natgillin/translations-raw huggingface dataset:
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o vašem liječenju, obratite se svom liječniku.
In addition, results of tests on capsules stored in nonrefrigerated conditions showed that they did not dissolve as expected, which could affect the release of the active substance from the capsule.
Osim toga, rezultati ispitivanja na kapsulama pohranjenim u nerashlađenim uvjetima pokazali su da se nisu otopile na očekivani način što bi moglo utjecati na otpuštanje djelatne tvari iz kapsule.
The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after
Glavna mjera djelotvornosti bio je broj bolesnika čije krvne pretrage nisu pokazale nikakav znak virusa hepatitisa C 12 tjedana nakon završetka liječenja.
In its letter notifying the Agency of the withdrawal of application, the company stated that since several new treatments for hepatitis C had become available after the application was first made, there was no longer an unmet medical need for such a medicine.
U svojem pismu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da, s obzirom da je od podnošenja zahtjeva za odobrenje postalo dostupno nekoliko novih terapija, medicinske potrebe za takvim lijekom više ne postoje.
This stops the hepatitis C virus from multiplying and infecting new cells.
Time zaustavlja umnožavanje virusa C i njegovo inficiranje novih stanica.
A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
Četvrto ispitivanje koje je uključivalo 308 bolesnika ispitivalo je učinke liječenja lijekom Faldeprevir Boehringer Ingelheim u bolesnika koji su također imali HIV infekciju.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Faldaprevir Boehringer Ingelheim.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi Faldaprevir Boehringer Ingelheim.
On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Dan 10. lipnja 2014. tvrtka Boehringer Ingelheim International GmbH službeno je obavijestila Povjerenstvo za humane lijekove (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Faldaprevir Boehringer Ingelheim za liječenje hepatitisa C.
Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Faldaprevir Boehringer Ingelheim bio je predviđen za liječenje odraslih osoba s kroničnim (dugotrajnim) hepatitisom C (infektivnom bolesti koja utječe na jetru, a uzrokuje je virus hepatitisa C).
Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Faldaprevir Boehringer Ingelheim je antivirusni lijek koji sadrži djelatnu tvar faldaprevil.
The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Djelatna tvar u lijeku Faldaprevir Boehringer Ingelheim, faldaprevir, blokira djelovanje enzima naziva „NS3/4A serinska proteaza” kod virusa hepatitisa C koje je neophodno za umnožavanje virusa.
Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Postoji nekoliko varijeteta (genotipa) virusa hepatitisa C: Faldaprevir Boehringer Ingelheim namijenjen je za upotrebu protiv genotipa 1 virusa hepatitisa C.
Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Faldaprevir Boehringer Ingelheim did not outweigh its risks.
Sukladno navedenome, do vremena povlačenja CHMP je smatrao da, zbog zabrinutosti oko kvalitete, koristi lijeka Faldaprevir Boehringer Ingelheim ne nadmašuju s njim povezane rizike.
What is Faldaprevir Boehringer Ingelheim?
Što je Faldaprevir Boehringer Ingelheim?
The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Tvrtka je predočila podatke koji su obuhvaćali rezultate tri glavna ispitivanja koja su uključivala 1 705 bolesnika s kroničnim hepatitisom C kod kojih je faldaprevir uspoređivan s placebom (liječenjem bez
What was Faldaprevir Boehringer Ingelheim expected to be used for?
Za što se Faldaprevir Boehringer Ingelheim trebao koristiti?
Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Faldaprevir Boehringer Ingelheim could not have been approved for the treatment of hepatitis C. The Committee had concerns regarding the starting materials used for the manufacture of the active substance.
Na temelju pregleda podataka, u trenutku povlačenja CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Faldaprevir Boehringer Ingelheim za liječenje hepatitisa C.
How is Faldaprevir Boehringer Ingelheim expected to work?
Kako je Faldaprevir Boehringer Ingelheim trebao djelovati?
EMA/354906/2014
Boehringer Ingelheim (faldaprevir) EMA/445616/2014
*This also applies to patients aged 15 years and older.
*Odnosi se također na bolesnike u dobi od 15 ili više godina.
Oral Contraceptives*
Oralni kontraceptivi*
Date of latest renewal: 8th February 2018
Datum posljednje obnove odobrenja: 8. veljače 2018
[Mechanism of interaction]
[Mehanizam interakcije]
• Existing symptomatic arrhythmias.
• postojeće simptomatske aritmije.
Frequency categories are expressed as: Very common (1/10); Common (1/100 to 1/10); Uncommon (1/1,000 to 1/100); Rare (1/10,000 to 1/1,000); Very rare (1/10,000); Not known (cannot be estimated from the available data).
Kategorije učestalosti izražene su kao: vrlo često ( 1/10); često ( 1/100 i < 1/10); manje često (  1/1000 i  1/100); rijetko ( 1/10 000 i  1/1000); vrlo rijetko ( 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Do sada dostupni podaci opisani su u dijelovima 4.8 i 5.1, međutim nije moguće dati preporuke za doziranje.
• Sinus bradycardia.
• sinusna bradikardija.
Dosage adjustment (Adults)
Prilagodba doze (Odrasli)
This leaflet was last approved in {MM/YYYY}.
Ova uputa je zadnji puta revidirana u {MM/GGGG}
Clinical experience Successful outcome in this section is defined as complete or partial response.
Pozitivan ishod u ovom je odjeljku definiran kao potpun ili djelomičan odgovor.
• Cardiomyopathy, in particular when heart failure is present.
• kardiomiopatija, posebice ako je prisutno i zatajivanje srca.
Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Od 7 navedenih bolesnika, 3 su imala infekciju oka, 1 sinusa, a u 3 je bolesnika infekcija bila diseminirana.
Women of child-bearing potential must always use effective contraception during treatment.
Žene reproduktivne dobi uvijek moraju koristiti učinkovitu kontracepciju tijekom liječenja.
Provides HCPs with the current recommendations to monitor and manage these risks.
- Pruža zdravstvenim radnicima trenutne preporuke za praćenje i upravljanje tim rizicima.
Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
- Podsjeća bolesnika kada i kako prijaviti značajne znakove i simptome fototoksičnosti i raka kože.
Children and adolescents Voriconazole Accord should not be given to children younger than 2 years of age.
Djeca i adolescenti Voriconazole Accord se ne smije davati djeci mlađoj od 2 godine.
Contraindicated (see section 4.3)
Kontraindicirana (vidjeti dio 4.3)
>R (Resistant)
S (Osjetljivi) > R (Rezistentni)
Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180days after HSCT.
Uspjeh je definiran kao sposobnost nastavljanja profilakse ispitivanim lijekom 100 dana nakon HSCT-a (bez prekida >14 dana) i preživljenje bez dokazane ili vjerojatne invazivne gljivične infekcije 180 dana nakon HSCT-a.
Voriconazole Accord film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Voriconazole Accord filmom obložene tablete moraju se uzimati najmanje jedan sat prije ili jedan sat nakon obroka.
Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Standardna ispitivanja sigurnosne farnakologije, genotoksičnosti odnosno kancerogenosti nisu otkrila poseban rizik za ljude.
How to take Voriconazole Accord Always take this medicine exactly as your doctor has told you.
Kako uzimati Voriconazole Accord Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatment-related adverse events.
Pri upotrebi u profilaksi, prilagodba doze se ne preporučuje u slučaju izostanka djelotvornosti ili štetnih događaja povezanih s liječenjem.
Prophylaxis in adults and children
Profilaksa u odraslih i djece
Do not take Voriconazole Accord If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Voriconazole Accord Ako ste alergični na vorikonazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Voriconazole was shown to be effective against the following rare fungal pathogens:
Vorikonazol se pokazao djelotvornim protiv sljedećih rijetkih patogenih gljivca:
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Voriconazole Accord if:
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Voriconazole Accord:
It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF),, as an increased sensitivity of skin to the sun's UV rays can occur.
Važno je da pokrijete područja kože izložena suncu i koristite sredstvo za zaštitu od sunca s visokim zaštitnim faktorom (SPF) jer može doći do pojačane osjetljivosti kože na sunčeve UV zrake.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2013
Datum prvog odobrenja:16. svibnja 2013.
Voriconazole Accord may cause blurring of vision or uncomfortable sensitivity to light.
Voriconazole Accord može uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost.
Continue taking Voriconazole Accord until your doctor tells you to stop.
Nastavite uzimati Voriconazole Accord sve dok Vam liječnik ne kaže da prestanete.
The following instructions apply to both treatment and prophylaxis
Sljedeće informacije odnose se i na liječenje i na profilaksu
Clinical studies examining QTc interval
Klinička ispitivanja u kojima je ispitivan QTc-interval
4.7 Effects on ability to drive and use machines Voriconazole Accord has moderate influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Voriconazole Accord umjereno utječe na sposobnost upravljanja vozilima i rada na strojevima.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacioalnim propisima.
This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Ovo je ispitivanje potvrdilo rezultate ranijeg prospektivnog ispitivanja, u kojem je zabilježen pozitivan ishod u bolesnika s faktorima rizika za lošu prognozu, uključujući reakciju presatka protiv primatelja, te posebice infekcije mozga (obično povezane s gotovo 100%-tnom smrtnošću).
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Accord Healthcare Limited, Sage House, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, Ujedinjeno Kraljevstvo
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
It is important to take your Voriconazole Accord tablets regularly at the same time each day.
Važno je da Voriconazole Accord tablete uzimate redovito, svakog dana u isto vrijeme.
Ritonavir (protease inhibitor)
Ritonavir (inhibitor proteaze)
If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Ako dobijete poremećaje kože opisane u prethodnom tekstu, Vaš liječnik Vas može uputiti dermatologu, koji nakon konzultacija može odlučiti da je važno da redovito dolazite na kontrole.
If you or your child are taking Voriconazole Accord for prevention of fungal infections, your doctor may stop giving Voriconazole Accord if you or your child develop treatment related side effects.
Ako Vi ili Vaše dijete uzimate Voriconazole Accord za prevenciju gljivičnih infekcija, liječnik Vam može prestati davati Voriconazole Accord ako Vi ili Vaše dijete razvijete nuspojave povezane s liječenjem.
Your doctor should monitor the function of your liver and kidney by doing blood tests.
Vaš liječnik Vam mora pratiti funkciju Vaše jetre i bubrega putem krvnih pretraga.
The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg
Preporučena doza za odrasle (uključujući starije bolesnike) je kako slijedi: Tablete Bolesnici tjelesne težine 40 kg i više
Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Pozitivan odgovor na liječenje vorikonazolom postignut je u 16 (6 potpunih, 10 djelomičnih odgovora) od 28 bolesnika s infekcijom uzročnika S. apiospermum te u 2 (oba djelomična odgovora) od 7 bolesnika s infekcijom uzročnika S. prolificans.
• inflammation)
• upale)
Astemizole, cisapride, pimozide, quinidine and terfenadine
Astemizol, cisaprid, pimozid, kinidin i terfenadin
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Dobroćudne, zloćudne i nespecificiran e novotvorine (uključujući ciste i polipe)
In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Uz to, uspješan odgovor je zabilježen i u 1 od 3 bolesnika s infekcijama izazvanima više nego jednim uzročnikom, uključujući i nekim iz roda
The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabeled metabolites in plasma.
Glavni metabolit vorikonazola je N-oksid, koji čini 72% radioaktivno obilježenih metabolita koji cirkuliraju u plazmi.
Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended and the dose of anticoagulants should be adjusted accordingly.
Preporučuje se pažljivo pratiti protrombinsko vrijeme ili druge primjerene testove antikoagulacije te prema tome prilagođavati dozu antikoagulansa.
Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above.
Stoga je, ako Vam liječnik nije rekao da prekinete liječenje, važno da Voriconazole Accord uzimate na pravilan način, kako je prethodno opisano.
On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
S obzirom na visoku bioraspoloživost lijeka nakon peroralne primjene (96%; vidjeti dio 5.2), moguće je prelaziti s intravenske na peroralnu primjenu i obrnuto kada je to klinički indicirano.
Voriconazole may also be available as powder for solution for infusion, powder and solvent for solution for infusion and powder for oral suspension, however not under this tradename.
Vorikonazol može biti dostupan i kao prašak za otopinu za infuziju, prašak i otapalo za otopinu za infuziju te prašak za oralnu suspenziju, ali ne pod ovim zaštićenim nazivom.
Serious side effects - Stop taking Voriconazole Accord and see a doctor immediately - Rash - Jaundice; Changes in blood tests of liver function - Pancreatitis
Ozbiljne nuspojave - prestanite uzimati Voriconazole Accord i odmah se javite liječniku - osip - žutica; promjene jetrenih funkcija u krvnim pretragama - pankreatitis (upala gušterače).
Voriconazole Accord should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Voriconazole Accord treba ukinuti ako se identificiraju premaligne lezije kože ili karcinom skvamoznih stanica (vidjeti u nastavku pod Dugotrajno liječenje).
Omeprazole (40 mg QD)*
Omeprazol (40 mg QD)*
• you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
• ako se zna da imate kardiomiopatiju, nepravilane otkucaje srca, usporene otkucaje srca ili nepravilnost u elektrokardiogramu (EKG) koja se naziva „sindrom produljenog QTc-intervala“.
Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with Voriconazole Accord and at least weekly for the first month of treatment.
Kliničko zbrinjavanje treba uključivati laboratorijsku procjenu funkcije jetre (osobito AST-a i ALT-a) na samom početku uzimanja lijeka Voriconazole Accord i zatim barem svaki tjedan tijekom prvog mjeseca uzimanja.
Contact your doctor immediately if you become pregnant while taking Voriconazole Accord.
Odmah se javite svom liječniku ako zatrudnite za vrijeme uzimanja lijeka Voriconazole Accord.
• serious fungal infections caused by Scedosporium sp.or Fusarium sp. (two different species of fungi).
• teške gljivične infekcije uzrokovane vrstama iz rodova Scedosporium ili Fusarium (dva različita tipa gljivica).
In addition Voriconazole Accord has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Uz to, Voriconazole Accord se povezuje s fototoksičnošću, uključujući reakcije kao što su pjege, lentigo, aktinička keratoza i pseudoporfirija.
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Sigurnost vorikonazola ispitana je u 288 pedijatrijskih bolesnika u dobi od 2 do < 12 godina (169) i 12 do <18 godina (119) koji su primili vorikonazol kao profilaksu (183) ili terapiju (105) u kliničkim ispitivanjima.
If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Accord.
Ako imate bolest jetre, liječnik će Vam možda propisati nižu dozu lijeka Voriconazole Accord.
[UDP-glucuronyl transferase substrate]
[supstrat UDP-glukuronil transferaze]
No dose adjustment is necessary for elderly patients (see section 5.2).
Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
Dose reduction of NSAIDs may be needed.
Možda će biti potrebno smanjiti dozu NSAR-a.
Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during Voriconazole Accord treatment.
Bolesnike, pogotovo djecu, u kojih postoje faktori rizika za razvoj akutnog pankreatitisa (npr. nedavna kemoterapija, transplantacija hematopoetskih matičnih stanica) treba pomno nadzirati tijekom liječenja lijekom Voriconazole Accord.
What Voriconazole Accord is and what it is used for
Što je Voriconazole Accord i za što se koristi
Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
Film ovojnica hipromeloza titanijev dioksid (E171) laktoza hidrat triacetin
• candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
• kandidemiju (drugu vrstu gljivične infekcije uzrokovanu vrstama iz roda Candida) u bolesnika bez neutropenije (bolesnika bez abnormalno sniženog broja bijelih krvih stanica),
Serious refractory Candida infections
Teške refraktorne infekcije gljivicom Candida
Extended and frequent monitoring for respiratory depression and other opiate associated adverse reactions is recommended.
Preporučuju se opsežne i česte kontrole zbog moguće depresije disanja i drugih nuspojava povezanih s opijatima.
Based on the population pharmacokinetic analysis, 12 to 14 year old adolescents weighing less than 50 kg should receive children's doses (sees ection4.2).
Na osnovu populacijske farmakokinetičke analize, adolescenti u dobi od 12-14 godina koji teže manje od 50 kg trebaju primati doze za djecu (vidjeti dio 4.2).
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis(1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
U 22 bolesnika mlađa od 2 godine koja su dobivala vorikonazol u okviru programa milosrdne primjene lijeka zabilježene su sljedeće nuspojave (za koje se nije mogla isključiti povezanost s vorikonazolom): reakcija fotoosjetljivosti (1), aritmija (1), pankreatitis (1), povišenje vrijednosti bilirubina u krvi (1), povišenje vrijednosti jetrenih enzima (1), osip (1), papiloedem (1).
Voriconazole Accord must not be taken during pregnancy, unless indicated by your doctor.
Voriconazole Accord se ne smije uzimati tijekom trudnoće osim ako Vaš liječnik nije tako odlučio.
The visual impairments were generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae.
Poremećaji vida su uglavnom bili blagi, rijetko su doveli do prekida primjene lijeka i nisu bili povezani s dugoročnim posljedicama.
The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12to <17 years.
Preporučene doze u djece i adolescenata temelje se na populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do < 12 godina i 26 imunokompromitiranih adolescentnih bolesnika u dobi 12 do < 17 godina.
Reminds patients to take steps to minimize the risk of skin reactions and skin SCC (by avoiding exposure to direct sunlight, use of a sunscreen and protective clothing) and inform HCPs if they experience relevant skin abnormalities.
- Podsjeća bolesnike na poduzimanje koraka radi umanjivanja rizika od kožnih reakcija i SCC-a kože (izbjegavanje izravnog izlaganja suncu, upotreba sredstava za sunčanje i zaštitne odjeće) te da informiraju zdravstvene radnike ako se pojave znatne promjene na koži.