FrancophonIA/ELRC3.0 huggingface dataset:
English: Control of cortisol levels, either in serum/plasma or urine, was used to assess the efficacy of the treatment, along with the evaluation of clinical symptoms of Cushing's syndrome.
Slovenian: Pri ocenjevanju učinkovitosti zdravljenja so upoštevali nadzor ravni kortizola v serumu/plazmi ali urinu in oceno kliničnih simptomov Cushingovega sindroma.
English: ASAT, ALAT, gammaGT, bilirubin and alkaline phosphatase should be monitored at frequent intervals during treatment (see sections 4.2 and 4.4).
Slovenian: Med zdravljenjem je treba redno spremljati ravni AST, ALT, gama-GT, bilirubina in alkalne fosfataze (glejte poglavji 4.2 in 4.4).
English: • Nervousness
Slovenian: • živčnost,
English: Antimigraine Drugs Ergots alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)
Slovenian: Alkaloidi ergot, kot so dihidroergotamin, ergometrin (ergonovin), ergotamin, metilergometrin (metilergonovin)
English: Transient decrease of testosterone concentrations
Slovenian: • prehodno zmanjšanje vrednosti testosterona,
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.
Slovenian: Zdravilo Ketokonazol HRA zavira dejavnost encimov, odgovornih za sintezo kortizola, kar posledično zmanjša čezmerno tvorbo kortizola v telesu in izboljša simptome Cushingovega sindroma.
English: Absorption Ketoconazole is a weak dibasic active substance and thus requires acidity for dissolution and absorption.
Slovenian: Ketokonazol je šibka dvobazna učinkovina, zato za raztapljanje in absorpcijo potrebuje kislost.
English: AUC: ↑ have been observed
Slovenian: AUC:opazili so ↑.
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.
Slovenian: Pri 17-letni deklici, ki se je zaradi adrenalnega karcinoma z jetrno metastazo zdravila z 1200 mg ketokonazola/dan, so po 22 dneh ugotovili spremenjene vrednosti preiskav delovanja jeter.
English: You may need to read it again.
Slovenian: - Navodilo shranite.Morda ga boste želeli ponovno prebrati.
English: The overall pharmacological activity of cilostazol increases 35% when coadministered with ketoconazole.
Slovenian: Skupna farmakološka dejavnost cilostazola se poveča za 35 %, če se uporablja sočasno s ketokonazolom.
English: You should not take antacids (eg aluminium hydroxide) or other medicines for acid indigestion for at least 2 hours after the intake of Ketoconazole HRA (see section Warning and Precautions).
Slovenian: Antacidov (npr. aluminijevega hidroksida) ali drugih zdravil za težave z želodcem ne smete vzeti vsaj 2 uri po zaužitju zdravila Ketokonazol HRA (glejte poglavje Opozorila in previdnostni ukrepi).
English: There are some medicines that must not be taken with Ketoconazole HRA (see section 2).
Slovenian: Nekaterih zdravil ne smete jemati skupaj z zdravilom Ketokonazol HRA (glejte poglavje 2).
English: Urological Drugs Fesoterodine Tolterodine Solifenacin
Slovenian: Fesoterodin Tolterodin Solifenacin
English: In patients with achlorhydria, such as certain AIDS patients and patients on acid secretion suppressors (e.g. H2-antagonists, proton pump inhibitors), it is advised to administer ketoconazole with an acidic beverage e.g. cola beverage, orange juice.
Slovenian: Pri bolnikih z aklorhidrijo, kot so nekateri bolniki z AIDS-om in bolniki, ki jemljejo zaviralce izločanja kisline (npr. H2-antagoniste, zaviralce protonske črpalke), je priporočljivo dajanje ketokonazola skupaj s kislo pijačo, npr. coca-cola, pomarančni sok.
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.
Slovenian: Ketokonazol je prav tako močan zaviralec sinteze androgenov, saj zavira dejavnost C17-20-laze v nadledvičnih žlezah in Leydigovih celicah.
English: If you take concomitant glucocorticoid replacement therapy with your Ketoconazole HRA treatment, your doctor should inform you how to adapt your glucocorticoid replacement therapy dose if you are under stress or have surgery or an infection.
Slovenian: Če ob zdravljenju z zdravilom Ketokonazol HRA sočasno prejemate nadomestno zdravljenje z glukokortikoidom, vas mora zdravnik poučiti, kako prilagoditi odmerek glukokortikoida pri nadomestnem zdravljenju, če ste izpostavljeni stresu, prestajate kirurški poseg ali imate okužbo.
English: Hepatic impairment Ketoconazole is contraindicated in patients with acute or chronic hepatic impairment (see sections 4.3, 4.4 and
Slovenian: Ketokonazol je kontraindiciran pri bolnikih z akutno ali kronično jetrno okvaro (glejte poglavja 4.3, 4.4 in 5.3).
English: You should contact your doctor immediately if you have symptoms such as weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure.
Slovenian: Takoj se posvetujte z zdravnikom, če imate simptome, kot so šibkost, utrujenost, izguba apetita, slabost, bruhanje, nizek krvni tlak.
English: Preclinical data show that ketoconazole crosses the placenta and is teratogenic.
Slovenian: Predklinični podatki kažejo, da ketokonazol prehaja skozi posteljico in je teratogen.
English: At the last follow-up, clinical signs were improved in 74/134 patients (55.2%), hypertension in 36/90 patients (40), hypokalaemia in 10/26 patients (38.4%), and diabetes mellitus in 23/39 patients (59%).
Slovenian: hipertenzija pri 36/90 bolnikov (40 %), hipokaliemija pri 10/26 bolnikov (38,4 %) in sladkorna bolezen pri
English: Reboxetine: AUC: ↑ 1.5-fold of both enantiomers
Slovenian: Reboksetin: AUC:↑ 1,5-krat pri obeh enantiomerih
English: Post Authorisation safety study (PASS): Multi-country, observational registry to collect clinical information on patients with Cushing Syndrome patients exposed with Ketoconazole (preferably using the existing European Registry on Cushing's syndrome (ERCUSYN) registry where feasible ), to assess drug utilization patterns and to document the safety (eg hepatotoxicity, QT prolongation) and effectiveness of ketoconazole
Slovenian: večdržavni opazovalni register za zbiranje kliničnih podatkov o bolnikih s Cushingovim sindromom, izpostavljenih ketokonazolu (po možnosti z uporabo obstoječega evropskega registra o Cushingovem sindromu (ERCUSYN), kadar je to mogoče), za ocenitev vzorcev uporabe zdravila ter dokumentiranje varnosti (npr. hepatotoksičnost, podaljšanje intervala QT) in učinkovitosti ketokonazola.
English: Not recommended because of reboxetine narrow's therapeutic margin.
Slovenian: Ni priporočljivo zaradi ozkega terapevtskega okna reboksetina.
English: Medicinal products affecting gastric acidity impair the absorption of ketoconazole (see section 4.4).
Slovenian: Zdravila, ki vplivajo na želodčno kislost, poslabšajo absorpcijo ketokonazola (glejte poglavje 4.4).
English: Not recommended due to increased risk of isavuconazole adverse reactions, please consult isavuconazole SmPC
Slovenian: Ni priporočen zaradi povečanega tveganja neželenih reakcij izavukonazola; glejte SmPC za izavukonazol.
English: The treatment must not be initiated in patients with liver enzymes levels above 2 times the upper limit of normal
Slovenian: Zdravljenja ni dovoljeno uvesti pri bolnikih z ravnmi jetrnih encimov nad 2-kratno zgornjo mejo od normalne vrednosti.
English: As a minimum requirement, women of childbearing potential must use an effective method of contraception (see section 4.6).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito metodo kontracepcije (glejte poglavje 4.6).
English: Coadministration of potent enzyme inducers of CYP3A4 may decrease the bioavailibity of ketoconazole.
Slovenian: Sočasna uporaba močnih induktorjev encima CYP3A4 lahko zmanjša biološko uporabnost ketokonazola.
English: Therefore, ketoconazole is an inhibitor of cortisol and aldosterone synthesis.
Slovenian: Ketokonazol je torej zaviralec sinteze kortizola in aldosterona.
English: However, ketoconazole may be an inhibitor of BCRP at the intestinal level at clinically relevant concentrations.
Slovenian: Vendar je lahko ketokonazol v klinično pomembnih koncentracijah zaviralec BCRP na črevesni ravni.
English: Heart disease Ketoconazole HRA can change how your heart beats - this can be serious.
Slovenian: Zdravilo Ketokonazol HRA lahko spremeni srčni utrip, kar je lahko resno.
English: Acute hepatocellular injury has been primarily observed as has cholestatic injury or a mixed pattern of toxicity.
Slovenian: Akutno hepatocelularno poškodbo so opazili predvsem v obliki holestatske poškodbe ali toksičnosti z mešanim vzorcem.
English: Ketoconazole HRA 200 mg tablets
Slovenian: Ketokonazol HRA 200 mg tablete
English: The pharmacokinetics of ketoconazole were not significantly different in patients with renal failure compared to healthy subjects.
Slovenian: Farmkokinetika ketokonazola se ni pomembno razlikovala pri bolnikih z ledvično odpovedjo in zdravih preizkušancih.
English: Date of first authorisation: 19 November 2014 Date of latest renewal: <DD month YYYY>
Slovenian: Datum zadnjega podaljšanja: <DD.
English: Ketoconazole dose should be adjusted accordingly.
Slovenian: Skladno s tem je treba prilagoditi odmerek ketokonazola.
English: Medicinal product by therapeutic area
Slovenian: Zdravilo glede na terapevtsko področje
English: The list above is not an inclusive list of compounds that may interact with ketoconazole and result in potentially life-threatening reactions.
Slovenian: Zgornji seznam morda ne vsebuje vseh snovi, ki bi lahko medsebojno delovale s ketokonazolom in povzročile morebitne smrtno nevarne reakcije.
English: A review of concomitant medicinal products should be conducted when initiating ketoconazole treatment since ketoconazole is a known strong CYP3A4 inhibitor.
Slovenian: Pri uvedbi zdravljenja s ketokonazolom je treba pregledati sočasno uporabljena zdravila, saj je ketokonazol znan močan zaviralec CYP3A4.
English: Alcohol intolerance, anorexia, increased appetite
Slovenian: Presnovne in prehranske motnje neznana intoleranca za alkohol, anoreksija, povečan apetit
English: Ketoconazole can be resumed thereafter at a lower dose (see section 4.2).
Slovenian: Potem se lahko ketokonazol ponovno uvede z manjšim odmerkom (glejte poglavje 4.2).
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.
Slovenian: Ketokonazol je imidazolni derivat, ki je močan zaviralec sinteze kortizola, saj je zmožen zavirati več encimov citokroma P450 v nadledvičnih žlezah.
English: Not recommended due to the risk of increased exposure to these medicinal products and QT prolongation.
Slovenian: Ni priporočljivo zaradi tveganja povečane izpostavljenosti tem zdravilom in podaljšanja intervala QT.
English: There are no or limited amount of data from the use of Ketoconazole HRA in pregnant women.
Slovenian: Podatkov o uporabi ketokonazola pri nosečnicah ni oziroma so omejeni.
English: Irinotecan:
Slovenian: Irinotekan:
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).
Slovenian: Bolnike spremljajte in jih poučite o znakih ter simptomih, povezanih s hipokortizolizmom (npr. šibkost, utrujenost, anoreksija, navzea, bruhanje, hipotenzija, hiperkaliemija, hiponatriemija, hiperkaliemija ali hipoglikemija).
English: Ketoconazole is a potent inhibitor of CYP3A4 and P-gp.
Slovenian: Ketokonazol je močan zaviralec CYP3A4 in P-gp.
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.
Slovenian: zdravljenih s ketokonazolom, od katerih jih je bilo 16 starih več kot 12 let, 8 pa manj kot 12 let.
English: Dose adjustment of dihydropyridines and verapamil may be required.
Slovenian: Skrbno spremljanje.Morda bo potrebna prilagoditev odmerka dihidropiridinov in verapamila.
English: Nevirapine
Slovenian: Nevirapin
English: In the case of increase of liver enzymes levels above 3 times the upper limit of normal, Ketoconazole should be stopped immediately and should not be reintroduced because of the risk of serious hepatic toxicity.
Slovenian: Če se ravni jetrnih encimov zvišajo na več kot trikratno zgornjo mejo normalnih vrednosti, je treba jemanje ketokonazola takoj prekiniti in ga ni dovoljeno ponovno uvesti zaradi tveganja resne jetrne toksičnosti.
English: Studies in pregnant rats and in guinea pigs with 3H-ketoconazole indicate that ketoconazole crosses the placenta.
Slovenian: Študije 3H-ketokonazola na brejih podganah in morskih prašičkih so pokazale, da ketokonazol prehaja skozi posteljico.
English: ranolazine
Slovenian: Ranolazin
English: Not recommended due to the potential for hepatic toxicity (see section 4.3).
Slovenian: Ni priporočljivo zaradi potenciala za jetrno toksičnost (glejte poglavje 4.3).
English: Therefore, do not stop taking Ketoconazole HRA unless your doctor tells you.
Slovenian: Zdravila Ketokonazol HRA zato ne prenehajte jemati, če vam tega ni naročil zdravnik.
English: Not recommended due to the increased risk of adverse reactions.
Slovenian: Ni priporočljivo zaradi povečanega tveganja neželenih učinkov.
English: The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation.
Slovenian: Glavne ugotovljene presnovne poti so oksidacija in razpad imidazolnih ter piperazinskih obročev,
English: Each tablet contains 200 milligram ketoconazole - The other ingredients are maize starch, lactose monohydrate (see section 2), povidone,
Slovenian: - Druge sestavine zdravila so koruzni škrob, laktoza monohidrat (glejte poglavje 2), povidon,
English: If you have taken more than the prescribed dose of Ketoconazole HRA, you must contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Ketokonazol HRA, kot bi smeli Če ste vzeli odmerek zdravila Ketokonazol HRA, ki je večji od predpisanega, se morate nemudoma posvetovati z zdravnikom.
English: Package leaflet: Information for the patient Ketoconazole HRA 200 mg tablets ketoconazole This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Ketokonazol HRA 200 mg tablete ketokonazol Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: The most frequent adverse reactions are adrenal insufficiency, nausea, vomiting, abdominal pain, diarrhoea, pruritus, rash and the hepatic enzymes increased.
Slovenian: Najpogostejši neželeni učinki so adrenalna insuficienca, navzea, bruhanje, bolečina v trebuhu, diareja, pruritus, izpuščaj in povišane ravni jetrnih encimov.
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.
Slovenian: V stanju dinamičnega ravnovesja so pri dnevnih odmerkih od 200 mg do 1200 mg poročali o povprečnih največjih koncentracijah od 1,7 µg/ml do 15,6 µg/ml.
English: Exceptional cases of a disulfiram-like reaction have been reported when ketoconazole was co-administered with alcohol, characterised by flushing, rash, peripheral oedema, nausea and headache, have been reported.
Slovenian: Kadar se je ketokonazol dajal sočasno z alkoholom, so poročali o izjemnih primerih disulfiramu podobnih reakcij, za katere so značilni zardevanje, izpuščaj, periferni edem, navzea in glavobol.
English: Off-white to light cream, round, 10 mm diameter, biconvex.
Slovenian: Umazano bele do svetlo kremaste barve, okrogla, bikonveksna s premerom 10 mm.
English: Contraindicated in patients with renal impairment (see section 4.3).
Slovenian: Kontraindicirano pri bolnikih z ledvično okvaro (glejte poglavje 4.3).
English: Liver enzyme monitoring should be performed once weekly during the first month of treatment and then monthly for 6 months.
Slovenian: V prvem mesecu zdravljenja je treba jetrne encime spremljati enkrat na teden, potem pa 6 mesecev enkrat na mesec.
English: If clinical symptoms are suggestive of adrenal insufficiency, cortisol levels should be measured and ketoconazole should be temporarily discontinued or the dose reduced and if necessary corticosteroid substitution should be initiated.
Slovenian: Če klinični simptomi kažejo na adrenalno insuficienco, je treba izmeriti ravni kortizola, ketokonazol začasno prekiniti ali zmanjšati njegov odmerek in po potrebi uvesti nadomestno zdravljenje s kortikosteroidi.
English: What Ketoconazole HRA is and what it is used for 2.
Slovenian: Kaj je zdravilo Ketokonazol HRA in za kaj ga uporabljamo 2.
English: Buspirone
Slovenian: Buspiron
English: (See also “Effects of other medicinal products on the metabolism of ketoconazole HRA ”).
Slovenian: (Glejte tudi »Učinki drugih zdravil na presnovo zdravila Ketokonazol HRA«.)
English: Ketoconazole:
Slovenian: Ketokonazol:
English: The buprenorphine dose should be adjusted.
Slovenian: Odmerek buprenorfina je treba prilagoditi.
English: Absorption is impaired when gastric acidity is decreased.
Slovenian: Če je kislost želodca zmanjšana, je absorpcija poslabšana.
English: You should know that your liver enzyme tests will be regularly monitored before starting the treatment, once weekly during the first month after Ketoconazole HRA initiation and then monthly for 6 months due to the risk of serious hepatic toxicity.
Slovenian: Zaradi tveganja resne toksičnosti za jetra bodo pri vas redno opravljali preiskave jetrnih encimov: pred začetkom zdravljenja, enkrat na teden v prvem mesecu po uvedbi zdravila Ketokonazol HRA in potem 6 mesecev enkrat na mesec.
English: Cinacalcet
Slovenian: Cinakalcet
English: No alcohol should be consumed during treatment with ketoconazole.
Slovenian: Med zdravljenjem s ketokonazolom ni dovoljeno uživati alkohola.
English: Overall, ketoconazole was shown to be an effective medicinal product for normalising cortisol levels in all causes of Cushing's syndrome and, if tolerated, ketoconazole treatment can be maintained for a long period.
Slovenian: Na splošno so pokazali, da je ketokonazol učinkovito zdravilo za normalizacijo ravni kortizola pri Cushingovem sindromu zaradi vseh vzrokov.
English: - In vitro data indicate that ketoconazole is an inhibitor of CYP1A2 and does not significantly inhibit CYP 2A6 and 2E1.
Slovenian: - Podatki in vitro kažejo, da je ketokonazol zaviralec CYP1A2, encimov CYP 2A6 in 2E1 pa ne zavira pomembno.
English: Ranolazine:
Slovenian: Ranolazin:
English: Expected effect on drug levels
Slovenian: Pričakovan učinek na ravni zdravila Priporočila za sočasno uporabo
English: If acid secretion suppressors are added to or removed from the concomitant medicinal products then ketoconazole dose should be adjusted according to cortisol levels.
Slovenian: Če se sočasnim zdravilom dodajo ali ukinejo zaviralci izločanja kisline, je treba odmerek ketokonazola prilagoditi glede na ravni kortizola.
English: Studies in animal have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Ketoconazole is a steroidogenesis inhibitor.
Slovenian: Mehanizem delovanja Ketokonazol je zaviralec steroidogeneze.
English: microcrystalline cellulose, silica colloidal, magnesium stearate
Slovenian: mikrokristalna celuloza, koloidni silicijev dioksid, magnezijev stearat.
English: If you are not sure, talk to your doctor or pharmacist before taking Ketoconazole HRA.
Slovenian: Če niste prepričani, se pred začetkom jemanja zdravila Ketokonazol HRA posvetujte z zdravnikom ali farmacevtom.
English: Ketoconazole has a moderate influence in the ability to drive and use machines Patients should be warned about the potential for dizziness and somnolence (see section 4.8) and should be advised not to drive or operate machines if any of these symptoms occur.
Slovenian: Bolnike je treba opozoriti na morebitno omotico in somnolenco (glejte poglavje 4.8) in jim svetovati, naj ne vozijo ali upravljajo strojev,
English: Domperidone:
Slovenian: Domperidon:
English: Domperidone
Slovenian: Domperidon
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).
Slovenian: Kontraindicirano zaradi povečanega tveganja resnih kardiovaskularnih dogodkov, vključno s podaljšanjem intervala QT in torsade de pointes, ali respiratorne depresije ali depresije osrednjega živčevja (glejte poglavje 4.3).
English: • Azoospermia (no sperm count)
Slovenian: • azoospermija (odsotnost semenčic),
English: Dose adjustment of aliskiren may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka aliskirena.
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
Slovenian: Ketokonazol je močan zaviralec CYP3A4: zaviranje CYP3A4, ki ga povzroča ketokonazol, lahko poveča bolnikovo izpostavljenost številnim zdravilom, ki se presnavljajo s tem encimskim sistemom (glejte poglavje 4.5).
English: As a precautionary measure, in case of a dose increase after the first six months of treatment, monitoring of liver enzymes should be repeated on a weekly basis for one month.
Slovenian: Če po prvih šestih mesecih zdravljenja povečate odmerek, je treba kot previdnostni ukrep jetrne encime en mesec ponovno spremljati enkrat tedensko.
English: Coexisting inflammatory/autoimmune disorders Tell your doctor if you suffer from an autoimmune disorder, you will be closely supervised.
Slovenian: Sočasne vnetne/avtoimunske motnje Obvestite zdravnika, če imate avtoimunsko motnjo, saj to zahteva skrben nadzor.
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).
Slovenian: Kontraindicirano pri bolnikih s hudo ledvično okvaro zaradi tveganja podaljšanja intervala QT in resnih jetrnih neželenih učinkov (glejte poglavje 4.3).
English: In case of adrenal insufficiency, Ketoconazole HRA treatment should be temporarily discontinued or the dose reduced and, if needed, a corticosteroid substitution therapy added.
Slovenian: Če pride do adrenalne insuficience, je treba uporabo zdravila Ketokonazol HRA začasno prekiniti ali zmanjšati njegov odmerek in po potrebi dodati nadomestno zdravljenje s kortikosteroidi.
English: Contraindicated due to an increased risk of skeletal muscle toxicity, including rhabdomyolysis (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanega tveganja mišičnoskeletne toksičnosti, vključno z rabdomiolizo (glejte poglavje 4.3).
English: Monitoring of QT-prolongation if used concomitantly.
Slovenian: Pri sočasni uporabi je potrebno spremljanje podaljšanja intervala QT.
English: Ciclesonide active metabolite:
Slovenian: Aktivni presnovek ciklezonida:
English: Liver enzymes should be monitored in all patients receiving ketoconazole.
Slovenian: Pri vseh bolnikih, ki prejemajo ketokonazol, je treba spremljati jetrne encime.
English: - certain heart medicines: epleronone, dronedarone, disopyramide, felodipine, nisoldipine,
Slovenian: - nekatera zdravila za srce: eplerenon, dronedaron, dizopiramid, felodipin, nizoldipin, ranolazin,
English: Dose adjustment of these medicinal products may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka teh zdravil.
English: Contraindicated due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Slovenian: Kontraindicirano zaradi tveganja morebitno podaljšane ali povečane sedacije in respiratorne depresije (glejte poglavje 4.3).