natgillin/translations-raw huggingface dataset:
Jorveza påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Jorveza has no or negligible influence on the ability to drive and use machines.
Jorveza leveres i blistre i pakninger med 20, 30, 60, 90 eller 100 smeltetabletter.
Jorveza comes in blisters in packs with 20, 30, 60, 90 or 100 orodispersible tablets.
Disse forsigtighedsregler sikrer, at den øsofageale slimhinde eksponeres optimalt for det aktive stof.
These measures ensure optimal exposure of the esophageal mucosa to the active substance.
Pakningsstørrelser: 20, 30, 60, 90 eller 100 smeltetabletter.
Pack sizes: 20, 30, 60, 90 or 100 orodispersible tablets.
Dette lægemiddel indeholder 52 mg natrium pr. daglig dosis, svarende til 2,6 % af den af WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
This medicinal product contains 52 mg of sodium per daily dose equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
I de tilfælde, hvor patienter skal opereres eller udsættes for andre stresssituationer, anbefales derfor supplerende systemisk glukokortikosteroidbehandling.
When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.
Administrationsmetode Tag smeltetabletten efter et måltid.
Method of administration Take the orodispersible tablet after a meal.
Bivirkninger, der blev observeret i kliniske studier med Jorveza angives i tabellen nedenfor, i henhold til MedDRA-systemorganklasse og hyppighed.
Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency.
Imidlertid foreligger der intet systematisk studie, som undersøger de forskellige grader af nedsat leverfunktion.
However, no systematic study investigating different levels of hepatic impairment is available.
Det skal besluttes, om amning skal ophøre eller behandling med budesonid seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
- Øvrige indholdsstoffer: Dinatriumhydrogencitrat, docusatnatrium, macrogol 6000, magnesiumstearat, mannitol, vandfri mononatriumcitrat, povidon K25, natriumhydrogencarbonat og sucralose (se også punkt 2, ”Jorveza indeholder natrium”).
- The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol 6000, magnesium stearate, mannitol, anhydrous monosodium citrate, povidone K25, sodium hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må ikke tygges eller synkes uopløst.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew or swallow.
MedDRA-systemorganklasse
MedDRA system organ class
Nogle glukokortikosteroider er rapporteret at forårsage ganespalte hos dyr.
Some glucocorticoids have been reported to produce cleft palate in animals.
Når ketoconazol blev givet ca. 12 timer efter budesonid, steg plasmakoncentrationen af budesonid ca. 3 gange.
When ketoconazole was administered approximately 12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.
Depression, irritabilitet, eufori, psykomotorisk hyperaktivitet, angst, aggression
Depression, irritability, euphoria, psychomotor hyperactivity, anxiety, aggression
Jorveza indeholder det aktive stof budesonid, et kortikosteroid-lægemiddel, der reducerer inflammation (betændelse).
Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.
I kliniske studier udført med Jorveza er orale, orofaryngeale og øsofageale svampeinfektioner blevet observeret med stor hyppighed (se pkt 4.8).
In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8).
− ritonavir og cobistat (til behandling af hiv-infektion)
− ritonavir and cobicistat (to treat HIV infections)
− østrogener (anvendes som hormonbehandling eller prævention)
− oestrogens (used for hormone replacement therapy or contraception)
Din læge vil beslutte den rette behandling, og om denne medicin stadig er den rette for dig.
Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.
Budesonid er et non-halogeneret glukokortikosteroid, hvis virkning primært er antiinflammatorisk via binding til glukokortikoid-receptoren.
Budesonide is a non-halogenated glucocorticosteroid, which acts primarily anti-inflammatory via binding to the glucocorticoid receptor.
Budenosid har ingen effekt på fertiliteten hos rotter.
Budesonide had no effect on fertility in rats.
Glukokortikosteroider kan forårsage undertrykkelse af hypothalamus-hypofyse-binyreaksen (HPA) og reducere stressresponset.
Glucocorticosteroids may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response.
Ved enhver brug af oral opløsning, spray eller tyggetabletter skal der gå mindst 30 minutter før og efter administration af Jorveza.
Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of Jorveza.
En betydelig del af budesonid metaboliseres i leveren af CYP3A4.
A relevant proportion of budesonide is metabolised in the liver by CYP3A4.
Behandlingen kan forlænges op til 12 uger for patienter, der ikke responderer tilfredsstillende i løbet af 6 uger.
For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.
Din læge vil hjælpe dig med beslutte, om du bør fortsætte behandlingen og undgå at amme, eller om du bør standse behandlingen i den periode, hvor du ammer dit barn.
Your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed.
I behandlingen af EoE med Jorveza hæmmer budesonid antigenstimuleret sekretion af mange proinflammatoriske signalmolekyler, såsom thymisk, stromal lymfopoeitin, interleukin-13 og eotaxin-3 i det øsofageale epitel, hvilket fører til en signifikant reduktion af det øsefageale inflammatoriske infiltrat.
In the treatment of EoE with Jorveza, budesonide inhibits antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, which results in a significant reduction of the esophageal eosinophilic inflammatory infiltrate.
EU/1/17/1254/001 (20 smeltetabletter) EU/1/17/1254/002 (30 smeltetabletter) EU/1/17/1254/003 (60 smeltetabletter) EU/1/17/1254/004 (90 smeltetabletter) EU/1/17/1254/005 (100 smeltetabletter)
EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Trafik- og arbejdssikkerhed Jorveza forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
Driving and using machines Jorveza is not expected to affect your ability to drive or use machines.
Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Tyskland
Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany
INFORMATION I BRAILLESKRIFT Jorveza 1 mg
INFORMATION IN BRAILLE Jorveza 1mg
(≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Under behandling af patienter med nedsat leverfunktion med andre budesonidholdige produkter var budesonidniveauerne øgede.
During treatment of patients with hepatic impairment with other budesonide containing products, budesonide levels were increased.
Der er ikke udført studier med Jorveza hos patienter med nedsat leverfunktion.
No studies have been conducted with Jorveza in patients with impaired liver function.
Forhøjede plasmakoncentrationer og øget virkning af glukokortikosteroider er beskrevet hos kvinder, som tager østrogener eller orale kontraceptiva.
Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives.
Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Hvis du har en leversygdom, må du ikke tage Jorveza.
If you have any liver disease, you should not take Jorveza.
Ketoconazol 200 mg 1 gang dagligt oralt øgede plasmakoncentrationen af budesonid (3 mg enkeltdosis) ca. 6 gange ved samtidig administration.
Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration.
Den mediane eliminationshalveringstid er 2 - 3 timer hos raske forsøgspersoner (der modtog 1 mg budesonid) og 4 - 5 timer hos EoE-patienter (der modtog 4 mg budesonid).
The median elimination half-life is 2 - 3 hours in healthy subjects (receiving 1 mg budesonide) and 4 - 5 hours in EoE patients (receiving 4 mg budesonide).
Farmakoterapeutisk klassifikation: Midler mod diarré og tarminflammation/-infektion, corticosteroider med lokal virkning, ATC-kode: A07EA06.
Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Fordelingsvolumen efter administration af 1 mg budesonid til raske personer var 35,52 ± 14,94 l/kg og 42,46 ± 23,90 l/kg efter administration af 4 mg budesonid til patienter med EoE.
The volume of distribution following administration of 1 mg budesonide to healthy subjects was 35.52 ± 14.94 L/kg and 42.46 ± 23.90 L/kg following administration of 4 mg budesonide to patients with EoE.
Øget risiko for trombose, vaskulitis (abstinenssyndrom efter langtidsterapi).
Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Jorvezas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Dosering Den anbefalede daglige dosis er 2 mg budesonid som én 1 mg tablet om morgenen og én om aftenen.
The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one in the evening.
Anvendes efter lægens anvisninger.
Use as directed by the physician.
I et randomiseret, placebokontrolleret, dobbeltblindet klinisk fase III-studie, der inkluderede 88 voksne patienter med aktiv EoE (randomiseringsrate: 2:1), inducerede 1 mg budesonid indgivet to gange dagligt som en smeltetablet i 6 uger klinisk-patologisk remission (defineret som både maksimalt < 16 eosinofiler/mm2 high power field (lysmikroskopi) i øsofageale biopsier, og ingen eller kun minimale symptomer på dysfagi eller smerter under synkning) hos 34 ud af 59 patienter (57,6 %) versus 0/29 patienter (0 %) i placebogruppen.
In a randomised, placebo-controlled, double-blind phase III clinical study including 88 adult patients with active EoE (randomisation rate: 2:1), 1 mg budesonide given twice daily as an orodispersible tablet for 6 weeks induced clinico-pathologic remission (defined as both peak of < 16 eosinophils/mm2 high power field in esophageal biopsies and no or only minimal symptoms of dysphagia or pain during swallowing) in 34 out of 59 patients (57.6%) versus 0/29 patients (0%) in the placebo-group.
Da budesonid ikke udskilles via nyrerne, kan patienter med let til moderat nedsat nyrefunktion blive behandlet med de samme doser, som bruges til patienter uden nedsat nyrefunktion, men der skal udvises forsigtighed.
Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
Budesonids metabolisme er nedsat hos EoE-patienter sammenlignet med raske forsøgspersoner, og fører til øgede plasmakoncentrationer af budesonid.
Metabolism of budesonide is decreased in EoE patients compared to healthy subjects resulting in increased plasma concentrations of budesonide.
Indehaver af markedsføringstilladelsen og fremstiller Dr. Falk Pharma GmbH
Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH
Der foreligger ingen data for budesonids påvirkning af menneskets fertilitet.
There are no data on the effect of budesonide on human fertility.
I det kliniske studie BUL-1/EEA oplevede i alt 10 ud af 87 (11,5 %) patienter eksponeret for Jorveza (dobbeltblindet forlænget behandlingsfase uden blinding) tilfælde af formodede svampeinfektioner forbundet med kliniske symptomer, der alle var lette i intensitet, undtagen hos én patient, hvor der blev rapporteret en moderat intensitet.
In the clinical study BUL-1/EEA, a total of 10 out of 87 patients (11.5%) exposed to Jorveza (double-blind and open-label extension phase) experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild intensity, except in one patient for whom a moderate intensity was reported.
Det tages af voksne (over 18 år) til at behandle eosinofil øsofagitis, som er en betændelsestilstand i spiserøret, der giver problemer med at synke føde.
It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
− hjerteglykosider, såsom digoxin (medicin til behandling af hjertelidelser)
− cardiac glycosides such as digoxin (medicines used to treat heart conditions)
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Dr. Falk Pharma GmbH
NAME OF THE MARKETING AUTHORISATION HOLDER Dr. Falk Pharma GmbH
Brug af Jorveza sammen med mad og drikke Du må ikke drikke grapefrugtjuice mens du tager denne medicin, da dette kan forværre bivirkningerne.
You should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side effects.
Virkningen af glykosider kan forstærkes ved kaliummangel, som er en potentiel og kendt bivirkning ved glukokortikosteroider.
The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.
Hvis dine nyreproblemer er svære, bør du ikke tage Jorveza.
In case your kidney problems are severe, you should not take Jorveza.
Budesonid gennemgår omfattende biotransformation af CYP3A4 i tyndtarmens slimhinde og i leveren til metabolitter med lav glukokortikosteroidaktivitet.
Budesonide undergoes extensive biotransformation by CYP3A4 in the mucosa of the small intestine and in the liver to metabolites of low glucocorticosteroid activity.
Et lidt øget antal af basofile hepatiske foci blev observeret i kroniske rottestudier med budesonid, og i carcinogene studier blev en øget forekomst af primære hepatocellulære neoplasmer, astrocytomer (hos hanrotter) og mammatumorer (hunrotter) iagttaget.
A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide, and in carcinogenicity studies, an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed.
Brug ikke oral opløsninger, sprays eller tyggetabletter i mindst 30 minutter før og efter administration af smeltetabletten.
Do not use any oral solutions, sprays or chewable tablets for at least 30 minutes before or after administration of the orodispersible tablet.
Brug af anden medicin sammen med Jorveza
Other medicines and Jorveza
Tag ikke Jorveza: - hvis du er allergisk over for budesonid eller et af de øvrige indholdsstoffer (angivet i punkt 6).
− if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Skoldkopper, herpes zoster og mæslinger har et mere alvorligt forløb hos patienter i behandling med glukokortikosteroider.
Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids.
Nyre- og leverproblemer
Kidney and liver problems
Samtidig behandling med potente CYP3A-hæmmere, såsom ketoconazol, ritonavir, itraconazol, clarithromycin, cobicistat og grapefrugtsaft kan forårsage en markant stigning i plasmakoncentrationen af budesonid og forventes at øge risikoen for systemiske bivirkninger.
Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions.
Samtidig anvendelse bør derfor undgås, medmindre fordelen opvejer den øgede risiko for systemiske kortikosteroid-bivirkninger.
Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Du må ikke tygge eller synke en uopløst smeltetablet.
Do not chew or swallow the undissolved orodispersible tablet.
20 smeltetabletter 30 smeltetabletter 60 smeltetabletter 90 smeltetabletter 100 smeltetabletter
20 orodispersible tablets 30 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Prækliniske data i akutte, subkroniske og kroniske toksikologiske undersøgelser med budesonid har vist atrofi af thymuskirtlen og binyrebarken og en reduktion især af lymfocytter.
Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes.
Hvis du har glemt at tage Jorveza
If you forget to take Jorveza
Jorveza anbefales ikke til brug til patienter med svært nedsat nyrefunktion.
Jorveza is not recommended for use in patients with severe renal impairment.
Hvis du har problemer med nyrerne eller leveren, skal du kontakte lægen.
If you have any problem with your kidney or liver, talk to your doctor.
Du må ikke tage dette lægemiddel under amning, medmindre du har rådført dig med din læge.
Do not take this medicine if you are breast-feeding unless you have checked with your doctor.
Clearance for budesonid er ca. 13 -15 l/time/kg hos raske forsøgspersoner og 6,54 ± 4,4 l/time/kg hos EoE-patienter.
Clearance of budesonide is about 1315 L/hour/kg in healthy subjects and 6.54 ± 4.4 L/hour/kg in EoE patients.
Svampeinfektioner i munden, svælget og spiserøret var de hyppigst observerede bivirkninger i kliniske studier med Jorveza.
Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza.
Hos drægtige dyr har budesonid, ligesom andre glukokortikosteroider, vist sig at forårsage fosterdød og abnormiteter i den føtale udvikling (mindre kuldstørrelse, intrauterin væksthæmning af fostre og skeletabnormiteter).
In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause foetal death and abnormalities of foetal development (smaller litter size, intrauterine growth retardation of foetuses and skeletal abnormalities).
Den anbefalede dosis er to smeltetabletter om dagen (2 mg budesonid).
The recommended dose is two orodispersible tablets (2 mg budesonide) per day.
For information om de observerede bivirkninger, se pkt.
For information about the observed adverse reactions, see section 4.8.
Administration Smeltetabletten skal tages efter et måltid.
The orodispersible tablet should be taken after a meal.
Den gennemsnitlige maksimale plasmakoncentration (± standardafvigelse) var 0,44 ± 0,31 ng/ml, arealet under kurven for plasmakoncentration som funktion af tiden (AUC0-12) var 1,44 ± 0,31 t*ng/ml.
The mean peak plasma concentration (± standard deviation) was 0.44 ± 0.31 ng/mL, the area under the plasma-concentration-time curve (AUC0-12) was 1.44 ± 0.31 hr*ng/mL.
Farmakokinetiske data efter administration af enkeltdoser på 1 mg budesonid til fastende raske forsøgspersoner viser en median latenstid på 0,17 timer (interval 0,00 - 0,33 timer), og en median tid til maksimal plasmakoncentration på 1,00 time (interval 0,50 - 2,00 timer).
Pharmacokinetic data following administration of single doses of 1 mg budesonide to fasted healthy subjects show a median lag time of 0.17 hours (range 0.00 - 0.33 hours) and a median time to peak plasma concentration of 1.00 hour (range 0.50 - 2.00 hours).
Jorveza indeholder natrium
Jorveza contains sodium
Synk det opløste materiale med spyttet lidt efter lidt, efterhånden som smeltetabletten smuldrer.
Swallow the dissolved material with saliva little by little, as the orodispersible tablet breaks up.
Udseende og pakningsstørrelser Smeltetabletterne er hvide, runde, biplane tabletter
What Jorveza looks like and contents of the pack The orodispersible tablets are white, round, biplane tablets.
Budesonid elimineres kun i begrænset omfang og i så fald via nyrerne.
Budesonide is eliminated only in marginal if any amounts by the kidney.
Budesonid absorberes hurtigt efter administration af Jorveza.
Following administration of Jorveza, budesonide is rapidly absorbed.
Hvis du holder op med at tage Jorveza
If you stop taking Jorveza
Mononatriumcitrat, vandfri Povidon K25
Anhydrous monosodium citrate Povidone K25
Glaukom, katarakt (herunder subkapsulær katarakt) sløret syn, central serøs korioretinopati (CSCR) (se også pkt.
Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)
I dyrestudier var fertiliteten ikke påvirket under budesonid-behandling (se pkt.
Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).
Hos drægtige dyr har budesonid vist, ligesom andre glukokortikosteroider, at forårsage abnormiteter i den føtale udvikling (se pkt.
In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3).
Nedsat kortisol i blodet
− decreased amount of the hormone cortisol in your blood.
Hver smeltetablet indeholder 1 mg budesonid.
Each orodispersible tablet contains 1 mg of budesonide.
Dyspepsi, ulcus gastroduodeni, pancreatitis, forstoppelse
Dyspepsia, duodenal or gastric ulcers, pancreatitis, constipation
Det opløste materiale skal synkes med spyttet lidt efter lidt, efterhånden som smeltetabletten smuldrer.
The dissolved material should be swallowed with saliva little by little while the orodispersible tablet disintegrates.
Samtidig anvendelse af glukokortikosteroider kan forårsage, øget udskillelse af kalium og forværret hypokaliæmi.
Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.
Patienter med tuberkulose, hypertension, diabetes mellitus, osteoporose, ulcus pepticum, glaukom, katarakt eller med familiær optræden af diabetes, eller familiær optræden af glaukom kan have en højere risiko for at opleve systemiske glukokortikosteroide bivirkninger (se nedenfor og i pkt.
Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should therefore be monitored for the occurrence of such effects.
Tlf: +49 (0)761 1514-0
Tel.: +49 (0)761 1514-0
Systemiske virkninger af glukokortikosteroider (f.eks. Cushing's syndrom, binyrebarksuppression, væksthæmning, katarakt, glaukom, nedsat knoglemineraltæthed og forskellige psykiatriske virkninger) kan opstå (se også pkt.
Systemic effects of glucocorticosteroids (e.g., Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur (see also section 4.8).