natgillin/translations-raw huggingface dataset:
Onsenal at a dose of 400 mg twice a day was more effective than placebo.
Zdravilo Onsenal v odmerku 400 mg dvakrat dnevno je bilo učinkovitejše od placeba.
What benefit has Onsenal shown during the studies?
Kakšne koristi je zdravilo Onsenal izkazalo med študijami?
The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje števila polipov v določenem predelu kolona ali danke po šestih mesecih zdravljenja.
For more information about treatment with Onsenal, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Onsenal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The recommended dose of Onsenal is 400 mg twice a day with food.
Priporočeni odmerek zdravila Onsenal je 400 mg dvakrat dnevno s hrano.
COX-2 is found at high levels in adenomatous colorectal polyps.
Velike količine COX-2 najdemo tudi v adenomatoznih kolorektalnih polipih.
Because the number of patients with FAP is low, the disease is considered ‘rare', and Onsenal was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 November 2001.
Ker je število bolnikov s familiarno adenomatozno polipozo majhno, velja ta bolezen za redko, zato je bilo zdravilo Onsenal dne 20. novembra 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Onsenal, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For the full list of restrictions, see the
Za celoten seznam omejitev glejte navodilo za uporabo.
The maximum recommended daily dose of Onsenal is 800 mg.
Največji priporočeni dnevni odmerek zdravila Onsenal je 800 mg.
This document is a summary of the European Public Assessment Report (EPAR) for Onsenal.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Onsenal.
In the study, 25 patients had an intact colon, but the remainder had had some or all of their colon removed through surgery.
V študiji je bil pri 25 bolnikih kolon cel, pri preostalih pa je bil v celoti ali delno kirurško odstranjen.
The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
Najpogostejša neželena učinka zdravila Onsenal (opažena pri več kot 1 bolniku od 10) sta hipertenzija (povišani krvni tlak) in driska.
Onsenal is a medicine that contains the active substance celecoxib.
Onsenal je zdravilo, ki vsebuje zdravilno učinkovino celekoksib.
What is the risk associated with Onsenal?
Kakšna tveganja so povezana z zdravilom Onsenal?
The summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal is available
Povzetek mnenja Odbora za zdravila sirote o zdravilu Onsenal je na voljo tukaj.
The Committee recommended that Onsenal be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Onsenal odobri dovoljenje za promet.
Onsenal must not be given to pregnant women or women who could become pregnant unless they are using an effective method of contraception, or to women who are breast-feeding.
Zdravila Onsenal ne smejo uporabljati nosečnice in ženske, ki bi lahko zanosile, razen če uporabljajo učinkovito kontracepcijsko zaščito, ali ženske, ki dojijo.
What information is still awaited for Onsenal?
Katere informacije o zdravilu Onsenal še pričakujemo?
In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number had fallen by 5% in the patients taking placebo.
Po šestih mesecih je zdravilo Onsenal pri odraslih zmanjšalo povprečno število polipov za 28 %, pri tistih, ki so prejemali placebo, pa se je to število zmanjšalo za 5 %.
In patients with moderate liver disease, the dose of Onsenal should be halved.
Pri bolnikih z zmerno jetrno okvaro je treba odmerek zdravila Onsenal zmanjšati za polovico.
The CHMP decided that Onsenal's benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Onsenal večje od z njim povezanih tveganj, vendar je pripomnil, da vpliv zdravila Onsenal na tveganje za nastanek raka v črevesju ni bil dokazan.
By blocking the activity of COX-2, celecoxib helps to slow down the formation of polyps by stopping them developing their own blood supply and by increasing the rate of cell death.
Celekoksib z zaviranjem delovanja COX-2 pripomore k upočasnitvi nastajanja polipov, saj prepreči njihovo lastno oskrbo s krvjo ter pospeši odmiranje celic v polipih.
Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Zdravilo Onsenal se uporablja kot dodatek operaciji (za odstranitev polipov) in endoskopskemu nadzoru (preverjanju, ali nastajajo polipi, kar se opravi z endoskopom - tanko cevko, s katero zdravnik lahko opazuje notranjost črevesja).
Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
Zdravilo Onsenal se uporablja za zmanjšanje števila polipov pri bolnikih s familiarno adenomatozno polipozo (FAP).
The company that makes Onsenal has committed to carrying out a study in patients with FAP, in order to collect more information on the medicine's safety and effectiveness.
Družba, ki izdeluje zdravilo Onsenal, bo opravila študijo pri bolnikih s familiarno adenomatozno polipozo, da bi zbrala več podatkov o varnosti in učinkovitosti zdravila.
The active substance in Onsenal, celecoxib, is a ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Zdravilna učinkovina zdravila Onsenal, celekoksib, je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino „zaviralcev ciklooksigenaze 2 (COX-2)“.
Onsenal has been studied in one main study involving 83 adults (aged 18 years or over) with FAP, in which two doses of Onsenal were compared with placebo (a dummy treatment).
Zdravilo Onsenal so proučevali v eni glavni študiji, v katero je bilo vključenih 83 odraslih (starih najmanj 18 let) s familiarno adenomatozno polipozo in v kateri so dva odmerka zdravila Onsenal primerjali s placebom (zdravilom brez zdravilne učinkovine).
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Celekoksib zavira encim COX-2, kar povzroči zmanjšanje nastajanja prostaglandinov, tj. snovi, ki sodelujejo pri procesih, kot so vnetja in dejavnosti gladkih mišic (mišic, ki opravljajo samodejne dejavnosti, kot so odpiranje in zapiranje žil).
Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Zdravila Onsenal ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) celekoksib, katero koli drugo sestavino zdravila ali sulfonamide (nekatere antibiotike).
This is a genetic disease that causes ‘adenomatous intestinal polyps', growths that project from the lining of the colon or rectum (large intestine).
To je genetska bolezen, pri kateri nastajajo „adenomatozni intestinalni polipi“, izrastki na sluznici kolona ali danke (debelega črevesa).
It must not be used in patients who have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type reactions after taking aspirin or an NSAID, including another COX-2 inhibitor.
Zdravila Onsenal ne smejo uporabljati osebe, ki imajo aktivno razjedo ali krvavitev v želodcu ali črevesju, in osebe, ki so kadar koli imele alergijsko reakcijo po uporabi aspirina ali nesteroidnega protivnetnega zdravila, vključno z drugimi zaviralci COX-2.
For the full list of all side effects reported with Onsenal, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onsenal, glejte navodilo za uporabo.
Onsenal must not be given to patients with severe liver or kidney problems.
Zdravila Onsenal ne smejo jemati bolniki s hudimi obolenji jeter ali ledvic.
It must not be given to patients with severe liver or kidney disease, patients with a disease causing inflammation of the bowel, or patients with certain problems affecting the heart or blood vessels.
Ne smejo ga uporabljati bolniki s hudim obolenjem jeter ali ledvic, bolniki z vnetno črevesno boleznijo ali bolniki z določenimi boleznimi srca in ožilja.
An additional study looked at the effects of Onsenal in 18 patients aged 10 to 14 years with FAP.
V dodatni študiji so proučevali učinke zdravila Onsenal pri 18 bolnikih, starih od 10 do 14 let, s familiarno adenomatozno polipozo.
How does Onsenal work?
Kako zdravilo Onsenal deluje?
A lower starting dose may be needed in patients whose bodies may break Onsenal down slowly.
Pri bolnikih, pri katerih bo presnova zdravila Onsenal morda počasnejša, bo morda potreben nižji začetni odmerek.
It is available as white capsules
Na voljo je v obliki belih kapsul (200 in 400 mg).
Onsenal also reduced the number of polyps in patients aged 10 to 14
Zdravilo Onsenal je povzročilo tudi zmanjšanje števila polipov pri bolnikih, starih od 10 do 14 let, ki so imeli familiarno adenomatozno polipozo.
The full EPAR for Onsenal can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Onsenal je na voljo tukaj.
The usual medical care for FAP
Povzetek EPAR za javnost
Date of first authorisation: 09 February 2018
Datum prve odobritve: 09. februarja 2018
After first opening: 60 days.
Po prvem odprtju: 60 dni.
No antidote is available.
Antidot ni na voljo.
Strength (ink colour) Also contains:
Jakost (barva črnila) Vsebuje tudi:
If your child becomes unwell
Če se otrok začne počutiti slabo
68.8% of healthy adult volunteers have described the taste as neutral.
68,8 % zdravih odraslih prostovoljcev je okus opisalo kot nevtralen.
50 capsules
50 kapsul
The lowest possible dosage should be used.
Uporabiti je treba najnižji možni odmerek.
ATC code: H02AB09
Oznaka ATC: H02AB09
The biological half-life of hydrocortisone is about 100 minutes.
Biološka razpolovna doba hidrokortizona znaša približno 100 minut.
During stress it may be necessary to increase the dose temporarily.
Med stresom bo morda treba začasno zvišati odmerek.
≥50% subjects reported that the taste, feel in mouth and ease of swallowing were very good and that they were likely to take the medicinal product again.
Pri tem je ≥ 50 % oseb poročalo, da so bili okus, občutek v ustih in preprostost požiranja zelo dobri in da bi zdravilo po vsej verjetnosti spet vzeli.
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Nadomestno zdravljenje adrenalne insuficience pri dojenčkih, otrocih in mladoletnikih (od rojstva do starosti < 18 let).
Indigotine (E132)
indigotin (E132)
Infections and immunisation
Okužbe in imunizacija
Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 France
Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 Francija
Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.
Pred začetkom dajanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
In which case, symptomatic treatment should be instituted as necessary.
tem primeru je treba po potrebi uvesti simptomatsko zdravljenje.
intense feeling of happiness and excitement (euphoria).
močan občutek sreče in vznemirjenja (evforija).
The study consisted of three consecutive cohorts, the first including 12 patients aged 2 to less than 6 years, the second including 6 patients aged 28 days to less than 2 years, and the third including 6 neonates aged from birth to less than 28 days.
Študijo so sestavljale tri zaporedne kohorte: prva je vključevala 12 bolnikov, starih od dve do manj kot šest let, druga je vključevala šest bolnikov, starih od 28 dni do manj kot dve leti, tretja pa šest novorojenčkov od rojstva do starosti manj kot 28 dni.
As this was a single-dose study, the primary efficacy assessment was serum cortisol at 60 minutes.
Ker je šlo za študijo z enim odmerkov, je bila primarna ocena učinkovitosti kortizol v serumu po 60 minutah.
Infants require frequent assessment and should be evaluated at a minimum every 3 to 4 months to assess growth, blood pressure, and general well-being.
Dojenčke je treba pregledovati pogosto; najmanj vsake tri do štiri mesece je treba oceniti njihovo rast, krvni tlak in splošno počutje.
Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Poročila o akutni toksičnosti in/ali smrtih po prevelikem odmerku hidrokortizona so redka.
If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use.
Če zrnca posujete po žlici mehke hrane, jih je otroku treba dati takoj (v petih minutah) in ne hraniti za prihodnjo uporabo.
In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening.
Kadar je telo izpostavljeno prekomernemu telesnemu in/ali duševnemu stresu, bolniki morda potrebujejo zvečan odmerek, še posebej popoldan ali zvečer.
Six of the 12 children in Cohort 1 (age range 2.6 to 4.7 years) responded to an adjusted palatability questionnaire.
Šest otrok od 12 v prvi kohorti (v starostnem razponu od 2,6 do 4,7 let) je odgovorilo na prilagojeni vprašalnik o sprejemljivosti okusa.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those which can be obtained without a prescription.
Obvestite zdravnika ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo, vključno z zdravili brez recepta.
• Periodic safety update reports (PSURs)
• Redna posodobljena poročila o varnosti zdravila (PSUR)
Risks may be higher with high doses/systemic exposure (see also section 4.5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions.
Pri višjih odmerkih/sistemski izpostavljenosti je tveganje lahko višje (glejte tudi poglavje 4.5), čeprav ravni odmerkov ne omogočajo predvidevanja glede začetka, vrste, resnosti ali trajanja učinkov.
If you forget to give your child a dose, give your child that dose as soon as you remember as well as their next dose at the usual time even if this means that your child receives two doses at the same time.
Če ste otroku pozabili dati odmerek, mu ta odmerek dajte takoj, ko se spomnite, hkrati pa mu ob običajnem času dajte tudi naslednji odmerek, tudi če to pomeni, da bo otrok prejel dva odmerka hkrati.
The need for dose adjustment when such medicinal products are used can be anticipated and patients should be closely monitored.
Pri uporabi takih zdravil je treba predvideti prilagoditev odmerka, bolnike pa je treba pozorno spremljati.
Treatment should be limited to the minimum dosage required to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual.
Zdravljenje mora biti omejeno na najmanjši odmerek, ki je potreben za doseganje želenega kliničnega odziva, kadar pa je odmerek mogoče znižati, mora biti znižanje postopno.
The binding is accounted for by two protein fractions.
Za vezavo sta pomembni dve beljakovinski frakciji.
- If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
- če je vaš otrok alergičen na hidrokortizon ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4).
Hidrokortizon se presnavlja s citokromom P450 3A4 (CYP3A4).
This does not mean the medicinal product has been ineffective and the patient should not take another dose for this reason.
To ne pomeni, da je bilo zdravilo neučinkovito, in bolnik zaradi tega ne sme vzeti še enega odmerka.
This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
Ta vrsta relativne insuficience lahko traja več mesecev po prekinitvi zdravljenja, zato je treba ob vsaki stresni situaciji v tem obdobju ponovno vzpostaviti zdravljenje s kortikosteroidi.
Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve
Pred operacijo, med resno travmo ali boleznijo pri bolnikih z znano adrenalno insuficienco ali vprašljivo adrenalno rezervo
Of these 24 patients, 23 had a diagnosis of CAH and 1 had a diagnosis of hypopituitarism including hypothyroidism.
Od teh 24 bolnikov jih je bilo 23 z diagnozo KAH, eden pa z diagnozo hipopituitarizma, vključno s hipotiroidizmom.
The lowest appropriate dose of steroid according to the response of the individual patient should be used.
Uporabiti je treba najnižji ustrezni odmerek steroidov glede na odziv posameznega bolnika.
Among parents and carers asked about their child's experience of taking the medication (n=23), 82.6% agreed/strongly agreed that their child found swallowing Alkindi easy; 65.2% agreed/strongly agreed that their child showed a positive reaction after Alkindi administration; 95.5% would be happy to give their child Alkindi in the future; and 95.5% said that they would prefer Alkindi for their child's treatment over their usual hydrocortisone formulation.
Med starši in skrbniki, ki so bili vprašani o otrokovi izkušnji jemanja zdravila (n = 23), se jih je 82,6 % strinjalo/močno strinjalo, da je otrok brez težav pogoltnil zdravilo Alkindi, 65,2 % se jih je strinjalo/močno strinjalo, da je njihov otrok po dajanju zdravila Alkindi pozitivno reagiral, 95,5 % bi jih z veseljem dajalo otroku zdravilo Alkindi tudi v prihodnje, 95,5 % pa jih je izjavilo, da bi pri zdravljenju svojega otroka raje kot formulacijo hidrokortizona, ki jo običajno uporabljajo, uporabili zdravilo Alkindi.
Infection should not be more likely at a replacement dose of hydrocortisone, but all infections should be treated seriously and stress dosing of steroid initiated early (see section 4.2).
Okužba pri nadomestnem odmerku hidrokortizona ni verjetnejša, vendar je treba vse okužbe obravnavati resno, odmerjanje steroidov ob stresu pa začeti zgodaj (glejte poglavje 4.2).
Studies in animals have shown reproductive toxicity of corticosteroids (see section 5.3)
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja kortikosteroidov (glejte poglavje 5.3).
The granules should be given into the mouth and should not be chewed.
Zrnca je treba dati v usta in se ne smejo žvečiti.
What you need to know before you give Alkindi 3.
Kaj morate vedeti, preden boste dali zdravilo Alkindi 3.
This does not mean the medicine will not work and you do not need to give your child another dose.
To ne pomeni, da zdravilo ne bo delovalo, in otroku ne smete dati še enega odmerka.
- If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth.
- če vaš otrok težko požira hrano ali pa je nedonošenček, ki še ne more biti hranjen prek ust.
Do NOT swallow the capsule - small children may choke.
Kapsula se NE sme pogoltniti - majhni otroci se lahko z njo zadušijo.
They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Zaradi svojih močnih protivnetnih učinkov se uporabljajo tudi pri boleznih mnogih organskih sistemov.
Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10-15 mg/m2/day in patients with congenital adrenal hyperplasia (CAH), typically in three or four divided doses.
Priporočeni nadomestni odmerki hidrokortizona znašajo 8-10 mg/m2/dan za bolnike samo z adrenalno insuficienco in 10-15 mg/m2/dan za bolnike s kongenitalno adrenalno hiperplazijo (KAH), ki se običajno dajejo v treh ali štirih ločenih odmerkih.
What Alkindi is and what it is used for 2.
Kaj je zdravilo Alkindi in za kaj ga uporabljamo 2.
- In some patients with allergies to other medicines, allergy to hydrocortisone has been seen.
- pri nekaterih bolnikih z alergijami na druga zdravila so opazili alergijo na hidrokortizon.
Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.
Takoj po dajanju zdravila je treba otroku dati piti, na primer vodo, mleko, materino mleko ali mlečno formulo, da zagotovo pogoltne vsa zrnca.
Alkindi has no or negligible influence on the ability to drive and use machines.
Zdravilo Alkindi nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
V resnih situacijah je treba takoj povečati odmerek, peroralno dajanje hidrokortizona pa je treba zamenjati s parenteralnim zdravljenjem.
- The capsule is made from hypromellose.
- Kapsula je izdelana iz hipromeloze.
- Changes in blood potassium levels, leading to excessive alkalinity of body tissues or fluids (hypokalaemic alkalosis).
- Spremenjene ravni kalija v krvi, ki povzročajo prekomerno bazičnost tkiv ali tekočin v telesu (hipokaliemična alkaloza).
If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone.
Če vaš otrok bruha ali se počuti zelo slabo, bo morda potreboval injekcijo hidrokortizona.
Long-term treatment with hydrocortisone may be associated with changes in the development of bones and reduced growth.
Dolgotrajno zdravljenje s hidrokortizonom je lahko povezano s spremembami pri razvoju kosti in upočasnjeno rastjo.
Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
Sheme nadomestnega zdravljenja s kortikosteroidi pri osebah z adrenalno insuficienco ne povzročajo imunosupresije in zato niso kontraindikacija za cepljenje z živimi cepivi.
Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Bolnikom/skrbnikom je treba svetovati, naj poiščejo zdravniško pomoč, če opazijo zaskrbljujoče psihološke simptome, še zlasti znake depresivnega razpoloženja ali samomorilnih misli.
Hard capsule for opening, containing a single dose of granules.
Trda kapsula za odpiranje, ki vsebuje en odmerek zrnc.
Historical cohorts of adults treated from childhood for CAH have been found to have reduced bone mineral density and increased fracture rates and growth retardation (see section 4.4) - it is unclear if these relate to hydrocortisone therapy using current replacement regimens.
Pri historičnih kohortah odraslih, ki so bili v otroštvu zdravljeni zaradi KAH, so odkrili zmanjšano mineralno kostno gostoto, več zlomov in upočasnjeno rast (glejte poglavje 4.4) - ni jasno, ali se to nanaša na zdravljenje s hidrokortizonom s trenutnimi režimi nadomeščanja.
Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi.
Ko je epizoda vmesne bolezni končana, lahko bolniki spet prejemajo običajni nadomestni odmerek zdravila Alkindi.
There were no adverse reactions and no episodes of adrenal crisis seen in any of the studies.
V nobeni od študij niso opazili neželenih učinkov ali epizod adrenalne krize.