FrancophonIA/ELRC3.0 huggingface dataset:
English: Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
Slovenian: Obliž vedno menjajte na enaka dneva v tednu, na primer vsako nedeljo in sredo, ali vsak ponedeljek in četrtek.
English: Date of first authorisation: 15/06/2004 Date of latest renewal: 30/04/2009
Slovenian: Datum prve odobritve: 15/06/2004 Datum zadnjega podaljšanja: 30/04/2009
English: The pump is now primed and ready for use.
Slovenian: Črpalka je zdaj napolnjena in pripravljena za uporabo.
English: The metered dose should be applied immediately.
Slovenian: Odmerjeni odmerek je treba uporabiti takoj.
English: Press for at least 10 seconds to make sure the patch will stay in place.
Slovenian: Pritiskajte vsaj 10 sekund in se prepričajte, da bo ostal na svojem mestu.
English: Of these 188 patients (38%) were 65 years of age and older and exhibited no overall differences in safety or effectiveness compared to younger patients.
Slovenian: Med temi je bilo 188 bolnikov (38 %) starih 65 let in več; pri teh se v primerjavi z mlajšimi bolniki ni pokazala splošna razlika v varnosti ali učinkovitosti.
English: Approximately 75% of patients had no prior pharmacological treatment for incontinence.
Slovenian: Približno 75 % bolnikov se predhodno ni farmakološko zdravilo zaradi inkontinence.
English: Bathing, showering, swimming and exercise:
Slovenian: Kopanje, prhanje, plavanje in telovadba:
English: Social relationships subscale -15.2 (20.07)
Slovenian: Podlestvica družbena razmerja -15,2 (20,07)
English: If it does, try putting the same patch back on the same spot.
Slovenian: Če se to zgodi, ga skušajte ponovno nalepiti na isto mesto.
English: If you forget to change the patch after 3-4 days:
Slovenian: Če po 3-4 dneh pozabite zamenjati obliž:
English: The results of the study indicate that showering after one hour does not affect the overall systemic exposure to oxybutynin.
Slovenian: Rezultati študije so pokazali, da prhanje po eni uri ne vpliva na splošno sistemsko izpostavljenost oksibutininu.
English: Allow the area to dry completely.
Slovenian: Počakajte, da se mesto popolnoma posuši.
English: The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients.
Slovenian: Najpogostejši neželeni učinki na zdravilo so bile reakcije na mestu uporabe, ki so se pojavile pri 23,1 % bolnikov.
English: - Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
Slovenian: - Pravkar umito, vendar suho in hladno (počakajte nekaj minut, če ste se prhali ali kopali v vroči vodi).
English: These results were evident after the first month of treatment and were maintained throughout double-blind treatment as shown in the table below.
Slovenian: Ti rezultati so bili opazni po prvem mesecu zdravljenja, ohranili pa so se ves čas dvojno slepega zdravljenja, kot je prikazano v preglednici spodaj.
English: Patients should be monitored until symptoms resolve.
Slovenian: Bolnike je treba spremljati, dokler simptomi ne izginejo.
English: Both patients recovered fully with symptomatic treatment.
Slovenian: Oba bolnika sta po simptomatskem zdravljenju popolnoma okrevala.
English: The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years).
Slovenian: Večina bolnikov je bila belcev (86,3 %) in žensk (89,2 %), povprečna starost pa je bila 59,4 leta (razpon: od 18 do 88 let).
English: After the sachets are opened and contents expelled, the gel should be used immediately.
Slovenian: Ko so vrečice odprte in vsebina iztisnjena, je treba gel uporabiti takoj.
English: How to use the sachets:
Slovenian: Kako uporabljati vrečice:
English: If a patient experiences such events, drug discontinuation should be considered.
Slovenian: Če se pri bolniku pojavijo takšni dogodki, je treba razmisliti o prekinitvi zdravljenja.
English: To apply Kentera: Step 1: Choose a spot for the patch that is:
Slovenian: Namestitev obliža Kentera: 1. korak: Izberite mesto za namestitev obliža, ki je:
English: Apply as directed above.
Slovenian: Nanesite skladno z navodili zgoraj.
English: If not, take it off and put a new patch on a new spot.
Slovenian: Če ne, ga snemite in na novo mesto nanesite nov obliž.
English: Urinary retention
Slovenian: Retencija urina
English: No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
Slovenian: Ne glede na to, kateri dan se to zgodi, se držite svojega urnika nanosa dvakrat tedensko za naslednji obliž, četudi to pomeni, da ga boste morali zamenjati, preden pretečejo 3 ali 4 dnevi.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1. dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Apply immediately upon opening.
Slovenian: Uporabite takoj po odprtju.
English: Apply a Kentera patch as soon as you realise your patch is missing, or you have missed a scheduled day of application.
Slovenian: Obliž Kentera namestite takoj, ko ugotovite, da manjka, ali če ste zamudili načrtovani dan uporabe.
English: Steady-state conditions are reached after the seventh day of administration.
Slovenian: Stanje dinamičnega ravnovesja se doseže po sedmem dnevu uporabe.
English: Northern Ireland BT51 3RP
Slovenian: Severna Irska BT51 3RP
English: Do not expose the patch to the sun.
Slovenian: Obliža ne izpostavljajte soncu.
English: The product should not come in contact with an open flame.
Slovenian: Zdravilo ne sme priti v stik z odprtim ognjem.
English: Repeat until the sachet is empty.
Slovenian: Ponavljajte, dokler vrečice ne izpraznite.
English: If it sticks firmly all over, leave it on.
Slovenian: Če je povsod dobro prilepljen, ga pustite na koži.
English: WHAT KENTERA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO KENTERA IN ZA KAJ GA UPORABLJAMO
English: For transdermal use only.
Slovenian: Samo za transdermalno uporabo.
English: Important: Kentera is for application to the skin only.
Slovenian: Pomembno: Zdravilo Kentera se nanaša samo na kožo.
English: - If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
Slovenian: - Če ste preobčutljivi (alergični) na oksibutinin ali druge sestavine zdravila Kentera.
English: You should wear each patch all the time until you apply a new one.
Slovenian: Obliž nosite ves čas, vse dokler ne nanesete novega.
English: When changing the patch, remove the old patch slowly.
Slovenian: Pri menjavi počasi odstranite stari obliž.
English: Significant positive effects were also noted for each subscale domain of the IIQ and for six of ten quality of life domains, including the incontinence impact domain, of the King's Health Questionnaire (KHQ) as shown in the table below.
Slovenian: Pomembne pozitivne učinke so opazili tudi pri vseh podlestvicah vprašalnika IIQ in pri šestih izmed desetih domen kakovosti življenja vprašalnika King's Health Questionnaire (KHQ), vključno z domeno vpliva inkontinence, kot je prikazano v preglednici spodaj.
English: - If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
Slovenian: - Če imate prebavne težave, ki jih povzroča zmanjšano praznjenje želodca po obroku, se pred uporabo Kentera posvetujte z zdravnikom.
English: Kentera should therefore not be applied to a recently shaved or damaged skin surface.
Slovenian: Zato se zdravilo Kentera ne sme nanašati na pred kratkim obrito ali poškodovano površino kože.
English: A small amount of baby oil may also be used to remove any excess residue.
Slovenian: Za odstranjevanje lahko uporabite tudi nekoliko otroškega olja.
English: Do not apply a patch to the same place on your body for at least 1 week.
Slovenian: Obliža vsaj 1 teden ne nanašajte na isto mesto telesa.
English: Avoid contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not approved for the application of Kentera.
Slovenian: Izogibajte se stiku z očmi, nosom, odprtimi ranami, pred kratkim obrito kožo in kožo z izpuščaji, ali drugimi površinami, na katere nanašanje zdravila Kentera ni dovoljeno.
English: The amount of gel in each sachet will be about the size of a small coin (20 mm in diameter) on your skin.
Slovenian: Količina gela v vsaki vrečici bo približno velikosti majhnega kovanca (20 mm v premeru) na koži.
English: Alcohol or other strong solvents may cause skin irritation and should not be used.
Slovenian: Alkohol ali druga močna topila lahko razdražijo kožo, zato jih ne uporabljajte.
English: Fold it in half (sticky sides together) and throw it away to keep out of the reach of children and pets.
Slovenian: Prepognite ga na polovico (lepljive strani skupaj) in zavrzite nedosegljivo otrokom in domačim živalim.
English: However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Slovenian: Vendar zaradi nepoznavanja povezave med toksičnostjo pri materah in učinki na razvoj ploda pomena za varnost pri človeku ni mogoče oceniti.
English: The effect of fever, exposition to external heat sources, sun bathing and sauna on the absorption characteristics of Kentera have not been investigated.
Slovenian: Vplivov zvišane telesne temperature, izpostavljanja zunanjim virom toplote, sončenja in uporabe savne na absorpcijske značilnosti zdravila Kentera niso raziskovali.
English: FURTHER INFORMATION What Kentera contains
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Kentera
English: - Tear open along arrows marked on the right side of the sachet as shown in drawing below.
Slovenian: - Vrečko raztrgajte vzdolž puščic na desni strani, kot je prikazano na sliki spodaj.
English: Other adverse reactions reported were application site pruritus (Kentera 2.1%, placebo 0.8%), application site dermatitis (Kentera 1.8%, placebo 0.3%), dizziness (Kentera 1.5%, placebo 0.5%), headache (Kentera 1.5%, placebo 2.8%), constipation (Kentera 1.3%, placebo 1.0%), and pruritus (Kentera 1.3%, placebo 1.3%).
Slovenian: (Kentera 2,1 %, placebo 0,8 %), dermatitis na mestu aplikacije (Kentera 1,8 %, placebo 0,3 %), omotica (Kentera 1,5 %, placebo 0,5 %), glavobol (Kentera 1,5 %, placebo 2,8 %), obstipacija (Kentera 1,3 %, placebo 1,0 %) in pruritus (Kentera 1,3 %, placebo 1,3 %).
English: Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Slovenian: Uporabljenih obližev se ne sme odplakniti v stranišču ali jih odvreči v sisteme za odstranjevanje tekočih odpadkov.
English: Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar.
Slovenian: Označite urnik, po katerem boste zdravilo nanašali in obliž menjajte na vedno enaka dneva v tednu, ki ste ju izbrali na koledarju.
English: Take special care when driving or using machinery.
Slovenian: Pri vožnji ali uporabi strojev bodite posebno previdni.
English: Concomitant application of sunscreen, either before or after Kentera application, had no effect on the systemic exposure of oxybutynin.
Slovenian: Sočasna uporaba kreme za sončenje, nanesene pred aplikacijo zdravila Kentera ali po njej, ni imela nikakršnega vpliva na sistemsko izpostavljenost oksibutininu.
English: Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
Slovenian: Druge vzroke pogostega uriniranja (nezadostno delovanje srca ali ledvične bolezni) je potrebno oceniti pred začetkom zdravljenja z obližem Kentera.
English: Steady-state conditions are reached during the second application of the transdermal patch.
Slovenian: Stanje dinamičnega ravnovesja je doseženo pri drugi aplikaciji transdermalnega obliža.
English: As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks.
Slovenian: Takoj, ko se spomnite, odstranite stari obliž in nanesite novega na novo mesto na trebuhu, bokih ali zadnjici.
English: Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Slovenian: Dejavnosti, ki vodijo do prekomernega znojenja ali izpostavljenost vodi oz. skrajnim temperaturam, lahko vplivajo na lepljivost.
English: Gel 30 sachets of 1 gram.
Slovenian: 30 vrečic po 1 gram
English: Each patch is individually sealed in a protective sachet.
Slovenian: Vsak obliž je posamično zapakiran v zaščitno vrečko.
English: Inflicted injury
Slovenian: - poškodbe
English: Sleep and energy Severity (coping) measures
Slovenian: Spanje in energija Stopnja ukrepanja
English: BT51 3RP Northern Ireland
Slovenian: BT51 3RP Severna Irska
English: Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use.
Slovenian: Nov obliž Kentera nanesite dvakrat tedensko (vsake 3 do 4 dni) skladno z navodili za uporabo.
English: Kentera is not recommended for use in children or adolescents.
Slovenian: Obliža Kentera ne priporočamo za uporabo pri otrocih in mladostnikih.
English: Available information shows that oxybutynin is excreted in milk of rats, but is not known whether oxybutynin is excreted in human milk.
Slovenian: Informacije, ki so na voljo, kažejo, da se oksibutinin pri podganah izloča v mleko, vendar ni znano, ali se izloča tudi v materino mleko.
English: The 12-week double-blind treatment included daily applications of Kentera or matching placebo gel.
Slovenian: 12-tedensko dvojno slepo zdravljenje je vključevalo vsakodnevno uporabo zdravila Kentera ali ustreznega gela s placebom.
English: As the stratum corneum is the rate-limiting step in transdermal delivery, any breach would provide direct access to the epidermis, potentially increasing penetration and facilitating the migration of the medicinal product to the blood stream.
Slovenian: Stratum corneum je plast, ki omejuje transdermalni prenos, zato bi kakršnakoli razpoka omogočila neposreden dostop do epidermisa, kar bi lahko povečalo penetracijo in pospešilo migracijo zdravila v krvni obtok.
English: Plasma concentrations of oxybutynin begin to decline 24 hours after Kentera application.
Slovenian: Koncentracije oksibutinina v plazmi se začnejo manjšati 24 ur po uporabi zdravila Kentera.
English: The untreated partners not protected by clothing demonstrated detectable plasma concentrations of oxybutynin (mean Cmax = 0.94 ng/ml).
Slovenian: Pri nezdravljenih partnerjih, ki niso bili zaščiteni z oblačili, so opazili zaznavne koncentracije oksibutinina v plazmi (povprečna vrednost Cmax = 0,94 ng/ml).
English: Each sachet contains 1 g of gel.
Slovenian: Ena vrečica vsebuje 1 g gela.
English: If the patch comes off:
Slovenian: Če se obliž odlepi:
English: Based on clinical trial experience no dose adjustment is considered necessary in this population.
Slovenian: Na podlagi izkušenj iz kliničnega preskušanja velja, da odmerka pri tej populaciji ni treba prilagajati.
English: The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%).
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali, so bila suha usta (6,9 % pri zdravilu Kentera in 2,8 % pri placebu).
English: - Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch.
Slovenian: - Nežno upognite obliž in odstranite prvo plast zaščitne folije, ki pokriva lepljivo površino obliža.
English: Kentera delivers approximately 0.08 mg/kg/day.
Slovenian: Zdravilo Kentera sprošča približno 0,08 mg/kg/dan.
English: Squeeze from the bottom of the sachet toward the open end.
Slovenian: Iztisnite od dna vrečice proti odprtem koncu.
English: Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s).
Slovenian: Koncentracija oksibutinina v plazmi pade v 1 do 2 urah po odstranitvi transdermalnega sistema / sistemov.
English: - If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem.
Slovenian: - Če imate težave z nepopolnim praznjenjem mehurja med uriniranjem, lahko uporaba oksibutinina težavo še poveča.
English: Kentera contains alcohol and is considered flammable and should not come in contact with an open flame.
Slovenian: Zdravilo Kentera vsebuje alkohol in je vnetljivo, zato ne sme priti v stik z odprtim ognjem.
English: In total 496 patients were exposed to Kentera in the randomised, double-blind, placebo-controlled 12week and the 14-week safety extension studies.
Slovenian: Skupaj je bilo zdravilu Kentera v randomiziranih, dvojno slepih, s placebom nadzorovanih, 12-tedenskih in 14-tedenskih podaljšanih študijah varnosti izpostavljenih 496 bolnikov.
English: Select an approved site for the application of Kentera.
Slovenian: Izberite odobreno mesto za nanašanje zdravila Kentera.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih občasni poškodbe
English: Kentera is formulated for daily application and is capable of maintaining therapeutic blood levels of oxybutynin.
Slovenian: Zdravilo Kentera je pripravljeno za uporabo enkrat dnevno in lahko vzdržuje terapevtske ravni oksibutinina v krvi.
English: Consumption of grapefruit juice may also influence metabolism of oxybutynin.
Slovenian: Tudi uživanje soka grenivke lahko vpliva na presnovo oksibutinina.
English: The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
Slovenian: Priporočen odmerek je 3,9 mg transdermalnega obliža dvakrat tedensko (vsake 3 do 4 dni).
English: Studies in animals have shown minor reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale manjši vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: After the priming step is complete, 30 full doses will remain in the pump.
Slovenian: Ko je polnjenje končano, je v črpalki še 30 odmerkov.
English: After applying the gel, hands should immediately be washed thoroughly with soap and water.
Slovenian: Po nanašanju gela je treba roke takoj temeljito umiti z milom in vodo.
English: - Erythromycin a macrolide antibiotic (used to treat bacterial infections).
Slovenian: - Makrolidni antibiotik eritromicin (uporablja se za zdravljenje bakterijskih okužb).
English: Try not to touch the sticky surface of the patch.
Slovenian: Pri tem se ne dotikajte lepljive površine obliža.
English: - Tricyclic antidepressants (used to treat depression).
Slovenian: - Triciklični antidepresivi (uporabljajo se za zdravljenje depresije).
English: You should not apply Kentera to the same site on consecutive days.
Slovenian: Zdravila Kentera ne smete nanesti na isto mesto ob zaporednih dneh.
English: Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Slovenian: Oksibutinin je racemna (50 : 50) zmes R- in S-izomerov.
English: Physical activity subscale
Slovenian: Podlestvica fizična aktivnost
English: Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume were evaluated.
Slovenian: Ocenjeno je bilo zmanjšanje tedenskih inkontinenčnih epizod, pogostost uriniranja ter volumen izpraznjenega urina.
English: Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7).
Slovenian: Bolnike je treba obvestiti, da alkohol lahko poveča dremavost, ki jo povzročajo antiholinergične zdravilne učinkovine, kot je oksibutinin (glejte poglavje 4.7).
English: Kentera is not recommended for use in children and adolescents under 18 years old.
Slovenian: Otroci in mladostniki Uporaba zdravila Kentera pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: Significant improvements in the quality of life evaluations measured during the study were also observed with Kentera.
Slovenian: Pri zdravljenju z zdravilom Kentera so opazili tudi pomembna izboljšanja pri ocenjevanjih kakovosti življenja, ki so jih opravili med študijo.
English: Application should not be made to the same site on consecutive days.
Slovenian: Zdravilo se ne sme nanašati na isto mesto v zaporednih dneh.
English: At a concentration of 0.4 mg/kg/day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
Slovenian: Pri koncentraciji 0,4 mg/kg/dan oksibutinina, odmerjenega subkutano, se pogostnost anomalij organov pomembno poveča, vendar so jih opazili samo v prisotnosti toksičnosti pri materah.
English: Step 4: Apply the second half of the patch to your skin.
Slovenian: 4. korak: Nalepite drugo polovico obliža na kožo.
English: Antimuscarinic activity resides predominantly in the R-isomer.
Slovenian: Antimuskarinsko delovanje je predvsem prisotno v R-izomeru.
English: When oxybutynin is used during breast-feeding, a small amount is excreted in the mother's milk.
Slovenian: Kadar se oksibutinin uporablja med dojenjem, se majhna količina izloči v materino mleko.
English: - Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
Slovenian: - Nemudoma ga nanesite na kožo; obliža ne shranjujte izven zaprte zaščitne vrečke.
English: Daily incontinence episodes Baseline
Slovenian: Dnevne epizode inkontinence
English: Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
Slovenian: Vse uporabljene ali neuporabljene obliže odstranite v skladu z lokalnimi zahtevami ali jih vrnite v lekarno.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
English: The safety of Kentera was evaluated in patients with urge urinary incontinence in a randomised, double-blind, placebo-controlled, parallel group Phase 3 study that included 789 patients (with 389 patients receiving Kentera and 400 patients receiving placebo).
Slovenian: Varnost zdravila Kentera so ocenili pri bolnikih z urgentno urinarno inkontinenco v randomizirani, dvojno slepi, s placebom nadzorovani študiji 3. faze z vzporednimi skupinami, v kateri je sodelovalo 789 bolnikov (389 bolnikov je prejemalo zdravilo Kentera, 400 bolnikov pa placebo).
English: - If you have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily.
Slovenian: - Če imate redko bolezen, imenovano miastenija gravis, zaradi katere so mišice šibke in se hitro utrujajo.
English: To prime the pump, fully depress the pump mechanism repeatedly until gel is observed, then depress the pump one more time, and discard this portion of the medicinal product to assure precise dose delivery.
Slovenian: Črpalko napolnite tako, da večkrat popolnoma pritisnete mehanizem črpalke, dokler ne opazite gela, nato ga pritisnite še enkrat in zavrzite ta del zdravila, da zagotovite natančno dovajanje odmerka.
English: You should not use Kentera if you are pregnant unless your doctor has told you to.
Slovenian: Zdravila Kentera ne smete uporabljati, če ste noseči, razen če vam je zdravnik tako naročil.
English: No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
Slovenian: kateri dan se to zgodi, se držite svojega urnika nanosa dvakrat tedensko, kot ste označili na škatlici.