natgillin/translations-raw huggingface dataset:
For the full list of all side effects reported with EMSELEX, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila EMSELEX, najdete v Navodilih za uporabo.
EMSELEX should not be used in people who may be hypersensitive (allergic) to darifenacin or any of the other ingredients, and in patients with: • Urinary retention (difficulty in passing urine) • Gastric retention (when the stomach doesn ’ t empty properly) • Uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) • Myasthenia gravis (a disease of the nerves causing muscle weakness). • Severe hepatic impairment (severe liver disease). • Severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding) • Toxic megacolon (a very serious complication of colitis – see above) EMSELEX should not be given to patients at the same time as medicine such cyclosporine (in transplant patients), verapamil (a heart medicine), protease inhibitors (medicines such as ritonavir, used in AIDS patients) or ketoconazole and itraconazole (used to treat fungal infections).
Zdravila EMSELEX bolniki ne smejo jemati sočasno z zdravili, kot so ciklosporin (bolniki po presaditvi), verapamil (zdravilo za srce), zaviralci proteaze (zdravila, ki se uporabljajo pri bolnikih z AIDS- om, npr. ritonavir), ketokonazol in itrakonazol (zdravila za zdravljenje glivičnih okužb).
Why has EMSELEX been approved?
Zakaj je bilo zdravilo EMSELEX odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that EMSELEX showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo EMSELEX pokazalo učinkovitost podobno drugim antiholinergičnim zdravilom za zdravljenje sindroma čezmerno aktivnega sečnega mehurja.
They decided that EMSELEX’ s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Odbor meni, da koristni učinki zdravila EMSELEX večji od tveganj za simptomatično zdravljenje urgentne inkontinence in/ ali povečane frekvence uriniranja in urgence, ki se lahko pojavijo pri bolnikih s sindromom čezmerno aktivnega sečnega mehurja.
They recommended that EMSELEX be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom EMSELEX.
Other information about EMSELEX:
Druge informacije o zdravilu EMSELEX:
The European Commission granted a marketing authorisation valid throughout the European Union for EMSELEX to Novartis Europharm Limited on 22 October 2004.
Evropska Komisija je dovoljenje za promet z zdravilom EMSELEX, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 22. oktobra 2004.
The full EPAR for EMSELEX is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo EMSELEX je na voljo tukaj.
Emselex 7.5 mg prolonged-release tablets
Emselex 7, 5 mg tablete s podaljšanim sproščanjem
Each tablet contains 7.5 mg of darifenacin (as hydrobromide)
Ena tableta vsebuje 7, 5 mg darifenacina (v obliki darifenacinijevega bromida).
Prolonged-release tablets
tablete s podaljšanim sproščanjem
White round, convex tablet, debossed with “ DF” on one side and “ 7.5” on the reverse.
Bela, okrogla, konveksna tableta, na eni strani je vtisnjen napis “ DF ”, na drugi pa “ 7. 5 ”.
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Simptomatsko zdravljenje urgentne inkontinence in zvečane pogostnosti mokrenja ali obeh ter urgence (nenadna močna nuja po mokrenju) pri bolnikih s sindromom čezmerno aktivnega sečnega mehurja.
For oral use.
za peroralno uporabo.
Adults (≥ 18 years) The recommended starting dose is 7.5 mg daily.
Odrasli (≥ 18 let) Priporočeni začetni odmerek je 7, 5 mg na dan.
The tablets can be taken with or without food, and must be swallowed whole and not chewed, divided or crushed.
Tablete Emselex je treba jemati enkrat na dan s tekočino, lahko s hrano ali brez nje; bolnik jih mora pogoltniti cele, ne da bi jih žvečil, razdelil na več delov ali zdrobil.
Elderly patients (≥ 65 years) The recommended starting dose for the elderly is 7.5 mg daily.
Starejši bolniki (≥ 65 let) Priporočeni začetni odmerek za starejše je 7, 5 mg na dan.
After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.
Dva tedna po začetku zdravljenja je treba bolnike ponovno oceniti glede učinkovitosti in varnosti.
For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2).
Za bolnike, ki imajo sprejemljiv profil tolerabilnosti, a potrebujejo večje lajšanje simptomov, je odmerek mogoče povečati na 15 mg na dan na podlagi posameznikovega odziva (glejte poglavje 5. 2).
Children Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Otroci Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Emselex pri otrocih pod 18 let ni priporočljiva.
Use in renal impairment No dose adjustment is required in patients with impaired renal function.
Uporaba pri ledvičnih okvarah Za bolnike z zmanjšanim ledvičnim delovanjem ni potrebno prilagajanje odmerjanja.
However, caution should be exercised when treating this population (see section 5.2).
Vendar je pri zdravljenju te skupine bolnikov potrebna previdnost (glejte poglavje 5. 2).
Use in hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A).
Uporaba pri jetrnih okvarah Za bolnike z blago jetrno okvaro (Child Pugh A) ni potrebno prilagajanje odmerjanja.
However, there is a risk of increased exposure in this population (see section 5.2).
Vendar je pri tej skupini nevarnost zvečane izpostavljenosti (glejte poglavje 5. 2).
2 In patients with moderate hepatic impairment (Child Pugh B), patients should only be treated if the benefit outweighs the risk, and patients should be restricted to 7.5 mg daily (see section 5.2).
2 Pri bolnikih z zmernimi okvarami jeter (Child Pugh B) smemo bolnike zdraviti le, če korist odtehta tveganje, bolnike pa je treba omejiti na 7, 5 mg na dan (glejte poglavje 5. 2).
Patients receiving concomitant treatment with substances that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4 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.
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.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Odmerek smemo povečati do 15 mg na dan, da dobimo izboljšan klinični odziv, pod pogojem, da bolnik odmerek dobro prenaša.
However, caution should be exercised.
Vendar je potrebna previdnost.
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.
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.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Odmerek smemo titrirati do 15 mg na dan, da dobimo izboljšan klinični odziv, pod pogojem, da bolnik odmerek dobro prenaša.
- Hypersensitivity to the active substance or to any of the excipients.
- s preobčutljivostjo za zdravilno učinkovino ali katerokoli pomožno snov,
- Urinary retention.
- z zastojem seča,
- Gastric retention.
- z zastojem v želodcu,
- Uncontrolled narrow-angle glaucoma.
- z neobvladanim glavkomom z zaprtim zakotjem,
- Myasthenia gravis.
- z miastenijo gravis,
- Severe hepatic impairment (Child Pugh C).
- s hudo okvaro jeter (Child Pugh C),
- Severe ulcerative colitis.
- s hudim ulcerativnim kolitisom,
- Toxic megacolon.
- s toksičnim megakolonom,
- Concomitant treatment with potent CYP3A4 inhibitors (see section 4.5).
- ki se sočasno zdravijo z močnimi zaviralci CYP3A4 (glejte poglavje 4. 5).
Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.
Emselex je treba previdno dajati bolnikom z avtonomno nevropatijo, s hiatusno kilo, klinično pomembno zaporo odtekanja seča iz sečnega mehurja, s pretečim zastojem seča, s hudo zapeko ali z obstruktivnimi boleznimi prebavil, na primer s pilorično stenozo.
Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Emselex je treba previdno uporabljati pri bolnikih, ki se zdravijo zaradi glavkoma z zaprtim zakotjem (glejte poglavje 4. 3).
Emselex should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophagal reflux and/ or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.
Emselex je treba previdno uporabljati pri bolnikih s tveganjem zmanjšane motilitete prebavnega trakta, z gastroezofagealnim refluksom in/ ali pri tistih, ki sočasno jemljejo zdravila (na primer peroralne difosfonate), ki lahko povzročijo ali poslabšajo ezofagitis.
Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
Pri bolnikih z nevrogenim vzrokom čezmerne aktivnosti detruzorja varnosti in učinkovitosti še niso dokazali.
Therefore, inhibitors of these enzymes may increase darifenacin exposure.
Delovanje drugih zdravil na darifenacin Presnovo darifenacina omogočajo predvsem encimi s citokromoma P450 CYP2D6 in CYP3A4, zato bi zaviralci teh encimov lahko povečali izpostavljenost darifenacinu.
3 CYP2D6 inhibitors 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.
Zaviralci CYP2D6 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.
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).
3 Sočasno zdravljenje z močnimi zaviralci CYP2D6 povzroči zvečano izpostavljenost (na primer za 33% pri 20- miligramskem odmerku paroksetina in 30- miligramskem odmerku darifenacina).
CYP3A4 inhibitors Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e. g. ritonavir), ketoconazole and itraconazole.
Zaviralci CYP3A4 Darifenacin se ne sme uporabljati skupaj z močnimi zaviralci CYP3A4 (glejte poglavje 4. 3), na primer proteaznimi inhibitorji (npr. ritonavirjem), ketokonazolom in itrakonazolom.
Co-administration of darifenacin 7.5 mg with the potent CYP3A4 inhibitor ketoconazole 400 mg resulted in a 5-fold increase in steady-state darifenacin AUC.
Sočasna uporaba darifenacina v odmerku 7, 5 mg z močnim zaviralcem CYP3A4 ketokonazolom v odmerku 400 mg je povzročila petkratno zvečanje AUC darifenacina v stanju dinamičnega ravnovesja.
In subjects who are poor metabolisers, darifenacin exposure increased approximately 10-fold.
Pri osebah z upočasnjeno presnovo se je izpostavljenost darifenacinu zvečala približno desetkrat.
Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Zaradi višjega prispevka CYP3A4 se pri 15 mg odmerkih darifenacina pričakuje še izrazitejši učinek le- tega v kombinaciji s ketokonazolom.
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.
Pri sočasni uporabi z zmernimi zaviralci CYP3A4, na primer eritromicinom, klaritromicinom, telitromicinom, flukonazolom in sokom grenivke, je priporočeni začetni odmerek darifenacina 7, 5 mg na dan.
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.
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.
Enzyme inducers Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John´s wort (Hypericum perforatum) are likely to decrease the plasma concentrations of darifenacin.
Encimski induktorji Snovi, ki so induktorji CYP3A4, na primer rifampicin, karbamazepin, barbiturati in šentjanževka (Hypericum perforatum), bodo verjetno znižale plazemske koncentracije darifenacina.
Effects of darifenacin on other medicinal products CYP2D6 substrates Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Vpliv darifenacina na druga zdravila Substrati CYP2D6 Darifenacin je zmeren zaviralec encima CYP2D6.
CYP3A4 substrates Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate midazolam.
Substrati CYP3A4 Zdravljenje z darifenacinom je povzročilo zmerno zvečanje izpostavljenosti substratu CYP3A4 midazolamu.
The interaction with midazolam lacks clinical relevance but is indicative of a slight CYP3A4 inhibition by darifenacin.
Medsebojno delovanje z midazolamom ni klinično pomembno, a kaže na to, da darifenacin nekoliko zavira CYP3A4.
Warfarin Standard therapeutic prothrombin time monitoring for warfarin should be continued.
Varfarin Nadaljevati je treba s standardnim terapevtskim spremljanjem protrombinskega časa.
Digoxin Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
Digoksin Terapevtsko spremljanje digoksina je potrebno v začetku in ob koncu zdravljenja z darifenacinom, pa tudi ob spremembi odmerka darifenacina.
Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC:
Darifenacin 30 mg enkrat na dan (to je dvakrat več od priporočenega dnevnega odmerka), dan sočasno z digoksinom, je v stanju dinamičnega ravnovesja povzročil majhno povečanje izpostavljenosti digoksinu (AUC:
16% and Cmax:
16% in Cmax:
The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Možno je, da bi lahko zvečanje izpostavljenosti digoksinu povzročilo tekmovanje med darifenacinom in digoksinom za glikoprotein P.
Other transporter-related interactions cannot be excluded.
Drugih reakcij, povezanih s prenašalci (transporterji), ne moremo izključiti.
Antimuscarinic agents As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more
Snovi, ki imajo antimuskarinski učinek Tako kot pri drugih antimuskarinskih sredstvih lahko sočasno zdravljenje z zdravili, ki imajo antimuskarinske lastnosti, na primer z oksibutininom, s tolterodinom in flavoksatom, povzroči izrazitejše terapevtske in neželene učinke.
Pregnancy There are no studies of darifenacin in pregnant women.
Nosečnost Ni študij o darifenacinu pri nosečnicah.
Animal studies have shown toxicity to parturition, peri and post-natal development (see section 5.3).
Študije na živalih so pokazale toksičnost za kotitev, perinatalni in postnatalni razvoj (glejte poglavje 5. 3).
Emselex is not recommended during pregnancy.
Med nosečnostjo zdravila Emselex ne priporočajo.
Lactation Darifenacin is excreted into the milk of rats.
Dojenje Pri podganah darifenacin prehaja v mleko.
It is not known whether darifenacin is excreted into human milk and therefore caution should be exercised before Emselex is administered to a nursing woman.
Ni znano, ali se izloča tudi v materino mleko, zato je pred uporabo zdravila Emselex pri doječi materi potrebna previdnost.
No studies of the effects of Emselex on the ability to drive and use machines have been performed.
Študij o vplivu Emselex na sposobnost vožnje in upravljanja s stroji niso izvedli.
As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence.
Tako kot drugi antimuskariniki tudi Emselex lahko povzroča učinke, kot so vrtoglavica, zamegljen vid, nespečnost in zaspanost.
Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Skladno s farmakološkim profilom so bili neželeni učinki, o katerih so najpogosteje poročali, suha usta (20, 2% oziroma 35% ob 7, 5- miligramskem oziroma 15- miligramskem odmerku, 18, 7% ob prilagodljivem titriranju odmerka in 8% - 9% ob placebu) in zapeka (14, 8% oziroma 21% ob 7, 5- miligramskem oziroma 15- miligramskem odmerku, 20, 9% ob prilagodljivem titriranju odmerka in 5, 4% - 7, 9% ob placebu)..
However, the patient discontinuation rates due to these adverse reactions were low (dry mouth:
Vendar je bil odstotek bolnikov, ki so zaradi navedenih neželenih učinkov prenehali jemati zdravilo, majhen (suha usta:
0% - 0.9% and constipation:
0% - 0, 9% in zapeka:
0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
0, 6% - 2, 2% ob darifenacinu v odvisnosti od odmerka, ob placebu pa 0% zaradi suhih ust in 0, 3% zaradi zapeke).
Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Neželeni učinki 7, 5- miligramskih in 15- miligramskih tablet s podaljšanim sproščanjem zdravila Emselex
Frequency estimate: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), not known (cannot be estimated from the available data)
Ocena pogostnosti: zelo pogosti (≥1/ 10), pogosti (≥1/ 10 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Infections and infestations Uncommon Psychiatric disorders
Infekcijske in parazitske bolezni občasni Psihiatrične motnje
Uncommon Nervous system disorders
občasni Bolezni živčevja
Common Uncommon Eye disorders
pogosti občasni Očesne bolezni
Headache Dizziness, dysgeusia, somnolence
glavobol vrtoglavica, motnje okušanja, zaspanost
Common Uncommon Vascular disorders
pogosti občasni Žilne bolezni
Dry eye Visual disturbance, including vision blurred
suhe oči motnje vida vključno z zamegljenim vidom
5 Respiratory, thoracic and mediastinal disorders Uncommon Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni Bolezni prebavil
Dyspnoea, cough, rhinitis
dispneja, kašelj, rinitis
Very common Common Uncommon Skin and subcutaneous tissue disorders
zelo pogosti pogosti občasni
Constipation, dry mouth Abdominal pain, nausea, dyspepsia Flatulence, diarrhoea, mouth ulceration
zapeka, suha usta bolečine v trebuhu, navzea, dispepsija vetrovi, diareja, ulceracije v ustih
Uncommon Not known Renal and urinary disorders
5 Bolezni kože in podkožja občasni pogostnost neznana Bolezni sečil
Uncommon Reproductive system and breast disorders
občasni Motnje reprodukcije in dojk
Uncommon General disorders and administration site Uncommon Investigations
erektilna disfunkcija, vaginitis
Erectile dysfunction, vaginitis conditions Oedema peripheral, asthenia, face oedema, oedema
Splošne težave in spremembe na mestu aplikacije občasni Preiskave
Aspartate aminotransferase increased, alanine aminotransferase increased
povišane vrednosti aspartat- aminotransferaze, povišane vrednosti alanin- aminotransferaze
Injury, poisoning, and procedural complications Uncommon
Poškodbe in zastrupitve in zapleti pri posegih občasni
In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above.
7, 5 mg in 15 mg zdravila Emselex so poročali o neželenih
Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.
Zdravljenje z zdravilom Emselex lahko včasih prekrije simptome, povezane z boleznimi žolčnika.
However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Vendar niso našli povezave med pojavljanjem neželenih učinkov, povezanih z žolčnim sistemom, pri bolnikih, zdravljenih z darifenacinom, niti glede na njihovo starost.
The incidence of adverse events with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months.
Pogostnost neželenih učinkov pri odmerkih 7, 5 mg in 15 mg zdravila Emselex se je med zdravljenjem, dolgim do 6 mesecev, zmanjšala.
Post-marketing experience The following events have been reported in association with darifenacin use in worldwide post- marketing experience: generalised hypersensitivity reactions including angioedema.
Postmarketinške izkušnje V okviru postmarketinških izkušenj širom sveta so v povezavi z uporabo darifenacina poročali o naslednjih dogodkih: generalizirane preobčutljivostne reakcije vključno z angioedemom.
Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
V kliničnih preskušanjih so Emselex uporabljali v odmerkih do 75 mg (ta odmerek je petkrat večji od največjega terapevtskega odmerka).
The most common adverse events seen were dry mouth, constipation, headache, dyspepsia and nasal dryness.
Najpogostejši neželeni učinki, ki so jih opazili, so bili suha usta, zapeka, glavobol, dispepsija in izsušitev nosne sluznice.
The use of agents such as physostigmine can assist in reversing such symptoms.
Zdravljenje mora biti usmerjeno v odpravljanje antiholinergičnih simptomov pod skrbnim medicinskim nadzorom, pri njihovem odpravljanju lahko pomagajo zdravila, kot je fizostigmin.
Urinary antispasmodic, ATC code:
Farmakoterapevtska skupina: urospazmolitiki, oznaka ATC:
G04B D10.
G04BD10
6 Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Darifenacin je selektiven antagonist muskarinskih receptorjev M3 (M3 SRA) in vitro.
Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
6 Cistometrične študije, ki so jih opravili z darifenacinom pri bolnikih z nehotenimi kontrakcijami sečnega mehurja, so po zdravljenju z njim pokazale zvečano zmogljivost sečnega mehurja, zvišan volumski prag za nestabilne kontrakcije in zmanjšano frekvenco nestabilnih kontrakcij detruzorja.
Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Zdravljenje z zdravilom Emselex v odmerkih po 7, 5 mg in 15 mg na dan so raziskovali v štirih dvojno slepih, randomiziranih, kontroliranih kliničnih študijah faze III pri bolnikih in bolnicah s simptomi čezmerno aktivnega mehurja.