FrancophonIA/ELRC3.0 huggingface dataset:
English: No neuropathology or adverse neurological effects were observed.
Croatian: Nisu opaženi neuropatološki ili neurološki neželjeni učinci.
English: If you have these signs, you should follow standard hygiene practices to prevent viral transmission to others.
Croatian: Ako imate ove znakove, trebate slijediti uobičajenu higijensku praksu kako biste spriječili prijenos virusa na druge.
English: Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Croatian: Uzorci krvi i urina prikupljeni su tijekom liječenja i do 30 dana nakon završetka liječenja.
English: Pregnant women, neonates, and immunocompromised individuals should not be exposed to potentially contaminated materials.
Croatian: Trudnice, novorođenčad i imunokompromitirane osobe ne smiju se izlagati potencijalno kontaminiranim materijalima.
English: What Imlygic looks like and contents of the pack
Croatian: Kako Imlygic izgleda i sadržaj pakiranja
English: After that, you will receive injections every 2 weeks for as long as you have the tumour(s).
Croatian: Nakon toga, injekcije će se u Vas primjenjivati svaka 2 tjedna sve dok imate tumor/e.
English: • Repeat these steps for other lesions that need to be injected.
Croatian: • Ponovite ove korake na svim ostalim lezijama koje je potrebno injicirati.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100).
English: • Wear gloves while changing your dressing.
Croatian: • Nose rukavice kada Vam mijenjaju zavoje.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,5% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: 4.1 months
Croatian: 4,1 mjeseca
English: Follow local institutional guidelines for handling and administration, personal protective equipment, accidental spills, and waste disposal.
Croatian: Pratite smjernice lokalnih institucija za rukovanje i primjenu, osobnu zaštitnu opremu, slučajna izlijevanja i odlaganje otpada.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been conducted with Imlygic.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija za lijek Imlygic.
English: The majority of patients, 98%, were caucasian.
Croatian: Većina bolesnika, 98%, su bili bijele rase.
English: Cellulitis*, Oral herpes
Croatian: Celulitis*, Oralni herpes
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 2.1 Opći opis
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.
Croatian: Srednja dob bila je 63 (raspon: 22 do 94) godine; 26,5% bilo je starije od 65 godina i 23,3% bilo je starije od 74 godine.
English: Multiple insertion points may be used if a lesion is larger than the radial reach of the needle.
Croatian: Višestruka mjesta injiciranja se mogu koristiti ako je lezija veća od radijalnog dosega igle.
English: The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
Croatian: Najčešća nuspojava 3. ili višeg stupnja bio je celulitits (2,1%) (vidjeti dio 4.4).
English: Transplacental metastases of malignant melanoma can occur.
Croatian: Mogu se pojaviti transplacentalne metastaze malignog melanoma.
English: 3.7 months
Croatian: 3,7 mjeseci
English: Imlygic has not been studied in immunocompromised patients.
Croatian: Imlygic nije ispitivan u imunokompromitiranih bolesnika.
English: Among the Imlygic-treated responders, 56 (72%) responses were still ongoing at the time of primary analysis.
Croatian: Među bolesnicima koji su odgovorili na liječenje lijekom Imlygic, 56 (72%) odgovora su i dalje trajali u trenutku primarne analize.
English: Apply the dressing as instructed by your healthcare professional.
Croatian: Stavljajte zavoj onako kako Vas je uputio Vaš zdravstveni radnik.
English: Use caution when driving or operating machinery until you are certain that Imlygic does not adversely affect you.
Croatian: Budite oprezni prilikom upravljanja vozilima ili strojevima, sve dok ne budete sigurni da Imlygic ne utječe negativno na Vas.
English: To get Imlygic from HSV-1, the virus has been changed so that it multiplies more effectively in tumours than in normal cells.
Croatian: Kako bi se iz HSV-1 dobio Imlygic, virus je promijenjen tako da se učinkovitije razmnožava u tumorima nego u normalnim stanicama.
English: Accidental spread of Imlygic to yourself and others
Croatian: Slučajno širenje lijeka Imlygic na Vas i druge
English: Inform your healthcare professional if you have a history of autoimmune disease.
Croatian: Obavijestite svog zdravstvenog radnika ako imate povijest autoimune bolesti.
English: Keep used dressings and cleaning materials away from newborns.
Croatian: Držite iskorištene zavoje i materijale za čišćenje dalje od novorođenčadi.
English: Use a new needle anytime the needle is completely removed from a lesion and each time a different lesion is injected.
Croatian: Koristite novu iglu svaki put kada se igla potpuno ukloni iz lezije i svaki put kada se injicira u drugu leziju.
English: Efficacy data for Imlygic in the current second or later line treatment settings are limited.
Croatian: Podaci o djelotvornosti lijeka Imlygic u trenutnim okolnostima druge ili kasnije linije liječenja su ograničeni.
English: Vitiligo, Rash, Dermatitis
Croatian: Vitiligo, osip, dermatitis
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.
Croatian: Dok pivotalno ispitivanje nije bilo namijenjeno za procjenu djelotvornosti u ovim pojedinim podskupinama, bolesnici bez visceralne bolesti imali su veću korist od liječenja lijekom Imlygic od onih čija je bolest bila više uznapredovala.
English: Ask your healthcare professional for advice if you:
Croatian: Obratite se svom zdravstvenom radniku za savjet ako:
English: Treatment with talimogene laherparepvec should be initiated and supervised by a qualified physician experienced in the treatment of cancer.
Croatian: Liječenje virusom talimogene laherparepvec treba započeti i nadzirati kvalificirani liječnik s iskustvom u liječenju raka.
English: Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
Croatian: Preporučuju se pažljiva njega rane i mjere predostrožnosti za infekcije, naročito ako nekroza tkiva rezultira otvorenim ranama.
English: You should tell your close contacts to:
Croatian: Svojim osobama u neposrednoj blizini morate reći da:
English: Duration of response (ongoing response at last tumour evaluation)
Croatian: Trajanje odgovora (odgovor koji je trajao pri zadnjoj procjeni tumora)
English: No adjustment of the dose is required in patients ≥ 65 years old (see section 5.1).
Croatian: Nije potrebna prilagodba doze u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.1).
English: This may impair your ability to drive or operate machinery.
Croatian: To može umanjiti Vašu sposobnost upravljanja vozilima ili strojevima.
English: If healthcare professionals are accidentally exposed to Imlygic, see sections 4.4 and 6.6.
Croatian: Ako se zdravstveni radnici slučajno izlože lijeku Imlygic, vidjeti dijelove 4.4. i 6.6.
English: 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).
Croatian: Nakon 6 mjeseci liječenja, bolesnici su trebali nastaviti s liječenjem sve do klinički relevantne progresije bolesti (tj. progresija bolesti povezana sa smanjenjem izvedbenog statusa i/ili je ispitivač smatrao da je potrebno alternativno liječenje).
English: Imlygic treatment may be reinitiated if new lesions appear following a complete response and the physician considers that the patient will benefit from treatment.
Croatian: Liječenje lijekom Imlygic može se ponovo započeti ako se pojave nove lezije nakon postizanja potpunog odgovora te ako liječnik smatra da će bolesnik imati koristi od liječenja.
English: However, none lead to permanent discontinuation of Imlygic treatment.
Croatian: Međutim, ni jedan nije doveo do trajnog prekida liječenja lijekom Imylgic.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Months
Croatian: Mjeseci
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L01XX51.
Croatian: Farmakoterapijska skupina: Antineoplastici i imunomodulatori, ATK oznaka: L01XX51.
English: • Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.
Croatian: • Prednost injiciranja ostalih lezija odredite na temelju veličine dok se ne dostigne maksimalan volumen injiciranja.
English: • Combination with other therapies like chemotherapy or immunosuppressive agents
Croatian: • Kombinacija s drugim terapijama poput kemoterapije ili imunosupresiva
English: Not reached (Range: > 0.0 to > 16.8 months)
Croatian: Nije postignut (Raspon: > 0,0 do > 16,8 mjeseci)
English: Immune-mediated events†*
Croatian: Imunološki posredovani događaji†*
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
Croatian: PRILOG II. A. PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
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.
Croatian: Obavijestite svog zdravstvenog radnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove, uključujući i lijekove, kao što je aciklovir, koji se primjenjuju za liječenje ili prevenciju infekcije herpes virusom.
English: Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Croatian: Također su provedene i eksploratorne analize DRR-a i sveukupnog preživljenja u podskupinama svih stupnjeva bolesti (vidjeti sliku 5 i tablicu 5).
English: Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
Croatian: Nađene su zanemarive količine (< 0,001% od razine u majčinskoj krvi) DNK virusa talimogene laherparepvec u krvi fetusa.
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.
Croatian: Ovi su događaji češće prijavljivani u periodu prvih 6 liječenja, naročito u bolesnika koji su na početku liječenja bili negativni na HSV-1.
English: You can expect to be treated with Imlygic for at least 6 months or longer.
Croatian: Možete očekivati da će Vaše liječenje lijekom Imlygic trajati najmanje 6 mjeseci ili duže.
English: The MAH shall ensure that in each Member State where IMLYGIC is marketed, a system aimed to control distribution to IMLYGIC beyond the level of control ensured by routine risk minimisation measures.
Croatian: Nositelj odobrenja će osigurati da je u svakoj državi članici u kojoj je lijek IMLYGIC u prometu uspostavljen sustav s ciljem kontrole distribucije lijeka IMLYGIC iznad razine kontrole koju osiguravaju rutinske mjere minimizacije rizika.
English: Talimogene laherparepvec may have a minor influence on the ability to drive and use machines.
Croatian: Virus talimogene laherparepvec može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: 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.
Croatian: Ako nikada u prošlosti niste imali infekciju herpes virusom, može biti vjerojatnije da ćete dobiti vrućicu, zimicu i bolesti nalik gripi unutar perioda prvih 6 liječenja lijekom Imlygic.
English: The difference in DRR between Imlygic and GM-CSF in the ITT population was statistically significant (see table 4) in favour of Imlygic.
Croatian: Razlika DRR-a između lijeka Imlygic i GM-CSF-a u ITT populaciji bila je statistički značajna (vidjeti tablicu 4) u korist lijeka Imlygic.
English: • Apply pressure to the injection site with a sterile gauze for at least 30 seconds.
Croatian: • Sterilnom gazom pritisnite na mjestu injiciranja tijekom najmanje 30 sekundi.
English: Censor indicated by vertical bar ׀ NE = not estimable
Croatian: Cenzor indiciran vertikalnom linijom ׀ NP = nije procjenjivo
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Croatian: Treba uzeti u obzir aditivni učinak istodobno primijenjenih lijekova koji sadrže sorbitol (ili fruktozu) te unos sorbitola (ili fruktoze) prehranom.
English: Maximum total injection volume
Croatian: Maksimalni ukupni volumen injiciranja
English: Accidental exposure
Croatian: Slučajna izloženost
English: However, available data for talimogene laherparepvec and wild-type HSV-1 do not indicate a carcinogenic risk in humans.
Croatian: Međutim, dostupni podaci za virus talimogene laherparepvec i divlji tip virusa HSV-1 ne ukazuju na kancerogeni rizik u ljudi.
English: The safety and efficacy of Imlygic in paediatric patients has not been established.
Croatian: Sigurnost i djelotvornost lijeka Imlygic u pedijatrijskih bolesnika nisu još ustanovljene.
English: • Patients with a history of hypersensitivity to talimogene laherparepvec or any of its excipients.
Croatian: • Bolesnici s povijesti preosjetljivosti na virus talimogene laherparepvec ili bilo koju od njegovih pomoćnih tvari.
English: In the 60 patients treated, data indicate that talimogene laherparepvec DNA was present in all sites during the study (see table 6).
Croatian: U 60 liječenih bolesnika, podaci ukazuju da je DNK virusa talimogene laherparepvec bila prisutna na svim mjestima tijekom ispitivanja (vidjeti tablicu 6).
English: • Determine injection volume for each lesion using table 2 above.
Croatian: • Odredite volumen injiciranja za svaku leziju koristeći Tablicu 2 navedenu gore.
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.
Croatian: Sveukupno, 58% svih bolesnika uključenih u ispitivanje bili su na početku liječenja seropozitivni na divlji tip HSV-1, dok su njih 32,6% bili seronegativni; HSV-1 serostatus ostalih 9,4% bio je nepoznat.
English: Immunocompromised patients
Croatian: Imunokompromitirani bolesnici
English: Other medicines and Imlygic
Croatian: Drugi lijekovi i Imlygic
English: Kaplan-Meier Percent Alive
Croatian: Kaplan-Meierov postotak preživjelih
English: Body fluid/site
Croatian: Tjelesna tekućina/mjesto
English: The injection site may take longer to heal than normal.
Croatian: Zacjeljivanje mjesta injiciranja može trajati duže nego što je to uobičajeno.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Imlygic za melanom u jednoj ili više podskupina pedijatrijske populacije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients with weakened immune systems
Croatian: Bolesnici s oslabljenim imunološkim sustavom
English: Difficulty breathing
Croatian: Otežano disanje
English: 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.
Croatian: Infektivni virus talimogene laherparepvec detektiran je na mjestu injiciranja kod 7 (11%) bolesnika u više vremenskih točaka u ispitivanju; nijedan uzorak nije bio pozitivan na infektivnost virusa nakon 2. ciklusa ili nakon završetka liječenja.
English: Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission.
Croatian: Bolesnike koji razviju infekcije herpes virusom se mora savjetovati da slijede standardnu higijensku praksu kako bi se spriječio prijenos virusa.
English: Male patients comprised 57% of study population and 70% of patients were baseline ECOG 0 performance status.
Croatian: Muški bolesnici činili su 57% ispitivane populacije, a u 70% bolesnika je ECOG izvedbeni status na početku liječenja iznosio 0.
English: Biodistribution (within the body) and viral shedding (excretion/secretion)
Croatian: Biodistribucija (u tijelu) i izlučivanje virusa (ekskrecija/sekrecija)
English: Deletion of ICP47 prevents downregulation of antigen presentation molecules and increases the expression of HSV US11 gene, thereby enhancing viral replication in tumour cells.
Croatian: Delecija ICP47 sprječava smanjenje broja molekula koje prezentiraju antigen i povećava ekspresiju HSV US11 gena, čime se pojačava replikacija virusa u tumorskim stanicama.
English: Imlygic can be spread to other parts of your body or to other people through direct contact with your body fluids or injection sites.
Croatian: Imlygic se može prenijeti na druge dijelove Vašeg tijela ili na druge osobe preko izravnog kontakta s Vašim tjelesnim tekućinama ili mjestima injiciranja.
English: 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.
Croatian: Prije puštanja lijeka IMLYGIC u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet i nacionalno nadležno tijelo moraju se složiti o sadržaju i obliku edukacijskog programa i programa kontrolirane distribucije, uključujući komunikacijske medije, načine distribucije i sve druge aspekte programa.
English: Although it is not known if Imlygic could be transmitted through sexual contact, it is known that wildtype HSV-1 can be transmitted through sexual contact.
Croatian: Iako nije poznato može li se Imlygic prenijeti seksualnim kontaktom, poznato je da se divlji tip virusa HSV-1 može prenijeti seksualnim kontaktom.
English: 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.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: Close contacts who are pregnant or who have a weakened immune system, and newborns
Croatian: Osobe u neposrednoj blizini koji su trudnice ili imaju oslabljen imunološki sustav i novorođenčad
English: • Areas of skin without any colour (vitiligo), rash, inflamed skin (dermatitis)
Croatian: • Područja kože bez ikakve boje (vitiligo), osip, upaljena koža (dermatitis)
English: Clinical biodistribution, elimination, and shedding
Croatian: Klinička biodistribucija, eliminacija i izlučivanje
English: Mice that had complete regression of theirprimary tumours following treatment were resistant to subsequent tumour rechallenge.
Croatian: Miševi u kojima je došlo do potpune regresije primarnih tumora, nakon liječenja su bili otporni na naknadno induciranje istih tumora (engl. tumour rechallenge).
English: Injectable anaesthetic may be injected around the periphery of the lesion but should not be injected directly into the lesion.
Croatian: Injekcijski anestetik može se injicirati u okolno područje lezije, ali se ne smije injicirati izravno u leziju.
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.
Croatian: Primarni ishod je bio učestalost održivog odgovora (engl. durable response rate (DRR)) [definirana kao postotak bolesnika s potpunim odgovorom (CR, od engl. complete response) ili djelomičnim odgovorom (PR, od engl. partial response) održanim kontinuirano kroz najmanje 6 mjeseci] po slijepoj centralnoj procjeni.
English: 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.
Croatian: Bolesnike također treba savjetovati da izbjegavaju dodirivanje ili grebanje mjesta injiciranja jer to može dovesti do nehotičnog prijenosa lijeka Imlygic na ostale dijelove tijela ili na osobe u njihovoj neposrednoj blizini.
English: • Wear protective gown or laboratory coat, safety glasses, or face shield and gloves while preparing or administering Imlygic.
Croatian: • Nosite zaštitni ogrtač ili laboratorijsku kutu, sigurnosne naočale ili štitnik za lice i rukavice tijekom pripreme i primjene lijeka Imlygic.
English: Pyrexia, chills, and influenza like illness, which can occur any time during Imlygic treatment, generally resolved within 72 hours.
Croatian: Pireksija, zimica te bolest nalik gripi, koji se mogu pojaviti u bilo kojem trenutku liječenja lijekom Imlygic, obično su se razriješili unutar 72 sata.
English: The mean (SD) treatment duration for the intent-to-treat (ITT) population was 15.76 weeks (15.79) in the GM-CSF arm and 26.83 weeks (18.39) in the Imlygic arm.
Croatian: Srednja vrijednost (SD) trajanja liječenja za populaciju s namjerom liječenja (ITT, od engl. intent to treat) iznosila je 15,76 tjedana (15,79) u GM-CSF skupini i 26,83 tjedana (18,39) u Imlygic skupini.
English: As a precautionary measure, it is preferable to avoid the use of talimogene laherparepvec during pregnancy.
Croatian: Kao mjeru predostrožnosti, poželjno je izbjegavati primjenu virusa talimogene laherparepvec tijekom trudnoće.
English: The safety of Imlygic was evaluated in the pivotal study where 292 patients received at least 1 dose of Imlygic (see section 5.1).
Croatian: Sigurnost lijeka Imlygic procijenjena je u pivotalnom ispitivanju u kojem su 292 bolesnika primila najmanje 1 dozu lijeka Imlygic (vidjeti dio 5.1).
English: What Imlygic contains
Croatian: Što Imlygic sadrži
English: However, no adjustment in dosage is necessary for patients with hepatic or renal impairment.
Croatian: Međutim, nije potrebna prilagodba doze u bolesnika s oštećenjem jetre ili bubrega.
English: 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.
Croatian: Zbog mogućih nuspojava kao što su omaglica i konfuzno stanje (vidjeti dio 4.8), bolesnike treba savjetovati da budu oprezni dok upravljaju vozilima i rade sa strojevima sve dok ne budu sigurni da nemaju nuspojava na virus talimogene laherparepvec.
English: The physician educational material should contain:
Croatian: Edukacijski materijali za zdravstvenog radnika moraju sadržavati: