FrancophonIA/ELRC3.0 huggingface dataset:
English: • Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams: left upper arm or right upper arm left upper chest or right upper chest (avoid breast) left upper back or right upper back left lower back or right lower back
Croatian: • Stavite JEDAN flaster na dan na SAMO JEDNO od mogućih mjesta prikazanih na dijagramima u nastavku: lijeva nadlaktica ili desna nadlaktica gornji dio lijevog ili desnog dijela prsnog koša (izbjegavati dojke) lijeva ili desna strana gornjeg dijela leđa lijeva ili desna strana donjeg dijela leđa
English: One transdermal patch is sealed in one sachet.
Croatian: Jedan transdermalni flaster zatvoren je u jednu vrećicu.
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Croatian: Ekstrapiramidni simptomi (uključujući pogoršanje Parkinsonove bolesti)
English: Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 h transdermal patch if such adverse reactions develop.
Croatian: Potrebno je pažljivo titrirati i nadzirati te bolesnike zbog nuspojava (npr. prekomjerne mučnine ili povraćanja) i razmotriti smanjivanje doze za održavanje na transdermalni flaster u dozi od 4,6 mg/24 h ako se razviju takve nuspojave.
English: • After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Croatian: • Nakon što skinete flaster presavinite ga na pola tako da su ljepljive strane okrenute prema unutra i pritisnite ih jednu o drugu.
English: • Allergic reaction where the patch was used, such as blisters or inflamed skin
Croatian: • Alergijska reakcija na mjestu primjene flastera, kao što su mjehurići ili upala kože
English: Preparing the bottle and syringe
Croatian: Priprema boce i štrcaljke
English: Misuse of the medicinal product and dosing errors with Prometax transdermal patch have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death (see section 4.9).
Croatian: Neodgovarajuća primjena lijeka i pogreške u doziranju s Prometax transdermalnim flasterom imale su za posljedicu ozbiljne nuspojave; neki su slučajevi zahtijevali hospitalizaciju, a rijetko imali i smrtni ishod (vidjeti dio 4.9).
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Croatian: U nekim su slučajevima ti događaji doveli do prekida liječenja rivastigminom (npr. prekidi liječenja zbog tremora u 1,7% bolesnika na rivastigminu naspram 0% na placebu).
English: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Prometax transdermal patches in a Japanese study.
Croatian: Bio je ocijenjen kao težak u ≤2,2% bolesnika u tim ispitivanjima te u ≤3,7% bolesnika liječenih Prometax transdermalnim flasterima u jednom japanskom ispitivanju.
English: Worsening of Parkinson's disease, seizure, tremor, somnolence
Croatian: Pogoršanje Parkinsonove bolesti, napadaji, tremor, pospanost
English: 30 transdermal patches.
Croatian: 30 transdermalnih flastera.
English: Alpha-tocopherol
Croatian: Alfa-tokoferol
English: Prometax should not be given at the same time as other medicines with similar effects to Prometax.
Croatian: Prometax se ne smije davati istodobno s drugim lijekovima sa sličnim djelovanjem Prometaxu.
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Croatian: Kapsule i oralna otopina također se mogu primjenjivati u liječenju demencije u odraslih bolesnika s Parkinsonovom bolešću.
English: Parkinson's disease (worsening)
Croatian: Parkinsonova bolest (pogoršanje)
English: Elevated liver function tests
Croatian: Povišeni rezultati testova funkcije jetre
English: Psychomotor hyperactivity
Croatian: Psihomotorička hiperaktivnost
English: DLSM - difference in least square means.
Croatian: DLSM - eng. difference in least square means - razlika u srednjim vrijednostima dobivenima metodom najmanjih kvadrata.
English: • Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Croatian: • Poremećaji jetre (žutilo kože, žute bjeloočnice, abnormalno tamna mokraća ili neobjašnjiva mučnina, povraćanje, umor i gubitak apetita)
English: • The highest dose that should be taken is 6.0 mg twice a day.
Croatian: • Najviša doza koju smijete uzimati je 6,0 mg dva puta na dan.
English: Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Croatian: Potrebno je izbjegavati kontakt s očima nakon rukovanja Prometax transdermalnim flasterima (vidjeti dio 5.3).
English: Prometax transdermal patches may cause fainting or severe confusion.
Croatian: Prometax transdermalni flasteri mogu uzrokovati nesvjesticu ili jaku smetenost.
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Croatian: Moraju se strogo slijediti preporuke za titriranje u skladu s individualnom podnošljivošću.
English: Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Croatian: Daljnja se povećanja na dozu od 4,5 mg, a zatim na 6 mg dva puta dnevno, trebaju također zasnivati na dobroj podnošljivosti trenutne doze, a mogu se razmatrati nakon najmanje dva tjedna liječenja tom dozom.
English: Available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Croatian: Dostupno u pakiranjima koja sadrže 7 ili 30 vrećica te u višestrukim pakiranjima koja sadrže 60 ili 90 vrećica.
English: • If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
Croatian: • Ako flaster otpadne, potrebno je primijeniti novi za ostatak dana, a zatim ga treba zamijeniti u uobičajeno vrijeme sljedećeg dana.
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Croatian: Međutim, u ovih populacija bolesnika, zbog veće izloženosti, nužno je pažljivo pratiti preporuke o doziranju glede titriranja prema individualnoj podnošljivosti, jer bolesnici s klinički značajnim oštećenjem bubrega ili jetre mogu razviti više nuspojava ovisnih o dozi.
English: times the maximum clinical exposure.
Croatian: puta veća od maksimalne kliničke izloženosti.
English: • Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Croatian: • Prije postavljanja flastera provjerite da Vam je koža čista, suha i bez dlaka, bez pudera, ulja, hidratantne kreme ili losiona koji mogu spriječiti pravilno lijepljenje flastera za kožu, bez posjekotina, osipa i/ili nadražaja.
English: • Do not cut the patch into pieces.
Croatian: • Ne režite flaster na komadiće.
English: • Hepatic impairment: Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed.
Croatian: • Oštećenje jetre: Zbog veće izloženosti kod blagog do umjerenog oštećenja jetre koja je bila uočena kod oralnih formulacija, nužno je pažljivo pratiti preporuke o doziranju glede titriranja prema individualnoj podnošljivosti.
English: Rivastigmine in vivo release rates per 24 h
Croatian: In vivo stope oslobađanja rivastigmina u 24 h
English: • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8);
Croatian: • u bolesnika s aktivnim želučanim ili duodenalnim ulkusima ili bolesnika koji su predisponirani za ta stanja, budući da rivastigmin može povećati gastrično izlučivanje (vidjeti dio 4.8);
English: If this applies to you, tell your doctor and do not apply Prometax transdermal patches.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i ne koristite Prometax transdermalne flastere.
English: When observed in patients treated with Prometax transdermal patches, skin irritation was mostly slight or mild in severity.
Croatian: Kada je bio uočen u bolesnika liječenih Prometax transdermalnim flasterima, nadražaj kože bio je uglavnom neznatan ili blag po težini.
English: Based on population analysis, creatinine clearance did not show any clear effect on steady state concentrations of rivastigmine or its metabolite.
Croatian: Na temelju populacijske analize klirens kreatinina nije pokazao nikakav jasan učinak na koncentracije rivastigmina ili njegovih metabolita u stanju dinamičke ravnoteže.
English: Prometax contains sodium benzoate
Croatian: Prometax sadrži natrijev benzoat
English: The exposure to rivastigmine and its metabolites was approximately equivalent to human exposure with highest doses of rivastigmine capsules and transdermal patches.
Croatian: Izloženost rivastigminu i njegovim metabolitima bila je približno jednaka izloženosti u ljudi pri najvišim dozama rivastigmin kapsula i transdermalnih flastera.
English: Your doctor will tell you what dose of Prometax to take.
Croatian: Liječnik će Vam reći koju dozu Prometaxa trebate uzimati.
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Croatian: Prethodna anamneza reakcija na mjestu primjene, koje ukazuju na alergijski kontaktni dermatitis s rivastigminskim flasterom (vidjeti dio 4.4).
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Croatian: Slično tome, zapažen je veći učinak u bolesnika s Parkinsonovom bolešću i vidnim halucinacijama (vidjeti dio 5.1).
English: • Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Croatian: • Bolesnici tjelesne težine ispod 50 kg: Valja biti posebno oprezan kod titriranja doze u bolesnika s tjelesnom težinom ispod 50 kg iznad preporučene djelotvorne doze od 9,5 mg/24 h (vidjeti dio 4.4).
English: What Prometax is and what it is used for
Croatian: Što je Prometax i za što se koristi Djelatna tvar
English: • Trembling hands
Croatian: • Drhtanje ruku
English: When and for how long to apply your Prometax transdermal patch
Croatian: Kada i koliko dugo koristiti Prometax transdermalni flaster
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Croatian: Djelotvornost je utvrđena primjenom dvije neovisne ljestvice, koje su procjenjivane u redovitim intervalima tijekom razdoblja liječenja od 6 mjeseci, kako je prikazano u Tablici 5: ADAS-Cog, mjerilo kognitivne sposobnosti i globalno mjerilo ADCS-CGIC (eng.
English: The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Prometax transdermal patches.
Croatian: Incidencija kožnih reakcija na mjestu primjene koje su dovele do prekida terapije bila je ≤2,3% u bolesnika liječenih Prometax transdermalnim flasterima.
English: Like all medicines, Prometax transdermal patches can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Prometax transdermalni flasteri mogu uzrokovati nuspojave iako se neće javiti kod svakoga.
English: • Problems with your heartbeat such as fast or slow heartbeat
Croatian: • Problemi s radom srca, poput ubrzanih ili usporenih otkucaja srca
English: Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
Croatian: Zatim dlanom čvrsto pritisnite flaster najmanje 30 sekundi kako biste bili sigurni da su se rubovi dobro zalijepili.
English: Following a single 3 mg or 6 mg oral dose, the mean oral clearance of rivastigmine was approximately 46-63% lower in patients with mild to moderate hepatic impairment (n=10, Child-Pugh score 5-12, biopsy proven) than in healthy subjects (n=10).
Croatian: Nakon jednokratne peroralne doze od 3 mg ili 6 mg, srednji oralni klirens rivastigmina bio je otprilike 46-63% niži u bolesnika s blagim do umjerenim oštećenjem jetre (n=10, rezultat 5-12 na Child-Pughovoj skali, dokazano biopsijom) nego u zdravih ispitanika (n=10).
English: • Urinary incontinence (inability to retain adequate urine)
Croatian: • Inkontinencija mokraće (nemogućnost primjerenog zadržavanja mokraće)
English: Absorption of rivastigmine from Prometax transdermal patches is slow.
Croatian: Absorpcija rivastigmina iz Prometax transdermalnih flastera je spora.
English: What Prometax is and what it is used for What you need to know before you take Prometax How to take Prometax
Croatian: Što je Prometax i za što se koristi Što morate znati prije nego počnete uzimati Prometax Kako uzimati Prometax
English: Other warnings and precautions
Croatian: Ostala upozorenja i mjere opreza
English: • Too much saliva and dehydration
Croatian: • Prekomjerno stvaranje sline i dehidracija
English: This may indicate a potential for Prometax transdermal patches to induce mild erythema in patients.
Croatian: To može upućivati na mogućnost da Prometax transdermalni flasteri uzrokuju blagi eritem u bolesnika.
English: • Instructions to provide patients and caregivers with the patient reminder card
Croatian: • Upute o davanju kartice s podsjetnikom za bolesnika bolesnicima i njegovateljima
English: Prometax may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Croatian: Prometax može uzrokovati omaglicu i pospanost, pogotovo na početku liječenja ili prilikom povećanja doze.
English: Prometax is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Croatian: Prometax se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika s blagom do umjerenom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson's disease
Croatian: Unaprijed definirane štetni događaji koji mogu odražavati pogoršanje simptoma parkinsonizma u bolesnika s demencijom povezanom s Parkinsonovom bolešću
English: The use of rivastigmine in patients with severe dementia of Alzheimer's disease or associated with Parkinson's disease, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Croatian: Nije istražena primjena rivastigmina u bolesnika s teškom demencijom Alzheimerove bolesti ili onom povezanom s Parkinsonovom bolešću, drugim vrstama demencije ili drugim vrstama poremećaja pamćenja (npr. smanjenje kognitivne sposobnosti povezano s dobi) te se stoga ne preporučuje primjena u ovoj populaciji bolesnika.
English: Patients and their caregivers must be instructed on important administration instructions for Prometax transdermal patch (see section 4.2).
Croatian: Bolesnici i njihovi njegovatelji moraju dobiti važne upute o primjeni Prometax transdermalnog flastera (vidjeti dio 4.2).
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
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji je opisan u Modulu 1.8.2
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Croatian: Blokiranjem tih enzima Prometax omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove bolesti.
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with Prometax transdermal patches.
Croatian: Dob nije imala utjecaja na izloženost rivastigminu u bolesnika s Alzheimerovom bolešću liječenih Prometax transdermalnim flasterima.
English: • Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake EXP.
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Croatian: Aritmija srca (npr. bradikardija, atrioventrikularni blok, fibrilacija atrija i tahikardija)
English: In two 24-week double-blind, placebo-controlled clinical trials, skin reactions were measured at each visit using a skin irritation rating scale.
Croatian: U dva 24-tjedna dvostruko slijepa, placebom kontrolirana klinička ispitivanja, kožne reakcije mjerile su se na svakom posjetu pomoću ljestvice za ocjenjivanje nadražaja kože.
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with Prometax capsules.
Croatian: Tablica 2 pokazuje nuspojave zabilježene tijekom kliničkih ispitivanja provedenih u bolesnika s demencijom povezanom s Parkinsonovom bolešću, liječenih Prometax kapsulama.
English: In double-blind controlled clinical trials, application site reactions were mostly mild to moderate in severity.
Croatian: U dvostruko slijepim kontroliranim kliničkim ispitivanjima, reakcije na mjestu primjene bile su uglavnom blage do umjerene težine.
English: 50 ml or 120 ml bottle.
Croatian: Boca volumena 50 ml ili 120 ml.
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus syndrome
Croatian: Atrioventrikularni blok, fibrilacija atrija, tahikardija, sindrom bolesnog sinusnog čvora
English: How to use this medicine
Croatian: Kako uzeti ovaj lijek
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Croatian: Tablica 3 navodi broj i postotak bolesnika iz specifičnog kliničkog ispitivanja u trajanju od 24 tjedna, provedenog Prometaxom u bolesnika s demencijom povezanom s Parkinsonovom bolešću, pri čemu su nuspojave, koje bi mogle odražavati pogoršanje simptoma parkinsonizma, bile unaprijed definirane.
English: • The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Croatian: • Flaster treba držati čvrsto pritisnut dlanom najmanje 30 sekundi dok se rubovi dobro ne zalijepe.
English: What you need to know before you take Prometax
Croatian: Što morate znati prije nego počnete uzimati Prometax
English: • Bleeding in the gut - shows as blood in stools or when being sick
Croatian: • Krvarenje u crijevu - prikazuje se kao krv u stolici ili kada povraćate
English: • Aggression
Croatian: • Agresija
English: If you have to undergo surgery whilst taking Prometax, tell your doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.
Croatian: Ako se, tijekom primjene Prometaxa, morate podvrgnuti operaciji, obavijestite liječnika prije nego što Vam primjeni bilo koji anestetik, jer Prometax može tijekom anestezije pojačati učinke nekih mišićnih relaksansa.
English: There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer's disease, except that plasma levels were higher on the second day of transdermal patch therapy than on the first.
Croatian: U plazmi bolesnika s Alzheimerovom bolešću nije bilo značajnog nakupljanja rivastigmina ili metabolita NAP226-90, osim što su razine plazme bile više drugog dana liječenja transdermalnim flasterom nego prvog.
English: If the oral dose of 9 mg/day has not been stable and well tolerated, a switch to 4.6 mg/24 h transdermal patches is recommended.
Croatian: Ako oralna doza od 9 mg/dan nije bila stabilna i nije se dobro podnosila, preporučuje se prebacivanje na transdermalni flaster u dozi od 4,6 mg/24 h.
English: The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Croatian: Transdermalni flasteri dostupni su u pakiranjima koja sadrže 7 ili 30 vrećica te u višestrukim pakiranjima koja sadrže 60 ili 90 vrećica.
English: Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with Prometax transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Croatian: Tablica 1 prikazuje nuspojave zabilježene u 1670 bolesnika s Alzheimerovom demencijom liječenih u randomiziranim, dvostruko slijepim, placebom i aktivno kontroliranim kliničkim ispitivanjima s Prometax transdermalnim flasterom u trajanju od 24-48 tjedana te iz podataka nakon stavljanja lijeka u promet.
English: Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Croatian: Nadalje, rivastigmin može dovesti do omaglice i pospanosti, posebice na početku liječenja ili pri povećavanju doze.
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Prometax capsules or oral solution can be switched to Prometax transdermal patches as follows:
Croatian: Na temelju usporedive izloženosti oralnom i transdermalnom rivastigminu (vidjeti dio 5.2), bolesnici liječeni Prometax kapsulama ili oralnom otopinom mogu prijeći na Prometax transdermalne flastere na sljedeći način:
English: • Aggression, feeling restless
Croatian: • Agresivnost, osjećaj nemira
English: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers.
Croatian: Svaki transdermalni flaster je tanki transdermalni flaster matriksnog tipa koji se sastoji od tri sloja.
English: • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
Croatian: • Jako povraćanje koje može dovesti do puknuća cijevi koja spaja usta sa želucem (jednjaka)
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with Prometax transdermal patches: agitation (common).
Croatian: Sljedeća dodatna nuspojava zabilježena je u ispitivanju na bolesnicima s demencijom povezanom s Parkinsonovom bolešću, koji su liječeni Prometax transdermalnim flasterima: agitiranost (često).
English: Do not take Prometax - if you are allergic to rivastigmine (the active substance in Prometax) or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Prometax - ako ste alergični na rivastigmin (djelatna tvar u Prometaxu) ili neki drugi sastojak ovog lijeka