natgillin/translations-raw huggingface dataset:
Advise patients to apply dressing as instructed by the healthcare professional and to replace the dressing if it falls off.
Savjetujte bolesnike da primijene zavoj onako kako ih je uputio zdravstveni radnik te da zamijene zavoj ako otpadne.
Suspected herpetic lesion samples were collected any time a patient experienced lesions of suspected herpetic origin.
Uzorci sumnjivih herpetičkih lezija prikupljeni su svaki put kada je bolesnik imao lezije sumnjivog herpetičkog porijekla.
No clinical studies have been performed to evaluate the effects of talimogene laherparepvec on fertility (see section 5.3).
Nisu provedena klinička ispitivanja za procjenu učinka virusa talimogene laherparepvec na plodnost (vidjeti dio 5.3).
It is thought that together with GM-CSF, it will promote a systemic anti tumour immune response and an effector T-cell response.
Smatra se da će zajedno s GM-CSF potaknuti sustavni antitumorski imunološki odgovor te odgovor efektorskih T-stanica.
Talimogene laherparepvec is cleared through general host-defence mechanisms (e.g. autophagy, adaptive immune responses).
Virus talimogene laherparepvec se eliminira općim obrambenim mehanizmima domaćina (npr. autofagija, odgovori stečene imunosti).
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.
DNK virusa talimogene laherparepvec kvantificirana je pomoću visoko-osjetljive i specifične analize, kvantitativne lančane reakcije polimerazom (qPCR, od engl. quantitative Polymerase Chain Reaction), koja se ne mora podudarati s rizikom od virusne infekcije.
Because wild-type HSV-1 does not integrate into the host genome, the risk of insertional mutagenesis with talimogene laherparepvec is negligible.
S obzirom da se divlji tip virusa HSV-1 ne ugrađuje u genom domaćina, rizik od insercijske mutageneze s virusom talimogene laherparepvec je zanemariv.
When you are being treated with Imlygic you may experience symptoms such as dizziness or confusion.
Za vrijeme liječenja lijekom Imlygic možete osjetiti simptome poput omaglice ili smetenosti.
• First inject any new lesions (lesions that may have developed since initial treatment).
• Prvo injicirajte u svaku novu leziju (lezije koje su mogle nastati od trenutka početnog liječenja).
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 bolesnika koji su odgovorili na liječenje, u njih 42 (54%) došlo je do povećanja sveukupne veličine postojećih lezija od ≥ 25% i/ili razvoja nove/ih lezije/a prije konačnog postizanja odgovora.
It is important to tell your healthcare professional if you are breast-feeding or plan to do so.
Važno je da obavijestite svojeg zdravstvenog radnika ako dojite ili planirate dojiti.
Blood
Krv
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.
Očekuje se da će simptomi lokalne ili sustavne infekcije koja može biti povezana s lijekom Imlygic biti slični simptomima uzrokovanima infekcijom divljim tipom virusa HSV-1.
Therefore, its pharmacokinetics and biodistribution are driven by the site of intralesional injection, tumour-selective replication, and release from tumour tissue.
Prema tome, njegova farmakokinetika i biodistribucija ovise o mjestu injiciranja u leziju, selektivnoj replikaciji unutar tumora i otpuštanju iz tumorskog tkiva.
31th December,
31. prosinca 2019.
• 108 (100 million) PFU/mL - For all subsequent doses.
• 108 (100 milijuna) PFU/ml - Za sve sljedeće doze.
Because talimogene laherparepvec is designed to enter and replicate in the tumour tissue, there could be a risk of foetal exposure to talimogene laherparepvec from tumour tissue that has crossed the placenta.
S obzirom da je virus talimogene laherparepvec dizajniran za ulazak i replikaciju u tumorskom tkivu, može postojati rizik od izlaganja fetusa virusu talimogene laherparepvec iz tumorskog tkiva koje je prešlo placentu.
If you miss a dose of Imlygic
Ako propustite dozu lijeka Imlygic
PHARMACEUTICAL FORM AND CONTENTS Solution for injection
OBLIK I SADRŽAJ Otopina za injekciju
• Before use, thaw frozen Imlygic vials at room temperature (20°C to 25°C) until Imlygic is liquid (approximately 30 minutes).
• Prije primjene odmrznite zamrznute bočice lijeka Imlygic na sobnoj temperaturi (od 20°C do 25°C) dok lijek Imlygic ne postane tekuć (otprilike 30 minuta).
• Physician educational material
• Edukacijski materijali za zdravstvenog radnika
• Spread of IMLYGIC to close contacts or healthcare providers after direct contact with injected lesions or body fluids
• Širenje lijeka IMLYGIC na osobe u neposrednoj blizini ili zdravstvene radnike nakon izravnog kontakta s injiciranim lezijama ili tjelesnim tekućinama
Please discuss with your Healthcare Professional.
Razgovarajte sa svojim zdravstvenim radnikom.
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.
Dok antivirusni imunološki odgovori štite normalne stanice nakon infekcije virusom talimogene laherparepvec, pokazalo se da su tumori skloni oštećenju i smrti stanica uzrokovanim ICP34.5-deficijentnim virusima HSV-1, uključujući i virus talimogene laherparepvec.
This leaflet was last revised in
Ova uputa je zadnji puta revidirana u {mjesec GGGG}.
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.
U slučaju sumnje na predoziranje ili nenamjernu intravensku primjenu, bolesnika treba liječiti simptomatski, npr. aciklovirom ili drugim antivirusnim lijekovima (vidjeti dio 4.4) i suportivnim mjerama prema potrebi.
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):
Kako biste spriječili širenje lijeka Imlygic na druge dijelove Vašeg tijela ili osobe u Vašoj neposrednoj blizini (osobe u neposrednoj blizini uključuju članove kućanstva, njegovatelje, seksualne partnere ili nekoga s kime dijelite krevet) morate napraviti sljedeće:
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Imlygic therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Imlygic, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Di-sodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Natrijev hidrogenfosfat dihidrat Natrijev dihidrogenfosfat dihidrat
• Patients who are severely immunocompromised (e.g. patients with severe congenital or acquired cellular and/or humoral immune deficiency) (see section 4.4).
• Bolesnici koji su teško imunokompromitirani (npr. bolesnici s ozbiljnom urođenom ili stečenom staničnom i/ili humoralnom imunodeficijencijom) (vidjeti dio 4.4).
• 106 (1 million) PFU/mL - For initial dose only.
• 106 (1 milijun) PFU/ml - Samo za početnu dozu.
Injection site, oral mucosa, and anogenital area samples were collected during treatment and for up to 60 days after the end of treatment.
Uzorci s mjesta injiciranja, uzorci oralne sluznice i uzorci iz anogenitalnog područja prikupljeni su tijekom liječenja i do 60 dana nakon završetka liječenja.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
If signs or symptoms of herpetic infection develop, they should contact their healthcare professional.
Ako se razviju simptomi ili znakovi infekcije herpes virusom, trebaju kontaktirati svog zdravstvenog radnika.
Talimogene laherparepvec causes the death of tumour cells and the release of tumour-derived antigens.
Virus talimogene laherparepvec uzrokuje smrt tumorskih stanica i otpuštanje antigena proizišlih iz tumora.
Table 8.
Tablica 8.
Influenza-like symptoms
Simptomi nalik gripi
Lethal systemic viral infection was observed in up to 20% of nude mice (primarily deficient in T lymphocyte function) and 100% of SCID mice (devoid of both T and B lymphocytes).
Sustavna virusna infekcija sa smrtnim ishodom opažena je u do 20% golih miševa (primarno deficijentni u funkciji T limfocita) i 100% SCID miševa (miševi koji nemaju ni T ni B limfocite).
It is unknown whether talimogene laherparepvec is transferred into human milk.
Nije poznato prenosi li se virus talimogene laherparepvec u majčino mlijeko u ljudi.
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.
Imlygic se primjenjuje za liječenje odraslih bolesnika s vrstom raka kože koji se zove melanom, koji se proširio u kožu ili limfne čvorove, kada operacija nije moguća.
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.
Virus talimogene laherparepvec je također kvantificiran u odabranim uzorcima bolesnika u kliničkim ispitivanjima primjenom testova infektivnosti virusa na mjestu injiciranja i u nekim slučajevima potencijalno herpetičkih lezija.
Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.
Virus talimogene laherparepvec se proizvodi u Vero stanicama tehnologijom rekombinantne DNK.
• First inject any new lesions (lesions that may have developed since previous treatment).
• Prvo injicirajte u svaku novu leziju (lezije koje su mogle nastati od početnog liječenja).
Healthcare professionals who are immunocompromised or pregnant should not administer Imlygic and should not come into direct contact with the Imlygic injection site(s) or body fluids of treated patients (see sections 4.3 and 4.4).
Zdravstveni radnici koji su imunokompromitirani ili su trudnice ne smiju primjenjivati lijek Imlygic i ne smiju doći u izravan kontakt s mjestom/mjestima injiciranja lijeka Imlygic ili tjelesnim tekućinama liječenih bolesnika (vidjeti dijelove 4.3 i 4.4).
The proportion of samples and subjects with talimogene laherparepvec DNA was highest during cycle 2 of treatment for the blood, urine, injection site, and occlusive dressings; highest in cycle 1 of treatment for the oral mucosa; and highest in cycles 1 and 2 for the anogenital area.
Udio uzoraka i ispitanika s DNK virusa talimogene laherparepvec bio je najviši tijekom 2. ciklusa liječenja za krv, urin, mjesto injiciranja i okluzivni zavoj; najviši u 1. ciklusu liječenja za oralnu sluznicu; i najviši u 1. i 2. ciklusu za anogenitalno područje.
• Disperse Imlygic evenly and completely within the lesion by pulling the needle back without exiting the lesion.
• Raspodijelite Imlygic ravnomjerno i potpuno unutar lezije izvlačenjem igle prema van bez vađenja igle iz lezije.
Patients were randomised in a 2:1 ratio to receive either Imlygic or GM-CSF (N = 436; 295 Imlygic, 141 GM-CSF).
Bolesnici su randomizirani u omjeru 2:1 za primjenu lijeka Imlygic ili GM-CSF (N = 436; 295 Imlygic, 141 GM-CSF).
The maximum dose of Imlygic that can be safely administered has not been determined.
Nije utvrđena maksimalna doza lijeka Imlygic koja se može sigurno primijeniti.
1: GM-CSF (N = 86) Median (95% CI) 21.5 (17.4, 29.6) months 2: Talimogene Laherparepvec (N = 163) Median (95% CI) 41.1 (30.6, NE) months
1: GM-CSF (N = 86) Medijan (95% CI) 21,5 (17,4, 29,6) mjeseci 2: Talimogene Laherparepvec (N = 163) Medijan (95% CI) 41,1 (30,6, NP) mjeseci
Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste.
Neiskorišteni lijek mora se zbrinuti sukladno lokalnim propisima za genetski modificirane organizme ili biološki otpad.
Follow the instructions below to prepare and administer Imlygic to patients:
Slijedite upute u nastavku za pripremu i primjenu lijeka Imlygic bolesnicima:
Immune-mediated events reported in the pivotal clinical study included a case of worsening psoriasis in a patient with a prior history of psoriasis, one case of pneumonitis in a patient with a prior history of autoimmune disease, one case of vasculitis, and two cases of glomerulonephritis of which one presented with acute renal failure.
Imunološki posredovani događaji prijavljeni u pivotalnom kliničkom ispitivanju uključivali su slučaj pogoršanja psorijaze u bolesnika s prethodnom poviješću psorijaze, jedan slučaj pneumonitisa u bolesnika s poviješću autoimune bolesti, jedan slučaj vaskulitisa i dva slučaja glomerulonefritisa od čega je u jednom došlo do akutnog zatajenja bubrega.
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.
U ispitivanjima, diseminirana virusna infekcija sa smrtnim ishodom opažena je u 14% golih miševa nakon liječenja virusom talimogene laherparepvec u dozama koje su 10 do 100 puta više od onih koje rezultiraju 100 postotnom smrtnosti s divljim tipom virusa HSV-1.
• The patient information pack should contain: o Patient information leaflet o A patient/carer and close contacts guide
• Informacijski paket za bolesnika mora sadržavati: o Uputu o lijeku o Vodič za bolesnika/njegovatelja i osobe u neposrednoj blizini
• Pain in ear, throat, abdomen, groin, back and underarm
• Bol u uhu, grlu, trbuhu, preponama, leđima i donjem dijelu ruke
• 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;
• Odgovarajuće educirani zdravstveni radnici s iskustvom, kako bi se minimizirao rizik od pojave specificiranih nuspojava u bolesnika, zdravstvenih radnika i osoba u neposrednoj blizini bolesnika:
Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.
Neiskorišteni lijek mora se zbrinuti sukladno lokalnim propisima za genetski modificirane organizme ili biološki otpad, kako je primjenjivo.
Adequate and well controlled studies with talimogene laherparepvec have not been conducted in pregnant women.
Nisu provedena primjerena i dobro kontrolirana ispitivanja virusa talimogene laherparepvec u trudnica.
• Vials should be thawed and stored in the original carton until administration in order to protect from light.
• Bočice se moraju odmrzavati i čuvati u originalnoj kutiji do primjene radi zaštite od svjetlosti.
The total injection volume for each treatment visit should be up to a maximum of 4 mL.
Ukupni volumen injiciranja pri svakom posjetu tijekom liječenja treba biti do najviše 4 ml.
Patients who were HSV-1 seronegative at baseline were reported to have a greater incidence of pyrexia, chills, and influenza-like illness compared with those who were HSV-1 seropositive at baseline, especially within the period of the first 6 treatments (see section 4.8).
Prijavljena je veća učestalost pireksije, zimice i bolesti nalik gripi u bolesnika koji su na početku liječenja bili seronegativni na HSV-1 u usporedbi s onima koji su na početku liječenja bili seropozitivni na HSV-1, posebno unutar perioda prvih 6 liječenja (vidjeti dio 4.8).
Single-use vial without a clear plastic sleeve
Bočica za jednokratnu primjenu bez prozirnog plastičnog omota
Talimogene laherparepvec is sensitive to acyclovir.
Virus talimogene laherparepvec je osjetljiv na aciklovir.
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.
Sigurnost i djelotvornost monoterapije lijekom Imlygic u u usporedbi sa supkutano primijenjenim GM-CSF procijenjene su u multinacionalnom, otvorenom, randomiziranom kliničkom ispitivanju faze 3, u bolesnika s melanomom stadija IIIB, IIIC i IV koji se nije smatrao operabilnim.
Very common (may affect more than 1 in 10 people):
Vrlo često (mogu se javiti u više od 1 na 10 osoba):
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.
U in vivo ispitivanju intracerebralnog injiciranja, virus talimogene laherparepvec bio je 10 000 puta manje neurovirulentan u usporedbi s dozom divljeg tipa virusa HSV-1 koja rezultira smrću u 50% slučajeva u miševa.
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.
Ovaj lijek sadrži približno 30 mg natrija u jednoj dozi od 4 ml, što odgovara 1,5% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.
Signs and symptoms of infection include pain, redness, warmth, swelling, discharge or a sore (ulcer), fever, and chills.
Znakovi i simptomi infekcije uključuju bol, crvenilo, toplinu, oticanje, iscjedak ili čir (ulcer), vrućicu i zimicu.
Caution should be used when injecting lesions close to major airways.
Potreban je oprez pri injiciranju u lezije u blizini glavnih dišnih puteva.
They will then help you decide whether to stop breast-feeding, or whether to stop taking Imlygic, taking into account the benefit of breast-feeding to the baby and the benefit of Imlygic to you.
On će Vam tada pomoći odlučiti o prekidu dojenja ili prekidu primjene lijeka Imlygic, uzimajući u obzir koristi dojenja za dijete i korist lijeka Imlygic za Vas.
To submit the preliminary results from Study 20110266 (a phase 2, multicentre, randomised, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery vs surgery alone for resectable stage IIIB to IVM1a melanoma)
Predati preliminarne rezultate ispitivanja 20110266 (multicentrično, randomizirano, otvoreno ispitivanje faze 2 za procjenu djelotvornosti i sigurnosti neoadjuvantnog liječenja virusom talimogene laherparepvec u kombinaciji s operacijom, u usporedbi sa samo operacijom za operabilni melanom stadija IIIB do IVM1a)
OR Figure 7.
ILI Slika 7.
• Infection caused by bacteria (cellulitis), cold sores (oral herpes)
• Infekcija uzrokovana bakterijom (celulitis), groznica (oralni herpes)
Study Month
Mjesec ispitivanja
This medicine contains approximately 30 mg sodium (main component of cooking/table salt) in each 4 mL dose.
Ovaj lijek sadrži približno 30 mg natrija (glavni sastojak kuhinjske soli) u jednoj dozi od 4 ml.
Name and address of the manufacturer of the biological active substance BioVex Inc. - Subsidiary of Amgen, Inc.
Naziv i adresa proizvođača biološke djelatne tvari BioVex Inc.
Imlygic was administered by intralesional injection at an initial concentration of 106 (1 million) PFU/mL on day 1, followed by a concentration of 108 (100 million) PFU/mL on day 21 and every 2 weeks thereafter at a dose of up to 4 mL.
Imlygic je primijenjen injiciranjem u lezije pri početnoj koncentraciji od 106 (1 milijun) PFU/ml 1. dan, nakon čega je slijedila koncentracija od 108 (100 milijuna) PFU/ml 21. dana i svaka 2 tjedna nakon toga u dozi od najviše 4 ml.
Signs and symptoms related to treatment with Imlygic may be the same as for herpes infections, and include pain, burning or tingling in a blister around the mouth or genitals, or on the fingers or ears, eye pain, light sensitivity, discharge from the eyes, or blurry vision, weakness in arms or legs, extreme drowsiness (feeling sleepy), and mental confusion.
Znakovi i simptomi povezani s liječenjem lijekom Imlygic mogu biti isti kao i za infekciju herpes virusom te uključuju bol, pečenje ili trnce u mjehuriću oko usta ili genitalija ili na prstima ili ušima, bol u očima, osjetljivost na svjetlost, iscjedak iz očiju ili zamagljeni vid, slabost ruku ili nogu, izrazitu pospanost i mentalnu smetenost.
Determining Imlygic dose volume (per lesion)
Određivanje volumena doze lijeka Imlygic (po leziji)
Patients should be advised to use a latex condom during sexual contact to prevent possible transmission of Imlygic.
Bolesnike treba savjetovati da koriste kondom od lateksa tijekom seksualnog kontakta kako bi se spriječio mogući prijenos lijeka Imlygic.
No clinical studies have been conducted to evaluate the effect of hepatic or renal impairment on the pharmacokinetics of talimogene laherparepvec.
Nisu provedena klinička ispitivanja za procjenu učinka oštećenja jetre ili bubrega na farmakokinetiku virusa talimogene laherparepvec.
Immune-mediated events
Imunološki posredovani događaji
Imlygic may cause cancerous white blood cells to collect at or near the injection site (plasmacytoma).
Imlygic može uzrokovati nakupljanje tumorskih bijelih krvnih stanica na mjestu ili u blizini mjesta injiciranja (plazmocitom).
Infection and delayed healing at Imlygic injection site
Infekcija i odgođeno zacjeljivanje na mjestu injiciranja lijeka Imlygic
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.
Poznato je da su osobe s infekcijom divljim tipom virusa HSV-1 cijeli život pod rizikom od simptomatske infekcije herpes virusom zbog reaktivacije latentnog virusa HSV-1 divljeg tipa.
Patients with active brain metastases, bone metastases, extensive visceral disease, primary ocular or mucosal melanoma, evidence of immunosuppression, or receiving treatment with a systemic anti-herpetic agent were excluded from the study.
Bolesnici s aktivnim metastazama u mozgu, koštanim metastazama, opsežnom viscelarnom bolesti, primarnim melanomom oka ili sluznice, s dokazima imunosupresije ili koji su liječeni sustavno primijenjenim lijekom za herpes virus bili su isključeni iz ispitivanja.
Acyclovir and other anti-viral agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Aciklovir i drugi antivirusni lijekovi mogu interferirati s učinkovitošću lijeka Imlygic ako se primijene sustavno ili lokalno izravno na mjesto injiciranja.
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.
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.
Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
Log-rang - p-vrijednost = 0,0511 Omjer rizika [95% CI] = 0,79 [0,62; 1,00]
Close contacts who are pregnant or immunocompromised should not change the patient's dressing or clean their injection site.
Osobe iz neposredne blizine koje su imunokompromitirane ili su trudnice ne smiju mijenjati bolesnikove zavoje ili čistiti njegovo mjesto injiciranja.
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).
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).
No pharmacokinetic studies using talimogene laherparepvec have been conducted in special populations.
Farmakokinetička ispitivanja virusa talimogene laherparepvec u posebnim populacijama nisu provedena.