FrancophonIA/ELRC3.0 huggingface dataset:
English: In less severe situations when intravenous administration of hydrocortisone is not required, for instance low grade infections, fever of any aetiology and stressful situations such as minor surgical procedures, the normal oral daily replacement dose must be increased temporarily; the total daily dose should be increased by administering the maintenance dose twice or thrice daily with 8 ±2 hours intervals (an increase in number of administrations, not increasing the morning dose).
Slovenian: V manj hudih primerih, kadar intravenska uporaba hidrokortizona ni potrebna, na primer pri blagih okužbah, zvišani telesni temperaturi katerekoli etiologije in stresnih situacijah, kot so manjši kirurški posegi, je treba običajni dnevni peroralni nadomestni odmerek začasno povečati; skupni dnevni odmerek je treba povečati z uporabo vzdrževalnega odmerka dvakrat ali trikrat na dan, v časovnih razmikih 8 ± 2 uri (povečati je treba število dnevnih odmerkov, ne jutranjega odmerka).
English: The cortisol levels in your blood increase rapidly to a maximum level, about 1 hour after taking the tablet in the morning, and then gradually decrease over the day with no or almost no cortisol level in the blood in the late evening and night when the levels should be low.
Slovenian: Približno eno uro po zaužitju tablete zjutraj se raven kortizola v krvi hitro poveča na najvišjo raven in nato preko dneva postopoma upada, pozno zvečer in ponoči, ko mora biti raven v krvi nizka, pa ga skorajda ni več.
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).
Slovenian: Močni induktorji CYP 3A4, kot so fenitoin, rifabutin, karbamazepin, barbiturati, rifampicin, šentjanževka, in manj močni induktorji, kot sta protiretrovirusni zdravili efavirenz in nevirapin, lahko povečajo presnovni očistek kortizola, skrajšajo končni razpolovni čas ter tako zmanjšajo koncentracijo v krvi in povečajo nihanje kortizola (zaradi krajšega končnega razpolovnega časa).
English: Metabolism and nutrition disorders Sodium and water retention and oedema tendency, hypertension, hypokalaemia.
Slovenian: Presnovne in prehranske motnje Zadrževanje natrija in vode ter nagnjenost k edemu, hipertenzija, hipokalemija.
English: Plenadren is used in adults to treat a condition known as adrenal insufficiency, or cortisol deficiency.
Slovenian: Zdravilo Plenadren se uporablja za zdravljenje odraslih z boleznijo, znano kot adrenalna insuficienca ali pomanjkanje kortizola.
English: All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate.
Slovenian: Vsi glukokortikoidi povečajo izločanje kalcija in zmanjšajo hitrost presnove kosti.
English: Treatment in pregnant women with adrenal insufficiency is unlikely to cause any harmful effects on the mother and/or the baby.
Slovenian: Ni verjetno, da bi imelo zdravljenje nosečnic z adrenalno insuficienco škodljive učinke na mater in/ali dojenčka.
English: Hydrocortisone is a glucocorticoid and the synthetic form of endogenously produced cortisol.
Slovenian: Hidrokortizon je glukokortikoid in je sintetična oblika endogenega kortizola.
English: • Raised pressure in the eye (glaucoma), clouding of the lens in the eye (cataract)
Slovenian: • zvišan tlak v očesu (glavkom), zamegljenost očesne leče (katarakta)
English: The 5 mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).
Slovenian: 5 mg tablete vsebujejo tudi rdeči železov oksid (E172), rumeni železov oksid (E172) in črni železov oksid (E172).
English: Plenadren replaces the natural cortisol that is missing in adrenal insufficiency.
Slovenian: Zdravilo Plenadren nadomešča naravni kortizol, ki ga pri adrenalni insuficienci ni dovolj.
English: When the oral dose is increased the total plasma exposure of cortisol increased less than proportional.
Slovenian: Če se peroralni odmerek poveča, se skupna izpostavljenost kortizola v plazmi zveča za manj kot sorazmerno.
English: Symptoms may range from excitement/arousal to mania or psychosis.
Slovenian: Simptomi so lahko različni in lahko obsegajo navdušenje/vzburjenje, manijo ali psihozo.
English: Once the intercurrent illness episode is over, patients can return to the normal maintenance dose.
Slovenian: Ko sočasna bolezen mine, lahko začne bolnik ponovno uporabljati običajni vzdrževalni odmerek.
English: • St. John's wort - used to treat depression and other conditions
Slovenian: • šentjanževko - uporablja se za zdravljenje depresije in drugih bolezni
English: Treatment of primary adrenal insufficiency often warrants addition of a mineralocorticoid.
Slovenian: Pri zdravljenju primarne adrenalne insuficience je pogosto treba dodati mineralokortikoide.
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.
Slovenian: Uporaba tablet s prirejenim sproščanjem ni priporočljiva pri bolnikih s povečano gastrointestinalno gibljivostjo, tj. pri kronični driski, zaradi tveganja za oslabljeno izpostavljenost kortizolu.
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.
Slovenian: Pri bolnikih z adrenalno insuficienco se je pokazala manjša rodnost, vzrok zanjo je najverjetneje osnovna bolezen, ni pa znakov, da bi odmerki hidrokortizona pri nadomestnem zdravljenju vplivali na plodnost.
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.
Slovenian: Hidrokortizon (kortizol) je lipofilno zdravilo, ki se v celoti izloča s presnavljanjem z nizkim očistkom in ima v skladu s tem nizko razmerje črevesnega in jetrnega izločanja.
English: Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Osteoporoza s spontanimi zlomi.
English: Overall, the frequency and type of adverse reactions were similar for Plenadren once daily modifiedrelease tablets and hydrocortisone tablets given three times daily in a 12-week study.
Slovenian: Na splošno sta bili pogostost in vrsta neželenih učinkov pri jemanju tablet zdravila Plenadren s prirejenim sproščanjem enkrat na dan in jemanju tablet hidrokortizona trikrat na dan v 12-tedenski študiji podobni.
English: • More prone to infection
Slovenian: • večja nagnjenost k okužbam
English: Stopping Plenadren may be life threatening.
Slovenian: Prenehanje jemanja zdravila Plenadren je lahko smrtno nevarno.
English: Patients with adrenal insufficiency on long-term glucocorticoid replacement therapy have been found to have reduced bone mineral density.
Slovenian: Pri bolnikih z adrenalno insuficienco na dolgotrajnem nadomestnem zdravljenju z glukokortikoidi so ugotovili, da imajo zmanjšano mineralno gostoto kosti.
English: The exposure increased three-fold when the dose of hydrocortisone modified-release increased from 5 mg to 20 mg.
Slovenian: Izpostavljenost se je pri povečanju odmerka hidrokortizona v obliki tablet s prirejenim sproščanjem s 5 mg na 20 mg povečala za trikrat.
English: The modified-release tablet has an outer coating layer that provides an immediate release of the drug and an extended release core.
Slovenian: Tablete s prirejenim sproščanjem imajo zunanjo oblogo, ki zagotavlja takojšnje sproščanje zdravila, in jedro s podaljšanim sproščanjem.
English: The transport of cortisol across membranes is expected to be mediated mainly by passive diffusion and therefore renal and biliary clearances are negligible.
Slovenian: Kortizol naj bi se skozi membrane prenašal predvsem s pasivno difuzijo, zaradi česar sta ledvični in žolčni očistek zanemarljiva.
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any clinically significant impact on the child.
Slovenian: Ni verjetno, da bi imeli odmerki hidrokortizona, ki se uporabljajo za nadomestno zdravljenje, klinično pomemben učinek na otroka.
English: How to take Plenadren
Slovenian: Kako jemati zdravilo Plenadren
English: - if your thyroid gland is not working normally tell your doctor since your dose of Plenadren may need to be adjusted.
Slovenian: - če vaša ščitnica ne deluje normalno, o tem obvestite zdravnika, saj bo morda treba prilagoditi odmerek zdravila Plenadren.
English: MedDRA System Organ Class
Slovenian: Organski sistem (MedDRA)
English: There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder.
Slovenian: Podatkov za bolnike s potrjenim upočasnjenim praznjenjem želodca ali motnjo/boleznijo zmanjšane gibljivosti črevesja ni.
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.
Slovenian: Ni znakov, da bi bilo nadomestno zdravljenje s hidrokortizonom pri nosečnicah z adrenalno insuficienco povezano z neželenim izidom pri materi in/ali plodu.
English: Hydrocortisone is a glucocorticoid.
Slovenian: Hidrokortizon je glukokortikoid.
English: • Erythromycin, telithromycin and clarithromycin - used to treat bacterial infections
Slovenian: • eritromicin, telitromicin in klaritromicin - uporabljajo se za zdravljenje bakterijskih okužb
English: The daily dose of Plenadren may have to be doubled or tripled in milder conditions such as a mild infection or stress.
Slovenian: Dnevni odmerek zdravila Plenadren bo pri lažjih boleznih, na primer blagi okužbi ali stresu, morda treba podvojiti ali potrojiti.
English: • Salt and water retention causing swelling and raised blood pressure (shown on medical examination) and low potassium level in the blood
Slovenian: • zadrževanje soli in vode, kar povzroča otekanje in zvišan krvni tlak (rezultati krvnih preiskav),
English: Eye disorders Increased intraocular pressure and cataract.
Slovenian: Očesne bolezni Povečan očesni tlak in katarakta.
English: • Ritonavir, efavirenz and nevirapine - used to treat HIV infection
Slovenian: • ritonavir, efavirenz in nevirapin - uporabljajo se za zdravljenje okužbe s HIV
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any effect on the child.
Slovenian: Ni verjetno, da bi odmerki hidrokortizona, ki se uporabljajo za nadomestno zdravljenje, imeli učinek na otroka.
English: The medicine delivers hydrocortisone to your body throughout the day.
Slovenian: Zdravilo skozi ves dan oskrbuje telo s hidrokortizonom.
English: Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported.
Slovenian: Poročali so o hudi utrujenosti in kratkotrajnih epizodah omotice (vrtoglavice).
English: During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency.
Slovenian: Uporaba pri sočasni bolezni Med sočasno boleznijo je treba zelo paziti na tveganje za razvoj akutne adrenalne insuficience.
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.
Slovenian: Intravenska uporaba hidrokortizona je nujno potrebna med prehodnimi epizodami bolezni, kot so hude okužbe, zlasti gastroenteritis, povezan z bruhanjem in/ali drisko, in močno zvišana telesna temperatura katerekoli etiologije ter pri velikem telesnem naporu, kot so hude nesreče ali operacije pod splošno anestezijo,
English: Plenadren contains a substance called hydrocortisone (sometimes called cortisol).
Slovenian: Kaj je zdravilo Plenadren in za kaj ga uporabljamo Zdravilo Plenadren vsebuje snov, ki se imenuje hidrokortizon (včasih tudi kortizol).
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.
Slovenian: Dolgotrajno zdravljenje z odmerki hidrokortizona, večjimi od fiziološkega odmerka, lahko povzroči klinične znake, podobne Cushingovemu sindromu s povečanim maščevjem, trebušno debelostjo, hipertenzijo in sladkorno boleznijo, s čimer se poveča tveganje za kardiovaskularne bolezni in smrtnost.
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 100 bolnikov)
English: Patients with adrenal insufficiency should be monitored for thyroid dysfunction as both hypothyroidism and hyperthyroidism may markedly influence the exposure of administered hydrocortisone.
Slovenian: Delovanje ščitnice Pri bolnikih z adrenalno insuficienco je treba spremljati delovanje ščitnice, saj lahko hipotiroidizem in hipertiroidizem pomembno vplivata na izpostavljenost uporabljenemu hidrokortizonu.
English: Observed mean serum cortisol concentration versus clock time following single and multiple dosing in primary adrenal insufficiency patients (n=62) after oral administration of Plenadren given once daily and hydrocortisone thrice daily.
Slovenian: Opažena povprečna koncentracija kortizola v serumu glede na čas po enem odmerku in več odmerkih pri bolnikih s primarno adrenalno insuficienco (n = 62) po peroralni uporabi zdravila Plenadren enkrat na dan in hidrokortizona trikrat na dan.
English: Adverse reactions from these studies and from postmarketing surveillance are listed below by system organ class and frequency as follows:
Slovenian: V nadaljevanju so po organskih sistemih in pogostnosti navedeni neželeni učinki iz teh študij in obdobja po začetku trženja zdravila:
English: The dose is specific for you and is decided by your doctor.
Slovenian: Odmerek zdravila je zdravnik določil posebej za vas.
English: • Do not divide, crush or chew the tablets.
Slovenian: • Tablet ne smete prelomiti, zdrobiti ali prežvečiti.
English: EU/1/11/715/003
Slovenian: EU/1/11/715/001 EU/1/11/715/003
English: Treatment of adrenal insufficiency in adults.
Slovenian: 4.1 Terapevtske indikacije Zdravljenje adrenalne insuficience pri odraslih.
English: Such effects have not been reported in patients receiving replacement therapy with glucocorticoids in doses used in adrenal insufficiency.
Slovenian: O takšnih učinkih niso poročali pri bolnikih, ki so bili na nadomestnem zdravljenju z glukokortikoidi in so prejemali odmerke za adrenalno insuficienco.
English: • Ketoconazole, itraconazole, posaconazole and voriconazole - used to treat fungal infections
Slovenian: • ketokonazol, itrakonazol, posakonazol in vorikonazol - uporabljajo se za zdravljenje glivičnih okužb
English: Fatigue has been reported as very common.
Slovenian: Zelo pogosto so poročali o utrujenosti.
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.
Slovenian: Prehod bolnikov z zdravljenja s tabletami hidrokortizona, ki se jemljejo dvakrat na dan, kortizonacetata ali sintetičnih glukokortikoidov na zdravljenje z zdravilom Plenadren ni bil preučen, vendar se v teh primerih priporoča, da bolniki preidejo na odmerek zdravila Plenadren z enakovredno vsebnostjo hidrokortizona.
English: The coating system is a mixture of macrogol (3350), polyvinyl alcohol, talc and titanium oxide (E171).
Slovenian: Obloga je sestavljena iz mešanice makrogola (3350), polivinil alkohola, smukca (E553b) in titanovega oksida (E171).
English: Fatigue and episodes of short-lasting vertigo have been reported.
Slovenian: Poročali so o utrujenosti in kratkotrajnih epizodah vrtoglavice.
English: Therefore, monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Slovenian: Zato se priporoča spremljanje kliničnega odziva, pri čemer bo morda potrebna prilagoditev odmerka, glejte poglavje 5.2.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Slovenian: Obloga tablete makrogol (3350) polivinilalkohol smukec titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) črni železov oksid (E172)
English: Plenadren has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Plenadren ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate
Slovenian: Jedro tablete hipromeloza mikrokristalinska celuloza predgelirani škrob (koruzni) brezvodni koloidni silicijev dioksid magnezijev stearat
English: Plenadren can be used during breast-feeding.
Slovenian: Zdravilo Plenadren se lahko uporablja med dojenjem.
English: No study has been performed in patients with hepatic impairment, however data in the literature for hydrocortisone support that no dose adjustment is required in mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter ni bila izvedena nobena študija, vendar pa podatki iz literature o hidrokortizonu potrjujejo, da pri blago do zmerno okvarjenem delovanju jeter prilagajanje odmerka ni potrebno.
English: Old age and low body mass index are known risk factors for common adverse reactions of pharmacological doses of glucocorticoids such as osteoporosis, thinning of skin, diabetes mellitus, hypertension and increased susceptibility to infections.
Slovenian: Starost in nizek indeks telesne mase sta znana dejavnika tveganja za pogoste neželene učinke farmakoloških odmerkov glukokortikoidov, kot so osteoporoza, tanjšanje kože, sladkorna bolezen,
English: • Heartburn, aggravation of any existing stomach ulcer
Slovenian: • zgaga, draženje morebitnih razjed v želodcu
English: EU/1/11/715/006
Slovenian: EU/1/11/715/002 EU/1/11/715/006
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.
Slovenian: Pri približno enem od petih bolnikov je bilo po prehodu s konvencionalnih tablet hidrokortizona, ki so se jemale trikrat na dan, na tablete s prirejenim sproščanjem, ki se jemljejo enkrat na dan, v obdobju do osem tednov opaženo začetno povečanje pogostosti neželenih učinkov.
English: The dose of hydrocortisone should be carefully monitored during pregnancy in women with adrenal insufficiency.
Slovenian: Pri ženskah z adrenalno insuficienco je treba med nosečnostjo pozorno spremljati odmerek hidrokortizona.
English: In addition the following adverse reactions have been reported for other hydrocortisone medicinal products given for indications other than adrenal insufficiency replacement therapy in higher doses (frequencies not known).
Slovenian: Poleg navedenih neželenih učinkov so pri uporabi večjih odmerkov drugih zdravil, ki vsebujejo hidrokortizon in se ne uporabljajo za nadomestno zdravljenje adrenalne insuficience, temveč za druge indikacije, poročali tudi o naslednjih neželenih učinkih (pogostnost ni znana):
English: However, seek immediate medical help if you notice any of the following: severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, reduced consciousness, delirium (very confused state).
Slovenian: bolečine v trebuhu, slabost s siljenjem na bruhanje (navzea), bruhanje, bolečina v hrbtu, zmedenost, zmanjšana stopnja zavesti, delirij (stanje močne zmedenosti).
English: - if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Plenadren Ne jemljite zdravila Plenadren - če ste alergični na hidrokortizon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: High (supra-physiological) dosages of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Slovenian: Uporaba večjih odmerkov hidrokortizona od običajnih Visoki (suprafiziološki) odmerki hidrokortizona lahko povzročijo zvišanje krvnega tlaka, zadrževanje soli in vode ter povečano izločanje kalija.
English: Oral replacement doses must be individualised according to the clinical response.
Slovenian: Peroralni nadomestni odmerki se določijo za vsakega bolnika posebej na podlagi kliničnega odziva.
English: It is therefore important to take this medicine as directed by your doctor when driving or using machines.
Slovenian: Zato je pomembno, da pri upravljanju vozil in strojev jemljete zdravilo v skladu z zdravnikovimi navodili.
English: • Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.
Slovenian: • oslabitev kosti - to lahko povzroči zlome kosti • strije, podplutbe, aknam podobni izpuščaji, prekomerna rast dlak na obrazu, počasno celjenje ran.
English: Adrenal crisis can develop in patients with acute adrenal insufficiency.
Slovenian: Pri bolnikih z akutno adrenalno insuficienco se lahko razvije adrenalna kriza.
English: 50 modified-release tablets 100 modified-release tablets (2x50)
Slovenian: 100 tablet s prirejenim sproščanjem (2x50)
English: Skin and subcutaneous tissue disorders Cushing-like symptoms, stria, ecchymoses, acne and hirsutism, impaired wound healing.
Slovenian: Simptomi, podobi Cushingovemu sindromu, strije, ekhimoze, akne in hirsutizem, upočasnjeno celjenje ran.
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.
Slovenian: V primeru nizke telesne mase, povezane s starostjo, se priporoča spremljanje kliničnega odziva, pri čemer bo morda potrebno zmanjšanje odmerka, glejte poglavje 5.2.
English: In patients with severe renal impairment monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem ledvic se priporoča spremljanje kliničnega odziva, pri čemer bo morda potrebna prilagoditev odmerka, glejte poglavje 5.2.
English: • Stomach pain/heartburn, feeling sick or nauseated
Slovenian: • bolečine v trebuhu/zgaga, slabost ali siljenje na bruhanje
English: Plenadren 5 mg: the tablets are pink.
Slovenian: 5 mg tablete so rožnate barve.
English: Plenadren comes in bottles with a screw cap containing 50 tablets.
Slovenian: Zdravilo Plenadren je na voljo v plastenkah z navojno zaporko, ki vsebujejo po 50 tablet.
English: The clinical response needs to be monitored in patients given medicinal products affecting gastric emptying and motility, see section 4.4.
Slovenian: Pri bolnikih, ki jemljejo zdravila, ki vplivajo na praznjenje želodca in gibljivost črevesja, je treba spremljati klinični odziv; glejte poglavje 4.4.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Plenadren Vsebina pakiranja in dodatne informacije
English: Changing from conventional oral glucocorticoid treatment to Plenadren When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given.
Slovenian: Pri prehodu bolnikov s konvencionalnega peroralnega nadomestnega zdravljenja s hidrokortizonom, ki so ga bolniki jemali trikrat na dan, na zdravljenje z zdravilom Plenadren se lahko daje enak skupni dnevni odmerek.