FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products affecting gastric acidity impair the absorption of ketoconazole (see section 4.4).
Maltese: Il-prodotti mediċinali li jaffettwaw l-aċidità gastrika jdgħajfu l-assorbiment ta' ketoconazole (ara sezzjoni 4.4).
English: Mizolastine Halofantrine
Maltese: Halofantrine
English: Data from 91 patients with the ectopic ACTH syndrome treated with ketoconazole were reviewed, along with 18 individual case reports.
Maltese: Kienet eżaminata dejta minn 91 pazjent bis-sindrome ta' ACTH ektopiku li ngħataw kura b'ketoconazole, flimkien ma' 18-il rapport ta' każijiet individwali.
English: AUC: ↑ 3.5-fold
Maltese: AUC: ↑ 3.5 darbiet
English: Each tablet contains 200 mg ketoconazole.
Maltese: Kull pillola fiha 200 mg ketoconazole.
English: When urinary free/serum/ plasma cortisol levels are normalised or close to target and the effective dose of ketoconazole is established, monitoring can be undertaken every 3 to 6 months (see section 4.2 for dose adjustment in case of adrenal insufficiency).
Maltese: Meta l-livelli tal-kortisol liberu fl-awrina/fis-serum/fil-plażma jkunu normalizzati jew qrib il-mira u tiġi stabbilita d-doża effettiva ta' ketoconazole, il-monitoraġġ jista' jitwettaq kull 3 sa 6 xhur (ara sezzjoni 4.2 għall-aġġustament tad-doża fil-każ ta' insuffiċjenza adrenali).
English: In the case of an increase in liver enzymes of less than 3 times the upper limit of normal, more frequent monitoring of liver function tests should be performed and the daily dose should be decreased by at least 200 mg.
Maltese: Fil-każ ta' żieda fl-enzimi tal-fwied ta' anqas minn 3 darbiet il-limitu ta' fuq tan-normal, għandu jsir monitoraġġ aktar frekwenti tat-testijiet tal-funzjoni tal-fwied u d-doża ta' kuljum għandha titnaqqas b'millanqas 200 mg.
English: AUC: ↑ 5-fold Cmax: ↑ 3.4-fold
Maltese: AUC: ↑ 5 darbiet Cmax: ↑ 3.4 darbiet
English: Contraindicated due to the increased risk of serious cardiovascular events including QT prolongation and torsade de pointes, or respiratory or CNS depression (see section 4.3).
Maltese: Kontraindikat minħabba ż-żieda firriskju ta' avvenimenti kardjovaskulari serji fosthom titwil tal-QT u torsade de pointes, jew depressjoni respiratorja jew tas-CNS (ara sezzjoni 4.3).
English: The adverse reactions listed below in table 2 are classified according to System Organ Class.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt fit-tabella 2 huma kklassifikati skont is-Sistema tal-Klassifika talOrgani.
English: • Flatulence
Maltese: • Fwawar
English: Ketoconazole has also been used with other therapies including surgery and pituitary radiation.
Maltese: Ketoconazole ntuża wkoll ma' terapiji oħra fosthom kirurġija u radjazzjoni pitwitarja.
English: The major route of excretion is through the bile into the intestinal tract.
Maltese: Ir-rotta prinċipali tal-eliminazzjoni hija permezz tal-bila fl-apparat intestinali.
English: Contraception
Maltese: Anti-infettivi
English: Potential ↑in plasma concentrations of carbamazepine and phenytoin
Maltese: ↑ potenzjali fil-konċentrazzjonijiet ta' carbamazepine u phenytoin fil-plażma
English: AUC: ↑ 1.5-fold Cmax: ↑1.7-fold
Maltese: AUC: ↑ 1.5 darbiet Cmax: ↑1.7 darbiet
English: Not recommended due to increased risk of isavuconazole adverse reactions, please consult isavuconazole SmPC
Maltese: Mhux rakkomandat minħabba żieda fir-riskju tar-reazzjonijiet avversi ta' isavuconazole, jekk jogħġbok ikkonsulta l-SmPC ta' isavuconazole
English: In approximately 10 to 15 % of ketoconazole treated patients, an "escape phenomenon" is observed and reinforces the need for a long-term clinical and biochemical follow-up of these patients.
Maltese: F'madwar 10 sa 15 % tal-pazjenti kkurati b'ketoconazole, huwa osservat "fenomenu tal-ħarba" u jirrinforza lħtieġa ta' segwitu kliniku u bijokimiku fit-tul ta' dawn il-pazjenti.
English: ↑in plasma concentrations of tolterodine have been observed
Maltese: Kienet osservata ↑ fil-konċentrazzjonijiet ta' tolterodine fil-plażma
English: AUC: ↑ 3.0-fold
Maltese: AUC: ↑ 3.0 darbiet
English: In vitro studies have shown that CYP3A4 is the major enzyme involved in the metabolism of ketoconazole.
Maltese: Studji in vitro wrew li CYP3A4 hija l-enzima prinċipali involuta fil-metaboliżmu ta' ketoconazole.
English: Electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QT interval.
Maltese: Studji elettrofiżjoloġiċi wrew li ketoconazole jinibixxi l-komponent ta' attivazzjoni rapida tal-kurrent rettifikatur ittardjat tal-potassju tal-qalb, itawwal id-dewmien potenzjali tal-azzjoni, u jista' jtawwal l-intervall QT.
English: - A maintenance dose from 400 mg/day to a maximal dose of 1,200 mg/day taken orally in 2 to 3 divided doses may be required to restore normal cortisol levels.
Maltese: - Tista' tkun meħtieġa doża ta' manteniment minn 400 mg/jum sa doża massima ta' 1,200 mg/jum meħuda b'mod orali fi 2 sa 3 dożi maqsuma biex jerġgħu jiġu stabbiliti livelli normali tal-kortisol.
English: (See also “Effects of other medicinal products on the metabolism of Ketoconazole HRA ”)
Maltese: (Ara wkoll “Effetti ta' prodotti mediċinali oħra fuq il-metaboliżmu ta' Ketoconazole HRA ”)
English: Diuretics Eplerenone
Maltese: Popolazzjoni pedjatrika
English: There are some medicines that must not be taken with Ketoconazole HRA (see section 2).
Maltese: Hemm xi mediċini li ma jridux jittieħdu ma' Ketoconazole HRA (ara sezzjoni 2).
English: Potential ↑in plasma concentrations of buspirone.
Maltese: ↑ potenzjali fil-konċentrazzjonijiet ta' buspirone fil-plażma.
English: Monitoring of adrenal function
Maltese: Monitoraġġ tal-funzjoni adrenali
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - Hypersensitivity to any imidazole antifungal medicinal product; - Acute or chronic liver disease and/or if pre-treatment liver enzymes levels are above 2 times the upper limit of normal (see sections 4.2 and 4.4): - Pregnancy (see section 4.6); - Breastfeeding (see section 4.6); - Congenital or documented acquired QTc prolongation ; - Concomitant therapy with any of the following medicinal products which may interact and result in potentially life-threatening adverse reactions (see section 4.5): o CYP3A4 metabolised HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin and lovastatin) due to an increased risk of skeletal muscle toxicity including rhabdomyolysis; o eplerenone due to an increased risk of hyperkalemia and hypotension; o substances that may have their plasma concentrations increased and have QT prolonging potential: methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran due to an increased bleeding risk; o triazolam, oral midazolam and alprazolam due to potential for prolonged or increased sedation and respiratory depression; o ergot alkaloids (eg dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) due to an increased risk of ergotism and other serious vasospastic adverse reactions; o lurasidone; o quetiapine due to an increased risk of toxicity; o telithromycin and clarithromycin in patients with severe renal impairment due to an increased risk of hepatotoxicity and QT interval prolongation; o felodipine, nisoldipine due to an increased risk of oedema and congestive heart failure;
Maltese: - Terapija konkomitanti b'xi wieħed mill-prodotti mediċinali li ġejjin li jistgħu jinteraġixxu u jwasslu għal reazzjonijiet avversi li jistgħu jkunu ta' periklu għall-ħajja (ara sezzjoni 4.5): o inibituri tal-HMG-CoA reductase metabolizzati minn CYP3A4 (eż simvastatin, atorvastatin u lovastatin) minħabba żieda fir-riskju ta' effett tossiku fuq il-muskoli skeletali, inkluż rabdomijoliżi; o eplerenone minħabba żieda fir-riskju ta' iperkalimja u pressjoni baxxa; o sustanzi li l-konċentrazzjonijiet tagħhom fil-plażma jistgħu jiżdiedu u li jkollhom il-potenzjal ta' titwil tal-QT: methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran minħabba ż-żieda fir-riskju ta' fsada; o triazolam, midazolam orali u alprazolam minħabba l-potenzjal għal sedazzjoni mtawla jew miżjuda u depressjoni respiratorja;
English: Data of inhibition indicate that risk of interaction with BCRP substrates cannot be excluded at the systemic level with very high doses of ketoconazole.
Maltese: Id-dejta tal-inibizzjoni tindika li riskju ta' interazzjoni ma' substrati tal-BCRP ma jistax jiġi eskluż fil-livell sistemiku b'dożi għoljin ħafna ta' ketoconazole.
English: Adrenal function should be monitored at regular intervals since adrenal insuficiency can occur during the treatment under conditions of a relative cortisol deficiency due to an increased glucocorticoid demand (e.g. in case of stress, surgery, or infection); and/or in case of ketoconazole overtreatment (for the patients treated with a block-only regimen); or if there is insufficient glucocorticoid replacement therapy (for the patients treated with a block-and-replace regimen).
Maltese: Il-funzjoni adrenali għandha tiġi mmonitorjata f'intervalli regolari billi l-insuffiċjenza adrenali tista' sseħħ waqt il-kura f'kundizzjonijiet ta' defiċjenza relattiva tal-kortisol minħabba żieda fid-domanda għallglukokortikojdi (eż. fil-każ ta' stress, kirurġija, jew infezzjoni); u/jew fil-każ ta' trattament eċċessiv b'ketoconazole (għall-pazjenti kkurati b'reġim ta' imblokk biss); jew jekk ikun hemm terapija ta' sostituzzjoni insuffiċjenti tal-glukokortikojdi (għall-pazjenti kkurati b'reġim ta' imblokk u sostituzzjoni).
English: AUC: ↑ 3.2-fold Cmax: ↑ 1.4-fold
Maltese: AUC : ↑ 3.2 darbiet Cmax: ↑ 1.4 darbiet
English: Potential ↑in plasma concentrations of pimozide.
Maltese: ↑ potenzjali fil-konċentrazzjonijiet ta' pimozide fil-plażma.
English: The safety of ketoconazole has been evaluated based on published literature and use of ketoconazole as an antifungal treatment.
Maltese: Is-sigurtà ta' ketoconazole ġiet evalwata abbażi tal-letteratura ppubblikata u l-użu ta' ketoconazole bħala kura antifungali.
English: In most of the publications the maintenance dose varied between 600 mg/day and 800 mg/day; - When the effective dose of ketoconazole is established, monitoring of urinary free cortisol and/or plasma cortisol levels may be performed every 3 to 6 months (see section 4.4); - In the case of adrenal insufficiency and depending on the severity of the event, the dose of ketoconazole should be decreased by at least 200 mg/day or the treatment should be temporarily discontinued and/or a corticosteroid therapy should be added until the resolution of the event.
Maltese: Filbiċċa l-kbira tal-pubblikazzjonijiet, id-doża ta' manteniment kienet tvarja bejn 600 mg/jum u 800 mg/jum; - Meta tiġi stabbilita d-doża effettiva ta' ketoconazole, il-monitoraġġ tal-livelli tal-kortisol liberu flawrina u/jew tal-kortisol fil-plażma jista' jitwettaq kull 3 sa 6 xhur (ara sezzjoni 4.4); - Fil-każ ta' insuffiċjenza adrenali u skont is-severità tal-avveniment, id-doża ta' ketoconazole għandha titnaqqas b'mill-anqas 200 mg/jum jew il-kura għandha tiġi temporanjament imwaqqfa u/jew għandha tiġi miżjuda terapija bil-kortikosterojdi sar-riżoluzzjoni tal-avveniment.
English: • Gynaecomastia (enlargement in breast tissues in male)
Maltese: • Dispepsja (diġestjoni mhux tajba)
English: The efficacy and safety of ketoconazole in the treatment of Cushing's syndrome from all causes have been described through several published retrospective studies, chart reviews and case reports.
Maltese: L-effikaċja u s-sigurtà ta' ketoconazole fil-kura tas-sindrome ta' Cushing mill-kawżi kollha ġew deskritti permezz ta' diversi studji retrospettivi ppubblikati, analiżi ta' ċarts u rapporti ta' każijiet.
English: Clinical improvement in hypokalaemia, metabolic alkalosis, diabetes mellitus, and hypertension occurred even in the absence of complete hormonal response.
Maltese: Seħħ titjib kliniku fl-ipokalimja, l-alkalożi metabolika, id-dijabete mellitus, u l-pressjoni għolja anki fin-nuqqas ta' rispons ormonali komplet.
English: Contraindicated in patients with severe renal impairment due to the risk of QT interval prolongation and serious hepatic adverse reactions (see section 4.3).
Maltese: Kontraindikat f'pazjenti b'indeboliment sever tal-kliewi minħabba r-riskju ta' titwil flintervall QT u reazzjonijiet avversi epatiċi serji (ara sezzjoni 4.3).
English: Effects of ketoconazole on the metabolism of the other medicinal products
Maltese: Effetti ta' ketoconazole fuq il-metaboliżmu tal-prodotti mediċinali l-oħra
English: Contraindicated due to the risk of QT prolongation (see section 4.3).
Maltese: Kontraindikat minħabba r-riskju ta' titwil tal-QT (ara sezzjoni 4.3).
English: Cmax and AUC increase more than proportionally with dose.
Maltese: Is-Cmax u l-AUC jiżdiedu b'mod aktar milli proporzjonali mad-doża.
English: Tolbutamide: AUC: ↑ 1.7-fold
Maltese: AUC: ↑ 1.7 darbiet
English: AUC: ↑2.2-fold Cmax: ↑1.7-fold
Maltese: ↑2.2 darbiet Cmax: ↑1.7 darbiet
English: AUC: ↑ 1.6-fold
Maltese: AUC: ↑ 1.6 darbiet
English: AUC: ↑ 1.6-fold Cmax: ↑ 1.4-fold
Maltese: Aripiprazole AUC: ↑ 1.6 darbiet Cmax: ↑ 1.4 darbiet
English: ranolazine
Maltese: Mizolastine
English: AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold
Maltese: AUC: ↑ 5 darbiet Cmax: ↑ 1.1 darbiet
English: Exacerbation or development of inflammatory/autoimmune disorders has been described after Cushing's syndrome remission, including after treatment with ketoconazole.
Maltese: It-taħrix jew l-iżvilupp ta' disturbi infjammatorji/awtoimmuni ġie deskritt wara r-remissjoni tas-sindrome ta' Cushing, inkluż wara l-kura b'ketoconazole.
English: • Dyspepsia (impaired digestion)
Maltese: • Artralġja (uġigħ fil-ġogi)
English: Renal impairment
Maltese: Oħrajn Tolvaptan
English: Cmax ↑ 9.6 fold
Maltese: ↑ 9.6 darbiet
English: It is used to treat endogenous Cushing's syndrome (when the body produces an excess of cortisol) in adults and adolescents above the age of 12 years.
Maltese: Jintuża għall-kura tas-sindrome endoġenu ta' Cushing (meta l-ġisem jipproduċi eċċess ta' kortisol) f'persuni adulti u adolexxenti minn 12-il sena 'l fuq.
English: Ketoconazole HRA is available in packs containing 60 tablets.
Maltese: Kif jidher Ketoconazole HRA u l-kontenut tal-pakkett Ketoconazole HRA jiġi f'pakketti li fihom 60 pillola.
English: ↑in plasma concentrations of oxycodone have been observed
Maltese: Kienet osservata ↑ fil-konċentrazzjonijiet ta' oxycodone fil-plażma
English: Frequency of hepatotoxicity could be higher in adolescents than in adults.
Maltese: Il-frekwenza tal-epatotossiċità tista' tkun ogħla fl-adolexxenti milli fl-adulti.
English: • Skin reactions (urticaria)
Maltese: • Reazzjonijiet tal-ġilda (urtikarja)
English: Patients with Cushing's syndrome and coexisting inflammatory/autoimmune disorders should be supervised after normalisation of cortisol levels on ketoconazole.
Maltese: Il-pazjenti bis-sindrome ta' Cushing u/jew disturbi infjammatorji/awtoimmuni koeżistenti għandhom jiġu sorveljati wara n-normalizzazzjoni tal-livelli talkortisol b'ketoconazole.
English: Liver function tests abnormal
Maltese: Testijiet abnormali tal-funzjoni tal-fwied
English: Potential ↑in plasma concentrations of alfentanil and fentanyl
Maltese: ↑ potenzjali fil-konċentrazzjonijiet ta' alfentanil u fentanyl fil-plażma
English: The oxycodone dose may be adjusted.
Maltese: Id-doża ta' oxycodone tista' tiġi aġġustata.
English: AUC: ↑ 4-fold Cmax: ↑ 1.2-fold
Maltese: AUC: ↑ 4 darbiet Cmax: ↑ 1.2 darbiet
English: Your adrenal function will be monitored at regular intervals as this is the standard care in the follow-up of Cushing's syndrome therapy and since adrenal insuficiency can occur during the treatment.
Maltese: Il-funzjoni adrenali tiegħek se tiġi mmonitorjata f'intervalli regolari billi din hija l-kura standard fis-segwitu tat-terapija għas-sindrome ta' Cushing u billi tista' sseħħ insuffiċjenza adrenali waqt il-kura.
English: Monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyperkalemia, hyponatraemia, hyperkalaemia or hypoglycaemia).
Maltese: Immonitorja u avża lill-pazjenti dwar is-sinjali u s-sintomi assoċjati ma' ipokortisoliżmu (eż. dgħufija, għeja, anoressija, dardir, rimettar, pressjoni baxxa, iperkalimja, iponatrimija, iperkalimja jew ipogliċemija).
English: Oedema peripheral, malaise, hot flush
Maltese: Edima periferali, telqa, fwawar
English: AUC: ↑ 15-fold Cmax: ↑ 1.4-fold
Maltese: Salmeterol AUC: ↑ 15 darbiet Cmax: ↑ 1.4 darbiet
English: Ketoconazole is contraindicated during pregnancy and it should not be used in women of childbearing potential not using an effective method of contraception (see section 4.3).
Maltese: Ketoconazole huwa kontraindikat waqt it-tqala u m'għandux jintuża f'nisa li jistgħu joħorġu tqal li ma jkunux qegħdin jużaw metodu effettiv ta' kontraċezzjoni (ara sezzjoni 4.3).
English: AUC: ↑ 10.9-fold Cmax: ↑ 4.4-fold
Maltese: 9 darbiet Cmax: ↑ 4.4 darbiet
English: Initiation
Maltese: Astenja
English: Contraindicated due to the potential for serious cardiovascular events including QT prolongation (see section 4.3).
Maltese: Kontraindikat minħabba l-potenzjal ta' avvenimenti kardjovaskulari serji fosthom titwil tal-QT (ara sezzjoni 4.3).
English: Dasatinib ↑in plasma concentrations of Dasatinib have been observed Dabrafenib
Maltese: Kienet osservata ↑ fil-konċentrazzjonijiet ta' Dasatinib fil-plażma Dabrafenib
English: Maize starch
Maltese: Mhux rakkomandat
English: ↑in plasma concentrations of nadolol have been observed
Maltese: Kienet osservata ↑ fil-konċentrazzjonijiet ta' nadolol fil-plażma
English: Contraindicated as it may increase quetiapine-related toxicity (see section 4.3).
Maltese: Kontraindikat minħabba li jista' jżid it-tossiċità relatata ma' quetiapine (ara sezzjoni 4.3).
English: In the case of signs suggestive of an adrenal insufficiency, in addition to the general measures to eliminate the medicinal product and reduce its absorption, a 100 mg dose of hydrocortisone should be administered at once, together with saline and glucose infusions.
Maltese: Fil-każ ta' sinjali li jissuġġerixxu insuffiċjenza adrenali, minbarra l-miżuri ġenerali sabiex jiġi eliminat ilprodott mediċinali u jitnaqqas l-assorbiment tiegħu, għandha tiġi amministrata mill-ewwel doża ta' 100 mg ta' hydrocortisone, flimkien ma' infużjonijiet ta' ilma bil-melħ u glukożju.
English: Each tablet contains 200 mg of ketoconazole.
Maltese: Kull pillola fiha 200 milligramma ketoconazole.
English: Potential ↑in plasma concentrations of disopyramide and quinidine
Maltese: ↑ potenzjali fil-konċentrazzjonijiet ta' disopyramide u quinidine fil-plażma
English: Liver enzyme levels returned to normal within 2-12 weeks after a dose decrease or withdrawal of ketoconazole.
Maltese: Il-livelli tal-enzimi tal-fwied reġgħu lura għan-normal fi żmien 2-12il ġimgħa wara tnaqqis fid-doża jew it-twaqqif ta' ketoconazole.
English: Concomitant therapy with medicinal products that are contraindicated during treatment with ketoconazole and resulting in potentially life-threatening adverse reactions :
Maltese: Terapija konkomitanti ma' prodotti mediċinali li huma kontraindikati waqt kura b'ketoconazole u li jirriżultaw f'reazzjonijiet avversi potenzjalment ta' periklu għall-ħajja:
English: Antipsychotics, Anxiolytics and Hypnotics Triazolam Alprazolam Midazolam oral
Maltese: Alprazolam Midazolam orali
English: AUC: ↑ 2-fold Cmax: ↑1.6-fold
Maltese: Apixaban AUC: ↑ 2 darbiet Cmax: ↑1.6 darbiet
English: Cushing's syndrome is caused by overproduction of a hormone called cortisol which is produced by the adrenal glands.
Maltese: Is-sindrome ta' Cushing huwa kkawżat minn produzzjoni eċċessiva ta' ormon imsejjaħ kortisol li jiġi prodott mill-glandoli adrenali.
English: How to store Ketoconazole HRA
Maltese: Jekk tinsa tieħu Ketoconazole HRA
English: AUC: ↑3.4-fold Cmax: ↑1.6-fold
Maltese: ↑3.4 darbiet Cmax: ↑1.6 darbiet
English: In case of co-administration of an medicinal product known to increase QTc interval (see section 4.5), ECG monitoring is recommended.
Maltese: Fil-każ ta' għoti fl-istess ħin ta' prodott mediċinali li jkun magħruf li jżid l-intervall QTc (ara sezzjoni 4.5), huwa rakkomandat monitoraġġ tal-ECG.
English: Studies in animals have shown effects on male and female reproductive parameters (see section 5.3).
Maltese: Studji f'annimali wrew effetti fuq il-parametri riproduttivi tal-irġiel u tan-nisa (ara sezzjoni 5.3).
English: Plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter.
Maltese: L-eliminazzjoni mill-plażma hija bifażika b'half-life ta' sagħtejn matul l-ewwel 10 sigħat u wara ta' 8 sigħat.
English: AUC: ↑ 1.2-fold Cmax: ↑ 1.2-fold
Maltese: AUC: ↑ 1.2 darbiet Cmax: ↑ 1.2 darbiet
English: Contraindicated due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Maltese: Kontraindikat minħabba r-riskju ta' titwil jew żieda potenzjali fissedazzjoni u depressjoni respiratorja (ara sezzjoni 4.3).
English: Potential ↑in AUC of risperidone:
Maltese: Studju tas-sigurtà ta' wara l-Awtorizzazzjoni (PASS):
English: Adjustment of the posology
Maltese: Reazzjoni avversa
English: Ketoconazole is a steroidogenesis inhibitor.
Maltese: Ketoconazole huwa inibitur tal-isterojdoġenesi.
English: Patients treated with a block-and-replace regimen should be taught to adjust their glucocorticoid replacement therapy dose under conditions of stress (see section 4.2).
Maltese: Il-pazjenti kkurati b'reġim ta' imblokk u sostituzzjoni għandhom jiġu mgħallma jaġġustaw id-doża tatterapija tagħhom ta' sostituzzjoni tal-glukokortikojdi f'kundizzjonijiet ta' stress (ara sezzjoni 4.2).
English: During the treatment: - close clinical follow-up should be undertaken - measurement of liver enzymes (ASAT, ALAT, gamma GT and alkaline phosphatase) and bilirubin, should be performed at frequent intervals:
Maltese: Waqt il-kura: - għandu jsir segwitu kliniku mill-qrib - għandu jsir kejl tal-enzimi tal-fwied (ASAT, ALAT, gamma GT u alkaline phosphatase) u tal-bilirubina,
English: Potential ↓ in plasma concentrations of ketoconazole are expected.
Maltese: Huwa mistenni ↓ potenzjali filkonċentrazzjonijiet ta' ketoconazole filplażma.
English: CYP3A4-metabolised and/or P-gp substrates known to prolong the QT interval may be contraindicated or not recommended depending on the observed or expected effect with ketoconazole (i.e. resulting in augmentation of the plasma concentration, AUC, Cmax of the drugs) and the known therapeutic margins of the drugs.
Maltese: Substrati metabolizzati minn CYP3A4 u/jew tal-P-gp li huma magħrufa li jtawlu l-intervall QT jistgħu jkunu kontraindikati jew mhux irrakkomandati skont l-effett osservat jew mistenni b'ketoconazole (jiġifieri li jirriżultaw f'tibdil fil-konċentrazzjoni fil-plażma, AUC, Cmax tal-mediċini) u l-marġini terapewtiċi magħrufa tal-mediċini.
English: - A dose increase of 200 mg/day every 7 to 28 days may be considered if urinary free cortisol and/or plasma cortisol levels are above the normal range, as long as the dose is tolerated by the patient;
Maltese: - Tista' tiġi kkunsidrata żieda ta' 200 mg/jum fid-doża kull 7 sa 28 ġurnata jekk il-livelli tal-kortisol liberu fl-awrina u/jew tal-kortisol fil-plażma jkunu ogħla mill-firxa normali, sakemm id-doża tkun ittollerata mill-pazjent;
English: Microcrystalline cellulose Silica colloidal Magnesium stearate
Maltese: Microcrystalline cellulose
English: Ketoconazole is a potent inhibitor of CYP3A4 and P-gp.
Maltese: Statins oħra li mhumiex substrati ta' CYP3A4
English: Since ketoconazole is excreted in the milk, mothers who are under treatment must not breast-feed whilst being treated with Ketoconazole HRA (see section 4.3).
Maltese: Billi ketoconazole jiġi eliminat fil-ħalib, l-ommijiet li jkunu qegħdin jieħdu l-kura m'għandhomx ireddgħu waqt li jkunu qed jiġu kkurati b'Ketoconazole HRA (ara sezzjoni 4.3).