FrancophonIA/ELRC3.0 huggingface dataset:
English: The terminal half-life of cortisol following administration of Plenadren was about 3 hours and formulation release controlled.
Croatian: Nakon primjene Plenadrena, terminalni poluvijek kortizola bio je oko 3 sata uz kontrolirano oslobađanje pripravka.
English: If you are to have surgery, tell your doctor/dentist before the surgery that you are taking this medicine.
Croatian: Ako se morate podvrgnuti operaciji, prije samog zahvata kažite liječniku/stomatologu da uzimate ovaj lijek.
English: During adrenal crisis parenteral, preferably intravenous administration of hydrocortisone in high doses, together with sodium chloride 9 mg/ml (0.9%) solution for infusion, should be administered according to current treatment guidelines.
Croatian: Za vrijeme adrenalne krize treba parenteralno davati visoke doze hidrokortizona, po mogućnosti intravenski, zajedno s otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9%) prema važećim terapijskim smjernicama.
English: Glucocorticoids cause profound and varied metabolic effects.
Croatian: Glukokortikoidi uzrokuju jake i različite metaboličke učinke.
English: During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency.
Croatian: Tijekom istovremene bolesti potrebno je izuzetno pozorno voditi računa o riziku od razvoja akutne adrenalne insuficijencije.
English: Hydrocortisone (cortisol) is a lipophilic drug that is eliminated completely via metabolism with a low clearance and accordingly low intestinal and hepatic extraction ratios.
Croatian: Hidrokortizon (kortizol) je lipofilni lijek koji se potpuno izluči putem metabolizma uz niži klirens, i prema tome, ima manje intestinalne i hepatičke omjere ekstrakcije.
English: How to take Plenadren
Croatian: Kako uzimati Plenadren
English: There is no indication that Plenadren, in doses used for replacement therapy, will have an effect on fertility.
Croatian: Nema indikacija da će Plenadren u dozama koje se primjenjuju u nadomjesnoj terapiji imati učinak na plodnost.
English: • Do not divide, crush or chew the tablets.
Croatian: • Nemojte lomiti, drobiti ili žvakati tablete.
English: The patient must be carefully informed how to act in these situations and also advised to immediately seek medical attention should an acute deterioration occur; especially in cases of gastroenteritis, vomiting and/or diarrhoea leading to fluid and salt loss, as well as to inadequate absorption of oral hydrocortisone.
Croatian: Bolesniku valja dati detaljne upute kako postupati u takvim situacijama te upozoriti da u slučaju akutnog pogoršanja odmah potraži liječničku pomoć; osobito u slučaju gastroenteritisa, povraćanja i/ili proljeva što uzrokuje gubitak tekućine i soli, a također i neodgovarajuću apsorpciju peroralnog hidrokortizona.
English: The bioavailability (AUC0-24h) is 20% lower with the modified-release tablet compared to the same daily dose of hydrocortisone given as conventional tablets three times daily.
Croatian: Biološka je raspoloživost (AUC0-24 h) za 20% niža uz tabletu s prilagođenim oslobađanjem u usporedbi s istom dnevnom dozom hidrokortizona uzetom u obliku konvencionalne tablete tri puta na dan.
English: Concomitant infections
Croatian: Istovremene infekcije
English: Endocrine disorders Induction of glucose intolerance or diabetes mellitus.
Croatian: Endokrini poremećaji Indukcija nepodnošenja glukoze ili dijabetes melitus.
English: There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder.
Croatian: Nema podataka za bolesnike s dokazanim sporim pražnjenjem želuca ili bolešću/poremećajem smanjenog motiliteta.
English: Compared to conventional tablets given three times daily, once daily modified-release tablets resulted in an increased cortisol exposure during the first four hours after intake in the morning but reduced exposure in the late afternoon/evening and over the 24-hour period (Figure 1).
Croatian: U usporedbi s konvencionalnim tabletama tri puta na dan, tablete s prilagođenim oslobađanjem jedanput na dan pokazale su povećanu izloženost kortizolu u prva četiri sata nakon uzimanja ujutro, ali smanjenu izloženost kada su ih bolesnici uzimali kasno poslije podne/uvečer te u razdoblju od 24 sata
English: Plenadren comes in bottles with a screw cap containing 50 tablets.
Croatian: Plenadren se dobije u bocama sa zatvaračem s navojem, koje sadrže 50 tableta.
English: You should tell your doctor if you become pregnant as the dose of Plenadren may have to be adjusted.
Croatian: Ako zatrudnite morate reći liječniku jer može biti potrebno prilagoditi dozu Plenadrena.
English: The adverse reaction profile in the treatment of adrenal insufficiency is therefore not comparable to that in other conditions requiring much higher doses of oral or parenteral glucocorticoids.
Croatian: Stoga profil nuspojava u liječenju adrenalne insuficijencije nije usporediv s profilom pri drugim bolestima koje zahtijevaju mnogo više doze peroralnih ili parenteralnih glukokortikoida.
English: Hydrocortisone is a glucocorticoid and the synthetic form of endogenously produced cortisol.
Croatian: Farmakodinamički učinci Hidrokortizon je glukokortikoid i sintetički oblik endogeno proizvedenog kortizola.
English: Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone.
Croatian: Liječenje vjerojatno nije indicirano za nuspojave nastale zbog kroničnog trovanja, osim kada se u bolesnika radi o stanju koje ga čini neobično osjetljivim na štetne učinke hidrokortizona.
English: Scientific reports do not support immunosuppressive effects of hydrocortisone in doses that have been used for replacement therapy in patients with adrenal insufficiency.
Croatian: Znanstveni izvještaji ne podupiru imunosupresivne učinke hidrokortizona u dozama koje su primjenjivane kao nadomjesna terapija u bolesnika s adrenalnom insuficijencijom.
English: Acute adrenal insufficiency may develop in patients with known adrenal insufficiency who are on inadequate daily doses or in situations with increased cortisol need.
Croatian: Akutna adrenalna insuficijencija može se razviti u bolesnika s ustanovljenom adrenalnom insuficijencijom koji su na neodgovarajućim dnevnim dozama ili u slučajevima povećane potrebe za kortizolom.
English: There was an initial increase in the frequency of adverse reactions in about one in five patients, observed up to eight weeks after first changing from conventional hydrocortisone tablets given three times daily to once daily modified-release tablets.
Croatian: U učestalosti nuspojava postojao je početni porast u otprilike jednog od pet bolesnika, opažen do osam tjedana od prvog prijelaza s tableta konvencionalnog hidrokortizona uzimanih triput na dan na tablete s prilagođenim oslobađanjem koje se uzimaju jednom dnevno.
English: The modified-release tablet has an outer coating layer that provides an immediate release of the drug and an extended release core.
Croatian: Tablete s prilagođenim oslobađanjem imaju vanjsku ovojnicu koja omogućava trenutno oslobađanje lijeka i jezgru s odgođenim oslobađanjem lijeka.
English: All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate.
Croatian: Svi glukokortikoidi povećavaju izlučivanje kalcija i smanjuju brzinu pregradnje kosti.
English: • Raised pressure in the eye (glaucoma), clouding of the lens in the eye (cataract)
Croatian: • povišen očni tlak (glaukom), zamućenje očnih leća (katarakta)
English: Intravenous administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia, see section 4.4.
Croatian: Intravenska primjena hidrokortizona nužna je tijekom prolaznih epizoda bolesti kao što su teške infekcije, posebice gastroenteritis povezan s povraćanjem i/ili proljevom, visoka temperatura bilo koje etiologije ili veliki tjelesni stres prouzročen primjerice teškom nesrećom i kirurškim zahvatom u općoj anesteziji, vidjeti dio 4.4.
English: - if your thyroid gland is not working normally tell your doctor since your dose of Plenadren may need to be adjusted.
Croatian: - Ako Vam štitna žlijezda ne radi normalno, recite to liječniku jer Vam možda treba prilagoditi dozu Plenadrena.
English: Hydrocortisone is a class II active substance according to the biopharmaceutical classification system (BCS) with a high intestinal permeability and a low dissolution rate, especially at higher doses.
Croatian: Prema biofarmaceutskom sustavu klasifikacije (BCS) hidrokortizon pripada djelatnim tvarima klase II s visokom intestinalnom propusnošću a niskim stupnjem otapanja, osobito u visokim dozama.
English: Modified-release tablets are not recommended in patients with increased gastrointestinal motility, i.e., chronic diarrhoea, due to the risk of impaired cortisol exposure.
Croatian: Tablete s prilagođenim oslobađanjem ne preporučuju se u bolesnika s povećanim motilitetom gastrointestinalnog sustava, tj. s kroničnim proljevom, zbog rizika od oslabljene izloženosti kortizolu.
English: Oral replacement doses must be individualised according to the clinical response.
Croatian: Peroralne nadomjesne doze treba odrediti za svakog bolesnika pojedinačno prema kliničkom odgovoru.
English: Patients with adrenal insufficiency have been shown to have reduced parity, which is most likely due to the underlying disease, but there is no indication that hydrocortisone in doses for replacement therapy will affect fertility.
Croatian: Pokazalo se da bolesnici s adrenalnom insuficijencijom imaju smanjenu sposobnost stvaranja potomstva, što je najvjerojatnije zbog osnovne bolesti, ali nema indikacije da hidrokortizon u dozama nadomjesne terapije utječe na plodnost.
English: Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three times daily (see section 5.2) clinical response needs to be monitored and further dose individualisation may be required.
Croatian: Zbog manje biološke raspoloživosti dnevne doze Plenadrena u usporedbi s onom konvencionalnih tableta hidrokortizona uzimanih tri puta na dan (vidjeti dio 5.2), potrebno je pratiti klinički odgovor i po potrebi dozu prilagoditi svakom bolesniku pojedinačno.
English: These medicines have also been given for other indications than adrenal insufficiency replacement therapy, often in higher doses.
Croatian: Ti su lijekovi davani za druge indikacije osim nadomjesne terapije u slučaju adrenalne insuficijencije, često u višim dozama.
English: Hydrocortisone is a glucocorticoid.
Croatian: Hidrokortizon je glukokortikoid.
English: During transient illnesses such as low grade infection, fever of any aetiology, stressful situations such as minor surgical procedures, the daily replacement dose must be increased temporarily, see section 4.2, ‘Use in intercurrent illness'.
Croatian: Tijekom prolaznih bolesti, kao što su blage infekcije, vrućica bilo koje etiologije, stresne situacije kao što su manji kirurški zahvati, dnevna nadomjesna doza mora se privremeno povećati, vidjeti dio 4.2. 'Primjena u slučaju istovremene bolesti'.
English: Potent CYP 3A4 inducers such as phenytoin, rifabutin, carbamazepine, barbiturates, rifampicin, St. John's wort and less potent inducers such as the antiretroviral medicinal products efavirenz and nevirapine can enhance the metabolic clearance of cortisol, decrease terminal half-life and thus reduce circulating levels and increase fluctuations of cortisol (due to shorter terminal half-life).
Croatian: Snažni induktori enzima CYP 3A4 kao što su fenitoin, rifabutin, karbamazepin, barbiturati, rifampicin, gospina trava, i manje snažni induktori kao što su antiretrovirusni lijekovi efavirenz i nevirapin, mogu povećati metabolički klirens kortizola, skratiti terminalni poluvijek i time smanjiti koncentraciju kortizola u krvi, a povećati njegove fluktuacije (zbog kraćeg terminalnog poluvijeka).
English: However, these adverse reactions (abdominal pain, diarrhoea, nausea and fatigue) are mild or moderate, transient, of short duration but may require dose adjustment or additional concomitant medicinal products, see section 4.2.
Croatian: Međutim, te nuspojave (bol u abdomenu, proljev, mučnina i umor) blage su ili umjerene, prolazne i kratkotrajne, ali mogu zahtijevati prilagodbu doze ili istodobno uzimanje dodatnih lijekova, vidjeti također dio 4.2. Umor je zabilježen kao vrlo česta nuspojava.
English: In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral, preferably intravenous treatment.
Croatian: U teškim slučajevima potrebno je odmah povećati dozu, a peroralnu primjenu hidrokortizona zamijeniti parenteralnom, po mogućnosti intravenskom terapijom.
English: The pivotal study was a randomised, two-period 12-week crossover multi-centre trial in 64 patients with primary adrenal insufficiency, 11 of whom had concomitant diabetes mellitus and 11 had hypertension.
Croatian: Klinička djelotvornost Ključno ispitivanje bilo je randomizirano, ukriženo, multicentrično ispitivanje od 12 tjedana u dva razdoblja, u kojemu je od 64 bolesnika s primarnom adrenalnom insuficijencijom njih 11 istovremeno imalo dijabetes melitus, a 11 hipertenziju.
English: Hydrocortisone is excreted in breast milk.
Croatian: Hidrokortizon se izlučuje u majčino mlijeko.
English: Patients with adrenal insufficiency should be monitored for thyroid dysfunction as both hypothyroidism and hyperthyroidism may markedly influence the exposure of administered hydrocortisone.
Croatian: Bolesnike s adrenalnom insuficijencijom treba pratiti zbog disfunkcije štitne žlijezde, jer i hipotireoidizam i hipertireoidizam mogu izrazito utjecati na izloženost primijenjenom hidrokortizonu.
English: At the discretion of the treating physician, immediate release hydrocortisone tablets can be given instead of Plenadren or may be added to treatment.
Croatian: Prema procjeni nadležnog liječnika, umjesto Plenadrena mogu se uzimati tablete hidrokortizona s trenutnim oslobađanjem ili ih se može dodati liječenju.
English: Changing patients from hydrocortisone tablets given twice daily, cortisone acetate or synthetic glucocorticoids to Plenadren has not been studied, but changing to a hydrocortisone equivalent daily dose of Plenadren is recommended in these instances; further dose individualisation may be required.
Croatian: Nije ispitano prelaženje bolesnika s tableta hidrokortizona koje se uzimaju dvaput na dan, kortizonacetata ili sintetičkih glukokortikoida, na liječenje Plenadrenom, ali u tim se slučajevima preporučuje promjena na dnevnu dozu Plenadrena jednaku onoj hidrokortizona; može biti potrebna daljnja prilagodba doze u skladu s bolesnikovim potrebama.
English: • Ritonavir, efavirenz and nevirapine - used to treat HIV infection
Croatian: • ritonavir, efavirenz i nevirapin - koriste se za liječenje infekcije HIV-om
English: The study compared modified-release tablets given once daily with conventional tablets given three times daily using the same daily dose of hydrocortisone (20 to 40 mg).
Croatian: U ispitivanju je uspoređena primjena tableta s prilagođenim oslobađanjem davanih jedanput na dan s konvencionalnim tabletama davanim tri puta na dan, pri čemu je dnevna doza hidrokortizona bila jednaka (20 do 40 mg)
English: Potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole erythromycin, telithromycin, clarithromycin, ritonavir and grapefruit juice can inhibit the metabolism of hydrocortisone, and thus increase blood levels.
Croatian: Snažni inhibitori enzima CYP 3A4 kao što su ketokonazol, itrakonazol, posakonazol, vorikonazol eritromicin, telitromicin, klaritromicin, ritonavir i sok od grejpa mogu inhibirati metabolizam hidrokortizona i time povećati njegovu koncentraciju u krvi.
English: EU/1/11/715/003
Croatian: EU/1/11/715/001 EU/1/11/715/003
English: • Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.
Croatian: • strije, modrice, osip poput akni, prekomjerni rast dlačica na licu, sporo cijeljenje rana Prijavljivanje nuspojava
English: Untreated adrenal insufficiency during pregnancy is associated with poor outcome of both the mother and the foetus, therefore it is important to continue treatment during pregnancy.
Croatian: S obzirom na to da je adrenalna insuficijencija koja se ne liječi tijekom trudnoće povezana s lošim ishodom za majku i plod, važno je liječenje nastaviti i u trudnoći.
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any clinically significant impact on the child.
Croatian: Nije vjerojatno da će doze hidrokortizona primjenjivane u zamjenskoj terapiji imati bilo kakav klinički značajan utjecaj na dijete.
English: - if you have short-term or temporary illness such as infections, fever or situations causing a great amount of physical stress, such as surgery: your dose of hydrocortisone must be temporarily increased.
Croatian: Ako imate kratkotrajnu ili privremenu bolest kao što su infekcije, vrućica ili ste izloženi situacijama koje predstavljaju veliki tjelesni stres kao što je kirurški zahvat, Vašu dozu hidrokortizona potrebno je privremeno povećati.
English: • Ketoconazole, itraconazole, posaconazole and voriconazole - used to treat fungal infections
Croatian: • ketokonazol, itrakonazol, posakonazol i vorikonazol - koriste se za liječenje gljivičnih infekcija
English: Treatment in pregnant women with adrenal insufficiency is unlikely to cause any harmful effects on the mother and/or the baby.
Croatian: Plenadrenom u trudnica s adrenalnom insuficijencijom imalo ikakve štetne učinke na majku i/ili dijete.
English: • More prone to infection
Croatian: • veća sklonost razvoju infekcija
English: Eye disorders Increased intraocular pressure and cataract.
Croatian: Povišen intraokularni tlak i katarakta.
English: Prolonged use of high doses of glucocorticoids may produce posterior subcapsular cataracts, and glaucoma with possible damage to the optic nerves.
Croatian: Produljena primjena visokih doza glukokortikoida može izazvati posteriorne supkapsularne katarakte i glaukom s mogućim oštećenjem vidnih živaca.
English: Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported.
Croatian: Zabilježen je izuzetni umor i epizode kratkotrajne omaglice (vrtoglavica).
English: Plenadren 20 mg: the tablets are white.
Croatian: Plenandren tablete od 20 mg: tablete su bijele boje.
English: Plenadren 5 mg: the tablets are pink.
Croatian: Plenandren tablete od 5 mg: tablete su ružičaste boje.
English: Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures.
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Osteoporoza sa spontanim lomovima.
English: Plenadren has minor influence on the ability to drive and use machines.
Croatian: Plenadren malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: These side effects can be: stomach pain, feeling sick and tiredness.
Croatian: Te nuspojave mogu biti bol u želucu, mučnina i umor.
English: This medicine may have minor influence on your ability to drive and use machines.
Croatian: Ovaj lijek može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: The coating system is a mixture of macrogol (3350), polyvinyl alcohol, talc and titanium oxide (E171).
Croatian: Ovojnica je mješavina makrogola (3350), poli(vinilnog alkohola), talka (E553b) i titanijeva oksida (E171).
English: Therefore, monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Croatian: Stoga se preporučuje praćenje kliničkog odgovora i možda je potrebna prilagodba doze, vidjeti dio 5.2.
English: There is no indication that hydrocortisone replacement therapy in pregnant women with adrenal insufficiency is associated with adverse outcome of the mother and/or the foetus.
Croatian: Nema indikacija da je u trudnica s adrenalnom insuficijencijom nadomjesna terapija hidrokortizonom povezana s lošim ishodom trudnoće za majku i/ili plod.
English: EU/1/11/715/006
Croatian: EU/1/11/715/002 EU/1/11/715/006
English: Such effects have not been reported in patients receiving replacement therapy with glucocorticoids in doses used in adrenal insufficiency.
Croatian: Takvi učinci nisu zabilježeni u bolesnika koji su nadomjesnu terapiju glukokortikoidima primali u dozama kakve se primjenjuju kod adrenalne insuficijencije.
English: The exposure increased three-fold when the dose of hydrocortisone modified-release increased from 5 mg to 20 mg.
Croatian: Sati u danu povećala trostruko kada se doza hidrokortizona s prilagođenim oslobađanjem povećala s 5 mg na
English: Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing´s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Croatian: Dugotrajno liječenje hidrokortizonom u dozama višim od fiziološke doze može uzrokovati kliničke znakove slične Cushingovom sindromu s povećanim masnim tkivom, gojaznošću u predjelu trbuha, hipertenzijom i dijabetesom, čime se povećava rizik od kardiovaskularnog morbiditeta i mortaliteta.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva pruritus osip
English: In these situations you should seek immediate medical care in order to receive treatment with injections of hydrocortisone and extra fluid administration.
Croatian: takvim situacijama morate bez odlaganja potražiti liječničku pomoć kako biste primili terapiju hidrokortizona u obliku injekcija te dodatnu tekućinu.
English: Gastric emptying and motility disorders
Croatian: Pražnjenje želuca i poremećaji motiliteta
English: In case of age-related low body weight, monitoring of the clinical response is recommended and dose adjustment to a lower dose may be required, see section 5.2.
Croatian: U slučaju manje tjelesne težine povezane s dobi, preporučuje se pratiti klinički odgovor i možda je potrebna prilagodba na nižu dozu, vidjeti dio 5.2.
English: The 5 mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).
Croatian: Tableta od 5 mg sadrži također crveni željezov oksid (E172), žuti željezov oksid
English: Patients with adrenal insufficiency on long-term glucocorticoid replacement therapy have been found to have reduced bone mineral density.
Croatian: U bolesnika s adrenalnom insuficijencijom na dugotrajnoj nadomjesnoj terapiji glukokortikoidima, ustanovljena je smanjena mineralna gustoća kostiju.
English: Talk to your doctor or pharmacist before taking Plenadren - when you have a condition that makes you unable to take this medicine or when the medicine is not absorbed properly from your stomach.
Croatian: Ako imate bolest zbog koje ne možete uzeti ovaj lijek ili kada se lijek ne apsorbira pravilno iz želuca.
English: Do not divide, crush or chew tablets.
Croatian: Ne lomiti, drobiti ili žvakati.
English: Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate
Croatian: Jezgra tablete hipromeloza mikrokristalična celuloza prethodno želatinizirani škrob (kukuruzni) koloidni bezvodni silicijev dioksid magnezijev stearat
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any effect on the child.
Croatian: Nije vjerojatno da će doze hidrokortizona, primjenjivane u nadomjesnoj terapiji, imati bilo kakav učinak na dijete.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow the tablets whole.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Tabletu progutati cijelu.
English: Untreated and poorly replaced adrenal insufficiency may affect the ability to drive and use machines.
Croatian: Neliječena adrenalna insuficijencija ili liječena neodgovarajućom nadomjesnom terapijom može utjecati na sposobnost vožnje i upravljanja strojevima.