FrancophonIA/ELRC3.0 huggingface dataset:
English: Events accumulated consistently over time, and the event rates for Onglyza and placebo did not diverge notably over time.
Croatian: Događaji su se postojano kumulirali tijekom vremena, a stope događaja za lijek Onglyza i placebo nisu značajno odstupale tijekom vremena.
English: In patients with GFR < 45 mL/min, the recommended dose is 2.5 mg once daily.
Croatian: U bolesnika koji imaju GFR < 45 ml/min, preporučena doza je 2,5 mg jedanput dnevno.
English: Onglyza should not be used during pregnancy unless clearly necessary.
Croatian: Onglyza se ne smije primjenjivati u trudnoći, osim ako to nije neophodno.
English: You should stop taking Onglyza and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: Morate prestati uzimati lijek Onglyza i odmah se javiti svom liječniku ako primjetite neku od sljedećih ozbiljnih nuspojava:
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Croatian: Ako imate smanjenu bubrežnu funkciju, liječnik Vam može propisati nižu dozu.
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
Croatian: U ispitivanjima in vitro, saksagliptin i njegov glavni metabolit nisu inhibirali CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4, niti su inducirali CYP1A2, 2B6, 2C9 i 3A4.
English: Onglyza contains lactose
Croatian: Onglyza sadrži laktozu
English: Acute Pancreatitis
Croatian: Akutni pankreatitis
English: This may be used to treat inflammation in different body parts and organs.
Croatian: On se može koristiti za liječenje upale raznih organa i dijelova tijela.
English: As initial combination with metformin, myalgia is reported as uncommon.
Croatian: Kao inicijalna kombinacija s metforminom, mijalgija je prijavljena kao manje česta.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Onglyza in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Onglyza u jednoj ili više podskupina pedijatrijske populacije u liječenju šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Onglyza clinical program.
Croatian: Imunokompromitirani bolesnici, kao što su bolesnici s presađenim organom ili dijagnozom sindroma humane imunodeficijencije, nisu bili ispitivani u sklopu kliničkog programa lijeka Onglyza.
English: Patients experienced relief of symptoms after discontinuation of the medication and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Croatian: U bolesnika je došlo do ublažavanja simptoma nakon prekida primjene lijeka, a u nekih je došlo do ponovne pojave simptoma nakon ponovnog uvođenja istog ili nekog drugog DPP4 inhibitora.
English: Talk to your doctor or pharmacist before taking Onglyza:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Onglyza:
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Croatian: Savjetujemo Vam da slijedite upute za njegu kože i stopala, koje su Vam dali liječnik ili medicinska sestra.
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Croatian: • u kombinaciji s ostalim lijekovima za liječenje šećerne bolesti, uključujući inzulin, kada oni ne osiguravaju primjerenu kontrolu glikemije (za dostupne podatke o različitim kombinacijama, vidjeti dijelove 4.4, 4.5 i 5.1)
English: • if you have reduced kidney function, your doctor will decide if you need to take a lower dose of Onglyza.
Croatian: • ako imate smanjenu bubrežnu funkciju, Vaš liječnik će odlučiti trebate li uzimati nižu dozu lijeka Onglyza.
English: The clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Croatian: Klinički značaj ovog smanjenja broja limfocita u odnosu na placebo nije poznat.
English: Onglyza may have a negligible influence on the ability to drive and use machines.
Croatian: Onglyza zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Croatian: Srednja vrijednost apsolutnog broja limfocita ostala je stabilna uz primjenu dnevne doze lijeka tijekom razdoblja do 102 tjedna.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Croatian: Učinci pušenja, prehrane, biljnih preparata i alkohola na farmakokinetiku saksagliptina nisu posebno ispitivani.
English: Table 4 Primary and Secondary Clinical Endpoints by Treatment Group in the SAVOR Study*
Croatian: Tablica 4: Primarne i sekundarne kliničke mjere ishoda prema skupini bolesnika u ispitivanju SAVOR*
English: Adverse reactions of hypoglycaemia were based on all reports of hypoglycaemia; a concurrent glucose measurement was not required.
Croatian: Nuspojave hipoglikemije temeljile su se na svim prijavama hipoglikemije; nije bilo potrebno istodobno mjerenje glukoze.
English: Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics'.
Croatian: Onglyza sadrži djelatnu tvar saksagliptin, koja pripada skupini lijekova koji se zovu „oralni antidijabetici“.
English: If pancreatitis is suspected, Onglyza should be discontinued; if acute pancreatitis is confirmed, Onglyza should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prestati uzimati lijek Onglyza; ako je akutni pankreatitis potvrđen, lijek Onglyza se ne smije ponovno početi uzimati.
English: Hypoglycaemia may affect your ability to drive and use machines or work with safe foothold and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia such as insulin and sulphonylureas.
Croatian: Hipoglikemija može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima ili rada sa sigurnim osloncem, a rizik od hipoglikemije postoji kada se ovaj lijek primjenjuje u kombinaciji s lijekovima za koje se zna da izazivaju hipoglikemiju, poput inzulina i sulfonilureja.
English: It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Croatian: Važno je da se pridržavate savjeta o dijeti i tjelovježbi koje ste dobili od svog liječnika ili medicinske sestre.
English: Onglyza is used for adult patients aged 18 years and older with ‘type 2 diabetes', if the disease cannot be adequately controlled with one oral anti-diabetic medicine, diet and exercise.
Croatian: Onglyza se koristi u odraslih bolesnika u dobi od 18 godina i starijih, sa „šećernom bolešću tipa 2“, ako im se bolest ne može kontrolirati na odgovarajući način jednim oralnim antidijabetikom, dijetom i tjelovježbom.
English: What Onglyza is and what it is used for What you need to know before you take Onglyza How to take Onglyza
Croatian: Što je Onglyza i za što se koristi Što morate znati prije nego počnete uzimati lijek Onglyza Kako uzimati lijek Onglyza
English: There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.
Croatian: Nije bilo štetnog učinka na bubrežnu funkciju na temelju procijenjene brzine glomerularne filtracije ili klirensa kreatinina u 12. i 52. tjednu.
English: • If you forget to take a dose of Onglyza, take it as soon as you remember it.
Croatian: • Ako ste zaboravili uzeti dozu lijeka Onglyza, uzmite tabletu čim se sjetite.
English: Talk to your doctor if you want to breast-feed while taking this medicine.
Croatian: Potražite savjet liječnika ako želite dojiti dok uzimate ovaj lijek.
English: • severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Croatian: • jaka i uporna bol u abdomenu (područje trbuha), koja se može proširiti i do leđa, kao i mučnina i povraćanje, jer to može biti znak upale gušterače (pankreatitis).
English: Onglyza should not be used to treat these conditions;
Croatian: Onglyza se ne smije koristiti za liječenje ovog stanja.
English: The mean metformin dose was approximately 1900 mg in each treatment group.
Croatian: Prosječna doza metformina u svakoj terapijskoj skupini bila je oko 1900 mg.
English: If you feel dizzy while taking Onglyza, do not drive or use any tools or machines.
Croatian: Ako osjetite omaglicu dok uzimate lijek Onglyza, nemojte voziti ni rukovati alatima i strojevima.
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Croatian: Primarna kompozitna mjera ishoda: MACE Sekundarna kompozitna mjera ishoda: MACE plus povezani događaji Smrt zbog bilo kojeg uzroka
English: The tablets contain lactose (milk sugar).
Croatian: Tablete sadrže laktozu (mliječni šećer).
English: Some patients have experienced constipation at an unknown frequency (cannot be determined from the available data) when Onglyza was used alone or in combination.
Croatian: Neki bolesnici su imali zatvor s nepoznatom učestalošću (ne može se utvrditi iz dostupnih podataka) kada se lijek Onglyza koristi samostalno ili u kombinaciji.
English: Includes saxagliptin in add-on to metformin and initial combination with metformin.
Croatian: Uključuje saksagliptin kao dodatak metforminu i početnu kombinaciju s metforminom.
English: The clinical relevance of the skin lesions is not known, however, clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Croatian: Klinički značaj kožnih lezija nije poznat, međutim, klinički korelati kožnim lezijama u majmuna nisu primijećeni u kliničkim ispitivanjima saksagliptina u ljudi.
English: • Uncommon (may affect 1 to 10 users in 1,000): joint pain (arthralgia) and difficulties in getting or maintaining an erection (erectile dysfunction).
Croatian: • Manje često (mogu se javiti u 1 do 10 na 1000 osoba): bol u zglobovima (artralgija) i poteškoće u postizanju ili održavanju erekcije (erektilna disfunkcija).
English: You should call your doctor if you experience the following side effect: • Severe joint pain.
Croatian: Morate obavijestiti svog liječnika ako osjetite sljedeću nuspojavu: • jaka bol u zglobovima
English: • Dexamethasone - a steroid medicine.
Croatian: • Deksametazon - steroidni lijek.
English: Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when Onglyza was used alone or in combination.
Croatian: Neki su bolesnici imali malo smanjen broj jedne vrste bijelih krvnih stanica (limfocita) u nalazima krvnih pretraga kada se lijek Onglyza koristi samostalno ili u kombinaciji.
English: The primary safety (noninferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischaemic stroke.
Croatian: Primarna mjera ishoda sigurnosti (neinferiornost) i djelotvornosti (superiornost) bila je kompozitna mjera ishoda koju je činilo vrijeme do prve pojave bilo kojeg od sljedećih velikih kardiovaskularnih štetnih događaja (engl. major adverse cardiac events, MACE): kardiovaskularna smrt, infarkt miokarda bez smrtnog ishoda ili ishemijski moždani udar bez smrtnog ishoda.
English: The reduction in FPG was slightly less in the saxagliptin-group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Croatian: Smanjenje FPG-a bilo je nešto manje u skupini liječenoj saksagliptinom, a bilo je i više prekida u terapiji (3,5% naspram 1,2%) zbog smanjene djelotvornosti temeljeno na FPG kriteriju za vrijeme prvih 24 tjedna ispitivanja.
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako je pakiranje oštećeno ili postoje vidljivi znakovi da je već otvarano.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Croatian: Klinički podaci opisani u nastavku upućuju na nizak rizik od klinički značajnih interakcija prilikom istodobne primijene s drugim lijekovima.
English: During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Croatian: Nakon stavljanja lijeka u promet, uključujući spontane prijave i klinička ispitivanja, prijavljene su sljedeće nuspojave saksagliptina: ozbiljne reakcije preosjetljivosti, uključujući anafilaktičku reakciju, anafilaktički šok i angioedem.
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Croatian: Učinak na tjelesnu težinu potomstva zamijećen je do 92. dana postnatalno u ženki i 120. dana u mužjaka.
English: You should not use Onglyza if you are pregnant.
Croatian: Ne smijete uzimati lijek Onglyza ako ste trudni.
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost kod primjene visokih doza (vidjeti dio 5.3).
English: Experience in NYHA class III-IV is still limited.
Croatian: Iskustvo u bolesnika sa zatajenjem srca NYHA stupnja III-IV i dalje je ograničeno.
English: Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Croatian: Pokazalo se da Onglyza nije imala klinički značajnog učinka na QTc-interval ili brzinu otkucaja srca kad se primjenjuje peroralno u dozi do 400 mg dnevno tijekom 2 tjedna ( 80 puta više od preporučene doze).
English: Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Croatian: Onglyza je indicirana u odraslih bolesnika sa šećernom bolešću tipa 2 kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije:
English: Because increases of this magnitude are not clinically relevant, dose adjustment in patients with mild renal impairment is not recommended.
Croatian: Kako povećanja ovog reda veličine nisu klinički značajna, ne preporučuje se prilagođavati dozu u bolesnika s blagim oštećenjem bubrega.
English: The effect of saxagliptin on fertility in humans has not been studied.
Croatian: Učinak saksagliptina na plodnost u ljudi nije ispitivan.
English: In this study, 98.2% of the patients received other antihyperglycaemic treatments (75.3% on insulin and 31.2% on oral antihyperglycaemics; some received both).
Croatian: U ovom se ispitivanju 98,2% bolesnika liječilo drugim antihiperglikemicima (75,3% inzulinom i 31,2% oralnim antihiperglikemicima; neki bolesnici su primali oboje).
English: In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Croatian: U bolesnika sa šećernom bolešću tipa 2, primjena saksagliptina dovela je do inhibicije aktivnosti enzima DPP-4 tijekom razdoblja od 24 sata.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity.
Croatian: Učinci na plodnost primijećeni su u mužjaka i ženki štakora pri visokim dozama, koje su izazvale vidljive znakove toksičnosti.
English: The use of saxagliptin has not been studied in pregnant women.
Croatian: Nije ispitivana primjena saksagliptina u trudnica.
English: In the SAVOR study subgroups over 65 and over 75 years of age, efficacy and safety were consistent with the overall study population.
Croatian: U ispitivanju SAVOR su djelotvornost i sigurnost u podskupinama bolesnika starijih od 65 godina i starijih od 75 godina bile u skladu s onima zabilježenima u cjelokupnoj ispitivanoj populaciji.
English: The degree of renal impairment did not affect the Cmax of saxagliptin or its major metabolite.
Croatian: Stupanj oštećenja funkcije bubrega nije utjecao na Cmax saksagliptina i njegovog glavnog metabolita.
English: What you need to know before you take Onglyza
Croatian: Što morate znati prije nego počnete uzimati lijek Onglyza
English: • if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with Onglyza in order to avoid low blood sugar;
Croatian: • ako uzimate inzulin ili antidijabetik koji se zove „sulfonilureja“, liječnik će Vam možda smanjiti dozu inzulina ili sulfonilureje ako ih uzimate zajedno s lijekom Onglyza da bi se izbjegla niska razina šećera u krvi.
English: Onglyza 2.5 mg film-coated tablets EU/1/09/545/011-015
Croatian: Onglyza 2,5 mg filmom obložene tablete EU/1/09/545/011-015
English: • Study CV181039: initial combination with metformin Overall population (n=306) Baseline HbA1c ≥ 10% stratum (n=107)
Croatian: • Ispitivanje CV181039: početna kombinacija s metforminom Ukupna populacija (n=306) Početni HbA1c ≥ 10% stratum (n=107)
English: If a dose is missed, it should be taken as soon as the patient remembers.
Croatian: Propusti li bolesnik dozu lijeka, treba ju uzeti čim se sjeti.
English: When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Croatian: Kada se Onglyza primjenjuje u kombinaciji s inzulinom ili sulfonilurejom, možda će biti potrebna niža doza inzulina ili sulfonilureje kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
English: Onglyza is not a substitute for insulin in insulin-requiring patients.
Croatian: Onglyza nije zamjena za inzulin u inzulin ovisnih bolesnika.
English: In the SAVOR trial a small increase in the rate for hospitalisation for heart failure was observed in the saxagliptin treated patients compared to placebo, although a causal relationship has not been established (see section 5.1).
Croatian: U ispitivanju SAVOR primijećeno je maleno povećanje stope hospitalizacije zbog zatajenja srca u bolesnika liječenih saksagliptinom u usporedbi s primjenom placeba, iako uzročna povezanost nije ustanovljena (vidjeti dio 5.1).
English: This is not considered clinically meaningful, therefore, no dose adjustment for Onglyza is recommended on the basis of age alone.
Croatian: To se ne smatra klinički značajnim nalazom, pa se stoga ne preporučuje prilagodba doze lijeka Onglyza samo na temelju dobi bolesnika.
English: Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Onglyza se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
English: Symptoms of a serious allergic reaction (seen rarely, may affect up to 1 in 1,000 people) may include: o Rash o Raised red patches on your skin (hives) o Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Croatian: Simptomi ozbiljne alergijske reakcije (rijetko se pojavljuju, mogu se javiti u do 1 na 1000 osoba) mogu uključivati: o osip o uzdignuta crvena područja na koži (koprivnjača) o oticanje lica, usana, jezika i grla što može uzrokovati poteškoće u disanju ili gutanju.
English: The decreases in lymphocyte count were not associated with clinically relevant adverse reactions.
Croatian: Smanjenje broja limfocita nije bilo povezano s klinički relevantnim nuspojavama.
English: * Intent-to-treat population
Croatian: * Populacija koju se namjeravalo liječiti
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP4) inhibitor (see sections 4.4 and 4.8).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1, ili anamneza ozbiljne reakcije preosjetljivosti, koja uključuje anafilaktičku reakciju, anafilaktički šok i angioedem na bilo koji inhibitor dipeptidil peptidaze-4 (DPP4) (vidjeti dijelove 4.4 i 4.8).
English: In addition, patients should be alerted to the risk of hypoglycaemia when Onglyza is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Croatian: Osim toga, bolesnike treba upozoriti na rizik od hipoglikemije kada se Onglyza primjenjuje u kombinaciji s drugim antidijabeticima za koje se zna da izazivaju hipoglikemiju (npr. inzulin, sulfonilureje).
English: Your doctor may prescribe Onglyza alone or together with insulin or other anti-diabetic medicines.
Croatian: Liječnik Vam može propisati lijek Onglyza sam ili zajedno s inzulinom ili nekim drugim antidijabetikom.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Croatian: Saksagliptin nije pokazao genotoksične učinke u konvencionalnom slijedu ispitivanja genotoksičnosti in vitro i in vivo.
English: In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Croatian: Osim toga, saksagliptin nije značajno promijenio farmakokinetiku metformina, glibenklamida, pioglitazona, digoksina, simvastatina, djelatnih sastojaka kombiniranog oralnog kontraceptiva (etinilestradiol i norgestimat), diltiazema ili ketokonazola.
English: The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups.
Croatian: Incidencija potvrđenih hipoglikemijskih epizoda bila je nešto veća u skupini koja je primala saksagliptin (9,4%) nego u placebo skupini (4,7%), premda nije bilo razlike u broju ispitanika s bilo kojim hipoglikemijskim događajem između te dvije terapijske skupine.
English: Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.
Croatian: Stoga će možda biti potrebna niža doza sulfonilureje ili inzulina kako bi se umanjio rizik od hipoglikemije kad se koriste u kombinaciji s lijekom Onglyza.
English: For the major metabolite, renal clearance values were comparable to estimated glomerular filtration rate.
Croatian: Vrijednosti bubrežnog klirensa glavnog metabolita bile su usporedive s procijenjenom brzini glomerularne filtracije.
English: The findings of these studies were confirmed with two subsequent 24-week regional (Asian) monotherapy studies comparing saxagliptin 5 mg with placebo.
Croatian: Rezultati tih ispitivanja potvrđeni su dvama naknadnim 24-tjednim regionalnim (azijskim) ispitivanjima monoterapije, u kojima se saksagliptin u dozi od 5 mg uspoređivao s placebom.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Croatian: Stoga se u sklopu redovite skrbi bolesnika sa šećernom bolešću preporučuje praćenje promjena na koži poput mjehurića, ulceracija ili osipa.