FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration, hydrocortisone is rapidly and well absorbed from the gastrointestinal tract and the absorption has been reported to be more than 95% for an oral 20 mg dose (tablets).
Slovenian: Po peroralni uporabi se hidrokortizon hitro in dobro absorbira iz prebavnega trakta in poročali so, da je absorpcija več kot 95-odstotna pri peroralnem 20-miligramskem odmerku (tablete).
English: Hydrocortisone is eliminated completely by metabolism by 11ßHSD type 1 and type 2 enzymes and CYP 3A4 in the liver and in peripheral tissue.
Slovenian: Hidrokortizon se v celoti izloča s presnavljanjem encimov 11ßHSD tipa 1 in tipa 2 ter CYP 3A4 v jetrih in v perifernih tkivih.
English: The dose must therefore be increased temporarily and your doctor may advise you to use other hydrocortisone tablets instead of, or in addition to Plenadren.
Slovenian: Odmerek je zato treba začasno povečati in zdravnik vam bo morda svetoval, da namesto ali poleg zdravila Plenadren jemljete druge tablete kortizona.
English: If you stop taking Plenadren
Slovenian: Če ste prenehali jemati zdravilo Plenadren
English: INFORMATION IN BRAILLE Plenadren 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Plenadren 5 mg
English: The terminal half-life of cortisol following administration of Plenadren was about 3 hours and formulation release controlled.
Slovenian: Končni razpolovni čas kortizola po uporabi zdravila Plenadren je bil okoli 3 ure, pri čemer je šlo za formulacijo z nadzorovanim sproščanjem.
English: Other medicines and Plenadren
Slovenian: Druga zdravila in zdravilo Plenadren
English: OTHER Shire Services BVBA
Slovenian: DRUGI PODATKI Shire Services BVBA
English: If divided, crushed or chewed this may prevent the hydrocortisone dose in the tablet to cover the whole day, as it should.
Slovenian: Če tableto prelomite, zdrobite ali prežvečite, lahko s tem preprečite, da bi odmerek hidrokortizona, ki ga vsebuje tableta, zadoščal za ves dan, kot bi bilo pravilno.
English: Your blood pressure may increase, you may gain extra weight and your blood sugar may become too high.
Slovenian: Zviša se lahko vaš krvni tlak, pridobite lahko telesno maso in raven krvnega sladkorja se lahko zviša na previsoko raven.
English: See section 4.
Slovenian: glejte poglavje 4.4.
English: The absorption rate of hydrocortisone was reduced after food intake resulting in a delay in the time to maximal concentration in plasma from on average less than 1 hour to over 2.5 hours.
Slovenian: Hitrost absorpcije hidrokortizona se je po vnosu hrane zmanjšala, zaradi česar je prišlo do zakasnitve pri doseganju največje koncentracije v plazmi s povprečnega trajanja manj kot 1 uro na več kot
English: Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced.
Slovenian: Plodnost pri ženskah z adrenalno insuficienco ali pomanjkanjem kortizola je lahko zmanjšana.
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids.
Slovenian: Farmakoterapevtska skupina: kortikosteroidi za sistemsko uporabo, glukokortikoidi.
English: Signs include high blood pressure, elevated plasma glucose levels and hypokalaemia.
Slovenian: Znaki vključujejo visok krvni tlak, zvišano koncentracijo glukoze v plazmi in hipokalemijo.
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.
Slovenian: Nezdravljena adrenalna insuficienca med nosečnostjo je povezana s slabim izidom tako za mater kot za plod, zato je pomembno, da se zdravljenje med nosečnostjo nadaljuje.
English: Hydrocortisone is excreted in breast milk.
Slovenian: Hidrokortizon se izloča v materino mleko.
English: This terminal half-life is similar to the pharmacokinetics of endogenous cortisol that also is secretion-controlled.
Slovenian: Ta končni razpolovni čas je podoben farmakokinetiki endogenega kortizola, pri katerem je nadzorovano tudi izločanje.
English: If you take more Plenadren than you should
Slovenian: Če ste vzeli večji odmerek zdravila Plenadren, kot bi smeli
English: CYP 3A4 is involved in the clearance of cortisol by the formation of 6β-hydroxycortisol which is excreted in urine.
Slovenian: CYP 3A4 vpliva na očistek kortizola s tvorjenjem 6β-hidroksikortizola, ki se izloča z urinom.
English: In situations when the body is exposed to excessive physical and/or mental stress, patients may need additional substitution of immediate release hydrocortisone tablets especially in the afternoon/evening, see also section ‘Use in intercurrent illness' where other ways of temporarily increasing the dose of hydrocortisone is described.
Slovenian: Kadar je telo izpostavljeno čezmernemu telesnemu in/ali psihičnemu naporu, bodo bolniki morda potrebovali dodatne nadomestne tablete hidrokortizona s takojšnjim sproščanjem, zlasti popoldne/zvečer; glejte tudi poglavje „Uporaba pri sočasni bolezni“, kjer so opisani drugi načini začasnega povečanja odmerka hidrokortizona
English: When your illness is over, return to your normal maintenance dose of this medicine.
Slovenian: Ko ozdravite, ponovno začnite jemati običajni vzdrževalni odmerek tega zdravila.
English: The following signs and symptoms may suggest that you need to take additional doses of Plenadren or other forms of hydrocortisone: fatigue, weight loss, stomach discomfort, feeling light headed when you change from sitting to standing or dizziness when standing, darkening of your skin particularly skin creases and exposed areas.
Slovenian: Naslednji znaki in simptomi lahko kažejo na to, da morate vzeti dodatne odmerke zdravila Plenadren ali drugih oblik hidrokortizona: utrujenost, hujšanje, nelagodje v želodcu, občutek omotičnosti, ko vstanete iz sedečega položaja, ali občutek omotice v stoječem položaju, potemnitev kože, posebno kožnih gub in izpostavljenih predelov.
English: Moreover, there is no reason to believe that doses of hydrocortisone used for replacement therapy in adrenal insufficiency may reduce the response to vaccines and increase the risk of generalised infection with live vaccines.
Slovenian: Prav tako ni nobenega razloga za mnenje, da bi odmerki hidrokortizona, ki se uporabljajo za nadomestno zdravljenje pri adrenalni insuficienci, lahko zmanjšali odziv na cepiva ali povečali tveganje za splošno okužbo z živimi cepivi.
English: INFORMATION IN BRAILLE Plenadren 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Plenadren 20 mg
English: Dosing according to individual clinical response is recommended.
Slovenian: Priporoča se odmerjanje glede na klinični odziv posameznice.
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.
Slovenian: Klinična učinkovitost Ključna študija je bilo randomizirano navzkrižno multicentrično 12-tedensko preskušanje v dveh obdobjih, v katerem je sodelovalo 64 bolnikov s primarno adrenalno insuficienco, od katerih jih je 11 imelo sočasno sladkorno bolezen in 11 hipertenzijo.
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.
Slovenian: Med adrenalno krizo se morajo dajati veliki parenteralni, po možnosti intravenski odmerki hidrokortizona, skupaj z raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje, v skladu z veljavnimi smernicami za zdravljenje.
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.
Slovenian: Bolnika je treba natančno poučiti o ravnanju v takšnih primerih in mu svetovati, da v primeru akutnega poslabšanja nemudoma poišče zdravniško pomoč; zlasti v primerih gastroenteritisa, bruhanja in/ali driske, ki povzroča izgubo tekočine in soli ter neustrezno absorpcijo peroralnega hidrokortizona.
English: The immediate-release part provides a rapid onset of absorption and the extended-release part provides a more extended plasma profile of cortisol.
Slovenian: Del s takojšnjim sproščanjem zagotavlja hiter začetek absorpcije, del s podaljšanim sproščanjem pa podaljšan profil kortizola v plazmi.
English: Since severe renal impairment may affect medicinal products completely eliminated via metabolism, dose adjustment may be needed.
Slovenian: Ker lahko hudo okvarjeno delovanje ledvic vpliva na zdravila, ki se v celoti izločajo s presnavljanjem, bo morda potrebna prilagoditev odmerka.
English: In plasma, cortisol is bound to corticosteroid-binding globulin (CBG, also called transcortin) and albumin.
Slovenian: V plazmi se kortizol veže na vezavni protein za kortikosteroid (CBG-corticosteroid-binding globulin, imenovan tudi transkortin), in albumin.
English: Glucocorticoids are important steroids for intermediary metabolism, immune function, musculoskeletal and connective tissue and the brain.
Slovenian: Glukokortikoidi so pomembni steroidi za vmesno presnavljanje, delovanje imunskega sistema, mišično-skeletni sistem in vezivno tkivo ter možgane.
English: Patients with adrenal insufficiency and concomitant retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
Slovenian: Bolniki z adrenalno insuficienco in sočasno retrovirusno okužbo, kot je HIV, potrebujejo natančno prilagoditev odmerka zaradi možnega medsebojnega delovanja s protiretrovirusnimi zdravili ter povečan odmerek hidrokortizona zaradi okužbe.
English: The terminal half-life has been reported to be about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets.
Slovenian: Poročali so, da je končni razpolovni čas okoli 1,5 ure po intravenski in peroralni uporabi tablet hidrokortizona.
English: Date of latest renewal: 8
Slovenian: Datum prve odobritve: 3. november 2011 Datum zadnjega podaljšanja: 8. avgust 2016
English: Plenadren can be used during pregnancy.
Slovenian: Zdravilo Plenadren se lahko uporablja med nosečnostjo.
English: Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations).
Slovenian: Poskusi na živalih so pokazali, da lahko predporodna izpostavitev zelo visokim odmerkom glukokortikoidov povzroči nepravilnosti (palatoshiza, skeletne malformacije).
English: If you are to have surgery, tell your doctor/dentist before the surgery that you are taking this medicine.
Slovenian: Če boste operirani, zdravnika/zobozdravnika pred posegom obvestite, da jemljete to zdravilo;
English: These tablets deliver hydrocortisone to your body throughout the day.
Slovenian: Tablete vaše telo skozi ves dan oskrbujejo s hidrokortizonom.
English: • Pain in the joints
Slovenian: • bolečine v sklepih
English: Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines.
Slovenian: Nezadostno zdravljena ali nezdravljena adrenalna insuficienca zmanjšuje vašo sposobnost koncentracije in bo vplivala na sposobnost vožnje in upravljanja s stroji.
English: Patients suffering from long-term (chronic) adrenal insufficiency need a replacement therapy to survive.
Slovenian: Bolniki z dolgotrajno (kronično) adrenalno insuficienco za preživetje potrebujejo nadomestno zdravljenje.
English: Glucocorticoids cause profound and varied metabolic effects.
Slovenian: Glukokortikoidi povzročajo močne in različne presnovne učinke.
English: The clinical response should be monitored in patients with these conditions.
Slovenian: Pri bolnikih s temi boleznimi je treba spremljati klinični odziv.
English: In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
Slovenian: Pri bolnikih, pri katerih se še tvori endogeni kortizol, bo morda zadostoval manjši odmerek.
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.
Slovenian: Biološka razpoložljivost (AUC0-24h) je za 20 % manjša pri tabletah s prirejenim sproščanjem v primerjavi z enakim dnevnim odmerkom hidrokortizona, ki se daje s konvencionalnimi tabletami trikrat na dan.
English: Plenadren is given as maintenance therapy.
Slovenian: Zdravilo Plenadren se daje kot vzdrževalna terapija.
English: 40 mg is the highest maintenance dose studied.
Slovenian: Največji preučeni vzdrževalni odmerek je 40 mg.
English: During long term treatment with medicines treating infections (antibiotics) the dose of Plenadren may need adjustment by your doctor.
Slovenian: Med dolgotrajnim zdravljenjem z zdravili za okužbe (antibiotiki) bo zdravnik morda moral prilagoditi odmerek zdravila Plenadren.
English: Hydrocortisone interactions listed below have been reported after therapeutic doses of glucocorticoids.
Slovenian: O spodaj navedenih interakcijah hidrokortizona so poročali po uporabi terapevtskih odmerkov glukokortikoidov.
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).
Slovenian: V primerjavi s konvencionalnimi tabletami, ki se dajejo trikrat na dan, se je pri tabletah s prirejenim sproščanjem, ki se jemljejo enkrat na dan, pokazala večja izpostavljenost kortizolu v prvih štirih urah po jemanju zjutraj, popoldne/zvečer in v 24 urah pa je bila izpostavljenost manjša (Slika 1).
English: In these situations you should seek immediate medical care in order to receive treatment with injections of hydrocortisone and extra fluid administration.
Slovenian: V teh primerih nemudoma poiščite zdravniško pomoč, da prejmete zdravljenje z injekcijami hidrokortizona in dodatno tekočino;
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.
Slovenian: Ti neželeni učinki (bolečine v trebuhu, driska, navzea in utrujenost) so blagi ali zmerni, prehodni in kratkotrajni, lahko pa zahtevajo prilagoditev odmerka ali dodatno sočasno zdravljenje z drugimi zdravili, glejte poglavje 4.2.
English: Psychiatric disorders Euphoria and psychosis, insomnia.
Slovenian: Psihiatrične motnje Evforija in psihoza, nespečnost.
English: Scientific reports do not support immunosuppressive effects of hydrocortisone in doses that have been used for replacement therapy in patients with adrenal insufficiency.
Slovenian: Znanstvena poročila ne podpirajo imunosupresivnih učinkov hidrokortizona v odmerkih, ki so se uporabljali kot nadomestno zdravljenje pri bolnikih z adrenalno insuficienco.
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.
Slovenian: Hidrokortizon je učinkovina skupine II po sistemu biofarmacevtske klasifikacije (BCS) z visoko prepustnostjo skozi črevesje in nizko stopnjo raztapljanja, zlasti pri večjih odmerkih.
English: Endocrine disorders Induction of glucose intolerance or diabetes mellitus.
Slovenian: Bolezni endokrinega sistema Pojav intolerance za glukozo ali sladkorne bolezni.
English: It should be swallowed whole; tablets should not be divided, chewed or crushed.
Slovenian: Tableto mora bolnik pogoltniti celo; ne sme je prelomiti, prežvečiti ali zdrobiti.
English: No antidote is available.
Slovenian: Antidota ni.
English: Increasing the dose of hydrocortisone at one dose occasion increases the total plasma exposure of cortisol less than proportional, see section 5.2.
Slovenian: Povečanje odmerka hidrokortizona z enkratnim odmerkom, poveča skupno izpostavljenost kortizola v plazmi manj kot sorazmerno, glejte poglavje 5.2.
English: Prolonged use of high doses of glucocorticoids may produce posterior subcapsular cataracts, and glaucoma with possible damage to the optic nerves.
Slovenian: Podaljšana uporaba visokih odmerkov glukokortikoidov lahko povzroči posteriorne subkapsularne katarakte in glavkom z možnimi poškodbami optičnih živcev.
English: If used with mifepristone, a treatment used to end a pregnancy, the effect of Plenadren may be reduced.
Slovenian: Če zdravilo Plenadren uporabljate skupaj z mifepristonom, zdravilom za prekinitev nosečnosti, bo učinek zdravila Plenadren morda manjši.
English: • Rifampicin or rifabutin - used to treat tuberculosis
Slovenian: • rifampicin ali rifabutin - uporabljata se za zdravljenje tuberkuloze
English: Naturally-occurring glucocorticoids (hydrocortisone and cortisol), which also have salt-retaining properties, are used as replacement therapy in adrenal insufficiency.
Slovenian: Naravno prisotni glukokortikoidi (hidrokortizon in kortizol), ki imajo sposobnost zadrževanja soli, se uporabljajo kot nadomestno zdravljenje pri adrenalni insuficienci.
English: In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone.
Slovenian: V primeru hudo okvarjenega delovanja jeter se masa delujočih jeter zmanjša in s tem tudi zmožnost presnavljanja hidrokortizona.
English: In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral, preferably intravenous treatment.
Slovenian: V hudih primerih je treba nemudoma povečati odmerek, peroralno uporabo hidrokortizona pa nadomestiti s parenteralnim, po možnosti intravenskim zdravljenjem.
English: There is no indication that Plenadren, in doses used for replacement therapy, will have an effect on fertility.
Slovenian: Nič ne kaže na to, da bi zdravilo Plenadren v odmerkih, ki se uporabljajo za nadomestno zdravljenje, vplivalo na plodnost.
English: During short-term or temporary illnesses such as infection, fever, or physical stress such as surgery you will need more hydrocortisone since the body cannot produce the additional amount of cortisol required in these situations.
Slovenian: Med kratkotrajnimi ali začasnimi boleznimi, kot sta okužba in zvišana telesna temperatura, ali pri telesnem naporu, kot je operacija, boste potrebovali več hidrokortizona, saj telo ne more proizvajati dodatne količine kortizola, ki ga v takšnih primerih potrebuje.
English: Untreated and poorly replaced adrenal insufficiency may affect the ability to drive and use machines.
Slovenian: Nezdravljena ali slabo nadomeščena adrenalna insuficienca lahko vpliva na sposobnost vožnje in upravljanja s stroji.
English: During long-term prophylactic treatment with any of the antibiotics, adjustment of the hydrocortisone dosage should be considered.
Slovenian: Med dolgotrajnim profilaktičnim zdravljenjem s katerim od navedenih antibiotikov je treba razmisliti o prilagoditvi odmerka hidrokortizona.
English: If you are changing treatment from other hydrocortisone tablets to Plenadren you may experience side effects during the first weeks.
Slovenian: Če spreminjate zdravljenje s prehodom z drugih tablet hidrokortizona na zdravilo Plenadren, se lahko v prvih tednih po prehodu pojavijo neželeni učinki.
English: Adrenal insufficiency occurs when your adrenal glands (just above your kidneys) do not produce enough of the hormone cortisol.
Slovenian: Do adrenalne insuficience pride, ko nadledvične žleze (tik nad ledvicami) ne tvorijo zadostne količine hormona kortizola.
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.
Slovenian: Akutna adrenalna insuficienca se lahko razvije pri bolnikih z znano adrenalno insuficienco, ki prejemajo nezadostne dnevne odmerke, ali v razmerah, ko so potrebe po kortizolu zvečane.
English: Immune system disorders Activation of infection (tuberculosis, fungal and viral infections including herpes).
Slovenian: Sprožitev okužbe (tuberkuloza, glivične in virusne okužbe, vključno s herpesom).
English: Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels.
Slovenian: Povzetek varnostnega profila Hidrokortizon se daje kot nadomestno zdravljenje za ponovno vzpostavitev normalne ravni kortizola.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Slovenian: V študiji so primerjali tablete s prirejenim sproščanjem, ki se jemljejo enkrat na dan, s konvencionalnimi tabletami, ki se dajejo trikrat na dan, pri čemer je bil v obeh primer uporabljen enak odmerek hidrokortizona (od 20 do 40 mg).
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.
Slovenian: Zdravljenje verjetno ni indicirano za neželene učinke zaradi kronične zastrupitve, razen če ima bolnik bolezen, zaradi katere je neobičajno občutljiv za škodljive učinke hidrokortizona.
English: At the discretion of the treating physician, immediate release hydrocortisone tablets can be given instead of Plenadren or may be added to treatment.
Slovenian: Po presoji lečečega zdravnika se lahko bolniku namesto zdravila Plenadren dajo tablete hidrokortizona s takojšnjim sproščanjem ali pa se dodajo zdravljenju.
English: Reproductive studies in animals have shown that glucocorticoids can cause foetal abnormalities and reproductive toxicity, see section 5.3.
Slovenian: Reproduktivne študije na živalih so pokazale, da lahko glukokortikoidi povzročajo nepravilnosti pri plodu, in vpliv na sposobnost razmnoževanja, glejte poglavje 5.3.
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.
Slovenian: Profil neželenih učinkov pri zdravljenju adrenalne insuficience zato ni primerljiv s profilom pri drugih boleznih, ki zahtevajo večje odmerke peroralnih ali parenteralnih glukokortikoidov.
English: Infants of mothers taking high doses of systemic glucocorticoids for prolonged periods may be at risk of adrenal suppression.
Slovenian: Dojenčki mater, ki dalj časa jemljejo visoke odmerke sistemskih glukokortikoidov, so lahko izpostavljeni tveganju za adrenalno supresijo.
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.
Slovenian: - če imate kratkotrajno ali začasno bolezen, kot so okužbe ali zvišana telesna temperatura, ali pri velikem telesnem naporu, kot je kirurški poseg: vaš odmerek hidrokortizona se mora začasno povečati.
English: These side effects can be: stomach pain, feeling sick and tiredness.
Slovenian: Ti neželeni učinki so lahko: bolečine v trebuhu, slabost in utrujenost.