natgillin/translations-raw huggingface dataset:
o Instruction on how to behave after accidental transmission. 
o Navodila, kako ravnati v primeru nenamernega prenosa.
• Physician educational material 
• Izobraževalno gradivo za zdravnike
The following requirements need to be fulfilled before the product is dispensed: 
Preden se zdravilo izda, morajo biti izpolnjene sledeče zahteve:
To get Imlygic from HSV-1, the virus has been changed so that it multiplies more effectively in tumours than in normal cells. 
Da so iz virusa HSV-1 pridobili zdravilo Imlygic, so virus spremenili tako, da se učinkoviteje razmnožuje v tumorjih kot v normalnih celicah.
Imlygic will be stored by the healthcare professionals at your healthcare facility. 
Zdravilo Imlygic bodo shranjevali zdravstveni delavci v vaši zdravstveni ustanovi.
• After thawing, administer Imlygic as soon as practically feasible. 
• Po odtajanju zdravilo Imlygic uporabite čim prej, kot je to praktično mogoče.
The MAH shall ensure that in each Member State where IMLYGIC is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense and use IMLYGIC have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo IMLYGIC trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo IMLYGIC, imeli dostop/prejeli naslednji paket izobraževalnih gradiv:
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 
Kaj morate vedeti pred in med zdravljenjem z zdravilom Imlygic Zdravila Imlygic ne boste dobili: - če ste alergični na talimogen laherparepvek ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Cover any exposed wounds before administering. 
Pred dajanjem zdravila pokrijte morebitne izpostavljene rane.
Imlygic may cause autoimmune reactions (an over-reaction of the body's immune system). 
Zdravilo Imlygic lahko povzroči avtoimunske reakcije (prekomeren odziv telesnega imunskega sistema).
o Adequate waste disposal and decontamination, following the recommendations for disposal of biohazardous waste. 
o Primerno odlaganje odpadkov in dekontaminacija v skladu s smernicami za odlaganje biološko nevarnih odpadkov.
Caregivers should be advised to wear protective gloves when assisting patients in applying or changing occlusive dressings and to observe safety precautions for disposal of used dressings and cleaning materials (see sections 4.2 and 6.6). 
Negovalcem je treba naročiti, naj nosijo zaščitne rokavice, kadar pomagajo bolnikom pri nameščanju ali menjavi okluzivnih povojev, ter naj upoštevajo varnostne ukrepe za odstranjevanje uporabljenih povojev in materialov za čiščenje (glejte poglavji 4.2 in 6.6).
The recommended dosing schedule for Imlygic is shown in table 1. 
Priporočena shema odmerjanja zdravila Imlygic je prikazana v preglednici 1.
Deletion of ICP47 prevents downregulation of antigen presentation molecules and increases the expression of HSV US11 gene, thereby enhancing viral replication in tumour cells. 
Delecija ICP47 prepreči zmanjšanje števila molekul, ki predstavijo antigen, in poveča izražanje gena HSV US11, s čimer okrepi razmnoževanje virusa v tumorskih celicah.
What Imlygic is and what it is used for What you need to know before and during Imlygic treatment How Imlygic is given 
Kaj je zdravilo Imlygic in za kaj ga uporabljamo Kaj morate vedeti pred in med zdravljenjem z zdravilom Imlygic Kako se daje zdravilo Imlygic
8 hours up to 25°C 
8 ur do 25°C
Close contacts who are pregnant or who have a weakened immune system, and newborns 
Osebe, ki so z vami v tesnem stiku in so noseče ali imajo oslabljen imunski sistem, in novorojenčki
The safety of Imlygic was evaluated in the pivotal study where 292 patients received at least 1 dose of Imlygic (see section 5.1). 
Varnost zdravila Imlygic so ocenili v ključni študiji, v kateri je 292 bolnikov prejelo vsaj 1 odmerek zdravila Imlygic (glejte poglavje 5.1).
Talimogene laherparepvec DNA was quantified with a highly sensitive and specific quantitative Polymerase Chain Reaction (qPCR) assay which may not correlate with viral infectivity risk. 
DNA talimogena laherparepveka so kvantificirali z visokoobčutljivim in specifičnim preizkusom kvantitativne polimerazne verižne reakcije (qPCR - quantitative Polymerase Chain Reaction), ki morda ne korelira s tveganjem infektivnosti virusa.
Your healthcare professional will inject Imlygic directly into your tumour(s) with a needle and syringe. 
Zdravstveni delavec vam bo zdravilo Imlygic injiciral neposredno v tumor(je) z iglo in brizgo.
• or are planning to have a baby. 
• ali če načrtujete zanositev.
Store in the original carton in order to protect from light. 
Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
Prior to launch of IMLYGIC in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila IMLYGIC na trg v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnih gradiv in programu nadzorovane distribucije, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki gradiv in programa.
Infectious talimogene laherparepvec virus was detected at the site of injection in 7 (11%) patients at multiple time points in the study; no samples were positive for viral infectivity after cycle 2 or after the end of treatment. 
Infektivni virus talimogena laherparepveka so pri 7 (11 %) bolnikih odkrili na mestu injiciranja pri več časovnih točkah v študiji; po 2. ciklusu ali koncu zdravljenja noben vzorec ni bil pozitiven za infektivnost virusa.
Patients with no prior herpes infection 
Bolniki brez predhodne okužbe s herpesom
Blood 
Kri
• Vials should be thawed and stored in the original carton until administration in order to protect from light. 
• Viale je treba odtajati in do uporabe shranjevati v originalni škatli za zagotovitev zaščite pred svetlobo.
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file. 
Za izboljšanje sledljivosti bioloških zdravil je treba v bolnikovi dokumentaciji jasno zabeležiti (ali navesti) ime in številko serije uporabljenega zdravila.
Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1). 
Talimogen laherparepvek je oslabljen herpes simpleks virus tipa 1 (HSV-1), pridobljen s funkcijsko delecijo 2 genov (ICP34.5 in ICP47) in vstavitvijo kodne sekvence za človeški granulocitno-makrofagne kolonije stimulirajoči faktor (GM-CSF - granulocyte macrophage colony-stimulating factor) (glejte poglavje 5.1).
What Imlygic is and what it is used for 
Kaj je zdravilo Imlygic in za kaj ga uporabljamo
Imlygic treatment may be reinitiated if new lesions appear following a complete response and the physician considers that the patient will benefit from treatment. 
Zdravljenje z zdravilom Imlygic se lahko znova začne, če se po bolnikovem popolnem odzivu pojavijo nove spremembe, zdravnik pa presodi, da bo bolniku zdravljenje koristilo.
Advise patients to apply dressing as instructed by the healthcare professional and to replace the dressing if it falls off. 
Bolnikom naročite, da namestijo povoj tako, kot jim je pokazal zdravstveni delavec, in da morajo povoj zamenjati, če odpade.
The secondary endpoints included overall survival (OS), overall response rate (ORR) [PR+CR], time to response, duration of response, and time to treatment failure (time from randomisation until the first episode of clinically relevant disease progression where there is no response achieved after the progression event, or until death). 
Med sekundarnimi opazovanimi dogodki so bili celokupno preživetje (OS - overall survival), celotni delež odziva (ORR - overall response rate) [PR + CR], čas do odziva, trajanje odziva in čas do neuspeha zdravljenja (čas od randomizacije do prvega klinično pomembnega napredovanja bolezni, ko po napredovanju bolezni ni bilo doseženega odziva, ali do smrti).
In the 60 patients treated, data indicate that talimogene laherparepvec DNA was present in all sites during the study (see table 6). 
Podatki 60 zdravljenih bolnikov kažejo, da je bila DNA talimogena laherparepveka med študijo prisotna na vseh mestih (glejte preglednico 6).
Patients should also be advised to avoid touching or scratching injection sites as this could lead to inadvertent transfer of Imlygic to other areas of their body or to their close contacts. 
Bolnikom je treba tudi naročiti, naj se ne dotikajo mest injiciranja in naj jih ne praskajo, ker bi to lahko povzročilo nenameren prenos zdravila Imlygic na druge dele telesa ali na osebe, s katerimi so v tesnem stiku.
After 6 months of treatment, patients were to continue treatment until clinically relevant disease progression (i.e. disease progression associated with a decline in performance status and/or alternative therapy was required in the opinion of the investigator). 
Po 6 mesecih zdravljenja so pri bolnikih nadaljevali z zdravljenjem do klinično pomembnega napredovanja bolezni (to je napredovanja bolezni, povezane z zmanjšanjem stanja zmogljivosti, in/ali če je bilo po mnenju raziskovalca potrebno drugo zdravljenje).
* See description of selected adverse reactions 
* Glejte opis izbranih neželenih učinkov
• Blood clot within a deep vein (deep vein thrombosis), high blood pressure (hypertension), 
• krvni strdek v globoki veni (globoka venska tromboza), visok krvni tlak (hipertenzija),
The modifications to talimogene laherparepvec from HSV-1 include deletion of ICP34.5 and ICP47. 
Spremembi v talimogenu laherparepveku v primerjavi s HSV-1 obsegata delecijo ICP34.5 in ICP47.
Each 4 mL dose contains approximately 30 mg (1.3 mmol) sodium and 80 mg sorbitol. 
En 4 ml odmerek vsebuje približno 30 mg (1,3 mmol) natrija in 80 mg sorbitola.
Biodistribution (within the body) and viral shedding (excretion/secretion) 
Biološka porazdelitev (v telesu) in izločanje virusa (ekskrecija/sekrecija)
If you have never had herpes infection in the past, you may be more likely to get fever, chills, and flulike illnesses within the period of the first 6 treatments with Imlygic. 
Če nikdar v preteklosti niste imeli okužbe s herpesom, je verjetneje, da se vam bodo v obdobju prvih 6 zdravljenj z zdravilom Imlygic pojavile zvišana telesna temperatura, mrzlica in gripi podobna bolezen.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L01XX51. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, oznaka ATC: L01XX51.
• Patients with a history of hypersensitivity to talimogene laherparepvec or any of its excipients. 
• Bolniki, ki imajo v anamnezi preobčutljivost na talimogen laherparepvek ali katero od njegovih pomožnih snovi.
Imlygic may harm your unborn baby. 
Zdravilo Imlygic lahko škoduje nerojenemu otroku.
The difference in DRR between Imlygic and GM-CSF in the ITT population was statistically significant (see table 4) in favour of Imlygic. 
Razlika v DRR med zdravilom Imlygic in GM-CSF v populaciji z-namenom-zdravljenja je bila statistično značilna (glejte preglednico 4) v korist zdravila Imlygic.
In an analysis to evaluate systemic activity of Imlygic, 27 of 79 patients (34.2%) had a ≥ 50% overall decrease in non-visceral lesions that were not injected with Imlygic, and 8 of 71 patients (11.3%) had a ≥ 50% overall decrease in visceral lesions that were not injected with Imlygic. 
V analizi za oceno sistemske aktivnosti zdravila Imlygic je imelo 27 od 79 bolnikov (34,2 %) ≥ 50 % celotno zmanjšanje nevisceralnih sprememb, v katere ni bilo vbrizgano zdravilo Imlygic, 8 od 71 bolnikov (11,3 %) pa je imelo ≥ 50 % celotno zmanjšanje visceralnih sprememb, v katere ni bilo vbrizgano zdravilo Imlygic.
No effects on embryo-foetal development have been observed in animal studies (see section 5.3). 
V študijah na živalih niso opazili učinkov na embriofetalni razvoj (glejte poglavje 5.3).
No pharmacokinetic studies using talimogene laherparepvec have been conducted in special populations. 
Študij farmakokinetike z uporabo talimogena laherparepveka v posebnih populacijah niso izvedli.
Use caution when driving or operating machinery until you are certain that Imlygic does not adversely affect you. 
Bodite previdni pri upravljanju vozil in strojev, dokler niste prepričani, da zdravilo Imlygic na vas ne vpliva neugodno.
5 (19%)a aFor the anogenital area, 26 patients were tested for Imlygic DNA. 
5 (19 %)a a Pri anogenitalnem predelu so za DNA zdravila Imlygic preiskali 26 bolnikov.
The total injection volume for each treatment visit should be up to a maximum of 4 mL. 
Celotna količina za injiciranje za vsak terapevtski obisk sme biti do največ 4 ml.
Sixty patients with melanoma received Imlygic intralesional injection at a dose and schedule same as clinical study 005/05 (see section 5.1). 
Šestdeset bolnikov z melanomom je prejelo intralezijsko injekcijo zdravila Imlygic v enakem odmerku in po enakem razporedu kot v klinični študiji 005/05 (glejte poglavje 5.1).
Because of potential adverse reactions such as dizziness and confusional state (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that talimogene laherparepvec does not adversely affect them. 
Zaradi možnih neželenih učinkov, npr. omotice in stanja zmedenosti (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri upravljanju vozil in strojev, dokler se ne prepričajo, da talimogen laherparepvek nanje nima neugodnega vpliva.
Your healthcare professional will determine if Imlygic is right for you. 
Zdravstveni delavec bo presodil, ali je zdravilo Imlygic primerno za vas.
Do NOT shake. 
NE STRESAJTE.
Patients treated with Imlygic must be given the patient alert card and be informed about the risks of Imlygic (see also package leaflet). 
Bolniki, zdravljeni z zdravilom Imlygic, morajo dobiti opozorilno kartico za bolnika in biti informirani o tveganjih zdravila Imlygic (glejte tudi navodilo za uporabo).
Clinical biodistribution, elimination, and shedding 
Klinični biološka porazdelitev, eliminacija in izločanje
• Symptomatic herpetic infection due to latency and reactivation of IMLYGIC or herpes (wildtype HSV-1) in patients 
• Simptomatska herpetična okužba zaradi latence in reaktivacije zdravila IMLYGIC ali herpesa (divjega tipa HSV-1) pri bolnikih.
You should tell your close contacts to: 
Osebam, s katerimi ste v tesnem stiku, naročite, naj:
Imlygic can be spread to other parts of your body or to other people through direct contact with your body fluids or injection sites. 
Zdravilo Imlygic se lahko prenese na druge dele telesa ali na druge osebe z neposrednim stikom z vašimi telesnimi tekočinami ali mesti injiciranja.
Symptomatic herpetic infection due to possible reactivation of Imlygic should be considered. 
Upoštevati je treba možnost simptomatske herpetične okužbe zaradi morebitne reaktivacije zdravila Imlygic.
Acyclovir and other anti-viral treatments may decrease the effects of Imlygic. 
Aciklovir in druga protivirusna zdravila lahko zmanjšajo učinke zdravila Imlygic.
Talimogene laherparepvec is sensitive to acyclovir. 
Talimogen laherparepvek je občutljiv na aciklovir.
It is important to tell your healthcare professional if you are breast-feeding or plan to do so. 
Pomembno je, da zdravstvenemu delavcu poveste, če dojite ali če nameravate dojiti.
To provide preliminary efficacy results from the phase III part of the Study 20110265 (a multicentre trial evaluating the combination of talimogene laherparepvec with pembrolizumab) 
Predložiti preliminarne rezultate učinkovitosti iz dela študije 20110265 faze III (multicentrične študije, ki ocenjuje kombinacijo talimogena laherparepveka s pembrolizumabom).
Unopened vial 
Neodprta viala
During this period, treatment was to continue despite an increase in size in existing lesion(s) and/or development of new lesion(s) unless the patient developed intolerable toxicity or the investigator believed that it was in the best interest of the patient to stop treatment or to be given other therapy for melanoma. 
Med tem obdobjem so zdravljenje nadaljevali kljub povečanju velikosti obstoječih sprememb in/ali pojavu novih sprememb, razen če se je pri bolniku pojavila nevzdržna toksičnost ali je raziskovalec menil, da je bilo v najboljšem interesu bolnika, da se zdravljenje ustavi ali da se mu da drugo zdravljenje za melanom.
Pyrexia, chills, and influenza like illness, which can occur any time during Imlygic treatment, generally resolved within 72 hours. 
Zvišana telesna temperatura, mrzlica, in gripi podobna bolezen, ki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Imlygic, so na splošno minili v 72 urah.
Apply the dressing as instructed by your healthcare professional. 
Povoj namestite, kot vam naroči zdravstveni delavec.
The volume of Imlygic to be injected into each lesion is dependent on the size of the lesion and should be determined according to table 2. 
Količina zdravila Imlygic za injiciranje v posamezno spremembo je odvisna od velikosti spremembe in jo je treba določiti v skladu s preglednico 2.
• 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.