natgillin/translations-raw huggingface dataset:
If you have these signs, you should follow standard hygiene practices to prevent viral transmission to others.
Če imate te znake, upoštevajte običajne higienske ukrepe, da boste preprečili prenos virusa na druge.
Lesion size (longest dimension)
Velikost spremembe (najdaljša razsežnost)
Difficulty breathing
Težko dihanje
If healthcare professionals are accidentally exposed to Imlygic, see sections 4.4 and 6.6.
Če so zdravstveni delavci nenamerno izpostavljeni zdravilu Imlygic, glejte poglavji 4.4 in 6.6.
While the pivotal study was not powered to evaluate efficacy in these individual subgroups, patients with no visceral disease derived greater benefit from Imlygic treatment than those with more advanced disease.
Ključna študija sicer ni imela moči za ovrednotenje učinkovitosti po teh posameznih podskupinah, vendar so imeli bolniki brez visceralne bolezni od zdravljenja z zdravilom Imlygic večjo korist kot bolniki z bolj napredovalo boleznijo.
up to 25°C
do 25°C
Previously treated patients
Bolniki, ki so bili predhodno zdravljeni
Granulomatous dermatitis
Občasni granulomatozni dermatitis
If you are pregnant or breast-feeding, ask your healthcare professional for advice before being given this medicine.
Če ste noseči ali dojite, se posvetujte z zdravstvenim delavcem, preden dobite to zdravilo.
Transplacental metastases of malignant melanoma can occur.
Pojavijo se lahko transplacentalni zasevki malignega melanoma.
Duration of response (ongoing response at last tumour evaluation)
Trajanje odziva (trajajoč odziv ob zadnji oceni tumorja)
The mean age was 63 (range: 22 to 94) years; 26.5% were over 65 years old and 23.3% were over 74 years old.
Povprečna starost je bila 63 (razpon: 22 do 94) let; 26,5 % bolnikov je bilo starejših od 65 let in 23,3 % je bilo starejših od 74 let.
Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
Priporočljivi so skrbna oskrba ran in ukrepi za preprečevanje okužbe, zlasti če nekroza tkiva povzroči odprte rane.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je natisnjen na nalepki in škatli poleg oznake »EXP«.
You can expect to be treated with Imlygic for at least 6 months or longer.
Pričakovati morate, da bo zdravljenje z zdravilom Imlygic trajalo vsaj 6 mesecev ali več.
Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Vzorce krvi in urina so odvzeli med zdravljenjem in do 30 dni po koncu zdravljenja.
Overall, 58% of all patients enrolled into the study were seropositive for wild-type HSV-1 at baseline and 32.6% were seronegative; the HSV-1 serostatus of the remaining 9.4% was unknown.
Skupno 58 % vseh bolnikov, vključenih v študijo, je bilo izhodiščno seropozitivnih za divji tip HSV-1 in 32,6 % jih je bilo seronegativnih; serološki status HSV-1 pri preostalih 9,4 % ni bil znan.
3 weeks after initial treatment Up to 4 mL
3 tedne po začetnem zdravljenju do 4 ml
Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Narejene so bile tudi analize eksplorativnih podskupin glede DRR in celokupnega preživetja glede na stadij bolezni (glejte sliko 5 in preglednico 5).
Tell your healthcare professional if you are taking, have recently taken or might take any other medicines, including medicines, such as acyclovir, to treat or prevent herpes infections.
Obvestite zdravstvenega delavca, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, kot je aciklovir, za zdravljenje ali preprečevanje okužb s herpesom.
The European Medicines Agency has deferred the obligation to submit the results of studies with Imlygic in one or more subsets of the paediatric population in melanoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Imlygic za eno ali več podskupin pediatrične populacije pri melanomu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
5 years.
5 let
The injection site may take longer to heal than normal.
Celjenje na mestu injiciranja lahko traja dlje kot je običajno.
If the dressing comes loose or falls off, replace it immediately with a clean dressing.
Če povoj postane ohlapen ali odpade, ga takoj zamenjajte s čistim povojem.
Time to response (median)
Čas do odziva (mediana)
Follow local institutional guidelines for handling and administration, personal protective equipment, accidental spills, and waste disposal.
Upoštevajte lokalne smernice ustanove za ravnanje z zdravilom in njegovo dajanje, osebno zaščitno opremo, nenamerna razlitja in odstranjevanje odpadkov.
• Combination with other therapies like chemotherapy or immunosuppressive agents
• Kombinacija z drugimi zdravljenji, kot sta kemoterapija ali imunosupresivna zdravila.
Patients with weakened immune systems
Bolniki z oslabelim imunskim sistemom
The primary endpoint was durable response rate (DRR) [defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months] per blinded central review.
Primarni opazovani dogodek je bil delež trajnega odziva (DRR - durable response rate) [opredeljen kot odstotek bolnikov s popolnim odzivom (CR - complete response) ali delnim odzivom (PR - partial response), ki se je neprekinjeno ohranil vsaj 6 mesecev] po oceni slepljenega centralnega pregleda.
Immunocompromised patients
Imunokompromitirani bolniki
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
• Avoid touching or scratching the injection sites.
• Izogibajte se dotikanju in praskanju mest injiciranja.
Among the Imlygic-treated responders, 56 (72%) responses were still ongoing at the time of primary analysis.
Med bolniki, zdravljenimi z zdravilom Imlygic, ki so se odzvali na zdravljenje, jih je 56 (72 %) imelo še trajajoč odziv v času primarne analize.
No neuropathology or adverse neurological effects were observed.
Nevropatoloških sprememb ali neželenih nevroloških učinkov niso opazili.
Avoid contact with skin, eyes or mucous membranes.
Izogibajte se stiku s kožo, očmi in sluznicami.
Imlygic contains sodium and sorbitol
Zdravilo Imlygic vsebuje natrij in sorbitol
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.