FrancophonIA/ELRC3.0 huggingface dataset:
English: th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Croatian: Ako acetilsalicilatnu kiselinu uzimaju žene koje pokušavaju začeti ili žene do 24-og tjedna amenoreje (5-og mjeseca trudnoće), doza treba biti što niža, a trajanje liječenja što kraće.
English: th month of pregnancy), acetylsalicylic acid should not be given unless clearly necessary.
Croatian: Acetilsalicilatna kiselina se ne preporučuje do 24-og tjedna amenoreje (5-og mjeseca trudnoće), osim ako je primjena neophodna.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets contain Allura Red AC Allura Red AC may cause allergic reactions.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan filmom obložene tablete od 75 mg/100 mg sadrže boju Allura Red AC koja može izazvati alergijske reakcije.
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastroduodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASA related GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Croatian: Vrlo rijetko, nepoznato crijeva)*; simptomi u gornjem gastrointestinalnom traktu*, npr. gastralgija (vidjeti dio 4.4); ove gastrointestinalne reakcije povezane s ASK mogu ili ne moraju biti udružene s krvarenjem, i mogu se javiti pri bilo kojoj dozi acetilsalicilatne kiseline i u bolesnika s ili bez upozoravajućih simptoma ili ranijih ozbiljnih gastrointestinalnih događaja u povijesti bolesti*.
English: Clopidogrel/Acetylsalicylic acid Mylan must not be used in patients with severe renal impairment (see section 4.3).
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 4.3).
English: 5.2 Pharmacokinetic properties
Croatian: 5.2 Farmakokinetička svojstva Klopidogrel:
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), bone marrow failure*, aplastic anaemia, pancytopenia, bicytopenia*, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency* (see section
Croatian: *, aplastična anemija, pancitopenija, bicitopenija agranulocitoza, teška trombocitopenija, stečena hemofilija A, granulocitopenija, anemija, hemolitička anemija u bolesnika s nedostatkom glukoza-6-fosfat dehidrogenaze (G6PD)
English: No genotoxicity or clastogenicity issues of concern have been found with ASA.
Croatian: U primjeni ASK nisu zabilježeni zabrinjavajući slučajevi genotoksičnosti i klastogeneze.
English: What Clopidogrel/Acetylsalicylic acid Mylan contains
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan sadrži natrij
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Pink, oval shaped, biconvex, film-coated tablets, approximately 14.8 mm x 7.8 mm debossed with “CA3” on one side of the tablet and “M” on the other side.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete Ružičaste, ovalne i bikonveksne filmom obložene tablete, veličine približno 14,8 mm × 7,8 mm, s utisnutim oznakama „CA3” na jednoj i „M” na drugoj strani.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Yellow, oval shaped, biconvex, film-coated tablets, approximately 14.5 mm x 7.4 mm debossed with “CA2” on one side of the tablet and “M” on the other side.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Žute, ovalne i bikonveksne filmom obložene tablete, veličine približno 14,5 mm × 7,4 mm, s utisnutim oznakama „CA2” na jednoj i „M” na drugoj strani.
English: Since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Croatian: Selektivni inhibitori ponovne pohrane serotonina (SSRI) Budući da lijekovi iz skupine SSRI utječu na aktivaciju trombocita i povećavaju rizik od krvarenja, potreban je oprez prilikom istodobne primjene SSRI i klopidogrela.
English: Tablet coating: hypromellose, triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauril sulfate, Allura Red AC (E129) (see section 2 ‘Clopidogrel/Acetylsalicylic acid Mylan contains Allura Red AC')
Croatian: Ovojnica tablete: hipromeloza, triacetin, talk, poli(vinilni alkohol) (djelomično hidroliziran), titanijev dioksid (E171), glicerol monokaprilokaprat (E422), natrijev laurilsulfat, Allura Red AC (E129) (vidjeti dio 2 „Klopidogrel/acetilsalicilatna kiselina Mylan sadrži boju Allura Red AC“) Kako Klopidogrel/acetilsalicilatna kiselina Mylan izgleda i sadržaj pakiranja Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete su žute, ovalne, bikonveksne tablete s utisnutom oznakom „CA2“ na jednoj i „M“ na drugoj strani.
English: Rash, pruritus, skin bleeding (purpura)
Croatian: Poremećaji kože i potkožnog tkiva stvaranje modrica osip, svrbež, krvarenja na koži (purpura)
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/75 mg dose.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Klopidogrel/acetilsalicilatna kiselina Mylan daje se u jednokratnoj dnevnoj dozi od 75 mg/75 mg.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Croatian: Poremećaji probavnog sustava gastrointestinalno krvarenje, proljev, bol u abdomenu, dispepsija ulkus želuca i dvanaesnika, gastritis, povraćanje, mučnina, konstipacija, flatulencija retroperitonealno krvarenje
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets EU/1/19/1395/001 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - Cartons of 100 film coated tablets in HDPE bottle packs
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete EU/1/19/1395/001 - kutije s 28 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/002 - kutije s 30 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/003 - kutije s 28 x 1 (jedinična doza) filmom obloženih tableta u aluminijskim blisterima
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 75 mg acetilsalicilatne kiseline (ASK).
English: Aluminium perforated unit dose blisters with desiccant layer containing 28 or 30 film-coated tablets.
Croatian: 28 ili 30 filmom obloženih tableta u perforiranim aluminijskim blisterima s jediničnim dozama, sa slojem sredstva za sušenje.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 100 mg acetilsalicilatne kiseline (ASK).
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.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete su ružičaste, ovalne, bikonveksne tablete s utisnutom oznakom „CA3“ na jednoj i „M“ na drugoj strani.
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: Upravljanje vozilima i strojevima
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets EU/1/19/1395/006 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - Cartons of 100 film coated tablets in HDPE bottle packs
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete EU/1/19/1395/006 - kutije s 28 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/007 - kutije s 30 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/008 - kutije s 28 x 1 (jedinična doza) filmom obloženih tableta u aluminijskim blisterima
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 75 mg acetylsalicylic acid.
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 75 mg acetilsalicilatne kiseline.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete Djelatne tvari su klopidogrel i acetilsalicilatna kiselina.
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Prije uzimanja bilo kojeg lijeka posavjetujte se sa svojim liječnikom ili ljekarnikom.
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
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete klopidogrel/acetilsalicilatna kiselina
English: Clopidogrel was not shown to alter fertility in animal studies.
Croatian: U ispitivanjima na životinjama, klopidogrel nije imao utjecaj na plodnost.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg tablets
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg tablete
English: Thrombocytopenia, leucopenia, eosinophilia
Croatian: Urikozurici (benzbromaron, probenecid, sulfinpirazon)
English: Aluminium blisters with desiccant layer containing 28 or 30 film-coated tablets.
Croatian: 28 ili 30 filmom obloženih tableta u aluminijskim blisterima, sa slojem sredstva za sušenje.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Hypromellose
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Hipromeloza
English: EU/1/19/1395/001 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - 100 film coated tablets in HDPE bottle packs
Croatian: EU/1/19/1395/001 - kutije s 28 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/002 - kutije s 30 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/003 - kutije s 28 x 1 (jedinična doza) filmom obloženih tableta u aluminijskim blisterima
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
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete Klopidogrel/acetilsalicilatna kiselina Mylan daje se u jednokratnoj dnevnoj dozi od 75 mg/100 mg.
English: If you experience prolonged bleeding when taking Clopidogrel/Acetylsalicylic acid Mylan If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Croatian: Ako pri uzimanju lijeka Klopidogrel/acetilsalicilatna kiselina Mylan imate produljeno krvarenje
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis (including Henoch-Schönlein purpura*), hypotension
Croatian: Krvožilni poremećaji hematomi ozbiljno krvarenje, krvarenje kirurške rane, vaskulitis (uključujući Henoch
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Croatian: Jedna tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 75 mg acetilsalicilatne kiseline.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Hypromellose
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete Hipromeloza
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 100 mg acetylsalicylic acid
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 100 mg acetilsalicilatne kiseline.
English: Haematuria
Croatian: Nikorandil
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Croatian: Jedna tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 100 mg acetilsalicilatne kiseline.
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
Croatian: EU/1/19/1395/006 - kutije s 28 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/007 - kutije s 30 filmom obloženih tableta u aluminijskim blisterima EU/1/19/1395/008 - kutije s 28 x 1 (jedinična doza) filmom obloženih tableta u aluminijskim blisterima
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete klopidogrel/acetilsalicilatna kiselina
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/100 mg filmom obložene tablete klopidogrel/acetilsalicilatna kiselina
English: • Severe hepatic impairment.
Croatian: • teškog oštećenja funkcije jetre,
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Croatian: Što Klopidogrel/acetilsalicilatna kiselina Mylan sadrži Klopidogrel/acetilsalicilatna kiselina Mylan 75 mg/75 mg filmom obložene tablete Djelatne tvari su klopidogrel i acetilsalicilatna kiselina.
English: Some other medicines may influence the use of Clopidogrel/Acetylsalicylic Mylan or vice versa You should specifically tell your doctor if you take
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Klopidogrel/acetilsalicilatna kiselina Mylan ili obratno.
English: If you get any side effects, talk to your doctor, or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Caution required due to ASA
Croatian: Zbog ASK u sastavu lijeka potreban je oprez
English: There is no experience in children
Croatian: Nema iskustva s primjenom u djece.
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).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: There is no dose adjustment necessary in this population.
Croatian: Nije potrebno prilagođavanje doze za tu populaciju.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Croatian: Trenutačno dostupni podaci opisani su u dijelu 4.8, međutim nije moguće dati preporuku o doziranju.
English: If a patient experiences such events, drug discontinuation should be considered.
Croatian: Ako se u bolesnika pojave takvi događaji, potrebno je razmotriti prekid primjene lijeka.
English: Kentera is not recommended for use in the paediatric population.
Croatian: Kentera se ne preporučuje za uporabu u pedijatrijskoj populaciji.
English: The safety and efficacy of Kentera in the paediatric population has not been established.
Croatian: Sigurnost i djelotvornost Kentere u pedijatrijskoj populaciji nisu ustanovljene.
English: Adopted at the 11-14 January 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 11. - 14. siječnja 2016.
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.
Croatian: Nuspojave za koje je poznato da su povezane s antikolinergičkom terapijom, kao što je oksibutinin, jesu anoreksija, povraćanje, refluksni ezofagitis, smanjeno znojenje, toplinski udar, smanjeno suzenje, midrijaza, tahikardija, aritmija, dezorijentiranost, smanjena sposobnost koncentracije, umor, noćne more, nemir, konvulzije, intraokularna hipertenzija i induciranje glaukoma, konfuzija, anksioznost, paranoja, halucinacija, fotoosjetljivost, erektilna disfunkcija.
English: Applicable to Kentera 3.9 mg / 24 hours transdermal patch only
Croatian: Primjenjivo samo na Kentera 3,9 mg / 24 sata transdermalni flaster
English: […] Paediatric population
Croatian: […] Pedijatrijska populacija
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
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.
Croatian: […] Kentera se mora primjenjivati uz oprez u starijih bolesnika, koji mogu biti osjetljiviji na učinke centralno djelujućih antikolinergika i pokazivati razlike u farmakokinetici.
English: Anxiety, confusion, nervousness, agitation, insomnia
Croatian: Anksioznost, konfuzija, nervoza, agitacija, nesanica
English: Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Croatian: Djeca bi mogla biti osjetljivija na učinke lijeka, osobito na nuspojave SŽS-a i na psihijatrijske nuspojave.
English: […] Tabulated list of adverse reactions
Croatian: […] Tablični popis nuspojava
English: Panic reaction#, delirium#, hallucinations#, disorientation#
Croatian: Panična reakcija#, delirij#, halucinacije#, dezorijentiranost#
English: Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping.
Croatian: Nuspojave kliničkih ispitivanja faze III i IV navedene su u nastavku i razvrstane prema klasifikaciji organskih sustava i učestalosti.
English: Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicines (see also section 4.5).
Croatian: Potreban je oprez ako se oksibutinin istodobno primjenjuje s drugim antikolinergičkim lijekovima (vidjeti također dio 4.5).
English: KENTERA (oxybutynin) - Psychiatric disorders (EPITT no
Croatian: KENTERA (oksibutinin) - psihijatrijski poremećaji (EPITT br. 18342)
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).
Croatian: # nuspojave zabilježene nakon stavljanja lijeka u promet samo iz izvješća nakon stavljanja lijeka u promet (nisu zabilježene u kliničkim ispitivanjima), pri čemu je kategorija učestalosti procijenjena na temelju sigurnosnih podataka kliničkog ispitivanja te je zabilježena u vezi s topikalnom primjenom oksibutinina (učinci skupine antikolinergika).
English: - anxiety - confusion - nervousness - agitation - difficulty in sleeping
Croatian: - tjeskoba - smetenost - nervoza - uznemirenost - poteškoće sa spavanjem
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 (see section 4.4).
Croatian: Kentera se mora primjenjivati uz oprez u starijih bolesnika, koji mogu biti osjetljiviji na učinke centralno djelujućih antikolinergika i pokazivati razlike u farmakokinetici (vidjeti dio 4.4).
English: During post-marketing use in this age group, cases of hallucinations (associated with anxiety manifestations) and sleep disorders correlated with oxybutynin have been reported.
Croatian: Tijekom primjene nakon stavljanja lijeka u promet u toj dobnoj skupini zabilježeni su slučajevi halucinacija (povezani s manifestacijama anksioznosti) te poremećaji spavanja u korelaciji s oksibutininom.
English: Postmarketing adverse reactions not seen in clinical trials are also included.
Croatian: Obuhvaćene su i nuspojave nakon stavljanja lijeka u promet koje nisu zabilježene u kliničkim ispitivanjima.
English: Memory impairment#, amnesia#, lethargy#, disturbance in attention#
Croatian: Problemi s pamćenjem#, amnezija#, letargija#, poremećaj pozornosti#
English: Rare side effects: - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness
Croatian: - mentalna smetenost - halucinacije - dezorijentiranost - problemi s pamćenjem - gubitak pamćenja - abnormalni umor - loša koncentracija
English: Other psychiatric events implying an anticholinergic mechanism have been reported during postmarketing use (see section 4.8).
Croatian: Tijekom primjene nakon stavljanja lijeka u promet zabilježeni su i drugi psihijatrijski događaji koji upućuju na antikolinergički mehanizam (vidjeti dio 4.8).
English: Psychiatric and CNS anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Croatian: S uporabom oksibutinina, osobito u starijih bolesnika, povezani su psihijatrijski događaji i antikolinergički događaji središnjeg živčanog sustava (SŽS) kao što su poremećaji spavanja (npr. nesanica) i kognitivni poremećaji.
English: How much?
Croatian: Koliko?
English: Date of first authorisation: 26 April 2019
Croatian: Datum prvog odobrenja: 26. travnja 2019.
English: This is normal
Croatian: To je normalno.
English: However, this observation is based on a limited number of subjects.
Croatian: Međutim, ovo se opažanje temelji na ograničenom broju ispitanika.