qanastek/EMEA-V3 huggingface dataset:
The recommended dosage of Kentera is one patch twice a week (every 3 to 4 days).
Ieteicamā Kentera deva ir viens plāksteris divreiz nedēļā (ik pēc 3 – 4 dienām).
The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Plāksteri ir jāuzliek uz sausas, nebojātas ādas vēdera rajonā (vēdera priekšpusē), gurna vai sēžamvietas tūlīt pēc izņemšanas no aizsargājošā maisiņa.
A new application site should be chosen with each new patch so the same place is not used within 7 days.
Katram nākamajam plāksterim ir jāizvēlas jauna uzlikšanas vieta, lai tā pati vieta netiktu izmantota 7 dienas.
How does Kentera work?
Kā Kentera darbojas?
The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Kentera aktīvā viela oksibutinīns ir antiholīnerģisks medikaments.
It blocks some receptors in the body, the muscarinic M1 and M3 receptors, and in the bladder, this causes the muscles that push urine out of the bladder to relax.
Tas ķermenī bloķē dažus receptorus – M1 un M3 muskarīna receptorus, tāpēc pūslī muskuļi, kas izspiež urīnu, atslābst.
This leads to an increase in the capacity of the bladder, and to changes in the way the bladder muscles contract as the bladder fills up.
Tas palielina pūšļa ietilpību un izmaina pūšļa muskuļu saraušanās veidu, kad pūslis piepildās.
This helps Kentera to prevent unwanted urination.
Tas palīdz Kentera novērst nevēlamu urinēšanu.
Oxybutinin has been available as a tablet for the treatment of overactive bladder since the 1970’ s.
Oksibutinīns ir bijis pieejams kā tablete pārāk aktīva pūšļa ārstēšanai kopš pagājušā gadsimta septiņdesmitajiem gadiem.
How has Kentera been studied?
Kā noritēja Kentera izpēte?
Kentera has been studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Divos galvenajos Kentera pētījumos kopumā bija iesaistīts 881 pacients, galvenokārt gados vecākas sievietes ar pārāk aktīvu pūsli.
In one study (520 patients), Kentera was compared with placebo (dummy treatment), in the second (361 patients), Kentera was compared with tolterodine capsules (another medicine used to treat urge incontinence).
Vienā pētījumā (520 pacienti) Kentera salīdzināja ar placebo (fiktīvu ārstēšanu), otrajā (361 pacients) Kentera salīdzināja ar tolterodīna kapsulām (cits medikaments trauksmes nesaturēšanas ārstēšanai).
The main measure of effectiveness was the effect of the treatment on the number of incontinence episodes over a 7- or a 3-day period.
Galvenais efektivitātes kritērijs bija ārstēšanas ietekme uz nesaturēšanas epizožu skaitu 7 vai 3 dienu ilgā periodā.
What benefit has Kentera shown during the studies?
Kāds ir Kentera iedarbīgums šajos pētījumos?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged episodes in the placebo group.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kāds pastāv risks, lietojot Kentera?
The most common side effects (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Visbiežākā blakusparādība (ko novēroja vairāk kā vienam pacientam no 10) ir reakcijas pielietošanas vietā (tostarp nieze ap plākstera uzlikšanas vietu).
Other side effects reported were redness at the site of application, dry mouth, constipation, diarrhoea, upset stomach, headache, or sleepiness dizziness, blurred vision, and urinary infection.
Citas novērotās blakusparādības bija apsārtums pielietošanas vietā, sausa mute, aizcietējumi, caureja, vēdera darbības traucējumi, galvassāpes vai miegainība, reiboņi, redzes traucējumi un urīnceļu infekcija.
For the full list of all side effects reported with Kentera, see the Package Leaflet.
Pilns Kentera lietojot novēroto blakusparādību saraksts ir atrodams lietošanas pamācībā.
Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients, and in patients with urinary retention (difficulty in passing urine), severe gastro- intestinal conditions, uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves causing muscle weakness).
Kentera nedrīkst lietot cilvēki, kas var būt hipersensitīvi (alerģiski) pret oksibutinīnu vai citām sastāvdaļām, un pacienti ar urīna aizturēšanu (apgrūtinātu urīna izvadīšanu), smagu gastrointestinālo stāvokli, nekontrolēto šaurā leņķa glaukomu (paaugstinātu spiedienu acīs, neskatoties uz ārstēšanu) vai myasthenia gravis (nervu slimību, kas izsauc muskuļu vājumu).
Why has Kentera been approved?
Kāpēc Kentera tika apstiprināts?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Kentera had been shown to be at the level of the oral presentation, already on the market.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka ir pierādīta Kentera efektivitāte tādā pašā līmenī, kā perorālajai formai, kas jau ir tirgū.
They decided that Kentera’ 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.
Komiteja nolēma, ka Kentera ieguvumi ir lielāki par riskiem pacientiem ar pārāk aktīva pūšļa sindromu piemītošās trauksmes nesaturēšanas un/ vai palielināta urinēšanas biežuma un neatliekamības simptomātiskajā ārstēšanā.
They recommended that Kentera be given marketing authorisation.
Komiteja ieteica izsniegt Kentera reģistrācijas apliecību.
Other information about Kentera:
Cita informācija par Kentera:
The European Commission granted a marketing authorisation valid throughout the European Union for Kentera to Nicobrand Limited on 15 June 2004.
15. jūnijā Eiropas Komisija izsniedza Kentera reģistrācijas apliecību, kas ir derīga visā Eiropas Savienībā, uzņēmumam Nicobrand Limited.
The full EPAR for Kentera is available here.
Pilns Kentera EPAR teksts ir atrodams šeit.
This summary was last updated in 10-2006.
Šis kopsavilkums pedejo reizi tika atjauninats 10- 2006.
Sachet (LDPE/ paper laminate)
Maisiņš (LDPE/ papīra lamināts)
8 transdermal patches
8 transdermāli plāksteri
24 transdermal patches
24 transdermāli plāksteri
2 transdermal patches
2 transdermāli plāksteri
Kentera 3.9 mg / 24 hours, transdermal patch
Kentera 3. 9 mg / 24 stundas, transderm lie pl ksteri
Each transdermal patch contains 36 mg of oxybutynin.
Viens transderm lais pl ksteris satur 36 mg oksibutin na.
The area of the patch is 39 cm2, releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Pl kstera laukums ir 39 cm2, un no t atbr voj mg oksibutin na 24 stund s.
Transdermal patch.
Transderm lie pl ksteri.
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with unstable bladder
Prepar ts paredz ts simptom tiskai imperat v s ur na nesatur šanas un/ vai palielin ta urin cijas biežuma un neatliekam bas pastiprin šan s rst šanai ur np š a disfunkcijas gad jumos.
The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.
Pl ksteri uzreiz p c iepakojuma no emšanas piestiprina sausai veselai dai uz v dera, augšstilba vai s žamvietas.
A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
Katru reizi nepieciešams izv l ties jaunu piestiprin šanas vietu, turpm ko septi u dienu laik izvairoties no atk rtotas pl kstera piestiprin šanas iepriekš j viet.
The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
(reizi 3 l dz 4 dien s).
No studies have been performed in children or adolescents, therefore Kentera is not recommended for use in children or adolescents.
T k nav p t jumu datu attiec b uz b rniem un pusaudžiem, Kentera b rniem un pusaudžiem lietot neiesaka.
Hypersensitivity to the active substance or to any other excipients of the transdermal patch.
Paaugstin ta jut ba pret transderm lo pl ksteru akt vo vielu un/ vai jebkuru no pal gviel m.
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.
Oksibutin ns ir kontrindic ts pacientiem ar ur na aizturi, smag m ku a un zarnu trakta patolo ij m, miastenia gravis vai sl gta kakta glaukomu, k ar pacientiem, kam ir šo slim bu risks.
4.4 Special warnings and special precautions for use
4. 4 paši br din jumi un piesardz ba lietošan
Kentera should be used with caution in patients with hepatic or renal impairment.
Kentera pacientiem ar pav jin t m aknu un nieru funkcij m j lieto ar piesardz bu.
The use of Kentera in patients with hepatic impairment should be carefully monitored.
Pacientiem ar aknu funkciju trauc jumiem, lietojot Kentera, ir r p gi j kontrol aknu funkcijas.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
Pirms Kentera noz m šanas nepieciešams izsl gt citus biežas urin cijas c lo us (sirds mazsp ju vai nieru saslimšanas).
If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Ur nce u infekcijas gad jum nepieciešama antibiotiku terapija.
Antichloinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Ur na aizture: pacientiem ar izteiktiem ur np š a iztukšošan s trauc jumiem antihol ner iskie prepar ti j ordin piesardz gi, jo ir ur na aiztures rašan s risks.
Because anticholinergic agents such as oxybutynin may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution.
T k antihol ner iskie prepar ti, k oksibutin ns, var izrais t miegain bu un redzes pav jin šanos, pacientiem j iesaka iev rot piesardz bu.
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
Pacientus nepieciešams inform t, ka alkohols var pastiprin t miegain bu, ko izraisa antihol ner iskie prepar ti, piem ram, oksibutin ns.
2 Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics..
2 Kentera paši piesardz gi j ordin vec ka gadag juma pacientiem, jo š du pacientu jut ba pret centr las iedarb bas antihol ner iskajiem prepar tiem var b t pastiprin ta un farmakokin tika - atš ir ga.
Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
Peror las oksibutin na ievad šanas rezult t var att st ties sekojoši trauc jumi, ta u š s par d bas netika nov rotas kl niskajos p t jumos ar Kentera:
Also in conditions such as ulcerative colitis, and intestinal atony.
Ku a – zarnu trakta darb bas trauc jumi: antihol ner iskie prepar ti var pav jin t ku a un zarnu peristaltiku, radot gremošanas trakta st zes att st bas risku, t d prepar ts pacientiem ar obstrukt v m gremošanas trakta slim b m, k ar laino kol tu un zarnu atoniju j lieto piesardz gi.
Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/ gastro-oesophageal reflux and/ or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
Antihol ner iskie prepar ti piesardz gi j lieto pacientiem ar bar bas vada diafragmas atveres tr ci / gastroezofage lu refluksu un/ vai pacientiem, kuri past v gi lieto prepar tus (piem ram, bifosfon tus), kas var izrais t vai paasin t ezofag tu.
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease
Antihol ner iskos prepar tus piesardz gi j lieto pacientiem ar autonomo neirop tiju, kognit vajiem trauc jumiem vai Parkinsona slim bu.
Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.
Pacientus nepieciešams inform t, ka, lietojot oksibutin nu un citus antihol ner iskos prepar tus vid, kur ir paaugstin ta gaisa temperat ra, sv šanas pav jin šan s d var rasties termoregul cijas trauc jumi (paaugstin ta temperat ra un karstuma d riens).
Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Oksibutin ns var paasin t hipertireo disma, koron r s sirds slim bas, sastr guma sirds mazsp jas, sirds aritmiju, tahikardijas, hipertensijas un priekšdiedzera hipertrofijas simptomus.
Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
Oksibutin ns var izrais t siekalu sekr cijas pav jin šanos, k rezult t var att st ties zobu kariess, parodontoze vai mutes kandidoze.
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
Lietojot oksibutin nu vienlaic gi ar citiem antihol ner iskajiem medikamentiem vai prepar tiem, kas konkur uz CYP3A4 metabolismu, var pastiprin ties t du simptomu, k sausuma saj ta mut, aizciet jums un miegain ba, rašan s biežums un smaguma pak pe.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Sakar ar to, ka antihol ner iskie prepar ti pav jina gremošanas trakta peristaltiku, var pav jin ties citu vienlaic gi lietotu prepar tu absorbcija.
As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with drugs that inhibit this isoenzyme cannot be ruled out.
T k oksibutin ns metaboliz jas ar citohroma P 450 izoenz ma CYP 3A4 pal dz bu, var rasties mijiedarb ba ar medikamentiem, kas inhib šo izoenz mu.
This should be borne in mind when using azole antifungals (e. g. ketoconasole) or macrolide antibiotics (e. g. erythromycin) concurrently with oxybutynin.
Tas j em v r, ja vienlaic gi ar oksibutin nu pacientam tiek noz m ti prets u prepar ti (piem., ketokonazols) vai makrol du antibiotikas (piem., eritromic ns).
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e. g. biperiden, levodopa), antihistamines, antipsychotics (e. g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinc antispasmodics, dipyridamole.
Oksibutin nu antihol ner isk aktivit te pastiprin s, lietojot to vienlaikus ar citiem antihol ner iskajiem prepar tiem vai prepar tiem, kuriem piem t antihol ner isk aktivit te, k amantad ns un citi antihol ner iskie pretparkinsonisma prepar ti (piem., biperid ns, levodopa), antihistam na prepar tiem, antipsihotiskajiem l dzek iem (piem., fenotiaz niem, butirofenoniem, klozap nu), hinid nu, tricikliskajiem antidepresantiem, atrop nu un tam radniec gaj m kombin cij m, k atrop nu saturošajiem spazmol tiskajiem prepar tiem, dipiridamolu.
Oxybutynin may antagonize prokinetic therapies.
Oksibutin ns var darboties k prokin tisko prepar tu antagonists.
Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women.
Gr tniec ba Pašreiz nav pietiekamu datu par oksibutin na transderm lo pl ksteru iedarb bu gr tniec m.
Kentera should not to be used during pregnancy unless clearly necessary
P t jumos ar dz vniekiem ir konstat ta neliela toksiska ietekme uz reprodukt vo funkciju (skat. p.
3 Lactation When oxybutynin is used during lactation, a small amount is excreted in the mother’ s milk.
5. 3.).
Breast feeding while using oxybutynin is therefore not recommended.
Kentera nedr kst lietot gr tniec bas laik, ja vien tas nav noteikti nepieciešams.
4.7 Effects on ability to drive and use machines
T d, lietojot oksibutin nu, neiesaka z d t b rnu.
Oxybutynin may cause drowsiness, blurred vision, dizziness and fatigue, therefore caution is recommended when driving or operating machines.
Oksibutin ns var izrais t miegain bu, redzes pav jin šanos, reiboni un nogurumu, t d rst šanas kursa laik transportl dzk u vad šana un meh nismu apkalpošana j veic ar piesardz bu.
The most commonly reported adverse drug reactions were application site reaction (Kentera 23.1%, placebo 7.6%).
Zi ojumos visbiež k min t s blakuspar d bas bija lok la das reakcijas pl kstera piestiprin šanas viet (Kentera 23. 1%, placebo 7. 6%).
Other adverse drug reactions reported were dry mouth (Kentera 8.6%, placebo 5.2%), constipation (Kentera 3.9%, placebo 2%), diarrhea (Kentera 3.2%, placebo 2%), headache (Kentera 3.0%, placebo 2.4%), dizziness (Kentera 2.3%, placebo 1.2%), and blurred vision (Kentera 2.3%, placebo 0.89%).
Citas zi ojumos min t s blakuspar d bas bija sausuma saj ta mut (Kentera 8. 6%, placebo 5. 2%), aizciet jumi (Kentera 3. 9%, placebo 2%), caureja (Kentera 3. 2%, placebo 2%), galvass pes (Kentera 3. 0%, placebo 2. 4%), reibonis (Kentera 2. 3%, placebo 1. 2%) un redzes trauc jumi (Kentera 2. 3%, placebo 0. 89%).
Undesirable effects known to be associated with anticholinergic therapy, but not observed with Kentera during clinical studies are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucinations, photosensitivity, erectile dysfunction.
Nev lam s blakuspar d bas, kas saist tas ar antihol ner isko prepar tu lietošanu, bet netika nov rotas kl niskajos p t jumos ar Kentera, ir apet tes zudums, vemšana, refluksa ezofag ts, sv šanas pav jin šan s, karstuma d riens, asaru izdal šan s samazin šan s, sašaurin tas acu z l tes, tahikardija, aritmijas, dezorient cija, izteikta koncentr šan s sp ju pav jin šan s, nogurums, murgi, nemiers, krampji, intraokul ra hipertensija un glaukomas att st ba, apjukums, trauksmes saj ta, paranoja, halucin cijas, paaugstin ta jut ba uz gaismu un erekt l disfunkcija.
Reported Adverse Drug Reactions and rate of occurrence:
Zi ojumos min t s blakuspar d bas un to sastopam bas biežums:
Application site reactions
- nieze piestiprin šanas viet
All application site reactions -Application site pruritis -Application site erythema -Application site reaction -Application site rash
- erit ma piestiprin šanas viet
23.1% 14.3% 5.7% 3.5% 3.0%
- reakcija piestiprin šanas viet
Very common very common common common common
- izsitumi piestiprin šanas viet
Urinary Tract Upper Respiratory Tract Fungal Eye disorders
- ur nizvadce u - augš jo elpce u - s u
common uncommon uncommon
Bieži Ret k Ret k
Vision abnormalities Ear and labyrinth disorders
Acu slim bas Redzes trauc jumi Ausu un labirinta boj jumi
Dizziness Cardiac Disorders
Reibonis Sirds funkcijas trauc jumi
Palpitations Vascular disorders
Sirdsklauves Asinsvadu sist mas trauc jumi
uncommon
Ret k
Hot flushes Urticaria Gastrointestinal disorders
Piesarkums N trene Ku a- zarnu trakta trauc jumi
uncommon uncommon
Ret k Ret k
Dry Mouth Constipation Diarrhea Nausea Abdominal Pain Dyspepsia Abdominal Discomfort Musculoskeletal disorders
Sausuma saj ta mut Aizciet jumi Caureja Slikta d ša S pes v der Dispepsija Diskomforta saj ta v der
8.6% 3.9% 3.2% 2.1% 1.2% 0.4% 0.5%
8. 6% 3. 9% 1. 2% 2. 1% 1. 2% 0. 4% 0. 5%
common common common common common uncommon uncommon
Bieži Bieži Bieži Bieži Bieži Ret k Ret k
Back Pain
0. 8%
0.8%
Ret k
uncommon
Ret k Ret k
Urinary retention Dysuria General disorders
Galvass pes Miegain ba Rin ts Ievainojumi
uncommon uncommon
Bieži Bieži Ret k
Inflicted Injury
das ievainojumi
Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s).
Plazmas oksibutin na koncentr cija samazin s 1 – 2 stundu laik p c transderm l pl kstera (- u) no emšanas.
Patients should be monitored until symptoms resolve.
Pacientus nepieciešams nov rot, l dz simptomi izz d.
Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.
Oksibutin na p rdoz šana ir saist ta ar antihol ner isko ietekmi, t. sk., CNS uzbudin jumu, piesarkumu, drebu iem, dehidrat ciju, sirds aritmij m, vemšanu un ur na aizturi.
Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine.
Tika zi ots par 100 mg oksibutin na peror lu lietošanu vienlaic gi ar alkoholu 13 gadus vecam z nam, kam nov roja atmi as zudumu, un 34 gadus vecai sievietei, kurai att st j s stupors ar sekojošu dezorient ciju un uzbudin jumu pamostoties, paplašin t m acu z l t m, das sausumu, sirds aritmiju un ur na aizturi.
Both patients recovered fully with symptomatic treatment.
Abi pacienti p c simptom tiskas terapijas piln b izvese oj s.
No cases of overdose have been reported with Kentera.
Nav zi ots par p rdoz šanas gad jumiem, lietojot Kentera.
Pharmacotherapeutic group: urinary antispasmodic, ATC code:
Farmakoterapeitisk grupa: ur nce u spazmol tiskais prepar ts, AT kods:
Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Darb bas meh nisms: oksibutin ns darbojas k konkur jošs acetilhol na antagonists uz postgangliju muskar na receptoriem, k rezult t rodas ur np š a glud s muskulat ras atsl bums.
Pharmacodynamic effects:
Farmakodinamisk ietekme:
In patients with overactive bladder, characterised by detrusor muscle instability or hyperreflexia, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Pacientiem ar hiperakt vu ur np sli, ko raksturo ur np š a atsl bin t jmusku a nestabilit te vai hiperrefleksija, cistometrijas p t jumos tika pier d ts, ka oksibutin ns paaugstina ur np š a maksim lo tilpumu un palielina tilpumu l dz pirmajai atsl bin t jmusku a kontrakcijai.
Oxybutynin thus decreases urinary urgency and the frequency of both incontinence episodes and voluntary urination.
T d j di oksibutin ns mazina urin cijas neatliekam bu, k ar samazina gan ur na nesatur šanas epizožu, gan patva gas urin cijas biežumu.
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Oksibutin ns ir racemiskais (50: 50) D - un S - izom ru mais jums.
Antimuscarinic activity resides predominantly in the R-isomer.
Antimuskar na aktivit te piem t galvenok rt prepar ta D - izom ram.
The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).
Oksibutin na D- izom ram piem t augsta selektivit te pret M1 un M3 muskar na apakštipiem (p rsvar ur np š a atsl bin t jmuskul un pieauss siekalu dziedzer), sal dzinot ar M2 apakštipu (p rsvar sird).
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.
Akt vajam metabol tam, N- dezetiloksibutin nam, piem t oksibutin na aktivit tei in vitro p t jumos l dz ga farmakolo isk aktivit te uz cilv ka ur np š a atsl bin t jmuskuli, ta u N- dezetiloksibutin nam, sal dzinot ar oksibutin nu, ir liel ka saistoš afinit te attiec b uz pieauss siekalu dziedzera audiem.
The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride.
Oksibutin na br v pamatforma ir farmakolo iski ekvivalenta oksibutin na hidrohlor dam.
Clinical efficacy:
Kl nisk efektivit te:
A total of 957 patients with urge urinary incontinence were evaluated in three controlled studies comparing Kentera to either placebo, oral oxybutynin and/ or tolterodine long acting capsules.
Trijos kontrol tos p t jumos Kentera sal dzin šanai ar placebo, peror lo oksibutin nu un/ vai ilgas darb bas tolterod na kapsul m tika iesaist ti 957 pacienti ar imperat vo ur na nesatur šanu.
Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume were evaluated.
Tika nov rt tas ikned as ur na nesatur šanas epizožu, urin šanas biežuma samazin šan s un atlieku ur na l menis.
Kentera led to consistent improvements in overactive bladder symptoms compared with placebo.
Kentera terapijas rezult t, sal dzinot ar placebo, hiperakt va ur np š a simptomu izpausmes samazin j s.
5 5.2 Pharmacokinetic Properties
5 5. 2 Farmakokin tisk s paš bas
Absorption Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Absorbcija Kentera saturoš oksibutin na koncentr cija ir pietiekama, lai nodrošin tu past v gu transportu, ievadot prepar tu reizi 3- 4 dien s.
Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum.
Oksibutin ns tiek transport ts caur veselu du un asinsrit iek st pas v s dif zijas ce caur das raga sl ni.
Following the application of Kentera, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4ng/ ml.
P c Kentera ievad šanas oksibutin na koncentr cija asins plazm pieaug uz aptuveni 24- 48 stund m, sasniedzot maksim lo vid jo prepar ta koncentr ciju 3- 4 ng/ ml.
Thereafter, steady concentrations are maintained for up to 96 hours.
Stabila prepar ta koncentr cija tiek sasniegta p c otr s pl kstera piestiprin šanas reizes, un prepar ta l menis saglab jas stabils l dz 96 stund m.
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.
Oksibutin na un akt v metabol ta AUC un maksim l s koncentr cijas plazm atš ir bas atkar b no to ievad šanas vietas - v dera, g žas, vai s žamvietas ir kl niski nenoz m gas.
Distribution Oxybutynin is widely distributed in body tissues following systemic absorption.
Sadale Oksibutin na sadale organism notiek sist mas absorbcijas ce.
The volume of distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin hydrochloride.
Sadal juma l menis tiek nov rt ts k 193 l p c intravenozas 5 mg oksibutin na hidrohlor da ievad šanas.
Metabolism Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall.
Metabolisms Peror li uz emtais oksibutin ns s kotn ji tiek metaboliz ts ar citohroma P 450 enz ma sist mu pal dz bu, paši CYP3A4, kas sastopams galvenok rt akn s un zarnu sien.
Metabolites include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, which is pharmacologically active.
Metabol tu sast v ietilpst farmakolo iski neakt v fenilcikloheksiglikolsk be un N- dezetiloksibutin ns, kas ir farmakolo iski akt vs.
Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
Transderm las oksibutin na ievad šanas rezult t tiek apiets ce š caur gremošanas traktu un akn m, t d j di samazinot N- dezetiloksibutin na metabol ta veidošanos.
Excretion Oxybutynin is extensively metabolised by the liver, see above with less than 0.1% of the administered dose excreted unchanged in the urine.
Izdal šan s Oksibutin ns intens vi tiek metaboliz ts akn s, maz k k 0. 1% no ievad t s devas tiek izdal ts ar ur nu neizmain t veid.
Also, less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
Turkl t, maz k k 0. 1% no ievad t s devas tiek izdal ta k metabol ts N - dezetiloksibutin ns.
5.3 Preclinical Safety Data
5. 3 Prekl niskie dati par droš bu
Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity.
Prekl niskajos standartp t jumos ieg tie dati par farmakolo isko droš bu, ak tu toksicit ti, atk rtotu devu toksicit ti, genotoksicit ti, iesp jamu kancerogenit ti un lok lu toksicit ti neliecina par pašu risku cilv kam.
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.
Subkut ni ievad tam oksibutin nam dev 0. 4 mg/ kg/ dien, org nu anom liju att st bas biežums iev rojami pieauga, ta u tika nov rots tikai m tes toksicit tes gad jumos.
Kentera delivers approximately 0.08 mg/ kg/ day.
Prepar ta deva, ko atbr vo Kentera, ir apm ram 0. 08 mg/ kg/ dien.
However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Tom r, t k tr kst pier d jumu par saist bu starp m tes toksicit ti un iedzimt m aug a att st bas anom lij m, prepar ta ietekme uz cilv ka droš bu nav skaidra.
In the subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was impaired and a NOAEL (no observed adverse effect level) of 5 mg/ kg was identified.
Subkut nos fertilit tes p t jumos ar žurk m netika nedz konstat ta ietekme uz m t t m un t vi iem, nedz augl bu, un tika konstat ts, ka deva, kas neizraisa nek das blakuspar d bas, bija 5 mg/ kg.
6 PHARMACEUTICAL PARTICULARS
FARMACEITISK INFORM CIJA
6.1 List of Excipients
6. 1 Pal gvielu saraksts
The transdermal patch is composed of three layers: a backing film, an adhesive/ drug layer and a release liner.
Transderm lie pl ksteri sast v no trim k rt m: pl ves, adhez v s substances/ prepar ta k rti as un nopl šam s da as.
The adhesive/ drug layer contains oxybutynin and triacetin.
Pl ve kalpo par pl kstera pamatu, nosl dzot to un nodrošinot t veselumu un aizsarg adhez v s substances / prepar ta k rti u, kas satur oksibutin nu un triacet ns.
The release liner is two overlapped siliconised polyester strips that are peeled off and discarded by the patient prior to applying the patch.
Nopl šam da a ir divas silikoniz tas poli stera str meles, ko pirms pl kstera piestiprin šanas nepieciešams nopl st un izmest.
Backing Film:
Pamata pl ve:
Polyethylene/ ethyl vinyl acetate (PET/ EVA), clear
Polietil na/ etilvinila acet ts, caursp d gs
6 Middle layer:
6 Vid j k rta triacet ns
Triacetin Acrylic Copolymer Adhesive Solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains
Akrila kopolim ra adhez vais š dums, kas satur 2- etilheksilakril ta N- vinilpirolidonu un heksametil nglikola dimetilakril tpolim ra dom nus
Siliconised Polyester
Nopl šam da a Silikoniz ts poli steris
Store in the original package.
Uzglab t ori in l iepakojum.
Do not refrigerate.
Neatdzes t.
The transdermal patches are individually contained in LDPE/ paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
Transderm lie pl ksteri tiek individu li iepakoti LDPE/ pap ra lamin ta iepakojum un safas ti kast s ar pacienta kalend ru, pa 2, 8 vai 24 pl ksteriem katr.
6.6 Instructions for use and handling
6. 6 Nor d jumi par sagatavošanu lietošanai un izn cin šanu.
Apply immediately upon removal from the protective sachet.
Pl ksteris j piestiprina t l t p c iz emšanas no tieš iepakojuma.
After use the patch still contains substantial quantities of active ingredients.
P c pl kstera izlietošanas tas v l satur noteiktu akt v s sast vda as daudzumu.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
Atlikus akt v sast vda a var rad t kait gu ietekmi, non kot dens vid.
Hence, after removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of reach of children.
T d p c no emšanas izlietotais pl ksteris j p rloka uz pus m ar lip go pusi uz iekšu, lai prepar ta k rta nekontakt tu ar r jo vidi, j ievieto ori in laj tiešaj iepakojum un j izmet viet, kur nevar piek t b rni.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
Visi izlietotie vai neizlietotie pl ksteri ir j izn cina atbilstoši viet j m pras b m vai j atgriež aptiek.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Izlietotos pl ksterus nedr kst mest tualet un š idraj s atkritumu izn cin šanas sist m s.
Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Visas darb bas, k rezult t var rasties p rm r ga sv šana, samirkšana vai atrašan s p r k augst temperat r, var ietekm t pl kstera pielipšanas sp ju.
Do not expose the patch to the sun.
Nepieciešams izvair ties no tiešas saules iedarb bas uz pl ksteri.
Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3RP
Nicobrand Limited 189 Castleroe Road Coleraine rija BT51 3RP
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
RAŽOŠANAS LICENCES PAŠNIEKS, KURŠ ATBILD PAR S RIJAS IZLAIDI
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A RAŽOŠANAS LICENCES PAŠNIEKS, KURŠ ATBILD PAR S RIJAS IZLAIDI
Name and address of the manufacturer responsible for batch release
Ražot ja, kas atbild par s rijas izlaidi, nosaukums un adrese
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP Northern Ireland
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP Zieme rija
B CONDITIONS OF THE MARKETING AUTHORISATION
B RE ISTR CIJAS APLIEC BAS NOSAC JUMI
• OTHER CONDITIONS
• CITI NOSAC JUMI
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Š s re istr cijas apliec bas pašniekam ir j inform Eiropas Komisija par marketinga pl niem saist b ar z l m, kas autoriz tas ar šo l mumu.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
12 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA VAI, JA R J IEPAKOJUMA NAV, UZ TIEŠ IEPAKOJUMA
CARTON (Containing 8 transdermal patches)
KARTONA K RBA (Satur 8 transderm los pl ksterus)
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
Kentera 3. 9 mg / 24 stundas transderm lie pl ksteri Oxybutynin
STATEMENT OF ACTIVE SUBSTANCE(S)
AKT V S( O) VIELAS( U) NOSAUKUMS( I) UN DAUDZUMS( I)
Each patch contains 36 mg oxybutynin.
Katrs pl ksteris satur 36 mg oksibutin na.
The area of the patch is 39 cm2 releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Pl kstera laukums ir 39 cm2, un no t atbr vojas 3. 9 mg oksibutin na 24 stund s.
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate; N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
Pal gvielas: triacet ns, akrila adhez vs (satur 2- etilheksilakril tu; N- vinilpirolidonu un heksametil nglikola dimetakril ta polim ra dom nus).
Backing: polyester/ ethylene-vinyl acetate film; siliconised polyester film.
Pamatsl nis: poli stera/ etil na- vinila acet ta pl ve; nopl šam da a - silikoniz ta poli stera pl ve.
8 transdermal patches
8
METHOD AND ROUTE(S) OF ADMINISTRATION
LIETOŠANAS METODE UN IEVAD ŠANAS VEIDS
Do not use if seal on sachet is broken
Paredz ti tikai transderm lai lietošanai Nelietot, ja tiešais iepakojums ir boj ts.
Apply immediately upon removal from sachet.
Piestiprin t t l t p c iz emšanas no tieš iepakojuma.
Read the package leaflet before use.
Pirms lietošanas iepaz stieties ar instrukciju.
Keep out of the reach and sight of children.
Uzglab t b rniem nepieejam un neredzam viet.
Date :< MM/YYYY >
Der gs l dz {MM/ GGGG}
Store in original package.
Uzglab t ori in l iepakojum.
MARKETING AUTHORISATION NUMBER (S)
RE ISTR CIJAS NUMURS( I)
MANUFACTURER’ S BATCH NUMBER
RAŽOŠANAS S RIJAS NUMURS
Batch No. :< >
S rija {numurs}
Sun/ Wed Mon/ Thu Tue/ Fri Wed/ Sat Thu/ Sun Fri/ Mon Sat/ Tue
Sv tdiena/ trešdiena Pirmdiena/ ceturtdiena Otrdiena/ piektdiena Trešdiena/ sestdiena Ceturtdiena/ sv tdiena Piektdiena/ pirmdiena Sestdiena/ otrdiena
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
14 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA VAI, JA R J IEPAKOJUMA NAV, UZ TIEŠ IEPAKOJUMA
CARTON (Containing 24 transdermal patches)
KARTONA K RBA (Satur 24 transderm los pl ksterus)
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
Pal gvielas: triacet ns, akrila adhez vs (satur 2- etilheksilakril tu; N- vinilpirolidonu un heksametil nglikola dimetakril ta polim ra dom nus).
24 transdermal patches
24 transderm lie pl ksteri
For transdermal use only Do not use if seal on sachet is broken.
Paredz ti tikai transderm lai lietošanai Nelietot, ja iepakojums ir boj ts.
Read package leaflet before use.
Pirms lietošanas iepaz stieties ar instrukciju.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
16 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA VAI, JA R J IEPAKOJUMA NAV, UZ TIEŠ IEPAKOJUMA
CARTON (Containing 2 transdermal patches)
KARTONA K RBA (Satur 2 transderm los pl ksterus)
2 transdermal patches
2 transderm lie pl ksteri
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 MINIM L INFORM CIJA IZVIETOJAMA UZ MAZA IZM RA TIEŠ IEPAKOJUM
SACHET (Contains 1 transdermal patch)
(satur vienu transderm lo pl ksteri)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
U NOSAUKUMS UN IEVAD ŠANAS VEIDS
For transdermal use only
Paredz ti tikai transderm lai lietošanai
Date :< MM/YYYY >
Der gs l dz
Batch No. :< >
S rija
Contains 1 transdermal patch.
Satur 1 transderm lo pl ksteri
20 PACKAGE LEAFLET
20 LIETOŠANAS INSTRUKCIJA
Read all of this leaflet carefully before you start using Kentera
Pirms z u lietošanas uzman gi izlasiet visu instrukciju.
- Keep this leaflet.
- Saglab jiet šo instrukciju!
You may need to read it again.
Iesp jams, ka v l k to vajadz s p rlas t.
- If you have further questions, please ask your doctor or your pharmacist.
- Ja Jums rodas v l k di jaut jumi, vaic jiet rstam vai farmaceitam.
- This medicine has been prescribed for you personally and you should not pass it on to others.
- Š s z les ir parakst tas tieši Jums, un t s nedr kst dot citiem.
It may
T s var nodar t aunumu pat tad, ja
harm them even if their symptoms are the same as yours.
šiem cilv kiem ir l dz gi simptomi.
In this leaflet:
Pirms Kentera lietošanas 3.
1. What Kentera is and what it is used for 2. Before you use Kentera 3. How to use Kentera 4. Possible side effects 5. Storing Kentera 6.
Iesp jam s blakuspar d bas 5 Kentera uzglab šana 6.
Further Information
S k ka inform cija
Kentera 3.9 mg / 24 h transdermal patch
Kentera 3. 9 mg / 24 h, transderm lie pl ksteri
The active substance is oxybutynin.
Akt v viela ir oksibutin ns (Oxybutynin).
Each transdermal patch contains 36 mg of oxybutynin.
Katrs transderm lais pl ksteris satur 36 mg oksibutin na.
The other ingredients are triacetin, acrylic adhesive solution (containing 2-ethylhexyl acrylate, N- vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains), clear backing film of polyester/ ethylene vinyl acetate (PET/ EVA), and siliconised polyester release liner (PET).
P r j s sast vda as ir triacet ns, akrila adhez vais š dums (satur 2- etilheksilakril tu; N- vinilpirolidonu un heksametil nglikola dimetakril ta polim ra dom nus), caursp d ga poli stera/ etil na- vinila acet ta (PET/ EVA) pl ve un silikoniz tas poli stera (PET) nopl šam s sloksnes.
Marketing Authorisation Holder and Manufacturer:
Re istr cijas apliec bas pašnieks un ražot js
WHAT KENTERA IS AND WHAT IT IS USED FOR
KAS IR KENTERA UN K DAM NOL KAM TO LIETO 1.
Kentera is a thin, flexible, translucent transdermal patch that you apply to your skin.
Kentera ir pl ns, elast gs, caursp d gs, pie das piestiprin ms transderm lais pl ksteris.
Oxybutynin, the active substance in the patch, is dissolved in the thin layer of adhesive, which is used to stick the patch to your skin.
Pl kstera akt v viela, oksibutin ns, tiek izš din ts pl n lip ga materi la sl n, ko izmanto, lai piestiprin tu pl ksteri pie das.
Each pack contains either 2, 8 or 24 patches.
Katrs iepakojums satur 2, 8 vai 24 pl ksterus.
Kentera controls the symptoms of urge incontinence and/ or increased urinary frequency and urgency.
Kentera rst imperat vas ur na nesatur šanas un/ vai palielin ta urin cijas biežuma un neatliekam bas pastiprin šan s simptomus.
2.
PIRMS KENTERA LIETOŠANAS 2.
BEFORE YOU USE KENTERA
Nelietojiet KENTERA š dos gad jumos:
Do not use Kentera:
ja Jums ir paaugstin ta jut ba (aler ija) pret oksibutin nu vai k du citu Kentera sast vda u.
If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
Ja Jums ir aler ija pret medic nisko pl ksteri vai citiem transderm lajiem pl ksteriem, konsult jieties pie sava rsta.
If you have allergies to medical tape or other transdermal patches, consult your doctor before using Kentera.
Ja Jums urin jot ur np slis iztukšojas nepiln gi, oksibutin na lietošana to var pastiprin t.
If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem.
Š d gad jum pirms Kentera lietošanas konsult jieties pie sava rsta.
You should discuss this problem with your doctor before using Kentera.
Ja Jums ir gremošanas probl mas, ko izraisa pal nin ta ku a iztukšošan s p c šanas, pirms pirms Kentera lietošanas konsult jieties pie sava rsta.
21 If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
21 Inform jiet savu rstu, ja Jums ir glaukoma vai k ds no J su imenes locek iem ir slimojis ar glaukomu.
If you have glaucoma or a family history of glaucoma, tell your doctor.
paša piesardz ba, lietojot Kentera, nepieciešama š dos gad jumos:
Take special care with Kentera:
- Ja Jums ir:
If you have any of the following: • Liver disease • Kidney disease • Bladder obstruction • Gastrointestinal obstruction • Ulcerative colitis • Generalized muscle weakness • Inflammation of the oesophagus
• aknu slim bas • nieru slim bas • ur np š a iztukšošan s trauc jumi • ku a- zarnu trakta nosprostojums • lainais kol ts • visp r js musku u v jums • bar bas vada iekaisums
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.
T k oksibutin na lietošana var izrais t sv šanas pav jin šanos, uzturoties vid, kur ir karsti, past v paaugstin tas temperat ras un karstuma d riena rašan s risks.
Kentera is not recommended for use in children or adolescents.
Kentera neiesaka lietot b rniem un pusaudžiem.
Kentera with food and drink:
Kentera lietošana kop ar p rtiku un dz rieniem:
Oxybutynin may cause drowsiness or blurred vision.
Oksibutin ns var izrais t miegain bu vai redzes trauc jumus.
Drowsiness may be increased by consumption of alcohol.
Miegain ba var pastiprin ties alkohola ietekm.
Pregnancy
Gr tniec ba
Ask your doctor for advice before taking any medicine.
Pirms jebkuru z u lietošanas konsult jieties ar rstu vai farmaceitu.
Kentera should not to be used during pregnancy unless clearly necessary
Kentera gr tniec m vajadz tu lietot tikai rk rtas nepieciešam bas gad jum.
Lactation
Z d šanas periods
Ask your doctor for advice before taking any medicine
Pirms jebkuru z u lietošanas konsult jieties ar rstu vai farmaceitu.
It is not known whether oxybutynin is excreted in human milk.
Nav zin ms, vai oksibutin ns nok st m tes pien.
Caution should be exercised when using Kentera when you are breast feeding.
Ja J s barojat b rnu ar kr ti, lietojot Kentera, iev rojiet piesardz bu.
Driving and using machines:
Transportl dzek u vad šana un meh nismu apkalpošana:
Kentera may cause drowsiness or blurred vision, requiring caution when driving or operating machines.
Kentera var izrais t miegain bu un redzes pasliktin šanos, t d, vadot transportl dzekli vai apkalpojot meh nismus, j iev ro piesardz ba.
Taking other medicines:
Citu z u lietošana:
Please inform your doctor or pharmacist if you are taking or have recently taken other medicinal products whether prescribed or not.
Past stiet rstam vai farmaceitam par vis m z l m, kuras p d j laik esat lietojis, ar par t d m, ko izsniedz bez receptes.
HOW TO USE KENTERA
K LIETOT KENTERA 3.
Always take Kentera exactly as your doctor has instructed you.
Vienm r lietojiet Kentera tieši t, k noteicis rsts.
You should check with your doctor or pharmacist if you are unsure.
Neskaidr bu gad jum vaic jiet rstam vai farmaceitam.
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use.
Piestipriniet jaunu Kentera pl ksteri divas reizes ned (reizi 3 - 4 dien s) atbilstoši lietošanas instrukcijai.
Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
Nomainiet pl ksteri katru ned u vien s un tais paš s dien s, piem ram, katru sv tdienu un trešdienu vai pirmdienu un ceturtdienu.
Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule.
Uz Kentera iepakojuma iekš j v ka J s atrad siet kalend ru, kas Jums pal dz s atcer ties, kur s dien s j lieto pl ksteris.
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.
Atz m jiet dienas, kad Jums pl ksteris j nomaina un vienm r atcerieties to nomain t vien s un tais paš s ned as dien s.
Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
Vien reiz lietojiet tikai vienu pl ksteri un neno emiet to l dz n koš pl kstera piestiprin šanai
Where to Apply
22 Kur piestiprin t pl ksteri
Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks.
Piel m jiet pl ksteri sausai v dera, augšstilba vai s žamvietas dai.
Avoid placing the patch in the waistline area to prevent tight clothing from rubbing against the patch.
Nepiestipriniet pl ksteri gurnu rajonam, lai izvair tos no cieša ap rba berz šanos gar to.
Place the patch underneath your clothing.
Izvairieties no tiešas saules iedarb bas uz pl ksteri.
Rotate application sites with each new application.
Piestipriniet pl ksteri zem ap rba un katru reizi mainiet piestiprin šanas vietu.
Do not apply a patch to the same place on your body for at least 1 week.
Nepiestipriniet pl ksteri atk rtoti iepriekš j viet vismaz 1 ned u.
hips
v ders
buttocks
augšstilbs s žamvieta
How to Apply
K piestiprin t pl ksteri
Each patch is individually sealed in a protective sachet.
Katrs pl ksteris ir ievietots atseviš tiešaj iepakojum.
Please read all the information below before you begin to apply Kentera.
L dzu pirms pl kstera piestiprin šanas r p gi izlasiet visu turpm k sniegto inform ciju.
To apply Kentera:
Lai piestiprin tu Kentera:
Step 1:
1. solis: izv lieties pl kstera piestiprin šanas vietu.
Choose a spot for the patch that is:
Tai j b t:
• Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower). • Free of body powder, lotion, and oil. • Free of cuts, rashes or any other skin irritation.
• Tikko nomazg tai, bet sausai un v sai (p c karstas vannas vai dušas nogaidiet dažas min tes). • Uz t s nedr kst b t p deris, kr ms vai e a. • Tai j b t veselai, bez izsitumiem vai citiem das kairin juma simptomiem.
Open the sachet that contains the patch.
Atveriet pl kstera tiešo iepakojumu