FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 mg/kg twice daily (10 mg/kg/day)
Slovenian: 5 mg/kg dvakrat na dan (10 mg/kg/dan)
English: The elevations resolved after discontinuation of cannabidiol.
Slovenian: Po prekinitvi zdravljenja s kanabidiolom so se zvišane vrednosti popravile.
English: Cough
Slovenian: Kašelj
English: Excretion
Slovenian: Izločanje
English: Placebo 20 mg/kg/day Difference or Percent Reduction Compared with Placebo (95% CI), p-valueb GWPCARE2
Slovenian: Razlika ali odstotek zmanjšanja v primerjavi s placebom (95-% IZ) p-vrednost b GWPCARE2 10 mg/kg/dan p = 0,0095
English: LIST OF EXCIPIENTS Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje rafinirano sezamovo olje, etanol in sestavine arome jagode (vključno z benzil alkoholom).
English: Management of overdose
Slovenian: Ukrepanje v primeru prevelikega odmerjanja
English: 0.5 mg/kg twice daily (1 mg/kg/day)
Slovenian: 0,5 mg/kg dvakrat na dan (1 mg/kg/dan)
English: No effects on cannabidiol or metabolite exposures were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild hepatic impairment.
Slovenian: Po enkratnem 200-miligramskem odmerku kanabidiola pri preiskovancih z blago okvaro jeter niso opazili učinkov na izpostavljenost kanabidiolu ali presnovku.
English: Gastrointestinal disorders
Slovenian: peroralna raztopina
English: Dose response
Slovenian: Odziv na odmerek
English: How to store Epidyolex
Slovenian: Shranjevanje zdravila Epidyolex
English: 20 mg/kg/day p=0.0006
Slovenian: 20 mg/kg/dan p = 0,0006
English: 20 mg/kg/day p=0.0069
Slovenian: 20 mg/kg/dan p = 0,0069
English: Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
Slovenian: V študijah z zdravimi prostovoljci je interakcija povzročila povečano izpostavljenost aktivnemu presnovku 7-OH-CBD.a
English: a Data for the overall population are presented as median percent reduction from baseline.
Slovenian: IZ = 95-odstotni interval zaupanja a Podatki za celotno populacijo so predstavljeni kot mediana vrednost odstotka zmanjšanja glede na izhodišče.
English: Each ml of solution contains:
Slovenian: Pomožne snovi z znanim učinkom En ml raztopine vsebuje:
English: Dose reduction of the substrates may be necessary when cannabidiol is administered concomitantly with substrates of these UGTs.
Slovenian: Pri sočasnem dajanju kanabidiola in substratov teh encimov UGT bo morda treba zmanjšati odmerek substratov.
English: 20 mg/kg/day p=0.0047
Slovenian: 20 mg/kg/dan p = 0,0047
English: Additional secondary outcome measures in the subgroup of patients treated with concomitant clobazam
Slovenian: N Podskupina bolnikov s klobazamom
English: Very common Somnolencea Common
Slovenian: Somnolencaa
English: Placebo 10 mg/kg/day p=0.0332
Slovenian: 10 mg/kg/dan p = 0,0332
English: Nervous system disorders
Slovenian: Okvara jetrnih celic
English: PHARMACEUTICAL FORM Oral solution
Slovenian: FARMACEVTSKA OBLIKA Peroralna raztopina
English: Placebo 20 mg/kg/day p=0.0784
Slovenian: GWPCARE1 Placebo 20 mg/kg/dan p = 0,0784
English: 2.5 mg/kg twice daily (5 mg/kg/day)
Slovenian: 2,5 mg/kg dvakrat na dan (5 mg/kg/dan)
English: Reduction in dose of clobazam should be considered if somnolence or sedation are experienced when clobazam is co-administered with cannabidiol.
Slovenian: Če se pri sočasnem dajanju klobazama in kanabidiola pojavi somnolenca ali sedacija, je treba razmisliti o zmanjšanju odmerka klobazama.
English: Clobazam
Slovenian: Klobazam
English: Hepatic impairment
Slovenian: Bolezni prebavil
English: In the case of one or more missed doses, the missed doses should not be compensated.
Slovenian: Izpuščenega(-ih) odmerka(-ov) se ne sme nadomeščati.
English: GWPCARE3 10 mg/kg/day p=0.0016
Slovenian: GWPCARE3 Placebo 10 mg/kg/dan p = 0,0030
English: In LGS and DS patients, the mean decrease in haemoglobin from baseline to end of treatment was −0.37 g/dL in cannabidiol-treated patients.
Slovenian: −0,37 g/dl pri bolnikih, zdravljenih s kanabidiolom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral solution contains 100 mg cannabidiol
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En ml peroralne raztopine vsebuje 100 mg kanabidiola.
English: Two 5 ml oral syringes with bottle adaptor
Slovenian: Dve 1-mililitrski brizgi za peroralno dajanje z nastavkoma za steklenico Dve 5-mililitrski brizgi za peroralno dajanje z nastavkoma za steklenico
English: Placebo 10 mg/kg/day 20 mg/kg/day
Slovenian: 20 mg/kg/dan
English: Decreased weight
Slovenian: Zmanjšana telesna masa
English: Posology
Slovenian: Presnova
English: Common
Slovenian: Pogostnost
English: Maintenance Dose Maximum Recommended Dose
Slovenian: - Navodilo shranite.
English: 1 week (7 days)
Slovenian: 1 teden (7 dni)
English: All subsequent treatment visits (including reinitiation)
Slovenian: Vsi nadaljnji terapevtski obiski (vključno s ponovno uvedbo)
English: 30th June, 2021
Slovenian: 30. junij 2021
English: This medicine contains genetically modified organisms.
Slovenian: To zdravilo vsebuje genetsko spremenjene organizme.
English: Study 005/05
Slovenian: Študija 005/05
English: Your second injection will be given 3 weeks after the first injection.
Slovenian: Drugo injekcijo boste dobili 3 tedne po prvi injekciji.
English: HSV-1 seronegative patients
Slovenian: HSV-1 seronegativni bolniki
English: Study Month
Slovenian: Mesec študije
English: All patients
Slovenian: Vsi bolniki
English: Continue until the full dose is evenly and completely dispersed.
Slovenian: Nadaljujte, dokler ni celotni odmerek porazdeljen enakomerno in popolnoma.
English: Previous systemic treatment for melanoma was allowed but not required.
Slovenian: Predhodno sistemsko zdravljenje melanoma je bilo dovoljeno, ni pa bilo zahtevano.
English: • think you may be pregnant
Slovenian: • če menite, da bi lahko bili noseči,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Slovenian: Datum prve odobritve: 16. december 2015
English: These symptoms generally resolve within the first 72 hours after treatment.
Slovenian: Ti simptomi po navadi izginejo v prvih 72 urah po zdravljenju.
English: Reproductive and development toxicity
Slovenian: Reproduktivna in razvojna toksičnost
English: Overall response rate (% CR, % PR)
Slovenian: Celokupni delež odziva (% CR, % PR)
English: - If you have any further questions, ask your healthcare professional (doctor or nurse).
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravstvenim delavcem (zdravnikom ali medicinsko sestro).
English: After that, you will receive injections every 2 weeks for as long as you have the tumour(s).
Slovenian: Pozneje boste dobivali injekcije vsaka 2 tedna, dokler boste imeli tumor(je).
English: Kaplan-Meier Percent Alive
Slovenian: Kaplan-Meier - odstotek živih
English: • Wear gloves while changing your dressing.
Slovenian: • nosijo rokavice, medtem ko vam menjajo povoje.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 2.1 Splošen opis
English: Number of Patients at Risk
Slovenian: Število bolnikov, izpostavljenih tveganju
English: No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Slovenian: V celoti niso ugotovili razlik v varnosti in učinkovitosti med starejšimi bolniki (starimi ≥ 65 let) in mlajšimi odraslimi bolniki.
English: Patients experiencing a response at 12 months of treatment could continue treatment for up to an additional 6 months.
Slovenian: Bolniki, ki so v 12 mesecih dosegli odziv, so lahko zdravljenje nadaljevali do dodatnih 6 mesecev.
English: Keeping wounds clean and dressed can help prevent these types of infections.
Slovenian: Ohranjanje ran čistih in pokritih pomaga preprečiti takšne okužbe.
English: Patients with detectable DNA during treatment (n = 60)
Slovenian: Bolniki z zaznavno DNA med zdravljenjem (n = 60)
English: You should tell your healthcare professional if you notice any of these symptoms.
Slovenian: Zdravstvenemu delavcu morate povedati, če opazite katerega od teh simptomov.
English: The physician educational material should contain:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati:
English: • Repeat these steps for other lesions that need to be injected.
Slovenian: • Ponovite te korake še na drugih spremembah, v katere morate injicirati.
English: Influenza-like symptoms
Slovenian: Gripi podobni simptomi
English: Twenty six (26) patients were exposed to Imlygic for at least one year.
Slovenian: Šestindvajset (26) bolnikov je bilo zdravilu Imlygic izpostavljenih vsaj eno leto.
English: The controlled distribution programme is aimed to manage the product supply chain to ensure that cold storage requirements are observed and to control the distribution of IMLYGIC to qualified centres and up to the patients.
Slovenian: Program nadzorovane distribucije je namenjen obvladovanju dobavne verige zdravila, da se zagotovi upoštevanje zahtev glede shranjevanja na hladnem, in se nadzoruje distribucijo zdravila IMLYGIC do kvalificiranih centrov in do bolnikov.
English: Imlygic is not recommended for children and adolescents since the effects of Imlygic in people younger than 18 years old are not known.
Slovenian: Zdravilo Imlygic ni priporočljivo za otroke in mladostnike, ker njegovi učinki pri osebah, mlajših od 18 let, niso znani.
English: Redirect the needle as many times as necessary while injecting the remainder of the dose of Imlygic.
Slovenian: Preusmerite iglo tolikokrat, kot je treba, in medtem injicirajte preostanek odmerka zdravila Imlygic.
English: Durable response rate Primary
Slovenian: Delež trajnega odziva Primarni
English: Exploratory subgroups
Slovenian: Eksplorativne podskupine
English: This leads to destruction of infected tumour cells.
Slovenian: To povzroči uničenje okuženih tumorskih celic.
English: The majority of patients, 98%, were caucasian.
Slovenian: Večina bolnikov (98 %) je bila belcev.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Cellulitis and systemic bacterial infection have been reported.
Slovenian: Poročali so o celulitisu in sistemski bakterijski okužbi.
English: The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Slovenian: Mediana trajanja izpostavljenosti zdravilu Imlygic je bila 23 tednov (5,3 meseca).
English: Keep used dressings and cleaning materials away from newborns.
Slovenian: Povoje in material za čiščenje shranjujte proč od novorojenčkov.
English: Due to the exploratory nature of the analysis and based on the current evidence, it has not been established that Imlygic is associated with an effect on overall survival.
Slovenian: Zaradi raziskovalnega značaja analiz in na podlagi trenutnih dokazov ni bilo ugotovljeno, da je zdravilo Imlygic povezano z učinkom na celokupno preživetje.
English: Efficacy data for Imlygic in the current second or later line treatment settings are limited.
Slovenian: Podatki o učinkovitosti zdravila Imlygic v trenutni drugi ali nadaljnjih linijah zdravljenja so omejeni.
English: These events were reported more frequently within the period of the first 6 treatments, particularly in patients who were HSV-1 negative at baseline.
Slovenian: O teh dogodkih so pogosteje poročali v obdobju prvih 6 zdravljenj, zlasti pri bolnikih, ki so bili izhodiščno HSV-1 negativni.
English: • Allergic reaction (hypersensitivity)
Slovenian: • alergijska reakcija (preobčutljivost).
English: • Provide specified safety information to patients and communicate to patients the importance for sharing this information with family and caregivers;
Slovenian: • Bolnikom je treba zagotoviti določene varnostne informacije in jim povedati, kako pomembno je, da te informacije delijo z družino in skrbniki.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
English: 1 vial.
Slovenian: 1 viala.
English: Months
Slovenian: Meseci
English: Imlygic 295 269 230 187 159 145 125 95 66 36 16 2 GM-CSF 141 124 100 83 63 52 46 36 27 15 5 0
Slovenian: Zdravilo Imlygic 295 269 230 187 159 145 125 95 66 36 16 2 GM-CSF 141 124 100 83 63 52 46 36 27 15 5
English: Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Slovenian: Skupno je bilo osemindevetdeset odstotkov (98 %) teh poročanih neželenih učinkov blagih ali zmernih.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To ustreza 1,5 % največjega priporočenega dnevnega prehranskega vnosa soli za odraslega.
English: Pregnant women, neonates, and immunocompromised individuals should not be exposed to potentially contaminated materials.
Slovenian: Nosečnice, novorojenčki in imunokompromitirane osebe ne smejo biti izpostavljene potencialno kontaminiranim materialom.
English: 4.1 months
Slovenian: 4,1 mesecev
English: • Low red blood cell numbers (anaemia)
Slovenian: • majhno število rdečih krvnih celic (anemija),
English: Time to treatment failure (median)
Slovenian: Čas do neuspeha zdravljenja (mediana)
English: The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
Slovenian: Najpogostejši neželeni učinek 3. ali višje stopnje je bil celulitis (2,1 %) (glejte poglavje 4.4).
English: Talimogene laherparepvec may have a minor influence on the ability to drive and use machines.
Slovenian: Talimogen laherparepvek ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: - if your healthcare professional has told you that you have a severely weakened immune system.
Slovenian: - če vam je zdravstveni delavec povedal, da imate močno oslabel imunski sistem.
English: In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
Slovenian: V ključnem kliničnem preskušanju (študija 005/05) so zabeležili pojave celulitisa, od teh so nekatere obravnavali kot resne neželene dogodke.
English: However, none lead to permanent discontinuation of Imlygic treatment.
Slovenian: Vendar noben ni vodil do trajnega prenehanja zdravljenja z zdravilom Imlygic.
English: Treatment with talimogene laherparepvec should be initiated and supervised by a qualified physician experienced in the treatment of cancer.
Slovenian: Zdravljenje s talimogenom laherparepvekom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje na področju zdravljenja raka.
English: Talk to your healthcare professional about suitable methods of contraception.
Slovenian: Z zdravstvenim delavcem se posvetujte o primernih načinih kontracepcije.
English: The maximum dose of Imlygic that can be safely administered has not been determined.
Slovenian: Največji odmerek zdravila Imlygic, ki ga je mogoče varno uporabiti, ni ugotovljen.
English: Women of childbearing potential/contraception
Slovenian: Ženske v rodni dobi/kontracepcija
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika v posebnih populacijah
English: Not reached (Range: > 0.0 to > 16.8 months)
Slovenian: Ni dosežen (Razpon: > 0,0 do > 16,8 mesecev)
English: Proportion Alive
Slovenian: Delež živih
English: Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
Slovenian: Zdravilo Imlygic poleg tega deluje tudi tako, da pomaga imunskemu sistemu prepoznati in uničiti tumorje po vsem telesu.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Slovenian: Treba je upoštevati aditivni učinek sočasnega dajanja zdravil, ki vsebujejo sorbitol (ali fruktozo), in prehranskega vnosa sorbitola (ali fruktoze).
English: 3.7 months
Slovenian: 3,7 mesecev
English: 90% of patients treated with Imlygic experienced influenza-like symptoms.
Slovenian: 90 % bolnikov, zdravljenih z zdravilom Imlygic, je imelo gripi podobne simptome.
English: The safety and efficacy of Imlygic in paediatric patients has not been established.
Slovenian: Varnost in učinkovitost zdravila Imlygic pri pediatričnih bolnikih še nista bili dokazani.
English: The educational programme is aimed to inform about important risks associated with IMLYGIC:
Slovenian: Izobraževalno gradivo je namenjeno informiranju o pomembnih tveganjih, povezanih z zdravilom IMLYGIC:
English: If you have these signs, you should follow standard hygiene practices to prevent viral transmission to others.
Slovenian: Če imate te znake, upoštevajte običajne higienske ukrepe, da boste preprečili prenos virusa na druge.
English: Lesion size (longest dimension)
Slovenian: Velikost spremembe (najdaljša razsežnost)
English: Difficulty breathing
Slovenian: Težko dihanje
English: If healthcare professionals are accidentally exposed to Imlygic, see sections 4.4 and 6.6.
Slovenian: Če so zdravstveni delavci nenamerno izpostavljeni zdravilu Imlygic, glejte poglavji 4.4 in 6.6.
English: 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.
Slovenian: 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.
English: up to 25°C
Slovenian: do 25°C
English: Previously treated patients
Slovenian: Bolniki, ki so bili predhodno zdravljeni
English: Granulomatous dermatitis
Slovenian: Občasni granulomatozni dermatitis
English: If you are pregnant or breast-feeding, ask your healthcare professional for advice before being given this medicine.
Slovenian: Če ste noseči ali dojite, se posvetujte z zdravstvenim delavcem, preden dobite to zdravilo.
English: Transplacental metastases of malignant melanoma can occur.
Slovenian: Pojavijo se lahko transplacentalni zasevki malignega melanoma.
English: Duration of response (ongoing response at last tumour evaluation)
Slovenian: Trajanje odziva (trajajoč odziv ob zadnji oceni tumorja)
English: 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.
Slovenian: 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.
English: 2°C to 8°C
Slovenian: 2°C do 8°C
English: Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
Slovenian: Priporočljivi so skrbna oskrba ran in ukrepi za preprečevanje okužbe, zlasti če nekroza tkiva povzroči odprte rane.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je natisnjen na nalepki in škatli poleg oznake »EXP«.
English: You can expect to be treated with Imlygic for at least 6 months or longer.
Slovenian: Pričakovati morate, da bo zdravljenje z zdravilom Imlygic trajalo vsaj 6 mesecev ali več.
English: Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Slovenian: Vzorce krvi in urina so odvzeli med zdravljenjem in do 30 dni po koncu zdravljenja.
English: 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.
Slovenian: 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.
English: 3 weeks after initial treatment Up to 4 mL
Slovenian: 3 tedne po začetnem zdravljenju do 4 ml
English: Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Slovenian: Narejene so bile tudi analize eksplorativnih podskupin glede DRR in celokupnega preživetja glede na stadij bolezni (glejte sliko 5 in preglednico 5).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 5 years.
Slovenian: 5 let
English: The injection site may take longer to heal than normal.
Slovenian: Celjenje na mestu injiciranja lahko traja dlje kot je običajno.
English: If the dressing comes loose or falls off, replace it immediately with a clean dressing.
Slovenian: Če povoj postane ohlapen ali odpade, ga takoj zamenjajte s čistim povojem.
English: Time to response (median)
Slovenian: Čas do odziva (mediana)
English: Follow local institutional guidelines for handling and administration, personal protective equipment, accidental spills, and waste disposal.
Slovenian: Upoštevajte lokalne smernice ustanove za ravnanje z zdravilom in njegovo dajanje, osebno zaščitno opremo, nenamerna razlitja in odstranjevanje odpadkov.
English: • Combination with other therapies like chemotherapy or immunosuppressive agents
Slovenian: • Kombinacija z drugimi zdravljenji, kot sta kemoterapija ali imunosupresivna zdravila.
English: Patients with weakened immune systems
Slovenian: Bolniki z oslabelim imunskim sistemom
English: 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.
Slovenian: 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.
English: Immunocompromised patients
Slovenian: Imunokompromitirani bolniki
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: • Avoid touching or scratching the injection sites.
Slovenian: • Izogibajte se dotikanju in praskanju mest injiciranja.
English: Among the Imlygic-treated responders, 56 (72%) responses were still ongoing at the time of primary analysis.
Slovenian: Med bolniki, zdravljenimi z zdravilom Imlygic, ki so se odzvali na zdravljenje, jih je 56 (72 %) imelo še trajajoč odziv v času primarne analize.
English: No neuropathology or adverse neurological effects were observed.
Slovenian: Nevropatoloških sprememb ali neželenih nevroloških učinkov niso opazili.
English: Avoid contact with skin, eyes or mucous membranes.
Slovenian: Izogibajte se stiku s kožo, očmi in sluznicami.