FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with Prometax.
Slovenian: Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z zdravilom Prometax.
English: The results for clinically relevant responders from the 24-week placebo-controlled study are provided in Table 3.
Slovenian: Rezultati bolnikov s klinično pomembnim odzivom iz 24-tedenske s placebom kontrolirane študije so navedeni v preglednici 3.
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).
Slovenian: Naslednji neželeni učinek so, poleg že navedenih, opažali v študiji pri bolnikih, ki so imeli demenco v povezavi s Parkinsonovo boleznijo in so bili zdravljeni s transdermalnimi obliži Prometax: agitiranost (pogosti).
English: Mean baseline  SD Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Slovenian: Povprečje ob izhodišču  SD 50,1  16,3 Povprečna sprememba po 24 tednih  SD Vrednost p proti placebu * p≤0,05 proti placebu ITT: namen zdraviti (Intent-To-Treat); LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward) Na podlagi ANCOVA z zdravljenjem in državo kot faktorjema in izhodiščno vrednostjo kot sospremenljivko.
English: • The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling
Slovenian: • poslabšanje znakov Parkinsonove bolezni - kot so tremor, okorelost in težave pri hoji
English: • The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Slovenian: • Obliža se ne sme izpostavljati zunanjim virom toplote (na primer prekomernemu sončenju, savni, solariju) za daljši čas.
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Slovenian: • bolnikom s sindromom bolnega sinusnega vozla ali prevodnimi motnjami (sinuatrialni blok, atrioventrikularni blok) (glejte poglavje 4.8);
English: • Push down and pull up the plunger a few times to get rid of any large bubbles.
Slovenian: • Bat nekajkrat potisnite navzdol in spet povlecite navzgor, s čimer odstranite večje mehurčke.
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses for up to 12 mg/day.
Slovenian: Rezultati populacijske farmakokinetične analize so pokazali, da pri bolnikih z Alzheimerjevo boleznijo (n=75 kadilcev in 549 nekadilcev) uporaba nikotina za 23 % poveča očistek rivastigmina pri peroralnem odmerjanju rivastigmina v kapsulah v odmerkih do 12 mg/dan.
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g. oxybutynin, tolterodine).
Slovenian: Rivastigmin lahko moti delovanje antiholinergičnih zdravil (na primer oksibutinina in tolterodina).
English: Also contains: sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) and purified water.
Slovenian: Vsebuje tudi: natrijev benzoat, citronsko kislino, natrijev citrat, kinolinsko rumeno barvilo (E104) in prečiščeno vodo.
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.
Slovenian: Če morate v času jemanja zdravila Prometax na operacijo, povejte zdravniku, da jemljete zdravilo Prometax, preden dobite kakršnokoli anestezijo, ker lahko zdravilo Prometax med anestezijo poveča učinke nekaterih mišičnih relaksantov.
English: One transdermal patch is sealed in one sachet.
Slovenian: V eni vrečki je zaprt en transdermalni obliž.
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.
Slovenian: • Če se obliž odlepi, je treba namestiti nov obliž za preostanek tega dne, nato pa novi obliž naslednji dan zamenjati ob istem času kot običajno.
English: Talk to your doctor before taking Prometax: - if you have, or have ever had, irregular or slow heartbeat.
Slovenian: Pred začetkom jemanja zdravila Prometax se posvetujte z zdravnikom: - če imate ali če ste kdaj imeli nepravilen ali počasen srčni utrip, - če imate ali če ste kdaj imeli aktivno želodčno razjedo,
English: Clinical studies in dementia associated with Parkinson's disease
Slovenian: Klinične študije pri demenci, povezani s Parkinsonovo boleznijo
English: At steady state, trough levels are approximately 50% of peak levels, in contrast to oral administration, with which concentrations fall off to virtually zero between doses.
Slovenian: V stanju dinamičnega ravnovesja je spodnja meja fluktuacije koncentracije približno 50 % vrednosti zgornje meje, v nasprotju s peroralnim odmerjanjem, pri katerem se koncentracije med odmerjanji znižajo praktično na nič.
English: Misuse of the medicinal product and dosing errors resulting in overdose
Slovenian: Preveliko odmerjanje zaradi nepravilne uporabe in napak pri odmerjanju zdravila
English: • Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium)
Slovenian: - Obliža ne izpostavljajte zunanjim virom toplote (na primer prekomernemu sončenju, savni,
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Slovenian: CIBIC-Plus: izboljšanje PDS: izboljšanje za najmanj
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).
Slovenian: Po odmerjanju enkratnih peroralnih odmerkov 3 mg ali 6 mg je bil povprečni peroralni očistek rivastigmina pri bolnikih z blago do zmerno okvaro jeter (n=10, z oceno 5-12 na Child-Pughovi lestvici in s potrditvijo z biopsijo) približno za 46-63 % manjši kot pri zdravih osebah (n=10).
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)).
Slovenian: Fluktuacijski indeks(FI), ki izraža relativno razliko med najvišjimi in najnižjimi koncentracijami ((Cmax-Cmin)/Cavg; pri tem je Cavg povprečna koncentracija v obdobju odmerjanja), je bil 0,58 pri transdermalnih obližih Prometax 4,6 mg/24 h, 0,77 pri transdermalnih obližih Prometax 9,5 mg/24 h in 0,72 pri transdermalnih obližih Prometax 13,3 mg/24 h, kar kaže na veliko manjšo fluktuacijo od najnižjih do najvišjih koncentracij kot pri peroralnem odmerjanju (FI = 3,96 za odmerjanje 6 mg/dan in 4,15 za odmerjanje 12 mg/dan).
English: Infections and infestations Very rare
Slovenian: Infekcijske in parazitske bolezni zelo redki okužba sečil
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.
Slovenian: Interindividualna variabilnost v študiji dinamičnega ravnovesja pri bolnikih z Alzheimerjevo demenco je bila največ 45 % za Cmax in 43 % za AUC0-24h po uporabi transdermalnega obliža v primerjavi z 71 % za Cmax in 73 % za AUC0-24h po aplikaciji peroralne oblike.
English: Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original sachet and discarded safely and out of the reach and sight of children.
Slovenian: Po uporabi transdermalni obliž prepognite na pol z lepljivo stranjo navznoter, vložite v originalno vrečko in varno zavrzite nedosegljivo otrokom.
English: If treatment is interrupted for more than three days, it should be re-initiated with 4.6 mg/24 h.
Slovenian: Če zdravljenje prekinemo za več kot tri dni, ga moramo spet začeti z odmerkom 4,6 mg/24 h.
English: Prometax capsules 12 mg/day
Slovenian: Prometax kapsule 12 mg/dan
English: Taking the two medicines together could cause problems such as such as stiff limbs and trembling hands.
Slovenian: Sočasno jemanje obeh navedenih zdravil lahko povzroči težave, kot sta okorelost okončin in tresenje rok.
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Slovenian: C, je bilo ledvično izločanje hitro, saj se je dejansko ves (>90 %) izločil v 24 urah.
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.
Slovenian: Zdravilo Prometax z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni in demence v povezavi s Parkinsonovo boleznijo.
English: Prometax contains sodium benzoate
Slovenian: Zdravilo Prometax vsebuje natrijev benzoat
English: The efficacy of Prometax transdermal patches in patients with Alzheimer's dementia has been demonstrated in a 24-week double-blind, placebo-controlled core study and its open-label extension phase and in a 48-week double-blind comparator study.
Slovenian: Učinkovitost transdermalnih obližev Prometax pri bolnikih z Alzheimerjevo demenco so dokazali v 24-tedenski dvojno slepi, s placebom kontrolirani osnovni študiji in njenem odprtem podaljšku ter v 48-tedenski dvojno slepi primerjalni študiji.
English: If you accidentally take more Prometax than you should, inform your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Prometax, kot bi smeli Če nehote vzamete več zdravila Prometax, kot bi smeli, obvestite svojega zdravnika.
English: Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions.
Slovenian: Pri bolnikih s klinično pomembno okvaro jeter lahko število od odmerka odvisnih neželenih učinkov večje.
English: If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Slovenian: Na obliž lahko s tankim kemičnim svinčnikom napišete na primer dan v tednu, če vam je to v pomoč.
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);
Slovenian: • bolnikom z aktivnimi razjedami želodca ali dvanajstnika ali bolnikom z nagnjenostjo k tem boleznim, ker rivastigmin lahko povzroči povečano izločanje želodčne kisline (glejte poglavje 4.8);
English: Cut the sachet along the dotted line with scissors and remove the patch from the sachet.
Slovenian: Vrečko s škarjami prerežite po črtkani črti in izvlecite obliž iz vrečke.
English: Prometax oral solution should be used within 1 month of opening the bottle.
Slovenian: Peroralno raztopino Prometax je treba porabiti v enem mesecu po prvem odprtju steklenice.
English: n Mean n Mean DLS M
Slovenian: n povpre čje n povpre čje
English: Prometax 2 mg/ml [folding box only]
Slovenian: Prometax 2 mg/ml [samo na škatli]
English: When observed in patients treated with Prometax transdermal patches, skin irritation was mostly slight or mild in severity.
Slovenian: Pri bolnikih, ki so se zdravili s transdermalnimi obliži Prometax, so večinoma opažali le rahlo ali blago izraženo vnetje.
English: • Patient reminder card
Slovenian: • opozorilno kartico za bolnika,
English: • Paediatric population: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Slovenian: • Pediatrična populacija: Zdravilo Prometax ni namenjeno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
English: Particular caution should be exercised in titrating these patients (see sections 4.4 and 5.2).
Slovenian: Pri titriranju odmerka tem bolnikom je potrebna posebna previdnost (glejte poglavji 4.4 in 5.2).
English: If you forget to use Prometax
Slovenian: Če ste pozabili uporabiti zdravilo Prometax
English: The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Prometax transdermal patches.
Slovenian: Do reakcij na mestu aplikacije, zaradi katerih je bilo treba zdravljenje prekiniti, je prišlo pri ≤2,3 % bolnikov, ki so se zdravili s transdermalnimi obliži Prometax.
English: A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Slovenian: Pri bolnikih z Alzheimerjevo demenco so opazovali razmerje med telesno maso in izpostavljenostjo zdravilni učinkovini (rivastigminu in presnovku NAP226-90) v stanju dinamičnega ravnovesja.
English: Crivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Slovenian: C, je bilo ledvično izločanje hitro, saj se je dejansko ves (> 90 %) izločil v 24 urah.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Slovenian: V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, za 10
English: • The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Slovenian: • Obliž je treba z dlanjo čvrsto pritiskati na kožo najmanj 30 sekund, dokler se robovi dobro ne prilepijo.
English: 28 hard capsules
Slovenian: 28 trdih kapsul
English: Particular caution must be exercised in titrating these patients (see sections 4.2 and 5.2).
Slovenian: Pri titriranju odmerka tem bolnikom je potrebna posebna previdnost (glejte poglavji 4.2 in 5.2)
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Slovenian: V preglednici 1 so neželeni učinki navedeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
English: EXP Use Prometax oral solution within 1 month of opening the bottle.
Slovenian: EXP Peroralno raztopino Prometax porabite v 1 mesecu po prvem odprtju steklenice.
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).
Slovenian: • Pri bolnikih s telesno maso manjšo od 50 kg je lahko število neželenih učinkov večje, obstaja pa tudi večja verjetnost, da bodo zaradi neželenih učinkov zdravljenje prekinili (glejte poglavje 4.2).
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).
Slovenian: Naslednje neželene učinke so opažali samo pri uporabi kapsul in peroralne raztopine Prometax, ne pa v kliničnih študijah s transdermalnimi obliži Prometax: splošno slabo počutje, zmedenost, povečano potenje (pogosto); razjede dvanajstnika, angino pektoris (redko); krvavitev v prebavila (zelo redko); in nekaj primerov hudega bruhanja, ki je bilo povezano z rupturo požiralnika (pogostnost neznana).
English: • Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Slovenian: Po rokovanju s transdermalnimi obliži Prometax se ne sme dotikati oči (glejte poglavje 5.3).
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.
Slovenian: Nato obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund, da se robovi obliža dobro prilepijo.
English: If you forget to take Prometax
Slovenian: Če ste pozabili vzeti zdravilo Prometax
English: You should not breast-feed during treatment with Prometax.
Slovenian: Med zdravljenjem z zdravilom Prometax ne smete dojiti.
English: • The highest dose that should be taken is 6.0 mg twice a day.
Slovenian: • Najvišji dovoljeni odmerek je 6,0 mg dvakrat na dan.
English: Carefully remove the existing patch before putting on a new one.
Slovenian: Previdno odstranite obliž, ki je že na koži, in šele potem namestite novega.
English: • Use Prometax oral solution within 1 month of opening the bottle.
Slovenian: • Peroralno raztopino Prometax porabite v 1 mesecu po prvem odprtju steklenice.
English: Rare (may affect up to 1 in 1,000 people) • Falling
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • padci
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Slovenian: ITT: namen zdraviti (Intent-To-Treat); RDO: upoštevani izpadli primeri (Retrieved Drop Outs); LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward)
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.
Slovenian: Ker ima rivastigmin plazemski razpolovni čas okrog 3,4 ure in trajanje zaviranja acetilholinesteraze okrog 9 ur, v primeru asimptomatičnega prevelikega odmerka priporočamo takojšnjo odstranitev vseh transdermalnih obližev Prometax.
English: 112 hard capsules
Slovenian: 112 trdih kapsul
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Slovenian: Zato bi lahko rivastigmin izboljšal stanje holinergično posredovanega upada kognitivnih funkcij pri demenci, povezani z Alzheimerjevo boleznijo in s Parkinsonovo boleznijo.
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Slovenian: Prav tako so boljši učinek opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli vidne halucinacije (glejte poglavje
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”.
Slovenian: Zunanja plast je rjavkasto bele barve z eno od naslednjih oznak: - “Prometax”, “4.6 mg/24 h” in “AMCX”, - “Prometax”, “9.5 mg/24 h” in “BHDI”, - “Prometax”, “13.3 mg/24 h” in “CNFU”.
English: 56 hard capsules
Slovenian: 56 trdih kapsul
English: FOLDING BOX AND BOTTLE LABEL
Slovenian: NALEPKA NA ŠKATLI IN STEKLENICI
English: What you need to know before you use Prometax
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Prometax
English: 95% CI p-value
Slovenian: DLSM 95% IZ
English: 7 transdermal patches 30 transdermal patches
Slovenian: 7 transdermalnih obližev 30 transdermalnih obližev
English: If you are pregnant, the benefits of using Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.
Slovenian: V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Prometax in možne učinke na nerojenega otroka.
English: Alpha-tocopherol Silicone oil Dimethicone
Slovenian: Adhezivni matriks zdravila α-tokoferol silikonsko olje dimetikon
English: Attaching the syringe to the bottle
Slovenian: Nameščanje brizge na steklenico
English: Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.
Slovenian: Vsak obliž je zaprt v vrečki, ki ga ščiti, dokler ga ne želite namestiti.
English: • Fainting or accidentally falling
Slovenian: • omedlevica ali nezgodni padci
English: What you need to know before you take Prometax
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Prometax
English: No dose adjustment is necessary in patients with renal impairment (see section 4.2).
Slovenian: Pri bolnikih z okvaro ledvic prilagajanje odmerkov ni potrebno (glejte poglavje 4.2).
English: • Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose exceeding 10
Slovenian: V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, ki je 104-krat presegal dotedanjo klinično izpostavljenost.
English: Your doctor will also monitor your weight whilst you are taking this medicine.
Slovenian: V času jemanja tega zdravila bo zdravnik spremljal tudi vašo telesno maso.
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).
Slovenian: Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Prometax v obliki kapsul, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in 5.2).
English: ITT + RDO population (n=87)
Slovenian: Skupina ITT + RDO (n=87)
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.
Slovenian: Če bolnik po prehodu na zdravljenje s transdermalnimi obliži 4,6 mg/24 h ta odmerek dobro prenaša, je treba po najmanj štirih tednih zvišati odmerek s 4,6 mg/24 h na 9,5 mg/24 h, kar je priporočeni učinkoviti odmerek.
English: One of the inactive ingredients in Prometax oral solution is sodium benzoate.
Slovenian: Ena od neaktivnih sestavin peroralne raztopine Prometax je natrijev benzoat.