekund pritiskajte s sterilno gazo.
No clinical studies have been performed to evaluate the effects of talimogene laherparepvec on fertility (see section 5.3).
Kliničnih študij za oceno vplivov talimogena laherparepveka na plodnost niso izvedli (glejte poglavje 5.3).
In the event of a suspected overdose or inadvertent intravenous administration, the patient should be treated symptomatically, e.g. with acyclovir or other anti-viral agents (see section 4.4) and supportive measures instituted as required.
V primeru suma na preveliko odmerjanje ali nenamerne intravenske uporabe je treba bolnika zdraviti simptomatsko, npr. z aciklovirjem ali drugimi protivirusnimi zdravili (glejte poglavje 4.4) ter uporabiti podporne ukrepe, kot je potrebno.
It is unknown whether talimogene laherparepvec is transferred into human milk.
Ni znano, ali se talimogen laherparepvek izloča v materino mleko.
If you miss an appointment, ask your healthcare professional when to schedule your next dose.
Če pregled izpustite, prosite zdravstvenega delavca za nov datum za naslednji odmerek.
• 106 (1 million) PFU/mL - For initial dose only.
• 106 (1 milijon) PFU/ml - samo za začetni odmerek.
To allow for delayed immune-mediated anti-tumour effects to occur, patients were treated for a minimum of 6 months or until there were no longer any injectable lesions.
Da bi omogočili pojav zakasnjenih imunsko pogojenih protitumorskih učinkov, so bolnike zdravili vsaj 6 mesecev, ali dokler niso več imeli nobene spremembe, v katero bi bilo mogoče injicirati.
As a precautionary measure, it is preferable to avoid the use of talimogene laherparepvec during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi talimogena laherparepveka bolje izogibati.
This medicinal product contains approximately 30 mg sodium per 4 mL dose, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje približno 30 mg natrija na 4 ml odmerek, kar ustreza 1,5 % dnevnega vnosa 2 g natrija za odraslo osebo, ki ga priporoča SZO.
Your healthcare professional will decide which tumour(s) to inject and may not inject every tumour.
Zdravstveni delavec bo presodil, v kateri tumor je treba injicirati zdravilo in ga morda ne bo injiciral v vsak tumor.
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.
Ker se talimogen laherparepvek injicira in razmnožuje v tumorju, biološka uporabnost in sistemska koncentracija talimogena laherparepveka ne napovedujeta aktivnosti učinkovine in ju zato niso ovrednotili.
Caution should be used when injecting lesions close to major airways.
Potrebna je previdnost pri injiciranju v spremembe, ki so blizu večjih dihalnih poti.
Herpes infection
Okužba s herpesom
The genotoxic potential of talimogene laherparepvec has not been evaluated in long-term animal or human studies.
Genotoksičnosti talimogena laherparepveka niso ocenili v dolgoročnih študijah na živalih ali pri človeku.
• In the event of an accidental occupational exposure to Imlygic (e.g. through a splash to the eyes or mucous membranes) during preparation or administration, flush with clean water for at least 15 minutes.
• V primeru nenamerne poklicne izpostavljenosti zdravilu Imlygic (npr. zaradi oškropitve oči ali sluznic) med pripravo ali dajanjem zdravila vsaj 15 minut izpirajte s čisto vodo.
Based on animal data, patients who are severely immunocompromised may be at an increased risk of disseminated herpetic infection and should not be treated with Imlygic (see sections 4.3 and 5.3).
Podatki na živalih kažejo, da imajo lahko zelo imunokompromitirani bolniki večje tveganje za diseminirano herpetično okužbo in ne smejo prejemati zdravila Imlygic (glejte poglavji 4.3 in 5.3).
Accidental spread of Imlygic to yourself and others
Nenamerno prenašanje zdravila Imlygic nase in na druge
When you are being treated with Imlygic you may experience symptoms such as dizziness or confusion.
Med zdravljenjem z zdravilom Imlygic se vam lahko pojavijo simptomi, kot sta omotica ali zmedenost.
8 hours
8 ur
Across studies, fatal disseminated viral infection was observed in 14% of nude mice following treatment with talimogene laherparepvec at doses that are 10 to 100-fold higher than those that result in 100% lethality with wild-type HSV-1.
V študijah so smrtne diseminirane virusne okužbe opažali pri 14 % golih miši po zdravljenju s talimogenom laherparepvekom v odmerkih, od 10- do 100-krat večjih od odmerkov, ki povzročijo 100 % smrtnost z divjim tipom HSV-1.
The safety and efficacy of Imlygic monotherapy compared with subcutaneously administered GM-CSF were evaluated in a phase 3, multinational, open-label, and randomised clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable.
Varnost in učinkovitost monoterapije z zdravilom Imlygic v primerjavi s subkutano uporabljenim GM-CSF so ocenili v mednarodni, odprti, randomizirani klinični študiji 3. faze pri bolnikih z melanomom stopenj IIIB, IIIC in IV, ki je bil ocenjen kot inoperabilen.
Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
V krvi plodov so našli zanemarljivo količino (< 0,001 % koncentracije v materini krvi) DNA talimogena laherparepveka.
• First inject any new lesions (lesions that may have developed since initial treatment).
• Najprej injicirajte v morebitne nove spremembe (spremembe, ki so se morda pojavile od začetnega zdravljenja).
As long as there are injectable lesion(s) remaining, Imlygic should be continued for at least 6 months unless the physician considers that the patient is not benefitting from Imlygic treatment or that other treatment is required.
Dokler obstajajo spremembe, v katere je mogoče injicirati, je treba uporabo zdravila Imlygic nadaljevati vsaj 6 mesecev, razen če zdravnik presodi, da bolniku zdravljenje z zdravilom Imlygic ne koristi ali da je potrebno drugo zdravljenje.
The most commonly reported adverse reactions (≥ 25%) in Imlygic-treated patients were fatigue (50.3%), chills (48.6%), pyrexia (42.8%), nausea (35.6%), influenza-like illness (30.5%), and injection site pain (27.7%).
Med bolniki, ki so prejemali zdravilo Imlygic, so najpogosteje (≥ 25 %) poročali o neželenih učinkih utrujenost (50,3 %), mrzlica (48,6 %), zvišana telesna temperatura (42,8 %), navzea (35,6 %), gripi podobna bolezen (30,5 %) in bolečina na mestu injiciranja (27,7 %).
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC
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.
Okužbe z divjim tipom HSV-1 so spremljali resni neželeni učinki, vključno z odpovedjo več organov in smrtjo, v primeru okužbe ploda ali novorojenčka z divjim tipom herpetične okužbe.
Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.
Talimogen laherparepvek je pridobljen v celicah Vero s tehnologijo rekombinantne DNA.
In an in vivo study of intracerebral injection, talimogene laherparepvec was 10,000-fold less neurovirulent as compared to the wild-type HSV-1 dose that results in death 50% of the time in mice.
V in vivo študiji intracerebralnega injiciranja je bil talimogen laherparepvek 10.000-krat manj nevrovirulenten kot odmerek divjega tipa HSV-1, ki pri miših v 50 % povzroči smrt.
• Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.
• Preostale spremembe razvrstite po pomembnosti glede na njihovo velikost, dokler ni dosežena največja količina za injiciranje.
Adequate and well controlled studies with talimogene laherparepvec have not been conducted in pregnant women.
Pri nosečnicah niso izvedli ustreznih in dobro kontroliranih študij s talimogenom laherparepvekom.
• Pain in ear, throat, abdomen, groin, back and underarm
• bolečine v ušesu, žrelu, trebuhu, dimljah, hrbtu in pod pazduho,
Imlygic is used to treat adult patients with a type of skin cancer called melanoma that has spread in the skin or to the lymph nodes, when surgery is not an option.
Zdravilo Imlygic uporabljamo za zdravljenje odraslih bolnikov s posebno vrsto kožnega raka, imenovanega melanom, ki se je razširil v kožo ali bezgavke, kadar operacija ni mogoča.