FrancophonIA/ELRC3.0 huggingface dataset:
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Prometax 4.6 mg/24 h transdermal patches, 0.77 for Prometax 9.5 mg/24 h transdermal patches and 0.72 for Prometax 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Croatian: Indeks fluktuacije (FI), mjera relativne razlike između vršne i najniže koncentracije ((Cmax-Cmin)/Cavg), bio je 0,58 za Prometax 4,6 mg/24 h transdermalne flastere, 0,77 za Prometax 9,5 mg/24 h transdermalne flastere i 0,72 za Prometax 13,3 mg/24 h transdermalne flastere, čime se potvrđuje puno manja fluktuacija između najniže i vršne koncentracije nego kod oralne formulacije (FI = 3,96 (6 mg/dan) i 4,15 (12 mg/dan)).
English: times the foreseen clinical exposure.
Croatian: puta veća od predviđene kliničke izloženosti.
English: • Hepatic impairment: Patients with clinically significant hepatic impairment may experience more adverse reactions.
Croatian: • Oštećenje jetre: Bolesnici s klinički značajnim oštećenjem jetre mogli bi osjetiti više nuspojava.
English: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Croatian: Većina slučajeva slučajnog predoziranja nije bila povezana s nekim od kliničkih znakova ili simptoma, a gotovo svi bolesnici, na koje se to odnosilo, nastavili su liječenje rivastigminom 24 sata nakon predoziranja.
English: • Take the syringe out of its protective case.
Croatian: • Izvadite dozirnu štrcaljku iz njezinog zaštitnog spremnika.
English: ITT - LOCF population (n=287)
Croatian: Populacija ITT - LOCF (n=287)
English: Positive ADCS-ADL changes indicate improvement.
Croatian: Pozitivne promjene na ADCS-ADL-u upućuju na poboljšanje.
English: Polyethylene terephthalate film, lacquered
Croatian: Polietilentereftalatni film, lakirani
English: EXP Use Prometax oral solution within 1 month of opening the bottle.
Croatian: EXP Upotrijebiti Prometax oralnu otopinu u roku od mjesec dana od otvaranja boce.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Prometax in all subsets of the paediatric population in the treatment of Alzheimer's dementia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Prometax u svim podskupinama pedijatrijske populacije u liječenju Alzheimerove demencije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Croatian: Varijabilnost između bolesnika s Alzheimerovom demencijom u stanju dinamičke ravnoteže bila je najviše 45% (Cmax) i 43% (AUC0-24h) nakon primjene transdermalnog flastera te 71% i 73% nakon primjene oralne formulacije.
English: • Loss of appetite
Croatian: • Gubitak apetita
English: Fall *In a 24-week controlled study in Japanese patients, application site erythema, application site oedema and application site pruritus were reported as “very common”.
Croatian: Pad *U 24-tjednom kontroliranom ispitivanju u japanskih bolesnika, eritem na mjestu primjene, edem na mjestu primjene i pruritus na mjestu primjene bili su zabilježeni kao „vrlo česti“.
English: If you have to undergo surgery whilst using Prometax transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Croatian: Ako se, tijekom primjene Prometax transdermalnih flastera morate podvrgnuti operaciji, obavijestite svog liječnika da ih koristite jer oni mogu tijekom anestezije pojačati učinke nekih mišićnih relaksansa.
English: • Slow and fast heartbeat
Croatian: • Usporeni i ubrzani otkucaji srca
English: Some people who have accidentally taken too much Prometax have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Croatian: Neki ljudi koji su slučajno uzeli previše Prometaxa su osjećali mučninu, povraćali, imali proljev, visoki krvni tlak i halucinacije.
English: Alpha-tocopherol Silicone oil Dimethicone
Croatian: Alfa-tokoferol Silikonsko ulje Dimetikon
English: Attaching the syringe to the bottle
Croatian: Umetanje štrcaljke u bocu
English: The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax transdermal patches: malaise, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Croatian: Sljedeće su nuspojave uočene samo s Prometax kapsulama i oralnom otopinom, a ne u kliničkim ispitivanjima s Prometax transdermalnim flasterima: malaksalost, smetenost, pojačano znojenje (često); ulkus na dvanaesniku, angina pectoris (rijetko); gastrointestinalno krvarenje (vrlo rijetko); a neki slučajevi teškog povraćanja bili su povezani s rupturom jednjaka (nepoznato).
English: • Increased sweating
Croatian: • Pojačano znojenje
English: Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
Croatian: Istodobna primjena rivastigmina s često propisivanim lijekovima kao što su antacidi, antiemetici, antidijabetici, antihipertenzivi sa središnjim djelovanjem, blokatori kalcijevih kanala, inotropni lijekovi, antianginalni lijekovi, nesteroidni protuupalni lijekovi, estrogeni, analgetici, benzodiazepini i antihistaminici, nije bila povezana s promjenom u kinetici rivastigmina ili s povećanim rizikom od klinički relevantnih nepovoljnih učinaka.
English: Also contains: sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) and purified water.
Croatian: Također sadrži: natrijev benzoat, citratnu kiselinu, natrijev citrat, boju kinolin žuta WS (E104) i pročišćenu vodu.
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 and dementia associated with Parkinson's disease.
Croatian: Blokiranjem tih enzima, Prometax omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove bolesti i demencije povezane s Parkinsonovom bolešću.
English: Overdose with Prometax transdermal patch resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting and rarely in clinical trials.
Croatian: Predoziranje Prometax transdermalnim flasterom koje je posljedica neodgovarajuće primjene/pogreške u doziranju (primjene više flastera istodobno) zabilježeno je nakon stavljanja lijeka u promet te rijetko u kliničkim ispitivanjima.
English: Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Croatian: Prometax može utjecati na antikolinergičke lijekove (lijekove koji se koriste za ublažavanje grčeva ili spazama u želucu, za liječenje Parkinsonove bolesti ili za sprečavanje mučnine na putovanju).
English: The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Croatian: Djelotvornost rivastigmina u demenciji povezanoj s Parkinsonovom bolešću pokazana je u 24-tjednom multicentričnom, dvostruko slijepom, placebo kontroliranom, osnovnom ispitivanju, te njegovoj 24tjednoj otvorenoj produženoj fazi.
English: It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
Croatian: Neki bolesnici, senzibilizirani na rivastigmin izlaganjem rivastigminskom flasteru, možda neće moći uzimati rivastigmin u bilo kojem obliku.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Prometax in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Prometax u svim podskupinama pedijatrijske populacije u liječenju Alzheimerove demencije te u liječenju demencije u bolesnika s idiopatskom Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Prometax transdermal patch.
Croatian: Kožne reakcije na mjestu primjene (obično blagi do umjereni eritem na mjestu primjene), najučestalije su nuspojave uočene s primjenom Prometax transdermalnih flastera.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Croatian: Poput drugih kolinomimetika, rivastigmin može pogoršati ili inducirati ekstrapiramidne simptome.
English: Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions.
Croatian: Bolesnici s klinički značajnim oštećenjem jetre mogu razviti više nuspojava ovisnih o dozi.
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Croatian: Bolesnici s tjelesnom težinom manjom od 50 kg mogu imati više nuspojava, pa je vjerojatnije da će prekinuti liječenje zbog nuspojava.
English: Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
Croatian: Titriranje doze: Nuspojave (npr. hipertenzija i halucinacije u bolesnika s Alzheimerovom demencijom te pogoršanje ekstrapiramidnih simptoma, osobito tremora, u bolesnika s demencijom povezanom s Parkinsonovom bolešću) zapažene su ubrzo nakon povećanja doze.
English: Urinary infection
Croatian: Urinarna inkontinencija
English: • Ulcers in your stomach or intestine
Croatian: • Čirevi na želucu ili crijevu
English: Prometax capsules 12 mg/day N = 256
Croatian: Prometax kapsule 12 mg/dan N=256
English: As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Prometax transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Croatian: S obzirom na to da je poluvijek rivastigmina u plazmi oko 3,4 sata, a trajanje inhibicije acetilkolinesteraze oko 9 sati, preporučuje se da se u slučajevima asimptomatskog predoziranja svi Prometax transdermalni flaster moraju se odmah ukloniti i novi se transdermalni flaster ne smije primijeniti sljedeća 24 sata.
English: No specific interaction studies have been performed with Prometax transdermal patches.
Croatian: Nisu provedena specifična ispitivanja interakcija s Prometax transdermalnim flasterima.
English: • The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Croatian: • Flaster ne smije biti izložen nikakvim vanjskim izvorima vrućine (npr. prekomjernoj sunčevoj svjetlosti, saunama, solariju) tijekom duljih vremenskih razdoblja.
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis (disseminated) Renal and urinary disorders Common
Croatian: Svrbež, eritem, urtikarija, vezikule, alergijski dermatitis (diseminirani) Poremećaji bubrega i mokraćnog sustava Često
English: One of the excipients in Prometax oral solution is sodium benzoate.
Croatian: Jedna od pomoćnih tvari u Prometax oralnoj otopini je i natrijev benzoat.
English: Prometax 9 mg/5 cm 2, 18 mg/10 cm and 27 mg/15 cm transdermal patches are individually packaged in child-resistant, heat-sealed sachets made of a paper/polyethyleneterephthalate/aluminum/polyacrylnitrile (PAN) multi-laminated material (paper/PET/alu/PAN) or in heat-sealed, child-resistant sachets made of multi-layer composite laminate consisting of paper/polyethylene terephthalate/polyethylene/aluminum/polyamide (paper/PET/PE/alu/PA).
Croatian: 6.5 Vrsta i sadržaj spremnika Prometax 9 mg/5 cm2, 18 mg/10 cm i 27 mg/15 cm transdermalni flasteri su pojedinačno pakirani u vrećice sa sigurnosnom zaštitom za djecu koje su zatvorene toplinom i izrađene od papir/polietilentereftalat/aluminij/poliakrilonitril (PAN) multilaminatnog materijala (papir/PET/alu/PAN) ili u vrećice sa sigurnosnom zaštitom za djecu koje su zatvorene toplinom i izrađene od papir/polietilentereftalat/polietilen/aluminij/poliamid multilaminatnog materijala (papir/PET/PE/alu/PA).
English: The prescribed amount of solution should be withdrawn from the bottle using the oral dosing syringe supplied.
Croatian: Propisana količina otopine mora se iz boce uzeti priloženom dozirnom štrcaljkom za usta.
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Croatian: Na temelju dokaza iz ispitivanja u životinja, glavni izoenzimi citokroma P450 minimalno su uključeni u metabolizam rivastigmina.
English: The oral solution is packaged with an oral dosing syringe in a plastic tube container.
Croatian: Oralna otopina pakirana je sa dozirnom štrcaljkom za usta u plastičnom cjevastom spremniku.
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 24 hours after the overdose.
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 24 sata nakon predoziranja.
English: If you forget to take Prometax
Croatian: Ako ste zaboravili uzeti Prometax
English: Aggression, restlessness
Croatian: Agresivnost, nemir
English: Extrapyramidal symptoms
Croatian: Ekstrapiramidni simptomi
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g. oxybutynin, tolterodine).
Croatian: Rivastigmin može utjecati na djelovanje antikolinergika (npr. oksibutinina, tolterodina).
English: Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.
Croatian: Rivastigmin oralna otopina može se uzimati naizmjenično s jednakim dozama rivastigmin kapsula.
English: A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Croatian: U bolesnika s Alzheimerovom demencijom uočena je povezanost između izloženosti djelatnoj tvari u stanju dinamičke ravnoteže (rivastigmin i metabolit NAP226-90) i tjelesne težine.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with Prometax.
Croatian: Sljedeće nuspojave, navedene u Tablici 1, prikupljene su u bolesnika s Alzheimerovom demencijom liječenih Prometaxom.
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Croatian: Rezultati ADAS-cog-a: Negativna razlika u DLSM-u upućuje na veće poboljšanje kod Prometaxa 15 cm u usporedbi s Prometaxom 10 cm
English: Patients with severe hepatic impairment have not been studied, however, Prometax capsules may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Croatian: Nisu proučavani bolesnici s teškim oštećenjem jetre, međutim, Prometax kapsule mogu se primjenjivati u ovoj bolesničkoj populaciji pod uvjetom da se provodi pažljivo praćenje (vidjeti dijelove 4.4 i 5.2).
English: Caution is advised in patients at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes (see sections 4.5 and 4.8).
Croatian: Savjetuje se oprez u bolesnika s visokim rizikom od razvoja torsades de pointes; primjerice, bolesnici s nekompenziranim zatajenjem srca, nedavnim infarktom miokarda, bradiaritmijama, predispozicijom za hipokalijemiju ili hipomagnezijemiju ili bolesnici koji istodobno uzimaju lijekove za koje je poznato da induciraju produženje QT- intervala i/ili torsades de pointes (vidjeti dijelove 4.5 i 4.8).
English: - if you have, or have ever had, asthma or severe respiratory disease.
Croatian: - ako imate ili ste imali astmu ili tešku bolest dišnih puteva.
English: ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Croatian: Rezultati ADCS-IADL-a: Pozitivna razlika u DLSM-u upućuje na veće poboljšanje kod Prometaxa 15 cm u usporedbi s Prometaxom 10 cm
English: ADCS-CGIC scores <4 indicate improvement.
Croatian: Rezultati na ADCS-CGIC-u od <4 upućuju na poboljšanje.
English: After using the syringe
Croatian: Nakon primjene štrcaljke
English: • Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
Croatian: • Bolesnici s tjelesnom težinom manjom od 50 kg mogu imati više nuspojava te je vjerojatnije da će prekinuti liječenje zbog nuspojava (vidjeti dio 4.2).
English: In other cases, Prometax has been discontinued (see section 4.8).
Croatian: U ostalim je slučajevima prekinuta primjena Prometaxa (vidjeti dio 4.8).
English: If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor.
Croatian: Ako niste stavljali flaster više od tri dana, sljedeći flaster nemojte stavljati dok se ne posavjetujete sa svojim liječnikom.
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Croatian: Blagi potencijal rivastigmina za nadražaj oka/sluznice uočen je u ispitivanju provedenom na zečevima.
English: Clinical studies in dementia associated with Parkinson's disease
Croatian: Klinička ispitivanja u demenciji povezanoj s Parkinsonovom bolešću
English: Mean change at week 24  SD -0.6  6.4 p-value versus placebo
Croatian: Srednja početna vrijednost  SD Srednja promjena nakon 24 tjedna  SD -0,6  6,4 p-vrijednost u odnosu na placebo ADCS-CGIC
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Croatian: Zbog osjetljivosti korištenih životinjskih modela, u ispitivanjima na životinjama nisu postignute granice sigurnosti za izloženost kod ljudi lijeku.
English: After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.
Croatian: Nakon prijelaza na transdermalni flaster u dozi od 4,6 mg/24 h, pod uvjetom da se dobro podnosi nakon najmanje četiri tjedna liječenja, dozu od 4,6 mg/24 h potrebno je povećati na 9,5 mg/24 h, što je preporučena djelotvorna doza.
English: • Take Prometax twice a day, in the morning and evening, with food.
Croatian: • Prometax morate uzimati dvaput na dan, jednom uz doručak i jednom uz večeru.
English: Prometax 2 mg/ml [folding box only]
Croatian: Prometax 2 mg/ml [samo kutija]
English: • Uneven heart rate (e.g. fast heart rate)
Croatian: • Nepravilan srčani ritam (npr. ubrzan rad srca)
English: Poly(butylmethacrylate, methylmethacrylate) Acrylic copolymer
Croatian: Poli(butilmetakrilat, metillmetakrilat), Akrilni kopolimer
English: Prometax capsules 12 mg/day
Croatian: Prometax kapsule 12 mg/dan
English: However, these events did not occur at a higher frequency with Prometax 13.3 mg/24 h transdermal patches than with placebo.
Croatian: Međutim, ti se događaji nisu javljali učestalije s Prometax transdermalnim flasterima od 13,3 mg/24 h nego s placebom.
English: The following additional adverse reactions have been observed with Prometax transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Croatian: Kod primjene Prometax transdermalnog flastera zabilježene su sljedeće dodatne nuspojave: delirij, pireksija, smanjeni apetit, inkontinencija mokraće (često), psihomotorička hiperaktivnost (manje često), eritem, urtikarija, vezikule, alergijski dermatitis (nepoznato).
English: • The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling
Croatian: • Pogoršanje znakova Parkinsonove bolesti - kao što su nevoljno drhtanje, ukočenost i poteškoće pri kretanju
English: • Wipe the outside of the syringe with a clean tissue.
Croatian: • Obrišite vanjski dio štrcaljke čistom maramicom.
English: Headache, syncope, dizziness
Croatian: Glavobolja, sinkopa, omaglica
English: • Generally feeling unwell
Croatian: • Općenito loše osjećanje
English: Abdominal pain and dyspepsia
Croatian: Bol u abdomenu i dispepsija
English: • Tell your caregiver that you are taking Prometax.
Croatian: • Osobi koja brine o Vama recite da uzimate Prometax.
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Croatian: Posljedično, rivastigmin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Cut the sachet along the dotted line with scissors and remove the patch from the sachet.
Croatian: Škarama prerežite vrećicu uzdužno po točkastoj crti i izvadite flaster iz vrećice.
English: • Accidentally falling
Croatian: • Nehotično padanje
English: Prometax might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
Croatian: Prometax može utjecati na antikolinergičke lijek (lijekovi koji se koriste za ublažavanje grčeva ili spazama u želucu (npr. diciklomin), za liječenje Parkinsonove bolesti (npr. amantadin) ili za sprječavanje putne mučnine (npr. difenhidramin, skopolamin ili meklizin).
English: The outer layer is beige and labelled with the following: - “Prometax”, “4.6 mg/24 h” and “AMCX”, - “Prometax”, “9.5 mg/24 h” and “BHDI”, - “Prometax”, “13.3 mg/24 h” and “CNFU”.
Croatian: Vanjski je sloj bež boje i označen sljedećim oznakama: - „Prometax“, „4,6 mg/24 h“ i „AMCX“, - „Prometax“, „9,5 mg/24 h“ i „BHDI“, - „Prometax“, „13,3 mg/24 h“ i „CNFU“.
English: • Only wear one Prometax patch at a time and replace the patch with a new one after 24 hours.
Croatian: • Smije se primijeniti samo jedan Prometax flaster koji je potrebno zamijeniti novim flasterom nakon 24 sata.
English: Only one patch should be worn at a time (see section 4.9).
Croatian: Odjednom se smije nositi samo jedan flaster (vidjeti dio 4.9).
English: 250 hard capsules
Croatian: 250 tvrdih kapsula