FrancophonIA/ELRC3.0 huggingface dataset:
English: • Blood clot within a deep vein (deep vein thrombosis), high blood pressure (hypertension),
Croatian: • Ugrušak u dubokoj veni (duboka venska tromboza), visok krvni tlak (hipertenzija), crvenilo u licu (crvenilo uz osjećaj žarenja)
English: Stage§ IVM1B/ IVM1C (Imlygic, n = 131;
Croatian: Stadij§ IVM1B/ IVM1C (Imlygic, n = 131; GM-CSF, n = 55)
English: • Guide for healthcare professionals shall contain the following key elements: o Information on the risk of herpetic infection in patients treated by IMLYGIC o Information on the risk of disseminated herpetic infection in immunocompromised individuals treated by IMLYGIC o Recommendation regarding accidental exposure of IMLYGIC to HCPs: o To always wear protective gown/laboratory coat, safety glasses and gloves while preparing or administrating IMLYGIC; o To avoid contact with skin, eyes, mucous membranes and ungloved direct contact with injected lesions or body fluids of treated patients; o Instruction on first aid after accidental exposure; o Immunocompromised and pregnant healthcare professionals should not prepare and administer IMLYGIC.
Croatian: • Vodič za zdravstvene radnike će sadržavati sljedeće ključne elemente: o Informacije o riziku od infekcije herpes virusom u bolesnika liječenih lijekom IMLYGIC; o Informacije o riziku od diseminirane infekcije herpes virusom u imunokompromitiranih osoba liječenih lijekom IMLYGIC; o Preporuke za zdravstvene radnike vezane uz slučajno izlaganje lijeku IMLYGIC; o Uputa da se uvijek tijekom pripreme ili primjene lijeka IMLYGIC nosi zaštitni ogrtač/laboratorijska kuta, zaštitne naočale i rukavice; o Da se izbjegava kontakt s kožom, očima, membranama sluznica i izravan kontakt s injiciranim lezijama ili tjelesnim tekućinama bolesnika bez zaštitnih rukavica; o Upute o prvoj pomoći nakon slučajnog izlaganja; o Imunokompromitirani zdravstveni radnici i trudnice ne smiju pripremati i primjenjivati lijek IMLYGIC; o Preporuke vezane uz slučajan prijenos lijeka IMLYGIC iz bolesnika na osobe u neposrednoj blizini ili zdravstvene radnike; o Upute o tome kako se ponašati nakon primjene/slučajnog izlaganja te kako i koliko često se mora mijenjati zavoj te tko ne smije mijenjati zavoj; o Upute za minimizaciju rizika od izlaganja krvi i tjelesnih tekućina osobama u neposrednoj blizini tijekom liječenja lijekom IMLYGIC i 30 dana nakon posljednje primjene lijeka IMLYGIC.
English: o the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 7).
Croatian: o vrijeme čuvanja u štrcaljki pri sobnoj temperaturi do najviše 25°C ne smije prekoračiti 2 sati za 106 (1 milijun) PFU/ml i 4 sata za 108 (100 milijuna) PFU/ml (vidjeti tablicu 7).
English: Viral activity was measured in samples that were positive for talimogene laherparepvec DNA from the injection site, occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Croatian: Aktivnost virusa mjerena je u uzorcima koji su bili pozitivni na DNK virusa talimogene laherparepvec s mjesta injiciranja, okluzivnih zavoja, oralne sluznice, anogenitalnog područja i sumnjivih herpetičkih lezija.
English: Median 23.3 (95% CI: 19.5, 29.6) months
Croatian: Medijan 23,3 (95% CI: 19,5; 29,6) mjeseca
English: Patients with detectable DNA during treatment
Croatian: Tablica 6. Bolesnici s detektabilnom razinom DNK tijekom liječenja
English: It is not known whether Imlygic is excreted in breast milk.
Croatian: Nije poznato izlučuje li se Imlygic u majčino mlijeko.
English: Malaise, Axillary pain
Croatian: Malaksalost, aksilarna bol
English: Intralesional use
Croatian: Intralezijska primjena
English: > 5 cm up to 4 mL
Croatian: > 5 cm do 4 ml
English: It is supplied as a 1 mL preservative free solution in a single -use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene).
Croatian: Dostupan je kao 1 ml otopine bez konzervansa u bočici za jednokratnu primjenu (plastična smola od cikličkog olefinskog polimera) s čepom (klorobutilni elastomer) i zatvaračem (aluminij) s flip-off poklopcem (polipropilen).
English: Adverse reactions from clinical trials in patients with melanoma and post-marketing experience
Croatian: Tablica 3. Nuspojave iz kliničkih ispitivanja bolesnika s melanomom i razdoblja nakon stavljanja lijeka u promet
English: • Wound complication, secretion, bruising (contusion), pain after procedure
Croatian: • Komplikacija rane, izlučivanje, stvaranje modrica (kontuzija), bol nakon zahvata
English: Name and address of the manufacturers responsible for batch release Amgen Europe B.V.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Amgen Europe B.V.
English: Injection
Croatian: Injiciranje
English: Imlygic is a clear to semi-translucent (106 PFU/mL) or semi-translucent to opaque (108 PFU/mL) liquid.
Croatian: Imlygic je bistra do poluprozirna (106 PFU/ml) ili poluprozirna do neprozirna (108 PFU/ml) tekućina.
English: o the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 1).
Croatian: o vrijeme čuvanja u štrcaljki pri sobnoj temperaturi do najviše 25°C ne smije prekoračiti 2 sati za 106 (1 milijun) PFU/ml i 4 sata za 108 (100 milijuna) PFU/ml (vidjeti tablicu 1).
English: Wound complication, Wound secretion, Contusion, Procedural pain § Injection site reactions include: very common term of injection site pain, common terms of injection site erythema, injection site haemorrhage, injection site swelling, injection site reaction, injection site inflammation, secretion discharge, injection site discharge, uncommon term of injection site warmth.
Croatian: Komplikacije rane, sekrecija iz rane, kontuzije, proceduralna bol § Reakcije na mjestu injiciranja uključuju: vrlo čestu pojavu boli na mjestu injiciranja, čestu pojavu eritema na mjestu injiciranja, krvarenja na mjestu injiciranja, oticanja na mjestu injiciranja, reakcija na mjestu injiciranja,
English: Discard any thawed Imlygic in the vial or syringe stored longer than the specified times below.
Croatian: Zbrinite sav odmrznuti lijek Imlygic u bočici ili štrcaljki koji se čuvao dulje od niže navedenog vremena.
English: (1 million) PFU/mL
Croatian: (1 milijun) PFU/ml
English: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with Imlygic.
Croatian: Žene reproduktivnog potencijala treba savjetovati da koriste učinkovitu metodu kontracepcije kako bi se spriječila trudnoća tijekom liječenja lijekom Imlygic.
English: 8 hours
Croatian: 8 sati
English: If your close contacts are accidentally exposed to Imlygic, they should clean the affected area on their body with soap and water and/or a disinfectant.
Croatian: Ako se osobe u Vašoj neposrednoj blizini slučajno izlože lijeku Imlygic, moraju očistiti zahvaćeno područje na svom tijelu sapunom i vodom i/ili dezinficijensom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intralesional use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Intralezijska primjena.
English: Occlusive dressings samples were collected during treatment.
Croatian: Tijekom liječenja prikupljeni su uzorci iz okluzivnih zavoja.
English: Plasmacytoma at injection site
Croatian: Plazmocitom na mjestu injiciranja
English: Tumour pain, Infected neoplasm
Croatian: Tumorska bol, infekcija neoplazme
English: Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1.
Croatian: Virus talimogene laherparepvec je onkolitički imunoterapeutik dobiven iz virusa HSV-1.
English: Imlygic injection volume
Croatian: Volumen injiciranja lijeka Imlygic
English: The vial cap is colour coded: 106 PFU/mL is light green and 108 PFU/mL is royal blue.
Croatian: Poklopac bočice je označen bojom: 106 PFU/ml je svjetlo zelene boje a 108 PFU/ml je kraljevsko plave boje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODACI KOJE NAJMANJE MORA SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI
English: (100 million) PFU/mL
Croatian: (100 milijuna) PFU/ml
English: Herpetic infection in Imlygic-treated patients
Croatian: Infekcija herpes virusom u bolesnika liječenih lijekom Imlygic
English: 12 hours
Croatian: 12 sati
English: Deep vein thrombosis, Hypertension, Flushing Respiratory, thoracic and mediastinal disorders Very common Cough Common
Croatian: Duboka venska tromboza, hipertenzija, crvenilo uz osjećaj vrućine Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često
English: • Accidental exposure of Healthcare Professionals (HCPs) to IMLYGIC
Croatian: • Slučajno izlaganje zdravstvenih radnika lijeku IMLYGIC
English: 4 hours
Croatian: 4 sata
English: United States
Croatian: Sjedinjene Američke Države
English: In clinical studies, herpetic infections (including cold sores and herpes keratitis) have been reported in patients treated with Imlygic.
Croatian: U kliničkim ispitivanjima, u bolesnika liječenih lijekom Imlygic prijavljene su infekcije herpes virusom (uključujući groznice i dendritički keratitis).
English: Summary of results for the ITT population from Imlygic study 005/05 Study endpoint
Croatian: Tablica 4. Sažetak rezultata za ITT populaciju iz ispitivanja 005/05 lijeka Imlygic
English: Table 7.
Croatian: Tablica 7.
English: • Muscle pain (myalgia), painful/swollen joints (arthralgia), limb pain
Croatian: • Bolovi u mišićima (mialgija), bolni/natečeni zglobovi (artralgija), bolovi u udovima
English: Urine
Croatian: Urin
English: Each vial contains 1 extractable mL of solution at a nominal concentration of 1 x 106 (1 million) plaque forming units (PFU)/mL or 1 x 108 (100 million) PFU/mL.
Croatian: Svaka bočica sadrži 1 ml otopine koji se može uvući u štrcaljku nominalne koncentracije1 x 106 (1 milijun) jedinica formiranih plakova (PFU)/ml ili 1 x 108 (100 milijuna) PFU/ml.
English: 2.1% (n = 3) (95% CI: 0.0, 4.5) Odds ratio 8.9; (95% CI: 2.7, 29.2) P < 0.0001
Croatian: 2,1% (n = 3) (95% CI: 0,0; 4,5) Omjer izgleda 8,9; (95% CI: 2,7; 29,2) P < 0,0001
English: Consider the risks and benefits of Imlygic treatment before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Croatian: Razmotrite rizike i koristi liječenja lijekom Imlygic prije primjene aciklovira ili drugih antivirusnih lijekova indiciranih za liječenje infekcije herpes virusom.
English: HIV/AIDS, blood or bone marrow cancer, or if you are taking steroids or other medicines that suppress your immune system.
Croatian: Obavijestite svog zdravstvenog radnika ako imate ili ste ikada imali oslabljen imunološki sustav, ako imate HIV/AIDS, rak krvi ili koštane srži ili ako uzimate steroide ili druge lijekove koji suzbijaju Vaš imunološki sustav.
English: Nervous system disorders Very common Headache Common
Croatian: Poremećaji živčanog sustava Vrlo često
English: In clinical studies, impaired healing at the injection site has been reported.
Croatian: U kliničkim ispitivanjima prijavljeno je otežano zacjeljivanje na mjestu injiciranja.
English: Immune system disorders Common
Croatian: Poremećaji imunološkog sustava Često
English: OTHER
Croatian: Drugi
English: • Flu-like illness, fever (pyrexia), chills, fatigue, pain
Croatian: • Bolest nalik gripi, vrućica (pireksija), zimica, umor, bol
English: The vial cap is colour coded: 106 (1 million) PFU/mL is light green and 108 (100 million) PFU/mL is royal blue.
Croatian: Poklopac bočice je označen bojom: za 106 (1 milijun) PFU/ml je svjetlo zelene boje a za 108 (100 milijuna) PFU/ml je Royal plave boje.
English: Imlygic is to be administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.
Croatian: Imlygic treba primijeniti intralezijskom injekcijom u kožne i/ili potkožne lezije i/ili lezije u limfnim čvorovima koje su vidljive, opipljive ili se mogu detektirati ultrazvukom.
English: • Inject Imlygic intralesionally into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.
Croatian: • Injicirajte Imlygic intralezijski u kožne i/ili potkožne lezije i/ili lezije u limfnim čvorovima koje su vidljive, opipljive ili se mogu detektirati ultrazvukom.
English: Plasmacytoma
Croatian: Plazmocitom
English: • Patient alert card
Croatian: • Karticu s upozorenjima za bolesnika
English: Dyspnoea, Oropharyngeal pain, Upper respiratory tract infection
Croatian: Dispneja, orofaringealna bol, infekcije gornjih dišnih puteva
English: Talimogene laherparepvec was injected into various xenograft tumours at doses up to 2 x 108 PFU/kg (30-fold over the highest proposed clinical dose) in immunodeficient mice (nude and SCID).
Croatian: Virus talimogene laherparepvec injiciran je u razne tumore presađene iz drugih vrsta na imunodeficijentne miševe (goli i SCID) u dozama od najviše 2 x 108 PFU/kg (30 puta više od najviše preporučene kliničke doze) u imunodeficijentnim miševima.
English: 3 weeks after initial treatment Up to 4 mL
Croatian: 3 tjedna nakon početnog liječenja
English: Abdominal pain, Abdominal discomfort Skin and subcutaneous tissue disorders Common
Croatian: Bol u abdomenu, nelagoda u abdomenu Poremećaji kože i potkožnog tkiva Često
English: Figure 2.
Croatian: Tablica 2.
English: • Pregnant and lactating women
Croatian: • Trudnice i dojilje
English: Keratitis herpetic Ear and labyrinth disorders Common
Croatian: Dendritički keratitis Poremećaji uha i labirinta Često
English: Back pain, Groin pain
Croatian: Bol u leđima, bol u preponama
English: • Compressed airways (obstructive airways disorder)
Croatian: • Suženi dišni putevi (opstruktivni poremećaj dišnih puteva)
English: What Imlygic is and what it is used for What you need to know before and during Imlygic treatment How Imlygic is given
Croatian: Što morate znati prije početka i tijekom liječenja lijekom Imlygic Kako primjenjivati Imlygic
English: ≤ 0.5 cm up to 0.1 mL
Croatian: ≤ 0,5 cm do 0,1 ml
English: 1 vial.
Croatian: 1 bočica.
English: Maximum cumulative storage time (storage time in vial plus storage time in syringe) for thawed Imlygic
Croatian: Maksimalno kumulativno vrijeme čuvanja (vrijeme čuvanja u bočici plus vrijeme čuvanja u štrcaljki) odmrznutog lijeka Imlygic
English: Prioritisation of lesions to be injected
Croatian: Lezije koje imaju prednost pri injiciranju
English: The active ingredient of Imlygic is talimogene laherparepvec.
Croatian: Djelatna tvar lijeka Imlygic je virus talimogene laherparepvec.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1064/001
English: The risks and benefits of Imlygic treatment should be considered before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Croatian: Potrebno je razmotriti rizike i koristi liječenja lijekom Imlygic prije primjene aciklovira ili drugih antivirusnih lijekova indiciranih za liječenja infekcija herpes virusom.
English: Accidental exposure to Imlygic
Croatian: Slučajno izlaganje lijeku Imlygic
English: Cold sores or a more serious herpes infection may occur during or after treatment with Imlygic.
Croatian: Tijekom ili nakon liječenja lijekom Imlygic može se javiti groznica ili ozbiljnija infekcija herpes virusom.
English: > 2.5 cm to 5 cm up to 2 mL
Croatian: > 2,5 cm do 5 cm do 2 ml
English: Infection caused by bacteria (cellulitis) at the injection site has been commonly seen in patients receiving Imlygic.
Croatian: U bolesnika liječenih lijekom Imlygic često je opažena pojava infekcije uzrokovane bakterijom (celulitits) na mjestu injiciranja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1064/002
English: Cellulitis
Croatian: Celulitis
English: Eye disorders Uncommon
Croatian: Poremećaji oka Manje često
English: • Inject largest lesion(s) first.
Croatian: • Prvo injicirajte u najveće lezije.
English: > 0.5 cm to 1.5 cm up to 0.5 mL
Croatian: > 0,5 cm do 1,5 cm do 0,5 ml
English: Plasmacytoma has been reported in proximity to the injection site after administration of Imlygic.
Croatian: Nakon primjene lijeka Imlygic prijavljen je plazmocitom u blizini mjesta injiciranja.
English: Cardiac disorders Common
Croatian: Srčani poremećaji Često
English: Proportion Alive
Croatian: Udio preživjelih
English: > 1.5 cm to 2.5 cm up to 1 mL
Croatian: > 1,5 cm do 2,5 cm do 1 ml
English: o Information on IMLYGIC use in pregnancy o Instructions how to handle possible adverse events including providing of batch number when reporting adverse drug reactions
Croatian: o Odgovarajući način zbrinjavanja i dekontaminacije, u skladu s preporukama za zbrinjavanje biološkog otpada; o Informacije o primjeni lijeka IMLYGIC tijekom trudnoće; o Upute o tome kako zbrinjavati moguće nuspojave, uključujući davanje informacije o broju serije prilikom prijavljivanja nuspojava.
English: Imlygic 108 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state.
Croatian: Imlygic 108 jedinica formiranih plakova (PFU)/ml, otopina za injekciju Poluprozirna do neprozirna tekućina nakon otapanja iz zamrznutog stanja.
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Clear to semi-translucent liquid following thaw from its frozen state.
Croatian: Imlygic 106 jedinica formiranih plakova (PFU)/ml, otopina za injekciju Prozirna do poluprozirna tekućina nakon otapanja iz zamrznutog stanja.
English: The following side effects have been reported in patients receiving Imlygic:
Croatian: U bolesnika liječenih lijekom Imlygic prijavljene su sljedeće nuspojave:
English: Post-injection
Croatian: Nakon injiciranja
English: How Imlygic is given
Croatian: Kako primjenjivati Imlygic
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection
Croatian: Imlygic 106 jedinica formiranih plakova (PFU)/ml otopina za injekciju Imlygic 108 jedinica formiranih plakova (PFU)/ml otopina za injekciju
English: Incidence of adverse reactions are presented by system organ class and by frequency.
Croatian: Incidencija nuspojava prikazana je prema klasifikaciji organskih sustava i učestalosti.
English: Maximum storage time for thawed Imlygic in syringe
Croatian: Maksimalno vrijeme čuvanja odmrznutog lijeka Imlygic u štrcaljki
English: • Cough
Croatian: • Kašalj
English: General disorders and administration site conditions Very common Influenza like illness*, Pyrexia, Chills, Fatigue, Pain, Injection site reactions§
Croatian: Bolest nalik gripi*, pireksija, zimica, umor, bol, reakcije na mjestu injiciranja §
English: Subcutaneous lesions
Croatian: Potkožne lezije
English: The initial recommended dose is up to 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Croatian: Preporučena početna doza je do 4 ml lijeka Imlygic u koncentraciji od 106 (1 milijun) PFU/ml.
English: Treatment interval
Croatian: Intervali liječenja
English: The initial recommended dose is up to a maximum of 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Croatian: Preporučena početna doza je do najviše 4 ml lijeka Imlygic u koncentraciji od 106 (1 milijun) PFU/ml.
English: • Vomiting, diarrhoea, constipation, nausea
Croatian: Povraćanje, proljev, konstipacija, mučnina
English: Package leaflet: Information for the patient Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Croatian: Uputa o lijeku: Informacije za korisnika Imlygic 106 jedinica formiranih plakova (PFU)/ml otopina za injekciju Imlygic 108 jedinica formiranih plakova (PFU)/ml otopina za injekciju virus talimogene laherparepvec
English: • Trained HCPs and support personnel regarding safe and appropriate storage, handling, and administration of IMLYGIC, and clinical follow-up for patients treated with IMLYGIC;
Croatian: rukovanje i primjenu lijeka IMLYGIC i kliničko praćenje bolesnika liječenih lijekom
English: In clinical studies, immune-mediated events including as glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with Imlygic.
Croatian: U kliničkim ispitivanjima, u bolesnika liječenih lijekom Imlygic prijavljeni su imunološki posredovani događaji koji uključuju glomerulonefritis, vaskulitis, pneumonitis, pogoršanje psorijaze i vitiligo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 106 (1 million) plaque forming units (PFU) of talimogene laherparepvec.
Croatian: Jedna bočica sadrži 1 ml sa 1 x 106 (1 milijun) jedinica formiranih plakova (PFU, od engl. plaque forming units) virusa talimogene laherparepvec.
English: - If you get any side effects, talk to your healthcare professional.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg zdravstvenog radnika.
English: Figure 3.
Croatian: Slika 3
English: No effects on embryo-foetal development were observed when talimogene laherparepvec was administered during organogenesis to pregnant mice at doses up to 4 x 108 (400 million) PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Croatian: Kada je virus talimogene laherparepvec primjenjivan tijekom organogeneze u gravidnih ženki miševa u dozama od najviše 4 x 108 (400 milijuna) PFU/kg (na temelju PFU/kg, doza 60 puta viša u odnosu na maksimalnu kliničku dozu) nisu opaženi učinci na embrio-fetalni razvoj.
English: o Recommendation regarding the accidental transmission of IMLYGIC from patient to close contacts or HCPs: o Instruction on how to behave after administration/accidental transmission and how and how often the dressing has to be changed and who should not change the dressing; o Instructions to minimise the risk of exposure of blood and body fluids to close contacts for the duration of IMLYGIC treatment through 30 days after the last administration of IMLYGIC.
Croatian: • Vodič za bolesnika/njegovatelja i osobe u neposrednoj blizini će sadržavati sljedeće ključne poruke: o Opis važnih rizika povezanih s primjenom lijeka IMLYGIC; o Upute o tome kako se ponašati nakon primjene te kako i koliko često se mora mijenjati zavoj te tko ne smije mijenjati zavoj; o Informacije o znakovima i simptomima rizika od infekcije herpes virusom; o Informacije o primjeni lijeka IMLYGIC tijekom trudnoće; o Preporuke vezane uz slučajan prijenos lijeka IMLYGIC sa bolesnika na osobe u neposrednoj blizini ili zdravstvene radnike; o Upute za minimizaciju rizika od izlaganja krvi i tjelesnih tekućina osobama u neposrednoj blizini tijekom liječenja lijekom IMLYGIC i 30 dana nakon posljednje primjene lijeka IMLYGIC.
English: Subsequent doses will be up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Croatian: Sljedeće doze biti će do najviše 4 ml lijeka Imlygic u koncentraciji od 108 (100 milijuna) PFU/ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 108 (100 million) plaque forming units (PFU) of talimogene laherparepvec.
Croatian: Jedna bočica sadrži 1 ml sa 1 x 108 (100 milijuna) jedinica formiranih plakova (PFU, od engl. plaque forming units) virusa talimogene laherparepvec.
English: If you get any side effects, talk to your healthcare professional.
Croatian: Ako primijetite bilo koji od ovih simptoma, trebate obavijestiti svog zdravstvenog radnika.
English: Necrosis or ulceration of tumour tissue may occur following Imlygic treatment.
Croatian: Nakon liječenja lijekom Imlygic može se javiti nekroza ili ulceracija tumorskog tkiva.
English: Subsequent doses should be administered up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Croatian: Sljedeće doze trebaju iznositi do najviše 4 ml lijeka Imlygic u koncentraciji od 108 (100 milijuna) PFU/ml.
English: • Tumour pain, infected tumour
Croatian: • Bol u tumoru, infekcija u tumoru
English: How Imlygic is stored
Croatian: Kako čuvati Imlygic
English: • Incision site infection
Croatian: • Infekcija na mjestu reza