FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjusted treatment difference p-value versus placebo
Slovenian: Prilagojena razlika v zdravljenju vrednost p v primerjavi s placebom
English: You may have side effects more often when you start your medicine or when your dose is increased.
Slovenian: Neželeni učinki bodo morda pogostejši ob začetku zdravljenja in ob zviševanju odmerka.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnost je definirana s pomočjo naslednjega dogovora: zelo pogosti (> 1/10); pogosti (> 1/100 do < 1/10); občasni (> 1/1000 do < 1/100); redki (> 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: - 28, 56 or 112 capsules in transparent PVC/Alu push through blisters
Slovenian: - 28, 50, 56 ali 112 kapsul v prosojnem pretisnem omotu iz PVC/Alu.
English: Taking this medicine
Slovenian: Kako jemati to zdravilo
English: Capsule contents - microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate.
Slovenian: Pomožne snovi so: vsebina kapsule - mikrokristalna celuloza, hipromeloza, koloidni silicijev dioksid, magnezijev stearat.
English: The PSUR submission schedule for Rivastigmine TEVA hard capsules should follow PSURs submission schedule for the reference medicinal product.
Slovenian: Načrt oddajanja PSUR-ov mora biti usklajen z načrtom oddajanja PSUR-ov za referenčno zdravilo.
English: Bottles 250 hard capsules
Slovenian: Steklenice 250 trdih kapsul
English: Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Slovenian: Holinomimetiki lahko sprožijo ali poslabšajo obstrukcijo sečil in epileptične napade.
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: 9 ur, zato je pri asimptomatičnem prevelikem odmerjanju priporočljivo naslednjih 24 ur prekiniti dajanje dodatnih odmerkov rivastigmina.
English: Metabolism and nutrition disorders Very common
Slovenian: Presnovne in prehranske motnje Zelo pogosti
English: If you have to undergo surgery whilst taking Rivastigmine Teva, tell your doctor before you are given any anaesthetics, because Rivastigmine Teva may exaggerate the effects of some muscle relaxants during anaesthesia.
Slovenian: preden vam dajo kakršenkoli anestetik, ker lahko zdravilo Rivastigmine Teva okrepi učinke nekaterih mišičnih relaksantov med anestezijo.
English: Pallagi út 13
Slovenian: Swensweg 5
English: Mean change at 24 weeks ± SD
Slovenian: Povprečna sprememba po 24
English: Sick sinus syndrome
Slovenian: Bolezen sinusnega vozla
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Slovenian: V tabeli 1 spodaj so prikazani neželeni učinki, ki so jih zbrali pri bolnikih z Alzheimerjevo demenco, ki so jemali rivastigmin.
English: Initial dose: 1.5 mg twice a day.
Slovenian: Začetni odmerek: 1,5 mg dvakrat na dan.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V.
English: Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Slovenian: Z izgubo telesne mase pri teh bolnikih so povezani zaviralci holinesteraze, vključno z rivastigminom.
English: No dose adjustment is necessary for patientS with mild to moderate renal or hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic ali jeter ni potrebno prilagajati odmerjanja.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Alzheimerjeva bolezen lahko postopno zmanjša sposobnost vožnje ali poslabša zmožnost upravljanja s stroji.
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Slovenian: Nekateri primeri hudega bruhanja so bili povezani z rupturo ezofagusa (glejte poglavje 4.8).
English: - if you have, or have ever had, asthma or severe respiratory disease.
Slovenian: - če imate ali ste kadarkoli imeli težave z uriniranjem, - če imate ali ste kadarkoli imeli epileptične napade, - če imate ali ste kadarkoli imeli astmo ali hudo bolezen dihal,
English: Iron oxide black
Slovenian: črni železov oksid amonijev hidroksid
English: You may become dehydrated (losing too much fluid) if vomiting or diarhoea are prolonged.
Slovenian: Če bruhanje ali driska trajata dolgo, lahko postanete dehidrirani (izgubite preveč tekočine).
English: Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson's disease (see section 4.8).
Slovenian: Pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, so opazili poslabšanje (vključno z bradikinezijo, diskinezijo in motnjami hoje) in povečano pogostnost ali stopnjo tremorja (glejte poglavje 4.8).
English: Table 6
Slovenian: Tabela 6
English: Ink used for imprinting - Black S-1-17822/S-1-17823 Shellac glaze-45%
Slovenian: Ovoj kapsule: titanov dioksid (E 171) želatina črnilo za tisk - črno S-1-17822/S-1-17823: glazura iz šelaka - 45 %
English: Table 2
Slovenian: Tabela 2
English: - if you have, or have ever had, an active stomach ulcer.
Slovenian: - če imate ali ste kadarkoli imeli aktivno razjedo na želodcu,
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide Magnesium stearate
Slovenian: mikrokristalna celuloza hipromeloza koloidni silicijev dioksid magnezijev stearat
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Slovenian: Kot zaviralec holinesteraze lahko rivastigmin poslabša učinke sukcinilholinskih mišičnih relaksantov med anestezijo.
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Slovenian: Nekateri primeri hudega bruhanja so bili povezani z rupturo ezofagusa (glejte poglavje 4,4).
English: Swallow the capsules whole with a drink.
Slovenian: • Kapsule pogoltnite cele z nekaj tekočine.
English: Dose titration:
Slovenian: Titracija odmerkov:
English: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Slovenian: Bolnikom z astmo ali obstrukcijsko pljučno boleznijo v anamnezi je treba zaviralce holinesteraze predpisovati previdno.
English: Movement disorder Bradykinesia
Slovenian: Diskinezija Parkinsonizem Hipokinezija Motnje gibanja Bradikinezija Distonija Motnje pri hoji
English: Rivastigmine Teva 1.5 mg hard capsules contains 1.5 mg rivastigmine as rivastigmine hydrogen tartrate
Slovenian: Zdravilo Rivastigmine Teva 1.5 mg trde kapsule vsebuje 1,5 mg rivastigmina v obliki rivastigminhidrogentartrata.
English: They also have some additional side effects:
Slovenian: Pri teh bolnikih so nekateri neželeni učinki bolj pogosti, poleg tega pa se pri njih pojavljajo nekateri dodatni neželeni učinki:
English: Table 3
Slovenian: Tabela 3
English: - If you have gastrointestinal reactions such as feeling sick (nausea) and being sick (vomiting) and diarrhoea.
Slovenian: - če imate prebavne težave, kot so slabost s siljenjem na bruhanje (navzea), bruhanje in driska.
English: Fatigue and asthenia
Slovenian: Utrujenost in astenija
English: Abdominal pain and dyspesia
Slovenian: Bolečine v trebuhu in dispepsija
English: - HDPE tablet container with a polypropylene cap and induction seal: 250 capsules
Slovenian: - Plastenka iz HDPE s polipropilenskim pokrovčkom in indukcijsko zatesnjenim vsebnikom:
English: • Feeling agitated
Slovenian: • občutek nemira
English: - Rivastigmine Teva 1.5 mg hard capsules: White cap imprinted with “R” & white body
Slovenian: - Rivastigmine Teva 1,5 mg trde kapsule: bela kapa z natisnjenim napisom »R« in belo telo z natisnjenim napisom »1.5«.
English: Hard capsule Orange colour cap imprinted with “R” & orange color body imprinted with “4.5”
Slovenian: Trda kapsula Kapa oranžne barve z natisnjenim napisom »R« in telo oranžne barve z natisnjenim napisom »4,5«.
English: Not applicable.
Slovenian: ni na voljo ni na voljo
English: Rivastigmine Teva 6 mg hard capsules contains 6 mg rivastigmine as rivastigmine hydrogen tartrate
Slovenian: Zdravilo Rivastigmine Teva 6 mg trde kapsule vsebuje 6 mg rivastigmina v obliki rivastigminhidrogentartrata.
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: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA
English: If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Slovenian: Če se pri bolnikih z demenco, povezano s Parkinsonovo boleznijo med zdravljenjem pojavijo neželeni učinki (npr. navzea, bruhanje, bolečine v trebuhu ali izguba apetita), če se zmanjša telesna masa ali če se poslabšajo ekstrapiramidni simptomi, (npr. tremor), bo morda treba izpustiti en ali več odmerkov.
English: If the dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Slovenian: Če po najmanj dveh tednih zdravljenja bolniki odmerek dobro prenašajo, se lahko poveča na 3 mg dvakrat na dan. Tudi nadaljnje povečanje odmerka na 4,5 mg in nato na
English: The use of this medicinal product is contraindicated in patients with - hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients
Slovenian: - s preobčutljivostjo za zdravilno učinkovino, druge derivate karbamata ali katero koli pomožno snov
English: Always take Rivastigmine Teva exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Rivastigmine Teva vedno upoštevajte zdravnikova navodila.
English: No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Slovenian: varfarinom, diazepamom ali fluoksetinom niso opazili.
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide
Slovenian: Vsebina kapsule: mikrokristalna celuloza hipromeloza koloidni silicijev dioksid magnezijev stearat
English: - If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva)
Slovenian: - če ste alergični (preobčutljivi) na rivastigmin (zdravilno učinkovino v zdravilu Rivastigmine Teva) ali katero koli sestavino zdravila Rivastigmin Teva, ki je navedena v poglavju 6 tega navodila za
English: Fall
Slovenian: Padci
English: Uncommon • Uneven heartbeat and poor control of movements
Slovenian: Občasni • nepravilen srčni utrip in motnje koordinacije gibov
English: TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő,
Slovenian: H-2100 Gödöllő,
English: Drugsales Ltd Tel: +356 21 419 070/1/2
Slovenian: Τel: +356 21 419 070/1/2
English: White cap imprinted with “R” & white body imprinted with “1.5”
Slovenian: Trda kapsula Bela kapa z natisnjenim napisom »R« in belo telo z natisnjenim napisom »1.5«.
English: • Fainting or accidentally falling
Slovenian: • omedlevica ali nezgodni padci • spremembe v delovanju jeter
English: Renal and hepatic impairment:
Slovenian: Ledvična in jetrna okvara:
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Slovenian: Povprečni dejanski dnevni odmerek med bolniki, ki so se po tej opredelitvi odzvali na zdravljenje, v skupini, ki je prejemala 6-12 mg, je bil 9,3 mg. Pomembno je vedeti, da se lestvice, ki se uporabljajo pri tej indikaciji, razlikujejo, in da neposredno primerjanje rezultatov pri različnih terapevtskih učinkovinah ni primerno.
English: - if you have, or have ever had, impaired liver function.
Slovenian: - če imate ali ste kadarkoli imeli okvarjeno delovanje ledvic,
English: HOW TO STORE RIVASTIGMINE TEVA
Slovenian: Kaj vsebuje zdravilo Rivastigmine Teva
English: The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Slovenian: vrednost AUC rivastigmina pa več kot dvakrat večja, kot pri zdravih osebah.
English: PSURs
Slovenian: PSURi
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.
Slovenian: 6 mg dvakrat na dan mora temeljiti na prenašanju trenutnega odmerka, poveča pa se lahko po najmanj dveh tednih zdravljenja s prejšnjim odmerkom.
English: Ink used for imprinting - Black S-1-17822/S-1-17823
Slovenian: rumeni železov oksid (E 172) titanov dioksid (E 171) želatina črnilo za tisk - črno S-1-17822/S-1-17823
English: Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Slovenian: Lečeči zdravnik mora zato rutinsko ocenjevati sposobnost bolnikov z demenco, ki jemljejo rivastigmin za vožnjo in upravljanje s stroji.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.. Rivastigmine Teva may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.If you feel dizzy or sleepy do not drive, use machines or perform any tasks that require your attention.
Slovenian: Zdravnik vam bo povedal, ali vam vaša bolezen dovoljuje, da varno upravljate vozila in uporabljate stroje.
English: Skin and subcutaneous tissue disorders Common
Slovenian: Bolezni kože in podkožja Pogosti
English: Elderly subjects:
Slovenian: Starejše osebe:
English: - if you have, or have ever had, irregular heartbeat.
Slovenian: - če imate ali ste kadarkoli imeli nereden srčni utrip,
English: or to any of the other ingredients of Rivastigmine Teva listed in section 6 of this leaflet - If this applies to you, tell your doctor and do not take Rivastigmine Teva.
Slovenian: - Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne jemljite zdravila Rivastigmine
English: ITT + RDO population
Slovenian: Populacija ITT + RDO (n = 329)
English: Cardiac disorders Common
Slovenian: Občasni Srčne bolezni
English: General disorders and administration site conditions Common
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti
English: please tell your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: Mean baseline ± SD
Slovenian: Malta Drugsales Ltd
English: Hard capsule Orange cap imprinted with “R” & flesh color body imprinted with “6”
Slovenian: Trda kapsula Kapa oranžne barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »6«.
English: Rash
Slovenian: ŠS
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Slovenian: 5.3 Predklinični podatki o varnosti Študije toksičnosti pri ponavljajočih se odmerkih pri podganah, miših in psih so pokazale samo učinke,
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 1.5 mg hard capsules
Slovenian: IME ZDRAVILA Rivastigmine Teva 1,5 mg trde kapsule
English: Rivastigmine Teva 1.5 mg hard capsules
Slovenian: Rivastigmine Teva 1,5 mg trde kapsule rivastigmin
English: Vascular Disorders Very rare
Slovenian: Infekcijske in parazitske bolezni Zelo redki
English: Rivastigmine Teva 4.5 mg hard capsules
Slovenian: Rivastigmine Teva 4,5 mg trde kapsule rivastigmin
English: Table 2 shows the adverse reactions reported in patients with dementia associated with Parkison's disease treated with rivastigmine.
Slovenian: V tabeli 2 so prikazani neželeni učinki, o katerih so poročali pri bolnikih z demenco, povezano s
English: • Severe confusion
Slovenian: • hujšanje
English: Fits (seizures)
Slovenian: • napadi krčev (epileptični napadi)
English: BATCH NUMBER BN
Slovenian: ŠTEVILKA SERIJE ŠS
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 4.5 mg hard capsules Rivastigmine
Slovenian: IME ZDRAVILA Rivastigmine Teva 4,5 mg trde kapsule
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 6 mg hard capsules Rivastigmine
Slovenian: IME ZDRAVILA Rivastigmine Teva 6 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 3 mg hard capsules Rivastigmine
Slovenian: IME ZDRAVILA Rivastigmine Teva 3 mg trde kapsule
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg
Slovenian: Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 4,5 mg rivastigmina.
English: - Rivastigmine Teva 4.5 mg hard capsules: Orange colour cap imprinted with “R” & orange
Slovenian: - Rivastigmine Teva 4,5 mg trde kapsule: kapa oranžne barve z natisnjenim napisom »R« in telo oranžne barve z natisnjenim napisom »4,5«.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 6 mg hard capsules
Slovenian: Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 6 mg trde kapsule
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet Container - Self-adhesive, paper label - Rivastigmine Teva 4.5 mg hard capsules
Slovenian: Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 4,5 mg trde kapsule
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 1.5 mg hard capsules
Slovenian: Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 1,5 mg trde kapsule
English: BN
Slovenian: V
English: Gastrointestinal disorders Very common Very common Very common Common
Slovenian: Žilne bolezni Zelo redki Bolezni prebavil Zelo pogosti Zelo pogosti Zelo pogosti Pogosti
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 3 mg hard capsules
Slovenian: Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 3 mg trde kapsule
English: Not known • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with
Slovenian: • močno bruhanje, ki lahko povzroči raztrganje požiralnika (cevi med usti in želodcem)
English: Weight loss
Slovenian: Izguba telesne mase
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg
Slovenian: Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 1,5 mg rivastigmina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 6 mg hard capsules
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 6 mg trde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 1.5 mg hard capsules
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 1,5 mg trde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 3 mg hard capsules
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 3 mg trde kapsule
English: - Rivastigmine Teva 6 mg hard capsules: Orange cap imprinted with “R” & flesh colour body
Slovenian: - Rivastigmine Teva 6 mg trde kapsule: kapa oranžne barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »6«.
English: WHAT RIVASTIGMINE TEVA IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Teva is rivastigmine Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Slovenian: Rivastigmin sodi v skupino učinkovin, ki jih imenujemo zaviralci holinesteraze.
English: Tell your doctor if you become pregnant during treatment.
Slovenian: Če zanosite v času zdravljenja, obvestite svojega zdravnika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg
Slovenian: Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 6 mg rivastigmina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 4.5 mg hard capsules
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 4,5 mg trde kapsule
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg
Slovenian: Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 3 mg rivastigmina.
English: To be swallowed whole without crushing or opening Read the package leaflet before use.
Slovenian: Kapsule je treba pogoltniti cele, brez drobljenja ali odpiranja.
English: Pruritus
Slovenian: Presnova
English: Rivastigmine 6-12 mg N=473
Slovenian: Rivastigmin 6-12 mg
English: Magnesium stearate
Slovenian: Prekomerno izločanje sline
English: Adjusted treatment difference n/a p-value versus placebo ITT - LOCF population (n=287)
Slovenian: Populacija ITT + RDO (n = 87)
English: - Rivastigmine Teva 3 mg hard capsules: Flesh colour cap imprinted with “R” & flesh colour
Slovenian: - Rivastigmine Teva 3 mg trde kapsule: kapa svetlo rjave barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »3«.
English: Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Slovenian: Parkinsonova bolezen (poslabšanje)
English: Gastrointestinal disorders Very common Very common Common
Slovenian: Pogostnost nezanana Bolezni prebavil Zelo pogosti Zelo pogosti Pogosti
English: To be swallowed whole without crushing or opening Read the package leaflet before use
Slovenian: Če ste omotični ali zaspani, ne vozite, ne uporabljajte strojev in ne izvajajte opravil, ki zahtevajo zbranost.
English: This dose may also be adjusted.
Slovenian: Ta odmerek se lahko tudi prilagodi.
English: It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).
Slovenian: Na voljo je v obliki kapsul (12,5 mg, 25 mg, 37,5 mg in 50 mg).
English: What measures are being taken to ensure the safe and effective use of Sutent?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sutent?
English: This was switched to a full marketing authorisation on 11 January 2007.
Slovenian: To je bilo 11. januarja 2007 spremenjeno v običajno dovoljenje za promet.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent on 19 July 2006.
Slovenian: Evropska komisija je pogojno dovoljenje za promet z zdravilom, veljavno po vsej Evropski uniji, izdala 19. julija 2006.
English: This means that it blocks some specific enzymes known as protein kinases.
Slovenian: To pomeni, da zavira določene encime, imenovane proteinske kinaze.
English: The full EPAR for Sutent can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sutent je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Sutent
Slovenian: Druge informacije o zdravilu Sutent
English: What benefit has Sutent shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sutent izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Sutent.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sutent.