FrancophonIA/ELRC3.0 huggingface dataset:
English: A 17 years old girl was treated on ketoconazole 1,200 mg/day for an adrenal carcinoma with liver metastasis and had altered liver function tests at 22 days.
Maltese: Tifla ta' 17il sena ngħatat kura b'ketoconazole 1,200 mg/jum għal karċinoma adrenali b'metastesi fil-fwied u kellha testijiet mibdula tal-funzjoni tal-fwied wara 22 ġurnata.
English: The requirements for submission of PSURsfor this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati PSURsgħal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Increases in liver enzymes (≤ 5N and > 5N) were observed in ~13.5 % and ~2.5% of patients respectively occurring mostly within the first 6 months of treatment.
Maltese: Kienu osservati żidiet fl-enzimi tal-fwied (≤5N u > 5N) fi ~13.5 % u ~2.5% tal-pazjenti rispettivament, u dawn seħħew l-aktar fl-ewwel 6 xhur tal-kura.
English: Buprenorphine IV and sublingual
Maltese: Buprenorphine IV u taħt l-ilsien
English: ASAT, ALAT, gammaGT, bilirubin and alkaline phosphatase should be monitored at frequent intervals during treatment (see sections 4.2 and 4.4).
Maltese: L-ASAT, l-ALAT, il-gammaGT, ilbilirubina u l-alkaline phosphatase għandhom jiġu mmonitorjati f'intervalli frekwenti waqt il-kura (ara sezzjonijiet 4.2 u 4.4).
English: Pharmacotherapeutic group: Antimycotics for systemic use, imidazole derivatives, ATC code: J02AB02
Maltese: Antimijotiċi għal użu sistemiku, derivattivi ta' imidazole, Kodiċi ATC:
English: In vitro data indicate that ketoconazole is a potent inhibitor of OATP1B1, OATP1B3, OAT3, OCT1 and OCT2 and to a lesser extent of OAT1 and BSEP.
Maltese: Dejta in vitro tindika li ketoconazole hu inibitur qawwi ta' OATP1B1, OATP1B3, OAT3, OCT1 u OCT2 u xi ftit inqas ta' OAT1 u BSEP.
English: Ketoconazole HRA is a medicine that contains the active substance ketoconazole.
Maltese: Ketoconazole HRA huwa mediċina li fiha s-sustanza attiva ketoconazole.
English: Monitoring of the QTc interval
Maltese: Monitoraġġ tal-intervall QTc
English: Some combinations may lead to an increased risk of ventricular tachyarrhythmias, including occurrences of torsade de pointes, a potentially fatal arrhythmia (see Table 1 Interactions and recommendations for co-administration, section 4.5).
Maltese: Xi kombinazzjonijiet jistgħu jwasslu għal żieda fir-riskju ta' takiarritmiji ventrikolari, fosthom inċidenzi ta' torsade de pointes, li hija arritmija potenzjalment fatali (ara Tabella 1 Interazzjonijiet u rakkomandazzjonijiet għall-għoti fl-istess ħin sezzjoni 4.5).
English: In a Canadian study, of the 12 assessable patients (out of 15), 10 showed a reduction in urinary free cortisol levels, but only five had complete resolution on ketoconazole doses 400 to 1200 mg/day.
Maltese: Fi studju Kanadiż, mit-12-il pazjent valutabbli (minn 15), 10 wrew tnaqqis fil-livelli ta' kortisol liberu fl-awrina, iżda ħamsa biss kellhom riżoluzzjoni kompleta fuq dożi ta' ketoconazole ta' 400 sa 1200 mg/jum.
English: Adrenal insufficiency is common and can be a serious side effect.
Maltese: Insuffiċjenza adrenali hija komuni u tista' tkun effett sekondarju serju.
English: AUC: ↑ 2.2 fold
Maltese: AUC: ↑ 2.2 darbiet
English: Data from 17 patients with adrenal tumours and from 2 patients with primary nodular adrenocortical hyperplasia (NAH) treated with ketoconazole are available in the literature along with 17 individual case reports of patients with benign or malignant tumours or NAH and 2 paediatric cases of McCune Albright syndrome.
Maltese: Fil-letteratura hija disponibbli dejta minn 17-il pazjent b'tumuri adrenali u minn 2 pazjenti b'iperplasija adrenokortikali nodulari (NAH) primarja li ngħataw kura b'ketoconazole, flimkien ma' 17-il rapport ta' każijiet individwali ta' pazjenti b'tumuri beninni jew malinni jew NAH u 2 każijiet pedjatriċi tas-sindrome ta' McCune Albright.
English: Block and replace regimen
Maltese: Reġim ta' imblokk u sostituzzjoni
English: (CYP3A4 enzyme induction)
Maltese: (induzzjoni tal-enzima CYP3A4)
English: Fesoterodine and solifenacin are contraindicated in patients with renal impairment (see section 4.3).
Maltese: Fesoterodine u solifenacin huma kontraindikati f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 4.3).
English: AUC: ↓0.28-fold
Maltese: ↓0.28 darbiet
English: Ketoconazole HRA 200 mg tablets ketoconazole
Maltese: Ketoconazole HRA 200 mg pilloli ketoconazole
English: Based on limited data, pharmacokinetics parameters (AUC, Cmax and half-life) of ketoconazole for doses of 5 to 10 mg/kg/days, corresponding approximately to daily doses of 200-800 mg, are similar in paediatric and adult population.
Maltese: Fuq il-bażi ta' dejta limitata, il-parametri farmakokinetiċi (AUC, Cmax u half-life) ta' ketoconazole għal dożi ta' 5 sa 10 mg/kg/jum, li jikkorrispondu bejn wieħed u ieħor għal dożi ta' 200-800 mg fil-ġurnata, huma simili fil-popolazzjoni pedjatrika u dik adulta.
English: AUC: ↑2.1-fold Cmax: ↑1.1-fold t1/2: ↑ 4-fold
Maltese: AUC: ↑2.1 darbiet Cmax: ↑1.1 darbiet t1/2: ↑ 4 darbiet
English: Intracranial pressure increased (papilloedema, fontanelle bulging), paraesthesia
Maltese: Żieda fil-pressjoni ġol-kranju (papilloedima, nefħa tal-fontanelli), parasteżija
English: Response rates varied between 43 and 80% depending on the studies and the criteria to define a response.
Maltese: Ir-rati ta' rispons varjaw bejn 43 u 80% skont l-istudji u l-kriterji għad-definizzjoni ta' rispons.
English: AUC: ↑ 5.5-fold
Maltese: AUC: ↑ 5.5 darbiet
English: In vitro, the plasma protein binding is about 99% mainly to the albumin fraction.
Maltese: In vitro, it-twaħħil mal-proteini tal-plażma huwa ta' madwar 99% l-aktar mal-frazzjon tal-albumina.
English: Ketoconazole at doses of 40 mg/kg/day and higher produces evidence of embryotoxicity and teratogenicity in rats and rabbits.
Maltese: Ketoconazole f'dożi ta' 40 mg/kg/jum u ogħla pproduċa evidenza ta' embrijotossiċità u teratoġeniċità fil-firien u l-fniek.
English: In a retrospective study conducted in several French centres, 200 patients with Cushing's disease were followed between 1995 and 2012.
Maltese: Fi studju retrospettiv imwettaq f'diversi ċentri Franċiżi, 200 pazjent bil-marda ta' Cushing kienu segwiti bejn l-1995 u l-2012.
English: Photosensitivity, erythema multiforme, dermatitis, erythema, , xeroderma
Maltese: Sensittività għad-dawl, eritema multiforme, dermatite, eritema, , kseroderma
English: The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation.
Maltese: Ir-rotot metaboliċi prinċipali identifikati huma l-ossidazzjoni u d-degradazzjoni taċ-ċrieki imidazole u piperazine, l-O-dealkilazzjoni ossidattiva u l-idrossilazzjoni aromatika.
English: Effects of other medicinal products on the metabolism of ketoconazole
Maltese: Effetti ta' prodotti mediċinali oħra fuq il-metaboliżmu ta' ketoconazole
English: Cmax: ↑1.5-fold
Maltese: Cmax: ↑ 1.5 darbiet
English: AUC: ↑ 1.8-fold
Maltese: AUC: ↑ 1.8 darbiet
English: Ketoconazole at doses up to 40 mg/kg had no effects on female fertility in the rat, whilst doses of 75 mg/kg and higher decreased the pregnancy rate and the number of implantation sites.
Maltese: Ketoconazole f'dożi sa 40 mg/kg ma kellux effetti fuq il-fertilità femminili fil-firien, filwaqt li dożi ta' 75 mg/kg u ogħla naqqsu r-rata tat-tqala u n-numru ta' siti tal-impjant.
English: Ketoconazole has a high potential for clinically important medicinal products interactions.
Maltese: Ketoconazole għandu potenzjal għoli ta' interazzjonijiet klinikament importanti ma' prodotti mediċinali.
English: Ketoconazole HRA is indicated for the treatment of endogenous Cushing's syndrome in adults and adolescents above the age of 12 years.
Maltese: Ketoconazole HRA huwa indikat għall-kura tas-sindrome endoġenu ta' Cushing f'persuni adulti u adolexxenti minn 12-il sena 'l fuq.
English: - In vitro data indicate that ketoconazole is an inhibitor of CYP1A2 and does not significantly inhibit CYP 2A6 and 2E1.
Maltese: - Dejta in vitro tindika li ketoconazole huwa inibitur ta' CYP1A2 u ma jinibixxix CYP 2A6 u 2E1 b'mod sinifikanti.
English: Vardenafil is contraindicated in men older than 75 years old (see section
Maltese: Vardenafil huwa kontraindikat f'irġiel ta' 'l fuq minn 75 sena (ara sezzjoni 4.3).
English: Doses of 25 mg/kg and higher in male rats and dogs produced sperm abnormalities and decreased fertility in rats.
Maltese: Dożi ta' 25 mg/kg u ogħla f'firien u klieb maskili ipproduċew abnormalitajiet fl-isperma u naqqsu l-fertilità fil-firien.
English: • Oedema peripheral (dropsy in extremities)
Maltese: • Edima periferali (idropsija fl-estremitajiet)
English: AUC: ↑ 24-fold Cmax: ↑ 29-fold
Maltese: AUC : ↑ 24 darba Cmax: ↑ 29 darba
English: Ketoconazole is mainly metabolised by cytochrome CYP3A4.
Maltese: Ketoconazole jiġi metabolizzat prinċipalment miċ-ċitokromu CYP3A4.
English: • Diarrhoea • Skin reactions (pruritus, rash)
Maltese: • Dijarea • Reazzjonijiet tal-ġilda (ħakk, raxx)
English: Ketoconazole is a potent inhibitor of CYP3A4: inhibition of CYP3A4 by ketoconazole can increase patients' exposure to a number of medicinal products which are metabolised through this enzymatic system (see section
Maltese: Ketoconazole huwa inibitur qawwi ta' CYP3A4: l-inibizzjoni ta' CYP3A4 minn ketoconazole tista' żżid lesponiment tal-pazjenti għal numru ta' prodotti mediċinali li jiġu metabolizzati permezz ta' din is-sistema enzimatika (ara sezzjoni 4.5).
English: (CYP3A enzyme induction)
Maltese: (induzzjoni tal-enzima CYP3A)
English: AUC: ↑ 1.8-fold Cmax: ↑ 1.8-fold
Maltese: AUC: ↑ 1.8 darbiet Cmax: ↑ 1.8 darbiet
English: Ketoconazole is also a potent inhibitor of androgens synthesis, inhibiting the activity of C17-20 lyase in the adrenals and also in Leydig cells.
Maltese: Ketoconazole huwa wkoll inibitur qawwi tas-sintesi tal-androġeni, billi jimpedixxi l-attività ta' C17-20 lyase fl-adrenali u anki fiċ-ċelloli Leydig.
English: Women must be provided with comprehensive information on pregnancy prevention.
Maltese: In-nisa jridu jingħataw informazzjoni komprensiva dwar il-prevenzjoni tat-tqala.
English: Coexisting inflammatory/autoimmune disorders
Maltese: Disturbi infjammatorji/awtoimmuni koeżistenti
English: After ketoconazole withdrawal, liver enzymes returned to normal levels within 3 weeks (section 5.1).
Maltese: Wara t-twaqqif ta' ketoconazole, l-enzimi tal-fwied reġgħu lura għal livelli normali fi żmien 3 ġimgħat (sezzjoni 5.1).
English: Data on 24 paediatric patients with endogenous Cushing's syndrome treated with ketoconazole are available in the literature, among which 16 were aged over 12 years old and 8 were aged less than 12 years old.
Maltese: Fil-letteratura hija disponibbli dejta dwar 24 pazjent pedjatriku b'sindrome ta' Cushing endoġenu li ngħataw kura b'ketoconazole, li 16 minnhom kellhom aktar minn 12-il sena u 8 kellhom anqas minn 12-il sena.
English: At steady state, mean peak concentrations of 1.7µg/mL to 15.6µg/mL were reported for total daily doses of 200 mg to 1,200 mg.
Maltese: 6µg/mL għal dożi totali ta' kuljum ta' 200 mg sa 1,200 mg.
English: AUC: ↑ 3.0 fold Cmax: ↑ 3.0 fold
Maltese: AUC: ↑ 3.0 darbiet Cmax: ↑ 3.0 darbiet
English: The following list is not an inclusive list of interactions between ketoconazole and other medicinal products
Maltese: Il-lista li ġejja mhijiex lista inklussiva tal-interazzjonijiet bejn ketconazole u prodotti mediċinali oħra.
English: Ketoconazole is an imidazole derivative that is a potent inhibitor of cortisol synthesis resulting from its ability to inhibit several cytochrome P450 enzymes in the adrenal glands.
Maltese: Ketoconazole huwa derivattiv ta' imidazole li huwa inibitur qawwi tas-sintesi tal-kortisol li jirriżulta mill-abilità tiegħu li jinibixxi diversi enzimi taċ-ċitokromu P450 filglandoli adrenali.
English: Ketoconazole is also a potent inhibitor of P-gp: inhibition of P-gp by ketoconazole can increase patients' exposure to medicinal products which are P-gp substrates (see section 4.5).
Maltese: Ketoconazole huwa wkoll inibitur qawwi tal-P-gp: l-inibizzjoni tal-P-gp minn ketoconazole tista' żżid lesponiment tal-pazjenti għal prodotti mediċinali li huma substrati tal-P-gp (ara sezzjoni 4.5).
English: • Tongue discoloration
Maltese: • Disfunzjoni tal-erezzjoni
English: Ketoconazole HRA is able to block the activity of the enzymes responsible for the synthesis of cortisol and consequently is able to decrease the over-production of cortisol by your body and to improve the symptoms of Cushing's syndrome.
Maltese: Ketoconazole HRA huwa kapaċi jimblokka l-attività tal-enzimi responsabbli għassintesi tal-kortisol u konsegwentement huwa kapaċi jnaqqas il-produzzjoni eċċessiva tal-kortisol mill-ġisem tiegħek u jtejjeb is-sintomi tas-sindrome ta' Cushing.
English: Indinavir (600mg TID): AUC= 0.8-fold
Maltese: Indinavir (600mg TID):
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure
Maltese: Dożi ripetuti ta' 200 mg ketoconazole kuljum irriżultaw f'żieda ta' 17-il darba fl-esponiment għal dronedarone
English: Menstrual disorder, azoospermia, erectile dysfunction, gynaecomastia
Maltese: Disturb mestrwali, azoospermja, disfunzjoni talerezzjoni, ginekomastja
English: Therefore, ketoconazole is an inhibitor of cortisol and aldosterone synthesis.
Maltese: Għalhekk, ketoconazole huwa inibitur tas-sintesi tal-kortisol u tal-aldosterone.
English: AUC: ↑ has been observed Cmax: ↑ has been observed
Maltese: AUC: kienet osservata ↑ Cmax: kienet osservata ↑
English: AUC: ↑ 10-fold Cmax: ↑ 4-fold
Maltese: AUC: ↑ 10 darbiet Cmax: ↑ 4 darbiet
English: A daily dose from 400 mg per day (2 tablets) to 1,200 mg per day (6 tablets) taken orally in 2 to 3 divided doses may be required to restore your normal cortisol levels.
Maltese: Tista' tkun meħtieġa doża ta' kuljum minn 400 mg kuljum (2 pilloli) sa 1,200 mg kuljum (6 pilloli) meħuda b'mod orali fi 2 sa 3 dożi maqsuma biex jerġgħu jiġu stabbiliti l-livelli tal-kortisol normali tiegħek.
English: Each tablet contains 200 milligram ketoconazole - The other ingredients are maize starch, lactose monohydrate (see section 2), povidone,
Maltese: - Is-sustanzi l-oħra huma lamtu tal-qamħirrum, lactose monohydrate (ara sezzjoni 2), povidone,
English: Data from 535 patients with Cushing's disease treated with ketoconazole, along with 13 individual case reports are available in the literature.
Maltese: Fil-letteratura hija disponibbli dejta minn 535 pazjent bil-marda ta' Cushing li ngħataw kura b'ketoconazole, flimkien ma' 13-il rapport ta' każijiet individwali.
English: Contraindicated due to an increased risk of skeletal muscle toxicity, including rhabdomyolysis (see section 4.3).
Maltese: Kontraindikat minħabba żieda firriskju ta' tossiċità tal-muskoli skeletali, inkluż rabdomijoliżi (ara sezzjoni 4.3).
English: Phosphodiesterase(PD E5) inhibitors Sildenafil
Maltese: Inibituri Phosphodiesterase(PD
English: Ketoconazole was not genotoxic in vitro and in vivo.
Maltese: Ketoconazole ma kienx ġenotossiku in vitro u in vivo.
English: Adrenal insufficiency may be detected by periodic clinical assessment and monitoring of plasma/serum or salivary cortisol levels.
Maltese: L-insuffiċjenza adrenali tista' tinstab permezz ta' valutazzjoni klinika perjodika u monitoraġġ tal-livelli tal-kortisol fil-plażma/serum jew fis-saliva.
English: AUC: ↑ 5.9-fold Cmax: ↑ 2.7-fold
Maltese: AUC: ↑ 5.9 darbiet Cmax: ↑ 2.7 darbiet
English: - Ketoconazole is a potent inhibitor of CYP3A4 and can inhibit the metabolism of medicinal products metabolised by this enzyme.
Maltese: - Ketoconazole huwa inibitur qawwi ta' CYP3A4 u jista' jinibixxi l-metaboliżmu tal-prodotti mediċinali metabolizzati minn din l-enzima.
English: In the literature, among 24 paediatric patients treated with ketoconazole, two developed severe hepatoxicity.
Maltese: Fil-letteratura, fost 24 pazjent pedjatriku li ngħataw ketoconazole, tnejn żviluppaw epatotossiċità severa.
English: • Sensation of tingling or pricking
Maltese: • Sensazzjoni ta' tingiż jew tnemnim
English: AUC: ↑ 2.6-fold Cmax: ↑2.5-fold
Maltese: AUC: ↑ 2.6 darbiet Cmax: ↑2.5 darbiet
English: Anticoagulants and antiplatelet drugs Dabigatran
Maltese: Antikoagulanti u mediċini kontra lplejtlits
English: AUC: ↑ 1.4-fold Cmax: ↔
Maltese: AUC: ↑1.3 darbiet Cmax: ↔
English: Enzyme-inducing medicinal products such as rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine, mitotane and phenytoin may significantly reduce the bioavailability of ketoconazole.
Maltese: Prodotti mediċinali li jinduċu l-enzimi bħal rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine, mitotane u phenytoin jistgħu jnaqqsu b'mod sinifikanti l-bijodisponibbiltà ta' ketoconazole.
English: AUC: ↑ 1.4-fold
Maltese: AUC: ↑ 1.4 darbiet
English: Dose reduction of indinavir to 600 mg every 8 hours should be considered.
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża ta' Indinavir għal 600 mg kull 8 sigħat.
English: AUC: ↑ have been observed
Maltese: AUC: ↑ 2 darbiet
English: isavuconazole - certain antidiabetics: repaglinide, saxagliptin, tolbutamide - certain medicines used for mental disorders: buspirone, aripipazole, haloperidol, reboxetine, risperidone - certain heart medicines - verapamil, digoxin, nadolol, aliskiren - certain anticonvulsivants: carbamazepine, phenitoin - certain glucocorticoids - such as budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide - certain stong painkillers (narcotics) - such as alfentanyl, fentanyl, buprenorphine (injection and sublingual),
Maltese: clarithromycin, isavuconazole - ċerti antidijabetiċi: repaglinide, saxagliptin, tolbutamide - ċerti mediċini użati għal disturbi mentali: buspirone, aripiprazole, haloperidol, reboxetine, risperidone - ċerti mediċini għall-qalb - verapamil, digoxin, nadolol, aliskiren - ċerti antikonvulsanti: carbamazepine, phenitoïn - ċerti glukokortikojdi - bħal budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide - ċerti mediċini qawwija li jnaqqsu l-uġigħ (narkotiċi) - bħal alfentanyl, fentanyl, buprenorphine (injezzjoni u taħt l-ilsien), oxycodone - ċerti mediċini użati għad-dardir u r-rimettar: domperidone, aprepitant - naloxegol (mediċina għall-kura tal-istitikezza kkawżata speċifikament minn mediċini għal kontra uġigħ qawwi) - solifenacin, fesoterodine f'pazjenti b'indeolimenti tal-kliewi - oħrajn: sildenafil, tolterodine, mitotane, praziquantel, eletriptan, salmeterol, bosentan, midazolam
English: About 75% of patients achieved a decrease of more than 50% of UFC levels on ketoconazole, compared to pre-treatment levels
Maltese: Madwar 75% tal-pazjenti kisbu tnaqqis ta' aktar minn 50% fil-livelli ta' UFC b'ketoconazole, meta mqabbel mal-livelli ta' qabel il-kura
English: How to store Ketoconazole HRA 6.
Maltese: Kif taħżen Ketoconazole HRA 6.
English: Dosing regimens for maintenance therapy Subsequent maintenance therapy can be administered in one of two ways: - Block-only regimen: the maintenance dose of ketoconazole may be continued as described above; - Block-and-replace regimen: the maintenance dose of ketoconazole should be further increased by 200 mg and concomitant corticosteroid replacement therapy should be added (see section 4.4).
Maltese: - Reġim ta' imblokk u sostituzzjoni: id-doża ta' manteniment ta' ketoconazole għandha tiżdied ulterjorment b'200 mg u għandha tiżdied terapija ta' sostituzzjoni konkomitanti bil-kortikosterojdi (ara sezzjoni 4.4).
English: Urological Drugs Fesoterodine Tolterodine Solifenacin
Maltese: Mediċini Uroloġiċi Fesoterodine
English: Treatment of juvenile rats for 30 day beginning at 21 days of age delayed the puberty onset.
Maltese: Il-kura ta' firien żgħar għal 30 ġurnata minn meta kellhom 21 jum ittardjat il-bidu talpubertà.
English: AUC: ↑ 6.2-fold Cmax: ↑ 3.4-fold
Maltese: AUC: ↑ 6.2 darbiet Cmax: ↑ 3.4 darbiet
English: AUC: ↑ 2.3-fold Cmax: ↑ 2.0-fold
Maltese: AUC: ↑ 2.3 darbiet Cmax: ↑ 2.0 darbiet
English: AUC: ↑ 2.6-fold Cmax: ↑1.7-fold
Maltese: AUC: ↑ 2.6 darbiet Cmax: ↑1.7 darbiet
English: cilostazol, warfarin and others coumarin like - HIV medicines such as maraviroc, indinavir, nevirapine, ritonavir - certain medicines used for cancer such as vinca alkaloids, busulfan, docetaxel, erlotinib, imatinib, dasatinib,
Maltese: edoxaban, cilostazol, warfarin u oħrajn tat-tip tal-coumarin - mediċini għall-HIV bħal maraviroc, indinavir, nevirapine, ritonavir - ċerti mediċini użati għall-kanċer bħall-alkalojdi vinka, busulfan, docetaxel, erlotinib, imatinib, dasatinib,
English: Saquinavir: AUC: ↔
Maltese: AUC: ↔
English: However, ketoconazole may be an inhibitor of BCRP at the intestinal level at clinically relevant concentrations.
Maltese: Madankollu, ketoconazole jista' jkun inibitur tal-BCRP fil-livell intestinali f'konċentrazzjonijiet klinikament rilevanti.
English: Potential ↑in plasma concentrations of warfarin
Maltese: ↑ potenzjali fil-konċentrazzjonijiet talwarfarin fil-plażma
English: AUC: ↑ 3.6-fold
Maltese: AUC: ↑ 3.6 darbiet
English: AUC: ↑ 2.1-fold
Maltese: AUC: ↑ 2.1 darbiet
English: • Change in laboratory markers
Maltese: • Tibdil fil-markers tal-laboratorju
English: The recommended initial dose is usually 600 mg per day taken orally (3 tablets per day in 3 divided times).
Maltese: Id-doża tal-bidu rakkomandata ġeneralment hija 600 mg kuljum meħuda mill-ħalq (3 pilloli kuljum fi 3 ħinijiet maqsuma).
English: Ketoconazole is mainly metabolised through CYP3A4.
Maltese: Ketoconazole jiġi metabolizzat prinċipalment permezz ta' CYP3A4.
English: Midazolam IV
Maltese: ANNESS II
English: The doses used in adolescents above 12 years old were similar to the doses used in adults' patients with endogenous Cushing's syndrome.
Maltese: Iddożi użati f'persuni adolexxenti ta' 'l fuq minn 12-il sena kienu simili għad-dożi użati f'pazjenti adulti li kellhom sindrome ta' Cushing ta' nisel endoġenu.
English: AUC: ↑ 1.3-fold
Maltese: AUC: ↑ 1.3 darbiet
English: Ketoconazole can be resumed thereafter at a lower dose (see section 4.2).
Maltese: Ketoconazole jista' jitkompla wara f'doża aktar baxxa (ara sezzjoni 4.2).
English: Use with hepatotoxic medicinal products
Maltese: Użu ma' prodotti mediċinali epatotossiċi
English: Ketoconazole can be reintroduced thereafter at a lower dose (see section 4.4); - Treatment with ketoconazole can be stopped abruptly without a need for progressive dose decrease where a change in the therapeutic strategy (e.g. surgery) is desired.
Maltese: Ketoconazole jista' jerġa' jiġi introdott wara f'doża aktar baxxa (ara sezzjoni 4.4); - Il-kura b'ketoconazole tista' titwaqqaf f'daqqa mingħajr il-ħtieġa ta' tnaqqis progressiv fid-doża meta tkun mixtieqa bidla fl-istrateġija terapewtika (eż. kirurġija).
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: (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: - Ketoconazole can inhibit the transport of medicinal products by P-gp, which may result in an increased plasma concentration of these medicinal products.
Maltese: - Ketoconazole jista' jinibixxi t-trasport ta' prodotti mediċinali mill-P-gp, li jista' jirriżulta f'żieda filkonċentrazzjoni ta' dawn il-prodotti mediċinali fil-plażma.
English: ↑in plasma concentrations of docetaxel have been observed Potential ↑in plasma concentrations of busulfan
Maltese: Kienet osservata ↑ fil-konċentrazzjonijiet ta' docetaxel fil-plażma ↑ potenzjali fil-konċentrazzjonijiet ta' busulfan fil-plażma
English: Consistent with the pharmacological action of ketaconazole, effects were observed on adrenal and gonads in rats and dogs.
Maltese: B'mod konsistenti mal-azzjoni farmakoloġika ta' ketaconazole, l-effetti kienu osservati fuq iċ-ċelloli adrenali u l-gonadi fil-firien u l-klieb.