qanastek/EMEA-V3 huggingface dataset:
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
Be to, pacientus b tina informuoti, jog alkoholis gali sustiprinti anticholinergini oksibutinino tipo preparat sukeliam mieguistum.
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..
Vyresnio amžiaus žmon s gali b ti jautresni centrinio poveikio anticholinerginiams preparatams, o pa i preparat farmakokinetika j organizme pakitusi, tod l jiems Oxybutynin Nicobran vert t skirti apgalvotai.
Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
Nors per klinikinius Kentera tyrimus žemiau išvardyt sutrikim nepasteb ta, geriamoji oksibutinino forma gali iššaukti tokius simptomus:
Gastrointestinal Disorders:
Virškinimo trakto sutrikimai:
Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Anticholinerginiai medikamentai gali sul tinti virškinamojo trakto motorik, tod l obstrukcini virškinamojo trakto sutrikim turintys pacientai juos tur t vartoti atsargiai, vengiant skrandžio turinio susilaikymo pavojaus.
Also in conditions such as ulcerative colitis, and intestinal atony.
Tas pats pasakytina ir opinio kolito bei žarnyno atonijos atvejais.
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.
Anticholinerginiai medikamentai atsargiai vartotini ir stempl s išvaržos/ skrandžio- stempl s refliukso atvejais bei lygiagreta vartojant medikamentus, galin ius sukelti arba pa minti stempl s uždegim (pvz., bifosfonato tipo preparatus).
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease
Anticholinerginiai medikamentai tur t b ti atsargiai skiriami pacientams, sergantiems autonomine neuropatija, kognityviniais sutrikimais bei Parkinsono liga.
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 privalu informuoti, jog, vartojant anticholinerginius ir ypa oksibutinino tipo medikamentus aukštos aplinkos temperat ros s lygomis, gali atsirasti šilumin prostracija (sumaž jusio prakaitavimo sukeltas karš iavimas ar šiluminis sm gis).
Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Oksibutininas gali pa minti hipertiroidizmo, koronarin s širdies ligos, gimtos širdies ydos, širdies aritmijos, tachikardijos, hipertenzijos ir prostatos hipertrofijos simptomus.
Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
Oksibutininas gali slopinti seili sekrecij ir šitaip sukelti dant karies, parodontoz ar burnos kandidoz.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 S veika su kitomis gydomosiomis medžiagomis bei kitos s veikos formos
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.
Vartojant oksibutinin su kitais anticholinerginiais medikamentais arba su medžiagomis, kuri metabolizme dalyvauja enzimas CYP3A4, gali padid ti ir padažn ti burnos dži vimas, viduri užkiet jimas ir mieguistumas.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Anticholinergini medžiag poveikis virškinamojo trakto motorikai gali pakeisti lygiagreta vartojam vaist sisavinim.
As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with drugs that inhibit this isoenzyme cannot be ruled out.
Oksibutinino metabolizme dalyvauja citochromo P 450 izoenzimas CYP 3A4, tad neatmestina jo s veikos su š izoenzim slopinan iais vaistais galimyb.
This should be borne in mind when using azole antifungals (e. g. ketoconasole) or macrolide antibiotics (e. g. erythromycin) concurrently with oxybutynin.
Tai b tina tur ti omeny, greta oksibutinino skiriant azolo antigrybelinius vaistus (pvz. ketokonazol) arba antibiotikus makrolidus (pvz., eritromicin).
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.
Anticholinerginis oksibutinino aktyvumas padid ja kartu vartojant kitus anticholinerginius vaistus arba medikamentus, kurie veikia anticholinergiškai, kaip amantadinas, kiti anticholinerginiai antiparkinsoniniai vaistai (pvz., biperidenas, levodopa), antihistamininiai, antipsichotiniai (pvz., fenotiazinai, butirofenonai, klozapinas), chinidinai, tricikliniai antidepresantai, atropinas bei atropino linijos preparatai, kaip atropininiai spazmolitikai, dipiridamolis.
Oxybutynin may antagonize prokinetic therapies.
Oksibutininas gali slopinti prokinetišk gydym.
Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women.
N štumas Duomen apie oksibutinino transdermalinio pleistro vartojim n štumo periodu nesukaupta.
Studies in animals have shown minor reproductive toxicity (see section 5.3).
5. 3 skyri).
Kentera should not to be used during pregnancy unless clearly necessary
N štumo metu Kentera tur t b ti vartojamas tik akivaizdžios b tinyb s atveju.
3 Lactation When oxybutynin is used during lactation, a small amount is excreted in the mother’ s milk.
3 Žindymas Vartojant oksibutinin žindymo metu, nedidelis jo kiekis išsiskiria su motinos pienu.
Breast feeding while using oxybutynin is therefore not recommended.
D l šios priežasties, vartojant oksibutinin, nerekomenduojama maitinti kr timi.
Oxybutynin may cause drowsiness, blurred vision, dizziness and fatigue, therefore caution is recommended when driving or operating machines.
Oksibutininas gali sukelti mieguistum, regos sutrikimus (neryškus, miglotas vaizdas), svaigul ir nuovarg, tad vairuojant ir valdant mechanizmus b tinas atsargumas.
The most commonly reported adverse drug reactions were application site reaction (Kentera 23.1%, placebo 7.6%).
Dažniausia šalutin reakcija medikament pasteb ta aplikacijos vietoje (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%).
Iš kit šalutini reakcij vaist pamin tinas burnos dži vimas (Kentera 8, 6%, placebo 5, 2%), viduri užkiet jimas (Kentera 3, 9%, placebo 2%), viduriavimas (Kentera 3, 2%, placebo 2%), galvos skausmai (Kentera 3, 0%, placebo 2, 4%), svaigulys (Kentera 2, 3%, placebo 1, 2%), pablog j s matymas (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.
Per klinikinius Kentera bandymus nepasteb ti, ta iau apskritai anticholinerginiame gydyme žinomi tokie nepageidaujami poveikiai: anoreksija, v mimas, refliuksinis stempl s uždegimas, sumaž j s prakaitavimas, šiluminis sm gis, sumaž j s ašar išsiskyrimas, midriaz, tachikardija, aritmija, orientacijos sutrikimas, sumaž j s sugeb jimas susikaupti, nuovargis, košmarai, nerimas, konvulsijos, padid j s akisp dis, glaukomos požymiai, sumišimas, paranoja, haliucinacijos, jautrumas šviesai, erekcijos sutrikimas.
Reported Adverse Drug Reactions and rate of occurrence:
Pasteb tos neigiamos reakcijos ir j dažnis:
Application site reactions
Reakcijos aplikacijos vietoje
All application site reactions -Application site pruritis -Application site erythema -Application site reaction -Application site rash
Visos reakcijos - Niežulys - Eritema - Reakcija - Išb rimas Infekcijos ir invazijos:
Very common very common common common common
Labai dažnai pasitaikan ios Labai dažnai pasitaikantis Dažnai pasitaikanti Dažnai pasitaikanti Dažnai pasitaikantis
Urinary Tract Upper Respiratory Tract Fungal Eye disorders
Šlapimo trakto Viršutini kv pavimo tak Grybelin s Regos sutrikimai
common uncommon uncommon
Dažnai pasitaiko Nedažnos pasitaiko Retai pasitaiko
Vision abnormalities Ear and labyrinth disorders
Matymo nukrypimai Ausies ir labirinto sutrikimai
common
Dažnai pasitaikantys
Dizziness Cardiac Disorders
Svaigulys Širdies veiklos sutrikimai
common
Dažnai pasitaikantis
Palpitations Vascular disorders
Plakimai Kraujotakos sutrikimai
uncommon
Retai pasitaikantys
Hot flushes Urticaria Gastrointestinal disorders
Karš io pylimai Dilg lin Virškinimo trakto negalavimai
uncommon uncommon
Retai pasitaikantys Retai pasitaikanti
Dry Mouth Constipation Diarrhea Nausea Abdominal Pain Dyspepsia Abdominal Discomfort Musculoskeletal disorders
Burnos dži vimas Viduri užkiet jimas Viduriavimas Pykinimas Pilvo skausmai Dispepsija Diskomfortas pilvo srityje
common common common common common uncommon uncommon
4 Sutrikimai raumen ir atramos sistemoje
Back Pain
Nugaros skausmai
4 Renal and urinary disorders
Šlapimo sistemos ir inkst sutrikimai
Urinary retention Dysuria General disorders
Šlapimo susilaikymas Dizurija Bendri sutrikimai
uncommon uncommon
Retai pasitaikantis Retai pasitaikanti
Headache Somnolence Rhinitis Injury
Galvos skausmai Mieguistumas Rinitas Traumos
common common uncommon
Dažnai pasitaikantys Dažnai pasitaikantis Retai pasitaikantis
Inflicted Injury
Sužalojimas
uncommon
Retai pasitaikantis
Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s).
Oksibutinino koncentracija plazmoje pradeda maž ti po 1- 2 val. nuo transdermalinio pleistro pašalinimo.
Patients should be monitored until symptoms resolve.
Pacient b kl reik t steb ti iki visiško simptom išsisklaidymo.
Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.
CNS sužadinimas, karš io bangos, karš iavimas, dehidracija, širdies aritmija, v mimas ir šlapimo susilakymas.
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.
34 met moter ištiko stuporas, atsigavus sutriko orientacija, vyko nerimo priepuolis, vyzdžiai buvo išsipl t, išdži vo oda, atsirado širdies aritmija bei sutriko šlapinimasis.
Both patients recovered fully with symptomatic treatment.
Abu asmenys po simptominio gydymo visiškai pasveiko.
No cases of overdose have been reported with Kentera.
Apie Kentera perdozavimo atvejus duomen n ra.
Pharmacotherapeutic group: urinary antispasmodic, ATC code:
Farmakoterapin grup - antispazminis preparatas šlapimo sistemai, ATC kodas:
Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Veikimo mechanizmas: oksibutininas veikia kaip konkurencinis acetilcholino antagonistas post - gangliniuose muskarininiuose receptoriuose, atpalaiduodamas lygiuosius šlapimo p sl s raumenis.
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.
Farmakodinaminis poveikis Cistometriniai tyrimai, atlikti pacientams su hiperaktyvia šlapimo p sle, kai ši yda susijusi su raumens detruzoriaus nestabilumu arba hiperrefleksija, parod, kad oksibutininas padidina maksimali šlapimo p sl s talp, taip pat t r iki pirmosios detruzoriaus kontrakcijos.
Oxybutynin thus decreases urinary urgency and the frequency of both incontinence episodes and voluntary urination.
Taip oksibutininas slopina poreik šlapintis bei šlapimo nelaikymo ir valingo šlapinimosi epizod dažn.
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Oksibutininas – tai raceminis R ir S- izomer mišinys (50: 50).
Antimuscarinic activity resides predominantly in the R-isomer.
Antimuskarininiu aktyvumu daugiausia pasižymi R- izomeras.
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).
Oksibutinino R- izomeras atrankesnis M1 ir M3 muskarininiams receptori potipiams – pastarieji vyrauja šlapimo p sl s raumenyje detruzoriuje ir paausin je liaukoje, kai M2 potipis - širdies audiniuose.
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.
Farmakologinis aktyviojo oksibutinino metabolito N- desetiloksibutinino, poveikis žmogaus raumeniui detruzoriui panašus oksibutinino poveik, aptikt in vitro tyrimuose, ta iau jo afinitetas paausin s liaukos audiniams didesnis nei oksibutinino.
The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride.
Laisva bazin oksibutinino forma yra farmakologiškai ekvivalentiška oksibutinino hidrochloridui.
Clinical efficacy:
Klinikinis veiksmingumas:
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.
Trij kontrolini tyrim metu steb ti 957 pacientai su miu šlapimo nelaikymu.
Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume were evaluated.
Vertinta, kaip veikia Kentera, palyginus su placebu, geriam ja oksibutinino forma ir/ arba ilgalaikio poveikio tolterodino kapsul mis.
Kentera led to consistent improvements in overactive bladder symptoms compared with placebo.
Matuotas inkontinencijos epizod skai ius per savait, šlapinimosi dažnumas ir šlapimo
5 5.2 Pharmacokinetic Properties
Palyginus su placebo poveikiu, Kentera sklandžiai šalino hiperaktyvios šlapimo p sl s simptomatik.
Absorption Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Vidutinis koncentracijos maksimumas siekia 3 iki 4 ng/ ml.
Steady-state conditions are reached during the second application of the transdermal patch.
Tolygus poveikis atsiranda sulyg antruoju pleistru.
Thereafter, steady concentrations are maintained for up to 96 hours.
Tuomet nusistov jusi koncentracija išsilaiko iki 96 val..
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.
Oksibutinino ir aktyvaus metabolito n - desetyloksibutinino AUC bei Cmax skirtumai, vartojant Kentera transdermaliniu b du ant pilvo, s dmen ar klub odos, klinikiniu poži riu nereikšmingi.
Distribution Oxybutynin is widely distributed in body tissues following systemic absorption.
Pasiskirstymas Absorbav sis oksibutininas pla iai pasklinda k no audiniuose.
The volume of distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin hydrochloride.
Suleidus ven 5 mg oksibutinino hidrochlorido, pasiskirstymo apimtis vertinta 193 l.
Metabolism Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall.
Metabolizmas vid vartojam oksibutinin pirmiausiai metabolizuoja citochromo P450 enzim sistemos, ypa CYP3A4, kurio daugiausiai kepenyse ir žarn sienel se.
Metabolites include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, which is pharmacologically active.
Jo metabolitai – tai farmakologiškai neaktyvi fenilcikloheksilglikolio r gštis ir farmakologiškai aktyvus N- desetyloksibutininas.
Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
Skiriant oksibutinin transdermališkai, apeinamas pirmasis metabolizmo etapas virškinamajame trakte ir kepenyse, o sykiu maž ja N- desetil metabolito susidarymas.
Excretion Oxybutynin is extensively metabolised by the liver, see above with less than 0.1% of the administered dose excreted unchanged in the urine.
Su šlapimu pašalinama mažiau nei 0. 1% suvartotos doz s neperdirbto oksibutinino.
Also, less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
Dar iki 0. 1% doz s išskiriama metabolito N - desetiloksibutinino forma.
5.3 Preclinical Safety Data
5. 3 Ikiklinikini saugumo tyrim duomenys
Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity.
Ikiklinikiniai vienkartinio toksiškumo, kartotin dozi toksiškumo, genotoksiškumo, kancerogeninio poveikio bei vietinio toksiškumo tyrimai nerod jokio akivaizdaus pavojaus žmogaus sveikatai.
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.
Poodin 0, 4 mg/ kg per par oksibutinino doz žymiai padidina organ anomalijas, ta iau tai atsiskleidžia tik vartojant n štumo s lygomis.
Kentera delivers approximately 0.08 mg/ kg/ day.
Kentera medžiagos išskiria maždaug 0, 08 mg/ kg/ d..
However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Tyrus poodinio preparato vartojimo poveik žiurki vaisingumui, patin li organizme pakitim nerasta, ta iau nustatyta pateli vaisingumo sutrikim.
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.
Tyrim metu nustatytas 5 mg/ kg NOAEL (no observed adverse effect level – maksimali neigiamo poveikio nesukelianti koncentracija) rodiklis.
6 PHARMACEUTICAL PARTICULARS
FARMACIN INFORMACIJA
6.1 List of Excipients
6. 1 Pagalbin s medžiagos
The transdermal patch is composed of three layers: a backing film, an adhesive/ drug layer and a release liner.
Transdermalin pleistr sudaro trys sluoksniai: nešan ioji pl vel, lipnusis/ vaistinis sluoksnis ir apsauginis apvalkalas.
The backing film provides the matrix system with occlusivity and physical integrity and protects the adhesive/ drug layer.
Nešan ioji pl vel uždengia ir saugo lipn j / vaistin sluoksn, kuris ant jos pritvirtintas.
The adhesive/ drug layer contains oxybutynin and triacetin.
Lipniojo/ vaistinio sluoksnio sud tyje yra oksibutinino ir triacetinas.
The release liner is two overlapped siliconised polyester strips that are peeled off and discarded by the patient prior to applying the patch.
Apsauginis apvalkalas - tai dvi viena ant kitos užleistos silikonizuotos poliesterio juostel s, kurias, pacientas nupl šia ir išmeta, o tuomet pleistr užsilipdo.
Backing Film:
Nešan ioji pl v:
Polyethylene/ ethyl vinyl acetate (PET/ EVA), clear
Polietileno/ etilo vinil acetatas (PET/ EVA), skaidrus
6 Middle layer:
6 Vidurinis sluoksnis: triacetinas
Triacetin Acrylic Copolymer Adhesive Solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains
Lipnus akrilo kopolimero tirpalas, kurio sud tyje yra 2- etilheksil akrilato N- vinil pirolidono ir heksametilenglikolio dimetakrilato polimer darini
Release Liner:
Apsauginis sluoksnis:
Siliconised Polyester
Silikonizuotas poliesteris
Not applicable.
N ra.
6.3 Shelf life
6. 3 Vartojimo laikas
6.4 Special precautions for storage
6. 4 Saugojimo s lygos
Store in the original package.
Laikyti originalioje pakuot je.
Do not refrigerate.
Nelaikyti šaltyje.
The transdermal patches are individually contained in LDPE/ paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
Transdermaliniai pleistrai atskirai supakuoti laminuotuose LDPE/ popieriaus maišeliuose, kurie sud ti d žutes su paciento patogumui skirtu kalendoriumi po 2, 8 arba 24 vienetus.
6.6 Instructions for use and handling
6. 6 Vartojimo ir manipuliacijos instrukcija
Apply immediately upon removal from the protective sachet.
Pleistras turi b ti klijuojamas vos tik nupl šus apsaugin apvalkal.
After use the patch still contains substantial quantities of active ingredients.
Panaudotame pleistre išlieka žymus kiekis veikliosios medžiagos.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
Pleistre likusios veikliosios medžiagos, patekusios dr gn aplink arba vanden, gali b ti žalingos.
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.
Tod l panaudot pleistr reikia perlenkti lipni ja puse vid, pasl piant vaistus išskirian i membran, d ti original maišel ir išmesti taip, kad nepasiekt vaikai.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
Ir panaudotus, ir nepanaudotus pleistrus dera likviduoti pagal vietos reikalavimus arba gr žinti vaistin.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Panaudot pleistr negalima mesti unitazus ar nuot k valymo renginius.
Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Fizinis kr vis, sukeliantis gaus prakaitavim, vanduo arba karštis mažina pleistro lipnum, jis gali atsiklijuoti.
Do not expose the patch to the sun.
Negalima pleistro laikyti saul kaitoje.
MARKETING AUTHORISATION HOLDER
PREKYBOS LEIDIMO (REGISTRACIJOS TEISI) SAVININKAS
Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3RP
Nicobrand Limited 189 Castleroe Road Coleraine Šiaur s Airija BT51 3RP
MARKETING AUTHORISATION NUMBER(S)
PREKYBOS LEIDIMO (REGISTRACIJOS TEISI) NUMERIS (- IAI)
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
PIRMOSIOS REGISTRACIJOS/ PERREGISTRACIJOS PRAT SIMO DATA
DATE OF REVISION OF THE TEXT
TEKSTO PERŽI R JIMO DATA
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
LEIDIMO GAMINTI TUR TOJAS, ATSAKINGAS UŽ SERIJOS IŠLEIDIM
CONDITIONS OF THE MARKETING AUTHORISATION
REGISTRAVIMO LIUDIJIMO S LYGOS
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
LEIDIMO GAMINTI TUR TOJAS, ATSAKINGAS UŽ SERIJOS IŠLEIDIM
Name and address of the manufacturer responsible for batch release
Gamintojo, atsakingo už serijos išleidim, pavadinimas ir adresas
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP Northern Ireland
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP Šiaur s Airija
B CONDITIONS OF THE MARKETING AUTHORISATION
REGISTRAVIMO LIUDIJIMO S LYGOS
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
ARTOJIMO S LYGOS AR
• OTHER CONDITIONS
• KITOS S LYGOS
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Šio registravimo liudijimo tur tojas privalo informuoti Europos Komisij apie vaistinio preparato, registruoto šiuo sprendimu, rinkodaros planus.
10 ANNEX III
10 PRIEDAS III
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
12 INFORMACIJA, KURI TURI B TI NURODOMA ANT IŠORIN S PAKUOT S ARBA, JEI TOKIOS N RA, ANT PIRMIN S PAKUOT S SIENEL S
CARTON (Containing 8 transdermal patches)
D ŽUT (8 transdermaliniai pleistrai)
NAME OF THE MEDICINAL PRODUCT
VAISTINIO GAMINIO PAVADINIMAS
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
Kentera 3, 9 mg / 24 val. transdermalinis pleistras Oksibutininas
STATEMENT OF ACTIVE SUBSTANCE(S)
VEIKLIOJI (- OSIOS) MEDŽIAGA (- OS) IR JOS( J) KIEKIS
Each patch contains 36 mg oxybutynin.
Kiekvieno pleistro sud tyje yra 36 mg oksibutinino.
The area of the patch is 39 cm2 releasing a nominal 3.9 mg of oxybutynin per 24 hours.
39 cm2 ploto pleistras per 24 val. nominaliai išskiria 3, 9 mg oksibutinino.
Excipients:
Pagalbin s medžiagos: triacetinas; akrilo klijai (sud tis:
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate; N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
2- etilheksilo akrilatas; N- vinil pirolidonas ir heksametilenglikolio dimetakrilato polimerai).
Backing: polyester/ ethylene-vinyl acetate film; siliconised polyester film.
Pagrindas: poliesterio/ etileno- vinilo acetato pl v; silikonizuota poliesterio pl vel.
PHARMACEUTICAL FORM AND CONTENTS
VAISTO FORMA IR KIEKIS
8 transdermal patches
8 transdermaliniai pleistrai
METHOD AND ROUTE(S) OF ADMINISTRATION
VARTOJIMO B DAS
Do not use if seal on sachet is broken
Tik transdermaliniam vartojimui Nenaudokite, jei pažeistas sandarusis maišelis.
Apply immediately upon removal from sachet.
Pleistras lipdomas vos tik nupl šus apsaugin apvalkal.
Read the package leaflet before use.
Prieš vartojim persiskaitykite informacin lapel.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ATSKIRAS SP JIMAS APIE B TINYB PREPARAT NEMATOMOJE IR NEPRIEINAMOJE VIETOJE
Keep out of the reach and sight of children.
Laikyti vaikams nematomoje ir neprieinamoje vietoje.
OTHER SPECIAL WARNING(S), IF NECESSARY
KITI SPECIAL S SP JIMAI (JEI TAIKYTINA)
EXPIRY DATE
GALIOJIMO LAIKAS
Date :< MM/YYYY >
(metai/ m nuo)
SPECIAL STORAGE CONDITIONS
SAUGOJIMO S LYGOS
Store in original package.
Laikyti originalioje pakuot je.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
SPECIAL S NURODYMAI D L NEPANAUDOT ATLIEK LIKVIDAVIMO (JEI TAIKYTINA)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
PREKYBOS LEIDIMO (REGISTRACIJOS TEISI) SAVININKO PAVADINIMAS IR ADRESAS
MARKETING AUTHORISATION NUMBER (S)
PREKYBOS LEIDIMO (REGISTRACIJOS) NUMERIS (- IAI)
Batch No. :< >
Serijos Nr.:
GENERAL CLASSIFICATION FOR SUPPLY
PLATINIMO TVARKA
Sun/ Wed Mon/ Thu Tue/ Fri Wed/ Sat Thu/ Sun Fri/ Mon Sat/ Tue
Sekm/ Tre Pirm/ Ketv Antr/ Penk Tre / Šešt Ketv/ Sekm Penk/ Pirm Šešt/ Antr
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
14 INFORMACIJA, KURI TURI B TI NURODOMA ANT IŠORIN S PAKUOT S ARBA, JEI N RA IŠORIN S PAKUOT S, ANT PIRMIN S PAKUOT S SIENEL S
CARTON (Containing 24 transdermal patches)
D ŽUT (24 transdermaliniai pleistrai)
STATEMENT OF ACTIVE SUBSTANCE(S)
VEIKLIOSIOS MEDŽIAGOS () APIB DINIMAS
Each patch contains 36 mg oxybutynin.
Kiekvieno pleistro sud tyje yra 36 mg oxibutinino.
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
2- etilheksil akrilatas, N- vinil pirolidonas ir heksametileneglikolio dimetakrilato polimerai).
24 transdermal patches
24 transdermaliniai pleistrai
METHOD AND ROUTE(S) OF ADMINISTRATION
VARTOJIMO B DAI
For transdermal use only Do not use if seal on sachet is broken.
Tik transdermaliniam varojimui Nenaudokite, jei yra pažeistas sandarusis maišelis.
Read package leaflet before use.
Prieš vartojim persiskaitykite informacin lapel.
Keep out of the reach and sight of children.
Vaistus laikyti vaikams neprieinamoje vietoje.
Store in original package.
Laikykite originalioje pakuot je.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
16 INFORMACIJA, KURI TURI B TI NURODOMA ANT IŠORIN S PAKUOT S ARBA, JEI N RA IŠORIN S PAKUOT S, ANT PIRMIN S PAKUOT S SIENEL S
CARTON (Containing 2 transdermal patches)
D ŽUT (2 transdermaliniai pleistrai)
2 transdermal patches
2 transdermaliniai pleistrai
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 MINIMALIOS B TINOS NUORODOS ANT SMULKIAUSIOS MEDIKAMENTO PAKUOT S
SACHET (Contains 1 transdermal patch)
SANDARUSIS MAIŠELIS (1 transdermalinis pleistras)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
VAISTO PAVADINIMAS IR VARTOJIMO B DAI
METHOD OF ADMINISTRATION
VARTOJIMO B DAS
For transdermal use only
Tik transdermaliniam vartojimui
Read the package leaflet before use.
Pleistras lipdomas vos tik nupl šus apsaugin apvalkal Prieš vartojim persiskaitykite pakuot s ind kl.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
TURINIO APRAŠAS PAGAL SVOR, T R ARBA VIENETUS
Contains 1 transdermal patch.
1 transdermalinis pleistras.
PACKAGE LEAFLET
PAKUOT S IND KLAS/ INFORMACINIS LAPELIS
20 PACKAGE LEAFLET
20 INFORMACINIS LAPELIS
Read all of this leaflet carefully before you start using Kentera
Prieš prad dami vartoti Kentera atidžiai persiskaitykite vis informacin lapel.
You may need to read it again.
- Neišmeskite šio lapelio – gali b ti, kad prireiks pasiskaityti dar kart.
- If you have further questions, please ask your doctor or your pharmacist.
- Jei kilt klausim, kreipkit s savo gydytoj ar vaistinink.
It may
- Šis vaistas išrašytas asmeniškai Jums, tod l nedalinkite jo kitiems: jiems jis gali pakenkti, nors
harm them even if their symptoms are the same as yours.
simptai atrodys panaš s j siškius.
In this leaflet:
Šiame lapelyje paaiškinsime:
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.
Kaip naudoti Kentera 4.
Further Information
Kur Kentera laikyti 6.
Kentera 3.9 mg / 24 h transdermal patch
Kentera 3, 9 mg / 24 val. transdermalinis pleistras
The active substance is oxybutynin.
Veiklioji šio preparato medžiaga - oksibutininas.
Each transdermal patch contains 36 mg of oxybutynin.
Kiekviename transdermaliniame pleistre yra 36 mg oksibutinino.
The area of the patch is 39 cm2 releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Pleistro plotas - 39 cm2, per 24 val. jis nominaliai išskiria 3, 9 mg oksibutinino.
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).
2- etilheksilo akrilatas, N- vinilo pirolidono ir heksametilenglikolio dimetakrilato polimerai), permatoma dengian ioji poliesterio/ etileno vinilo acetato (PET/ EVA) pl vel ir vaistin medžiag išskiriantis silikonizuotas poliesterinis sluoksnis (PET).
Marketing Authorisation Holder and Manufacturer:
Prekybos leidimo (registracijos teisi) savininkas ir gamintojas:
WHAT KENTERA IS AND WHAT IT IS USED FOR
KAS YRA KENTERA IR KADA JIS NAUDOJAMAS
Kentera is a thin, flexible, translucent transdermal patch that you apply to your skin.
Kentera – tai plonas, lankstus, pusiau permatomas transdermalinis, ant odos lipdomas pleistras.
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.
Veiklioji pleistro medžiaga oksibutininas ištirpinta ploname pleistr prie odos prilipdan ios lipniosios medžiagos sluoksnyje.
Each pack contains either 2, 8 or 24 patches.
Kiekvienoje pakuot je yra 2, 8 arba 24 pleistrai.
Kentera controls the symptoms of urge incontinence and/ or increased urinary frequency and urgency.
Kentera slopina mios inkontinencijos (šlapimo nelaikymo) simptomus ir/ arba padažn jus šlapinim si ar poreik šlapintis.
BEFORE YOU USE KENTERA
K DARYTI PRIEŠ NAUDOJANT KENTERA
Do not use Kentera:
Kada Kentera vartoti negalima:
If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
Jei esate jautrus (- i) (alergiškas (- a)) oksibutininui ar bet kuriai iš Kentera sudaran i medžiag.
If you have allergies to medical tape or other transdermal patches, consult your doctor before using Kentera.
Jei esate jautrus (- i) (alergiškas (- a)) gydomiesiems ar kitokiems transdermaliniams pleistrams, prieš vartodami Kentera, pasitarkite su gydytoju.
If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem.
21 Jei jau iate, jog šlapinantis p sl ne visiškai ištušt ja, oksibutininas ši b kl gali dar apsunkinti, tad prieš vartojant Kentera b tina pasitarti su gydytoju.
You should discuss this problem with your doctor before using Kentera.
Jei turite virškinimo sistemos sutrikim (pavalgius maistas užsilieka skrandyje), prieš vartojant Kentera irgi b tina pasitarti su gydytoju.
If you have glaucoma or a family history of glaucoma, tell your doctor.
Persp kite gydytoj ir tuomet, jei sergate glaukoma ar ja sirgo kas nors iš J s artim j.
Take special care with Kentera:
Ypa atsargiai Kentera vartotinas, jei sergate:
If you have any of the following: • Liver disease • Kidney disease • Bladder obstruction • Gastrointestinal obstruction • Ulcerative colitis • Generalized muscle weakness • Inflammation of the oesophagus
• Kepen liga • Inkst liga • P sl s obstrukcija • Virškinimo sistemos obstrukcija • Opiniu kolitu • Išs tiniu raumen silpnumu • Stempl s uždegimu
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.
Vartojant oksibutin gali sumaž ti prakaitavimas, tod l, b nant karštyje, padid ja perkaitimo ar šiluminio sm gio pavojus.
Kentera is not recommended for use in children or adolescents.
Kentera nerekomenduojamas vaikams ar paaugliams.
Kentera with food and drink:
Kentera bei maisto produktai ir g rimai
Oxybutynin may cause drowsiness or blurred vision.
Oksibutininas gali sukelti mieguistum arba sutrikdyti reg jim.
Drowsiness may be increased by consumption of alcohol.
Vartojant alkohol, mieguistumas gali dar sustipr ti.
Pregnancy
N štumas
Ask your doctor for advice before taking any medicine.
Prieš vartodami medikament pasitarkite su gydytoju.
Kentera should not to be used during pregnancy unless clearly necessary
N štumo metu Kentera neder t vartoti, nebent akivaizdžiai b tina.
Lactation
Maitinimas kr timi
Ask your doctor for advice before taking any medicine
Prieš vartodami bet kokius vaistus pasitarkite su gydytoju.
Caution should be exercised when using Kentera when you are breast feeding.
N ra žinoma, ar oksibutininas išsiskiria su motinos pienu, tod l, maitinant kr timi, Kentera patartina vartoti labai atsargiai.
Driving and using machines:
Vairavimas ir mechanizm valdymas
Kentera may cause drowsiness or blurred vision, requiring caution when driving or operating machines.
Kentera gali sukelti mieguistum ir matymo sutrikim, tod l, vairuojant ar valdant mechanizmus, b tinas papildomas atsargumas.
Taking other medicines:
Jei vartojate kitus medikamentus:
Please inform your doctor or pharmacist if you are taking or have recently taken other medicinal products whether prescribed or not.
Jei dabar vartojate ar neseniai vartojote kitus medikamentus pagal recept arba be recepto, praneškite apie tai gydytojui ar vaistininkui.
HOW TO USE KENTERA
KAIP NAUDOTI KENTERA
Always take Kentera exactly as your doctor has instructed you.
Jei nesate tikras (- a), ar visk darote teisingai, pasitarkite su gydytoju arba vaistininku.
You should check with your doctor or pharmacist if you are unsure.
Pleistr patartina keisti tomis pa iomis savait s dienomis, pavyzdžiui, kas sekmadien ir tre iadien arba
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use.
22 pirmadien ir ketvirtadien.
Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
J s patogumui kitoje atver iamosios Kentera pakuot s pus je išspausdintas Kentera kalendorius, kuris pad s prisiminti dozavimo tvarkarašt.
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.
Pasižym kite kalendoriuke pasirinkt medikamento vartojimo tvarkarašt – dienas, kada ketinate keisti pleistrus.
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.
Nepamirškite j keisti tomis pa iomis dienomis, kurias pasižym jote savo kalendoriuje.
Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
Atminkite – tuo pat metu klijuojamas tik vienas pleistras ir nuimamas tik tuomet, kai ateina metas pakeisti kitu.
Where to Apply
Kur klijuoti?
Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks.
Pleistras lipdomas ant sausos, švarios, lygios pilvo, klub ar s dmen odos.
Place the patch underneath your clothing.
Ver iau neklijuoti ant juosmens, kad pleistro netrint priglud r bai.
Rotate application sites with each new application.
Saugokite j nuo saul kaitos - pleistr nešiokite priklijuot taip, kad j dengt drabužiai.
Do not apply a patch to the same place on your body for at least 1 week.
Toje pa ioje vietoje pleistro nelipdykite mažiausiai savait.
abdomen
pilvas
hips
klubai
buttocks
s dmenys
How to Apply
Kaip prilipdyti?
Each patch is individually sealed in a protective sachet.
Kiekvienas pleistras atskirai pakuotas apsauginiame apvalkale.
Please read all the information below before you begin to apply Kentera.
Prieš vartodami Kentera pleistr, perskaitykite vis žemiau pateikiam informacij.
To apply Kentera:
Nor dami priklijuoti Kentera:
Step 1:
(nusipraus
Choose a spot for the patch that is:
karštoje vonioje arba po dušu,
• 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.
Nepatept pudra, losjonu ar aliejumi Nesužalot, neišbert ar kitaip nesudirgint.
Step 2:
Antra
Open the sachet that contains the patch.
- atpl škite pleistro pakavimo maišel.
• Tear open along arrows marked on the right side of the sachet as shown in drawing below. • Do not cut the sachet with scissors, which might damage the patch inside. • Pull the patch out. • Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
• Pl škite rodykl mis paženklint dešin j maišelio krašt, kaip parodyta paveiksl lyje. • Nekirpkite maišelio žirkl mis - galite nety ia pažeisti viduje esant pleistr. • Ištraukite pleistr. •
23 Step 3:
iš
Apply one half of the patch to your skin.
Tre ia – priglauskite prie odos vien pleistro dal.
• Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch. • Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
• Švelniai pleistr sulenk, pašalinkite vien lipn j pleistro pavirši dengiant lapel.
Apply the second half of the patch to your skin.
23 • Nesiliesdami prie lipnaus paviršiaus, stipriai prispauskite pleistr lipni ja puse prie pasirinktos pilvo, klub ar s dmen odos.
• Bend the patch back over itself.
• Užverskite antr j pleistro dal ant priklijuotos dalies.
Press down on the liner firmly. • Push the liner forward a little to loosen the edge. • Grab the loose edge at either corner and peel off the second piece of the liner.
Stipriai prispauskite. • Kad atpalaiduotum te apsauginio sluoksnio kraštel, kilstel kite šiek tiek priek. • Su m atsipalaidavus kraštel, nuimkite likus apsaugin sluoksn.
Try not to touch the sticky surface of the patch. • Press the entire patch firmly onto the skin with your fingertips.
Stenkit s neliesti lipniojo pleistro paviršiaus. • Piršt galais stipriai prispauskite pleistr prie odos.
Press for at least 10 seconds to make sure the patch will stay in place.
Prispaud palaikykite apie 10 sekundži, kad pleistras gerai prilipt.
Be sure all of it sticks to your skin, even around the edges. • Discard the protective liners.
Patikrinkite, kad prilipo visas, net pakraš iuose. • Apsauginio sluoksnio lapelius išmeskite.
You should wear each patch all the time until you apply a new one.
Vonia, dušas, plaukiojimas ir sportas Pleistr der t nešioti be pertraukos, iki ateis laikas pakeisti nauju.
Baths, showers, swimming and exercise should not affect the patch as long as you don ’ t rub the patch as you wash.
Jei jo netrinsite, pleistras netur t atsiklijuoti nei prausiantis vonioje, nei po dušu, nei plaukiojant baseine, nei sportuojant.
Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
Ilgesn laik mirkstant karštoje vonioje pleistras gali atlipti, tad ver iau to vengti.
If the patch comes off:
J ei pleistras atsiklijuoja:
If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips.
Jei pleistras pradeda atšokti, pabandykite prispausti pirštais ir palaikyti.
The patch is designed to re-stick.
Jis pagamintas taip, kad tur t v l prilipti.
Very rarely will the patch come off completely.
Labai retai kada pleistras visiškai atšoka.
If it does, try putting the same patch back on the same spot.
Tokiu atveju pabandykite t pat pleistr priklijuoti toje pa ioje vietoje.
If it sticks firmly all over, leave it on.
Jei v l visas gerai prilips – palikite.
If not, take it off and put a new patch on a new spot.
Jei nebelimpa, nuimkite ir priklijuokite kitoje vietoje nauj.
No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
Kad ir kuri dien tai atsitikt, tolesnes aplikacijas t skite laikydamiesi dviej kart per savait pagal grafik, kur susiplanavote ant kalendoriuko pakuot je.
If you forget to change the patch after 3-4 days:
Jei po 3- 4 dien pamiršote pleistr pakeisti:
As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks.
Vos prisimin, nuimkite sen j pleistr ir prilipdykite nauj kitoje vietoje – ant pilvo, klub ar s dmen.
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.
Kad ir kuri dien tai nutikt, toliau pleistrus keiskite laikydamiesi savojo grafiko, nors ir tekt nauj pleistr klijuoti nesulaukus, kol prab gs prastos 3- 4 dienos.
24 How to Remove
Kaip pleistr pašalinti?
When changing the patch, remove the old patch slowly.
Keisdami pleistrus, sen j nupl škite iš l to.
Fold it in half (sticky sides together) and throw it away to keep out of the reach of children and pets.
Sulenkite pusiau, suglausdami lipni sias dalis ir išmeskite, kad nerast nei vaikai, nei naminiai gyv nai.
Mild redness may be present at the application site.
Toje vietoje, kur pleistras buvo prilipdytas, kur laik gali laikytis švelnus paraudimas.
This redness should disappear within several hours after removal of the patch.
Paraudimas tur t išnykti per kelet valand.
If irritation persists, please contact your doctor.
Jei nepraeina ilgiau, kreipkit s gydytoj.
Gently washing the application site with warm water and a mild soap should remove any adhesive that remains on your skin after removal of the patch.
Pašalinus pleistr, klij liku iai nuo odos nusiplaus šiltu vandeniu ir švelniu muilu.
A small amount of baby oil may also be used to remove any excess residue.
Galima pabandyti patrinti ir k diki odai skirtu aliejumi.
Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist.
Nešvarias žymes, kur buvo pleistro pakraš iai, gali tekti pašalinti medicininiu tirpikliu, kurio reikia paieškoti vaistin je.
Alcohol or other strong solvents may cause skin irritation and should not be used.
Nenaudokite alkoholio arba stipri tirpikli – jie gali sudirginti od.
After use the patch still contains substantial quantities of active ingredients.
24 Panaudotame pleistre išlieka žymus kiekis veikliosios medžiagos.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
Likusios veikliosios medžiagos, patekusios dr gn aplink arba vanden, gali b ti žalingos.
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.
Tod l panaudot pleistr reikia perlenkti lipni ja puse vid, paslepiant vaistus išskirian i membran, d ti original maišel ir išmesti taip, kad nepasiekt vaikai.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems
Panaudot pleistr negalima mesti unitazus ar nuot k valymo renginius.
Like all medicines Kentera can have side effects.
Kaip ir kiti vaista, Kentera gali tur ti nepageidaujam poveik.
Patients using Kentera may experience the following very common (1 in ten persons) side effect: itching around the site of patch application.
Itin dažnas nepageidaujamas Kentera poveikis (vienu iš dešimties atvej) – niežulys aplink aplikacijos viet.
They may also experience the following common (1 in 100 persons) side effects: redness or rash at the site of patch application; dry mouth constipation, diarrhea, upset stomach, stomach pain, headache, or sleepiness, urinary tract infections, blurred vision, and dizziness.
Kiti dažni šalutiniai poveikiai (1 iš 100 atvej) – paraudimas arba b rimas pleistro priklijavimo vietoje; burnos dži vimas, viduri užkiet jimas, viduriavimas, skrandžio veiklos sutrikimas, skrandžio skausmai, galvos skausmai, mieguistumas, šlapimo tak infekcijos, neryškus reg jimas, svaigulys.
Finally, those using Kentera may experience the following uncommon (1 in 1000 persons): upper respiratory tract or fungal infections, palpitations, hot flashes, back pain, urinary retention, difficulty urinating, common cold, and accidental injury.
Galop reti nepageidaujami poveikiai (1 iš 1000 atvej) – viršutini kv pavimo tak arba grybelin s infekcijos, širdies plakimas, karš io bangos, nugaros skausmas, šlapimo retencija, šlapinimosi sunkumai, šaltkr tis, atsitiktiniai susižalojimai.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
Pasteb j šiame informaciniame lapelyje nepamin t nepageidaujam poveik, praneškite gydytojui arba vaistininkui.
STORING KENTERA
KENTERA SAUGOJIMO S LYGOS 5.
Keep out of the reach and sight of children.
Saugokite vaikams neprieinamoje vietoje.
Do not refrigerate.
Nelaikykite šaltyje.
Do not use Kentera after the date shown on the sachet and the carton.
Nevartokite Kentera, pasibaigus ant maišelio ir vaisto pakuot s nurodytam galiojimo laikui.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Daugiau informacijos apie š vaist gali suteikti vietinis registravimo liudijimo tur tojo atstovas.
Recordati Hellas Pharmaceuticals A. E..: +30 210-6773822
25 España Recordati Hellas Pharmaceuticals A. E..: +30 210- 6773822
Slovenija Nicobrand Limited A Subsidiary of Watson Pharmaceuticals, Inc.
26 Slovenija Nicobrand Limited A Subsidiary of Watson Pharmaceuticals, Inc.
Ve ká Británia Tel: +44 (0)28 7086 8733
Ve! ká Británia Tel: +44 (0) 28 7086 8733
This leaflet was approved in
Šis informacinis lapelis patvirtintas
What is Kepivance?
Kas yra Kepivance?
Kepivance is a vial containing a powder to be made into a solution for injection.
Kepivance yra buteliukas su milteliais, iš kurių gaminamas injekcinis tirpalas.