FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg
English: EU/1/19/1395/006 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - 100 film coated tablets in HDPE bottle packs
Slovenian: EU/1/19/1395/006 - 28 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/19/1395/007 - 30 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/19/1395/008 - 28 x 1 (pakiranja s posameznimi odmeki) filmsko obložena tableta v aluminijastih pretisnih omotih
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/100 mg dose
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Mylan se mora dajati kot enkratni dnevni odmerek 75 mg/100 mg.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
English: Clopidogrel was not shown to alter fertility in animal studies.
Slovenian: Študije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 75 mg acetylsalicylic acid.
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 75 mg acetilsalicilne kisline.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA with frequency “not known”.
Slovenian: Informacije, v literaturi navedene za ASA s pogostnostjo »ni znana«.
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Slovenian: Poleg kliničnih študij so vir ocen varnosti klopidogrela in ASA tudi pomarketinške izkušnje.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets are yellow, oval shaped biconvex tablets imprinted with CA2 on one side of the tablet and M on the other side.
Slovenian: Filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg so rumene bikonveksne tablete ovalne oblike z vtisnjeno oznako »CA2« na eni in »M« na drugi strani tablete.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets are pink, oval-shaped biconvex, tablets imprinted with CA3 on one side of the tablet and M on the other side.
Slovenian: Filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg so rožnate bikonveksne tablete ovalne oblike z vtisnjeno oznako »CA3« na eni in »M« na drugi strani tablete.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete Učinkovini sta klopidogrel in acetilsalicilna kislina.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg tablets
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg tablete
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Slovenian: Ena tableta vsebuje 75 mg klopidogrela (kot hidrogensulfata) in 100 mg acetilsalicilne kisline.
English: The safety of the concomitant administration of clopidogrel/acetylsalicylic acid with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Slovenian: Varnost sočasne uporabe klopidogrela in acetilsalicilne kisline z drugimi trombolitiki ni formalno ugotovljena.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg tablets
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg tablete
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 100 mg acetylsalicylic acid
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 100 mg acetilsalicilne kisline.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Učinkovini sta klopidogrel in acetilsalicilna kislina (ASA).
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete
English: How to store Clopidogrel/Acetylsalicylic acid Mylan
Slovenian: Shranjevanje zdravila Klopidogrel/acetilsalicilna kislina Mylan
English: The desiccant should not be eaten.
Slovenian: odmerka ne sme podvojiti.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Slovenian: Ena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 75 mg acetilsalicilne kisline.
English: You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Mylan.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel/acetilsalicilna kislina Mylan
English: If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Slovenian: Če jemljete to zdravilo, se o dojenju posvetujte s svojim zdravnikom.
English: While you are taking Clopidogrel/Acetylsalicylic acid Mylan
Slovenian: Ko jemljete zdravilo Klopidogrel/acetilsalicilna kislina Mylan:
English: Since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Slovenian: Selektivni zaviralci privzema serotonina (SSRI-Selective serotonin re-uptake inhibitors) Selektivni zaviralci privzema serotonina vplivajo na aktivacijo trombocitov in povečajo nevarnost krvavitve, zato je ob sočasnem jemanju selektivnih zaviralcev privzema serotonina in klopidogrela potrebna previdnost.
English: • if you have a risk of bleeding such as: a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če imate tveganje za krvavitev, kot je: - bolezen, zaradi katere ste v nevarnosti za notranjo krvavitev (npr. razjeda na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitvam v katerokoli tkivo, organ ali sklep v telesu), - nedavna huda poškodba, - nedaven kirurški poseg (vključno z zobozdravstvenimi posegi), - načrtovan kirurški poseg (vključno z zobozdravstvenimi posegi) v naslednjih sedmih dneh,
English: Croscarmellose sodium Hydroxypropylcellulose Colloidal anhydrous silica Talc
Slovenian: Jedro mikrokristalna celuloza laktoza premreženi natrijev karmelozat hidroksipropilceluloza brezvodni koloidni silicijev dioksid smukec hidrogenirano ricinusovo olje predgelirani škrob stearinska kislina rumeni železov oksid (E172)
English: Some other medicines may influence the use of Clopidogrel/Acetylsalicylic Mylan or vice versa You should specifically tell your doctor if you take
Slovenian: Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel/acetilsalicilna kislina Mylan in obratno.
English: Keep this leaflet.
Slovenian: Pretisni omot
English: Nicorandil
Slovenian: Nikorandil
English: Reproductive systems and breast disorders
Slovenian: Motnje reprodukcije in dojk ginekomastija
English: This summary was last updated in 04-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2012.
English: The patients were mainly of Asian origin and had an average age of 36 years.
Slovenian: Bolniki so bili v glavnem azijskega porekla in v povprečju stari 36 let.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sebivo on 24 April 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sebivo, veljavno po vsej Evropski uniji, odobrila dne 24. aprila 2007.
English: None of the patients had been treated with nucleoside analogues before.
Slovenian: Noben izmed bolnikov predhodno ni bil zdravljen z nuklezoidnimi analogi.
English: If this is not possible, they should take the tablets less often.
Slovenian: Če to ni mogoče, naj vzamejo tablete redkeje.
English: What benefit has Sebivo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sebivo izkazalo med študijami?
English: EPAR summary for the public telbivudine
Slovenian: Povzetek EPAR za javnost telbivudin
English: The main measure of effectiveness was the number of patients who had responded to treatment after a year.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se po enem letu odzvali na zdravljenje.
English: The full EPAR for Sebivo can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sebivo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (600 mg) and as an oral solution (20 mg/ml).
Slovenian: Na voljo je v obliki tablet (600 mg) in peroralne raztopine (20 mg/ml).
English: What is the risk associated with Sebivo?
Slovenian: Kakšna tveganja so povezana z zdravilom Sebivo?
English: Patients with kidney problems should be closely monitored.
Slovenian: Bolnike z obolenji ledvic je treba skrbno spremljati.
English: The CHMP decided that Sebivo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Sebivo večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The medicine can only be obtained with a prescription.
Slovenian: Izdaja zdravila je samo na recept.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sebivo.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sebivo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Patients who have problems with their kidneys may need to take a lower daily dose using the oral solution.
Slovenian: Bolniki, ki imajo težave z ledvicami, bodo morda morali jemati manjši dnevni odmerek zdravila, ki se odmeri z uporabo peroralne raztopine.
English: Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine which the hepatitis B virus is less likely to develop resistance to.
Slovenian: Zdravljenje z zdravilom Sebivo je primerno samo, kadar ni možno ali ni primerno uporabiti nadomestnega zdravila, za katerega je manj verjetno, da se bo razvila odpornost virusa B na to zdravilo.
English: This is a summary of the European public assessment report (EPAR) for Sebivo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sebivo.
English: For more information about treatment with Sebivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sebivo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because creatine phosphokinase is an enzyme that is raised when muscles are damaged, doctors need to monitor all muscle-related side effects closely.
Slovenian: Ker je keratin fosfokinaza encim, katerega koncentracija se poveča pri poškodbi mišic, mora zdravnik skrbno spremljati vse neželene učinke, ki so povezani z mišicami.
English: Why has Sebivo been approved?
Slovenian: Zakaj je bilo zdravilo Sebivo odobreno?
English: Treatment with Sebivo should be started by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Sebivo is 600 mg (one tablet) once a day.
Slovenian: Zdravljenje z zdravilom Sebivo mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B. Priporočeni odmerek zdravila Sebivo je 600 mg (ena tableta) enkrat dnevno.
English: Other information about Sebivo
Slovenian: Druge informacije o zdravilu Sebivo
English: The company also presented the results of a study showing that the oral solution produced the same levels of the active substance in the blood as the tablets.
Slovenian: Družba je predstavila tudi izsledke študije, ki kaže, da se pri jemanju peroralne raztopine ustvarijo enake koncentracije zdravilne učinkovine v krvi kot pri jemanju tablet.
English: The oral solution can be considered for patients who have difficulty swallowing tablets.
Slovenian: Peroralna raztopina je namenjena bolnikom, ki težko pogoltnejo tableto.
English: The most common side effects with Sebivo (seen in between 1 and 10 patients in 100) are dizziness, headache, cough, increased levels of some enzymes in the blood (amylase, lipase, creatine phosphokinase and alanine aminotransferase), diarrhoea, nausea (feeling sick), abdominal pain (stomach ache), skin rash and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Sebivo (opaženi pri 1 do 10 bolnikih izmed 100) so omotičnost, glavobol, kašelj, povečana koncentracija nekaterih encimov v krvi (amilaze, lipaze, keratin fosfokinaze in alanin aminotransferaze), driska, slabost, bolečine v trebuhu, kožni izpuščaji in utrujenost.
English: The results were also calculated separately between ‘HBeAg-positive' patients (infected with the common hepatitis B virus) and ‘HBeAg-negative' patients (infected with a virus that has mutated, leading to a form of chronic hepatitis B that is more difficult to treat).
Slovenian: Rezultati so bili izračunani tudi ločeno za bolnike, ki so bili „HBeAg pozitivni“ (okuženi z običajnim virusom hepatitisa B), in za bolnike, ki so bili „HBeAg negativni“ (okuženi z virusom, ki je mutiral, kar je privedlo do oblike kroničnega hepatitisa B, ki jo je težje zdraviti).
English: Sebivo must not be used in combination with pegylated or standard interferon alfa (other medicines used in the treatment of hepatitis).
Slovenian: Zdravilo Sebivo se ne sme uporabljati v kombinaciji s pegiliranim ali običajnim interferonom alfa (drugima zdraviloma za hepatitis).
English: By stopping the virus making DNA, telbivudine prevents it from multiplying and spreading.
Slovenian: Telbivudin ustavi tvorbo DNK v virusu ter tako prepreči njegovo razmnoževanje in širjenje.
English: Sebivo must not be used in people who are hypersensitive (allergic) to telbivudine or to any of the other ingredients.
Slovenian: Zdravila Sebivo ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) telbivudin ali katero koli drugo sestavino zdravila.
English: In the HBeAg-negative patients, Sebivo was as effective as lamivudine (75% and 77% responding, respectively).
Slovenian: V skupini HBeAg-negativnih bolnikov je bilo zdravilo Sebivo enako učinkovito kot lamivudin (na zdravljenje se je odzvalo 75 % oziroma 77 % bolnikov).
English: The active substance in Sebivo, telbivudine, is an antiviral medicine that belongs to the class ‘nucleoside analogues'.
Slovenian: Zdravilna učinkovina zdravila Sebivo, telbivudin, je protivirusno zdravilo, ki spada v razred nukleozidnih analogov.
English: Telbivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Slovenian: Telbivudin zavira delovanje virusnega encima, imenovanega DNK-polimeraza, ki je udeležen pri tvorbi virusne DNK.
English: What is Sebivo used for?
Slovenian: Za kaj se zdravilo Sebivo uporablja?
English: A response was defined as low levels of viral DNA in the blood, together with either the levels of a liver enzyme called alanine aminotransferase (ALT) returning to normal or the marker for the hepatitis B virus disappearing from the blood.
Slovenian: Odziv je bil opredeljen kot nizka koncentracija virusne DNK v krvi ter sočasno bodisi vzpostavitev normalnih koncentracij jetrnega encima, imenovanega alanin aminostransferaza (ALT), ali izginotje pokazatelja virusa hepatitisa B v krvi.
English: After one year of treatment, Sebivo was more effective than lamivudine in the HBeAg-positive patients, with 75% responding to Sebivo and 67% to lamivudine.
Slovenian: Po enem letu zdravljenja je bilo zdravilo Sebivo učinkovitejše od lamivudina v skupini HBeAg-pozitivnih bolnikov, v kateri se je na zdravljenje odzvalo 75 % bolnikov, ki so prejemali zdravilo Sebivo, in 67 % bolnikov, ki so prejemali lamivudin.
English: Sebivo is a medicine that contains the active substance telbivudine.
Slovenian: Sebivo je zdravilo, ki vsebuje zdravilno učinkovino telbivudin.
English: For the full list of all side effects reported with Sebivo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sebivo, glejte navodilo za uporabo.
English: How has Sebivo been studied?
Slovenian: Kako je bilo zdravilo Sebivo raziskano?
English: How does Sebivo work?
Slovenian: Kako zdravilo Sebivo deluje?
English: The patient's blood should be monitored every six months for the presence of DNA from the hepatitis B virus.
Slovenian: Bolnikom je treba vsakih šest mesecev opraviti krvno preiskavo za ugotavljanje prisotnosti DNK virusa hepatitisa B. Če preiskava pokaže prisotnost virusne DNK, je treba spremeniti zdravljenje.
English: Overall, Sebivo was at least as effective as lamivudine, with about three-quarters of the patients responding to treatment after a year.
Slovenian: Na splošno je bilo zdravilo Sebivo, pri katerem se je približno tri četrtine bolnikov po enem letu odzvalo na zdravljenje, vsaj tako učinkovito kot lamivudin.
English: It is used in patients who have compensated liver disease (when the liver is damaged but is still able to work normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised liver enzymes in the blood or signs of damage when liver tissue is examined under a microscope).
Slovenian: Zdravilo Sebivo se uporablja za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom B, tj. obolenjem jeter, ki ga povzroči okužba z virusom hepatitisa B. Uporablja se pri bolnikih, ki imajo kompenzirano bolezen jeter (jetra so poškodovana, vendar še vedno zmorejo delovati normalno) in izkazujejo tudi znake nadaljnjega razmnoževanja virusa ter znake poškodb jeter (zvišano koncentracijo jetrnega encima v krvi ali znake poškodb pri preiskavi tkiva jeter pod mikroskopom).
English: Sebivo tablets were compared with lamivudine (another medicine used in chronic hepatitis B) in a twoyear study involving 1,367 patients.
Slovenian: V dvoletni študiji, ki je zajela 1 367 bolnikov, so primerjali učinkovitost tablet Sebivo z učinkovitostjo lamivudina (drugega zdravila za zdravljenje kroničnega hepatitisa B).
English: How is Sebivo used?
Slovenian: Kako se zdravilo Sebivo uporablja?
English: What is Sebivo?
Slovenian: Kaj je zdravilo Sebivo?
English: ANNEX A
Slovenian: DODATEK A
English: Number
Slovenian: Številka
English: Content Package size Withdrawal period
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: There is no experience in children
Slovenian: Izkušenj pri otrocih ni.
English: Adopted at the 11-14 January 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 11. in 14. januarjem 2016
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti(≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: There is no dose adjustment necessary in this population.
Slovenian: Pri tej populaciji odmerka ni treba prilagoditi.
English: If a patient experiences such events, drug discontinuation should be considered.
Slovenian: Če se pri bolniku pojavijo takšni učinki, je treba razmisliti o prekinitvi zdravljenja.
English: The safety and efficacy of Kentera in the paediatric population has not been established.
Slovenian: Varnost in učinkovitost zdravila Kentera v pediatrični populaciji še nista bili dokazani.
English: […] Paediatric population
Slovenian: […] Pediatrična populacija
English: Adverse reactions known to be associated with anticholinergic therapy, such as oxybutynin, 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, hallucination, photosensitivity, erectile dysfunction.
Slovenian: Neželeni učinki, ki so znano povezani z antiholinergičnimi zdravili, kot je oksibutinin, so anoreksija, bruhanje, refluksni ezofagitis, zmanjšano znojenje, vročinski udar, zmanjšano solzenje, midriaza, tahikardija, aritmija, dezorientiranost, zmanjšana zmožnost koncentracije, utrujenost, more, nemir, konvulzije, intraokularna hipertenzija in indukcija glavkoma, zmedenost, tesnobnost, paranoja, halucinacije, preobčutljivost za svetlobo, erektilna disfunkcija.
English: Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping.
Slovenian: Spodaj so navedeni neželeni učinki iz kliničnih študij 3. in 4. faze glede na organski sistem in pogostnost.
English: # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).
Slovenian: # neželeni učinki iz obdobja trženja samo iz poročil iz obdobja trženja (ki jih v kliničnih preskušanjih niso opazili), s pogostnostjo, ki so jo ocenili na podlagi podatkov o varnosti iz kliničnih preskušanj, in o katerih so poročali v povezavi z lokalno uporabo oksibutinina (učinki razreda antiholinergikov).
English: KENTERA (oxybutynin) - Psychiatric disorders (EPITT no
Slovenian: KENTERA (oksibutinin) - psihiatrične motnje (št. EPITT
English: […] 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.
Slovenian: […] Pri starejših bolnikih je treba zdravilo Kentera uporabljati previdno, ker so lahko občutljivejši za učinke antiholinergikov s centralnim delovanjem in lahko pri njih obstajajo razlike v farmakokinetiki.
English: Postmarketing adverse reactions not seen in clinical trials are also included.
Slovenian: Vključeni so tudi neželeni učinki iz obdobja trženja, ki jih v kliničnih preskušanjih niso opazili.