FrancophonIA/ELRC3.0 huggingface dataset:
English: Risk Factors for Hepatocellular injury Concomitant Valproate and Clobazam, Dose of cannabidiol and Baseline Transaminase Elevations
Croatian: Istovremeno uzimanje valproata i klobazama, doza kanabidiola i povišenja početnih vrijednosti transaminaza
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Placebo 10 mg/kg/day p=0.0332
Croatian: Placebo 10 mg/kg/dan p = 0,0332
English: In juvenile rats, administration of cannabidiol for 10 weeks (subcutaneous doses of 0 or 15 mg/kg on postnatal days [PNDs] 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on PNDs 7-77
Croatian: U mladih štakora, primjena kanabidiola tijekom 10 tjedana (supkutana doza od 0 ili 15 mg/kg u dane nakon poroda [engl. postnatal days, PND] 4-6 praćena oralnom primjenom 0, 100, 150 ili 250 mg/kg na dane nakon poroda 7-77, dovela je do porasta tjelesne težine, kasnijeg spolnog dozrijevanja mužjaka, neurološko-bihevioralnih učinaka, smanjene mineralne gustoće kostiju i vakuolizacije jetrenih hepatocita.
English: Greater improvements in overall condition, as measured by Global Impression of Change scores at the last visit, were reported by caregivers and patients with both doses of cannabidiol (76% on 10 mg/kg/day, 80% for each group on 20 mg/kg/day, 31% to 46% on placebo; p=0.0005 for 10 mg/kg/day and p<0.0001 and 0.0003 for 20 mg/kg/day vs. placebo).
Croatian: Veća poboljšanja u ukupnom stanju, mjereno rezultatima Globalnog dojma promjene na zadnjem posjetu, prijavljena su i od njegovatelja i bolesnika s obje doze kanabidiola (76% na 10 mg/kg/dan, 80% za svaku skupinu na 20 mg/kg/dan, 31% do 46% na placebu; p = 0,0005 za 10 mg/kg/dan i p< 0,0001 i 0,0003 za 20 mg/kg/dan u usporedbi s placebom).
English: In rats, the EFD study evaluated doses of 75, 150, or 250 mg/kg/day.
Croatian: Kod štakora je ispitivanje embriofetalnog razvoja procjenjivalo doze od 75, 150 ili 250 mg/kg/dan.
English: GWPCARE3 10 mg/kg/day p=0.0016
Croatian: GWPCARE3 10 mg/kg/dan p = 0,0016
English: Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Croatian: Podaci za podskupine s klobazamom predstavljeni su kao postotno smanjenje u odnosu na početnu vrijednost procijenjeno analizom negativne binomne regresije.
English: GWPCARE4 20 mg/kg/day p=0.0135
Croatian: GWPCARE4 20 mg/kg/dan p = 0,0135
English: Placebo 20 mg/kg/day p=0.0784
Croatian: Placebo 20 mg/kg/dan p = 0,0784
English: • If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
Croatian: • Ako je Vaša doza veća od 1 ml (100 mg), trebali biste upotrebljavati veću štrcaljku od 5 ml.
English: Increased seizure frequency
Croatian: Povećana učestalost napadaja
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Dose response
Croatian: Odgovor na dozu
English: In vitro assessment of interaction with UGT enzymes In vitro data suggest that cannabidiol is a reversible inhibitor of UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Croatian: In vitro podaci sugeriraju kako je kanabidiol reverzibilni inhibitor aktivnosti posredovane putem UGT1A9 i UGT2B7 u klinički značajnim koncentracijama.
English: Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Croatian: Kanabidiol je supstrat za CYP3A4, CYP2C19, UGT1A7, UGT1A9 i UGT2B7.
English: Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Croatian: Kanabidiol je supstrat za UGT1A7, UGT1A9 i UGT2B7.
English: The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Croatian: Izoforme UGT odgovorne za metabolizam kanabidiola faze II su UGT1A7, UGT1A9 i UGT2B7.
English: DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
Croatian: KONVULZIVNI NAPADAJI NA 28 DANA
English: Drug interaction studies
Croatian: Ispitivanja interakcija lijekova
English: In each trial, patients receiving cannabidiol experienced a greater median percentage reduction in total seizures compared with placebo (53% 10 mg/kg/day, 64% to 66% 20 mg/kg/day, 25% for each placebo group; p=0.0025 for 10 mg/kg/day and p<0.0001 for each 20 mg/kg/day group vs. placebo).
Croatian: U svakom od ispitivanja, bolesnici koji su dobivali kanabidiol imali su veći medijan postotka smanjenja ukupnih napadaja u usporedbi s placebom (53% 10 mg/kg/dan, 64% do 66% 20 mg/kg/dan, 25% za svaku skupinu na placebu; p = 0,0025 za 10 mg/kg/dan i p < 0,0001 za svaku skupinu od 20 mg/kg/dan u usporedbi s placebom).
English: If the calculated dose is 100 mg (1 ml) or less, the smaller 1 ml oral syringe should be used.
Croatian: Ako je izračunata doza 100 mg (1 ml) ili manje, treba upotrebljavati manju štrcaljku za usta od 1 ml.
English: How to take Epidyolex
Croatian: Kako uzimati Epidyolex
English: In each trial, patients receiving cannabidiol experienced a greater percentage reduction in total seizures compared with placebo (66% 10 mg/kg/day, 54% to 58% 20 mg/kg/day, 27% to 41% placebo; p=0.0003 for 10 mg/kg/day and p=0.0341 and 0.0211 for 20 mg/kg/day vs. placebo).
Croatian: U svakom od ispitivanja, bolesnici koji su dobivali kanabidiol imali su veće postotno smanjenje ukupnih napadaja u usporedbi s placebom (66% 10 mg/kg/dan, 54% do 58% 20 mg/kg/dan, 27% do 41% na placebu; p = 0,0003 za 10 mg/kg/dan i p = 0,0341 i 0,0211 za 20 mg/kg/dan u usporedbi s placebom).
English: p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Croatian: Postotak bolesnika s ≥ 50% odgovorom, p-vrijednostd GWPCARE3 Placebo
English: b For study GWPCARE1, overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for study GWPCARE2 and the with clobazam subgroup are estimated from a negative binomial regression analysis.
Croatian: b Za ispitivanje GWPCARE1 ukupni podaci prikazani su kao procijenjeni medijan razlike i p-vrijednost iz Wilcoxonovog testa sume rangova.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: • A plastic bag containing two 5 ml oral syringes and a bottle adaptor A spare syringe of each size is provided in the pack in case the first one is damaged or lost.
Croatian: U pakiranju se nalazi rezervna štrcaljka od svake veličine, za slučaj da se prva ošteti ili izgubi.
English: Haematologic abnormalities
Croatian: Hematološke abnormalnosti
English: If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Croatian: Ako je izračunata doza veća od 100 mg (1 ml), treba upotrebljavati veću štrcaljku za usta od 5 ml.
English: - The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol)
Croatian: - Ostali sastojci su rafinirano sezamovo ulje, bezvodni etanol, sukraloza i okus jagode
English: CONVULSIVE SEIZURES PER 28 DAYS Percentage Reduction from Baselinea GWPCARE2
Croatian: Postotno smanjenje u odnosu na Početaka GWPCARE2
English: Dose adjustment or discontinuation of valproate or dose adjustment of clobazam should be considered if transaminase elevations occur.
Croatian: U slučaju povišenja transaminaza, treba razmisliti o prilagodbi doze ili prekidu uzimanja valproata ili prilagodbi doze klobazama.
English: A NOAEL of 15 mg/kg/day was established.
Croatian: Utvrđena je razina bez uočenih štetnih učinaka (NOAEL) od 15 mg/kg/dan.
English: Moderate 1.25 mg/kg twice daily (2.5 mg/kg/day)
Croatian: Umjereno 1,25 mg/kg dvaput dnevno (2,5 mg/kg/dan)
English: Monitoring
Croatian: Praćenje
English: Very common Decreased appetite Common
Croatian: Smanjeni apetit
English: Very common Pyrexia, Fatigue
Croatian: Pireksija, umor
English: Based on a healthy volunteer study, elevated levels (3- to 4-fold) of N-desmethylclobazam (an active metabolite of clobazam) can occur when combined with cannabidiol, likely mediated by CYP2C19 inhibition.
Croatian: N-desmetilklobazama (aktivni metabolit klobazama) kad se kombinira s kanabidiolom, što je vjerojatno posredovano inhibicijom CYP2C19.
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in convulsive seizure frequency during the treatment period in each trial (36% 10 mg/kg/day cannabidiol, 25% for each 20 mg/kg/day cannabidiol group, 10% to 13% placebo).
Croatian: Dodatne sekundarne mjere ishoda u podskupinama bolesnika istovremeno liječenih klobazamom Kanabidiol je povezan s povećanjem postotka ispitanika koji su doživjeli smanjenje učestalosti konvulzivnih napadaja do 75% ili više u razdoblju liječenja tijekom oba ispitivanja (36% 10 mg/kg/dan kanabidiola, 25% za svaku skupinu na kanabidiolu od 20 mg/kg/dan, 10% do 13% na placebu).
English: b Overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for the with clobazam subgroup are estimated from a negative binomial regression analysis.
Croatian: b Ukupni podaci su prikazani kao procijenjeni medijan razlike i p-vrijednost iz Wilcoxonovog testa sume rangova.
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in drop seizure frequency during the treatment period in each trial (11% 10 mg/kg/day cannabidiol, 31% to 36% 20 mg/kg/day cannabidiol, 3% to 7% placebo).
Croatian: Dodatne sekundarne mjere ishoda u podskupinama bolesnika istovremeno liječenih klobazamom Kanabidiol je povezan s povećanjem postotka ispitanika koji su doživjeli smanjenje učestalosti astatskih napadaja do 75% ili više u razdoblju liječenja tijekom oba ispitivanja (11% 10 mg/kg/dan kanabidiola, 31% do 36% 20 mg/kg/dan kanabidiola, 3% do 7% na placebu).
English: 1 mg/kg twice daily (2 mg/kg/day)
Croatian: 1 mg/kg dvaput dnevno (2 mg/kg/dan)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral solution contains 100 mg cannabidiol
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml oralne otopine sadrži 100 mg kanabidiola.
English: Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap anti-clockwise.
Croatian: Skinite zatvarač siguran za djecu s bočice tako da pritisnete zatvarač dok ga okrećete u smjeru suprotnom od kretanja kazaljki na satu.
English: 20 mg/kg/day p=0.0123
Croatian: 20 mg/kg/dan p = 0,0123
English: 20 mg/kg/day p=0.0299
Croatian: 20 mg/kg/dan p = 0,0299
English: 5 mg/kg twice daily (10 mg/kg/day)
Croatian: 5 mg/kg dvaput dnevno (10 mg/kg/dan)
English: Each ml of solution contains:
Croatian: Pomoćne tvari s poznatim učinkom Jedan ml otopine sadrži:
English: Excretion
Croatian: Izlučivanje
English: 10 mg/kg/day p=0.0030
Croatian: 10 mg/kg/dan p = 0,0030
English: 10 mg/kg/day p=0.0095
Croatian: 10 mg/kg/dan p = 0,0095
English: p=0.0032c ≥ 50% REDUCTION IN CONVULSIVE SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE2
Croatian: p = 0,0032c ≥ 50% SMANJENJE KONVULZIVNIH
English: How to store Epidyolex
Croatian: Kako čuvati Epidyolex
English: a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
Croatian: CI = 95% interval pouzdanosti a Za ispitivanje GWPCARE1 ukupni podaci prikazani su kao medijan postotnog smanjenja u odnosu na početak.
English: 0.5 mg/kg twice daily (1 mg/kg/day)
Croatian: 0,5 mg/kg dvaput dnevno (1 mg/kg/dan)
English: CI=95% confidence interval.
Croatian: CI = 95% interval pouzdanosti a Podaci za ukupnu populaciju prikazani su kao medijan postotnog smanjenja u odnosu na početnu vrijednost.
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Croatian: Epidyolex 100 mg/ml oralna otopina kanabidiol
English: 20 mg/kg/day p=0.0069
Croatian: 20 mg/kg/dan p = 0,0069
English: Cough
Croatian: Kašalj
English: 20 mg/kg/day p=0.0047
Croatian: 20 mg/kg/dan p = 0,0047
English: Concomitant AED treatments
Croatian: Istovremeno primijenjeni antiepileptik
English: 20 mg/kg/day p=0.0006
Croatian: 20 mg/kg/dan p = 0,0006
English: Very common Diarrhoea, Vomiting
Croatian: Proljev, povraćanje
English: PHARMACEUTICAL FORM Oral solution
Croatian: OBLIK Oralna otopina
English: Abuse
Croatian: Zlouporaba
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution
Croatian: OBLIK I SADRŽAJ
English: Two 5 ml oral syringes with bottle adaptor
Croatian: Dvije štrcaljke za usta od 1 ml s adapterom za bočicu Dvije štrcaljke za usta od 5 ml s adapterom za bočicu
English: listed in Appendix V.
Croatian: PRILOG III.
English: 2.5 mg/kg twice daily (5 mg/kg/day)
Croatian: 2,5 mg/kg dvaput dnevno (5 mg/kg/dan)
English: Severe
Croatian: Teško
English: Instructions for the oral use of Epidyolex
Croatian: Upute za primjenu Epidyolexa kroz usta
English: Drug interaction studies with AEDs
Croatian: In vitro procjena interakcije s UGT enzimima
English: If you or your patient stop taking Epidyolex
Croatian: Ako Vi ili bolesnik uzmete više Epidyolexa nego što ste trebali
English: Renal impairment
Croatian: Oralna otopina
English: Discontinuation
Croatian: Prekid primjene
English: 2 mg/kg twice daily (4 mg/kg/day)* *Higher doses of cannabidiol may be considered in patients with severe hepatic impairment where the potential benefits outweigh the risks.
Croatian: * Veće se doze kanabidiola mogu razmotriti u bolesnika s teškim oštećenjem funkcije jetre kad moguće koristi nadilaze rizike.
English: Open-label data
Croatian: Podaci iz ispitivanja otvorenog tipa
English: What Epidyolex contains - The active substance is cannabidiol.
Croatian: - Djelatna tvar je kanabidiol.
English: • or are planning to have a baby.
Croatian: • ili planirate imati dijete.
English: • think you may be pregnant
Croatian: • mislite da biste mogli biti trudni
English: 1 week (7 days)
Croatian: 1 tjedan (7 dana)
English: 30th June, 2021
Croatian: 30. lipnja 2021.
English: Continue until the full dose is evenly and completely dispersed.
Croatian: Nastavite dok se cijela doza ravnomjerno i potpuno ne raspodijeli.
English: Your second injection will be given 3 weeks after the first injection.
Croatian: Druga injekcija bit će Vam primijenjena 3 tjedna nakon prve injekcije.
English: Lesion size (longest dimension)
Croatian: Veličina lezije (najduža dimenzija)
English: o Instruction on how to behave after accidental transmission.
Croatian: o Upute o tome kako se ponašati nakon slučajnog izlaganja.
English: Previous systemic treatment for melanoma was allowed but not required.
Croatian: Prethodno sustavno liječenje melanoma je bilo dozvoljeno, ali ne neophodno.
English: Study 005/05
Croatian: Ispitivanje 005/05
English: Reproductive and development toxicity
Croatian: Reproduktivna i razvojna toksičnost
English: Overall response rate (% CR, % PR)
Croatian: Učestalost sveukupnog odgovora (% CR, % PR)
English: Time to response (median)
Croatian: Vrijeme do odgovora (medijan)
English: Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Croatian: Sveukupno, devedeset osam posto (98%) od tih prijavljenih nuspojava bile su blage ili umjerene po ozbiljnosti.
English: Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
Croatian: Imlygic također djeluje tako da pomaže Vašem imunološkom sustavu prepoznati i uništiti tumore u cijelom Vašem tijelu.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: U nedostatku ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: • Imlygic must not be refrozen once it has thawed.
Croatian: • Imlygic se ne smije ponovo zamrzavati jednom kada se odmrzne.
English: All subsequent treatment visits (including reinitiation)
Croatian: Svi sljedeći posjeti (uključujući ponovno uvođenje liječenja)
English: Autoimmune reactions
Croatian: Autoimune reakcije
English: No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Croatian: Nije opažena razlika u sigurnosti ili djelotvornosti između starijih (u dobi od ≥ 65 godina) i mlađih odraslih bolesnika.
English: Cover any exposed wounds before administering.
Croatian: Pokrijte sve izložene rane prije primjene.
English: This medicine contains genetically modified organisms.
Croatian: Ovaj lijek sadrži genetski modificirane organizme.
English: 2 weeks after previous treatment
Croatian: 2 tjedna nakon prethodnog liječenja
English: Talk to your healthcare professional about suitable methods of contraception.
Croatian: Razgovarajte sa svojim zdravstvenim radnikom o odgovarajućim metodama kontracepcije.
English: Number of Patients at Risk
Croatian: Broj bolesnika pod rizikom
English: Women of childbearing potential/contraception
Croatian: Žene reproduktivnog potencijala/kontracepcija
English: - If you have any further questions, ask your healthcare professional (doctor or nurse).
Croatian: - Ako imate dodatnih pitanja, obratite se svom zdravstvenom radniku (liječniku ili medicinskoj sestri).
English: All patients
Croatian: Svi bolesnici
English: Granulomatous dermatitis
Croatian: Granulomatozni dermatitis
English: These symptoms generally resolve within the first 72 hours after treatment.
Croatian: Ovi simptomi obično nestaju unutar prvih 72 sata nakon primjene lijeka.
English: Number of Subjects at Risk:
Croatian: Broj ispitanika izloženih riziku:
English: Do NOT shake.
Croatian: NE tresite.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC
English: Imlygic may harm your unborn baby.
Croatian: Imlygic može naštetiti Vašem nerođenom djetetu.
English: The educational programme is aimed to inform about important risks associated with IMLYGIC:
Croatian: Cilj edukacijskog programa je informirati o važnim rizicima povezanima s lijekom IMLYGIC:
English: Imlygic may cause autoimmune reactions (an over-reaction of the body's immune system).
Croatian: Imlygic može uzrokovati autoimune reakcije (pretjerana reakcija imunološkog sustava tijela).
English: It may contain white, visible, variously shaped, virus-containing particles.
Croatian: Može sadržavati bijele, vidljive, različito oblikovane čestice koje sadrže virus.
English: What Imlygic is and what it is used for
Croatian: Što je Imlygic i za što se koristi
English: Cellulitis and systemic bacterial infection have been reported.
Croatian: Prijavljeni su celulitis i sustavna bakterijska infekcija.
English: Avoid contact with skin, eyes or mucous membranes.
Croatian: Izbjegavajte kontakt s kožom, očima ili membranama sluznice.
English: Metabolism/elimination
Croatian: Metabolizam/eliminacija
English: • Low red blood cell numbers (anaemia)
Croatian: • Nizak broj crvenih krvnih stanica (anemija)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Croatian: Datum prvog odobrenja: 16. prosinca 2015.
English: Keeping wounds clean and dressed can help prevent these types of infections.
Croatian: Održavanje rana čistima i pokrivenima zavojima može spriječiti ovakve vrste infekcija.
English: The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Croatian: Medijan trajanja izloženosti lijeku Imlygic bio je 23 tjedna (5,3 mjeseca).
English: Previously treated patients
Croatian: Prethodno liječeni bolesnici
English: Exploratory subgroups
Croatian: Eksploratorne podskupine
English: Twenty six (26) patients were exposed to Imlygic for at least one year.
Croatian: Dvadeset šest (26) bolesnika bilo je izloženo lijeku Imlygic najmanje jednu godinu.
English: Time to treatment failure (median)
Croatian: Vrijeme do neuspjeha liječenja (medijan)
English: Your healthcare professional will determine if Imlygic is right for you.
Croatian: Vaš će zdravstveni radnik odlučiti je li Imlygic pogodan za Vas.
English: up to 25°C
Croatian: Do 25°C
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.
Croatian: Zbog eksploratorne prirode analize i na temelju trenutnih dokaza, nije ustanovljeno da je lijek Imlygic povezan s učinkom na sveukupno preživljenje.
English: • Allergic reaction (hypersensitivity)
Croatian: • Alergijska reakcija (preosjetljivost)
English: Censor indicated by Vertical Bar I.
Croatian: Cenzor indiciran vertikalnom linijom I.
English: Redirect the needle as many times as necessary while injecting the remainder of the dose of Imlygic.
Croatian: Preusmjerite iglu koliko god je puta potrebno dok injicirate ostatak doze lijeka Imlygic.
English: Imlygic contains sodium and sorbitol
Croatian: Imlygic sadrži natrij i sorbitol
English: If you miss an appointment, ask your healthcare professional when to schedule your next dose.
Croatian: Ako propustite termin, pitajte svojeg zdravstvenog radnika kada da zakažete sljedeću dozu.
English: § American Joint Committee on Cancer (AJCC) staging 6th edition.
Croatian: § Stupanj prema AJCC (American Joint Committee on Cancer) klasifikaciji, 6. izdanje.
English: The following requirements need to be fulfilled before the product is dispensed:
Croatian: Sljedeći zahtjevi se moraju ispuniti prije puštanja lijeka u promet:
English: If the dressing comes loose or falls off, replace it immediately with a clean dressing.
Croatian: Ako se zavoj olabavi ili padne, odmah ga zamijenite čistim zavojem.
English: Imlygic is not recommended for children and adolescents since the effects of Imlygic in people younger than 18 years old are not known.
Croatian: Primjena lijeka Imlygic se ne preporučuje u djece i adolescenata, s obzirom da učinci lijeka Imlygic u osoba mlađih od 18 godina nisu poznati.
English: This leads to destruction of infected tumour cells.
Croatian: To dovodi do uništavanja inficiranih tumorskih stanica.
English: Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Croatian: Obavijestite svog zdravstvenog radnika ako imate povijest raka krvi uključujući multipli mijelom.
English: Patients with detectable DNA during treatment (n = 60)
Croatian: Bolesnici s detektabilnom razinom DNK tijekom liječenja (n = 60)
English: 2°C to 8°C
Croatian: 2°C do 8°C
English: Patients experiencing a response at 12 months of treatment could continue treatment for up to an additional 6 months.
Croatian: Bolesnici u kojih je postignut odgovor nakon 12 mjeseci liječenja, mogli su nastaviti liječenje do dodatnih 6 mjeseci.
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.
Croatian: Cilj programa kontrolirane distribucije je upravljati lancem opskrbe lijekom kako bi se osiguralo ispunjavanje zahtjeva za čuvanjem u hladnim uvjetima i distribucija lijeka IMLYGIC kvalificiranim centrima i do bolesnika.
English: 5 (19%)a aFor the anogenital area, 26 patients were tested for Imlygic DNA.
Croatian: 5 (19%)a a Za anogenitalno područje, 26 bolesnika testirano je za DNK lijeka Imlygic.
English: In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
Croatian: U pivotalnom kliničkom ispitivanju (ispitivanje 005/05), zabilježeni su događaji celulitisa od kojih su neki bili smatrani ozbiljnim nuspojavama.
English: • Provide specified safety information to patients and communicate to patients the importance for sharing this information with family and caregivers;
Croatian: • Dostavljanje specificiranih sigurnosnih informacija bolesnicima i informiranje bolesnika o važnosti prosljeđivanja tih informacija obitelji i njegovateljima;