FrancophonIA/ELRC3.0 huggingface dataset:
English: Adopted at the 30 September-3 October 2019 PRAC
Maltese: Adottata fil-PRAC ta' bejn it-30 ta' Settembru-3 ta' Ottubru 2019
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Maltese: Minħabba l-mekkaniżmu ta' azzjoni ta' IMFINZI, jistgħu jseħħu reazzjonijiet avversi medjati potenzjali oħrajn mis-sistema immunitarja.
English: Other immune-mediated adverse reactions
Maltese: Reazzjonijiet avversi medjati oħrajn missistema immunitarja
English: B - 1000 Brussels Belgium
Maltese: B - 1000 Brussels
English: ATC code: H02AB09.
Maltese: H02AB09.
English: OTHER Shire Services BVBA
Maltese: Shire Services BVBA
English: • You should preferably be in an upright position.
Maltese: • Preferibbilment għandek tkun f'pożizzjoni wieqfa.
English: Tel: +44(0)1256 894 959
Maltese: Tel: +44(0)1256 894 959 E-mail: medinfoEMEA@shire.com
English: INFORMATION IN BRAILLE Plenadren 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Plenadren 5 mg
English: INFORMATION IN BRAILLE Plenadren 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Plenadren 20 mg
English: Very common (1/10); Common (1/100 to <1/10).
Maltese: Komuni ħafna (≥1/10); Komuni (≥1/100 sa <1/10).
English: No antidote is available.
Maltese: Ma hemm l-ebda antidotu disponibbli.
English: EU/1/11/715/003
Maltese: EU/1/11/715/001 EU/1/11/715/003
English: MedDRA System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: Plenadren is given as maintenance therapy.
Maltese: Plenadren jingħata bħala terapija ta' manteniment.
English: EU/1/11/715/006
Maltese: EU/1/11/715/002 EU/1/11/715/006
English: Psychiatric disorders Euphoria and psychosis, insomnia.
Maltese: Ewforija u psikożi, insomnja.
English: • Ketoconazole, itraconazole, posaconazole and voriconazole - used to treat fungal infections
Maltese: • Ketoconazole, itraconazole, posaconazole u voriconazole - użati fil-kura ta' infezzjonijiet fungali
English: The coating system is a mixture of macrogol (3350), polyvinyl alcohol, talc and titanium oxide (E171).
Maltese: Is-sistema ta' kisi hija taħlita ta' macrogol (3350), alkoħol polyvinyl, talc (E553b) u titanium oxide (E171).
English: • Phenytoin, carbamazepine and barbiturates - used to treat epilepsy
Maltese: • Phenytoin, carbamazepine u barbiturates - użati fil-kura tal-epilessija
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.
Maltese: Hydrocortisone jiġi kompletament eliminat permezz tal-metaboliżmu permezz tal-enzimi 11ßHSD tat tip 1 u tat-tip 2 u CYP 3A4 fil-fwied u fit-tessut periferali.
English: • Rifampicin or rifabutin - used to treat tuberculosis
Maltese: • Rifampicin jew rifabutin - użati fil-kura tat-tuberkolożi
English: August 2016
Maltese: Data tal-aħħar tiġdid: 8 ta' Awwissu 2016
English: Hydrocortisone is a glucocorticoid.
Maltese: Hydrocortisone huwa glukokortikojde.
English: • The active substance is hydrocortisone.
Maltese: Is-sustanza attiva hija hydrocortisone.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Maltese: Titanium dioxide (E171) Iron oxide red (E172)
English: This regimen has been documented in over 300 intercurrent illness episodes within the clinical study programme.
Maltese: Dan ir-reġimen ġie ddokumentat f'aktar minn 300 episodju ta' mard interkurrenti fil programm tal-istudju kliniku.
English: Glucocorticoids are important steroids for intermediary metabolism, immune function, musculoskeletal and connective tissue and the brain.
Maltese: Ilglukokortikojdi huma sterojdi importanti għall-metaboliżmu intermedjarju, għall-funzjoni immuni, it tessut muskuloskeletali u konnettiv u għall-moħħ.
English: Potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole erythromycin, telithromycin, clarithromycin, ritonavir and grapefruit juice can inhibit the metabolism of hydrocortisone, and thus increase blood levels.
Maltese: Inibituri qawwijin ta' CYP 3A4 bħal ketoconazole, itraconazole, posaconazole, voriconazole erythromycin, telithromycin, clarithromycin, ritonavir u l-meraq tal-grejpfruit jistgħu jinibixxu lmetaboliżmu ta' hydrocortisone, u b'hekk iżidu l-livelli fid-demm.
English: Plenadren replaces the natural cortisol that is missing in adrenal insufficiency.
Maltese: Plenadren jieħu post il-kortisol naturali li huwa nieqes fl-insuffiċjenza adrenali.
English: • Ritonavir, efavirenz and nevirapine - used to treat HIV infection
Maltese: • Ritonavir, efavirenz u nevirapine - użati fil-kura tal-infezzjoni tal-HIV
English: • St. John's wort - used to treat depression and other conditions
Maltese: • St.John's wort - użat fil-kura tad-dipressjoni u ta' kundizzjonijiet oħra
English: The 5 mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).
Maltese: 5 mg fihom ukoll iron oxide aħmar (E172), iron oxide isfar (E172) u iron oxide iswed (E172).
English: • When you wake up in the morning swallow Plenadren tablets whole with a glass of water at least 30 minutes before your breakfast, preferable between 6.00 am and 8.00 am in the morning.
Maltese: • Meta tqum filgħodu ibla' l-pilloli ta' Plenadren sħaħ b'tazza ilma mill-inqas nofs siegħa qabel il-kolazzjon tiegħek, preferibbilment bejn is-6.00am u t-8.00am ta' filgħodu.
English: Pruritus Rash
Maltese: Prurite Raxx
English: A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies.
Maltese: Total ta' 80 pazjent (173 pazjenti-snin ta' dejta) irċevew kura b'hydrocortisone li jerħi b'mod modifikat fi studji kliniċi.
English: Thyroid function
Maltese: Il-funzjoni tat-tirojde
English: Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Maltese: Rapporti ta' tossiċità akuta u/jew ta' mwiet wara doża eċċessiva b'hydrocortisone huma rari.
English: The binding is about 90%.
Maltese: Ir-rabta hija ta' madwar 90%.
English: Concomitant infections
Maltese: Infezzjonijiet konkomitanti
English: This terminal half-life is similar to the pharmacokinetics of endogenous cortisol that also is secretion-controlled.
Maltese: Dan il-half-life terminali huwa simili għallfarmakokinetika ta' kortisol endoġenu li t-tnixxija tiegħu hija wkoll ikkontrollata.
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.
Maltese: Waqt kriżi adrenali parenterali, għandha tingħata preferibbilment permezz ta' għoti ġol-vini ta' hydrocortisone f'dożi għoljin, flimkien ma' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall infużjoni, skont il-linji-gwida kurrenti tal-kura.
English: 50 modified-release tablets 100 modified-release tablets (2x50)
Maltese: 100 pillola li jerħu l-mediċina b'mod modifikat (2x50).
English: Other medicines and Plenadren
Maltese: Mediċini oħra u Plenadren
English: Plenadren is used in adults to treat a condition known as adrenal insufficiency, or cortisol deficiency.
Maltese: Plenadren jintuża fl-adulti fil-kura ta' kundizzjoni magħrufa bħala insuffiċjenza adrenali, jew defiċjenza ta' kortisol.
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids.
Maltese: Kortikosterojdi għall-użu sistemiku, glukokortikojdi.
English: The effect of corticosteroids may be reduced for 3-4 days after treatment with mifepristone.
Maltese: L-effetti tal-kortikosterojdi jistgħu jitnaqqsu għal 3-4 ijiem wara l-kura b'mifepristone.
English: In plasma, cortisol is bound to corticosteroid-binding globulin (CBG, also called transcortin) and albumin.
Maltese: Fil-plażma, kortisol jintrabat ma' globulina li tintrabat mal-kortikosterojdi (CBG, msejħa wkoll transcortin) u mal-albumina.
English: Metabolism and nutrition disorders Sodium and water retention and oedema tendency, hypertension, hypokalaemia.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Retenzjoni tas-sodju u tal-ilma u tendenza għall-edema, ipertensjoni, ipokalemija.
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.
Maltese: Skont issistema ta' klassifikazzjoni bijofarmaċewtika (BCS) hydrocortisone huwa sustanza attiva ta' klassi II b'permeabilità intestinali għolja u b'rata baxxa ta' dissoluzzjoni, speċjalment f'dożi ogħla.
English: When your illness is over, return to your normal maintenance dose of this medicine.
Maltese: Meta tfieq mill-marda, erġa' lura għad-doża normali ta' manteniment ta' din il mediċina.
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).
Maltese: Wara l-għoti orali, hydrocortisone jiġi assorbit sew u b'mod rapidu mill-passaġġ gastro-intestinali u ġie rrapportat li l-assorbiment kien ta' aktar minn 95% għal doża orali (pilloli) ta' 20 mg.
English: Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels.
Maltese: Hydrocortisone jingħata bħala terapija ta' sostituzzjoni bil-għan li jreġġa' lura l-livelli normali ta' kortisol.
English: Do not take Plenadren
Maltese: X'fih Plenadren
English: Hydrocortisone is a glucocorticoid and the synthetic form of endogenously produced cortisol.
Maltese: Hydrocortisone huwa glukokortikojdi u l-forma sintetika ta' kortisol prodott b'mod endoġenu.
English: The terminal half-life has been reported to be about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets.
Maltese: Ġie rrapportat li l-half-life terminali tal-pilloli ta' hydrocortisone kien ta' madwar 1.5 sigħat wara dożi orali u fil-vini.
English: Events have been reported in patients treated with Plenadren.
Maltese: Ġew irrappurtati avvenimenti f'pazjenti kkurati bi Plenadren.
English: The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established.
Maltese: Is-sigurtà u effikaċja ta' Plenadren fit-tfal/adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
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.
Maltese: Bidla minn kura konvenzjonali bil-glukokortikojdi orali għal Plenadren Meta l-pazjenti jaqilbu minn terapija ta' sostituzzjoni konvenzjonali b'hydrocortisone mogħti tliet darbiet kuljum għal Plenadren, tista' tingħata l-istess doża totali ta' kuljum.
English: Gastrointestinal disorders Dyspepsia and deterioration of existing gastric ulcer.
Maltese: Dispepsja u deterjorazzjoni ta' ulċera gastrika eżistenti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/002 50 modified-release tablets EU/1/11/715/006 100 (2x50) modified-release tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/715/002 50 pillola li jerħu l-mediċina b'mod modifikat EU/1/11/715/006 100 pillola (2x50) li jerħu l-mediċina b'mod modifikat
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jaffetwaw sa 1 minn kull 10 persuni)
English: Immune system disorders Activation of infection (tuberculosis, fungal and viral infections including herpes).
Maltese: Attivazzjoni ta' infezzjoni (tuberkulożi, infezzjonijiet fungali u virali li jinkludu l-ħerpes).
English: Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets Hydrocortisone
Maltese: Plenadren 5 mg pilloli li jerħu l-mediċina b'mod modifikat Plenadren 20 mg pilloli li jerħu l-mediċina b'mod modifikat Hydrocortisone
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.
Maltese: Il-bijodiponibilità (AUC0-24h) hija 20% aktar baxxa bil-pillola li terħi l-mediċina b'mod modifikat meta mqabbla mal-istess doża ta' kuljum ta' hydrocortisone mogħti bħala pilloli konvenzjonali tliet darbiet kuljum.
English: The lowest possible maintenance dosage should be used.
Maltese: Għandha tintuża l-aktar doża baxxa ta' manteniment possibbli.
English: The clinical response needs to be monitored in patients given medicinal products affecting gastric emptying and motility, see section 4.4.
Maltese: Ir-rispons kliniku għandu jiġi mmonitorjat f'pazjenti li jingħataw prodotti mediċinali li jaffettwaw it tbattil u l-motilità gastrika, ara sezzjoni 4.4.
English: During transient illnesses such as low grade infection, fever of any aetiology, stressful situations such as minor surgical procedures, the daily replacement dose must be increased temporarily, see section 4.2, ‘Use in intercurrent illness'.
Maltese: Waqt mard tranżitorju bħal f'infezzjoni ta' grad baxx, deni ta' kwalunkwe etjoloġija, sitwazzjonijiet stressanti bħal proċeduri kirurġiċi minuri, id-doża ta' sostituzzjoni ta' kuljum għandha tiżdied temporanjament, ara sezzjoni 4.2, ‘Użu f'mard interkurrenti'.
English: Patients should be instructed to take Plenadren orally with a glass of water on awakening at least 30 minutes before food intake, preferably in an upright position and between 6.00 am and 8.00 am in the morning.
Maltese: Il-pazjenti għandhom jingħataw struzzjonijiet biex jieħdu Plenadren orali ma' tazza ilma meta jqumu mill-inqas nofs siegħa qabel ma jieklu, preferibbilment waqt li jkunu f'pożizzjoni wieqfa u bejn is6.00am u t-8.00am ta' filgħodu.
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).
Maltese: John's wort u indutturi inqas qawwijin bħal prodotti mediċinali antiretrovirali efavirenz u nevirapine jistgħu iżidu t-tneħħija metabolika ta' kortisol, inaqqsu l-half-life terminali u b'hekk inaqqsu ż-żieda fil-varjazzjonijiet u l-livelli ta' kortisol li jkunu qegħdin jiċċirkolaw (minħabba half-life terminali iqsar).
English: Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures.
Maltese: Osteoporożi bi fratturi spontanji.
English: • The other ingredients are hypromellose, microcrystalline cellulose, pregelatinised starch (maize), colloidal anhydrous silica and magnesium stearate.
Maltese: Is-sustanzi mhux attivi huma hypromellose (E464), ċelluluża mikrokristallina (E460), lamtu preġelatinizzat (qamħirrun), silika anidra kollojdali (E551) u magnesium stearate.
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Maltese: Jintużaw ukoll għall-effetti anti-infjammatorji potenti tagħhom f'disturbi ta' bosta sistemi tal-organi.
English: Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink.
Maltese: Il-pilloli huma tondi (dijametru ta' 8 mm), konvessi u roża.
English: You should then take the second dose of this medicine 6 to 10 hours after the morning dose.
Maltese: F'dan il-każ għandek tieħu t-tieni doża ta' din il-mediċina minn 6 sa 10 sigħat wara d-doża ta' filgħodu.
English: • Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.
Maltese: • Stretch marks, tbenġil, raxx qisu akne, tkabbir eċċessiv ta' xagħar tal-wiċċ, fejqan bil-mod ta'
English: Pack sizes:
Maltese: Daqsijiet tal-pakkett:
English: Additional side effects have been reported for other hydrocortisone medicines.
Maltese: Ġew irrapportati effetti sekondarji addizzjonali għal mediċini oħra li fihom hydrocortisone.
English: Treatment of adrenal insufficiency in adults.
Maltese: Kura tal-insuffiċjenza renali fl-adulti.
English: Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported.
Maltese: Ġew irrappurtati każijiet ta' għejja estrema u episodji ta' sturdament li jgħaddi malajr (vertigo).
English: A small amount of cortisol is excreted in the urine unchanged (<0.5% of the daily production), meaning that cortisol is eliminated completely by metabolism.
Maltese: 5% tal-produzzjoni ta' kuljum), li jfisser li kortisol jiġi kompletament eliminat permezz tal-metaboliżmu.
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.
Maltese: Il-konċentrazzjoni medja ta' kortisol osservata kontra l-ħin tal-arloġġ wara doża singola u dożi multipli f'pazjenti bl-insuffiċjenza adrenali primarja (n=62) wara l-għoti orali ta' Plenadren mogħti darba kuljum u hydrocortisone mogħti tliet darbiet kuljum.
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.
Maltese: Hydrocortisone (kortisol) huwa mediċina lipofilika li hija kompletament eliminata permezz talmetaboliżmu bi tneħħija baxxa u b'hekk bi proporzjonijiet baxxi ta'estrazzjoni intestinali u epatiċi.
English: Plenadren contains a substance called hydrocortisone (sometimes called cortisol).
Maltese: Plenadren fih sustanza msejħa hydrocortisone (xi drabi msejħa kortisol).
English: Vertigo Headache
Maltese: Artralġja
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.
Maltese: L-għoti ġol-vini ta' hydrocortisone huwa ġġustifikat waqt episodji ta' mard tranżitorju bħal infezzjonijiet severi, b'mod partikolari l-gastroenterite assoċjata ma' rimettar u /jew dijarea, deni għoli ta' kwalunkwe etjoloġija jew stress fiżiku estensiv, bħal pereżempju inċidenti serji u kirurġija taħt anestesija ġenerali, ara sezzjoni 4.4.
English: th
Maltese: L
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).
Maltese: pereżempju f'infezzjonijiet ta' grad baxx, deni ta' kwalunkwe etjoloġija u sitwazzjonijiet stressanti bħal proċeduri kirurġiċi minuri, id-doża orali normali ta' sostituzzjoni ta' kuljum għandha tiżdied b'mod temporanju; id-doża totali ta' kuljum għandha tiżdied billi d-doża ta' manteniment tingħata darbtejn jew tliet darbiet kuljum b'intervalli ta' 8 ±2 sigħat (żieda fin-numru ta' għotjiet, u mhux iż-żieda tad-doża ta' filgħodu).
English: • More prone to infection
Maltese: • Aktar suxxettibbli għal infezzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/001 50 modified-release tablets EU/1/11/715/003 100 (2x50) modified-release tablets
Maltese: EU/1/11/715/003 100 pillola (2x50) li jerħu l-mediċina b'mod modifikat
English: It belongs to a group of medicines called corticosteroids.
Maltese: Jagħmel parti minn grupp ta' mediċini li jissejħu kortikosterojdi.
English: Reproductive studies in animals have shown that glucocorticoids can cause foetal abnormalities and reproductive toxicity, see section 5.3.
Maltese: Studji riproduttivi f'annimali urew li l-glukokortikojdi jistgħu jikkawżaw abnormalitajiet tal-fetu u effett tossiku fuq is-sistema riproduttiva, ara sezzjoni 5.3.
English: Endocrine disorders Induction of glucose intolerance or diabetes mellitus.
Maltese: Induzzjoni ta' intolleranza għall-glukożju jew tad-dijabete mellitus.
English: Adverse reactions from these studies and from postmarketing surveillance are listed below by system organ class and frequency as follows:
Maltese: Ir-reazzjonijiet avversi minn dawn l-istudji u minn sorveljanza ta' wara ttqegħid fis-suq huma elenkati hawn isfel skont is-sistema tal-klassifika tal-organi u l-frekwenza kif ġejjin:
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: CYP 3A4 is involved in the clearance of cortisol by the formation of 6β-hydroxycortisol which is excreted in urine.
Maltese: CYP 3A4 huwa nvolut fit-tneħħija ta' kortisol permezz tal-formazzjoni ta' 6β-hydroxycortisol li jiġi eliminat fl-awrina.
English: Patients with adrenal insufficiency on long-term glucocorticoid replacement therapy have been found to have reduced bone mineral density.
Maltese: Il pazjenti bl-insuffiċjenza adrenali li qegħdin fuq terapija ta' sostituzzjoni fit-tul bil-glukokortikojdi, instabu li kellhom tnaqqis fid-densità tal-minerali fl-għadam.
English: Macrogol (3350)
Maltese: Kisja tal-pillola Macrogol (3350) Polyvinyl alcohol Talc
English: PHARMACEUTICAL PARTICULARS
Maltese: Azzjoni farmakodinamika
English: Frequency of adverse reactions Very common Common
Maltese: Frekwenza tar-reazzjonijiet avversi
English: Glucocorticoids cause profound and varied metabolic effects.
Maltese: Il-glukokortikojdi jikkawżaw effetti metaboliċi qawwija u varji.
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).
Maltese: Madankollu, fittex għajnuna medika immedjata jekk tinnota kwalunkwe minn dawn li ġejjin: dgħufija severa, ħass ħażin, uġigħ ta' żaqq, dardir, rimettar, uġigħ fid-dahar, konfużjoni, tnaqqis filkoxjenza, delirju (tkun fi stat konfuż ħafna).
English: • Itchiness
Maltese: • Għejja
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.
Maltese: Pilloli li jerħu l-mediċna b'mod modifikat mhumiex irrakkomandati f'pazjenti b'żieda fil-motilità gastro-intestinali, jiġifieri, dijarea kronika, minħabba r-riskju ta' espożizzjoni indebolita għal kortisol.
English: E-mail: medinfoEMEA@shire.com
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: A common maintenance dose is 20-30 mg per day, given once daily in the morning.
Maltese: Doża komuni ta' manteniment hija ta' 2030 mg kuljum, li tingħata darba filgħodu.
English: If used with mifepristone, a treatment used to end a pregnancy, the effect of Plenadren may be reduced.
Maltese: Jekk użat ma' mifepristone, kura użata biex ittemm it-tqala, l-effett ta' Plenadren jista' jitnaqqas.
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.
Maltese: Ix-xjuħija u indiċi baxx tal-massa tal-ġisem huma fatturi magħrufa ta' riskju għal reazzjonijiet avversi komuni ta' dożi farmakoloġiċi tal-glukokortikojdi bħall-osteoporożi, it-traqqiq tal-ġilda, id-dijabete mellitus, l-ipertensjoni u żieda fis-suxxettibilita għall-infezzjonijiet.
English: There is no indication that Plenadren, in doses used for replacement therapy, will have an effect on fertility.
Maltese: M'hemm l-ebda indikazzjoni li Plenadren, f'dożi użati għat-terapija ta' sostituzzjoni, se jkollu effett fuq il-fertilità.
English: Acute adrenal insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced.
Maltese: Il-fertilità f'nisa b'insuffiċjenza adrenali jew defiċjenza ta' cortisol tista' titnaqqas.