FrancophonIA/ELRC3.0 huggingface dataset:
English: A possible association between domperidone and QT-prolongation and cardiac adverse events was identified in the mid-1980s, when high and rapidly administered intravenous doses were used as an anti-emetic during cytotoxic treatment in cancer patients.
Slovenian: Sredi 80. let prejšnjega stoletja so odkrili možno povezavo med domperidonom ter podaljšanjem intervala QT in srčnimi neželenimi dogodki pri hitrem intravenskem dajanju velikih odmerkov domperidona za preprečevanje bruhanja med citotoksičnim zdravljenjem bolnikov z rakom.
English: − combination products containing domperidone/cinnarizine
Slovenian: − kombinirana zdravila, ki vsebujejo domperidon in cinarizin;
English: Subsequently, cardiovascular events including risk of QT-prolongation, arrhythmia and sudden cardiac death in association with other pharmaceutical forms of domperidone have since been discussed at the European level by the Pharmacovigilance Working Party (PhVWP).
Slovenian: Vse od takrat je delovna skupina za farmakovigilanco (PhVWP) na evropski ravni razpravljala o srčno-žilnih dogodkih, ki vključujejo tveganje za podaljšanje intervala QT, aritmijo in nenadno srčno smrt, v povezavi z drugimi farmacevtskimi oblikami domperidona.
English: A formulation for intravenous (IV) administration was discontinued in 1985.
Slovenian: uporabo so leta 1985 umaknili s trga.
English: − rectal formulations dosed at 10 mg and 60 mg
Slovenian: − farmacevtske oblike za rektalno uporabo z jakostjo 10 mg in 60 mg,
English: o Is favourable in the relief of the symptoms of nausea and vomiting.
Slovenian: o ugodno za lajšanje simptomov slabosti in bruhanja;
English: Doc ID:LMD21025;EDMS-ERI-47362001 2 Englert W, Schlich D. A double-blind crossover trial of domperidone in chronic postprandial dyspepsia.
Slovenian: Englert W, Schlich D. A double-blind crossover trial of domperidone in chronic postprandial dyspepsia.
English: Scientific conclusions and grounds for revocation or variation to the terms of the marketing authorisations, as applicable, and detailed explanation for the differences from the PRAC recommendation
Slovenian: Znanstveni zaključki in podlaga za odvzem dovoljenj za promet z zdravilom ali spremembo pogojev dovoljenj za promet z zdravilom,
English: o epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain o bloating, eructation, flatulence o nausea and vomiting o heartburn with or without regurgitations of gastric contents in the mouth
Slovenian: o občutek polnosti v epigastrični regiji, hiter občutek sitosti, občutek distenzije trebuha, bolečina v zgornjem delu trebuha,
English: Domperidone-containing medicines are available as over-the-counter (OTC) or prescription-only medicines (POM).
Slovenian: Zdravila, ki vsebujejo domperidon, se izdajajo bodisi brez recepta bodisi le na recept.
English: Janssen Clinical Research Report April 1979.
Slovenian: Janssen Clinical Research Report.
English: The PRAC also considered that the combination domperidone/cinnarizine, which contains 15 mg domperidone (higher than the newly recommended individual dose), has a negative benefit-risk balance.
Slovenian: Odbor PRAC je menil, da je razmerje med tveganji in koristmi negativno tudi za kombinacijodomperidona in cinarizina, ki vsebuje 15 mg domperidona (večji odmerek od novega priporočenega posameznega odmerka).
English: − oral formulations at a strength higher than 10 mg
Slovenian: − farmacevtske oblike za peroralno uporabo, katerih jakost presega 10 mg,
English: Whereas
Slovenian: Ob upoštevanju naslednjega:
English: − oral formulations dosed higher than 10 mg
Slovenian: − farmacevtske oblike za peroralno uporabo, ki vsebujejo več kot 10 mg domperidona,
English: • At the request of the European Medicines Agency;
Slovenian: • na zahtevo Evropske agencije za zdravila.
English: You may require medical attention.
Slovenian: Morda boste potrebovali zdravniško pomoč.
English: Diagnosis should be made according to current guidelines.
Slovenian: Diagnozo moramo postaviti v skladu s trenutno veljavnimi smernicami.
English: How to start treatment
Slovenian: Kako začeti zdravljenje
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je potrebno predložiti:
English: Patients with clinically significant response (%)
Slovenian: Bolniki s klinično pomembnim odzivom (%)
English: Clinical studies in Alzheimer's dementia
Slovenian: Klinične študije pri Alzheimerjevi demenci
English: solarium) for long periods of time.
Slovenian: solariju) za daljši čas.
English: - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
Slovenian: - če ste imeli kdaj prej alergično reakcijo na podobno vrsto zdravil (derivate karbamata).
English: • Additional risk minimisation measures
Slovenian: • Dodatne meritve za zmanjšanje tveganja
English: What to do if a patch falls off
Slovenian: Kaj storiti, če se obliž odlepi
English: Use of scopolamine as an antidote is not recommended.
Slovenian: Uporabe skopolamina kot protistrupa ne priporočamo.
English: CI - confidence interval.
Slovenian: IZ - interval zaupanja
English: The in vivo micronucleus test was negative.
Slovenian: Mikronukleusni test in vivo je bil negativen.
English: Patients and caregivers should be instructed accordingly.
Slovenian: Bolnike in negovalce je treba na to opozoriti.
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Slovenian: V času pridobitve dovoljenja za promet z zdravilom se za to zdravilo predložitev redno posodobljenih poročil o varnosti zdravila ne zahteva.
English: - The patch can be used in everyday situations, including bathing and during hot weather.
Slovenian: - Obliž je mogoče uporabljati v vsakdanjih situacijah, tudi med kopanjem in v vročem vremenu.
English: • Only one patch per day.
Slovenian: • Samo en obliž na dan.
English: These adverse reactions occur more commonly in women.
Slovenian: Ti neželeni učinki so pogostejši pri ženskah.
English: - Bathing, swimming or showering should not affect the patch.
Slovenian: - Kopanje, plavanje in prhanje ne bi smeli vplivati na obliž.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Slovenian: Rivastigmina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and published on the European medicines web-portal
Slovenian: Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik, ki je izkušen v diagnostiki in zdravljenju Alzheimerjeve demence.
English: Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days.
Slovenian: Zdravljenje s transdermalnim obližem lahko nadaljujemo z istim odmerkom, če zdravljenje ni bilo prekinjeno za več kot tri dni.
English: The clinical benefit of rivastigmine should be reassessed on a regular basis.
Slovenian: Klinične koristi rivastigmina je treba ponovno ocenjevati v rednih presledkih.
English: - Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams:
Slovenian: - Namestite EN obliž na dan na SAMO ENO od možnih mest, ki so prikazana na naslednji skici:
English: The pouch can be torn open in two places.
Slovenian: Vrečko se lahko pretrga na dveh mestih.
English: Frequency categories are defined using the following convention: 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); not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: 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); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: During the course of the treatment your doctor may adjust the dose to suit your individual needs.
Slovenian: Med potekom zdravljenja vam lahko zdravnik prilagodi odmerek, da bo ustrezal vašim osebnim
English: If you find you have forgotten to apply a patch, apply one immediately.
Slovenian: Če ugotovite, da ste pozabili namestiti obliž, ga takoj namestite.
English: • Instructions to provide patients and caregivers with the patient reminder card The patient reminder card should contain the following key messages:
Slovenian: • Navodila za izročanje opozorilne kartice za bolnika bolnikom in negovalcem Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
English: In massive overdose, atropine can be used.
Slovenian: Pri izjemno prevelikem odmerku lahko uporabimo atropin.
English: If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
Slovenian: Če se počutite omotično ali zmedeno, ne vozite, ne uporabljajte strojev in ne izvajajte opravil, ki zahtevajo zbranost.
English: It is not known if rivastigmine is excreted into human milk.
Slovenian: Ni znano, ali rivastigmin prehaja tudi v človeško mleko.
English: No clinical data on exposed pregnancies are available.
Slovenian: Na voljo ni kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: The most commonly observed symptom was erythema which disappeared within 24 hours in the vast majority of patients.
Slovenian: Najpogosteje opaženi simptom je bila rdečina, ki je pri veliki večini bolnikov izginila v 24 urah.
English: Efficacy was established by the use of independent, domain-specific assessment tools which were applied at regular intervals during the 24-week treatment period.
Slovenian: Učinkovitost so ugotavljali z uporabo neodvisnih, področno specifičnih metod ocenjevanja, ki so jih izvajali v rednih presledkih med 24-tedenskim obdobjem zdravljenja.
English: Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Slovenian: Uporabljene in neuporabljene transdermalne obliže zavrzite v skladu z lokalnimi predpisi ali jih vrnite v lekarno.
English: It readily crosses the blood-brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Slovenian: Dobro prehaja skozi krvnomožgansko pregrado in ima navidezni volumen porazdelitve v območju 1,8-2,7 l/kg.
English: Make sure the patch does not loosen during these activities.
Slovenian: Preverite, da med temi dejavnostmi obliž ne popusti.
English: Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Slovenian: Peroralno in lokalno odmerjanje je bilo v raziskavah na živalih omejeno zaradi občutljivosti uporabljenih živalskih modelov.
English: - Each patch is sealed in its own protective pouch.
Slovenian: - Vsak obliž je zaprt v svojo zaščitno vrečko.
English: When changing the patch, you must remove the previous day's patch before you apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day).
Slovenian: Kadar menjate obliž, morate najprej odstraniti obliž prejšnjega dne, preden namestite novega vsakokrat na drugo mesto (na primer en dan na desno stran telesa, naslednji dan na levo stran ali pa en dan na zgornji del telesa, naslednji dan pa na spodnji del).
English: The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes.
Slovenian: Pogostnost in stopnja izraženosti neželenih učinkov se na splošno povečujeta z večanjem odmerkov, posebno ob spremembah odmerka.
English: • How to use the reminder card to record patch application and removal.
Slovenian: • Kako uporabljati opozorilno kartico za beleženje nameščanja in odstranjevanja obližev.
English: Rivastigmine transdermal patches were not phototoxic.
Slovenian: Transdermalni obliži z rivastigminom niso bili fototoksični.
English: Patients involved in the placebo-controlled study had an MMSE (Mini-Mental State Examination) score of 10-20.
Slovenian: Bolniki, vključeni v s placebom kontrolirano študijo, so imeli rezultat MMSE (Mini-Mental State Examination - kratek preizkus spoznavnih sposobnosti) med 10 in 20.
English: No target organ toxicity was observed.
Slovenian: Toksičnosti za tarčni organ niso opazili.
English: In some other dermal toxicity studies, a mild irritant effect on the skin of laboratory animals, including controls, was observed.
Slovenian: V nekaterih drugih študijah toksičnosti za kožo so opazili blag dražilen učinek na kožo laboratorijskih živali, vključno s kontrolnimi živalmi.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli
English: 2 Based on CMH test (van Elteren test) blocking for country.
Slovenian: 2 Na podlagi testa CMH (van Elternovega testa) analize po kategorijah za posamezne države.
English: You should only open the pouch when you are ready to apply the patch.
Slovenian: Vrečko odprite šele, ko boste pripravljeni na nameščanje obliža.
English: Furthermore, rivastigmine may induce syncope or delirium.
Slovenian: Nadalje lahko rivastigmin povzroči sinkopo ali delirij.
English: Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
Slovenian: Zaradi znanega vagotoničnega učinka holinesteraznih zaviralcev na srčni utrip se lahko pojavita tudi bradikardija in/ali sinkopa.
English: ITT-LOCF population
Slovenian: Skupina ITT-LOCF
English: Do not use Rivastigmine 3M Health Care Ltd. - if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Rivastigmin 3M Health Care Ltd. - če ste alergični na rivastigmin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Otherwise, return used patches to a pharmacy, preferably in the original packaging.
Slovenian: V nasprotnem primeru vrnite rabljene obliže v lekarno, najbolje v originalni ovojnini.
English: Usually, the side effects will slowly go away as your body gets used to the medicine.
Slovenian: Običajno neželeni učinki počasi izzvenijo, ko se telo zdravila navadi.
English: Most cases of accidental overdose of oral rivastigmine have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment.
Slovenian: Simptomi Večina primerov nenamernega prevelikega odmerjanja peroralnega rivastigmina ni bila povezana z nikakršnimi kliničnimi znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminom.
English: Do not apply a new patch to the same skin area twice within 14 days.
Slovenian: V obdobju 14 dni ne namestite novega obliža dvakrat na isti predel na koži.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rivastigminom za vse podskupine pediatrične populacije glede zdravljenja Alzheimerjeve demence (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The patches are available in packs containing 7, 30, 60 and 90 pouches.
Slovenian: Obliži so na voljo v pakiranju, ki vsebuje 7, 30 , 60 ali 90 vrečk.
English: A direct comparison of the rate of skin irritation events reported in each of these studies cannot be made due to the difference in data collection methods employed.
Slovenian: Neposredne primerjave pogostnosti opisanih kožnih reakcij med obema študijama ni mogoče opraviti, ker se metodi zbiranja podatkov med študijama razlikujeta.
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Slovenian: Farmakoterapevtska skupina: psihoanaleptiki, antiholinesteraze, oznaka ATC: N06DA03
English: Do not apply two patches to make up for the one that you missed.
Slovenian: Ne nameščajte dveh obližev hkrati, da bi nadomestili pozabljenega.
English: - The patch should be replaced by a new one after 24 hours.
Slovenian: - Obliž je treba po 24 urah zamenjati z novim.
English: Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Slovenian: O prekinitvi zdravljenja je treba razmisliti tudi v primeru, da pri uporabi optimalnega odmerka ni več znakov terapevtskih
English: Available in packs containing 7, 30, 60 and 90 pouches.
Slovenian: Na voljo so v pakiranjih po 7, 30, 60 in 90 vrečk.
English: Rivastigmine is weakly bound to plasma proteins (approximately 40%).
Slovenian: Rivastigmin se šibko veže na beljakovine v plazmi (približno 40%).
English: Maintenance dose
Slovenian: Vzdrževalni odmerek
English: Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
Slovenian: Če bi imeli na koži več obližev hkrati, bi bili izpostavljeni preveliki količini zdravila, kar je lahko nevarno.
English: Klöcknerstraat 1 3930 Hamont-Achel Belgium
Slovenian: Klöcknerstraat 1 3930 Hamont-Achel Belgija
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Slovenian: Zaradi tega ima rivastigmin blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Slovenian: Priporočamo začetni odmerek 0,03 mg/kg atropinijevega sulfata intravensko, nadaljnji odmerki pa naj temeljijo na kliničnem odzivu.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravnik vam bo povedal, ali vam vaša bolezen dovoljuje, da varno upravljate vozila in uporabljate stroje.
English: In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Slovenian: Pri bolnikih z Alzheimerjevo demenco določene celice v možganih odmrejo, to pa povzroči znižano koncentracijo nevrotransmiterja acetilholina (to je snov, ki omogoča živčnim celicam, da komunicirajo med seboj).
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Slovenian: Aktivnost encima se vrne na izhodiščno raven okrog 9 ur po dosegu največjega zaviralnega učinka.
English: You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
Slovenian: Ko nameščate nove obliže, lahko preskušate različna mesta na koži, da bi ugotovili, katero vam je najbolj udobno in kje oblačila
English: Klöcknerstraat 1, 3930 Hamont-Achel Belgium
Slovenian: Klöcknerstraat 1, 3930 Hamont-Achel Belgija
English: 9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
Slovenian: 9,5 mg/24 h je priporočeni dnevni učinkoviti odmerek, s katerim naj bolnik nadaljuje, dokler kaže, da ima od njega terapevtske koristi.
English: p-value versus placebo *p<0.05 versus placebo
Slovenian: Vrednost p proti placebu *p<0,05 proti placebu
English: You may apply the next patch at the usual time the next day.
Slovenian: Naslednji obliž boste namestili naslednji dan ob običajnem času.
English: Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations.
Slovenian: Kadar so se simptomi pojavili, so obsegali navzeo, bruhanje in drisko, hipertenzijo ali halucinacije.
English: • Summary of Product Characteristics
Slovenian: • Povzetek glavnih značilnosti zdravila
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish.
Slovenian: Če imate v vaši okolici urejeno sežiganje gospodinjskih odpadkov, lahko obliž odvržete med gospodinjske odpadke.
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Slovenian: Če je treba, velja razmisliti o morebitni spremembi odmerka ali začasni prekinitvi zdravljenja.
English: Dehydration can be associated with serious outcomes.
Slovenian: Dehidracija sicer lahko povzroča resne zaplete.
English: • Patient reminder card
Slovenian: • Opozorilno kartico za bolnika
English: Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20-30% lower when applied to the abdomen or thigh.
Slovenian: Izpostavljenost (AUC∞) rivastigminu (in presnovku NAP266-90) je bila največja pri aplikaciji transdermalnega obliža na zgornji del hrbta, prsi ali nadlaket ter približno 20-30 % manjša pri aplikaciji na trebuh ali stegno.
English: In animals, rivastigmine is excreted into milk.
Slovenian: Pri živalih se rivastigmin izloča v mleko.
English: Rivastigmine may exacerbate or induce extrapyramidal symptoms.
Slovenian: Rivastigmin lahko poslabša ali sproži ekstrapiramidne simptome.
English: After the first dose, detectable plasma concentrations are observed after a lag time of 0.5-1 hour.
Slovenian: Po prvem odmerjanju doseže merljive koncentracije v plazmi po odzivnem času 0,5-1 ure.
English: If you have not applied a patch for three days, do not apply the next one before you have talked to your doctor.
Slovenian: Če obliža niste namestili tri dni, ne nameščajte novega obliža, dokler se ne pogovorite s svojim zdravnikom.
English: Rivastigmine is rapidly and extensively metabolised with an apparent elimination half-life in plasma of approximately 3.4 hours after removal of the transdermal patch.
Slovenian: Rivastigmin se hitro in obsežno presnavlja z navideznim razpolovnim časom izločanja iz plazme približno 3,4 ure po odstranitvi transdermalnega obliža.
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease.
Slovenian: Zato bi lahko rivastigmin izboljšal stanje holinergično posredovanega upada kognitivnih funkcij pri demenci, povezani z Alzheimerjevo boleznijo.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machines.
Slovenian: Alzheimerjeva bolezen lahko povzroči postopno zmanjšanje sposobnosti upravljanja motornih vozil ali zmanjša sposobnost uporabe strojev.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: Rivastigmine capsules 12 mg/day
Slovenian: Rivastigmin kapsule 12 mg/dan