FrancophonIA/ELRC3.0 huggingface dataset:
English: • In view of the available data the PRAC concluded, subject to the amendments to the product information and implementation of other risk minimisation measures, that the benefit-risk balance of domperidone-containing products:
Croatian: • U svjetlu dostupnih podataka, PRAC je zaključio da je uz promjene informacija o lijeku i implementacije drugih mjera smanjenja rizika, omjer koristi i rizika za lijekove koji sadrže domperidon:
English: De Loose F. Clinical Research Report.
Croatian: Clinical Research Report.
English: • In view of the available data the PRAC also concluded that the benefit-risk balance of domperidone-containing products:
Croatian: • U svjetlu dostupnih podataka, Povjerenstvo je također zaključilo da omjer koristi i rizika lijekova koji sadrže domperidon:
English: • The PRAC considered the totality of the data submitted in support of the safety and efficacy of domperidone.
Croatian: • Povjerenstvo je također razmatralo ukupne predane podatke kao potporu djelotvornosti i sigurnosti domperidona.
English: o Is favourable in the relief of the symptoms of nausea and vomiting.
Croatian: o Povoljan za olakšavanje simptoma mučnine i povraćanja.
English: Whereas
Croatian: S obzirom na navedeno
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).
Croatian: Naknadno se na europskoj razini, u Radnoj skupini za farmakovigilanciju (PhVWP) raspravljalo i o kardiovaskularnim događajima uključujući i rizik od produljenja QT segmenta, aritmije i iznenadne srčane smrti koji su povezani s drugim farmaceutskim oblicima domperidona.
English: − rectal formulations dosed at 10 mg and 60 mg
Croatian: − rektalne formulacije u jačinama od 10 mg i 60 mg
English: In view of the cardiac risk, off-label use should be monitored.
Croatian: Potrebno je nadzirati primjenu izvan odobrenih indikacija zbog srčanog rizika.
English: − oral formulations at a strength higher than 10 mg
Croatian: − peroralne formulacije jačina većih od 10 mg
English: • The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis:
Croatian: • Kompleks dispeptičkih simptoma koji se često povezuje s odgođenim pražnjenjem želudca,
English: − oral formulations dosed higher than 10 mg
Croatian: − peroralne formulacije u dozama većim od 10 mg
English: Taking into account the Commission Decision of the Article 30
Croatian: Stoga, u skladu s člankom 116.
English: Cmax is reached after 10-16 hours.
Croatian: Cmax se postiže nakon 10-16 sati.
English: 2 years
Croatian: 2 godine.
English: These reactions are not in themselves an indication of sensitisation.
Croatian: Takve reakcije same po sebi nisu indikacija senzitizacije.
English: You may require medical attention.
Croatian: Možda ćete trebati liječničku pomoć.
English: Population/Visit
Croatian: Populacija/Posjet
English: Always use this medicine exactly as described in this leaflet and as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi i kako Vam je rekao Vaš liječnik.
English: How to start treatment
Croatian: Kako započeti liječenje
English: • Additional risk minimisation measures
Croatian: Dodatne mjere minimizacije rizika
English: These measures will help protect the environment.
Croatian: Ove mjere će pomoći u očuvanju okoliša.
English: CI - confidence interval.
Croatian: Confidence Interval - interval pouzdanosti.
English: United Kingdom Tel: +44 (0)1509 611611
Croatian: Ujedinjeno Kraljevstvo Tel: +44 (0)1509 611611
English: - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
Croatian: - Ako ste ikada imali alergijsku reakciju na sličnu vrstu lijeka (derivate karbamata).
English: Diagnosis should be made according to current guidelines.
Croatian: Dijagnozu treba postaviti u skladu s trenutnim smjernicama.
English: The in vivo micronucleus test was negative.
Croatian: In vivo mikronukleusni test bio je negativan.
English: The pouch can be torn open in two places.
Croatian: Vrećica se može otvoriti na dva mjesta.
English: During the course of the treatment your doctor may adjust the dose to suit your individual needs.
Croatian: Tijekom liječenja liječnik Vam može prilagoditi dozu prema Vašim individualnim potrebama.
English: ITT-LOCF population
Croatian: ITT-LOCF populacija
English: What to do if a patch falls off
Croatian: Što učiniti ako se flaster odlijepi
English: Rivastigmine is weakly bound to plasma proteins (approximately 40%).
Croatian: Rivastigmin se slabo veže na proteine plazme (otprilike 40%).
English: Dehydration can be associated with serious outcomes.
Croatian: Dehidracija može biti povezana s ozbiljnim ishodima.
English: These adverse reactions occur more commonly in women.
Croatian: Ove se nuspojave češće javljaju u žena.
English: Use of scopolamine as an antidote is not recommended.
Croatian: Primjena skopolamina kao antidota se ne preporučuje.
English: If you find you have forgotten to apply a patch, apply one immediately.
Croatian: Ako ustanovite da ste zaboravili staviti flaster, odmah ga stavite.
English: - if you have a low body weight.
Croatian: - ako imate malu tjelesnu težinu.
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.
Croatian: Izravna usporedba stope događaja nadražaja kože prijavljenih u svakom od ovih ispitivanja ne može se napraviti zbog razlike u korištenim metodama prikupljanja podataka.
English: Usually, the side effects will slowly go away as your body gets used to the medicine.
Croatian: Obično će nuspojave polako nestati nakon što se Vaše tijelo navikne na lijek.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni
English: If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish.
Croatian: Ako se u Vašoj zajednici spaljuje kućno smeće, flaster možete baciti u kućno smeće.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Croatian: In vitro ovaj metabolit pokazuje minimalnu inhibiciju acetilkolinesteraze (<10%).
English: - Do not cut the patch into pieces.
Croatian: - Ne režite flaster na komadiće.
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Croatian: Aktivnost enzima vraća se na početne razine za oko 9 sati nakon što se postigne maksimalno inhibicijsko djelovanje.
English: Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Croatian: Oralno i topičko doziranje u ispitivanjima na životinjama bilo je ograničeno zbog osjetljivosti korištenih životinjskih modela.
English: You may apply the next patch at the usual time the next day.
Croatian: Sljedeći flaster možete staviti sljedeći dan u uobičajeno vrijeme.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Croatian: Liječenje treba započeti i nadgledati liječnik s iskustvom u dijagnosticiranju i liječenju Alzheimerove demencije.
English: Patients and caregivers should be instructed accordingly.
Croatian: Bolesnicima i njegovateljima je potrebno dati uputu u skladu s time.
English: You may have side effects more often when you start your medicine or when your dose is increased.
Croatian: Možda ćete češće imati nuspojave kad počnete primjenjivati svoj lijek ili kod povećanja doze.
English: Klöcknerstraat 1, 3930 Hamont-Achel Belgium
Croatian: Klöcknerstraat 1, 3930 Hamont-Achel Belgija
English: This leaflet was last revised in {month YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {mjesec GGGG}
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).
Croatian: Kategorije učestalosti definirane su prema sljedećim pravilima: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često(≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The clinical benefit of rivastigmine should be reassessed on a regular basis.
Croatian: Kliničku korist rivastigmina potrebno je redovito procjenjivati.
English: - if you have impaired liver function.
Croatian: - ako imate oštećenu funkciju jetre.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti
English: In these cases, treatment should be discontinued (see section 4.3).
Croatian: U takvim slučajevima, liječenje se mora prekinuti (vidjeti dio 4.3).
English: The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes.
Croatian: Incidencija i težina nuspojava općenito se povećavaju s povećanjem doze, osobito kod promjena doze.
English: The most commonly observed symptom was erythema which disappeared within 24 hours in the vast majority of patients.
Croatian: Najučestalije opaženi simptom bio je eritem, koji je nestao u roku od 24 sata u velike većine bolesnika.
English: solarium) for long periods of time.
Croatian: solariju) tijekom duljih vremenskih razdoblja.
English: The patch should be worn continuously until it is time to replace it with a new one.
Croatian: Flaster je potrebno stalno nostiti dok nije vrijeme da ga zamijenite novim.
English: • Only one patch per day.
Croatian: - Samo jedan flaster dnevno.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: One transdermal patch is sealed in one pouch.
Croatian: Jedan transdermalni flaster zatvoren je u jednu vrećicu.
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).
Croatian: Kada zamjenjujete flaster morate ukloniti flaster od prethodnog dana prije nego što stavite novi, svaki put na drugo mjesto na koži (primjerice, jedan dan na desnu stranu tijela, zatim na lijevu stranu sljedeći dan, te jedan dan na gornji dio tijela, pa na donji dio tijela drugi dan).
English: Do not apply two patches to make up for the one that you missed.
Croatian: Nemojte staviti dva flastera kako biste nadoknadili propušteni.
English: Available in packs containing 7, 30, 60 and 90 pouches.
Croatian: Dostupno u pakiranjima koja sadrže 7, 30, 60 i 90 vrećica.
English: In massive overdose, atropine can be used.
Croatian: Kod masivnog predoziranja može se primijeniti atropin.
English: No target organ toxicity was observed.
Croatian: Nije zapažena toksičnost u ciljnim organima.
English: Maintenance dose
Croatian: Doza održavanja
English: Otherwise, return used patches to a pharmacy, preferably in the original packaging.
Croatian: U suprotnom vratite iskorištene flastere u ljekarnu, po mogućnosti u originalnom pakiranju.
English: Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.
Croatian: Ponovnu primjenu na isto mjesto unutar 14 dana treba izbjegavati, kako bi se potencijalni rizik od nadraživanja kože sveo na najmanju moguću mjeru.
English: Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Croatian: Potrebno je razmotriti prekid liječenja kada više nema dokaza terapijskog učinka pri optimalnoj dozi.
English: DLSM - difference in least square means.
Croatian: DLSM - eng. difference in least square means - razlika u srednjim vrijednostima dobivenima metodom
English: The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with rivastigmine oral formulations.
Croatian: Tipični simptomi zabilježeni u tim slučajevima slični su onima viđenima sa slučajevima predoziranja povezanima s oralnim formulacijama rivastigmina.
English: - Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams:
Croatian: - Stavite JEDAN flaster na dan na SAMO JEDNO od mogućih mjesta prikazanih na
English: - A protective liner covers the sticky side of the patch.
Croatian: - Zaštitna folija pokriva ljepljivu stranu flastera.
English: Less than 1% of the administered dose is excreted in the faeces.
Croatian: Manje od 1% primijenjene doze izlučuje se u stolici.
English: After the first dose, detectable plasma concentrations are observed after a lag time of 0.5-1 hour.
Croatian: Nakon prve doze, zamjetne koncentracije u plazmi opažaju se nakon 0,5-1 sata.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje
English: - Each patch is sealed in its own protective pouch.
Croatian: Svaki je flaster zapakiran u vlastitu zaštitnu vrećicu.
English: Specific dermal studies in pregnant animals have not been conducted.
Croatian: Specifična ispitivanja kožne primjene u gravidnih životinja nisu provedena.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Croatian: Liječnik će Vas obavijestiti dopušta li Vam bolest da sigurno upravljate vozilima i strojevima.
English: Ingestion of 46 mg of oral rivastigmine occurred in one case; following conservative management the patient fully recovered within 24 hours.
Croatian: U jednom je slučaju došlo do ingestije 46 mg oralnog rivastigmina; nakon konzervativnog liječenja bolesnik se potpuno oporavio unutar 24 sata.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Croatian: Ako se bilo što od navedenog odnosi na Vas, možda će Vas liječnik pobliže pratiti dok primjenjujete
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
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Infections and infestations Common
Croatian: Infekcije i infestacije Često
English: Negative ADAS-Cog changes indicate improvement.
Croatian: Negativne promjene na ADAS-Cog-u upućuju na poboljšanje.
English: - Do not use this medicine if you see that the patch is damaged or shows signs of tampering.
Croatian: - Ne koristiti ovaj lijek ako je flaster oštećen ili ima znakove otvaranja.
English: 2 Based on CMH test (van Elteren test) blocking for country.
Croatian: Pozitivne promjene na 2 Na temelju CMH testa (van Elterenovog testa) blokiranjem za zemlju.
English: Polyester
Croatian: poliester
English: Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
Croatian: Više flastera zalijepljenih na Vašem tijelu moglo bi Vas izložiti prevelikoj količini ovog lijeka, što
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Croatian: Posljedično, rivastigmin ima mali ili umjereni utjecaj na sposobnost vožnje i rada sa strojevima.
English: Rivastigmine 3M Health Care Ltd. can be used with food, drink and alcohol.
Croatian: Rivastigmin 3M Health Care Ltd. se može koristiti uz hranu, piće i alkohol.
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Croatian: Rivastigmin u interakciji sa svojim ciljnim enzimima tvori kovalentno vezani kompleks koji privremeno inaktivira enzime.
English: - Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second half of the protective liner.
Croatian: - Stavite ljepljivu stranu flastera na gornji ili donji dio leđa, nadlakticu ili prsa i zatim povucite drugi dio zaštitne folije.
English: You should only open the pouch when you are ready to apply the patch.
Croatian: Vrećicu otvorite tek kada ste spremni postaviti flaster.
English: N is the number of patients with an assessment at baseline (last assessment in the initial open-label phase) and with at least 1 post-baseline assessment (for the LOCF).
Croatian: N je broj bolesnika s procjenom na početku (posljednja procjena u početnoj otvorenoj fazi) i s najmanje 1 procjenom nakon određivanja početnih vrijednosti (za LOCF).
English: Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days.
Croatian: Liječenje transdermalnim flasterom može se nastaviti u istoj dozi, ako liječenje nije prekinuto na duže od tri dana.
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Croatian: U trenutku izdavanja odobrenja za ovaj lijek podnošenje periodičkih izvješća o neškodljivosti nije potrebno.
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.
Croatian: Brzo prolazi kroz krvnomoždanu barijeru te ima prividni volumen distribucije u rasponu od 1,8 do 2,7 l/kg.
English: Application site reactions were mostly mild to moderate in severity and were rated as severe in less than 2% of patients.
Croatian: Reakcije na mjestu primjene bile su uglavnom blagog do umjerenog intenziteta, a kao teške su bile ocijenjene u manje od 2% bolesnika.
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.
Croatian: Većina slučajeva slučajnog predoziranja oralnim rivastigminom nije bila povezana s nekim od kliničkih znakova ili simptoma, a gotovo su svi bolesnici, na koje se to odnosilo, nastavili liječenje rivastigminom.
English: Rivastigmine transdermal patches were not phototoxic.
Croatian: Transdermalni flasteri s rivastigminom nisu fototoksični.
English: LOCF - Last Observation Carried Forward.
Croatian: Last Observation Carried Forward - prijenos posljednjeg provedenog opažanja.
English: Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Croatian: Sve iskorištene ili neiskorištene transdermalne flastere valja zbrinuti sukladno lokalnim propisima ili vratiti u
English: Peel off one half of the protective liner and do not touch the sticky part of the patch with the fingers.
Croatian: Povucite jednu stranu zaštitne folije i ne dodirujte prstima ljepljivi dio flastera.
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Croatian: Rivastigmin pripada skupini tvari koje se nazivaju inhibitori kolinesteraze.
English: left upper back or right upper back left lower back or right lower back
Croatian: • lijeva ili desna strana gornjeg dijela leđa
English: In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
Croatian: U slučaju dodira s očima, ili ako oči postanu crvene nakon rukovanja flasterom, odmah ih isperite s puno vode i zatražite liječnički savjet ako se simptomi ne povuku.
English: If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
Croatian: Ako se osjećate slabo ili smeteno nemojte upravljati vozilima i strojevima niti izvoditi bilo
English: The DLSM, 95% CI, and p-value are based on an ANCOVA (analysis of covariance) model adjusted for country and baseline ADAS-cog score.
Croatian: DLSM, 95% CI i p-vrijednost temelje se na modelu ANCOVA (analiza kovacijance) prilagođenom za zemlju i
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).
Croatian: U bolesnika s Alzheimerovom demencijom, određene živčane stanice u mozgu odumiru, što ima za posljedicu nisku koncentraciju neurotransmitera acetilkolina (tvari koja omogućuje živčanim stanicama da međusobno komuniciraju).
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machines.
Croatian: Alzheimerova bolest može postupno smanjiti sposobnost upravljanja vozilima ili narušiti sposobnost rada sa strojevima.
English: In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Croatian: U slučaju predoziranja praćenog teškom mučninom i povraćanjem, treba razmotriti primjenu antiemetika.
English: It is recommended to apply the first transdermal patch on the day following the last oral dose.
Croatian: Prvi transdermalni flaster preporučuje se primijeniti prvi sljedeći dan nakon posljednje oralne doze.
English: Heat-sealed pouches made of paper/aluminium/acrylonitrile-methacrylate copolymer laminate.
Croatian: Toplinski zatvorene vrećice izrađene su od papira/aluminija/akrilonitril-metakrilat kopolimer laminata.
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Croatian: Ukoliko je potrebno, mogu se razmotriti moguće prilagodbe doze ili privremeni prekid liječenja.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Croatian: Rivastigmin djeluje tako da blokira enzime koji razgrađuju acetilkolin: acetilkolinesterazu i butirilkolinesterazu.
English: Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
Croatian: Zbog poznatog vagotoničkog djelovanja inhibitora kolinesteraze na brzinu otkucaja srca, također može doći do bradikardije i/ili sinkope.
English: The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Croatian: Primjena ovog lijeka kontraindicirana je u bolesnika s poznatom preosjetljivošću na djelatnu tvar, druge derivate karbamata ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • How to use the reminder card to record patch application and removal.
Croatian: • Upute za korištenje kartice s podsjetnikom za bilježenje postavljanja i uklanjanja flastera.
English: - if you suffer from trembling.
Croatian: - ako imate drhtavicu.
English: Metabolism is primarily via cholinesterase-mediated hydrolysis to the metabolite NAP226-90.
Croatian: Metabolizam se odvija u prvom redu hidrolizom posredovanom kolinesterazom do metabolita NAP226-90.
English: Patients with clinically significant response (%)
Croatian: Bolesnici s klinički značajnim odgovorom (%) Kapsule s rivastigminom