FrancophonIA/ELRC3.0 huggingface dataset:
English: • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases;
Slovenian: • bolnikom, ki so nagnjeni k zapori sečnih izvodil in k epileptičnim napadom, ker holinomimetiki lahko sprožijo te bolezni ali njihovo poslabšanje;
English: What Prometax is and what it is used for
Slovenian: Kaj je zdravilo Prometax in za kaj ga uporabljamo
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Slovenian: Kapsule in peroralno raztopino lahko uporabljamo tudi za zdravljenje demence pri odraslih bolnikih s Parkinsonovo boleznijo.
English: Your doctor will tell you what dose of Prometax to take.
Slovenian: Zdravnik vam bo povedal, kakšen odmerek zdravila Prometax morate jemati.
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
Slovenian: • Namestite EN obliž na dan na SAMO ENO od možnih mest, ki so prikazana na naslednji skici: levi nadlaket ali desni nadlaket levi zgornji del prsi ali desni zgornji del prsi (ne na dojko) levi zgornji del hrbta ali desni zgornji del hrbta levi spodnji del hrbta ali desni spodnji del hrbta
English: • Trembling or feeling confused
Slovenian: • tresenje ali občutek zmedenosti
English: • The patch should be replaced by a new one after 24 hours.
Slovenian: • Obliž je treba po 24 urah zamenjati z novim.
English: • After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Slovenian: • Po odstranitvi obliža s kože ga prepognite na pol z lepljivo stranjo navznoter in stisnite.
English: Only one patch should be worn at a time (see section 4.9).
Slovenian: Nameščen sme biti samo en obliž naenkrat (glejte poglavje 4.9).
English: If you have not taken Prometax for more than three days, do not take the next dose until you have talked to your doctor.
Slovenian: Če zdravila Prometax niste jemali že več kot tri dni, ne vzemite naslednjega odmerka, dokler se ne pogovorite s svojim zdravnikom.
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).
Slovenian: Zaradi nepravilne uporabe in napak pri odmerjanju zdravila Prometax je prišlo do resnih neželenih učinkov; v nekaterih primerih je bila potrebna hospitalizacija, redko pa je prišlo do smrtnega izida (glejte poglavje 4.9).
English: • to patients with a history of asthma or obstructive pulmonary disease.
Slovenian: • bolnikom z anamnezo astme ali obstruktivne pljučne bolezni.
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.
Slovenian: Preglednica 3 navaja število in delež bolnikov iz specifične 24-tedenske klinične študije z zdravilom Prometax pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, z vnaprej opredeljenimi neželenimi dogodki, ki lahko odražajo poslabšanje simptomov Parkinsonove bolezni.
English: • Fast or uneven heartbeat
Slovenian: • hitro ali neenakomerno bitje srca
English: How to apply your Prometax transdermal patch Prometax patches are thin, opaque, plastic patches that stick to the skin.
Slovenian: Kako namestiti transdermalni obliž Prometax Obliži Prometax so tanki neprozorni plastični obliži, ki jih prilepite na kožo.
English: times the maximum clinical exposure.
Slovenian: 4-krat večjem od največje klinične izpostavljenosti.
English: The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Slovenian: Obliži so na voljo v pakiranju, ki vsebuje 7 ali 30 vrečk in v skupnem pakiranju, ki vsebuje 60 ali 90 vrečk.
English: Patients and their caregivers must be instructed on important administration instructions for Prometax transdermal patch (see section 4.2).
Slovenian: Bolnike in njihove negovalce je treba opozoriti na pomembne napotke za uporabo transdermalnega obliža Prometax (glejte poglavje 4.2).
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.
Slovenian: Zdravilo Prometax uporabljamo za zdravljenje odraslih bolnikov z blago do zmerno hudo Alzheimerjevo demenco, to je napredujoča bolezen možganov, ki postopoma prizadene spomin in intelektualne sposobnosti ter vpliva na vedenje bolnika.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Slovenian: Pred prihodom zdravila na trg mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici od nacionalnega pristojnega organa pridobiti soglasje za izobraževalno gradivo.
English: • Swallow your medicine straight from the syringe.
Slovenian: • Zdravilo zaužijte naravnost iz brizge.
English: If you stop using Prometax Tell your doctor or pharmacist if you stop using the patch.
Slovenian: Če ste prenehali uporabljati zdravilo Prometax Svojemu zdravniku povejte, če ste prenehali uporabljati obliže.
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:
Slovenian: Prehod z zdravljenja s kapsulami ali peroralno raztopino na zdravljenje z obliži Glede na to, da je izpostavljenost rivastigminu primerljiva pri peroralni in transdermalni aplikaciji (glejte poglavje 5.2), lahko bolniki, ki se zdravijo s kapsulami ali peroralno raztopino Prometax, preidejo na zdravljenje s transdermalnimi obliži Prometax na naslednji način:
English: Patients and caregivers should be instructed on important administration instructions:
Slovenian: Bolnike in negovalce je treba opozoriti na pomembne napotke za uporabo zdravila:
English: It is recommended to apply the first transdermal patch on the day following the last oral dose.
Slovenian: Prvi transdermalni obliž je priporočljivo namestiti na dan, ki sledi dnevu zadnjega peroralnega odmerka.
English: • Hepatic impairment: Patients with clinically significant hepatic impairment may experience more adverse reactions.
Slovenian: • Okvara jeter: Pri bolnikih s klinično pomembno okvaro jeter je lahko število neželenih učinkov večje.
English: If this applies to you, tell your doctor and do not take Prometax.
Slovenian: Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne jemljite zdravila Prometax.
English: [folding box only]
Slovenian: [samo na škatli]
English: • Feeling agitated or sleepy
Slovenian: • občutek vznemirjenosti ali zaspanost
English: • Aggression
Slovenian: • agresivnost
English: The 48-week results for the two assessment tools are summarised in Table 4.
Slovenian: 48-tedenski rezultati teh dveh metod ocenjevanja so zbrani v preglednici 4.
English: Less than 1% of the administered dose is excreted in the faeces.
Slovenian: Manj kot 1 % apliciranega odmerka se izloči z blatom.
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.
Slovenian: Učinkovitost rivastigmina pri demenci, povezani s Parkinsonovo boleznijo, so pokazali v 24-tedenski multicentrični, dvojno slepi, s placebom kontrolirani osnovni študiji in njeni 24-tedenski odprti podaljšani fazi.
English: Available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Slovenian: Na voljo so v pakiranju, ki vsebuje 7 ali 30 vrečk, in v skupnem pakiranju, ki vsebuje 60 ali 90 vrečk.
English: In two 24-week double-blind, placebo-controlled clinical trials, skin reactions were measured at each visit using a skin irritation rating scale.
Slovenian: V dveh 24-tedenskih dvojno slepih, s placebom kontroliranih kliničnih študijah so kožne reakcije pri vsakem obisku merili s pomočjo lestvice za oceno kožnega vnetja.
English: However, these events did not occur at a higher frequency with Prometax 13.3 mg/24 h transdermal patches than with placebo.
Slovenian: Vendar pa se ti dogodki niso pojavljali pogosteje pri uporabi transdermalnega obliža Prometax 13,3 mg/24 h v primerjavi s placebom.
English: Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.
Slovenian: Najprej odstranite eno polovico zaščitne plasti in se pri tem s prsti ne dotikajte lepljivega dela obliža.
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.
Slovenian: • Okvara jeter: Zaradi povečane izpostavljenosti zdravilu pri blagi do zmerni okvari jeter, kar so opažali pri uporabi peroralnih oblik zdravila, se je treba natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje.
English: Like all medicines, Prometax transdermal patches can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila imajo lahko tudi transdermalni obliži Prometax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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).
Slovenian: Transdermalni obliži Prometax jakosti 9 mg/5 cm 2, 18 mg/10 cm in 27 mg/15 cm so posamično pakirani v za otroke varne, toplotno zavarjene vrečke, narejene iz multilaminatnega materiala iz papirja/polietilen tereftalata/aluminija/poliakrilonitrila (PAN) (papir/PET/alu/PAN) ali v toplotno zavarjene, za otroke varne vrečke, narejene iz večplastne kompozitne folije iz papirja/polietilen tereftalata/polietilena/aluminija/poliamida (papir/PET/PE/alu/PA).
English: • The recommended usual daily dose is Prometax 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
Slovenian: • Priporočeni običajni dnevni odmerek zdravila Prometax je 9,5 mg/24 h. Če ta odmerek dobro prenašate, lahko lečeči zdravnik razmisli o zvišanju odmerka na 13,3 mg/24 h.
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Slovenian: Izpostavljenost rivastigminu in njegovim presnovkom, preračunana na telesno površino, je bila približno enakovredna največjemu priporočenemu odmerku za ljudi 12 mg/dan; vendar je bil v primerjavi z največjim odmerkom za ljudi dosežen pri živalih približno njegov 6-kratni mnogokratnik.
English: - HDPE bottles with plastic closure with induction innerseal.
Slovenian: - Steklenice iz HDPE s plastično zaporko z zaščitno folijo.
English: Care must be taken when prescribing Prometax transdermal patches:
Slovenian: Previdnost je potrebna pri predpisovanju transdermalnih obližev Prometax:
English: • Wipe the outside of the syringe with a clean tissue.
Slovenian: • Zunanjost brizge obrišite s čisto krpo.
English: Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Slovenian: O prekinitvi zdravljenja je treba razmisliti tudi v primeru, da pri uporabi optimalnega odmerka ni več znakov terapevtskih koristi.
English: If this applies to you, tell your doctor and do not apply Prometax transdermal patches.
Slovenian: Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne uporabljajte transdermalnih obližev Prometax.
English: • Take Prometax twice a day, in the morning and evening, with food.
Slovenian: • Zdravilo Prometax jemljite s hrano dvakrat na dan, zjutraj in zvečer.
English: ITT - LOCF population (n=287)
Slovenian: Skupina ITT - LOCF (n=287)
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.
Slovenian: Preglednica 2 prikazuje neželene učinke, o katerih so poročali iz kliničnih študij, ki so jih izvajali pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, zdravljenih s kapsulami zdravila Prometax.
English: Absorption of rivastigmine from Prometax transdermal patches is slow.
Slovenian: Rivastigmin se iz transdermalnih obližev Prometax absorbira počasi.
English: • Only wear one Prometax patch at a time and replace the patch with a new one after 24 hours.
Slovenian: • Nosite samo en transdermalni obliž Prometax naenkrat in ga po 24 urah zamenjajte z novim.
English: • Treatment usually starts with Prometax 4.6 mg/24 h.
Slovenian: • Zdravljenje se običajno začne z obližem Prometax 4,6 mg/24 h.
English: Some people who have accidentally taken too much Prometax have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Slovenian: Pri nekaterih ljudeh, ki so nehote vzeli preveč zdravila Prometax, je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, visokega krvnega tlaka in halucinacij.
English: Prometax may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Slovenian: Zdravilo Prometax lahko povzroči vrtoglavost in zaspanost, predvsem na začetku zdravljenja ali ob povečanju odmerka.
English: • Instructions to provide patients and caregivers with the patient reminder card
Slovenian: • navodila za izročanje opozorilne kartice za bolnika bolnikom in negovalcem.
English: If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Slovenian: Če ste uporabili večji odmerek zdravila Prometax, kot bi smeli Če ste nehote namestili več kot en obliž, odstranite s kože vse obliže in obvestite zdravnika, da ste nehote namestili več kot en obliž.
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.
Slovenian: Če obliža niste namestili kot tri dni, ne nameščajte naslednjega, dokler se ne pogovorite s svojim zdravnikom.
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.
Slovenian: Zdravilo Prometax z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni.
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.
Slovenian: Če morate v času uporabe transdermalnih obližev Prometax na operacijo, morate obvestiti zdravnika, da jih uporabljate, ker lahko med anestezijo povečajo učinke nekaterih mišičnih relaksantov.
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).
Slovenian: Zdravilo Prometax bi lahko vplivalo na zdravljenje z antiholinergičnimi zdravili (zdravili, ki se uporabljajo za lajšanje želodčnih krčev ali spazmov, za zdravljenje Parkinsonove bolezni ali za preprečevanje slabosti na potovanju).
English: • Allergic reaction where the patch was used, such as blisters or inflamed skin
Slovenian: • alergijske reakcije na mestu uporabe obliža, kot je pojav mehurjev ali vnete kože
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.
Slovenian: Večina primerov nenamernega prevelikega odmerjanja ni bila povezana z nikakršnimi kliničnimi znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminom 24 ur po prevelikem odmerjanju.
English: In double-blind controlled clinical trials, application site reactions were mostly mild to moderate in severity.
Slovenian: V dvojno slepih kontroliranih kliničnih študijah so bile reakcije na mestu aplikacije večinoma le blago do zmerno izražene.
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochrome isoenzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Slovenian: Po podatkih raziskav in vitro ni pričakovati farmakokinetičnih interakcij z zdravili, ki jih presnavljajo naslednji izoencimi s citokromi: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 in CYP2B6.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Prometax za vse podskupine pediatrične populacije glede zdravljenja Alzheimerjeve demence (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Slovenian: • Preden namestite obliž, se prepričajte, da je izbrani predel kože čist, suh in neporaščen, da na izbranem predelu kože ni pudra, olja, vlažilne kreme ali losjona, ki bi lahko preprečili, da se obliž pravilno prilepi na kožo, in da na izbranem predelu kože ni ureznin, izpuščajev ter da izbrani predel kože ni nadražen.
English: • Do not use any patch that is damaged or shows signs of tampering.
Slovenian: • Ne uporabljajte obliža, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: For patients starting treatment for the first time and for patients restarting Prometax after treatment interruption, please begin with the second picture.
Slovenian: Bolniki, ki si prvič nameščate obliž ali ponovno začenjate z uporabo zdravila Prometax po prekinitvi zdravljenja, lahko začnete z naslednjim korakom.
English: As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
Slovenian: Ker ima rivastigmin plazemski razpolovni čas okrog 1 ure in traja njegovo zaviranje acetilholinesteraze okrog 9 ur, priporočamo, da v primeru asimptomatičnega prevelikega odmerka bolnik v naslednjih 24 urah ne prejme nadaljnjih odmerkov rivastigmina.
English: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers.
Slovenian: Vsak transdermalni obliž je tanek transdermalni obliž z matriks sistemom, sestavljen iz treh plasti.
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.
Slovenian: Večina primerov nenamernega prevelikega odmerjanja peroralnega rivastigmina ni bila povezana z nikakršnimi kliničnimi znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminom 24 ur po prevelikem odmerjanju.
English: • The Summary of Product Characteristics
Slovenian: • Povzetek glavnih značilnosti zdravila,
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).
Slovenian: • Bolniki s telesno maso manjšo od 50 kg: Pri bolnikih s telesno maso manjšo od 50 kg je pri zviševanju odmerka nad priporočeni učinkoviti odmerek 9,5 mg/24 h potrebna posebna previdnost (glejte poglavje 4.4).
English: This may indicate a potential for Prometax transdermal patches to induce mild erythema in patients.
Slovenian: To lahko nakazuje možnost, da bi transdermalni obliži Prometax sprožili nastanek blage rdečine pri bolnikih.
English: • Chest pain - this may be caused by heart spasm
Slovenian: • bolečina v prsih - lahko zaradi krča žil okrog srca
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Prometax za vse podskupine pediatrične populacije glede zdravljenja Alzheimerjeve demence in zdravljenja demence pri bolnikih z idiopatsko Parkinsonovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Magnesium stearate Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Shellac
Slovenian: 6.1 Seznam pomožnih snovi želatina magnezijev stearat hipromeloza mikrokristalna celuloza brezvoden koloidni silicijev dioksid rumeni železov oksid (E172) rdeči železov oksid (E172) titanov dioksid (E171) šelak
English: • To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Slovenian: • Da bi vam zdravljenje koristilo, morate obliž zamenjati vsak dan, če se le da vsak dan ob istem času.
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.
Slovenian: V preglednici 1 so navedeni neželeni učinki o katerih so poročali pri 1.670 bolnikih z Alzheimerjevo demenco, zdravljenih v okviru randomiziranih dvojno slepih, s placebom in aktivno kontroliranih kliničnih študij s transdermalnimi obliži Prometax, ki so trajale od 24 do 48 tednov, in neželeni učinki po podatkih iz obdobja trženja zdravila.
English: - A protective liner covers the sticky side of the patch.
Slovenian: Lepljivo stran obliža pokriva zaščitna plast.
English: The 24-week results for the three assessment tools are summarised in Table 2.
Slovenian: 24-tedenski rezultati teh treh metod ocenjevanja so zbrani v preglednici 2.
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.
Slovenian: Sočasna uporaba rivastigmina s katerim od pogosto predpisanih zdravil, kot so antacidi, antiemetiki, antidiabetiki, antihipertenzivi z osrednjim delovanjem, zaviralci kalcijevih kanalčkov, inotropne učinkovine, antianginiki, nesteroidne protivnetne učinkovine, estrogeni, analgetiki, benzodiazepini in antihistaminiki, ni bila povezana s spremembami kinetike rivastigmina ali s povečanim tveganjem za klinično pomembne neželene učinke.