FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case an increase of liver enzymes is detected which is less than 3 times the upper limit of normal, closer monitoring of liver function should be performed and the daily dose should be decreased by at least 200 mg.
Slovenian: Če se ugotovi povišanje ravni jetrnih encimov, ki je manjše od trikratne zgornje meje normalnih vrednosti, je treba izvajati skrbnejše spremljanje delovanja jeter, dnevni odmerek pa zmanjšati za vsaj 200 mg.
English: Dose of edoxaban needs to be reduced when used concomitantly, please consult edoxaban SmPC.
Slovenian: Odmerek edoksabana je treba zmanjšati pri sočasni uporabi; glejte
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.
Slovenian: Če se pojavi povečanje vrednosti jetrnih encimov, ki je manjše od trikratne zgornje meje normalnih vrednosti, je treba izvajati pogostejše preiskave delovanja jeter, dnevni odmerek pa je treba zmanjšati za vsaj 200 mg.
English: What Ketoconazole HRA is and what it is used for
Slovenian: Kaj je zdravilo Ketokonazol HRA in za kaj ga uporabljamo
English: Nevirapine: plasma levels: ↑1.15-1.28fold compared to historical controls
Slovenian: Nevirapin: ravni v plazmi: ↑ 1,15-1,28
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve:19. november 2014
English: Contraindicated due to the risk of QT prolongation (see section 4.3).
Slovenian: Kontraindicirano zaradi tveganja podaljšanja intervala QT (glejte poglavje 4.3).
English: Not recommended due to an increased risk of QT prolongation.
Slovenian: Ni priporočljivo zaradi povečanega tveganja podaljšanja intervala QT.
English: Co-administration of ketoconazole and pasireotide is not recommended since the combination can lead to a QT prolongation in patients with known cardiac rhythm disorders.
Slovenian: Sočasna uporaba ketokonazola in pasireotida ni priporočljiva, saj lahko ta kombinacija pri bolnikih z znanimi motnjami srčnega ritma podaljša interval QT.
English: - Ketoconazole is a potent inhibitor of CYP3A4 and can inhibit the metabolism of medicinal products metabolised by this enzyme.
Slovenian: - Ketokonazol je močan zaviralec CYP3A4 in lahko zavira presnovo zdravil, ki se presnavljajo s tem encimom.
English: Contraindicated due to an increased bleeding risk (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanega tveganja krvavitve (glejte poglavje 4.3).
English: Ketoconazole is mainly metabolised through CYP3A4.
Slovenian: Ketokonazol se večinoma presnavlja prek CYP3A4.
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.
Slovenian: Za ponovno vzpostavitev normalnih ravni kortizola bo morda potreben dnevni odmerek od 400 mg na dan (2 tableti) do 1200 mg na dan (6 tablet) peroralno, ki se vzame v 2 do 3 ločenih odmerkih.
English: colchicine: medicine to treat gout fesoterodine and solifenacin: medicines to treat the symptoms of an overactive bladder telithromycin and clarithromycin: medicine used to treat infections
Slovenian: - pri bolnikih z ledvičnimi motnjami: kolhicin: zdravilo za zdravljenje protina (putike), fesoterodin in solifenacin: zdravili za zdravljenje simptomov čezmerno dejavnega sečnega mehurja, telitromicin in klaritromicin: zdravili za zdravljenje okužb.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I:Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij Centre Spécialités Pharmaceutiques
English: If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost, dojenje in plodnost Tega zdravila ne smete jemati med nosečnostjo.Če menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Anticonvulsants Carbamazepine Phenytoin
Slovenian: Karbamazepin Fenitoin
English: Effects of ketoconazole on the metabolism of the other medicinal products
Slovenian: Učinki ketokonazola na presnovo drugih zdravil
English: Contraindicated due to an increase in the plasma concentrations (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanja koncentracij v plazmi (glejte poglavje 4.3).
English: Dyspepsia, flatulence, tongue discoloration, dry mouth, dysgeusia
Slovenian: diareja neznana dispepsija, flatulenca, sprememba barve jezika, suha usta, disgevzija
English: Menstrual disorder, azoospermia, erectile dysfunction, gynaecomastia
Slovenian: Motnje reprodukcije in dojk neznana motnje menstruacije, azoospermija, erektilna disfunkcija, ginekomastija
English: Ketoconazole HRA is a medicine that contains the active substance ketoconazole.
Slovenian: Ketokonazol HRA je zdravilo, ki vsebuje zdravilno učinkovino ketokonazol.
English: Other medicinal products and Ketoconazole HRA
Slovenian: Druga zdravila in zdravilo Ketokonazol HRA
English: Elevated liver enzymes and histological changes in the liver consisting in dose-related lipofuscin accumulation in hepatocytes were reported in rats and dogs after repeated administration of ketoconazole.
Slovenian: Pri podganah in psih so po večkratnem dajanju ketokonazola poročali o povišanih ravneh jetrnih encimov in histoloških spremembah v jetrih, ki so vključevale od odmerka odvisno kopičenje lipofuscina v hepatocitih.
English: Dose adjustment of each medicinal product may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka posameznih zdravil.
English: Phosphodiesterase(PD E5) inhibitors Sildenafil
Slovenian: Zaviralci fosfodiesteraze (PDE5)
English: If you forget to take Ketoconazole HRA
Slovenian: Če ste pozabili vzeti zdravilo Ketokonazol HRA
English: - if you are allergic to ketoconazole and/or to any imidazole antifungal medicine, or to any of the other ingredients of this medicine (listed in section 6) - if you have liver problems - if you are pregnant - if you are breastfeeding - if you have a history of an irregular heart beat - if you are taking any of the following medicines:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ketokonazol HRA Ne jemljite zdravila Ketokonazol HRA - če ste alergični na ketokonazol in/ali katero koli imidazolno antimikotično zdravilo in/ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate težave z jetri; - če ste noseči; - če dojite;
English: AUC: ↑ 24-fold Cmax: ↑ 29-fold
Slovenian: AUC: ↑ 24-krat Cmax: ↑ 29-krat
English: The recommended dose at initiation in adults and adolescents is 400-600 mg/day taken orally in two or three divided doses and this dose can be increased rapidly to 800-1,200 mg/day in two or three divided doses.
Slovenian: Priporočeni začetni odmerek pri odraslih in mladostnikih je 400-600 mg/dan peroralno v dveh ali treh ločenih odmerkih.
English: What Ketoconazole HRA looks like and contents of the pack
Slovenian: Izgled zdravila Ketokonazol HRA in vsebina pakiranja
English: Midazolam IV
Slovenian: Midazolam, i.v.
English: Careful monitoring A cilostazol dose of 50 mg twice daily is recommended in combination with ketoconazole.
Slovenian: V kombinaciji s ketokonazolom se priporoča odmerek cilostazola 50 mg dvakrat na dan.
English: Not recommended due to the risk of QT interval prolongation and serious hepatic adverse reactions.
Slovenian: Ni priporočljivo zaradi tveganja podaljšanja intervala QT in hudih neželenih učinkov na jetra.
English: • Menstrual disorders
Slovenian: • motnje menstruacije,
English: sertindole, lurasidone, quetiapine - certain medicines used for the allergies: mizolastine - dabigatran - medicine used to prevent the formation of blood clots - certain medicines to help to sleep and for anxiety: triazolam, alprazolam, midazolam (taken by mouth) - certain medicines used for migraine attacks: dihydroergotamine, ergometrine (ergonovine)
Slovenian: - nekatera zdravila, ki se uporabljajo pri alergijah: mizolastin, - dabigatran - zdravilo za preprečevanje tvorbe krvnih strdkov, - nekatera zdravila proti nespečnosti in tesnobi: triazolam, alprazolam, midazolam (peroralni), - nekatera zdravila, ki se uporabljajo pri napadih migrene: dihidroergotamin, ergometrin
English: Careful monitoring and dose adjustment of these medicinal products may be required.
Slovenian: Ni priporočljivo, razen če je nujno.Morda bosta potrebna skrbno spremljanje in prilagoditev odmerka teh zdravil.
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:
Slovenian: - redno je treba izvajati meritve jetrnih encimov (AST, ALT, gama GT ter alkalne fosfataze) in bilirubina:
English: Ketoconazole HRA 200 mg tablets ketoconazole
Slovenian: Ketokonazol HRA 200 mg tablete ketokonazol
English: How to store Ketoconazole HRA 6.
Slovenian: Shranjevanje zdravila Ketokonazol HRA 6.
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).
Slovenian: Delovanje nadledvične žleze je treba redno spremljati, saj se lahko med zdravljenjem pri pogojih relativnega pomanjkanja kortizola pojavi adrenalna insuficienca, ki je posledica povečane potrebe po glukokortikoidih (npr. pri stresu, kirurškem posegu ali okužbi) in/ali čezmernega zdravljenja s ketokonazolom (pri bolnikih, zdravljenih z režimom samo zaviranja) ali nezadostnega nadomestnega zdravljenja z glukokortikoidi (pri bolnikih, zdravljenih z režimom zaviranja in nadomeščanja).Največ en teden po uvedbi zdravljenja s ketokonazolom je treba preveriti ravni kortizola v serumu ali plazmi in/ali slini in/ali prostega kortizola v urinu, potem pa jih redno spremljati.
English: If you stop taking Ketoconazole HRA
Slovenian: Če ste prenehali jemati zdravilo Ketokonazol HRA
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema občasni trombocitopenija
English: • Pyrexia (fever)
Slovenian: • pireksija (povišana telesna temperatura).
English: Ketoconazole is mainly metabolised by cytochrome CYP3A4.
Slovenian: Ketokonazol se večinoma presnavlja prek citokroma CYP3A4.
English: Co-administration of ketoconazole and pasireotide is not recommended since the combination can lead to QT prolongation in patients with known cardiac rhythm disorders (see section 4.5).
Slovenian: Sočasna uporaba ketokonazola in pasireotida ni priporočljiva, saj lahko ta kombinacija pri bolnikih z znanimi motnjami srčnega ritma podaljša interval QT (glejte poglavje 4.5).
English: Contraindicated due to an alteration of the metabolism of this medicinal product (see section 4.3).
Slovenian: Kontraindicirano zaradi spremembe presnove tega zdravila (glejte poglavje 4.3).
English: Quetiapine:
Slovenian: Kvetiapin:
English: Contraindicated due to the increased risk of hyperkalaemia and hypotension (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanega tveganja hiperkaliemije in hipotenzije (glejte poglavje 4.3).
English: Potencial ↓ in plasma concentrations of ketoconazole are expected.
Slovenian: Pričakovano je morebitno ↓ koncentracij ketokonazola v plazmi.
English: Dose adjustement of buspirone may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka buspirona.
English: The oxycodone dose may be adjusted.
Slovenian: Odmerek oksikodona bo morda treba prilagoditi.
English: Effects of other medicinal products on the metabolism of ketoconazole
Slovenian: Učinki drugih zdravil na presnovo ketokonazola
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).
Slovenian: Ker se ketokonazol izloča v mleko, matere med zdravljenjem z zdravilom Ketokonazol HRA ne smejo dojiti
English: Anti-infectives Rifabutin Rifampicin Isoniazid
Slovenian: Rifampicin Izoniazid
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).
Slovenian: - Režim zaviranja in nadomeščanja: vzdrževalni odmerek ketokonazola je treba nadalje povečati za 200 mg in dodati sočasno nadomestno zdravljenje s kortikosteroidi (glejte poglavje 4.4).
English: 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”.
Slovenian: o everolimus, sirolimus (imenovan tudi rapamicin) zaradi povečanja koncentracij teh zdravil v plazmi, o vardenafil pri moških, starejših od 75 let, zaradi povečanega tveganja neželenih učinkov, o paritaprevir/ombitasvir (ritonavir) zaradi povečanega tveganja neželenih učinkov, o fesoterodin in solifenacin pri bolnikih z ledvično okvaro, o tolvaptan, ki se uporablja za specifično bolezen, imenovano »sindrom neustreznega izločanja antidiuretičnega hormona«.
English: cabazitaxel, crizotinib, ibrutinib - certain medicines used to treat infections: rifabutin, telithromycin, rifampicin, isoniazide, clarithromycin,
Slovenian: - nekatera zdravila za zdravljenje okužb: rifabutin, telitromicin, rifampicin, izoniazid, klaritromicin, izavukonazol;
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila:http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: AUC: ↑2.1-fold Cmax: ↑1.1-fold t1/2: ↑ 4-fold
Slovenian: AUC: ↑2,1-krat Cmax: ↑1,1-krat t1/2: ↑ 4-krat
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.
Slovenian: - Zdravljenje s ketokonazolom se lahko prekine takoj, brez postopnega zmanjševanja odmerka, kadar je želena sprememba oblike zdravljenja (npr. kirurški poseg).
English: Each tablet contains 200 mg ketoconazole.
Slovenian: Ena tableta vsebuje 200 mg ketokonazola.
English: Contraindicated due to an increase risk of edema and congestive heart failure (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanega tveganja edema in kongestivnega srčnega popuščanja (glejte poglavje 4.3).
English: (CYP3A4 enzyme induction)
Slovenian: (indukcija encima CYP3A4)
English: Intracranial pressure increased (papilloedema, fontanelle bulging), paraesthesia
Slovenian: Bolezni živčevja občasni glavobol, omotica, somnolenca neznana povišan intrakranialni tlak (papiloedem, nabreklost fontanel), parestezija
English: Analgesic opioid Methadone
Slovenian: Opioidni anestetik
English: AUC: ↑ 5.5-fold
Slovenian: AUC:↑ 5,5-krat
English: Monitoring of adrenal function
Slovenian: Spremljanje delovanja nadledvične žleze
English: AUC: ↑ 1.4-fold Cmax: ↔
Slovenian: AUC:↑ 1,4-krat Cmax:↔
English: All potential associated factors of hepatotoxicity, and abnormal liver enzyme levels detected before ketoconazole initiation, should be taken into account before considering ketoconazole treatment.
Slovenian: Pred uvedbo zdravljenja s ketokonazolom je treba upoštevati vse morebitne s hepatotoksičnostjo povezane dejavnike in odkriti nenormalne ravni jetrnih encimov.
English: Dose adjustment of tolbutamide may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka tolbutamida.
English: AUC ↑ 12.9 fold
Slovenian: Naloksegol AUC ↑ 12,9-krat Cmax ↑ 9,6-krat
English: Cmin: ↑ 1.3-fold
Slovenian: Cmin:↑ 1,3-krat
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Ketoconazole HRA with alcohol
Slovenian: Zdravilo Ketoconazole HRA skupaj z alkoholom
English: A 14 year-old girl who was treated for Cushing's disease with ketoconazole 200 mg twice daily presented one month later with jaundice, fever anorexia, nausea and vomiting.
Slovenian: Pri 14-letni deklici, ki se je zaradi Cushingovega sindroma zdravila z 200 mg ketokonazola dvakrat na dan, so se pojavili zlatenica,
English: Coexisting inflammatory/autoimmune disorders
Slovenian: Sočasne vnetne/avtoimunske motnje
English: Allergic conditions including anaphylactic shock, anaphylactoid reaction and anaphylactic reaction and angioedema
Slovenian: Bolezni imunskega sistema občasni alergijska stanja, vključno z anafilaktičnim šokom, anafilaktoidno reakcijo,
English: 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
Slovenian: - 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.
English: Decreased gastric acidity
Slovenian: Zmanjšana želodčna kislost
English: Eplerenone:
Slovenian: Eplerenon:
English: Ombitasvir: AUC: ↑1.3-fold
Slovenian: Ombitasvir: AUC: ↑1,3-krat
English: Rest of drugs ↑in plasma concentrations of these drugs have been observed
Slovenian: Opazili so ↑ koncentracij teh zdravil v plazmi.
English: Initiation
Slovenian: Uvajanje
English: Dose adjustment of saxagliptin may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka saksagliptina.
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),
Slovenian: 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
English: - If you get any side effects, talk to your doctor, or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.Posvetujte se tudi,
English: Dose adjustment of cinacalcet may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka cinakalceta.
English: Warning regarding excipients
Slovenian: Opozorila glede pomožnih snovi
English: Insomnia, nervousness
Slovenian: Psihiatrične motnje neznana nespečnost, nervoznost
English: Potential ↑in plasma concentrations of alfentanil and fentanyl
Slovenian: Morebitno ↑ koncentracij alfentanila in fentanila v plazmi.
English: Tolbutamide
Slovenian: Tolbutamid
English: Antidiabetics Repaglinide
Slovenian: Antidiabetiki
English: Cmax: ↑1.5-fold
Slovenian: Cmax:↑ 1,5-krat
English: Serious hepatotoxicity, including jaundice, hepatitis, hepatic necrosis, hepatic cirrhosis, hepatic failure including cases necessitating transplantation or resulting in death.
Slovenian: jetrno cirozo, jetrno odpovedjo, vključno s primeri, ki zahtevajo transplantacijo ali povzročijo smrt
English: Potential ↑in plasma concentrations of ergot alkaloids
Slovenian: Morebitno ↑ koncentracij alkaloidov ergot v plazmi.
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.
Slovenian: 400 mg/dan do največjega odmerka 1200 mg/dan peroralno, ki se vzame v 2 do 3 ločenih odmerkih.
English: AUC: ↑ 2-fold
Slovenian: AUC:↑ 2-krat
English: • Gynaecomastia (enlargement in breast tissues in male)
Slovenian: • ginekomastija (povečanje tkiva dojk pri moških), • periferni edem (otekanje okončin),
English: Contraindicated due to the increased risk of ergotism and other serious vasospastic adverse reactions (see section 4.3).
Slovenian: Kontraindicirano zaradi povečanega tveganja ergotizma in drugih resnih vazospastičnih neželenih učinkov
English: Fesoterodine active metabolite:
Slovenian: Aktivni presnovek fesoterodina:
English: Antiarrhythmics Disopyramide Quinidine
Slovenian: Dizopiramid Kinidin
English: • Dyspepsia (impaired digestion)
Slovenian: • dispepsija (slaba prebava),
English: Potential ↑in plasma concentrations of pimozide.
Slovenian: Morebitno ↑ koncentracij pimozida v plazmi.
English: AUC: ↑ 2.2 fold
Slovenian: AUC:↑ 2,2-krat
English: Potential ↑in plasma concentrations of carbamazepine and phenytoin
Slovenian: Morebitno ↑ koncentracij karbamazepina in fenitoina v plazmi.
English: DATE OF REVISION OF THE TEXT
Slovenian: Letno sporočanje podatkov
English: 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.
Slovenian: o enkrat tedensko en mesec, kadar se poveča odmerek.
English: Careful monitoring INR (international normalised ratio) monitoring recommended.
Slovenian: (internacionalnega normaliziranega razmerja).
English: Fesoterodine and solifenacin are contraindicated in patients with renal impairment (see section 4.3).
Slovenian: Ni priporočljivo zaradi povečanega tveganja podaljšanja intervala QT. Fesoterodin in solifenacin sta kontraindicirana pri bolnikih z ledvično okvaro (glejte poglavje 4.3).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM
English: Potential ↑in plasma concentrations of these drugs
Slovenian: Morebitno ↑ koncentracij teh zdravil v plazmi.
English: Dose adjustment of nadolol may be required.
Slovenian: Skrbno spremljanje.Morda bo potrebna prilagoditev odmerka nadolola.
English: AUC: ↑ 15-fold Cmax: ↑ 1.4-fold
Slovenian: AUC:↑ 15-krat Cmax:↑ 1,4-krat
English: Potential ↑ in plasma concentrations of rifabutine.
Slovenian: Morebitno ↑ koncentracij rifabutina v plazmi.