FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping.
Maltese: Reazzjonijiet avversi minn studji kliniċi ta' fażi 3 u 4 huma elenkati hawn taħt skont is-sistema talklassifika tal-organi u l-grupp ta' frekwenza.
English: The area of the patch is 39 cm2, releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Maltese: L-erja tal-garża hija ta' 39 cm2, u terħi 3.9 mg nominali ta' oxybutynin kull 24 siegħa.
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Maltese: Jekk ikun hemm infezzjoni fl-apparat urinarju, għandha tinbeda terapija antibatterika xierqa.
English: The multidose container is comprised of an outer polypropylene bottle with a Low Density Polyethylene (LDPE) pouch liner, a polypropylene metering pump, with ethylene propylene diene monomer (EPDM) gaskets, and a polypropylene cap.
Maltese: Il-kontenitur b'ħafna dożi jinkludi flixkun tal-polypropylene fuq barra b'kisja tal-borża tal-Polyethylene ta' Densità Baxxa (LDPE - Low Density Polyethylene), pompa tal-kejl tal-polypropylene, b'gaskits tal ethylene propylene diene monomer (EPDM), u b'għatu tal-polypropylene.
English: Kentera contains the active substance oxybutynin and is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
Maltese: Kentera fih is-sustanza attiva oxybutynin u jintuża fl-adulti biex jikkontrolla s-sintomi tal-inkontinenza impulsiva u/jew żieda fil-frekwenza u l-urgenza tal-awrina.
English: POSSIBLE SIDE EFFECTS
Maltese: Effetti sekondarji komuni
English: Recordati Ireland Ltd. Tel: +353 (0) 21 4379400
Maltese: Tel: +353 (0) 21 4379400
English: Daily incontinence episodes Baseline
Maltese: Episodji ta' inkontinenza ta' kuljum
English: Rare side effects - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness - poor concentration
Maltese: Effetti sekondarji rari - reazzjoni ta' paniku - konfużjoni mentali - alluċinazzjonijiet - diżorjentament - indeboliment tal-memorja - telf ta' memorja - għeja mhix normali - konċentrazzjoni batuta
English: Gel 1 multidose container with metering pump of 30 grams
Maltese: Ġel Kontenitur b'ħafna dożi wieħed b'pompa tal-kejl ta' 30 gramma
English: - Phenothiazines or clozapine (used to treat mental illness).
Maltese: - Phenothiazines jew clozapine (użati għat-trattament ta' mard mentali).
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.
Maltese: pazjent (38%) kellhom 65 sena jew aktar u ma wrew l-ebda differenza globali fis-sigurtà jew fl-effikaċja meta mqabbla ma' pazjenti iżgħar.
English: Kentera transdermal patch:
Maltese: Biex tapplika Kentera:
English: In total 496 patients were exposed to Kentera in the randomised, double-blind, placebo-controlled 12week and the 14-week safety extension studies.
Maltese: B'kollox 496 pazjent kienu esposti għal Kentera fl-istudju randomised, double-blind, ikkontrollat bi plaċebo, ta' 12-il ġimgħa u fl-istudju ta' estensjoni dwar is-sigurtá ta' 14-il ġimgħa.
English: Application site erythema, application site reaction, application site rash
Maltese: Eritema fil-post tal-applikazzjoni, reazzjoni fil-post tal-applikazzjoni, raxx fil-post tal-applikazzjoni
English: Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Maltese: Kentera għandu konċentrazzjoni ta' oxybutynin biżżejjed biex iżżomm trasport kontinwu matul l-interval tad-dożaġġ ta' 3 sa 4 ijiem.
English: Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum.
Maltese: Oxybutynin huwa trasportat minn ġol-ġilda intatta għaċ-ċirkolazzjoni sistemika permezz ta' diffużjoni passiva minn ġol-istratum corneum.
English: Diarrhoea, nausea, dyspepsia, vomiting, haemorrhoids
Maltese: Disurja, ematurja, uġigħ renali, żamma tal-awrina
English: Pharmacotherapeutic group: urinary antispasmodic, ATC code: G04B D04.
Maltese: Kategorija farmakoterapewtika: anti-spażmodiku urinarju, kodiċi ATC:
English: Transdermal patch.
Maltese: Għall-użu transdermali biss.
English: As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme cannot be ruled out.
Maltese: Minħabba li oxybutynin huwa metabolizzat mill-isoenzim taċ-ċitokromju P 450, CYP 3A4, l-interazzjonijiet ma' prodotti mediċinali li jinibixxu dan l-isoenzim ma jistgħux jiġu esklużi.
English: - Atropine and other anticholinergic medicines (used for treatment in stomach disorders such as irritable bowel syndrome).
Maltese: - Atropine u mediċini antikolinerġiċi oħra (użati għat-trattament ta' disturbi tal-istonku bħas sindrome tal-imsaren irritabbli).
English: Urinary tract infection
Maltese: Infezzjonijiet tal-apparat urinarju
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
Maltese: L-għoti orali ta' oxybutynin jista' jiġġustifika dawn id-dikjarazzjonijiet ta' twissija li ġejjin, iżda dawn l avvenimenti ma kinux osservati matul il-provi kliniċi b'Kentera:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON ( Containing 30 sachets)
Maltese: KARTUNA (Fiha 30 qartas)
English: Headache, dizziness
Maltese: Żamma tal-awrina, disurja
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics, ATC code: G04B D04.
Maltese: Uroloġiċi, anti-spażmodiċi urinarji, Kodiċi ATC:
English: - Antihistamines (used in the treatment of allergies such as hayfever).
Maltese: - Antistamini (użati fit-trattament ta' allerġiji bħall-hayfever).
English: EU/1/03/270/001 <8 transdermal patches> EU/1/03/270/002 <24 transdermal patches> EU/1/03/270/003 <2 transdermal patches>
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/270/001 <8 gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda> EU/1/03/270/002 <24 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda> EU/1/03/270/003 <2 gareżli jipprovdu mediċina li tgħaddi minn ġol-ġilda>
English: - Dipyridamole (used to treat blood clotting problems).
Maltese: - Dipyridamole (użat għat-trattament ta' problemi fit-tagħqid tad-demm).
English: Orion Pharma AB Tel: +46 8 623 64 40
Maltese: Tel: +46 8 623 64 40
English: Each sachet contains 1 g of gel.
Maltese: Kull qartas fih 1 g ta' ġel.
English: Data on possible effects of the use of oxybutynin on human male and female fertility are not available.
Maltese: Dejta dwar l-effetti possibbli tal-użu ta' oxybutynin fuq il-fertilità umana fl-irġiel u n-nisa mhijiex disponibbli.
English: Each multidose container contains at least 30 grams of Kentera and dispenses 30 metered 1 gram doses.
Maltese: Kull kontenitur b'ħafna dożi fih għallinqas 30 gramma ta' Kentera u jagħti 30 doża mkejla ta' gramma waħda.
English: Mean (SD) change from baseline for IIQ total score and subscales at Week 12 (LOCF)
Maltese: Tibdil medju (SD) mil-linja bażi għal punteġġ totali tal-IIQ u subskali f'Ġimgħa 12
English: Rhinitis
Maltese: Inċidenza
English: Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: - dry skin - itchy rash - painful or difficulty urinating - blood in urine - kidney pain - delayed or slow start of urinary flow - tiredness, exhaustion - swelling of ankles, feet or fingers - small bumps at application site - numbness at application site - redness at application site - irritation at application site - pain at application site - pus filled bumps at application site - abnormal electrocardiogram (ECG or EKG,test of heart) - change in ECG or EKG - high chloride levels in blood
Maltese: - tnemnim fis-sit tal-applikazzjoni - ħmura fis-sit tal-applikazzjoni - irritazzjoni fis-sit tal-applikazzjoni - uġigħ fis-sit tal-applikazzjoni - ponot żgħar mimlija bil-materja fis-sit tal-applikazzjoni - elettrokardjogramma anormali (ECG jew EKG, test tal-qalb) - tibdil fl-ECG jew EKG
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja dwar ilMediċini: http://www.ema.europa.eu
English: As oxybutynin is metabolised by the cytochrome P 450 isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme, or known inducers of CYP 3A4, cannot be ruled out.
Maltese: Minħabba li oxybutynin huwa metabolizzat mill-isoenzim taċ-ċitokromju P 450, CYP 3A4, l-interazzjonijiet ma' prodotti mediċinali li jinibixxu dan l-isoenzim, jew indutturi magħrufa ta' CYP 3A4, ma jistgħux jiġu esklużi.
English: Following the application of Kentera, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4 ng/ml.
Maltese: Wara l-applikazzjoni ta' Kentera, il konċentrazzjoni ta' oxybutynin fil-plażma tiżdied għal madwar 24 sa 48 siegħa, u tilħaq il-medja talkonċentrazzjonijiet massimi ta' 3 sa 4ng/mL.
English: The transdermal patches are individually contained in LDPE/paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
Maltese: Kentera hija garża li tipprovdi mediċina li tgħaddu minn ġol-ġilda u hija ppakkjata f'kartun li fihom 2, 8, u 24 garża.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku ta'l-Aġenzija Ewropeja dwar il-Mediċini (EMA) http://www.ema.europa.eu
English: Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Maltese: Kull qartas ta' gramma waħda ta' ġel fih 90.7 mg ta' oxybutynin (bħala 100 mg oxybutynin hydrochloride) li jirriżulta f'għoti nominali ta' madwar 4 mg/jum.
English: The efficacy and safety of Kentera were evaluated in patients with urge urinary incontinence in a single Phase 3 study.
Maltese: L-effikaċja u s-sigurtà ta' Kentera ġew evalwati f'pazjenti b'inkontinenza urinarja impulsiva fi studju wieħed ta' Fażi 3.
English: - Biperiden, levodopa, or amantadine (used to treat Parkinson's disease).
Maltese: - Biperiden, levodopa, jew amantadine (użati għat-trattament tal-marda ta' Parkinson).
English: Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.
Maltese: Doża eċċessiva b'oxybutynin kienet assoċjata ma' effetti antikolinerġiċi inkluż eċitazzjoni tas-CNS, fwawar, deni, deidratazzjoni, arritmija kardijaka, rimettar, u żamma tal-awrina.
English: Anticholinergic medicinal products may potentially alter the absorption of some concomitantly administered medicinal products due to anticholinergic effects on gastrointestinal motility.
Maltese: Prodotti mediċinali antikolinerġiċi jistgħu potenzjalment ibiddlu l-assorbiment ta' xi prodotti mediċinali mogħtija fl-istess ħin minħabba l-effetti antikolinerġiċi fuq il-motilità gastro-intestinali.
English: Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall.
Maltese: Oxybutynin mogħti b'mod orali huwa primarjament metabolizzat mis-sistemi tal-enzimi taċ-ċitokromju P450, b'mod partikulari mis-CYP3A4, li fil-biċċa l-kbira tinsab fil-fwied u mas-superfiċje ta' ġewwa talimsaren.
English: Following the application of Kentera, oxybutynin plasma concentration increases for approximately 7 days, reaching average maximum concentrations of 4 to 5 ng/ml.
Maltese: Wara l-applikazzjoni ta' Kentera, il konċentrazzjoni ta' oxybutynin fil-plażma tiżdied għal madwar 7 ijiem, u tilħaq il-konċentrazzjonijiet massimi medji ta' 4 sa 5 ng/mL.
English: The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro studies, but has a greater binding affinity for parotid tissue than oxybutynin.
Maltese: Il-metabolit attiv, N-desethyloxybutynin, għandu attività farmakoloġika fuq il-muskolu detrusor uman li tixbah lil dik li nstabet fi studji in vitro ta' oxybutynin, iżda għandu affinità akbar biex jintrabat mat-tessuti tal-parotid minn oxybutynin.
English: Oxybutynin may antagonise prokinetic therapies, such as cisapride and metocloparamide, and should be avoided in the presence of reduced gastrointestinal motility conditions.
Maltese: Oxybutynin jista' jantagonizza terapiji prokinetiċi, bħal cisapride u metocloparamide, u għandu jiġi evitat fil-preżenza ta' kondizzjonijiet ta' motilità gastro-intestinali mnaqqsa.
English: Dysuria, haematuria, renal pain, urinary retention
Maltese: Dijarea, nawsja, dispepsja, rimettar, murliti
English: Change from baseline P-value vs. placebo
Maltese: Linja bażi Tibdil mil-linja bażi Valur P vs. plaċebo
English: Studies in animals have shown minor reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku minuri fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Maltese: Oxybutynin jista' jaggrava s-sintomi tal-ipertirojdiżmu, il-mard koronarju tal-qalb, l-insuffiċjenza konġestiva tal-qalb, l-arritmiji kardijaċi, it-takikardja, il-pressjoni għolja u l-ipertrofija tal-prostata.
English: Adverse reactions considered associated with anticholinergic therapy,in general or observed with oral administration of oxybutynin, but as of yet not with Kentera in clinical trials or post-marketing, are: anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, paranoia, photosensitivity, erectile dysfunction.
Maltese: Reazzjonijiet avversi kkunsidrati li huma assoċjati mat-terapija antikolinerġika b'mod ġenerali, jew osservati b'għoti mill-ħalq ta' oxybutynin iżda s'issa mhux b'Kentera fil-provi kliniċi jew wara t-tqegħid fis-suq huma: anoressija, rimettar, esofaġite ta' rifluss, nuqqas ta' għaraq, kolp ta' sħana, nuqqas taddmugħ, midrijasi, takikardija, arritmija, inkubi, irrekwitezza, konvulżjoni, pressjoni għolja intraokulari u induzzjoni ta' glawkoma, paranojja, fotosensittività, disfunzjoni erettili.
English: Two of the 14 untreated subjects participating in the clothing-to-skin contact regimen had measurable oxybutynin plasma concentrations (Cmax < 0.1 ng/ml) during the 48 hours following contact with treated subjects; oxybutynin was not detectable with the remaining 12 untreated subjects.
Maltese: Tnejn mill-14-il individwu li ma kinux qegħdin jirċievu trattament li pparteċipaw fir-reġimen ta' kuntatt tal-ħwejjeġ mal-ġilda kellhom konċentrazzjonijiet li jistgħu jitkejlu ta' oxybutynin fil-plażma (Cmax < 0.1 ng/mL) waqt it-48 siegħa wara l-kuntatt ma' individwi ttrattati; oxybutynin ma setax jitkejjel fit-12-il individwu li baqa' li ma kinux qegħdin jirċievu trattament.
English: - confusion - nervousness - agitation - difficulty in sleeping - palpitations - hot flushes - back pain - urinary retention - difficulty urinating - common cold - accidental injury
Maltese: - ansjetà - konfużjoni - nervi - aġitazzjoni - diffikultajiet biex torqod - palpitazzjonijiet - fwawar tas-sħana
English: Middle layer
Maltese: Vista mċajpra
English: EU/1/03/270/001 8 transdermal patches EU/1/03/270/002 24 transdermal patches EU/1/03/270/003 2 transdermal patches
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/270/001 8 gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda EU/1/03/270/002 24 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda EU/1/03/270/003 2 gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda
English: Also, less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
Maltese: Barra dan, inqas minn 0.1% tad-doża mogħtija titneħħa bħala l metabolit N-desethyloxybutynin.
English: EU/1/03/270/005 <1 multidose container with metering pump>
Maltese: FIS-SUQ EU/1/03/270/005 <kontenitur b'ħafna dożi wieħed b'pompa tal-kejl>
English: Especially: - Ketoconasole, itraconazole or fluconazole (used for the treatment of fungal infections).
Maltese: - Ketoconasole, itraconazole jew fluconazole (użati għat-trattament ta' infezzjonijiet fungali).
English: Consumption of grapefruit juice may also influence metabolism of oxybutynin.
Maltese: Il-konsum tal-meraq tal-grejpfrut ukoll jista' jinfluwenza l-metaboliżmu ta' oxybutynin.
English: Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7).
Maltese: Il-pazjenti għandhom jiġu infurmati li l-alkoħol jista' jżid il-ħedla ikkawżata minn sustanzi antikolinerġiċi bħal oxybutynin (ara s-sezzjoni 4.7).
English: The oxybutynin, triacetin and acrylic adhesive are coated on clear PET/EVA backing film and covered with a siliconised polyester release liner.
Maltese: L-oxybutynin, triacetin u l-adeżiv akriliku huma miksija fuq kisja rqiqa ta' rinforż ċar tal-PET/EVA u miksija b'kisja ta' rilaxx tal-poliester silikonizzat.
English: Application site pruritis, application site dermatitis
Maltese: Prurite fis-sit tal-applikazzjoni, dermatite fis-sit talapplikazzjoni
English: Very common Application site pruritis Common
Maltese: Ħakk fil-post tal-applikazzjoni
English: Especially: - Ketoconazole, itraconazole or fluconazole (used for the treatment of fungal infections).
Maltese: - Ketoconazole, itraconazole jew fluconazole (użati għat-trattament ta' infezzjonijiet fungali).
English: Daily nocturia episodes Baseline
Maltese: Episodji ta' awrina bil-lejl kuljum
English: Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions.
Maltese: Kentera huwa kontraindikat f'pazjenti b'żamma tal-awrina, b'kondizzjoni gastro-intestinali severa, mijastenja gravis jew bi glawkoma b'angolu dejjaq u f'pazjenti li qegħdin f'riskju għal dawn ilkondizzjonijiet.
English: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Maltese: Trattament sintomatiku ta' inkontinenza impulsiva u/jew żieda fil-frekwenza u l-urġenza urinarja kif tista' sseħħ f'pazjenti adulti bil-bużżieqa tal-awrina instabbli.
English: The untreated partners not protected by clothing demonstrated detectable plasma concentrations of oxybutynin (mean Cmax = 0.94 ng/ml).
Maltese: L-imsieħba li ma kinux qegħdin jirċievu trattament li ma kinux protetti mill-ħwejjeġ urew konċentrazzjonijiet traċċabbli ta' oxybutynin fil-plażma (Cmax medja = 0.94 ng/mL).
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.
Maltese: 0.4 mg/kg/jum ta' oxybutynin mogħti taħt il-ġilda, l-okkorrenza ta' anomaliji fl-organi tiżdied b'mod sinifikanti, iżda hija osservata biss fil-preżenza ta' tossiċità materna.
English: Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
Maltese: Kentera jintuża fl-adulti biex jikkontrolla s-sintomi tal-inkontinenza impulsiva u/jew żieda fil-frekwenza u l-urġenza tal-awrina.
English: Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Maltese: Mekkaniżmu ta' azzjoni: oxybutynin jaġixxi bħala antagonista kompetittiv tal-acetylcholine f'riċetturi muskariniċi post-ganglijoniċi, li jirriżulta fir-rilassament tal-muskolu lixx tal-bużżieqa tal-awrina.
English: Innova Pharma S.p.A. Tel: +39 02 48787.1
Maltese: Tel: +39 02 48787.
English: Kentera is formulated for daily application and is capable of maintaining therapeutic blood levels of oxybutynin.
Maltese: Kentera huwa formulat għal applikazzjoni ta' kuljum u huwa kapaċi li jżomm livelli terapewtiċi ta' oxybutynin fid-demm.
English: Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
Maltese: L-għoti transdermali ta' oxybutynin jevita lewwel passaġġ tal-metaboliżmu gastro-intestinali u epatiku, u b'hekk inaqqas il-formazzjoni tal-metabolit N-desethyl.
English: Sun/Wed Mon/Thu Tue/Fri Wed/Sat Thu/Sun Fri/Mon Sat/Tue
Maltese: Ħad/Erb Tne/Ħam Tli/Ġim
English: The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
Maltese: Id-doża rakkomandata hija ta' garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda waħda ta' 3.9 mg li tiġi applikata darbtejn fil-ġimgħa (kull 3 sa 4 t'ijiem).
English: Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary frequency, and urinary void volume between placebo and active treatment groups are summarised in the table below.
Maltese: It-tibdil medju u medjan mil-linja bażi fl-episodji ta' inkontinenza ta' kuljum (punt finali primarju), ilfrekwenza urinarja, u l-volum ta' tbattil urinarju bejn il-plaċebo u l-gruppi ta' trattament attiv huma miġbura fil-qosor fit-tabella hawn taħt.
English: Each metered dose of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Maltese: Kull doża mkejla ta' gramma waħda ta' ġel fih 90.7 mg ta' oxybutynin (bħala 100 mg oxybutynin hydrochloride) li jirriżulta f'għoti nominali ta' madwar 4 mg/jum.
English: Mean and median change from baseline for incontinence episodes, urinary frequency, and urinary void volume at Week 12 (LOCF)
Maltese: Tibdil medju u medjan mil-linja bażi fl-episodji ta' inkontinenza, il-frekwenza urinarja,
English: The difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following transdermal administration of Kentera on either the abdomen, buttocks or hip is not clinically relevant.
Maltese: Id-differenza fl-AUC u fis-Cmax ta' oxybutynin u l metabolu attiv N-desethyloxybutynin wara l-applikazzjoni transdermali ta' Kentera fuq l-addome, il warrani jew il-ġenbejn mhijiex klinikament relevanti.
English: Psychiatric and central nervous system (CNS) anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Maltese: Episodji psikjatriċi u tas-sistema nervuża ċentrali (CNS - central nervous system) antikolinerġiċi bħal disturbi fl-irqad (eż. insomnija) u disturbi konjittivi ġew assoċjati mal-użu ta' oxybutynin, speċjalment f'pazjenti anzjani.
English: Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
Maltese: Minħabba li t-trattament b'oxybutynin jista' jikkawża nuqqas ta' għaraq, hemm żieda fir-riskju ta' deni u ta' puplesija relatata mas-sħana jekk tkun espost għal temperaturi ambjentali għoljin.
English: Available information shows that oxybutynin is excreted in milk of rats, but is not known whether oxybutynin is excreted in human milk.
Maltese: L-informazzjoni disponibbli turi li oxybutynin jiġi eliminat fil-ħalib tal-firien, iżda mhuwiex magħruf jekk oxybutynin jiġix eliminat fil-ħalib uman.