natgillin/translations-raw huggingface dataset:
Allergic conditions including anaphylactic shock, anaphylactoid reaction and anaphylactic reaction and angioedema 
Bolezni imunskega sistema občasni alergijska stanja, vključno z anafilaktičnim šokom, anafilaktoidno reakcijo,
Stop taking Ketoconazole HRA and tell your doctor straight away if you experience any of the following: - long-lasting severe headache or blurred vision - severe lack of appetite (anorexia) - weight loss - nausea or vomiting - unusual tiredness or fever - stomach pain - muscle weakness - yellowing of the skin or whites of the eyes - unusually dark urine or pale stools 
- izguba telesne mase, - slabost ali bruhanje, - nenavadna utrujenost ali povišana telesna temperatura, - bolečina v želodcu, - mišična šibkost, - porumenelost kože ali beločnic, - nenavadno temen urin ali bledo blato.
Decreased gastric acidity 
Zmanjšana želodčna kislost
Eplerenone: 
Eplerenon:
Ombitasvir: AUC: ↑1.3-fold 
Ombitasvir: AUC: ↑1,3-krat
Rest of drugs ↑in plasma concentrations of these drugs have been observed 
Opazili so ↑ koncentracij teh zdravil v plazmi.
Initiation 
Uvajanje
Dose adjustment of saxagliptin may be required. 
Morda bo potrebna prilagoditev odmerka saksagliptina.
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), 
risperidon; - nekatera zdravila za srce: verapamil, digoksin, nadolol, aliskiren; - nekateri antikonvulzivi: karbamazepin, fenitoin; - nekateri glukokortikoidi, kot so budezonid, flutikazon, deksametazon, metilprednizolon, ciklezonid; - nekatera močna protibolečinska zdravila (narkotiki), kot so alfentanil, fentanil, buprenorfin (za injiciranje in sublingvalni), oksikodon; - nekatera zdravila proti slabosti in bruhanju: domperidon, aprepitant; - naloksegol (zdravilo za zdravljenje zaprtja, še posebej zaradi močnih zdravil proti bolečinam); - solifenacin, fesoterodin pri bolnikih z ledvično okvaro; - druga zdravila: sildenafil, tolterodin, mitotan, prazikvantel, eletriptan, salmeterol, bosentan, midazolam
- If you get any side effects, talk to your doctor, or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.Posvetujte se tudi,
Dose adjustment of cinacalcet may be required. 
Morda bo potrebna prilagoditev odmerka cinakalceta.
Warning regarding excipients 
Opozorila glede pomožnih snovi
Insomnia, nervousness 
Psihiatrične motnje neznana nespečnost, nervoznost
Potential ↑in plasma concentrations of alfentanil and fentanyl 
Morebitno ↑ koncentracij alfentanila in fentanila v plazmi.
Antidiabetics Repaglinide 
Antidiabetiki
Cmax: ↑1.5-fold 
Cmax:↑ 1,5-krat
Serious hepatotoxicity, including jaundice, hepatitis, hepatic necrosis, hepatic cirrhosis, hepatic failure including cases necessitating transplantation or resulting in death. 
jetrno cirozo, jetrno odpovedjo, vključno s primeri, ki zahtevajo transplantacijo ali povzročijo smrt
Potential ↑in plasma concentrations of ergot alkaloids 
Morebitno ↑ koncentracij alkaloidov ergot v plazmi.
- 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. 
400 mg/dan do največjega odmerka 1200 mg/dan peroralno, ki se vzame v 2 do 3 ločenih odmerkih.
AUC: ↑ 2-fold 
AUC:↑ 2-krat
• Gynaecomastia (enlargement in breast tissues in male) 
• ginekomastija (povečanje tkiva dojk pri moških), • periferni edem (otekanje okončin),
Contraindicated due to the increased risk of ergotism and other serious vasospastic adverse reactions (see section 4.3). 
Kontraindicirano zaradi povečanega tveganja ergotizma in drugih resnih vazospastičnih neželenih učinkov
Fesoterodine active metabolite: 
Aktivni presnovek fesoterodina:
• Dyspepsia (impaired digestion) 
• dispepsija (slaba prebava),
Potential ↑in plasma concentrations of pimozide. 
Morebitno ↑ koncentracij pimozida v plazmi.
AUC: ↑ 2.2 fold 
AUC:↑ 2,2-krat
Potential ↑in plasma concentrations of carbamazepine and phenytoin 
Morebitno ↑ koncentracij karbamazepina in fenitoina v plazmi.
DATE OF REVISION OF THE TEXT 
Letno sporočanje podatkov
o weekly for one month after initiation of the treatment o then monthly for 6 months o weekly during one month whenever the dose was increased. 
o enkrat tedensko en mesec, kadar se poveča odmerek.
Careful monitoring INR (international normalised ratio) monitoring recommended. 
(internacionalnega normaliziranega razmerja).
Fesoterodine and solifenacin are contraindicated in patients with renal impairment (see section 4.3). 
Ni priporočljivo zaradi povečanega tveganja podaljšanja intervala QT. Fesoterodin in solifenacin sta kontraindicirana pri bolnikih z ledvično okvaro (glejte poglavje 4.3).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM
Potential ↑in plasma concentrations of these drugs 
Morebitno ↑ koncentracij teh zdravil v plazmi.
Dose adjustment of nadolol may be required. 
Skrbno spremljanje.Morda bo potrebna prilagoditev odmerka nadolola.
AUC: ↑ 15-fold Cmax: ↑ 1.4-fold 
AUC:↑ 15-krat Cmax:↑ 1,4-krat
Potential ↑ in plasma concentrations of rifabutine. 
Morebitno ↑ koncentracij rifabutina v plazmi.
Contraindicated due to the potential for serious cardiovascular events including QT prolongation (see section 4.3). 
Kontraindicirano zaradi potenciala za resne kardiovaskularne dogodke, vključno s podaljšanjem intervala QT
Bortezomib Busulfan Docetaxel Imatinib Cabazitaxel 
Docetaksel Imatinib Kabazitaksel
if you get palpitations or an irregular heartbeat during treatment. 
Takoj se posvetujte z zdravnikom, če imate med zdravljenjem palpitacije ali nereden srčni utrip.
Dose adjustement of repaglinide may be required. 
Morda bo potrebna prilagoditev odmerka repaglinida.
AUC: ↑ 1.8-fold 
AUC:↑ 1,8-krat
AUC: ↑ 6.2-fold Cmax: ↑ 3.4-fold 
AUC:↑ 6,2-krat Cmax:↑ 3,4-krat
Careful monitoring of adverse reactions (respiratory depression, sedation) is recommended. 
Priporočljivo je skrbno spremljanje neželenih učinkov (respiratorne depresije, sedacije).Morda bo potrebno zmanjšati odmerek alfentanila in fentanila.
(CYP3A enzyme induction) 
(indukcija encima CYP3A)
Within the first hour after ingestion gastric lavage may be performed. 
V prvi uri po zaužitju se lahko opravi izpiranje želodca.
AUC: ↑ 1.4-fold 
AUC:↑ 1,4-krat
Potential ↑in plasma concentrations of sertindole. 
Morebitno ↑ koncentracij sertindola v plazmi.
↑in plasma concentrations of ebastine have been observed 
Opazili so ↑ koncentracij ebastina v plazmi.
AUC: ↑ 1.3-fold 
AUC:↑ 1,3-krat
Potential ↑in plasma concentrations of buspirone. 
Morebitno ↑ koncentracij buspirona v plazmi.
AUC: ↑ 5.9-fold Cmax: ↑ 2.7-fold 
AUC:↑ 5,9-krat Cmax:↑ 2,7-krat
• Diarrhoea • Skin reactions (pruritus, rash) 
• kožne reakcije (srbenje, izpuščaj).
sunitinib, lapatinib, nilotinib, bortezomib, paclitaxel, vincristine, vinblastine, cabozantinib, dabrafenib, 
- nekatera zdravila za zdravljenje raka, kot so alkaloidi rožnatega zimzelena, busulfan, docetaksel, erlotinib, imatinib, dasatinib, sunitinib, lapatinib, nilotinib, bortezomib, paklitaksel, vinkristin, vinblastin,
Potential ↑in plasma concentrations of clarithromycin 
Morebitno ↑ koncentracij klaritromicina v plazmi.
AUC: ↑ 2.6-fold Cmax: ↑2.5-fold 
AUC:↑ 2,6-krat Cmax:↑ 2,5-krat
Potential ↑in plasma concentrations of haloperidol. 
Morebitno ↑ koncentracij haloperidola v plazmi.
AUC: ↑ 1.9-fold Cmax: ↑ 1.7-fold 
AUC:↑ 1,9-krat Cmax:↑ 1,7-krat
Saxagliptin: 
Saksagliptin:
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora neznana epistaksa
AUC: ↑ 1.7-fold Cmax: ↑ 1.3-fold 
AUC:↑ 1,7-krat Cmax:↑ 1,3-krat
↑in plasma concentrations of tolterodine have been observed 
AUC:↑ 3,0-krat Opazili so ↑ koncentracij tolterodina v plazmi.
They will be checked again after that in case your doctor increases your daily ketoconazole dose. 
Če vam bo za tem zdravnik še povečal dnevni odmerek ketokonazola, bo preiskave jetrnih encimov znova preveril.
• Arthralgia (joint pain) 
• artralgija (bolečina v sklepih),
↑in plasma concentrations of praziquantel have been observed 
Opazili so ↑ koncentracij prazikvantela v plazmi.
↑in plasma concentrations of oxycodone have been observed 
Opazili so ↑ koncentracij oksikodona v plazmi.
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. 
Ketokonazol v odmerkih do 40 mg/kg ni imel nobenega učinka na plodnost podganjih samic,
AUC: ↑2.2-fold Cmax: ↑1.7-fold 
AUC: ↑2,2-krat Cmax: ↑1,7-krat
AUC: ↔ Cmax: ↔ 
Cmax:↔
AUC: ↑ 2-fold Cmax: ↑1.6-fold 
AUC:↑ 2-krat Cmax:↑ 1,6-krat
AUC: ↑ 2.3-fold Cmax: ↑ 2.0-fold 
AUC:↑ 2,3-krat Cmax:↑ 2,0-krat
Talk to your doctor or pharmacist before taking Ketoconazole HRA. 
Pred začetkom jemanja zdravila Ketokonazol HRA se posvetujte z zdravnikom ali farmacevtom.
Cmax: ↑ 6 fold 
Cmax: ↑ 1,6-krat
AUC: ↑ 10-fold Cmax: ↑ 4-fold 
AUC:↑ 10-krat Cmax:↑ 4-krat
AUC: ↑ 2.6-fold Cmax: ↑1.7-fold 
AUC:↑ 2,6-krat Cmax:↑ 1,7-krat
Exacerbation or development of inflammatory/autoimmune disorders has been described after Cushing's syndrome remission, including after treatment with ketoconazole. 
Po remisiji Cushingovega sindroma, vključno po zdravljenju s ketokonazolom, so opazili poslabšanje ali razvoj vnetnih/avtoimunskih motenj.
Nausea, abdominal pain, vomiting, diarrhoea 
povišana telesna temperatura, anoreksija, navzea in bruhanje.
A dose reduction of ketoconazole should be considered when coadministered with ritonavir dosed as an antiretroviral medicinal product or as a pharmacokinetic enhancer. 
Pri sočasni uporabi z ritonavirjem, odmerjanim kot protivirusnim zdravilom ali farmakokinetičnim ojačevalcem, je treba razmisliti o zmanjšanju odmerka ketokonazola.
Endocrine disorders Common 
Bolezni endokrinega sistema pogosti adrenalna insuficienca
Edoxaban 
Aprepitant
Dasatinib ↑in plasma concentrations of Dasatinib have been observed Dabrafenib 
Opazili so ↑ koncentracij dasatiniba v plazmi.
Nervous system disorders 
Alfaadrenergični antagonisti
How to take Ketoconazole HRA 
Kako jemati zdravilo Ketokonazol HRA
Contraindicated due to the risk of serious cardiovascular events including QT prolongation (see section 4.3). 
Kontraindicirano zaradi tveganja resnih kardiovaskularnih dogodkov, vključno s podaljšanjem intervala QT
Cmax ↑ 9.6 fold 
Cmax:↑ 1,6-krat
AUC: ↑ 1.5-fold Cmax: ↑1.7-fold 
AUC:↑ 1,5-krat Cmax:↑ 1,7-krat
Potential ↑in plasma concentrations of warfarin 
Morebitno ↑ koncentracij varfarina v plazmi.
Ketoconazole has not been demonstrated to induce its own metabolism. 
Spodbujanja lastne presnove pri ketokonazolu niso dokazali.
AUC: ↑ 3.6-fold 
AUC:↑ 1,6-krat
↑in plasma concentrations of colchicine have been observed 
Opazili so ↑ koncentracij kolhicina v plazmi.
No change in plasma concentration were shown with paclitaxel concentrate. 
Pri koncentratu paklitaksela niso opazili nobene spremembe v plazmi.Z
(CYP3A enzyme inhibition) 
(zaviranje encima CYP3A)
Musculoskeletal and connective tissue disorder 
Bolezni mišično skeletnega sistema in vezivnega tkiva neznana mialgija, artralgija
AUC: ↑ 2.7-fold Cmax:↑ 1.5-fold 
AUC:↑ 2,7-krat Cmax: ↑ 1,5-krat
AUC: ↑ 1.6-fold Cmax: ↑ 1.4-fold 
AUC:↑ 1,6-krat Cmax:↑ 1,4-krat
- This medicine does not require any special storage conditions - Do not throw away any medicines via wastewater or household waste. 
- Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.Taki ukrepi pomagajo varovati okolje.
AUC: ↑ 5-fold 
AUC:↑ 5-krat
Potential ↑in plasma concentrations of digoxine 
Morebitno ↑ koncentracij digoksina v plazmi.
AUC: ↑ 2.1-fold 
AUC:↑ 2,1-krat
- 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; 
o zaviralci reduktaze HMG-CoA, ki jih presnavlja CYP3A4 (npr. simvastatin, atorvastatin in lovastatin), zaradi povečanega tveganja mišičnoskeletne toksičnosti, vključno z rabdomiolizo, o eplerenon zaradi povečanega tveganja hiperkaliemije in hipotenzije, o učinkovine, katerih koncentracija v plazmi se lahko poveča in ki imajo potencial za podaljšanje intervala QT: metadon, dizopiramid, kinidin, dronedaron, pimozid, sertindol, sakvinavir (sakvinavir/ritonavir 1000/100 mg dvakrat na dan), ranolazin, mizolastin, halofantrin,
Potential ↑ in plasma concentrations of methadone 
Morebitno ↑ koncentracij metadona v plazmi.
AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold 
AUC:↑ 1,5-krat Cmax:↑ 1,5-krat
Not recommended due to the increased risk of QT prolongation and extrapyramidal symptoms. 
Ni priporočljivo zaradi povečanega tveganja podaljšanja intervala QT in ekstrapiramidnih simptomov.Morda bo potrebno zmanjšati odmerek haloperidola.
AUC: ↑ 5-fold Cmax: ↑ 1.1 -fold 
AUC: ↑ 5-krat Cmax: ↑ 1,1-krat
Buprenorphine IV and sublingual 
Buprenorfin i.v.
Dose adjustment of paclitaxel may be required. 
Morda bo potrebna prilagoditev odmerka paklitaksela.
Patients with Cushing's syndrome and coexisting inflammatory/autoimmune disorders should be supervised after normalisation of cortisol levels on ketoconazole. 
Po normalizaciji ravni kortizola med jemanjem ketokonazola je treba bolnike s Cushingovim sindromom in sočasnimi vnetnimi/avtoimunskimi motnjami nadzorovati.
AUC: ↑ 3.0-fold 
AUC:↑ 3,0-krat
AUC: ↑ 3.2-fold Cmax: ↑ 1.4-fold 
AUC: ↑ 3,2-krat Cmax: ↑ 1.4-krat
AUC: ↑ 3.0 fold Cmax: ↑ 3.0 fold 
AUC:↑ 3,0-krat Cmax:↑ 3,0-krat
Ebastine 
Irinotekan
AUC: ↑ 5-fold Cmax: ↑ 3.4-fold 
AUC:↑ 5-krat Cmax:↑ 3,4-krat
Cmax: ↑ 2-fold 
AUC:↑ 2-krat Cmax:↑ 2-krat
Dose adjustment of praziquantel may be required. 
Morda bo potrebna prilagoditev odmerka prazikvantela.
You should stop your treatment and contact your doctor immediately if you feel unwell or experience symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine. 
Če se ne počutite dobro ali imate simptome, kot so pomanjkanje apetita, slabost, bruhanje, utrujenost, zlatenica, bolečina v trebuhu ali temen urin, morate prekiniti zdravljenje in se takoj posvetovati z zdravnikom.
• Skin redness, drying, itching 
• pordelost, suhost, srbenje kože,
Contraindicated due to the increased risk of adverse reactions (see section 
Kontraindicirano zaradi povečanega tveganja neželenih učinkov (glejte poglavje 4.3).
• Hot flush 
flutikazon,
Before starting the treatment, it is mandatory: - to measure liver enzymes (ASAT, ALAT, gammaGT and alkaline phosphatase) and bilirubin - to inform the patients about the risk of hepatotoxicity, including to stop the treatment and to contact their doctor immediately if they feel unwell or in the event of symptoms such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine. 
- bolnike obvestiti o tveganju hepatotoksičnosti, vključno s prekinitvijo zdravljenja in takojšnjem posvetu z zdravnikom, če se ne počutijo dobro ali se pojavijo simptomi, kot so anoreksija, navzea, bruhanje, utrujenost, zlatenica, bolečina v trebuhu ali temen urin.Če se pojavijo taki simptomi, je treba zdravljenje takoj prekiniti in opraviti preiskave delovanja jeter.
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. 
Pri vas bodo redno spremljali delovanje nadledvične žleze, saj je to standardna oskrba pri spremljanju zdravljenja Cushingovega sindroma in ker se lahko med zdravljenjem pojavi nezadostno delovanje nadledvične žleze (adrenalna insuficienca).Takoj se posvetujte z zdravnikom, če imate simptome, kot so šibkost, utrujenost, pomanjkanje apetita, slabost, bruhanje ali nizek krvni tlak.
AUC: ↑ 1.2-fold Cmax: ↑ 1.2-fold 
AUC:↑ 1,2-krat Cmax:↑ 1,2-krat
• Dry mouth 
vročinski oblivi
AUC: ↑ 15.3-fold Cmax: ↑ 4.1-fold 
AUC:↑ 15,3-krat Cmax:↑ 4,1-krat Sirolimus (rapamicin): AUC:↑ 10,9-krat
Anticoagulants and antiplatelet drugs Dabigatran 
Antikoagulanti in antitrombotiki
Microcrystalline cellulose Silica colloidal Magnesium stearate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob laktoza monohidrat povidon mikrokristalna celuloza koloidni silicijev dioksid magnezijev stearat
mostly produced in the testes 
krat v primerjavi z zgodovinskimi kontrolami
Dizziness or somnolence have been reported during treatement with Ketoconazole HRA. 
Med zdravljenjem z zdravilom Ketokonazol HRA so poročali o omotici in somnolenci (zaspanosti).
MARKETING AUTHORISATION NUMBER(S) 
Študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):
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. 
- Če pride do adrenalne insuficience, je treba glede na resnost dogodka odmerek ketokonazola zmanjšati za vsaj 200 mg/dan ali zdravljenje začasno prekiniti in/ali dodati zdravljenje s kortikosteroidi, dokler dogodek ne izzveni.
ergotamine and methylergometrine (methylergonovine) - certain medicines used in cancers: irinotecan, everolimus - sirolimus: used to prevent your body from rejecting a kidney transplant - tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion” - vardenafil in men older than 75 years - medicine to treat erectile dysfunction in adults men - certain medicines for HIV: saquinavir/ritonavir, saquinavir - certain medicines to treat long-term (chronic) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus): Paritaprevir/Ombitasvir (ritonavir) - methadone: medicine to treat dependence to drugs - In patients with renal disorders: 
- vardenafil pri moških, starejših od 75 let - zdravilo za zdravljenje erektilne disfunkcije pri odraslih moških, - nekatera zdravila za zdravljenje HIV: sakvinavir/ritonavir, sakvinavir,
Ask your doctor or pharmacist for more information if you are taking Ketoconazole HRA with other medicines. 
Če zdravilo Ketokonazol HRA jemljete sočasno z drugimi zdravili, se za več informacij obrnite na zdravnika ali farmacevta.
The SmPC for concomitantly used products must be consulted for the recommendations regarding coadministration with strong CYP3A4 inhibitors. 
Za priporočila glede sočasnega dajanja z močnimi zaviralci CYP3A4 je treba preveriti povzetke glavnih značilnosti sočasno uporabljenih zdravil.
Cardiovascular Drugs, Miscellaneous Ranolazine 
Kardiovaskularna zdravila, razno
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 reactionsevents 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; o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”. 
(metilergonovin)) zaradi povečanega tveganja ergotizma in drugih resnih vazospastističnih neželenih učinkov, o lurasidon, o kvetiapin zaradi povečanega tveganja toksičnosti, o telitromicin in klaritromicin pri bolnikih s hudo ledvično okvaro zaradi povečanega tveganja hepatotoksičnosti in podaljšanja intervala QT, o felodipin, nizoldipin zaradi povečanega tveganja edema in kongestivnega srčnega popuščanja, o kolhicin pri bolnikih z ledvično okvaro zaradi povečanega tveganja hudih neželenih učinkov,
AUC: ↑ 4-fold Cmax: ↑ 1.2-fold 
AUC:↑ 4-krat Cmax:↑ 1,2-krat
• Tongue discoloration 
• sprememba barve jezika,
Dexamethasone, fluticasone, methylprednisolone 
sertindol, lurasidon, kvetiapin,
Dose adjustment of risperidone may be required. 
Morda bo potrebna prilagoditev odmerka aprepitanta.
Cabozantinib 
Dabrafenib
Pregnancy, breast-feeding and fertility 
Antipsihotiki, anksiolitiki in hipnotiki
Potential ↑in plasma concentrations of sildenafil 
Morebitno ↑ koncentracij sildenafila v plazmi.
AUC: ↑ 1.8-fold Cmax: ↑ 1.8-fold 
Cmax: ↑ 1,8-krat
Press down at 1 and at the same time pull at 2. 
Pritisnite navzdol pri 1 in istočasno povlecite pri 2.
The patient alert card shall contain the following key elements: 
Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
MN = Multiples of Normal 
MN = večkratnik normalne vrednosti
Monitoring of clinical response 
Spremljanje kliničnega odziva
Take one capsule in the morning and one capsule at night. 
Eno kapsulo vzemite zjutraj in eno zvečer.