FrancophonIA/ELRC3.0 huggingface dataset:
English: In peri and post-natal studies in rats, dystocia, increased foetal deaths in utero and toxicity to post-natal development (pup body weight and development land marks) were observed at systemic exposure levels up to 11 times the AUC0-24h of free plasma concentration at MRHD.
Slovenian: V perinatalnih in postnatalnih študijah na podganah so opažali distocijo, pogostejšo smrt ploda in utero in toksične učinke na postnatalnem razvoju (na telesno maso mladičev in razvojne mejnike) pri sistemski izpostavljenosti do AUC0-24h koncentracije proste učinkovine v plazmi, ki je bila 11-krat večja kot pri najvišjem priporočenem odmerku za človeka.
English: No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A).
Slovenian: Za bolnike z blago jetrno okvaro (Child Pugh A) ni potrebno prilagajanje odmerjanja.
English: • antiviral medicines (e.g. nelfinavir and ritonavir),
Slovenian: • protivirusna zdravila (na primer nelfinavir in ritonavir),
English: In one pharmacokinetic study the steady-state exposure in poor metabolisers was 164% and 99% higher during treatment with 7.5 mg and 15 mg once daily, respectively.
Slovenian: V eni farmakokinetični študiji je bila izpostavljenost v stanju dinamičnega ravnovesja pri osebah z upočasnjeno presnovo med zdravljenjem s 7,5 mg oziroma 15 mg na dan za 164 % oziroma 99 % večja kot pri osebah z obsežno presnovo.
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Slovenian: Pomožne snovi so: brezvodni kalcijev hidrogenfosfat, hipromeloza, magnezijev stearat, polietilenglikol, smukec, titanov dioksid (E171), rdeči železov oksid (E172) in rumeni železov oksid (E172).
English: • if you have severe liver problems.
Slovenian: • če imate hude težave z jetri,
English: During treatment with Emselex, tell your doctor straight away and stop taking Emselex if you experience swelling of the face, lips, tongue and/or throat (signs of angioedema).
Slovenian: Če se tekom zdravljenja pojavijo otekanje obraza, ustnic, jezika in/ali grla (znaki angioedema), takoj obvestite zdravnika in prekinite jemanje zdravila Emselex.
English: Emselex should be taken with caution while breast-feeding.
Slovenian: Med dojenjem je treba zdravilo Emselex jemati previdno.
English: For Emselex, these side effects have been reported to be uncommon (see section 4).
Slovenian: Poročajo, da so bili ob zdravilu Emselex našteti neželeni učinki občasni (glejte poglavje 4).
English: Emselex is for oral use.
Slovenian: Tablete Emselex so za peroralno uporabo.
English: Darifenacin is metabolised by CYP3A4 and CYP2D6.
Slovenian: Darifenacin presnavljata CYP3A4 in CYP2D6.
English: Darifenacin undergoes significant metabolism by cytochrome CYP3A4 and CYP2D6 in the liver and by CYP3A4 in the gut wall.
Slovenian: Darifenacin pomembno presnovita citokroma CYP3A4 in CYP2D6 v jetrih in CYP3A4 v črevesni steni.
English: If you stop taking Emselex
Slovenian: Če ste prenehali jemati zdravilo Emselex
English: • other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate).
Slovenian: • druga antimuskarinska zdravila (na primer tolterodin, oksibutinin in flavoksat).
English: As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence.
Slovenian: Tako kot druga antimuskarinska zdravila tudi zdravilo Emselex lahko povzroča učinke, kot so vrtoglavica, zamegljen vid, nespečnost in zaspanost.
English: The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Slovenian: Možno je, da bi lahko zvečanje izpostavljenosti digoksinu povzročilo tekmovanje med darifenacinom in digoksinom za glikoprotein P. Drugih reakcij, povezanih s prenašalci (transporterji), ni mogoče izključiti.
English: Due to extensive first-pass metabolism darifenacin has a bioavailability of approximately 15% and 19% after 7.5 mg and 15 mg daily doses at steady state.
Slovenian: Zaradi obsežne presnove pri prvem prehodu ima darifenacin po dnevnih odmerkih 7,5 mg oziroma 15 mg v stanju dinamičnega ravnovesja biološko uporabnost približno 15 % oziroma 19 %.
English: What Emselex is and what it is used for
Slovenian: Kaj je zdravilo Emselex in za kaj ga uporabljamo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z “BLUE BOX” PODATKI)
English: There were no effects on reproductive organs in either sex in dogs treated for 1 year at oral doses up to 6 mg/kg/day (82 times the AUC0-24h of free plasma concentration at MRHD).
Slovenian: Darifenacin ni vplival na spolne organe pri nobenem od obeh spolov pri psih, ki so jim 1 leto peroralno dajali odmerke do 6 mg/kg/dan (kar pomeni 82-krat večjo AUC0-24h koncentracije proste učinkovine v plazmi kot pri najvišjem priporočenem odmerku za človeka).
English: Keep the blister packs in the outer carton in order to protect from light.
Slovenian: Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: There were no effects on fertility in male and female rats treated at oral doses up to 50 mg/kg/day (78 times the AUC0-24h of free plasma concentration at maximum recommended human dose [MRHD]).
Slovenian: Darifenacin ni vplival na plodnost samcev in samic pri podganah, ki so jim peroralno dajali odmerke do 50 mg/kg/dan (kar pomeni 78-krat večjo AUC0-24h koncentracije proste učinkovine v plazmi kot pri najvišjem priporočenem odmerku za človeka).
English: The potentiation of anticholinergic effects with antiparkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
Slovenian: Če se antimuskarinska zdravila uporabljajo sočasno z antiparkinsonskimi zdravili in tricikličnimi antidepresivi, se lahko okrepijo tudi antiholinergični učinki slednjih zdravil.
English: At the dose of 30 mg/kg/day in rabbits (28 times the AUC0-24h of free plasma concentration at MRHD), maternal toxicity and foetotoxicity (increased post implantation loss and decreased number of viable foetuses per litter) were observed.
Slovenian: Pri kuncih so pri odmerku 30 mg/kg/dan (kar pomeni 28-krat večjo AUC0-24h koncentracije proste učinkovine v plazmi kot pri najvišjem priporočenem odmerku za človeka) opažali toksične učinke na mater in plod (več smrti zarodka po nidaciji in zmanjšano število živih plodov v zarodu).
English: How Emselex works
Slovenian: Kako zdravilo Emselex deluje
English: • antipsychotic medicines (e.g. thioridazine),
Slovenian: • antipsihotična zdravila (na primer tioridazin),
English: What you need to know before you take Emselex
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Emselex
English: What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “DF” on one side and “7.5” on the other.
Slovenian: Emselex 7,5 mg tablete s podaljšanim sproščanjem so okrogle, konveksne bele tablete, ki imajo na eni strani vtisnjen napis “DF”, na drugi pa “7.5”.
English: At the dose of 50 mg/kg/day in rats (59 times the AUC0-24h of free plasma concentration at MRHD), delay in the ossification of the sacral and caudal vertebrae was observed.
Slovenian: Pri podganah so pri odmerku 50 mg/kg/dan (kar pomeni 59-krat večjo AUC0-24h koncentracije proste učinkovine v plazmi kot pri najvišjem priporočenem odmerku za človeka) opažali zakasnitev osifikacije križnih in repnih vretenc.
English: In patients receiving substances that are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily.
Slovenian: Pri bolnikih, ki prejemajo snovi, ki so zmerni zaviralci CYP3A4, na primer flukonazol, sok grenivke in eritromicin, je priporočeni začetni odmerek 7,5 mg na dan.
English: However, protein binding of darifenacin was affected by moderate hepatic impairment.
Slovenian: Vendar pa je zmerna jetrna okvara vplivala na vezavo darifenacina na proteine.
English: Titanium dioxide (E171)
Slovenian: Filmska obloga polietilenglikol hipromeloza titanov dioksid (E171) smukec
English: How to store Emselex 6.
Slovenian: Shranjevanje zdravila Emselex 6.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: In patients receiving substances that are potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
Slovenian: Pri bolnikih, ki dobivajo snovi, ki so močni zaviralci CYP2D6 (na primer paroksetin, terbinafin, cimetidin in kinidin), je priporočeni začetni odmerek 7,5 mg na dan.
English: How long to take Emselex
Slovenian: Kako dolgo je treba jemati zdravilo Emselex
English: Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e.g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Slovenian: Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan. Sočasno zdravljenje z močnimi zaviralci CYP2D6 povzroči zvečano izpostavljenost (na primer za 33 % pri 20-miligramskem odmerku paroksetina in 30-miligramskem odmerku darifenacina).
English: When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Slovenian: Pri sočasni uporabi z zmernimi zaviralci CYP3A4, na primer z eritromicinom, s klaritromicinom, s telitromicinom, s flukonazolom in s sokom grenivke, je priporočeni začetni odmerek darifenacina 7,5 mg na dan.
English: Emselex is contraindicated in patients with severe hepatic impairment (Child Pugh C) (see section 4.3).
Slovenian: Pri bolnikih s hudo jetrno okvaro (Child Pugh C) je zdravilo Emselex kontraindicirano (glejte poglavje 4.3).
English: The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
Slovenian: Pri sočasni uporabi z darifenacinom se učinek varfarina na protrombinski čas ni spremenil.
English: What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” on the other.
Slovenian: Emselex 15 mg tablete s podaljšanim sproščanjem so okrogle, konveksne tablete svetlo breskove barve z vtisnjenim napisom “DF” na eni strani in “15”na drugi
English: Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Slovenian: Darifenacin je zmeren zaviralec encima CYP2D6.
English: White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse.
Slovenian: Bela, okrogla, konveksna tableta, na eni strani je vtisnjen napis “DF”, na drugi pa “7.5”.
English: Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision.
Slovenian: Zdravljenje mora biti usmerjeno v odpravljanje antiholinergičnih simptomov pod skrbnim medicinskim nadzorom, pri njihovem odpravljanju lahko pomagajo zdravila, kot je fizostigmin.
English: Emselex 15 mg prolonged-release tablets Darifenacin
Slovenian: Emselex 15 mg tablete s podaljšanim sproščanjem darifenacin
English: The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Slovenian: Farmakokinetika darifenacina v stanju dinamičnega ravnovesja je zaradi nasičenja encima s CYP2D6 odvisna od odmerka.
English: People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness.
Slovenian: Pri ljudjeh, ki so vzeli prevelik odmerek, lahko pride do suhih ust, zapeke, glavobola, prebavnih motenj in izsušenosti nosne sluznice.
English: Visual disturbance, including vision blurred
Slovenian: Očesne bolezni pogosti suhe oči občasni motnje vida vključno z zamegljenim vidom
English: Infections and infestations Uncommon
Slovenian: Infekcijske in parazitske bolezni občasni okužba sečil
English: The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Slovenian: Presnovo darifenacina pri osebah z upočasnjeno presnovo CYP2D6 posreduje predvsem CYP3A4.
English: Effects of darifenacin on other medicinal products CYP2D6 substrates
Slovenian: Vpliv darifenacina na druga zdravila
English: Each tablet contains 15 mg darifenacin (as hydrobromide).
Slovenian: Vsaka tableta vsebuje 15 mg darifenacina (v obliki darifenacinijevega bromida).
English: • if you have a digestive motility disorder.
Slovenian: • če imate motnjo gibanja prebavne cevi (motilitete črevesja),
English: • if you suffer from urinary retention (inability to empty your bladder).
Slovenian: • če imate težave zaradi zastajanja seča (nezmožnosti praznjenja mehurja),
English: Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Slovenian: Vsaka tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
English: Urinary retention, urinary tract disorder, bladder pain
Slovenian: Bolezni sečil občasni zastoj urina, bolezni sečil, bolečina v sečnem mehurju
English: Darifenacin AUC24 and Cmax from 30 mg once daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
Slovenian: Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan. AUC24 and Cmax darifenacina pri odmerku 30 mg enkrat dnevno pri osebah z obsežno presnovo sta bili za 95 % oziroma za 128 % večji, kadar so osebe dobivale sočasno z darifenacinom eritromicin (zmeren zaviralec CYP3A4), kot takrat, ko so dobivale samo darifenacin.
English: Yellow iron oxide (E172)
Slovenian: Filmska obloga polietilenglikol hipromeloza smukec titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
English: What Emselex can be used for
Slovenian: Za kaj lahko zdravilo Emselex uporabljamo
English: Emselex 7.5 mg prolonged-release tablets Darifenacin
Slovenian: Emselex 7,5 mg tablete s podaljšanim sproščanjem darifenacin
English: The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Slovenian: Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan, vendar je pri tem potrebna previdnost.
English: How to take Emselex
Slovenian: Kako jemati zdravilo Emselex
English: Always take Emselex exactly as your doctor has told you.
Slovenian: Ne prenehajte jemati zdravila Emselex dokler vam tega ne naroči zdravnik.
English: Urinary retention.
Slovenian: Navodilo shranite.
English: What Emselex contains
Slovenian: Kaj vsebuje zdravilo Emselex
English: NAME OF THE MEDICINAL PRODUCT Emselex 7.5 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Emselex 7,5 mg tablete s podaljšanim sproščanjem2.
English: Change from baseline (median)
Slovenian: sprememba od začetnega stanja (mediana)
English: Baseline (median)
Slovenian: začetno stanje (mediana)
English: You should not drive or use machines if you are affected by these symptoms.
Slovenian: Če imate navedene simptome, ne smete voziti ali upravljati strojev.
English: Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Slovenian: Preglednica 1: Neželeni učinki 7,5-miligramskih in 15-miligramskih tablet s podaljšanim sproščanjem zdravila Emselex
English: • if you have liver problems.
Slovenian: • če imate težave z jetri,
English: (PVC/CTFE/alu blisters)
Slovenian: (PVC/CTFE/alu pretisni omoti)
English: NAME OF THE MEDICINAL PRODUCT Emselex 15 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Emselex 15 mg tablete s podaljšanim sproščanjem2.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Merus Labs Luxco II S.à R.L.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Merus Labs Luxco II S.à R.L.
English: Grapefruit juice may interact with Emselex.
Slovenian: Grenivkin sok lahko medsebojno deluje z zdravilom Emselex, vendar prilagajanje odmerka zdravila Emselex ni potrebno.
English: Light peach round, convex tablet debossed with “DF” on one side and “15” on the reverse.
Slovenian: Svetlomarelična, okrogla, konveksna tableta, na eni strani je vtisnjen napis “DF”, na drugi pa “15”.
English: Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
Slovenian: V primerjavi s placebom je bil Emselex v odmerkih 7,5 mg in 15 mg povezan s statistično značilnim izboljšanjem nekaterih vidikov kakovosti življenja, izmerjenih s Kingsovim zdravstvenim vprašalnikom.
English: In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose.
Slovenian: Bolniki, ki se sočasno zdravijo s snovmi, ki so močni zaviralci CYP2D6 ali zmerni zaviralci CYP3A4 Pri bolnikih, ki prejemajo snovi, ki so močni zaviralci CYP2D6, na primer paroksetin, terbinafin, kinidin in cimetidin, se mora zdravljenje začeti z odmerkom 7,5 mg.
English: • certain anticonvulsants (carbamazepine, barbiturates),
Slovenian: • določena zdravila za zdravljenje ali preprečevanje krčev - antikonvulzive (karbamazepin,
English: (PVC/PVDC/alu blisters)
Slovenian: (PVC/PVDC/alu pretisni omoti)
English: However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Slovenian: Vendar pri bolnikih, zdravljenih z darifenacinom, niso našli povezave med staranjem in pojavljanjem neželenih učinkov, povezanih z žolčnim sistemom.
English: P value2
Slovenian: P2
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Metabolism Darifenacin is extensively metabolised by the liver following oral administration.
Slovenian: Presnova Po peroralnem jemanju se darifenacin obsežno presnavlja v jetrih.
English: 56 tablets (PVC/PVDC/alu blisters)
Slovenian: 56 tablet (PVC/PVDC/ALU pretisni omoti)
English: Talk to your doctor before taking Emselex
Slovenian: Pred začetkom jemanja zdravila Emselex se posvetujte z zdravnikom
English: Food had no effect on darifenacin pharmacokinetics during multiple-dose administration of prolonged-release tablets.
Slovenian: Med jemanjem večkratnih odmerkov tablet s podaljšanim sproščanjem hrana ni vplivala na farmakokinetiko darifenacina.
English: 56 tablets (PVC/CTFE/alu blisters)
Slovenian: 56 tablet (PVC/CTFE/ALU pretisni omoti)
English: How to store Emselex
Slovenian: Shranjevanje zdravila Emselex
English: 49 tablets (PVC/CTFE/alu blisters)
Slovenian: 49 tablet (PVC/CTFE/ALU pretisni omoti)
English: • if you have heartburn and belching.
Slovenian: • če imate zgago in se vam spahuje,
English: 7 tablets (PVC/CTFE/alu blisters)
Slovenian: 7 tablet (PVC/CTFE/ALU pretisni omoti)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Merus Labs Luxco II S.à R.L.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Merus Labs Luxco II S.à R.L.
English: 7 tablets (PVC/PVDC/alu blisters)
Slovenian: 7 tablet (PVC/PVDC/ALU pretisni omoti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/013
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/013
English: 49 tablets (PVC/PVDC/alu blisters)
Slovenian: 49 tablet (PVC/PVDC/ALU pretisni omoti)
English: 98 tablets (PVC/CTFE/alu blisters)
Slovenian: 98 tablet (PVC/CTFE/ALU pretisni omoti)
English: 98 tablets (PVC/PVDC/alu blisters)
Slovenian: 98 tablet (PVC/PVDC/ALU pretisni omoti)
English: 28 tablets (PVC/CTFE/alu blisters)
Slovenian: 28 tablet (PVC/CTFE/ALU pretisni omoti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/014
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/014
English: 28 tablets (PVC/PVDC/alu blisters)
Slovenian: 28 tablet (PVC/PVDC/ALU pretisni omoti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/001
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
English: Respiratory, thoracic and mediastinal disorders Common
Slovenian: Žilne bolezni občasni hipertenzija
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Merus Labs Netherlands B.V.,
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: 14 tablets (PVC/PVDC/alu blisters)
Slovenian: 14 tablet (PVC/PVDC/ALU pretisni omoti)
English: Renal insufficiency
Slovenian: Ledvična odpoved
English: 14 tablets (PVC/CTFE/alu blisters)
Slovenian: 14 tablet (PVC/CTFE/ALU pretisni omoti)
English: Marketing Authorisation Holder Merus Labs Luxco II S.à R.L.
Slovenian: Imetnik dovoljenja za promet z zdravilom Merus Labs Luxco II S.à R.L.
English: It can therefore be concluded that darifenacin administration does not alter the pharmacokinetics of CYP3A4 substrates in vivo.
Slovenian: Razpoložljivi podatki pa ne kažejo, da bi darifenacin vplival na izločanje ali biološko uporabnost midazolama, zato je mogoče sklepati, da uporaba darifenacina in vivo ne vpliva na farmakokinetične lastnosti substratov CYP3A4.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
English: Rash, dry skin, pruritus, hyperhidrosis
Slovenian: Bolezni kože in podkožja občasni izpuščaj, suha koža, srbenje, čezmerno znojenje pogostnost neznana angioedem
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg darifenacin (as hydrobromide).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg darifenacina (v obliki darifenacinijevega bromida).
English: • if you are receiving treatment for narrow-angle glaucoma.
Slovenian: • če se zdravite zaradi glavkoma z zaprtim zakotjem,
English: Abdominal pain, nausea, dyspepsia
Slovenian: Psihiatrične motnje občasni nespečnost, motnje mišljenja
English: Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
Slovenian: Presnovo darifenacina omogočajo predvsem encimi s citokromoma P450 CYP2D6 in CYP3A4, zato bi zaviralci teh encimov lahko povečali izpostavljenost darifenacinu.
English: For Emselex, these side effects have been reported to be uncommon.
Slovenian: Našteti neželeni učinki so se pri zdravilu Emselex pojavljali občasno.
English: This is a summary of the European public assessment report.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila.
English: The benefit-risk balance may be found in the scientific discussion 6 of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v znanstveni razpravi 6 tega povzetka EPAR.
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Slovenian: Pri izpostavitvi kateremu koli od teh virusov pozneje v življenju se mačka ne bo okužila ali pa bo okužba bistveno blažja.